78 FR 4725 - Escrow Requirements Under the Truth in Lending Act (Regulation Z)

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-22

...The Bureau of Consumer Financial Protection (Bureau) is publishing a final rule that amends Regulation Z (Truth in Lending) to implement certain amendments to the Truth in Lending Act made by the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act). Regulation Z currently requires creditors to establish escrow accounts for higher-priced mortgage loans secured by a first lien on a principal dwelling. The rule implements statutory changes made by the Dodd-Frank Act that lengthen the time for which a mandatory escrow account established for a higher-priced mortgage loan must be maintained. The rule also exempts certain transactions from the statute's escrow requirement. The primary exemption applies to mortgage transactions extended by creditors that operate predominantly in rural or underserved areas, originate a limited number of first-lien covered transactions, have assets below a certain threshold, and do not maintain escrow accounts on mortgage obligations they currently service.

Complying with the Drug-Free Schools and Campuses Regulations (34 CFR Part 86). A Guide for University and College Administrators.

ERIC Educational Resources Information Center

Pittayathikhun, Tanutda; Ku, Richard; Rigby, Donna; Mattsson, Marilyn; DeJong, William

This document describes ways in which higher education institutions have responded to the requirements of the 1989 amendments to the Drug-Free Schools and Campuses Act, Part 86, Regulations, and is intended to help institutions improve current programs and avoid overlooking requirements that might result in noncompliance. Chapter 1 presents the…

Transient Performance Improvement Circuit (TPIC)s for DC-DC converter applications

NASA Astrophysics Data System (ADS)

Lim, Sungkeun

Gordon Moore famously predicted the exponential increase in transistor integration and computing power that has been witnessed in recent decades [1]. In the near future, it is expected that more than one billion transistors will be integrated per chip, and advanced microprocessors will require clock speeds in excess of several GHz. The increasing number of transistors and high clock speeds will necessitate the consumption of more power. By 2014, it is expected that the maximum power consumption of the microprocessor will reach approximately 150W, and the maximum load current will be around 150A. Today's trend in power and thermal management is to reduce supply voltage as low as possible to reduce delivered power. It is anticipated that the Intel cores will operate on 0.8V of supply voltage by 2014 [2]. A significant challenge in Voltage Regulator Module (VRM) development for next generation microprocessors is to regulate the supply voltage within a certain tolerance band during high slew rate load transitions, since the required supply voltage tolerance band will be much narrower than the current requirement. If VR output impedance is maintained at a constant value from DC to high frequency, large output voltage spikes can be avoided during load cur- rent transients. Based on this, the Adaptive Voltage Position (AVP) concept was developed to achieve constant VR output impedance to improve transient response performance [3]. However, the VR output impedance can not be made constant over the entire frequency range with AVP design, because the AVP design makes the VR output impedance constant only at low frequencies. To make the output impedance constant at high frequencies, many bulk capacitors and ceramic capacitors are required. The tight supply voltage tolerance for the next generation of microprocessors during high slew rate load transitions requires fast transient response power supplies. A VRM can not follow the high slew rate load current transients, because of the slow inductor current slew rate which is determined by the input voltage, output voltage, and the inductance. The remaining inductor current in the power delivery path will charge the output capacitors and develop a voltage across the ESR. As a result, large output voltage spikes occur during load current transients. Due to their limited control bandwidth, traditional VRs can not sufficiently respond rapidly to certain load transients. As a result, a large output voltage spike can occur during load transients, hence requiring a large amount of bulk capacitance to decouple the VR from the load [2]. If the remaining inductor current is removed from the power stage or the inductor current slew rate is changed, the output voltage spikes can be clamped, allowing the output capacitance to be reduced. A new design methodology for a Transient Performance Improvement Circuit(TPIC) based on controlling the output impedance of a regulator is presented. The TPIC works in parallel with a voltage regulator (VR)'s ceramic capacitors to achieve faster voltage regulation without the need for a large bulk capacitance, and can serve as a replacement for bulk capacitors. The specific function of the TPIC is to mimic the behavior of the bulk capacitance in a traditional VRM by sinking and sourcing large currents during transients, allowing the VR to respond quickly to current transients without the need for a large bulk capacitance. This will allow fast transient response without the need for a large bulk capacitor. The main challenge in applying the TPIC is creating a design which will not interfere with VR operation. A TPIC for a 4 Switch Buck-Boost (4SBB) converter is presented which functions by con- trolling the inductor current slew rate during load current transients. By increasing the inductor current slew rate, the remaining inductor current can be removed from the 4SBB power delivery path and the output voltage spike can be clamped. A second TPIC is presented which is designed to improve the performance of an LDO regulator during output current transients. A TPIC for a LDO regulator is proposed to reduce the over voltage spike settling time. During a load current step down transient, the only current discharging path is a light load current. However, it takes a long time to discharge the current charged in the output capacitors with the light load current. The proposed TPIC will make an additional current discharging path to reduce the long settling time. By reducing the settling time, the load current transient frequency of the LDO regulator can be increased. A Ripple Cancellation Circuit (RCC) is proposed to reduce the output voltage ripple. The RCC has a very similar concept with the TPIC which is sinking or injecting additional current to the power stage to compensate the inductor ripple current. The proposed TPICs and RCC have been implemented with a 0.6m CMOS process. A single-phase VR, a 4SBB converter, and a LDO regulator have been utilized with the proposed TPIC to evaluate its performance. The theoretical analysis will be confirmed by Cadence simulation results and experimental results.

ANALYZING BIOSOLIDS FOR FECAL COLIFORM AND SALMONELLAE

EPA Science Inventory

Current federal regulations required monitoring for fecal coliforms or Salmonella in biosolids destined for land application. Standard protocols designed to quantify these organisms in water or wastewater were identified and specified in these regulations. However, proto...

78 FR 25818 - Truth in Lending (Regulation Z)

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-03

...The Bureau of Consumer Financial Protection (Bureau) issues this final rule to amend Regulation Z, which implements the Truth in Lending Act (TILA), and the official interpretations to the regulation. Regulation Z generally prohibits a card issuer from opening a credit card account for a consumer, or increasing the credit limit applicable to a credit card account, unless the card issuer considers the consumer's ability to make the required payments under the terms of such account. Regulation Z currently requires that issuers consider the consumer's independent ability to pay, regardless of the consumer's age; in contrast, TILA expressly requires consideration of an independent ability to pay only for applicants who are under the age of 21. The final rule amends Regulation Z to remove the requirement that issuers consider the consumer's independent ability to pay for applicants who are 21 or older, and permits issuers to consider income and assets to which such consumers have a reasonable expectation of access.

78 FR 79650 - Definitions and Reporting Requirements for Shareholders of Passive Foreign Investment Companies

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-31

...In the Rules and Regulations section of this issue of the Federal Register, the IRS and the Department of the Treasury (Treasury Department) are issuing temporary regulations that provide guidance on determining the ownership of a passive foreign investment company (PFIC), the annual filing requirements for shareholders of PFICs, and an exclusion from certain filing requirement for shareholders that constructively own interests in certain foreign corporations. The temporary regulations primarily affect shareholders of PFICs that do not currently file Form 8621, ``Information Return by a Shareholder of a Passive Foreign Investment Company or Qualified Electing Fund'', with respect to their PFIC interests. The temporary regulations also affect certain shareholders that rely on a constructive ownership exception to the requirement to file Form 5471, ``Information Return of U.S. Persons with Respect to Certain Foreign Corporations.'' The text of those temporary regulations published in this issue of the Federal Register also serves as the text of these proposed regulations.

Current and Proposed Regulations Related to Minimum Risk Pesticides

EPA Pesticide Factsheets

Minimum risk pesticides are exempted from requirements for registration with EPA but are still subject to certain criteria to qualify as minimum risk and may be further regulated by states. See links to the key regulatory citations.

75 FR 79763 - Regulatory Agenda

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-20

... Current Food Good Manufacturing Practices Regulation 0910-AG36 Food and Drug Administration--Completed... Sequence Title Identifier Number Number 310 Quality Assurance Requirements for Respirators 0920-AA04 Food and Drug Administration--Prerule Stage Regulation Sequence Title Identifier Number Number 311 Food...

Design of a quasi-CW laser diode driver for space-based laser transmitter

NASA Astrophysics Data System (ADS)

Singh, Ravindra; Dangwal, Nishma; Chandraprakash, .; Agrawal, Lalita; Pal, Suranjan; Kamlakar, J. A.

2006-12-01

LASTEC Delhi in a joint collaborative activity with LEOS, Bangalore is developing a space qualified diode array pumped Nd:YAG laser transmitter delivering 30 mJ @ 10 pps of 10 ns duration. For space applications laser diodes are preferred because of their excellent reliability with lifetimes exceeding 100,000 hours. However, they are extremely sensitive to electro-static discharge, excessive current levels, and current spikes and transients. Small variations in bias voltage may produce large fluctuations in the current causing instability and damage to the device. Hence instead of the traditional power supplies a current controlled laser diode driver is required. This paper presents the design of a Q-CW laser diode driver based on closed loop current regulator, capable of driving 24 QCW laser diode bars each with 75W peak power at 70 A. The driver can generate up to 100 Amp peak current and 200μsec pulse width operating at 10 Hz. The current source design includes special circuits for low noise operation, slow turn-on and turn-off, circuits for over voltage and transient current protection; and good regulation. Space qualified and radiation hardened components are required to be used to sustain stringent space environment requirements during mission life of two years.

75 FR 44842 - Proposed Collection; Comment Request for Regulation Project

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-29

... necessary to ensure compliance with tax law requirements relating to loans and hardship distributions from... Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning final regulation, REG-155608-02, Revised Regulations Concerning Section 403(b) Tax...

76 FR 10205 - Department of Homeland Security Implementation of OMB Guidance on Drug-Free Workplace Requirements

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-24

... Guidance on Drug-Free Workplace Requirements AGENCY: Department of Homeland Security (DHS). ACTION: Final... consolidate all Federal regulations on drug-free workplace requirements for financial assistance into one...-wide common rule on drug-free workplace requirements for financial assistance, currently located within...

21 CFR 4.4 - How can I comply with these current good manufacturing practice requirements for a co-packaged or...

Code of Federal Regulations, 2014 CFR

2014-04-01

... practice operating system in accordance with paragraph (b) of this section, the following requirements..., and the current good manufacturing practice operating system has been shown to comply with the drug... operating system has been shown to comply with the QS regulation, the following provisions of the drug CGMPs...

21 CFR 4.4 - How can I comply with these current good manufacturing practice requirements for a co-packaged or...

Code of Federal Regulations, 2013 CFR

2013-04-01

... practice operating system in accordance with paragraph (b) of this section, the following requirements..., and the current good manufacturing practice operating system has been shown to comply with the drug... operating system has been shown to comply with the QS regulation, the following provisions of the drug CGMPs...

Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements. Final rule.

PubMed

2016-11-18

The Food and Drug Administration (FDA or the Agency) is amending its current good manufacturing practice (CGMP) and labeling regulations regarding medical gases. FDA is requiring that portable cryogenic medical gas containers not manufactured with permanent gas use outlet connections have gas-specific use outlet connections that cannot be readily removed or replaced except by the manufacturer. FDA is also requiring that portable cryogenic medical gas containers and high-pressure medical gas cylinders meet certain labeling, naming, and color requirements. These requirements are intended to increase the likelihood that the contents of medical gas containers are accurately identified and reduce the likelihood of the wrong gas being connected to a gas supply system or container. FDA is also revising an existing regulation that conditionally exempts certain medical gases from certain otherwise-applicable labeling requirements in order to add oxygen and nitrogen to the list of gases subject to the exemption, and to remove cyclopropane and ethylene from the list.

An Incubatable Direct Current Stimulation System for In Vitro Studies of Mammalian Cells

PubMed Central

Panitch, Alyssa; Caplan, Michael; Sweeney, James D.

2012-01-01

Abstract The purpose of this study was to provide a simplified alternative technology and format for direct current stimulation of mammalian cells. An incubatable reusable stimulator was developed that effectively delivers a regulated current and does not require constant monitoring. PMID:23514694

Caffeine Content Labeling: A Missed Opportunity for Promoting Personal and Public Health

PubMed Central

Kole, Jon

2013-01-01

Current regulation of caffeine-containing products is incoherent, fails to protect consumers' interests, and should be modified in multiple ways. We make the case for one of the regulatory reforms that are needed: all consumable products containing added caffeine should be required by the Food and Drug Administration (FDA) to include caffeine quantity on their labels. Currently, no foods or beverages that contain caffeine are required to include caffeine content on their labels. Strengthening these lax labeling requirements could prevent direct caffeine-induced harm, protect those most vulnerable to caffeine-related side effects, and enhance consumer autonomy and effective caffeine use. Consumers have an interest in regulating their intake of caffeine and thus, ought to know how much caffeine their foods and beverages contain. PMID:24761278

7 CFR 735.403 - Audits.

Code of Federal Regulations, 2011 CFR

2011-01-01

... REGULATIONS FOR WAREHOUSES REGULATIONS FOR THE UNITED STATES WAREHOUSE ACT Electronic Providers § 735.403... electronic data processing audit that meets the minimum requirements as provided in the applicable provider agreement. The electronic data processing audit will be used by DACO to evaluate current computer operations...

7 CFR 735.403 - Audits.

Code of Federal Regulations, 2010 CFR

2010-01-01

... REGULATIONS FOR WAREHOUSES REGULATIONS FOR THE UNITED STATES WAREHOUSE ACT Electronic Providers § 735.403... electronic data processing audit that meets the minimum requirements as provided in the applicable provider agreement. The electronic data processing audit will be used by DACO to evaluate current computer operations...

28 CFR Appendix A to Part 35 - Preamble to Regulation on Nondiscrimination on the Basis of Disability in State and Local...

Code of Federal Regulations, 2010 CFR

2010-07-01

... regulations for federally assisted and federally conducted programs, that a public entity evaluate its current... requirement to the rule, it would be appropriate for public entities to evaluate training efforts because, in...

Overload protection for switching regulators

NASA Technical Reports Server (NTRS)

Lachochi, E.

1980-01-01

Circuit protects all output lines of switching regulator against overloads without requiring current sensors on every line. If overload is sensed, device short circuits bias on switching transistor so that power is rapidly cut off from loads. Circuit also includes delay network to inhibit erroneous operation during startup.

EVALUATION OF BIOSOLID SAMPLE PROCESSING TECHNIQUES TO MAXIMIZE RECOVERY OF BACTERIA

EPA Science Inventory

Current federal regulations (40 CFR 503) require enumeration of fecal coliform or Salmoella prior to land application of Class A biosolids. This regulation specifies use of enumeration methods included in "Standard Methods for the Examination of Water and Wastewater 18th Edition,...

49 CFR 537.5 - General requirements for reports.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 537.5 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL HIGHWAY TRAFFIC... requirements for reports. (a) For each current model year, each manufacturer shall submit a pre-model year report, a mid-model year report, and, as required by § 537.8, supplementary reports. (b)(1) The pre-model...

EU Regulation of Nanobiocides: Challenges in Implementing the Biocidal Product Regulation (BPR)

PubMed Central

Brinch, Anna; Hansen, Steffen Foss; Hartmann, Nanna B.; Baun, Anders

2016-01-01

The Biocidal Products Regulation (BPR) contains several provisions for nanomaterials (NMs) and is the first regulation in the European Union to require specific testing and risk assessment for the NM form of a biocidal substance as a part of the information requirements. Ecotoxicological data are one of the pillars of the information requirements in the BPR, but there are currently no standard test guidelines for the ecotoxicity testing of NMs. The overall objective of this work was to investigate the implications of the introduction of nano-specific testing requirements in the BPR and to explore how these might be fulfilled in the case of copper oxide nanoparticles. While there is information and data available in the open literature that could be used to fulfill the BPR information requirements, most of the studies do not take the Organisation for Economic Co-operation and Development’s nanospecific test guidelines into consideration. This makes it difficult for companies as well as regulators to fulfill the BPR information requirements for nanomaterials. In order to enable a nanospecific risk assessment, best practices need to be developed regarding stock suspension preparation and characterization, exposure suspensions preparation, and for conducting ecotoxicological test. PMID:28344290

EU Regulation of Nanobiocides: Challenges in Implementing the Biocidal Product Regulation (BPR).

PubMed

Brinch, Anna; Hansen, Steffen Foss; Hartmann, Nanna B; Baun, Anders

2016-02-16

The Biocidal Products Regulation (BPR) contains several provisions for nanomaterials (NMs) and is the first regulation in the European Union to require specific testing and risk assessment for the NM form of a biocidal substance as a part of the information requirements. Ecotoxicological data are one of the pillars of the information requirements in the BPR, but there are currently no standard test guidelines for the ecotoxicity testing of NMs. The overall objective of this work was to investigate the implications of the introduction of nano-specific testing requirements in the BPR and to explore how these might be fulfilled in the case of copper oxide nanoparticles. While there is information and data available in the open literature that could be used to fulfill the BPR information requirements, most of the studies do not take the Organisation for Economic Co-operation and Development's nanospecific test guidelines into consideration. This makes it difficult for companies as well as regulators to fulfill the BPR information requirements for nanomaterials. In order to enable a nanospecific risk assessment, best practices need to be developed regarding stock suspension preparation and characterization, exposure suspensions preparation, and for conducting ecotoxicological test.

ASSESSING THE EFFECTS OF DICHLOROACETIC ACID (DCA) USING A MULTI-ENDPOINT MEDAKA ASSAY

EPA Science Inventory

In regulating the safety of water, EPA makes decisions on what chemical contaminants to regulate and at what levels. To make these decisions, the EPA needs hazard identification and dose-response information. Current rodent methods for generating required information have limita...

28 CFR Appendix B to Part 35 - Guidance on ADA Regulation on Nondiscrimination on the Basis of Disability in State and Local...

Code of Federal Regulations, 2011 CFR

2011-07-01

... regulations for federally assisted and federally conducted programs, that a public entity evaluate its current... requirement to the rule, it would be appropriate for public entities to evaluate training efforts because, in...

28 CFR Appendix B to Part 35 - Guidance on ADA Regulation on Nondiscrimination on the Basis of Disability in State and Local...

Code of Federal Regulations, 2014 CFR

2014-07-01

... regulations for federally assisted and federally conducted programs, that a public entity evaluate its current... requirement to the rule, it would be appropriate for public entities to evaluate training efforts because, in...

28 CFR Appendix B to Part 35 - Guidance on ADA Regulation on Nondiscrimination on the Basis of Disability in State and Local...

Code of Federal Regulations, 2012 CFR

2012-07-01

... regulations for federally assisted and federally conducted programs, that a public entity evaluate its current... requirement to the rule, it would be appropriate for public entities to evaluate training efforts because, in...

28 CFR Appendix B to Part 35 - Guidance on ADA Regulation on Nondiscrimination on the Basis of Disability in State and Local...

Code of Federal Regulations, 2013 CFR

2013-07-01

... regulations for federally assisted and federally conducted programs, that a public entity evaluate its current... requirement to the rule, it would be appropriate for public entities to evaluate training efforts because, in...

78 FR 46005 - NPDES Electronic Reporting Rule

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-30

... reports, and enforcement responses is provided (i.e., electronic rather than paper-based), it does not... is proposing a regulation that would require electronic reporting for current paper-based NPDES....regulations.gov Web site is an ``anonymous access'' system, which means EPA will not know your identity or...

USE OF A MOLECULAR PROBE ASSAY FOR MONITORING SALMONELLA SPP. IN BIOSOLIDS SAMPLES

EPA Science Inventory

Current federal regulations (40 CFR 503) require enumeration of fecal coliform or salmonellae prior to land application of biosolids. This regulation specifies use of enumeration methods included in "Standard methods for the Examination of Water and Wastewater 18th Edition," (SM)...

78 FR 64735 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-29

...The Food and Drug Administration (FDA) is proposing regulations for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish requirements for current good manufacturing practice in manufacturing, processing, packing, and holding of animal food. FDA also is proposing regulations to require that certain facilities establish and implement hazard analysis and risk-based preventive controls for food for animals. FDA is taking this action to provide greater assurance that animal food is safe and will not cause illness or injury to animals or humans and is intended to build an animal food safety system for the future that makes modern, science and risk-based preventive controls the norm across all sectors of the animal food system.

75 FR 13422 - Federal Acquisition Regulation; FAR Case 2008-015, Payments Under Fixed-Price Architect-Engineer...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-19

...-AL26 Federal Acquisition Regulation; FAR Case 2008-015, Payments Under Fixed-Price Architect-Engineer..., Payments Under Fixed-Price Architect-Engineer Contracts, currently requires contracting officers to... judgment regarding the amount of payment withheld to apply under fixed-price architect-engineer (A-E...

Student Health Insurance Program. Fall 1994.

ERIC Educational Resources Information Center

Massachusetts State Dept. of Medical Security, Boston.

This report contains data on current participation in and compliance with Massachusetts state regulations on health insurance coverage for college students. State regulations require that all full and three quarter time college students enrolled in the 121 public or independent institutions in the state participate in a qualifying student health…

77 FR 73967 - Drawbridge Operation Regulation; Bear Creek, Dundalk, MD

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-12

... owner displayed on the Wise Avenue Bridge signage that stated a 48-hour advance notice was required to open the draw bridge. This signage portrayed improper operational information since the current operation regulation had not changed. The Coast Guard determined the signage that stated a 48-hour advance...

76 FR 31271 - Public Meeting: Preliminary Regulatory Determinations for the Third Contaminant Candidate List...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-31

... Regulatory Determinations for the Third Contaminant Candidate List (CCL 3) AGENCY: Environmental Protection... require the EPA to determine every five years, whether to regulate at least five contaminants from the current Contaminant Candidate List (CCL) with a national primary drinking water regulation. The process of...

78 FR 45880 - Hazardous Materials: Approval and Communication Requirements for the Safe Transportation of Air...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-30

... Communication Requirements for the Safe Transportation of Air Bag Inflators, Air Bag Modules, and Seat-Belt... Materials Regulations applicable to air bag inflators, air bag modules, and seat-belt pretensioners. The... amending the current approval and documentation requirements for a material classified as a UN3268 air bag...

48 CFR 9904.412-40 - Fundamental requirement.

Code of Federal Regulations, 2010 CFR

2010-10-01

... in current and future cost accounting periods. (b) Measurement of pension cost. (1) For defined.... 9904.412-40 Section 9904.412-40 Federal Acquisition Regulations System COST ACCOUNTING STANDARDS BOARD... ACCOUNTING STANDARDS COST ACCOUNTING STANDARDS 9904.412-40 Fundamental requirement. (a) Components of pension...

Comparing airport licensing requirements : Alabama vs. selected states and the FAA

DOT National Transportation Integrated Search

2001-12-01

Many states in the United States of America have licensing requirements for their general use airports. The objective of this study was to determine if current Alabama's regulations for general use airports are timely and if they compare favorably wi...

Public health law for the collection and reporting of health care-associated infections.

PubMed

Meier, Benjamin Mason; Stone, Patricia W; Gebbie, Kristine M

2008-10-01

State-based laws for reporting of health care-associated infections (HAI) have developed and changed dramatically in recent years, affecting the costs of reporting and impact on infection rates. It is necessary for practitioners of infection control to understand these changing legal frameworks and their application to practice. Employing systematic state-based research, the researchers have documented legislation and administrative regulations for institution-specific HAI reporting, using this information to create a comprehensive resource on state-based laws for mandatory HAI reporting. As of August 27, 2007, 24 states have adopted laws requiring reporting of HAI rates, with an additional 7 states currently considering legislation that would require HAI reporting and 19 states employing detailed regulation in the absence of any current legislative authorization specific to HAI. This study documents (1) which states require reporting of HAI and, if so, whether this is done by legislation or administrative regulation; (2) whether the specific HAIs to be reported are identified in state law or codified generally as "diseases of public health importance," with reporting specified by administrative regulation; and (3) what reporting policies and procedures are detailed in law. Through analysis of the collected information, the researchers have examined the degree to which states have modernized their respective public health laws to approach mandatory reporting by way of general legislation regarding "matters of public health importance" and subsequent detailed administrative regulation to specify those matters.

Demand-side management: Why ratemaking should`nt control tax policy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Haney, J.D.

1995-01-01

As utilities spend money on demand-side management (DSM) programs, they usually deduct their costs currently as ordinary and necessary business expenses. However, state regulators may force deferral of DSM costs for ratemaking purposes, with possible consequences on tax returns. When regulators defer DSM costs, the Internal Revenue Service (IRS) has offered several theories to challenge current tax deductions. One theory requires capitilization instead of a current deduction if regulators include the DSM cost in rate base and provide for a rate of return on the balance. The IRS explained this theory two years ago in a White Paper on conservationmore » expenses: The direct relationship between a rate of return allowed by the Regulator for conservation expenditures allowed in rate base and future profits establishes a prima facie case for capitalization under the future benefit standard. The authors believe that IRS policy should not be linked to ratemaking decisions.« less

Maryland's efforts to develop regulations creating an air emissions offset trading program

DOE Office of Scientific and Technical Information (OSTI.GOV)

Guy, D.M.; Zaw-Mon, M.

1999-07-01

Under the federal Clean Air Act's New Source Review program, many companies located in or planning to locate in areas that do not meet federal air quality standards or in the Northeast Ozone Transport Region (northern Virginia to Maine) must obtain emission reductions (called offsets) of volatile organic compounds and nitrogen oxides that are greater than the new emissions that will be released. This offset requirement allows growth in industry while protecting air quality against deterioration. Despite the federal offset requirement, a formal banking and trading program is not mandated by the Clean Air Act Amendments of 1990. Still, amore » mechanism is needed to ensure that emission reduction credits (ERCs) are available for sources to use to meet the offset requirement. Currently, Maryland does not have regulations covering the sale or transfer of ERCs from one facility to another. Maryland works with industry on a case-by-case basis to identify potential sources of ERCs and to assist in obtaining them. Then, the offset requirement and the ERCs used to meet the offsets are incorporated into individual permits using various permitting mechanisms. Desiring certainty and stability in the banking and trading process, Maryland's business community has pressed for regulations to formalize Maryland's procedures. Working over several years through a stakeholder process, Maryland has developed concepts for a trading program and a draft regulation. This paper describes Maryland's current case-by-case banking and trading procedure and traces efforts to develop a regulation to formalize the process. The paper discusses complex policy issues related to establishing a banking and trading program, describes the principal elements of Maryland's draft regulation, and summarizes elements of other states' emissions banking and trading programs.« less

Input current shaped ac-to-dc converters

NASA Technical Reports Server (NTRS)

1985-01-01

Input current shaping techniques for ac-to-dc converters were investigated. Input frequencies much higher than normal, up to 20 kHz were emphasized. Several methods of shaping the input current waveform in ac-to-dc converters were reviewed. The simplest method is the LC filter following the rectifier. The next simplest method is the resistor emulation approach in which the inductor size is determined by the converter switching frequency and not by the line input frequency. Other methods require complicated switch drive algorithms to construct the input current waveshape. For a high-frequency line input, on the order of 20 kHz, the simple LC cannot be discarded so peremptorily, since the inductor size can be compared with that for the resistor emulation method. In fact, since a dc regulator will normally be required after the filter anyway, the total component count is almost the same as for the resistor emulation method, in which the filter is effectively incorporated into the regulator.

Institutional Ethics Committee Regulations and Current Updates in India.

PubMed

Mahuli, Amit V; Mahuli, Simpy A; Patil, Shankargouda; Bhandi, Shilpa

2017-08-01

The aim of the review is to provide current updates on regulations for ethics committees and researchers in India. Ethical dilemmas in research since time immemorial have been a major concern for researchers worldwide. The question "what makes clinical research ethical" is significant and difficult to answer as multiple factors are involved. The research involving human participants in clinical trials should follow the required rules, regulations, and guidelines in one's own country. It is a dynamic process, and updates have to be learned by researcher and committee members. The review highlights the ethical regulation from the Drug Controller General of India, Clinical Trial Registry of India, and Indian Council of Medical Research guidelines. In this article, the updates on Indian scenario of the Ethical Committee and guidelines are compiled. The review comes handy for clinical researchers and ethics committee members in academic institutions to check on the current updates and keep abreast with the knowledge on regulations of ethics in India.

PKA modulation of Kv4.2-encoded A-type potassium channels requires formation of a supramolecular complex.

PubMed

Schrader, Laura A; Anderson, Anne E; Mayne, Amber; Pfaffinger, Paul J; Sweatt, John David

2002-12-01

A-type channels, encoded by the pore-forming alpha-subunits of the Kv4.x family, are particularly important in regulating membrane excitability in the CNS and the heart. Given the key role of modulation of A currents by kinases, we sought to investigate the protein structure-function relationships underlying the regulation of these currents by PKA. We have previously shown the existence of two PKA phosphorylation sites in the Kv4.2 sequence; therefore, we focused this study on the Kv4.2 primary subunit. In the present studies we made the surprising finding that PKA phosphorylation of the Kv4.2 alpha-subunit is necessary but not sufficient for channel modulation; channel modulation by PKA required the presence of an ancillary subunit, the K+ channel interacting protein (KChIP3). Therefore, these findings indicate a surprising complexity to kinase regulation of A currents, in that an interaction of two separate molecular events, alpha-subunit phosphorylation and the association of an ancillary subunit (KChIP3), are necessary for phosphorylation-dependent regulation of Kv4.2-encoded A channels by PKA. Overall, our studies indicate that PKA must of necessity act on a supramolecular complex of pore-forming alpha-subunits plus ancillary subunits to alter channel properties.

Regulation and Function of Cdt1; A Key Factor in Cell Proliferation and Genome Stability

PubMed Central

Pozo, Pedro N.; Cook, Jeanette Gowen

2016-01-01

Successful cell proliferation requires efficient and precise genome duplication followed by accurate chromosome segregation. The Cdc10-dependent transcript 1 protein (Cdt1) is required for the first step in DNA replication, and in human cells Cdt1 is also required during mitosis. Tight cell cycle controls over Cdt1 abundance and activity are critical to normal development and genome stability. We review here recent advances in elucidating Cdt1 molecular functions in both origin licensing and kinetochore–microtubule attachment, and we describe the current understanding of human Cdt1 regulation. PMID:28025526

Healthcare software assurance.

PubMed

Cooper, Jason G; Pauley, Keith A

2006-01-01

Software assurance is a rigorous, lifecycle phase-independent set of activities which ensure completeness, safety, and reliability of software processes and products. This is accomplished by guaranteeing conformance to all requirements, standards, procedures, and regulations. These assurance processes are even more important when coupled with healthcare software systems, embedded software in medical instrumentation, and other healthcare-oriented life-critical systems. The current Food and Drug Administration (FDA) regulatory requirements and guidance documentation do not address certain aspects of complete software assurance activities. In addition, the FDA's software oversight processes require enhancement to include increasingly complex healthcare systems such as Hospital Information Systems (HIS). The importance of complete software assurance is introduced, current regulatory requirements and guidance discussed, and the necessity for enhancements to the current processes shall be highlighted.

Healthcare Software Assurance

PubMed Central

Cooper, Jason G.; Pauley, Keith A.

2006-01-01

Software assurance is a rigorous, lifecycle phase-independent set of activities which ensure completeness, safety, and reliability of software processes and products. This is accomplished by guaranteeing conformance to all requirements, standards, procedures, and regulations. These assurance processes are even more important when coupled with healthcare software systems, embedded software in medical instrumentation, and other healthcare-oriented life-critical systems. The current Food and Drug Administration (FDA) regulatory requirements and guidance documentation do not address certain aspects of complete software assurance activities. In addition, the FDA’s software oversight processes require enhancement to include increasingly complex healthcare systems such as Hospital Information Systems (HIS). The importance of complete software assurance is introduced, current regulatory requirements and guidance discussed, and the necessity for enhancements to the current processes shall be highlighted. PMID:17238324

Education Regulations: Burying Schools in Paperwork. Hearing before the Subcommittee on Early Childhood, Elementary and Secondary Education of the Committee on Education and the Workforce. U.S. House of Representatives, One Hundred Twelfth Congress, First Session (March 15, 2011). Serial Number 112-12

ERIC Educational Resources Information Center

US House of Representatives, 2011

2011-01-01

This paper presents the Committee on Education and the Workforce's hearing examining the adverse impact extensive federal regulations and reporting requirements have on teachers, administrators and students in elementary and secondary schools. Too many schools and school districts are overwhelmed by unnecessary paperwork requirements. Currently,…

46 CFR 111.30-25 - Alternating-current ship's service switchboards.

Code of Federal Regulations, 2010 CFR

2010-10-01

...-25 Section 111.30-25 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) ELECTRICAL ENGINEERING ELECTRIC SYSTEMS-GENERAL REQUIREMENTS Switchboards § 111.30-25 Alternating-current ship's service... regulator unit acting on the exciter field, each switchboard must have: (1) A generator field rheostat; (2...

46 CFR 111.30-25 - Alternating-current ship's service switchboards.

Code of Federal Regulations, 2011 CFR

2011-10-01

...-25 Section 111.30-25 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) ELECTRICAL ENGINEERING ELECTRIC SYSTEMS-GENERAL REQUIREMENTS Switchboards § 111.30-25 Alternating-current ship's service... regulator unit acting on the exciter field, each switchboard must have: (1) A generator field rheostat; (2...

76 FR 43953 - Continued Application of Regulations to Savings and Loan Holding Companies

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-22

... System (``Board'') is issuing this notice of its intention to continue to enforce certain regulations... current intention regarding enforcement of such part. The Board notes that failure to transfer an OTS.... cross-reference in part result of a cross- 575). reference. 563c Accounting requirements...... All of...

75 FR 55402 - Proposed Collection; Comment Request for Regulation Project

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-10

... required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently... Care Act Notice of Patient Protection. DATES: Written comments should be received on or before November...-10-Affordable Care Act Notice of Patient Protection. OMB Number: 1545-2181. Regulation Project Number...

HMPT: Introduction: Live #27916, Test 27917

DOE Office of Scientific and Technical Information (OSTI.GOV)

Singledecker, Amalia

This course, HMPT: Introduction Live 27916, addresses the Department of Transportation’s (DOT’s) general awareness, transportation security awareness, and safety training requirements for Los Alamos National Laboratory (LANL) in the Hazardous Materials Packaging and Transportation (HMPT) training. Although the course itself is suggested to be taken one time only, the accompanying test (27917) is required initially and then every 36 months. This course is intended to help you learn how to navigate the regulations found in 49 Code of Federal Regulations (CFR), Parts 107–178, Transportation. These regulations change frequently, and it is your responsibility to keep up to date with thesemore » changes. This course will give you tools to perform your hazardous materials (HAZMAT) tasks according to the most current regulations.« less

78 FR 3646 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-16

...The Food and Drug Administration (FDA) is proposing to amend its regulation for Current Good Manufacturing Practice In Manufacturing, Packing, or Holding Human Food (CGMPs) to modernize it and to add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and risk- based preventive controls for human food. FDA also is proposing to revise certain definitions in FDA's current regulation for Registration of Food Facilities to clarify the scope of the exemption from registration requirements provided by the FD&C Act for ``farms.'' FDA is taking this action as part of its announced initiative to revisit the CGMPs since they were last revised in 1986 and to implement new statutory provisions in the FD&C Act. The proposed rule is intended to build a food safety system for the future that makes modern, science-, and risk-based preventive controls the norm across all sectors of the food system.

Principle considerations for the risk assessment of sprayed consumer products.

PubMed

Steiling, W; Bascompta, M; Carthew, P; Catalano, G; Corea, N; D'Haese, A; Jackson, P; Kromidas, L; Meurice, P; Rothe, H; Singal, M

2014-05-16

In recent years, the official regulation of chemicals and chemical products has been intensified. Explicitly for spray products enhanced requirements to assess the consumers'/professionals' exposure to such product type have been introduced. In this regard the Aerosol-Dispensers-Directive (75/324/EEC) with obligation for marketing aerosol dispensers, and the Cosmetic-Products-Regulation (1223/2009/EC) which obliges the insurance of a safety assessment, have to be mentioned. Both enactments, similar to the REACH regulation (1907/2006/EC), require a robust chemical safety assessment. From such assessment, appropriate risk management measures may be identified to adequately control the risk of these chemicals/products to human health and the environment when used. Currently, the above-mentioned regulations lack the guidance on which data are needed for preparing a proper hazard analysis and safety assessment of spray products. Mandatory in the process of inhalation risk and safety assessment is the determination and quantification of the actual exposure to the spray product and more specifically, its ingredients. In this respect the current article, prepared by the European Aerosol Federation (FEA, Brussels) task force "Inhalation Toxicology", intends to introduce toxicological principles and the state of the art in currently available exposure models adapted for typical application scenarios. This review on current methodologies is intended to guide safety assessors to better estimate inhalation exposure by using the most relevant data. Copyright © 2014 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Shared Solar. Current Landscape, Market Potential, and the Impact of Federal Securities Regulation

DOE Office of Scientific and Technical Information (OSTI.GOV)

Feldman, David; Brockway, Anna M.; Ulrich, Elaine

2015-04-07

This report provides a high-level overview of the current U.S. shared solar landscape, the impact that a given shared solar program’s structure has on requiring federal securities oversight, as well as an estimate of market potential for U.S. shared solar deployment.

21 CFR 1271.150 - Current good tissue practice requirements.

Code of Federal Regulations, 2011 CFR

2011-04-01

....150 Section 1271.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.150... implemented for reproductive HCT/Ps described in § 1271.10 and regulated solely under section 361 of the...

21 CFR 1271.150 - Current good tissue practice requirements.

Code of Federal Regulations, 2012 CFR

2012-04-01

....150 Section 1271.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.150... implemented for reproductive HCT/Ps described in § 1271.10 and regulated solely under section 361 of the...

21 CFR 1271.150 - Current good tissue practice requirements.

Code of Federal Regulations, 2013 CFR

2013-04-01

....150 Section 1271.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.150... implemented for reproductive HCT/Ps described in § 1271.10 and regulated solely under section 361 of the...

21 CFR 1271.150 - Current good tissue practice requirements.

Code of Federal Regulations, 2014 CFR

2014-04-01

....150 Section 1271.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.150... implemented for reproductive HCT/Ps described in § 1271.10 and regulated solely under section 361 of the...

Shared Solar. Current Landscape, Market Potential, and the Impact of Federal Securities Regulation

DOE Office of Scientific and Technical Information (OSTI.GOV)

Feldman, David; Brockway, Anna M.; Ulrich, Elaine

2015-04-01

This report provides a high-level overview of the current U.S. shared solar landscape and the impact that a given shared solar program’s structure has on requiring federal securities oversight, as well as an estimate of market potential for U.S. shared solar deployment.

SMALL DRINKING WATER SYSTEMS: STATE OF THE INDUSTRY AND TREATMENT TECHNOLOGIES TO MEET THE SAFE DRINKING WATER ACT REQUIREMENTS

EPA Science Inventory

This report reviews current national data for small drinking water treatment systems, regulations pertaining to small systems, current treatment technologies, disposal of wastes, source water protection, security, and monitoring. The document serves as a roadmap for future small...

Data Quality Objectives for Regulatory Requirements for Hazardous and Radioactive Air Emissions Sampling and Analysis

DOE Office of Scientific and Technical Information (OSTI.GOV)

MULKEY, C.H.

1999-07-06

This document describes the results of the data quality objective (DQO) process undertaken to define data needs for state and federal requirements associated with toxic, hazardous, and/or radiological air emissions under the jurisdiction of the River Protection Project (RPP). Hereafter, this document is referred to as the Air DQO. The primary drivers for characterization under this DQO are the regulatory requirements pursuant to Washington State regulations, that may require sampling and analysis. The federal regulations concerning air emissions are incorporated into the Washington State regulations. Data needs exist for nonradioactive and radioactive waste constituents and characteristics as identified through themore » DQO process described in this document. The purpose is to identify current data needs for complying with regulatory drivers for the measurement of air emissions from RPP facilities in support of air permitting. These drivers include best management practices; similar analyses may have more than one regulatory driver. This document should not be used for determining overall compliance with regulations because the regulations are in constant change, and this document may not reflect the latest regulatory requirements. Regulatory requirements are also expected to change as various permits are issued. Data needs require samples for both radionuclides and nonradionuclide analytes of air emissions from tanks and stored waste containers. The collection of data is to support environmental permitting and compliance, not for health and safety issues. This document does not address health or safety regulations or requirements (those of the Occupational Safety and Health Administration or the National Institute of Occupational Safety and Health) or continuous emission monitoring systems. This DQO is applicable to all equipment, facilities, and operations under the jurisdiction of RPP that emit or have the potential to emit regulated air pollutants.« less

Food Buying Guide for Family Day Care Homes.

ERIC Educational Resources Information Center

Food and Nutrition Service (USDA), Chicago, IL. Midwest Regional Office.

Offered in this guide are facts enabling family day care providers in Michigan to serve meals meeting meal pattern requirements of the state's Child Care Food Program. Adapted from the "Food Buying Guide for Child Nutrition Programs," contents are based on the latest Federal regulations and meal pattern requirements, current food…

7 CFR 1405.6 - Crop insurance requirement.

Code of Federal Regulations, 2011 CFR

2011-01-01

... contributed in the previous year, or is expected to contribute in the current crop year, 10 percent or more of... 7 Agriculture 10 2011-01-01 2011-01-01 false Crop insurance requirement. 1405.6 Section 1405.6 Agriculture Regulations of the Department of Agriculture (Continued) COMMODITY CREDIT CORPORATION, DEPARTMENT...

75 FR 82565 - Federal Acquisition Regulation; Federal Acquisition Circular 2005-48; Introduction

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-30

... delete the requirement for submission of full social security numbers and home addresses of individual... subcontractors to maintain the full social security number and current address of each covered worker, and... Department of Labor for purposes of an investigation or audit of compliance with prevailing wage requirements...

78 FR 310 - Draft Revision of Guidance for Industry on Providing Regulatory Submissions in Electronic Format...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-03

...ApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm253101.htm , http://www.regulations.../Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm253101.htm , http...), in a format that FDA can process, review, and archive. Currently, the Agency can process, review, and...

49 CFR 365.511 - Requirement for CVSA inspection of vehicles during first three consecutive years of permanent...

Code of Federal Regulations, 2010 CFR

2010-10-01

..., DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS RULES GOVERNING APPLICATIONS FOR OPERATING AUTHORITY Special Rules for Certain Mexico-domiciled Carriers § 365.511 Requirement for CVSA... Vehicle Safety Alliance (CVSA)-certified inspectors every three months and display a current inspection...

Public health law for the collection and reporting of health care–associated infections

PubMed Central

Meier, Benjamin Mason; Stone, Patricia W.; Gebbie, Kristine M.

2015-01-01

Background State-based laws for reporting of health care-associated infections (HAI) have developed and changed dramatically in recent years, affecting the costs of reporting and impact on infection rates. It is necessary for practitioners of infection control to understand these changing legal frameworks and their application to practice. Methods Employing systematic state-based research, the researchers have documented legislation and administrative regulations for institution-specific HAI reporting, using this information to create a comprehensive resource on state-based laws for mandatory HAI reporting. Results As of August 27, 2007, 24 states have adopted laws requiring reporting of HAI rates, with an additional 7 states currently considering legislation that would require HAI reporting and 19 states employing detailed regulation in the absence of any current legislative authorization specific to HAI. This study documents (1) which states require reporting of HAI and, if so, whether this is done by legislation or administrative regulation; (2) whether the specific HAIs to be reported are identified in state law or codified generally as “diseases of public health importance,” with reporting specified by administrative regulation; and (3) what reporting policies and procedures are detailed in law. Conclusion Through analysis of the collected information, the researchers have examined the degree to which states have modernized their respective public health laws to approach mandatory reporting by way of general legislation regarding “matters of public health importance” and subsequent detailed administrative regulation to specify those matters. PMID:18926306

21 CFR 886.1665 - Ophthalmic rotary prism.

Code of Federal Regulations, 2014 CFR

2014-04-01

... used to measure ocular deviation in patients with latent or manifest strabismus (eye muscle deviation... also exempt from the current good manufacturing practice requirements of the quality system regulation...

21 CFR 886.1665 - Ophthalmic rotary prism.

Code of Federal Regulations, 2013 CFR

2013-04-01

... used to measure ocular deviation in patients with latent or manifest strabismus (eye muscle deviation... also exempt from the current good manufacturing practice requirements of the quality system regulation...

21 CFR 886.1665 - Ophthalmic rotary prism.

Code of Federal Regulations, 2012 CFR

2012-04-01

... used to measure ocular deviation in patients with latent or manifest strabismus (eye muscle deviation... also exempt from the current good manufacturing practice requirements of the quality system regulation...

21 CFR 886.1665 - Ophthalmic rotary prism.

Code of Federal Regulations, 2010 CFR

2010-04-01

... used to measure ocular deviation in patients with latent or manifest strabismus (eye muscle deviation... also exempt from the current good manufacturing practice requirements of the quality system regulation...

21 CFR 886.1665 - Ophthalmic rotary prism.

Code of Federal Regulations, 2011 CFR

2011-04-01

... used to measure ocular deviation in patients with latent or manifest strabismus (eye muscle deviation... also exempt from the current good manufacturing practice requirements of the quality system regulation...

[Individual rights vs public health in the fight against contagious diseases: proposals to improve the current legal framework].

PubMed

Salamero Teixidó, Laura

2016-11-01

The public health protection constitutional mandate requires public powers to protect the population from contagious diseases. This requires a legal framework that both protects public health effectively and respects individual rights and freedoms that could be undermined by the public administrations. This article analyses, from a legal perspective, the current legal framework regulating the adoption of health measures to protect public health against contagious diseases. It argues that current regulations generate legal uncertainty on the basis of the wide range of discretionary powers they give to the public administration and the lack of provisions for limiting these powers. As a result, the guarantee mechanisms (primarily judicial consent) only weakly protect the rights and freedoms of the citizens affected by health measures. To conclude, the article proposes several amendments to improve public health regulations related to contagious diseases. The purpose is to render a legal framework that offers more legal certainty, in which it is possible to protect individual rights and freedoms when measures are adopted, without sacrificing the effective protection of public health. Copyright © 2016 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

76 FR 39260 - Direct Investment Surveys: Alignment of Regulations With Current Practices

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-06

... are eliminated from the regulations are: A survey of foreign direct investment in the U.S. seafood... requirements for two surveys of new foreign direct investment in the United States. BEA suspended collection of... Enters into a Joint Venture With, a Foreign Person BE-21, Survey of Foreign Direct Investment in U.S...

21 CFR 874.1500 - Gustometer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... sides of the tongue at different taste centers and that provides a galvanic stimulus resulting in taste... the current good manufacturing practice requirements of the quality system regulation in part 820 of...

21 CFR 874.1500 - Gustometer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... sides of the tongue at different taste centers and that provides a galvanic stimulus resulting in taste... the current good manufacturing practice requirements of the quality system regulation in part 820 of...

Overview of existing regulations for ventilation requirements of enclosed vehicular parking facilities

DOE Office of Scientific and Technical Information (OSTI.GOV)

Krarti, M.; Ayari, A.M.

1999-07-01

This paper provides an overview of the current standards and regulations regarding the ventilation in enclosed parking facilities in the US and other countries. First, the paper discusses the emission rates of motor vehicle pollutants and their health effects. In particular, typical emission rates for different vehicle and fuel types are presented to highlight the effect of various parameters on the ventilation rate requirements for parking garages. In addition, the paper provides a brief description of some of the common ventilation problems reported in the literature for enclosed parking garages.

76 FR 37162 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-24

... (February 7, 2011). \\3\\ Letter from Gene Thomas (Retired), (April 24, 2011); letter from Andrew S. Margolin... CFTC's regulations. OCC By-Laws, Article I, Definitions. OCC's current internal cross-margining program...-CME program. Article VI, Section 25(b) of OCC's By-Laws currently requires clearing members to obtain...

Cumulative impacts: current research and current opinions at PSW

Treesearch

R. M. Rice

1987-01-01

Consideration of cumulative watershed effects (CWEs) has both political and physical aspects. Regardless of the practical usefulness of present methods of dealing with CWEs, the legal requirement to address them remains. Management of federal land is regulated by the National Environmental Policy Act (NEPA) and the Federal Water Pollution Control Act of 1972. The...

Current Hale ROA Voice and Control Communication Practices and Performance: White Paper

NASA Technical Reports Server (NTRS)

2007-01-01

The objective of this white paper is to help achieve the ACCESS 5 goal by sharing the UNITE members knowledge of current HALE ROA communication systems with other ACCESS 5 participants so that all interested parties start from a common understanding as we begin the clarification of requirements for voice and C2 communication. This white paper is also intended to describe the point of departure for any future developments that need to be realized to achieve the long term ACCESS 5 goal. Although this white paper describes the current systems, the functional and performance requirements that are also being developed under ACCESS 5 may not require the same levels of functionality and performance as currently exist. The paper addresses the following: 1) A description of a typical current HALE ROA communications system, 2) HALE ROA communications systems performance metrics, 3) HALE ROA communications systems performance, and 5) A comparison of current HALE ROA communications systems with current regulations.

21 CFR 886.1400 - Maddox lens.

Code of Federal Regulations, 2014 CFR

2014-04-01

... intended to be handheld or placed in a trial frame to evaluate eye muscle dysfunction. (b) Classification... the current good manufacturing practice requirements of the quality system regulation in part 820 of...

21 CFR 886.1400 - Maddox lens.

Code of Federal Regulations, 2010 CFR

2010-04-01

... intended to be handheld or placed in a trial frame to evaluate eye muscle dysfunction. (b) Classification... the current good manufacturing practice requirements of the quality system regulation in part 820 of...

21 CFR 886.1400 - Maddox lens.

Code of Federal Regulations, 2011 CFR

2011-04-01

... intended to be handheld or placed in a trial frame to evaluate eye muscle dysfunction. (b) Classification... the current good manufacturing practice requirements of the quality system regulation in part 820 of...

21 CFR 886.1400 - Maddox lens.

Code of Federal Regulations, 2013 CFR

2013-04-01

... intended to be handheld or placed in a trial frame to evaluate eye muscle dysfunction. (b) Classification... the current good manufacturing practice requirements of the quality system regulation in part 820 of...

21 CFR 886.1400 - Maddox lens.

Code of Federal Regulations, 2012 CFR

2012-04-01

... intended to be handheld or placed in a trial frame to evaluate eye muscle dysfunction. (b) Classification... the current good manufacturing practice requirements of the quality system regulation in part 820 of...

78 FR 37164 - Revisions to the Air Emissions Reporting Requirements: Revisions to Lead (Pb) Reporting Threshold...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-20

...Today's action proposes changes to the existing EPA emission inventory reporting requirements on state, local, and tribal agencies in the current Air Emissions Reporting Requirements rule published on December 17, 2008. The proposed amendments would lower the current threshold for reporting Pb sources as point sources; eliminate the requirement for reporting emissions from wildfires and prescribed fires; and replace a requirement for reporting mobile source emissions with a requirement for reporting the input parameters that can be used to run the EPA models that generate the emissions estimates. In addition, the proposed amendments would reduce the reporting burden on state, local, and tribal agencies by removing the requirements to report daily and seasonal emissions associated with carbon monoxide (CO), ozone (O3), and particulate matter up to 10 micrometers in size (PM10) nonattainment areas and nitrogen oxides (NOX) State Implementation Plan (SIP) call areas, although reporting requirements for those emissions would remain in other regulations. Lastly, the proposed amendments would clarify, remove, or simplify some current emissions reporting requirements which we believe are not necessary or are not clearly aligned with current inventory terminology and practices.

Local health rules and building regulations: a survey on local hygiene and building regulations in Italian municipalities.

PubMed

Gola, Marco; Signorelli, Carlo; Buffoli, Maddalena; Rebecchi, Andrea; Capolongo, Stefano

2017-01-01

WHO has highlighted the need to strengthen the relationship between health and built environment factors, such as inappropriate housing conditions. Local Health Rules (LHRs) and Building Regulations (BRs) are tools which provide safety and building hygiene in construction practices. Currently the Italian Government is considering to establish a National Building Regulation and, related to the following purpose, this paper presents a survey on the status of adoption and updating of LHRs and BRs in Italian municipalities. The current Italian state of LHRs, BRs and Municipal Development Plans (MDPs) have been examined by a survey considering a sample of about 550 cities, with different demo graphic and geographic features, starting from the previous research work by Signorelli et al. (1999). The analysis underlines a serious shortage of updated LHRs, especially in small and medium-sized municipalities whereas BRs and MDPs are widespread. Only 30% of them are previously approved and validated by Local Health Authorities. Starting from a survey, the present scenario of Building Regulations requires the introduction of further performance guidelines instead of normative ones and, therefore, the current actions to give rise to a National Building Regulation could be integrated by building hygiene contents of LHRs.

The Family and Medical Leave Act. Final rule.

PubMed

2013-02-06

This Final Rule amends certain regulations of the Family and Medical Leave Act of 1993 (the FMLA or the Act) to implement amendments to the military leave provisions of the Act made by the National Defense Authorization Act for Fiscal Year 2010, which extends the availability of FMLA leave to family members of members of the Regular Armed Forces for qualifying exigencies arising out of the servicemember's deployment; defines those deployments covered under these provisions; extends FMLA military caregiver leave for family members of current servicemembers to include an injury or illness that existed prior to service and was aggravated in the line of duty on active duty; and extends FMLA military caregiver leave to family members of certain veterans with serious injuries or illnesses. This Final Rule also amends the regulations to implement the Airline Flight Crew Technical Corrections Act, which establishes eligibility requirements specifically for airline flight crewmembers and flight attendants for FMLA leave and authorizes the Department to issue regulations regarding the calculation of leave for such employees as well as special recordkeeping requirements for their employers. In addition, the Final Rule includes clarifying changes concerning the calculation of intermittent or reduced schedule FMLA leave; reorganization of certain sections to enhance clarity; the removal of the forms from the regulations; and technical corrections to the current regulations.

The Law of Federal Employment.

DTIC Science & Technology

1991-08-01

See Ryan v. Federal Deposit Insurance Corp., 565 F.2d 762 (D.C. Cir. 1977). The EEOC regulations in this area are currently codified at 29 C.F.R. SS...attorney’s fee as part of the costs. 10.2 Reculatory Requirements. a. EEOC Implementation of Title VII, 1964 Civil Riqhts Act. EEOC regulations ...complaint proced.res and rights to appeal to EEOC and obtain judicial review are described in the following regulations . 29 C.F.R. S 1613.213

78 FR 51664 - Vessel Traffic Service Updates, Including Establishment of Vessel Traffic Service Requirements...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-21

... requirements. The changes made by this rule will align regulations with the current operating procedures of the... History V. Discussion of Comments and Changes VI. Regulatory Analyses A. Regulatory Planning and Review B... Waterways Safety System PWSA Ports and Waterways Safety Act SOLAS International Convention for the Safety of...

Inactivation kinetics of a four-strain composite of Salmonella Enteritidis and Oranienberg in commercially-acquired liquid egg yolk

USDA-ARS?s Scientific Manuscript database

Introduction: Current liquid egg pasteurization requirements are based on command and control prescribed time/temperature combinations for specified egg products. Requirements are found in the Code of Federal Regulations, Title 9, Ch. III, Sec. 590.570. These standards were based on data for the ...

7 CFR 798.3 - Index.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 7 2010-01-01 2010-01-01 false Index. 798.3 Section 798.3 Agriculture Regulations of... RECORDS AVAILABILITY OF INFORMATION TO THE PUBLIC § 798.3 Index. 5 U.S.C. 552(a)(2) requires that each agency publish or otherwise make available a current index of all materials required to be made available...

75 FR 82581 - Federal Acquisition Regulation; Federal Acquisition Circular 2005-48; Small Entity Compliance Guide

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-30

..., Payrolls and Basic Records to delete the requirement for submission of full social security numbers and... requires contractors and subcontractors to maintain the full social security number and current address of... Wage and Hour Division of the Department of Labor for purposes of an investigation or audit of...

Current Regulations and Regulatory Actions

EPA Pesticide Factsheets

This site will provide basic information on clean air permitting under the title V operating permits program, provide access to state and regional permitting programs, and maintain access to proposed and final regulatory requirements.

Effectiveness of the Civil Aviation Security Program.

DTIC Science & Technology

1977-04-05

diversions. Perhaps the best evidence of the effectiveness of airline and airport security measures is the number of hijackings and related crimes prevented...airports. Consideration is being given to include a provision in the airport security regulation which would prohibit the introduction of...Security Program. A complete revision of the regulation that established basic airport security requirements is currently underway. One of the more

75 FR 33888 - Proposed Collection; Comment Request for Regulation Project

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-15

... required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently... Tax; TD 8432, Branch Profits Tax; and TD 8657, Regulations on Effectively Connected Income and the Branch Profits Tax (Sec. Sec. 1.884-1, 1.884-2, 1.884- 2T, 1.884-4, 1.884-5). DATES: Written comments...

BLENDING BIOSOLIDS SAMPLES MAKES A DIFFERENCE IN ORGANISM RECOVERY, PRINTED IN WATER ENVIRONMENT LABORATORY SOLUTIONS, VOL 8, NO. 3, PGS 10-14, PUBLISHED BY WATER ENVIRONMENT FEDERATION, 2001

EPA Science Inventory

Current federal regulations (40 CFR 503) require enumeration of fecal coliform or Salmoella prior to land application of Class A biosolids. This regulation specifies use of enumeration methods included in "Standard Methods for the Examination of Water and Wastewater 18th Edi...

75 FR 5756 - Notice of Request for Revision of a Currently Approved Information Collection (Registration...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-04

...In accordance with the Paperwork Reduction Act of 1995 and the Office of Management and Budget (OMB) regulations, this notice announces the Food Safety and Inspection Service's (FSIS) intention to request an extension of a currently approved information collection regarding registration requirements because the OMB approval will expire on May 31, 2010.

The role of the landscape architect in applied forest landscape management: a case study on process

Treesearch

Wayne Tlusty

1979-01-01

Land planning allocations are often multi-resource concepts, with visual quality objectives addressing the appropriate level of visual resource management. Current legislation and/or regulations often require interdisciplinary teams to implement planning decisions. A considerable amount of information is currently avail-able on visual assessment techniques both for...

Brightening up: the effect of the Physician Payment Sunshine Act on existing regulation of pharmaceutical marketing.

PubMed

Gorlach, Igor; Pham-Kanter, Genevieve

2013-01-01

With the passage of the Physician Payment Sunshine Act as part of the federal health care reform law, pharmaceutical manufacturers are now required to disclose a wide range of payments made by manufacturers to physicians. We review current state regulation of pharmaceutical marketing and consider how the federal sunshine provision will affect existing marketing regulation. We analyze the legal and practical implications of the Physician Payment Sunshine Act. © 2013 American Society of Law, Medicine & Ethics, Inc.

Moving toward a paradigm shift in the regulatory requirements for pediatric medicines.

PubMed

Chin, William Wei Lim; Joos, Angelika

2016-12-01

Over the past two decades, there has been growing concern over the lack of proper medication for children. This review attempts to evaluate the current progress of EU Pediatric Regulation made since 2007. The lack of properly evaluated pediatric medication has for long been a source of concern in the European Union. The drugs that were used in the past were often not properly evaluated, and dosage was arbitrarily calculated. Therefore, it was necessary to establish the Pediatric Regulation (EC no. 1901/2006) in the EU which would mandate research for pediatric drugs. Current legislations in place not only require mandatory research by pharma industry but also have guidelines to direct the quality of pediatric research performed. The main aim of this regulation was to advance high-quality research and development of pediatric drugs, thereby increasing the availability of safe and effective drugs for children. It also aimed to improve the information available on existing pediatric drugs. It has been 9 years since the pediatric regulation was framed. The pharma industry now sees pediatric research as an integral process of development. Drug companies which develop plans for a new drug, new form of drug, new indication, or new route of administration for adults are obliged to integrate in their development plan similar research for pediatric populations as well. It is hoped that the implementation of the current legislation will be reflected better in the future by the marketing of better and safer drugs for the pediatric population. The upcoming assessment to the European Commission in 2017 will further inform us on the impact after 10 years implementation of the legislation. What is Known: • The lack of properly evaluated pediatric medication has for long been a source of concern in the European Union. • Therefore, it was necessary to establish the EU Pediatric Regulation which would mandate research for pediatric drugs. What is New: • It has been 9 years since the pediatric regulation was framed, and the teething problems are slowly being overcome and the regulation is being used with increasing confidence. • As the Regulation is due for revision in 2017, this paper gives a current perspective on the impact of the regulation on availability and access to medicine for children.

2 CFR 25.200 - Requirements for program announcements, regulations, and application instructions.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 2 Grants and Agreements 1 2014-01-01 2014-01-01 false Requirements for program announcements... on or after the effective date of this part; or (2) Has application or plan due dates after October 1... application or plan; (2) Maintain an active CCR registration with current information at all times during...

2 CFR 25.200 - Requirements for program announcements, regulations, and application instructions.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 2 Grants and Agreements 1 2012-01-01 2012-01-01 false Requirements for program announcements...) Is issued on or after the effective date of this part; or (2) Has application or plan due dates after... an application or plan; (2) Maintain an active CCR registration with current information at all times...

2 CFR 25.200 - Requirements for program announcements, regulations, and application instructions.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 2 Grants and Agreements 1 2013-01-01 2013-01-01 false Requirements for program announcements...) Is issued on or after the effective date of this part; or (2) Has application or plan due dates after... an application or plan; (2) Maintain an active CCR registration with current information at all times...

49 CFR 195.12 - What requirements apply to low-stress pipelines in rural areas?

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 3 2010-10-01 2010-10-01 false What requirements apply to low-stress pipelines in... low-stress pipelines in rural areas? (a) General. This section does not apply to a rural low-stress pipeline regulated under this part as a low-stress pipeline that crosses a waterway currently used for...

2 CFR 25.200 - Requirements for program announcements, regulations, and application instructions.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 2 Grants and Agreements 1 2011-01-01 2011-01-01 false Requirements for program announcements...) Is issued on or after the effective date of this part; or (2) Has application or plan due dates after... an application or plan; (2) Maintain an active CCR registration with current information at all times...

78 FR 30782 - Avocados Grown in South Florida; Change in Minimum Grade Requirements

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-23

..., regardless of market destination. However, maintaining the current minimum grade requirement for avocados... Service 7 CFR Part 915 [Doc. No. AMS-FV-12-0067; FV13-915-1 PR] Avocados Grown in South Florida; Change in... prescribed under the Florida avocado marketing order (order). The order regulates the handling of avocados...

Acoustic flight test of the Piper Lance

DOT National Transportation Integrated Search

1986-12-01

Research is being conducted to refine current noise regulation of propeller-driven small airplanes. Studies are examining the prospect of a substituting a takeoff procedure of equal stringency for the level flyover certification test presently requir...

21 CFR 888.5850 - Nonpowered orthopedic traction apparatus and accessories.

Code of Federal Regulations, 2013 CFR

2013-04-01

..., pulleys, or weights, and that is intended to apply a therapeutic pulling force to the skeletal system. (b... from the current good manufacturing practice requirements of the quality system regulation in part 820...

21 CFR 888.5850 - Nonpowered orthopedic traction apparatus and accessories.

Code of Federal Regulations, 2014 CFR

2014-04-01

..., pulleys, or weights, and that is intended to apply a therapeutic pulling force to the skeletal system. (b... from the current good manufacturing practice requirements of the quality system regulation in part 820...

21 CFR 888.5850 - Nonpowered orthopedic traction apparatus and accessories.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., pulleys, or weights, and that is intended to apply a therapeutic pulling force to the skeletal system. (b... from the current good manufacturing practice requirements of the quality system regulation in part 820...

A minimalist biosensor: Quantitation of cyclic di-GMP using the conformational change of a riboswitch aptamer.

PubMed

Kellenberger, Colleen A; Sales-Lee, Jade; Pan, Yuchen; Gassaway, Madalee M; Herr, Amy E; Hammond, Ming C

2015-01-01

Cyclic di-GMP (c-di-GMP) is a second messenger that is important in regulating bacterial physiology and behavior, including motility and virulence. Many questions remain about the role and regulation of this signaling molecule, but current methods of detection are limited by either modest sensitivity or requirements for extensive sample purification. We have taken advantage of a natural, high affinity receptor of c-di-GMP, the Vc2 riboswitch aptamer, to develop a sensitive and rapid electrophoretic mobility shift assay (EMSA) for c-di-GMP quantitation that required minimal engineering of the RNA.

Current good manufacturing practices, quality control procedures, quality factors, notification requirements, and records and reports, for infant formula. Final rule.

PubMed

2014-06-10

The Food and Drug Administration (FDA or we) is issuing a final rule that adopts, with some modifications, the interim final rule (IFR) entitled "Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula'' (February 10, 2014). This final rule affirms the IFR's changes to FDA's regulations and provides additional modifications and clarifications. The final rule also responds to certain comments submitted in response to the request for comments in the IFR.

Current knowledge of microRNA-mediated regulation of drug metabolism in humans.

PubMed

Nakano, Masataka; Nakajima, Miki

2018-05-01

Understanding the factors causing inter- and intra-individual differences in drug metabolism potencies is required for the practice of personalized or precision medicine, as well as for the promotion of efficient drug development. The expression of drug-metabolizing enzymes is controlled by transcriptional regulation by nuclear receptors and transcriptional factors, epigenetic regulation, such as DNA methylation and histone acetylation, and post-translational modification. In addition to such regulation mechanisms, recent studies revealed that microRNAs (miRNAs), endogenous ~22-nucleotide non-coding RNAs that regulate gene expression through the translational repression and degradation of mRNAs, significantly contribute to post-transcriptional regulation of drug-metabolizing enzymes. Areas covered: This review summarizes the current knowledge regarding miRNAs-dependent regulation of drug-metabolizing enzymes and transcriptional factors and its physiological and clinical significance. We also describe recent advances in miRNA-dependent regulation research, showing that the presence of pseudogenes, single-nucleotide polymorphisms, and RNA editing affects miRNA targeting. Expert opinion: It is unwavering fact that miRNAs are critical factors causing inter- and intra-individual differences in the expression of drug-metabolizing enzymes. Consideration of miRNA-dependent regulation would be a helpful tool for optimizing personalized and precision medicine.

Mock Certification Basis for an Unmanned Rotorcraft for Precision Agricultural Spraying

NASA Technical Reports Server (NTRS)

Hayhurst, Kelly J.; Maddalon, Jeffrey M.; Neogi, Natasha A.; Verstynen, Harry A.; Buelow, Barry; McCormick, G. Frank

2015-01-01

This technical report presents the results of a case study using a hazard-based approach to develop preliminary design and performance criteria for an unmanned agricultural rotorcraft requiring airworthiness certification. This case study is one of the first in the public domain to examine design and performance criteria for an unmanned aircraft system (UAS) in tandem with its concept of operations. The case study results are intended to support development of airworthiness standards that could form a minimum safety baseline for midsize unmanned rotorcraft performing precision agricultural spraying operations under beyond visual line-of-sight conditions in a rural environment. This study investigates the applicability of current methods, processes, and standards for assuring airworthiness of conventionally piloted (manned) aircraft to assuring the airworthiness of UAS. The study started with the development of a detailed concept of operations for precision agricultural spraying with an unmanned rotorcraft (pp. 5-18). The concept of operations in conjunction with a specimen unmanned rotorcraft were used to develop an operational context and a list of relevant hazards (p. 22). Minimum design and performance requirements necessary to mitigate the hazards provide the foundation of a proposed (or mock) type certification basis. A type certification basis specifies the applicable standards an applicant must show compliance with to receive regulatory approval. A detailed analysis of the current airworthiness regulations for normal-category rotorcraft (14 Code of Federal Regulations, Part 27) was performed. Each Part 27 regulation was evaluated to determine whether it mitigated one of the relevant hazards for the specimen UAS. Those regulations that did were included in the initial core of the type certification basis (pp. 26-31) as written or with some simple modifications. Those regulations that did not mitigate a recognized hazard were excluded from the certification basis. The remaining regulations were applicable in intent, but the text could not be easily tailored. Those regulations were addressed in separate issue papers. Exploiting established regulations avoids the difficult task of generating and interpreting novel requirements, through the use of acceptable, standardized language. The rationale for the disposition of the regulations was assessed and captured (pp. 58-115). The core basis was then augmented by generating additional requirements (pp. 38-47) to mitigate hazards for an unmanned sprayer that are not covered in Part 27.

Complex role of STIM1 in the activation of store-independent Orai1/3 channels

PubMed Central

Zhang, Wei; González-Cobos, José C.; Jardin, Isaac; Romanin, Christoph; Matrougui, Khalid

2014-01-01

Orai proteins contribute to Ca2+ entry into cells through both store-dependent, Ca2+ release–activated Ca2+ (CRAC) channels (Orai1) and store-independent, arachidonic acid (AA)-regulated Ca2+ (ARC) and leukotriene C4 (LTC4)-regulated Ca2+ (LRC) channels (Orai1/3 heteromultimers). Although activated by fundamentally different mechanisms, CRAC channels, like ARC and LRC channels, require stromal interacting molecule 1 (STIM1). The role of endoplasmic reticulum–resident STIM1 (ER-STIM1) in CRAC channel activation is widely accepted. Although ER-STIM1 is necessary and sufficient for LRC channel activation in vascular smooth muscle cells (VSMCs), the minor pool of STIM1 located at the plasma membrane (PM-STIM1) is necessary for ARC channel activation in HEK293 cells. To determine whether ARC and LRC conductances are mediated by the same or different populations of STIM1, Orai1, and Orai3 proteins, we used whole-cell and perforated patch-clamp recording to compare AA- and LTC4-activated currents in VSMCs and HEK293 cells. We found that both cell types show indistinguishable nonadditive LTC4- and AA-activated currents that require both Orai1 and Orai3, suggesting that both conductances are mediated by the same channel. Experiments using a nonmetabolizable form of AA or an inhibitor of 5-lipooxygenase suggested that ARC and LRC currents in both cell types could be activated by either LTC4 or AA, with LTC4 being more potent. Although PM-STIM1 was required for current activation by LTC4 and AA under whole-cell patch-clamp recordings in both cell types, ER-STIM1 was sufficient with perforated patch recordings. These results demonstrate that ARC and LRC currents are mediated by the same cellular populations of STIM1, Orai1, and Orai3, and suggest a complex role for both ER-STIM1 and PM-STIM1 in regulating these store-independent Orai1/3 channels. PMID:24567509

78 FR 46177 - Third-Party Provision of Ancillary Services; Accounting and Financial Reporting for New Electric...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-30

...The Federal Energy Regulatory Commission (Commission) is revising its regulations to foster competition and transparency in ancillary services markets. The Commission is revising certain aspects of its current market-based rate regulations, ancillary services requirements under the pro forma open-access transmission tariff (OATT), and accounting and reporting requirements. Specifically, the Commission is revising its regulations to reflect reforms to its Avista policy governing the sale of ancillary services at market-based rates to public utility transmission providers. The Commission is also requiring each public utility transmission provider to add to its OATT Schedule 3 a statement that it will take into account the speed and accuracy of regulation resources in its determination of reserve requirements for Regulation and Frequency Response service, including as it reviews whether a self-supplying customer has made ``alternative comparable arrangements'' as required by the Schedule. The final rule also requires each public utility transmission provider to post certain Area Control Error data as described in the final rule. Finally, the Commission is revising the accounting and reporting requirements under its Uniform System of Accounts for public utilities and licensees and its forms, statements, and reports, contained in FERC Form No. 1, Annual Report of Major Electric Utilities, Licensees and Others, FERC Form No. 1-F, Annual Report for Nonmajor Public Utilities and Licensees, and FERC Form No. 3-Q, Quarterly Financial Report of Electric Utilities, Licensees, and Natural Gas Companies, to better account for and report transactions associated with the use of energy storage devices in public utility operations.

77 FR 51104 - Parts and Accessories Necessary for Safe Operation; Application for an Exemption From...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-23

... vehicles (CMVs). The Federal Motor Carrier Safety Regulations (FMCSRs) currently require antennas... the driver's field of view by devices mounted at the top of the windshield. Antennas, transponders and...

[Regulatory requirements regarding cell-based medicinal products for human and veterinary use - a comparison].

PubMed

Kuhlmann-Gottke, Johanna; Duchow, Karin

2015-11-01

At present, there is no separate regulatory framework for cell-based medicinal products (CBMP) for veterinary use at the European or German level. Current European and national regulations exclusively apply to the corresponding medicinal products for human use. An increasing number of requests for the regulatory classification of CBMP for veterinary use, such as allogeneic stem cell preparations and dendritic cell-based autologous tumour vaccines, and a rise in scientific advice for companies developing these products, illustrate the need for adequate legislation. Currently, advice is given and decisions are made on a case-by-case basis regarding the regulatory classification and authorisation requirements.Since some of the CBMP - in particular in the area of stem-cell products - are developed in parallel for human and veterinary use, there is an urgent need to create specific legal definitions, regulations, and guidelines for these complex innovative products in the veterinary sector as well. Otherwise, there is a risk that that the current legal grey area regarding veterinary medicinal products will impede therapeutic innovations in the long run. A harmonised EU-wide approach is desirable. Currently the European legislation on veterinary medicinal products is under revision. In this context, veterinary therapeutics based on allogeneic cells and tissues will be defined and regulated. Certainly, the legal framework does not have to be as comprehensive as for human CBMP; a leaner solution is conceivable, similar to the special provisions for advanced-therapy medicinal products laid down in the German Medicines Act.

Developing New Modelling Tools for Environmental Flow Assessment in Regulated Salmon Rivers

NASA Astrophysics Data System (ADS)

Geris, Josie; Soulsby, Chris; Tetzlaff, Doerthe

2013-04-01

There is a strong political drive in Scotland to meet all electricity demands from renewable sources by 2020. In Scotland, hydropower generation has a long history and is a key component of this strategy. However, many rivers sustain freshwater communities that have both high conservation status and support economically important Atlantic salmon fisheries. Both new and existing hydropower schemes must be managed in accordance with the European Union's Water Framework Directive (WFD), which requires that all surface water bodies achieve good ecological status or maintain good ecological potential. Unfortunately, long-term river flow monitoring is sparse in the Scottish Highlands and there are limited data for defining environmental flows. The River Tay is the most heavily regulated catchment in the UK. To support hydropower generation, it has an extensive network of inter- and intra- catchment transfers, in addition to a large number of regulating reservoirs for which abstraction legislation often only requires minimum compensation flows. The Tay is also considered as one of Scotland's most important rivers for Atlantic salmon (Salmo salar), and there is considerable uncertainty as to how best change reservoir operations to improve the ecological potential of the river system. It is now usually considered that environmental flows require more than a minimum compensation flow, and instead should cover a range of hydrological flow aspects that represent ecologically relevant streamflow attributes, including magnitude, timing, duration, frequency and rate of change. For salmon, these hydrological indices are of particular interest, with requirements varying at different stages of their life cycle. To meet the WFD requirements, rationally alter current abstraction licences and provide an evidence base for regulating new hydropower schemes, advanced definitions for abstraction limits and ecologically appropriate flow releases are desirable. However, a good understanding of the natural flow variability and the hydrological impacts of the regulation is unavailable, partly because pre-regulation data of existing hydropower schemes are lacking. Here we develop a novel modelling approach for characterising natural flow regimes and defining hydrological flow indices. This allows us to quantitatively assess the impacts of hydropower to better inform environmental flow requirements for the Atlantic salmon river ecosystem. Results are presented for the River Lyon (390 km2), a regulated headwater catchment of the River Tay. The HBV hydrological rainfall-runoff model is used to simulate flows, based on calibrated parameters from regulated flow data, with the current hydropower scheme active. For this, the HBV model is adapted to be able to incorporate water transfers and regulated flows. The natural hydrological indices are derived from the simulated pre-regulation data, and compared with those of the regulated data to investigate the impact of the regulation on these at different critical times for Atlantic salmon. The sensitivity of the system to change is also investigated to explore the extent to which flow variables can be modified without major degradation to the river's ecosystem, while still maintaining viable hydropower generation. The modelling approach presented will provide the basis for assessing impacts on hydrological flow indices and informing environmental flows in regions with similar heavily regulated mountain river ecosystems.

Bee guide to complying with the Safe Drinking Water Act. Final report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Garland, J.G.; Acker, A.M.

This report provides current information on the Safe Drinking Water Act and recent amendments. The report describes the evolution of the Safe Drinking Water Act and the responsibilities of base personnel involved in compliance with the Act. It also describes the monitoring requirements, analytical requirements, best available technology for controlling contaminants, and public notification requirements for regulated contaminants. The appendixes include proposed contaminants and state water quality agencies. Each Air Force public water distribution system (PWDS) must comply with the SDWA, and the National Primary Drinking Water Regulations (NPDWRs). In the United States and its territories, the provisions of themore » SDWA and the NPDWRs are enforced by the states except in the few instances in which the state has not been delegated primary enforcement responsibility (primacy) by the EPA. States that have primacy may establish drinking water regulations, monitoring schedules, and reporting requirements more stringent than, or in addition to, those in the NPDWRs. Air Force public water systems in these states are required to comply with these additional requirements as well as federal enforcement actions as carried out by the EPA Regional Office.« less

10 CFR Appendix C to Part 50 - A Guide for the Financial Data and Related Information Required To Establish Financial...

Code of Federal Regulations, 2010 CFR

2010-01-01

... reflecting the financial results of past operations. With respect, however, to the applicant which is a newly... information usually contained in current annual financial reports, including summary data of prior years, will... questions they may have relating to the requirements of the Commission's regulations or the information set...

75 FR 10740 - New Car Assessment Program (NCAP); Safety Labeling

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-09

... separated from each other by a dark line that is a minimum of 3 points in width. Also as is currently required, the entire safety rating label would be required to be surrounded by a solid dark line that is a... dark background. \\4\\ The full study report is available at http://www.regulations.gov in Docket No...

Differential contribution of Ca2+ sources to day and night BK current activation in the circadian clock

PubMed Central

McNally, Beth A.

2018-01-01

Large conductance K+ (BK) channels are expressed widely in neurons, where their activation is regulated by membrane depolarization and intracellular Ca2+ (Ca2+i). To enable this regulation, BK channels functionally couple to both voltage-gated Ca2+ channels (VGCCs) and channels mediating Ca2+ release from intracellular stores. However, the relationship between BK channels and their specific Ca2+ source for particular patterns of excitability is not well understood. In neurons within the suprachiasmatic nucleus (SCN)—the brain’s circadian clock—BK current, VGCC current, and Ca2+i are diurnally regulated, but paradoxically, BK current is greatest at night when VGCC current and Ca2+i are reduced. Here, to determine whether diurnal regulation of Ca2+ is relevant for BK channel activation, we combine pharmacology with day and night patch-clamp recordings in acute slices of SCN. We find that activation of BK current depends primarily on three types of channels but that the relative contribution changes between day and night. BK current can be abrogated with nimodipine during the day but not at night, establishing that L-type Ca2+ channels (LTCCs) are the primary daytime Ca2+ source for BK activation. In contrast, dantrolene causes a significant decrease in BK current at night, suggesting that nighttime BK activation is driven by ryanodine receptor (RyR)–mediated Ca2+i release. The N- and P/Q-type Ca2+ channel blocker ω-conotoxin MVIIC causes a smaller reduction of BK current that does not differ between day and night. Finally, inhibition of LTCCs, but not RyRs, eliminates BK inactivation, but the BK β2 subunit was not required for activation of BK current by LTCCs. These data reveal a dynamic coupling strategy between BK channels and their Ca2+ sources in the SCN, contributing to diurnal regulation of SCN excitability. PMID:29237755

Differential contribution of Ca2+ sources to day and night BK current activation in the circadian clock.

PubMed

Whitt, Joshua P; McNally, Beth A; Meredith, Andrea L

2018-02-05

Large conductance K + (BK) channels are expressed widely in neurons, where their activation is regulated by membrane depolarization and intracellular Ca 2+ (Ca 2+ i ). To enable this regulation, BK channels functionally couple to both voltage-gated Ca 2+ channels (VGCCs) and channels mediating Ca 2+ release from intracellular stores. However, the relationship between BK channels and their specific Ca 2+ source for particular patterns of excitability is not well understood. In neurons within the suprachiasmatic nucleus (SCN)-the brain's circadian clock-BK current, VGCC current, and Ca 2+ i are diurnally regulated, but paradoxically, BK current is greatest at night when VGCC current and Ca 2+ i are reduced. Here, to determine whether diurnal regulation of Ca 2+ is relevant for BK channel activation, we combine pharmacology with day and night patch-clamp recordings in acute slices of SCN. We find that activation of BK current depends primarily on three types of channels but that the relative contribution changes between day and night. BK current can be abrogated with nimodipine during the day but not at night, establishing that L-type Ca 2+ channels (LTCCs) are the primary daytime Ca 2+ source for BK activation. In contrast, dantrolene causes a significant decrease in BK current at night, suggesting that nighttime BK activation is driven by ryanodine receptor (RyR)-mediated Ca 2+ i release. The N- and P/Q-type Ca 2+ channel blocker ω-conotoxin MVIIC causes a smaller reduction of BK current that does not differ between day and night. Finally, inhibition of LTCCs, but not RyRs, eliminates BK inactivation, but the BK β2 subunit was not required for activation of BK current by LTCCs. These data reveal a dynamic coupling strategy between BK channels and their Ca 2+ sources in the SCN, contributing to diurnal regulation of SCN excitability. © 2018 Whitt et al.

Claims procedures for employee benefit plans--Pension and Welfare Benefits Administration, Department of Labor. Request for information.

PubMed

1997-09-08

This document requests information from the public concerning the advisability of amending the existing regulation under the Employee Retirement Income Security Act of 1974 (ERISA) that establishes minimum requirements for employee benefit plan claims procedures. The term "claims procedure" refers to the process that employee benefit plans must provide for participants and beneficiaries who seek to obtain pension or welfare plan benefits, including requests for medical treatment or services, consideration of claims, and review of denials of claims by plans. The primary purpose of this notice is to obtain information to assist the Department of Labor (the Department) in evaluating (1) the extent to which the current claims procedure regulation assures that group health plan participants and beneficiaries are provided with effective and timely means to file and resolve claims for health care benefits, and (1) whether and in what way the existing minimum requirements should be amended with respect to group health plans covered by ERISA. The furnished information also will assist the Department in determining whether the regulation should be amended with respect to pension plans covered by ERISA and in developing legislative proposals to address any identified deficiencies relating to the claims procedures that cannot be addressed by amending the current regulation.

Visualizing and Validating Metadata Traceability within the CDISC Standards.

PubMed

Hume, Sam; Sarnikar, Surendra; Becnel, Lauren; Bennett, Dorine

2017-01-01

The Food & Drug Administration has begun requiring that electronic submissions of regulated clinical studies utilize the Clinical Data Information Standards Consortium data standards. Within regulated clinical research, traceability is a requirement and indicates that the analysis results can be traced back to the original source data. Current solutions for clinical research data traceability are limited in terms of querying, validation and visualization capabilities. This paper describes (1) the development of metadata models to support computable traceability and traceability visualizations that are compatible with industry data standards for the regulated clinical research domain, (2) adaptation of graph traversal algorithms to make them capable of identifying traceability gaps and validating traceability across the clinical research data lifecycle, and (3) development of a traceability query capability for retrieval and visualization of traceability information.

Visualizing and Validating Metadata Traceability within the CDISC Standards

PubMed Central

Hume, Sam; Sarnikar, Surendra; Becnel, Lauren; Bennett, Dorine

2017-01-01

The Food & Drug Administration has begun requiring that electronic submissions of regulated clinical studies utilize the Clinical Data Information Standards Consortium data standards. Within regulated clinical research, traceability is a requirement and indicates that the analysis results can be traced back to the original source data. Current solutions for clinical research data traceability are limited in terms of querying, validation and visualization capabilities. This paper describes (1) the development of metadata models to support computable traceability and traceability visualizations that are compatible with industry data standards for the regulated clinical research domain, (2) adaptation of graph traversal algorithms to make them capable of identifying traceability gaps and validating traceability across the clinical research data lifecycle, and (3) development of a traceability query capability for retrieval and visualization of traceability information. PMID:28815125

CAN CONTINGENT VALUATION MEASURE PASSIVE USE VALUES

EPA Science Inventory

Contingent valuation (CV) is the only method currently available for practically measuring passive-use values. Because proposed laws may require that environmental regulations pass a benefit-cost test, CV has become central to the policy debate on environmental protection. Crit...

77 FR 71028 - Parts and Accessories Necessary for Safe Operation; Grant of Exemption for Transecurity LLC...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-28

... Carrier Safety Regulations (FMCSRs) currently require antennas, transponders, and similar devices to be... the driver's field of view by devices mounted at the top of the windshield. Antennas, transponders and...

ENVIRONMENTAL DESIGN TO ADDRESS AIR POLLUTION AND EQUITY IN SOUTHWESTERN DETROIT

EPA Science Inventory

This project supplements current regulations with creative mitigation strategies, and requires interdisciplinary thinking in order to achieve a balance between local economic, social, and environmental needs by combining scientific knowledge, community engagement and education...

12 CFR 217.122 - Qualification requirements.

Code of Federal Regulations, 2014 CFR

2014-01-01

... related processes; (ii) Have and document a process (which must capture business environment and internal... current business activities, risk profile, technological processes, and risk management processes; and (ii... assessment systems. (D) Business environment and internal control factors. The Board-regulated institution...

AMBIENT AIR MONITORING STRATEGY

EPA Science Inventory

The Clean Air Act requires EPA to establish national ambient air quality standards and to regulate as necessary, hazardous air pollutants. EPA uses ambient air monitoring to determine current air quality conditions, and to assess progress toward meeting these standards and relat...

Cathodic Protection Measurement Through Inline Inspection Technology Uses and Observations

NASA Astrophysics Data System (ADS)

Ferguson, Briana Ley

This research supports the evaluation of an impressed current cathodic protection (CP) system of a buried coated steel pipeline through alternative technology and methods, via an inline inspection device (ILI, CP ILI tool, or tool), in order to prevent and mitigate external corrosion. This thesis investigates the ability to measure the current density of a pipeline's CP system from inside of a pipeline rather than manually from outside, and then convert that CP ILI tool reading into a pipe-to-soil potential as required by regulations and standards. This was demonstrated through a mathematical model that utilizes applications of Ohm's Law, circuit concepts, and attenuation principles in order to match the results of the ILI sample data by varying parameters of the model (i.e., values for over potential and coating resistivity). This research has not been conducted previously in order to determine if the protected potential range can be achieved with respect to the predicted current density from the CP ILI device. Kirchhoff's method was explored, but certain principals could not be used in the model as manual measurements were required. This research was based on circuit concepts which indirectly affected electrochemical processes. Through Ohm's law, the results show that a constant current density is possible in the protected potential range; therefore, indicates polarization of the pipeline, which leads to calcareous deposit development with respect to electrochemistry. Calcareous deposit is desirable in industry since it increases the resistance of the pipeline coating and lowers current, thus slowing the oxygen diffusion process. This research conveys that an alternative method for CP evaluation from inside of the pipeline is possible where the pipe-to-soil potential can be estimated (as required by regulations) from the ILI tool's current density measurement.

Digitally controlled twelve-pulse firing generator

DOE Office of Scientific and Technical Information (OSTI.GOV)

Berde, D.; Ferrara, A.A.

1981-01-01

Control System Studies for the Tokamak Fusion Test Reactor (TFTR) indicate that accurate thyristor firing in the AC-to-DC conversion system is required in order to achieve good regulation of the various field currents. Rapid update and exact firing angle control are required to avoid instabilities, large eddy currents, or parasitic oscillations. The Prototype Firing Generator was designed to satisfy these requirements. To achieve the required /plus or minus/0.77/degree/firing accuracy, a three-phase-locked loop reference was designed; otherwise, the Firing Generator employs digital circuitry. The unit, housed in a standard CAMAC crate, operates under microcomputer control. Functions are performed under program control,more » which resides in nonvolatile read-only memory. Communication with CICADA control system is provided via an 11-bit parallel interface.« less

Transportation improvement program : Richland, Ohio : fiscal year 1997-2000

DOT National Transportation Integrated Search

1996-06-01

As part of the Urban Transportation Planning Process, under the Federal Planning regulations (Title 23 U.S.C. and Title 49 U.S.C.), the Metropolitan Planning Organization (MPO) is required to develop and keep current a Transportation Improvement Prog...

75 FR 77449 - Interagency Appraisal and Evaluation Guidelines

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-10

... manner. Further, the Guidelines promote consistency in the application and enforcement of the Agencies... promote consistency in the application and enforcement of the Agencies' current appraisal requirements and... application of the Agencies' appraisal regulations, thereby promoting safe and sound collateral valuation...

78 FR 76702 - Parts and Accessories Necessary for Safe Operation; Application for an Exemption From Volvo...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-18

... Regulations (FMCSRs) currently require antennas, transponders, and similar devices to be located not more than... the driver's field of view by devices mounted at the top of the windshield. Antennas, transponders and...

A Database and Tool for Boundary Conditions for Regional Air Quality Modeling: Description and Evaluation

EPA Science Inventory

Transported air pollutants receive increasing attention as regulations tighten and global concentrations increase. The need to represent international transport in regional air quality assessments requires improved representation of boundary concentrations. Currently available ob...

Architecture, Voltage, and Components for a Turboelectric Distributed Propulsion Electric Grid

NASA Technical Reports Server (NTRS)

Armstrong, Michael J.; Blackwelder, Mark; Bollman, Andrew; Ross, Christine; Campbell, Angela; Jones, Catherine; Norman, Patrick

2015-01-01

The development of a wholly superconducting turboelectric distributed propulsion system presents unique opportunities for the aerospace industry. However, this transition from normally conducting systems to superconducting systems significantly increases the equipment complexity necessary to manage the electrical power systems. Due to the low technology readiness level (TRL) nature of all components and systems, current Turboelectric Distributed Propulsion (TeDP) technology developments are driven by an ambiguous set of system-level electrical integration standards for an airborne microgrid system (Figure 1). While multiple decades' worth of advancements are still required for concept realization, current system-level studies are necessary to focus the technology development, target specific technological shortcomings, and enable accurate prediction of concept feasibility and viability. An understanding of the performance sensitivity to operating voltages and an early definition of advantageous voltage regulation standards for unconventional airborne microgrids will allow for more accurate targeting of technology development. Propulsive power-rated microgrid systems necessitate the introduction of new aircraft distribution system voltage standards. All protection, distribution, control, power conversion, generation, and cryocooling equipment are affected by voltage regulation standards. Information on the desired operating voltage and voltage regulation is required to determine nominal and maximum currents for sizing distribution and fault isolation equipment, developing machine topologies and machine controls, and the physical attributes of all component shielding and insulation. Voltage impacts many components and system performance.

Application of high-brightness LEDs in aircraft position lights

NASA Astrophysics Data System (ADS)

Machi, Nicolo; Mangum, Scott; Singer, Jeffrey M.

2004-10-01

Solid state lighting devices have made their way into a number of niche markets and continue to make inroads into other markets as their price / performance ratios improve. One of these markets is aviation lighting. Although this paper will focus on the use of LEDs for aircraft position lights, much of the discussion is applicable to other installations on the interior and exterior of the aircraft. The color, light distribution and intensity levels for a position light are all closely regulated through Code of Federal Regulation (CFR; formerly Federal Aviation Regulation (FAR)) documents. These lighting requirements, along with harsh thermal and environmental requirements, drive the design. In this paper, we will look at these requirements and discuss what is required in order to use LEDs for this type of application. We will explore the optical, thermal and electrical issues associated with the use of LEDs for position lights and examine the specific case study of the Astreon forward position lights. Finally, we will discuss some of the challenges that we see with solid state lighting in current and future aircraft applications.

Evaluation of a rapid diagnostic field test kit for identification of Phytophthora ramorum, P. kernoviae and other Phytophthora species at the point of inspection

Treesearch

C.R. Lane; E. Hobden; L. Laurenson; V.C. Barton; K.J.D. Hughes; H. Swan; N. Boonham; A.J. Inman

2008-01-01

Plant health regulations to prevent the introduction and spread of Phytophthora ramorum and P. kernoviae require rapid, cost effective diagnostic methods for screening large numbers of plant samples at the time of inspection. Current on-site techniques require expensive equipment, considerable expertise and are not suited for plant...

Patents for Soldiers

DTIC Science & Technology

2016-06-10

required for the U.S. Army to achieve overmatch of its enemies.6 It is one of the eight tenets prescribed for commanders to consider while conducting ...regulations that are current as of January 1, 2016. Sixth, interviews were generally not conducted due to time constraints, procedural requirements, and a...development process, were searching for such a material to develop a catheter. The named inventors conducted extensive research and demonstrations with this

International laser-safety regulations: a status update

NASA Astrophysics Data System (ADS)

Weiner, Robert M.

1990-07-01

There is an increase in international laser safety requirements as part of the emphasis on world-wide standardization of products and regulations. In particular the documents which will evolve from the 1992 consolidation efforts of the European Community (EC) will impact both laser manufacturers and users. This paper provides a discussion of the current status of the various laser radiation standards. NORTH AMERICAN REQUIREMENTS United States Requirements on manufacturers from the Food and Drug Administration (FDA) have been in effect since 1975. The Center for Devices and Radiological Health (CDRH) within that agency ensures that these mandatory requirements [1] are satisfied. The CDRH regulations include the division of products into classes depending on their potential for hazard criteria for power measurement and requirements for product features labels and manuals and records and reports. Manufacturers must test products and certify that they comply with the CDRH requirements. User requirements are found in a standard published by the American National Standards Institute (ANSI) and in requirements from several individual states. Specific ANSI standards have also been published for fiber communications systems [34] and for lasers in medical applications [35]. Please note that the Appendix includes additional information on the standards discussed in this paper including sources for obtaining the documents. Canada In the past Canada has had requirements for two specified product categories (bar code scanners and educational lasers) [26 These will be replaced

Estimating Energy Consumption of Mobile Fluid Power in the United States

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lynch, Lauren; Zigler, Bradley T.

This report estimates the market size and energy consumption of mobile off-road applications utilizing hydraulic fluid power, and summarizes technology gaps and implementation barriers. Mobile fluid power is the use of hydraulic fluids under pressure to transmit power in mobile equipment applications. The mobile off-road fluid power sector includes various uses of hydraulic fluid power equipment with fundamentally diverse end-use application and operational requirements, such as a skid steer loader, a wheel loader or an agriculture tractor. The agriculture and construction segments dominate the mobile off-road fluid power market in component unit sales volume. An estimated range of energy consumedmore » by the mobile off-road fluid power sector is 0.36 - 1.8 quads per year, which was 1.3 percent - 6.5 percent of the total energy consumed in 2016 by the transportation sector. Opportunities for efficiency improvements within the fluid power system result from needs to level and reduce the peak system load requirements and develop new technologies to reduce fluid power system level losses, both of which may be facilitated by characterizing duty cycles to define standardized performance test methods. There are currently no commonly accepted standardized test methods for evaluating equipment level efficiency over a duty cycle. The off-road transportation sector currently meets criteria emissions requirements, and there are no efficiency regulations requiring original equipment manufacturers (OEM) to invest in new architecture development to improve the fuel economy of mobile off-road fluid power systems. In addition, the end-user efficiency interests are outweighed by low equipment purchase or lease price concerns, required payback periods, and reliability and durability requirements of new architecture. Current economics, low market volumes with high product diversity, and regulation compliance challenge OEM investment in commercialization of new architecture development.« less

The future of the OSHA PSM standard.

PubMed

Kaelin, David E

2014-07-01

The significance of the proposed PSM changes could be to greatly expand coverage of processes in order to include many not currently covered by the PSM regulation. New chemicals will likely be added to Appendix A, and reactive chemicals (a definition will be needed) also may be covered. What exactly will be the definition of a reactive chemical is unclear at this time, although definitions used in New Jersey in the TCPA Act may guide OSHA. It is likely that atmospheric storage of flammable liquids will be included more specifically and the exemption of these tanks eliminated. In applying RAGAGEP, sites may be required to apply the most recent codes and standards to covered processes, perhaps at the time of PHA auditing: A narrowing of the PSM exemption for retail facilities could bring many of them under the PSM regulation at some level. Process safety management practices should be applied to all facilities that store and process hazardous materials that have fire, explosion, reactivity, and toxic properties. If changes are made to the PSM regulation, many new sites will be covered and will need to formally adopt PSM as defined in the OSHA regulation. The addition of reactive chemicals to the PSM regulation will greatly expand the number of processes covered by the regulation. Keeping up with the most current codes, standards, and legislative changes is a daunting task that may require the support of specialists. The results of the proposed legislation will be an increase in the level of process safety excellence throughout the chemical industries.

Development of requirements on safety cases of machine industry products for power engineering

NASA Astrophysics Data System (ADS)

Aronson, K. E.; Brezgin, V. I.; Brodov, Yu. M.; Gorodnova, N. V.; Kultyshev, A. Yu.; Tolmachev, V. V.; Shablova, E. G.

2016-12-01

This article considers security assurance for power engineering machinery in the design and production phases. The Federal Law "On Technical Regulation" and the Customs Union Technical Regulations "On Safety of Machinery and Equipment" are analyzed in the legal, technical, and economic aspect with regard to power engineering machine industry products. From the legal standpoint, it is noted that the practical enforcement of most norms of the Law "On Technical Regulation" makes it necessary to adopt subordinate statutory instruments currently unavailable; moreover, the current level of adoption of technical regulations leaves much to be desired. The intensive integration processes observed in the Eurasian Region in recent years have made it a more pressing task to harmonize the laws of the region's countries, including their technical regulation framework. The technical aspect of analyzing the technical regulation of the Customs Union has been appraised by the IDEF0 functional modeling method. The object of research is a steam turbine plant produced at the turbine works. When developing the described model, we considered the elaboration of safety case (SC) requirements from the standpoint of the chief designer of the turbine works as the person generally responsible for the elaboration of the SC document. The economic context relies on risk analysis and appraisal methods. In their respect, these are determined by the purposes and objectives of analysis, complexity of considered objects, availability of required data, and expertise of specialists hired to conduct the analysis. The article proposes the description of all sources of hazard and scenarios of their actualization in all production phases of machinery life cycle for safety assurance purposes. The detection of risks and hazards allows forming the list of unwanted events. It describes the sources of hazard, various risk factors, conditions for their rise and development, tentative risk appraisals, and elaboration of tentative guidelines for reducing hazard and risk levels.

78 FR 6407 - Ability-to-Repay and Qualified Mortgage Standards Under the Truth in Lending Act (Regulation Z)

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-30

...The Bureau of Consumer Financial Protection (Bureau) is amending Regulation Z, which implements the Truth in Lending Act (TILA). Regulation Z currently prohibits a creditor from making a higher-priced mortgage loan without regard to the consumer's ability to repay the loan. The final rule implements sections 1411 and 1412 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act), which generally require creditors to make a reasonable, good faith determination of a consumer's ability to repay any consumer credit transaction secured by a dwelling (excluding an open-end credit plan, timeshare plan, reverse mortgage, or temporary loan) and establishes certain protections from liability under this requirement for ``qualified mortgages.'' The final rule also implements section 1414 of the Dodd-Frank Act, which limits prepayment penalties. Finally, the final rule requires creditors to retain evidence of compliance with the rule for three years after a covered loan is consummated.

Open consent, biobanking and data protection law: can open consent be 'informed' under the forthcoming data protection regulation?

PubMed

Hallinan, Dara; Friedewald, Michael

2015-01-01

This article focuses on whether a certain form of consent used by biobanks--open consent--is compatible with the Proposed Data Protection Regulation. In an open consent procedure, the biobank requests consent once from the data subject for all future research uses of genetic material and data. However, as biobanks process personal data, they must comply with data protection law. Data protection law is currently undergoing reform. The Proposed Data Protection Regulation is the culmination of this reform and, if voted into law, will constitute a new legal framework for biobanking. The Regulation puts strict conditions on consent--in particular relating to information which must be given to the data subject. It seems clear that open consent cannot meet these requirements. 4 categories of information cannot be provided with adequate specificity: purpose, recipient, possible third country transfers, data collected. However, whilst open consent cannot meet the formal requirements laid out by the Regulation, this is not to say that these requirements are substantially undebateable. Two arguments could be put forward suggesting the applicable consent requirements should be rethought. First, from policy documents regarding the drafting process, it seems that the informational requirements in the Regulation are so strict in order to protect the data subject from risks inherent in the use of the consent mechanism in a certain context--exemplified by the online context. There are substantial differences between this context and the biobanking context. Arguably, a consent transaction in the biobanking does not present the same type of risk to the data subject. If the risks are different, then perhaps there are also grounds for a reconsideration of consent requirements? Second, an argument can be made that the legislator drafted the Regulation based on certain assumptions as to the nature of 'data'. The authors argue that these assumptions are difficult to apply to genetic data and accordingly a different approach to consent might be preferable. Such an approach might be more open consent friendly.

Reduced volatile organic compound (VOC) ammunition coatings. Progress report, October 1994-September 1995

DOE Office of Scientific and Technical Information (OSTI.GOV)

Duncan, J.L.

1996-05-01

Production requirements and film thickness limitations typically require that ammunition coating systems consist of a single film. This single film must provide the corrosion resistance of a primer plus such properties as color, gloss, and solvent resistance that are required of a topcoat, a compromise at best. Federal and local regulations resulting from the Clean Air Act and its amendments restrict the amount of VOC emitted during the application of protective coatings, and regulations on worker safety restrict exposure to hazardous materials such as chromates. These materials also generate hazardous wastes and the associated high disposal costs. This report summarizesmore » progress in developing ammunition coatings that perform as well as or better than current systems, but at reduced VOC levels with chromate-free pigmentation.« less

KLF6 and iNOS regulates apoptosis during respiratory syncytial virus infection

PubMed Central

Mgbemena, Victoria; Segovia, Jesus; Chang, Te-Hung; Bose, Santanu

2013-01-01

Human respiratory syncytial virus (RSV) is a highly pathogenic lung-tropic virus that causes severe respiratory diseases. Enzymatic activity of inducible nitric oxide (iNOS) is required for NO generation. Although NO contributes to exaggerated lung disease during RSV infection, the role of NO in apoptosis during infection is not known. In addition, host trans-activator(s) required for iNOS gene expression during RSV infection is unknown. In the current study we have uncovered the mechanism of iNOS gene induction by identifying kruppel-like factor 6 (KLF6) as a critical transcription factor required for iNOS gene expression during RSV infection. Furthermore, we have also uncovered the role of iNOS as a critical host factor regulating apoptosis during RSV infection. PMID:23831683

A-type potassium currents in smooth muscle.

PubMed

Amberg, Gregory C; Koh, Sang Don; Imaizumi, Yuji; Ohya, Susumu; Sanders, Kenton M

2003-03-01

A-type currents are voltage-gated, calcium-independent potassium (Kv) currents that undergo rapid activation and inactivation. Commonly associated with neuronal and cardiac cell-types, A-type currents have also been identified and characterized in vascular, genitourinary, and gastrointestinal smooth muscle cells. This review examines the molecular identity, biophysical properties, pharmacology, regulation, and physiological function of smooth muscle A-type currents. In general, this review is intended to facilitate the comparison of A-type currents present in different smooth muscles by providing a comprehensive report of the literature to date. This approach should also aid in the identification of areas of research requiring further attention.

Symposium on "The challenge of translating nutrition research into public health nutrition". Session 4: Challenges facing the food industry in innovating for health. Regulatory challenges and opportunities for food innovation.

PubMed

Binns, Nino

2009-02-01

The primary role of the extensive and complex modern food legislation is to protect the consumer. Providing a framework for industry and enabling free trade are secondary aims. In the EU the 2006 Regulation on nutrition and health claims made on foods was adopted in December 2006. This Regulation defines detailed lists of permitted claims with precise conditions, requires foods making claims to meet specific nutrient profiles and requires the submission of a dossier for approval of new health claims. Nutrient profiles and an initial list of existing health claims will not be agreed until January 2009 and January 2010 respectively. The uncertainty about profiles and the initial list of claims as well as the prescriptive nature of the Regulation will have a major impact, some negative but some positive, on food innovation. Worldwide legislation on nutrition and health claims continues to develop. The current paper also provides an outline of some other key pieces of European legislation that affect food innovation. However, currently, all this legislation remains in development and up-to-date information can be sought from the reference material provided.

Food labeling; nutrient content claims, definition of sodium levels for the term "healthy." Final rule.

PubMed

2005-09-29

The Food and Drug Administration (FDA) is amending its regulations concerning the maximum sodium levels permitted for foods that bear the implied nutrient content claim "healthy." The agency is retaining the currently effective, less restrictive, "first-tier" sodium level requirements for all food categories, including individual foods (480 milligrams (mg)) and meals and main dishes (600 mg), and is dropping the "second-tier" (more restrictive) sodium level requirements for all food categories. Based on the comments received about technological barriers to reducing sodium in processed foods and poor sales of products that meet the second-tier sodium level, the agency has determined that requiring the more restrictive sodium levels would likely inhibit the development of new "healthy" food products and risk substantially eliminating existing "healthy" products from the marketplace. After reviewing the comments and evaluating the data from various sources, FDA has become convinced that retaining the higher first-tier sodium level requirements for all food products bearing the term "healthy" will encourage the manufacture of a greater number of products that are consistent with dietary guidelines for a variety of nutrients. The agency has also revised the regulatory text of the "healthy" regulation to clarify the scope and meaning of the regulation and to reformat the nutrient content requirements for "healthy" into a more readable set of tables, consistent with the Presidential Memorandum instructing that regulations be written in plain language.

77 FR 37907 - Information Collection; Service Contracting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-25

... ADMINISTRATION [OMB Control No. 9000-0152: Docket 2012-0076; Sequence 16] Information Collection; Service... request to review and approve an extension of a currently approved information collection requirement... information is necessary for the proper performance of functions of the Federal Acquisition Regulation (FAR...

ENVIRONMENTAL REGULATIONS AND TECHNOLOGY - AUTOTHERMAL THERMOPHILIC AEROBIC DIGESTION OF MUNICIPAL WASTEWATER SLUDGE

EPA Science Inventory

This document describes a promising technology — autothermal thermophilic aerobic digestion — for meeting the current and proposed U.S. federal requirements for pathogen controJ and land application of municipal wastewater sludge. Autothermal thermophilic aerobic digestion, or AT...

78 FR 46406 - Parts and Accessories Necessary for Safe Operation; Application for an Exemption From Help, Inc.

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-31

... Regulations (FMCSRs) currently require antennas, transponders, and similar devices to be located not more than.... Antennas, transponders and similar devices must not be mounted more than 152 mm (6 inches) below the upper...

77 FR 71089 - Pilot Loading of Aeronautical Database Updates

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-29

... the use of newer systems and data-transfer mechanisms such as those employing wireless technology. In... which enables wireless updating of systems and databases. The current regulation does not accommodate... maintenance); Recordkeeping requirements; Training for pilots; Technological advancements in data-transfer...

76 FR 17126 - Federal Acquisition Regulation; Information Collection; Place of Performance

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-28

...; Information Collection; Place of Performance AGENCY: Department of Defense (DOD), General Services... currently approved information collection requirement concerning place of performance. Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of...

7 CFR 926.15 - Importer.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements... RECORDKEEPING REQUIREMENTS APPLICABLE TO CRANBERRIES NOT SUBJECT TO THE CRANBERRY MARKETING ORDER § 926.15... cranberry products into the current of commerce. Effective Date Note: At 71 FR 78046, Dec. 28, 2006, § 926...

Modified Pressure System for Imaging Egg Cracks

USDA-ARS?s Scientific Manuscript database

One aspect of grading table eggs is shell checks or cracks. Currently, USDA voluntary regulations require that humans grade a representative sample of all eggs processed. However, as processing plants and packing facilities continue to increase their volume and throughput, human graders are having ...

Modified Pressure System for Imaging Egg Cracks

USDA-ARS?s Scientific Manuscript database

Abstract One aspect of grading table eggs is shell checks or cracks. Currently, USDA voluntary regulations require that humans grade a representative sample of all eggs processed. However, as processing plants and packing facilities continue to increase their volume and throughput, human graders a...

21 CFR 868.6225 - Nose clip.

Code of Federal Regulations, 2010 CFR

2010-04-01

... ANESTHESIOLOGY DEVICES Miscellaneous § 868.6225 Nose clip. (a) Identification. A nose clip is a device intended to close a patient's external nares (nostrils) during diagnostic or therapeutic procedures. (b... from the current good manufacturing practice requirements of the quality system regulation in part 820...

The Snail Family in Normal and Malignant Haematopoiesis.

PubMed

Carmichael, Catherine L; Haigh, Jody J

2017-01-01

Snail family proteins are key inducers of the epithelial-mesenchymal transition (EMT), a critical process required for normal embryonic development. They have also been strongly implicated in regulating the EMT-like processes required for tumour cell invasion, migration, and metastasis. Whether these proteins also contribute to normal blood cell development, however, remains to be clearly defined. Increasing evidence supports a role for the Snail family in regulating cell survival, migration, and differentiation within the haematopoietic system, as well as potentially an oncogenic role in the malignant transformation of haematopoietic stem cells. This review will provide a broad overview of the Snail family, including key aspects of their involvement in the regulation and development of solid organ cancer, as well as a discussion on our current understanding of Snail family function during normal and malignant haematopoiesis. © 2017 S. Karger AG, Basel.

[On the implementation by Rospotrebnadzor (Federal service for the oversight of consumer protection and welfare) common principles and rules of technical regulation within the agreement of the Customs Union].

PubMed

Onishchenko, G G

2013-01-01

In accordance with the Agreement of the Customs Union on sanitary measures between the Government of the Russian Federation, the Republic of Belarus and the Republic of Kazakhstan in the customs territory of the Customs Union the Uniform sanitary and epidemiological and hygienic requirements for goods subject to sanitary-epidemiological control are applied. Common sanitary requirements are binding for executive authorities of the Member States of the Customs union, local authorities, legal persons, whatever legalform, individual entrepreneurs, individuals. Currently, out of 47 planned to take priority technical regulations of the Customs Union 31 regulation, including the safety of railway rolling stock, production of perfumery and cosmetics, toys and products for children and teenagers, food products, grain, and other furniture products was adopted.

An Evaluation of New York City's 2015 Birth Certificate Gender Marker Regulation.

PubMed

Lee, Erica J; Gurr, Danielle; Van Wye, Gretchen

2017-10-01

In 1971, the New York City (NYC) Department of Health and Mental Hygiene amended Section 207.05 of the NYC Health Code to allow individuals who had undergone "convertive surgery" (interpreted by the code to mean genital surgery) to amend the gender on their birth certificates. This surgery requirement was removed in 2015. In a survey evaluating the regulation change, we sought to characterize the transgender population newly eligible to obtain a gender-congruent NYC birth certificate by comparing respondents with and without genital surgery. We mailed a 42-question survey with each newly issued birth certificate. We compared respondents across current gender identity, race, Hispanic ethnicity, age, insurance status, income, current general health status, other transition-related care obtained, and healthcare access, stigma, and discrimination. Of 642 applicants, 219 responded and were thus enrolled in our 5-year study (34.1%). Most (n = 158 out of 203 who answered, 77.8%) had not received genital surgery. Compared to respondents with genital surgery, respondents without surgery were significantly more likely to be transgender men (50.0% vs. 20.0%); younger (median age 32 vs. 56.5); on Medicaid (31.6% vs. 11.1%); identify as Hispanic (28.5% vs. 8.9%); and live in households making <$20,000 annually (35.3% vs. 12.8%). Removing a genital surgery requirement more equitably enables transgender men and those with limited resources to obtain a gender-congruent birth certificate. Jurisdictions with such requirements should consider similar regulation changes to address the inequities that this requirement likely imposes in accessing birth certificates.

78 FR 79315 - Copayments for Medications in 2014

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-30

...The Department of Veterans Affairs (VA) amends its medical regulations concerning the copayment required for certain medications. But for this rulemaking, beginning on January 1, 2014, the copayment amount would increase based on a formula set forth in regulation. The maximum annual copayment amount payable by veterans would also increase. This rulemaking freezes copayments at the current rate for 2014 for veterans in priority categories 2 through 8, and thereafter resumes increasing copayments in accordance with the regulatory formula.

Environmentally regulated aerospace coatings

NASA Technical Reports Server (NTRS)

Morris, Virginia L.

1995-01-01

Aerospace coatings represent a complex technology which must meet stringent performance requirements in the protection of aerospace vehicles. Topcoats and primers are used, primarily, to protect the structural elements of the air vehicle from exposure to and subsequent degradation by environmental elements. There are also many coatings which perform special functions, i.e., chafing resistance, rain erosion resistance, radiation and electric effects, fuel tank coatings, maskants, wire and fastener coatings. The scheduled promulgation of federal environmental regulations for aerospace manufacture and rework materials and processes will regulate the emissions of photochemically reactive precursors to smog and air toxics. Aerospace organizations will be required to identify, qualify and implement less polluting materials. The elimination of ozone depleting chemicals (ODC's) and implementation of pollution prevention requirements are added constraints which must be addressed concurrently. The broad categories of operations affected are the manufacture, operation, maintenance, and repair of military, commercial, general aviation, and space vehicles. The federal aerospace regulations were developed around the precept that technology had to be available to support the reduction of organic and air toxic emissions, i.e., the regulations cannot be technology forcing. In many cases, the regulations which are currently in effect in the South Coast Air Quality Management District (SCAQMD), located in Southern California, were used as the baseline for the federal regulations. This paper addresses strategies used by Southern California aerospace organizations to cope with these regulatory impacts on aerospace productions programs. All of these regulatory changes are scheduled for implementation in 1993 and 1994, with varying compliance dates established.

21 CFR 886.1870 - Stereoscope.

Code of Federal Regulations, 2012 CFR

2012-04-01

...-dimensional appearance of solidity and relief. It is intended to measure the angle of strabismus (eye muscle... exercises of eye muscles. (b) Classification. Class I (general controls). The AC-powered device and the... current good manufacturing practice requirements of the quality system regulation in part 820 of this...

21 CFR 886.1870 - Stereoscope.

Code of Federal Regulations, 2014 CFR

2014-04-01

...-dimensional appearance of solidity and relief. It is intended to measure the angle of strabismus (eye muscle... exercises of eye muscles. (b) Classification. Class I (general controls). The AC-powered device and the... current good manufacturing practice requirements of the quality system regulation in part 820 of this...

21 CFR 886.1870 - Stereoscope.

Code of Federal Regulations, 2013 CFR

2013-04-01

...-dimensional appearance of solidity and relief. It is intended to measure the angle of strabismus (eye muscle... exercises of eye muscles. (b) Classification. Class I (general controls). The AC-powered device and the... current good manufacturing practice requirements of the quality system regulation in part 820 of this...

49 CFR 236.338 - Mechanical locking required in accordance with locking sheet and dog chart.

Code of Federal Regulations, 2012 CFR

2012-10-01

... locking sheet and dog chart. 236.338 Section 236.338 Transportation Other Regulations Relating to... in accordance with locking sheet and dog chart. Mechanical locking shall be in accordance with locking sheet and dog chart currently in effect. ...

49 CFR 236.338 - Mechanical locking required in accordance with locking sheet and dog chart.

Code of Federal Regulations, 2014 CFR

2014-10-01

... locking sheet and dog chart. 236.338 Section 236.338 Transportation Other Regulations Relating to... in accordance with locking sheet and dog chart. Mechanical locking shall be in accordance with locking sheet and dog chart currently in effect. ...

49 CFR 236.338 - Mechanical locking required in accordance with locking sheet and dog chart.

Code of Federal Regulations, 2013 CFR

2013-10-01

... locking sheet and dog chart. 236.338 Section 236.338 Transportation Other Regulations Relating to... in accordance with locking sheet and dog chart. Mechanical locking shall be in accordance with locking sheet and dog chart currently in effect. ...

5 CFR 843.303 - Marriage duration requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... cause of death for criminal or insurance purposes is conclusive evidence of whether a death is accidental. (3) A death certificate showing the cause of death as accident or homicide is prima facie... REGULATIONS (CONTINUED) FEDERAL EMPLOYEES RETIREMENT SYSTEM-DEATH BENEFITS AND EMPLOYEE REFUNDS Current and...

49 CFR 236.338 - Mechanical locking required in accordance with locking sheet and dog chart.

Code of Federal Regulations, 2011 CFR

2011-10-01

... locking sheet and dog chart. 236.338 Section 236.338 Transportation Other Regulations Relating to... in accordance with locking sheet and dog chart. Mechanical locking shall be in accordance with locking sheet and dog chart currently in effect. ...

41 CFR 101-30.604 - Availability.

Code of Federal Regulations, 2014 CFR

2014-07-01

... FEDERAL PROPERTY MANAGEMENT REGULATIONS SUPPLY AND PROCUREMENT 30-FEDERAL CATALOG SYSTEM 30.6-GSA Section of the Federal Supply Catalog § 101-30.604 Availability. Agencies that require current copies of and desire to be placed on distribution lists to receive Federal supply catalogs and related publications...

41 CFR 101-30.604 - Availability.

Code of Federal Regulations, 2013 CFR

2013-07-01

... FEDERAL PROPERTY MANAGEMENT REGULATIONS SUPPLY AND PROCUREMENT 30-FEDERAL CATALOG SYSTEM 30.6-GSA Section of the Federal Supply Catalog § 101-30.604 Availability. Agencies that require current copies of and desire to be placed on distribution lists to receive Federal supply catalogs and related publications...

41 CFR 101-30.604 - Availability.

Code of Federal Regulations, 2012 CFR

2012-07-01

... FEDERAL PROPERTY MANAGEMENT REGULATIONS SUPPLY AND PROCUREMENT 30-FEDERAL CATALOG SYSTEM 30.6-GSA Section of the Federal Supply Catalog § 101-30.604 Availability. Agencies that require current copies of and desire to be placed on distribution lists to receive Federal supply catalogs and related publications...

41 CFR 101-30.604 - Availability.

Code of Federal Regulations, 2010 CFR

2010-07-01

... FEDERAL PROPERTY MANAGEMENT REGULATIONS SUPPLY AND PROCUREMENT 30-FEDERAL CATALOG SYSTEM 30.6-GSA Section of the Federal Supply Catalog § 101-30.604 Availability. Agencies that require current copies of and desire to be placed on distribution lists to receive Federal supply catalogs and related publications...

41 CFR 101-30.604 - Availability.

Code of Federal Regulations, 2011 CFR

2011-07-01

... FEDERAL PROPERTY MANAGEMENT REGULATIONS SUPPLY AND PROCUREMENT 30-FEDERAL CATALOG SYSTEM 30.6-GSA Section of the Federal Supply Catalog § 101-30.604 Availability. Agencies that require current copies of and desire to be placed on distribution lists to receive Federal supply catalogs and related publications...

77 FR 66539 - Freedom of Information Act Regulations

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-06

...) (electronic reading room), (d) (pamphlets distribution), (e) (records disposition), Sec. 1401.22 (deletion... Information policy. * * * * * (c) FMCS maintains a public reading room that contains the records required by... available for public inspection and copying a current subject-matter index of its reading room records. Each...

Social Moderation, Assessment and Assuring Standards for Accounting Graduates

ERIC Educational Resources Information Center

Watty, Kim; Freeman, Mark; Howieson, Bryan; Hancock, Phil; O'Connell, Brendan; de Lange, Paul; Abraham, Anne

2014-01-01

Evidencing student achievement of standards is a growing imperative worldwide. Key stakeholders (including current and prospective students, government, regulators and employers) want confidence that threshold learning standards in an accounting degree have been assured. Australia's new higher education regulatory environment requires that student…

49 CFR 236.338 - Mechanical locking required in accordance with locking sheet and dog chart.

Code of Federal Regulations, 2010 CFR

2010-10-01

... locking sheet and dog chart. 236.338 Section 236.338 Transportation Other Regulations Relating to... in accordance with locking sheet and dog chart. Mechanical locking shall be in accordance with locking sheet and dog chart currently in effect. ...

EVALUATION OF A DNA PROBE TEST KIT FOR DETECTION OF SALMONELLAE IN BIOSOLIDS

EPA Science Inventory

Aims: Current United States regulations (40 CFR 503) for "Class A" biosolids requires use of multiple-tube fermentation techniques for fecal coliform or multiple tube enrichment techniques for Salmonella spp. followed by isolation and biochemical and serological confirmation. T...

Liminality and the Limits of Law in Health Research Regulation: What are we Missing in the Spaces in-Between?

PubMed Central

2017-01-01

Abstract This article fundamentally challenges the way in which law currently regulates human health research. It invokes the anthropological concept of liminality—the quality of in-between-ness—to suggest deeper ways of understanding ongoing challenges in delivering acceptable and effective regulation of research involving human participants. In stark contrast to the structural regulatory spaces constructed by law, the metaphor of the liminal space is explored to explain what is lost through our failure to see health research regulation as an inherently human experiential process, involving potentially profound transformative events for participants and researchers alike. The implications for the future of health research regulation are then examined. In particular, the analysis calls into question key features of the current regulatory paradigm, and demands that we reconsider our own demands of law in this context. The argument is made that health research is a liminal process and that we fail to treat it as such. This requires a rethink of corollary regulation also in processual terms. Ultimately, the charge is to undertake a radical reimagining of regulatory space to accommodate and promote liminal regulatory spaces. PMID:27940525

Liminality and the Limits of Law in Health Research Regulation: What are we Missing in the Spaces in-Between?

PubMed

Laurie, Graeme

2017-02-01

This article fundamentally challenges the way in which law currently regulates human health research. It invokes the anthropological concept of liminality-the quality of in-between-ness-to suggest deeper ways of understanding ongoing challenges in delivering acceptable and effective regulation of research involving human participants. In stark contrast to the structural regulatory spaces constructed by law, the metaphor of the liminal space is explored to explain what is lost through our failure to see health research regulation as an inherently human experiential process, involving potentially profound transformative events for participants and researchers alike. The implications for the future of health research regulation are then examined. In particular, the analysis calls into question key features of the current regulatory paradigm, and demands that we reconsider our own demands of law in this context. The argument is made that health research is a liminal process and that we fail to treat it as such. This requires a rethink of corollary regulation also in processual terms. Ultimately, the charge is to undertake a radical reimagining of regulatory space to accommodate and promote liminal regulatory spaces. © The Author 2016. Published by Oxford University Press.

[Legal framework of data protection : current requirements in Germany and requirements in planned European Union regulations].

PubMed

Schütze, B

2013-05-01

The federal system in Germany necessitates that in addition to federal laws, country and church-specific legislations must also be considered during the evaluation of relevant legal stipulations concerning data protection. Furthermore, there are also special legal regulations for hospitals in almost every federal state which are governed by the principle of subsidiarity: special legal regulations are to be preferentially used, so that findings from one federal state are difficult to transfer to another federal state.Patient data may only be used and processed without legal regulations with informed consent of the patient. The use of patient data for purposes of quality assurance, research and further education of students and doctors is possible under the present laws according to a positive weighting of interests. Patient data can also be exchanged via online services for the purposes of patient care; however, informed consent of the patient for medical online services is almost always unavoidable.

STEP activation by Gαq coupled GPCRs opposes Src regulation of NMDA receptors containing the GluN2A subunit

PubMed Central

Tian, Meng; Xu, Jian; Lei, Gang; Lombroso, Paul J.; Jackson, Michael F.; MacDonald, John F.

2016-01-01

N-methyl-D-aspartate receptors (NMDARs) are necessary for the induction of synaptic plasticity and for the consolidation of learning and memory. NMDAR function is tightly regulated by functionally opposed families of kinases and phosphatases. Herein we show that the striatal-enriched protein tyrosine phosphatase (STEP) is recruited by Gαq-coupled receptors, including the M1 muscarinic acetylcholine receptor (M1R), and opposes the Src tyrosine kinase-mediated increase in the function of NMDARs composed of GluN2A. STEP activation by M1R stimulation requires IP3Rs and can depress NMDA-evoked currents with modest intracellular Ca2+ buffering. Src recruitment by M1R stimulation requires coincident NMDAR activation and can augment NMDA-evoked currents with high intracellular Ca2+ buffering. Our findings suggest that Src and STEP recruitment is contingent on differing intracellular Ca2+ dynamics that dictate whether NMDAR function is augmented or depressed following M1R stimulation. PMID:27857196

A Voltage Dependent Non-Inactivating Na+ Channel Activated during Apoptosis in Xenopus Oocytes

PubMed Central

Englund, Ulrika H.; Gertow, Jens; Kågedal, Katarina; Elinder, Fredrik

2014-01-01

Ion channels in the plasma membrane are important for the apoptotic process. Different types of voltage-gated ion channels are up-regulated early in the apoptotic process and block of these channels prevents or delays apoptosis. In the present investigation we examined whether ion channels are up-regulated in oocytes from the frog Xenopus laevis during apoptosis. The two-electrode voltage-clamp technique was used to record endogenous ion currents in the oocytes. During staurosporine-induced apoptosis a voltage-dependent Na+ current increased three-fold. This current was activated at voltages more positive than 0 mV (midpoint of the open-probability curve was +55 mV) and showed almost no sign of inactivation during a 1-s pulse. The current was resistant to the Na+-channel blockers tetrodotoxin (1 µM) and amiloride (10 µM), while the Ca2+-channel blocker verapamil (50 µM) in the bath solution completely blocked the current. The intracellular Na+ concentration increased in staurosporine-treated oocytes, but could be prevented by replacing extracellular Na+ whith either K+ or Choline+. Prevention of this influx of Na+ also prevented the STS-induced up-regulation of the caspase-3 activity, suggesting that the intracellular Na+ increase is required to induce apoptosis. Taken together, we have found that a voltage dependent Na+ channel is up-regulated during apoptosis and that influx of Na+ is a crucial step in the apoptotic process in Xenopus oocytes. PMID:24586320

Encouraging Maternal Sacrifice: How Regulations Governing the Consumption of Pharmaceuticals During Pregnancy Prioritize Fetal Safety over Maternal Health and Autonomy.

PubMed

Donley, Greer

Pregnant women are routinely faced with the stressful decision of whether to consume needed medications during their pregnancies. Because the risks associated with pharmaceutical drug consumption during pregnancy are largely unknown, pregnant women both inadvertently consume dangerous medications and avoid needed drugs. Both outcomes are harmful to pregnant women and their fetuses. This unparalleled lack of drug safety information is a result of ill-conceived, paternalistic regulations in two areas of the law: regulations governing ethical research in human subjects and regulations that dictate the required labels on drugs. The former categorizes pregnant women as "vulnerable" and thus precludes them from most medical research. The result is that ninety-one percent of drugs lack any reliable safety information for pregnant consumers. The latter currently requires all drug labels to encourage drug avoidance during pregnancy, despite ample evidence that avoiding needed medications can harm pregnant women. On June 30, 2015, new pregnancy labeling regulations took effect. Though these regulations make important improvements, they continue to treat pregnant women unlike any population, including other unique subpopulations, such as children. As a result, the new regulations do not fix the problem of over-warning pregnant women about the risks of drug consumption. This article questions the legitimacy of both regulations and suggests three reforms for how to improve access to vital safety information: (1) amend the regulations governing ethical research in human subjects to reclassify pregnant women as non-vulnerable adults; (2) create incentives to generate safety data in pregnant women by granting a period of market exclusivity for drug companies that invest in this research; and (3) make the FDA pregnancy labeling regulations consistent with the routine FDA practice of requiring the display of balanced, human data on risk.

[Inconsistencies between building regulations in force in Italy for indoor environment and wellness factors].

PubMed

Faggioli, A; Capasso, L

2015-01-01

Indoor environment is one of major health determinants, and the regulations that set the sanitary requirements are of primary importance for the protection of public health. The authors analyse the critical aspects of the complex Italian regulatory system, starting from the EU regulations, through national and regional laws, and finally the municipal regulations. They underline the need for more uniformity and clarity in the determination of health standards, as well as for a simplification of the existing legislation. Moreover, they highlight the importance of controlling and monitoring indoor environment, currently almost completely absent in Italy due to the effects of the regulatory changes of the latest years.

2005 Donor Eligibility Requirements: Unintended Consequences for Stem Cell Development.

PubMed

Couture, Larry A; Carpenter, Melissa K

2015-10-01

Several human embryonic stem cell (hESC)-derived cell therapeutics have entered clinical testing and more are in various stages of preclinical development. The U.S. Food and Drug Administration (FDA) regulates these products under existing regulations and has stated that these products do not constitute a new class of biologic. However, as human tissue, hESCs are subject to regulations that were developed before hESCs were first described. The regulations have not been revised since 2005, well before the first hESC-derived product entered clinical studies. The current regulations require donors of hESCs to be tested in the same manner as donors of tissues intended for transplantation. However, because hESC-derived cell products are more than minimally manipulated, they are also subject to the same end-of-production release testing as most other biologic agents. In effect, this makes hESC products subject to redundant testing. No other biologic is subject to a similar testing requirement. Furthermore, the regulations that require donor testing are specifically applicable to hESC cells harvested from donors after a date in 2005. It is unclear which regulations cover hESCs harvested before 2005. Ambiguity in the guidelines and redundant testing requirements have unintentionally created a burdensome regulatory paradigm for these products and reluctance on the part of developers to invest in these promising therapeutics. We propose a simple solution that would address FDA safety concerns, eliminate regulatory uncertainty and risk, and provide flexibility for the FDA in the regulation of hESC-derived cell therapies. Regulatory ambiguity concerning donor eligibility screening and testing requirements for human embryonic stem cell lines, in particular those lines created before 2005, are causing significant concern for drug developers. Technically, most of these lines fail to meet eligibility under U.S. Food and Drug Administration (FDA) rules for product licensure, and many developers are unaware that FDA approval to begin trials under an exemption is not an assurance that the FDA will grant licensure of the product. This Perspective outlines the ambiguity and the problem it has caused and proposes a workable solution. The intent is to generate stakeholder and FDA discussion on this issue. ©AlphaMed Press.

A 0.18 μm CMOS LDO Regulator for an On-Chip Sensor Array Impedance Measurement System.

PubMed

Pérez-Bailón, Jorge; Márquez, Alejandro; Calvo, Belén; Medrano, Nicolás

2018-05-02

This paper presents a fully integrated 0.18 μm CMOS Low-Dropout (LDO) Voltage Regulator specifically designed to meet the stringent requirements of a battery-operated impedance spectrometry multichannel CMOS micro-instrument. The proposed LDO provides a regulated 1.8 V voltage from a 3.6 V to 1.94 V battery voltage over a −40 °C to 100 °C temperature range, with a compact topology (<0.10 mm² area) and a constant quiescent current of only 7.45 μA with 99.985% current efficiency, achieving remarkable state-of-art Figures of Merit (FoMs) for the regulating⁻transient performance. Experimental measurements validate its suitability for the target application, paving the way towards the future achievement of a truly portable System on Chip (SoC) platform for impedance sensors.

75 FR 8180 - Proposed Agency Information Collection Activities; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-23

... Emergency Preparedness. OMB Control Number: 2130-0545. Type of Request: Extension of a currently approved... passenger train emergency regulations set forth in 49 CFR Parts 223 and 239 which require railroads to meet minimum Federal standards for the preparation, adoption, and implementation of emergency preparedness...

42 CFR 405.2401 - Scope and definitions.

Code of Federal Regulations, 2010 CFR

2010-10-01

... to time, but usually not less frequently than once every 60 days. Nurse-midwife means a registered professional nurse who meets the following requirements: (1) Is currently licensed to practice in the State as a registered professional nurse. (2) Is legally authorized under State law or regulations to...

75 FR 21503 - Transferring Certain Enforcement Hotline Matters to the Dispute Resolution Service

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-26

.... Currently, the Commission's regulations require that natural gas pipeline companies provide contact... project under the Natural Gas Act. In practice, the Enforcement Hotline also attempts to resolve disputes between individuals and natural gas pipeline companies on all certificated construction projects under the...

Learning Disabilities. Final Report.

ERIC Educational Resources Information Center

Delaware State Dept. of Education, Dover.

This report responds to Delaware state legislation requiring the development of proposed revised regulations for the classification of students as learning disabled (LD). The report first describes the current system, noting that in 1997 15 percent of the student population were served under the Individuals with Disabilities Education Act and over…

75 FR 38854 - Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-06

... compliance for these respondents is $621,270.00 per year (10,530 burden hours multiplied by $59/hour... Regulation ATS. There are currently 81 respondents. These respondents will spend approximately 10,530 hours per year (81 respondents at 130 burden hours/respondent) to comply with the recordkeeping requirements...

76 FR 42127 - Federal Acquisition Regulation; Submission for OMB Review; Place of Performance

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-18

..., company name (if any), and ``Information Collection 9000-0047 Place of Performance'' on your attached...; Submission for OMB Review; Place of Performance AGENCY: Department of Defense (DOD), General Services... currently approved information collection requirement concerning place of performance. Public comments are...

78 FR 46583 - Agency Information Collection Activities; Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-01

... ask the Office of Management and Budget (OMB) to extend through November 30, 2016, the current Paperwork Reduction Act (PRA) clearance for the FTC's shared enforcement with the Consumer Financial Protection Bureau (CFPB) of the information collection requirements in Regulation N (Mortgage Acts and...

76 FR 52383 - Reports, Forms, and Recordkeeping Requirements

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-22

... OMB: Title: 49 CFR 575--Consumer Information Regulations (sections 103 and 105) Quantitative Research... research and is now requesting to conduct follow- up quantitative research with consumers to assess current.... The results of that research phase were used to inform the quantitative phase of research which this...

STANDARDIZATION AND VALIDATION OF METHODS FOR ENUMERATION OF FECAL COLIFORM AND SALMONELLA IN BIOSOLIDS

EPA Science Inventory

Current federal regulations required monitoring for fecal coliforms or Salmonella in biosolids destined for land application. Methods used for analysis of fecal coliforms and Salmonella were reviewed and a standard protocol was developed. The protocols were then...

STANDARDIZATION AND VALIDATION OF METHODS FOR ENUMERATION OF FECAL COLIFORM AND SALMONELLA IN BIOSOLIDS

EPA Science Inventory

Current federal regulations require monitoring for fecal coliforms or Salmonella in biosolids destined for land application. Methods used for analysis of fecal coliforms and Salmonella were reviewed and a standard protocol was developed. The protocols were then evaluated by testi...

[Municipal Health Promotion in Germany: Duties, Rights and Potential].

PubMed

Walter, U; Volkenand, K

2017-04-01

Municipalities have an overarching structure in health promotion. Due to the right to self-government, municipalities are in charge of both voluntary and obligatory tasks. Some of the original and fundamental tasks can be summarized as "services to the public". Current common definitions do not include the term "health promotion". In the present study, a sub-target of a joint project, legal acts, requirements and recommendations were researched and analyzed. The results show substantive cornerstones of health promotion in various regulations of different disciplines. Based on these findings, health promotion can be interpreted as being part of services to the public. Currently the regulations for education, social tasks, environmental and consumer protection constitute the legal framework for community health promotion, but also include constitutions. They range from public international law to municipal resolutions. Quality management and also quality development are already an integral part in some communal departments. The management of structures, processes and results arises from commitments or measurable targets. In contrast, quality management for health promotion is not based on binding requirements. Specifications of other neighboring sectors (e. g. education, social sector) demonstrate the potential and effectiveness of legal policy guidelines, seen as a frame. A transparent communication about the current regulations is indispensable for formulating future guidelines. The German National Prevention Act opens opportunities for municipalities. However, its interpretation and local engagement will still guide the practice of communal health promotion. © Georg Thieme Verlag KG Stuttgart · New York.

75 FR 26121 - Regulation of Fuels and Fuel Additives: Alternative Affirmative Defense Requirements for Ultra...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-11

...EPA is issuing a direct final rule to amend the diesel sulfur regulations to allow refiners, importers, distributors, and retailers of highway diesel fuel the option to use an alternative affirmative defense if the Agency finds highway diesel fuel samples above the specified sulfur standard at retail facilities. This alternative defense consists of a comprehensive program of quality assurance sampling and testing that would cover all participating companies that produce and/or distribute highway diesel fuel if certain other conditions are met. The sampling and testing program would be carried out by an independent surveyor. The program would be conducted pursuant to a survey plan approved by EPA that is designed to achieve the same objectives as the current regulatory quality assurance requirement. This rule also amends the gasoline benzene regulations to allow disqualified small refiners the same opportunity to generate gasoline benzene credits as that afforded to non-small refiners.

Improving medical device regulation: the United States and Europe in perspective.

PubMed

Sorenson, Corinna; Drummond, Michael

2014-03-01

Recent debates and events have brought into question the effectiveness of existing regulatory frameworks for medical devices in the United States and Europe to ensure their performance, safety, and quality. This article provides a comparative analysis of medical device regulation in the two jurisdictions, explores current reforms to improve the existing systems, and discusses additional actions that should be considered to fully meet this aim. Medical device regulation must be improved to safeguard public health and ensure that high-quality and effective technologies reach patients. We explored and analyzed medical device regulatory systems in the United States and Europe in accordance with the available gray and peer-reviewed literature and legislative documents. The two regulatory systems differ in their mandate and orientation, organization, pre- and postmarket evidence requirements, and transparency of process. Despite these differences, both jurisdictions face similar challenges for ensuring that only safe and effective devices reach the market, monitoring real-world use, and exchanging pertinent information on devices with key users such as clinicians and patients. To address these issues, reforms have recently been introduced or debated in the United States and Europe that are principally focused on strengthening regulatory processes, enhancing postmarket regulation through more robust surveillance systems, and improving the traceability and monitoring of devices. Some changes in premarket requirements for devices are being considered. Although the current reforms address some of the outstanding challenges in device regulation, additional steps are needed to improve existing policy. We examine a number of actions to be considered, such as requiring high-quality evidence of benefit for medium- and high-risk devices; moving toward greater centralization and coordination of regulatory approval in Europe; creating links between device identifier systems and existing data collection tools, such as electronic health records; and fostering increased and more effective use of registries to ensure safe postmarket use of new and existing devices. © 2014 Milbank Memorial Fund.

Improving Medical Device Regulation: The United States and Europe in Perspective

PubMed Central

SORENSON, CORINNA; DRUMMOND, MICHAEL

2014-01-01

Context: Recent debates and events have brought into question the effectiveness of existing regulatory frameworks for medical devices in the United States and Europe to ensure their performance, safety, and quality. This article provides a comparative analysis of medical device regulation in the two jurisdictions, explores current reforms to improve the existing systems, and discusses additional actions that should be considered to fully meet this aim. Medical device regulation must be improved to safeguard public health and ensure that high-quality and effective technologies reach patients. Methods: We explored and analyzed medical device regulatory systems in the United States and Europe in accordance with the available gray and peer-reviewed literature and legislative documents. Findings: The two regulatory systems differ in their mandate and orientation, organization, pre-and postmarket evidence requirements, and transparency of process. Despite these differences, both jurisdictions face similar challenges for ensuring that only safe and effective devices reach the market, monitoring real-world use, and exchanging pertinent information on devices with key users such as clinicians and patients. To address these issues, reforms have recently been introduced or debated in the United States and Europe that are principally focused on strengthening regulatory processes, enhancing postmarket regulation through more robust surveillance systems, and improving the traceability and monitoring of devices. Some changes in premarket requirements for devices are being considered. Conclusions: Although the current reforms address some of the outstanding challenges in device regulation, additional steps are needed to improve existing policy. We examine a number of actions to be considered, such as requiring high-quality evidence of benefit for medium-and high-risk devices; moving toward greater centralization and coordination of regulatory approval in Europe; creating links between device identifier systems and existing data collection tools, such as electronic health records; and fostering increased and more effective use of registries to ensure safe postmarket use of new and existing devices. PMID:24597558

Predicting wood pellet stove ownership and acquisition in Albuquerque, NM

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lansford, R.; Skaggs, R.; Owensby, F.

1994-12-31

Wood pellet stove (WPS) ownership and acquisition in Albuquerque, New Mexico was predicted using a model of qualitative choice. Using data obtained from a telephone survey, households were divided into four groups: current WPS owners, non-owners considering ownership, non-owners not considering ownership, and those who had not heard of WPS technology. Variables used to predict what category a household will be in include homeowners` socioeconomic and home-heating characteristics. Results indicate few WPS stoves are currently in use in Albuquerque. However, current WPS owners and those considering WPS acquisition tend to have higher incomes, more years of education, larger homes, andmore » use their fireplaces more frequently than average. Clean air regulations in Albuquerque will require changes in home woodburning. The WPS is an efficient and clean device; however, lack of knowledge of WPS technology, satisfaction with current heating systems, and limited awareness of the potential impact of clean air regulations indicate WPS usage in Albuquerque will remain limited.« less

76 FR 213 - National Environmental Policy Act Implementing Procedures

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-03

...The U.S. Department of Energy (DOE or the Department) proposes to amend its existing regulations governing compliance with the National Environmental Policy Act (NEPA). The majority of the changes are proposed for the categorical exclusions provisions contained in its NEPA Implementing Procedures, with a small number of related changes proposed for other provisions. These proposed changes are intended to better align the Department's regulations, particularly its categorical exclusions, with DOE's current activities and recent experiences, and to update the provisions with respect to current technologies and regulatory requirements. DOE proposes to establish 20 new categorical exclusions, and to remove two categorical exclusion categories, one environmental assessment (EA) category, and two environmental impact statement (EIS) categories. Other proposed changes modify and clarify DOE's existing provisions.

75 FR 68570 - Approval and Disapproval and Promulgation of Air Quality Implementation Plans; Colorado; Revision...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-08

... and with current Federal NSR regulations. These definitions include clean coal technology, electric... restrictions on increment consumption, add innovative control technology as an alternative to BACT requirements... initials RACT mean or refer to Reasonably Available Control Technology, and the initials NAAQS mean or...

48 CFR 570.401 - Renewal options.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 4 2010-10-01 2010-10-01 false Renewal options. 570.401... Requirements 570.401 Renewal options. (a) Exercise of options. Before exercising an option to renew, follow the... survey. Before exercising an option to renew a lease, review current market information to ensure the...

77 FR 71083 - Regulations Affecting Credit Unions; Technical Amendments

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-29

...(d)(3) of the APA.\\15\\ The rule will, therefore, be effective immediately upon publication. \\14\\ 5 U...) of Appendix A to part 749 states that credit unions should permanently retain all current manuals... NCUA and other governmental agencies. This requirement has become outdated. All publications noted in...

microRNAs of parasites: current status and future perspectives

USDA-ARS?s Scientific Manuscript database

MicroRNAs (miRNAs) are a class of endogenous non-coding small RNAs regulating gene expression in eukaryotes at the post-transcriptional level. The complex life cycles of parasites may require the ability to respond to environmental and developmental signals through miRNA-mediated gene expression. Ov...

A PRELIMINARY EVALUATION OF MODELS-3 CMAQ USING PARTICULATE MATTER DATA FROM THE IMPROVE NETWORK

EPA Science Inventory

The Clean Air Act and its Amendments require the United States Environmental Protection Agency (EPA) to establish National Ambient Air Quality Standards for Particulate Matter (PM) and to assess current and future air quality regulations designed to protect human health and wel...

75 FR 72827 - Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-26

... Manufacturing Practice Regulations for Type A Medicated Articles AGENCY: Food and Drug Administration, HHS... on the recordkeeping requirements for manufacturers of type A medicated articles. DATES: Submit... Type A Medicated Articles--21 CFR Part 226 (OMB Control Number 0910-0154)--Extension Under section 501...

77 FR 39194 - Combined Drug and Alcohol Testing Programs

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-02

...-0688; Notice No. 12-04] RIN 2120-AK01 Combined Drug and Alcohol Testing Programs AGENCY: Federal... tour operations to combine the drug and alcohol testing required for each operation into one testing... programs while maintaining the level of safety intended by the current drug and alcohol testing regulations...

77 FR 65508 - Annual Charge Filing Procedures for Natural Gas Pipelines

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-29

...] Annual Charge Filing Procedures for Natural Gas Pipelines AGENCY: Federal Energy Regulatory Commission... FERC) is proposing to amend its regulations to revise the filing requirements for natural gas pipelines...) clause. Currently, natural gas pipelines utilizing an ACA clause must make a tariff filing to reflect a...

78 FR 19409 - Annual Charge Filing Procedures for Natural Gas Pipelines

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-01

...; Order No. 776] Annual Charge Filing Procedures for Natural Gas Pipelines AGENCY: Federal Energy... Commission (Commission or FERC) is amending its regulations to revise the filing requirements for natural gas...) clause. Currently, natural gas pipelines utilizing an ACA clause must make an annual tariff filing to...

75 FR 59740 - Agency Information Collection; Proposed Revisions to a Currently Approved Information Collection...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-28

... information collection to the Office of Management and Budget (OMB): Individual Landholder's and Farm Operator... McPhee at: (303) 445-2897. SUPPLEMENTARY INFORMATION: Title: Individual Landholder's and Farm Operator's... and Regulations, 43 CFR part 426, and Information Requirements for Certain Farm Operations In Excess...

Exploring the Validity of a Unified Learning Program for Remedial and Handicapped Students.

ERIC Educational Resources Information Center

Jenkins, Joseph R.; And Others

The instructional and political validity of current educational policy regarding categorical programs for low-achieving elementary school students are examined. The categorical organization of services for these students, characterized by a vast array of eligibility requirements, rules and regulations, and accounting systems, has resulted in a…

Recent Case Law Regarding Functional Behavioral Assessments: Implications for Practice

ERIC Educational Resources Information Center

Losinski, Mickey L.; Katsiyannis, Antonis; Ryan, Joseph B.

2014-01-01

While functional behavioral assessments (FBAs) are currently federally mandated requirements, public schools have not been provided clear federal guidance concerning what constitutes an acceptable FBA through Individuals With Disabilities Education Act or related regulations. The purpose of this article is to examine recent rulings regarding FBAs…

76 FR 20351 - Federal Acquisition Regulation; Information Collection; Architect-Engineer Qualifications (SF 330)

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-12

...; Information Collection; Architect-Engineer Qualifications (SF 330) AGENCIES: Department of Defense (DOD... approve an extension of a currently approved information collection requirement for the Architect-Engineer... Standard Form 330, Part I is used by all Executive agencies to obtain information from architect-engineer...

7 CFR 412.3 - Index.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 6 2010-01-01 2010-01-01 false Index. 412.3 Section 412.3 Agriculture Regulations of... AGRICULTURE PUBLIC INFORMATION-FREEDOM OF INFORMATION § 412.3 Index. 5 U.S.C. 552(a)(2) requires that each agency publish, or otherwise make available, a current index of all materials available for public...

75 FR 36480 - Proposed Collection; Comment Request for Regulation Project

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-25

... required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently..., Qualified Severance of a Trust for Generation-Skipping Transfer (GST) Tax Purposes. DATES: Written [email protected] . SUPPLEMENTARY INFORMATION: Title: Qualified Severance of a Trust for Generation-Skipping...

Food Buying Guide for Child Nutrition Programs. Revised.

ERIC Educational Resources Information Center

Davis, Dorothy W.; And Others

This guide is based on the latest federal regulations and meal pattern requirements for the National School Lunch and Breakfast Programs. It considers current food production and marketing techniques, packaging methods, grading standards, and changing food habits in the American population. The guide gives average yield information on over 600…

Applying Adverse Outcome Pathways (AOPs) to support Integrated Approaches to Testing and Assessment (IATA workshop report)

EPA Science Inventory

Chemical regulation is challenged by the large number of chemicals requiring assessment for potential human health and environmental impacts. Current approaches are too resource intensive in terms of time, money and animal use to evaluate all chemicals under development or alread...

75 FR 58505 - Regulation Z; Truth in Lending

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-24

... requirement applicable to higher-priced mortgage loans, for loans that exceed the maximum principal balance.... 1639D). For loans that exceed the Freddie Mac maximum principal balance, TILA Section 129D provides that...)). The current maximum principal balance for a mortgage loan to be eligible for purchase by Freddie Mac...

75 FR 54524 - Defense Federal Acquisition Regulation Supplement; Guidance on Personal Services (DFARS Case 2009...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-08

... parts 211 and 237 are being amended to (1) require that statements of work or performance work statements clearly distinguish between Government employees and contractor employees and (2) ensure that... Department, including several checklists currently used. This interim rule adopts best practices and...

Rapid pasteurization of shell eggs using RF

USDA-ARS?s Scientific Manuscript database

A novel method for rapidly pasteurizing eggs in the shell could enhance the safety of the United States’ food supply. Current federal regulations do not require eggs sold in stores to be pasteurized, yet these eggs are often consumed raw or undercooked and cause untold cases of salmonella illness ea...

24 CFR 1710.215 - Subdivision characteristics and climate.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 24 Housing and Urban Development 5 2012-04-01 2012-04-01 false Subdivision characteristics and climate. 1710.215 Section 1710.215 Housing and Urban Development Regulations Relating to Housing and Urban... Requirements § 1710.215 Subdivision characteristics and climate. (a) Submit two copies of a current geological...

24 CFR 1710.215 - Subdivision characteristics and climate.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 24 Housing and Urban Development 5 2013-04-01 2013-04-01 false Subdivision characteristics and climate. 1710.215 Section 1710.215 Housing and Urban Development Regulations Relating to Housing and Urban... Requirements § 1710.215 Subdivision characteristics and climate. (a) Submit two copies of a current geological...

24 CFR 1710.215 - Subdivision characteristics and climate.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 24 Housing and Urban Development 5 2011-04-01 2011-04-01 false Subdivision characteristics and climate. 1710.215 Section 1710.215 Housing and Urban Development Regulations Relating to Housing and Urban... Requirements § 1710.215 Subdivision characteristics and climate. (a) Submit two copies of a current geological...

24 CFR 1710.215 - Subdivision characteristics and climate.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 24 Housing and Urban Development 5 2014-04-01 2014-04-01 false Subdivision characteristics and climate. 1710.215 Section 1710.215 Housing and Urban Development Regulations Relating to Housing and Urban... Requirements § 1710.215 Subdivision characteristics and climate. (a) Submit two copies of a current geological...

75 FR 28230 - Request for Extension and Revision of a Currently Approved Information Collection Under the Clear...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-20

... Collection Under the Clear Title Program AGENCY: Grain Inspection, Packers and Stockyards Administration... reporting and recordkeeping requirements under the ``Clear Title'' regulations as authorized by section 1324.... Instructions: All comments should be identified as ``P&SP, Clear Title Information Collection,'' and should...

75 FR 60507 - Proposed Collection; Comment Request for Regulation Project

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-30

..., or a property transfer (or transfer of the right to use property) a fair market value. Current... opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork... Service, room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224. FOR FURTHER INFORMATION CONTACT...

24 CFR 1710.215 - Subdivision characteristics and climate.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 24 Housing and Urban Development 5 2010-04-01 2010-04-01 false Subdivision characteristics and climate. 1710.215 Section 1710.215 Housing and Urban Development Regulations Relating to Housing and Urban... Requirements § 1710.215 Subdivision characteristics and climate. (a) Submit two copies of a current geological...

Regulation of bone remodeling by vitamin K2.

PubMed

Myneni, V D; Mezey, E

2017-11-01

All living tissues require essential nutrients such as amino acids, fatty acids, carbohydrates, minerals, vitamins, and water. The skeleton requires nutrients for development, maintaining bone mass and density. If the skeletal nutritional requirements are not met, the consequences can be quite severe. In recent years, there has been growing interest in promotion of bone health and inhibition of vascular calcification by vitamin K2. This vitamin regulates bone remodeling, an important process necessary to maintain adult bone. Bone remodeling involves removal of old or damaged bone by osteoclasts and its replacement by new bone formed by osteoblasts. The remodeling process is tightly regulated, when the balance between bone resorption and bone formation shifts to a net bone loss results in the development of osteoporosis in both men and women. In this review, we focus on our current understanding of the effects of vitamin K2 on bone cells and its role in prevention and treatment of osteoporosis. Published 2016. This article is a U.S. Government work and is in the public domain in the USA.

KCNQ Channels Regulate Age-Related Memory Impairment

PubMed Central

Cavaliere, Sonia; Malik, Bilal R.; Hodge, James J. L.

2013-01-01

In humans KCNQ2/3 heteromeric channels form an M-current that acts as a brake on neuronal excitability, with mutations causing a form of epilepsy. The M-current has been shown to be a key regulator of neuronal plasticity underlying associative memory and ethanol response in mammals. Previous work has shown that many of the molecules and plasticity mechanisms underlying changes in alcohol behaviour and addiction are shared with those of memory. We show that the single KCNQ channel in Drosophila (dKCNQ) when mutated show decrements in associative short- and long-term memory, with KCNQ function in the mushroom body α/βneurons being required for short-term memory. Ethanol disrupts memory in wildtype flies, but not in a KCNQ null mutant background suggesting KCNQ maybe a direct target of ethanol, the blockade of which interferes with the plasticity machinery required for memory formation. We show that as in humans, Drosophila display age-related memory impairment with the KCNQ mutant memory defect mimicking the effect of age on memory. Expression of KCNQ normally decreases in aging brains and KCNQ overexpression in the mushroom body neurons of KCNQ mutants restores age-related memory impairment. Therefore KCNQ is a central plasticity molecule that regulates age dependent memory impairment. PMID:23638087

[100 years of drinking water regulation. Retrospective review, current situation and prospects].

PubMed

Rakhmanin, Yu A; Krasovsky, G N; Egorova, N A; Mikhailova, R I

2014-01-01

There is considered the history of the development of legislative requirements to the regulation of the quality of drinking water in different countries and international organizations during the period from 1912 to the present time. In terms of comparative analysis there is analyzed the current state of regulatory frameworks of the Russian Federation, WHO, EU, Finland, the UK, Singapore, Australia, Japan, China, Nigeria, the United States and Canada in the field of providing favorable conditions of population drinking water use. There has been noted the significant progress in standardization of the content of the biogenic elements and chemical pollution of drinking water in the absence of uniform requirements to the composition and properties of drinking water globally, that is bound to the need to take into account the national peculiarities of drinking water supply within the separate countries. As promising directions for improving regulation of drinking water quality there are noted: the development of new standards for prioritized water pollution, periodic review ofstandards after appearance of the new scientific data on the biological action of substances, the use of the concept of risk, the harmonization of the normative values and the assessment of the possibility of introduction into the practice the one more criterion of profitableness of population water use--the bioenergetic state of the water.

Self-Regulated Learning: Examining the Baccalaureate Millennial Nursing Student's Approach.

PubMed

Robb, Meigan K

2016-01-01

Pre-licensure baccalaureate nursing programs are facing the demand to retain and graduate students with the skills needed for the complex health care environment. Nursing faculty are challenged to identify the best pedagogical methods for educating the current generation of students. The influence of student-centered approaches is documented in the literature. However, the effective use of these methods requires a collaborative partnership. The cognitive, self-regulated approaches used by millennial nursing students is not well understood. This article describes the findings of a study that examined the relationship between self-regulated approaches to learning, self-efficacy, independent study behaviors, and grade point average.

Sixth Warren K. Sinclair keynote address: The role of a strong regulator in safe and secure nuclear energy.

PubMed

Lyons, Peter B

2011-01-01

The history of nuclear regulation is briefly reviewed to underscore the early recognition that independence of the regulator was essential in achieving and maintaining public credibility. The current licensing process is reviewed along with the status of applications. Challenges faced by both the NRC and the industry are reviewed, such as new construction techniques involving modular construction, digital controls replacing analog circuitry, globalization of the entire supply chain, and increased security requirements. The vital area of safety culture is discussed in some detail, and its importance is emphasized. Copyright © 2010 Health Physics Society

76 FR 5537 - Electronic On-Board Recorders and Hours of Service Supporting Documents

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-01

...The Federal Motor Carrier Safety Administration (FMCSA) proposes to amend the Federal Motor Carrier Safety Regulations (FMCSRs) to require certain motor carriers operating commercial motor vehicles (CMVs) in interstate commerce to use electronic on-board recorders (EOBRs) to document their drivers' hours of service (HOS). Under this proposal, all motor carriers currently required to maintain Records of Duty Status (RODS) for HOS recordkeeping would be required to use EOBRs to systematically and effectively monitor their drivers' compliance with HOS requirements. Additionally, this proposal sets forth the supporting documents that all motor carriers currently required to use RODS would still be required to obtain and keep, as required by section 113(a) of the Hazardous Materials Transportation Authorization Act (HMTAA). It explains, however, that although motor carriers subject to the proposed EOBR requirements would still need to retain some supporting documents, they would be relieved of the requirements to retain supporting documents to verify driving time. FMCSA also proposes to require all motor carriers--both RODS and timecard users--to systematically monitor their drivers' compliance with HOS requirements. Motor carriers would be given 3 years after the effective date of the final rule to comply with these requirements.

SEPP-ZVS High Frequency Inverter Incorporating Auxiliary Switch

NASA Astrophysics Data System (ADS)

Ogiwara, Hiroyuki; Itoi, Misao; Nakaoka, Mutsuo

This paper presents a novel circuit topology to attain ZVS operation of a high frequency inverter over a wide range output power regulation using a PWM control technique by connecting an auxiliary switch to the conventional single ended push-pull (SEPP) ZVS high frequency inverter. A switching current is injected into the main switches via the auxiliary switch only during the short period between its turn-on and off times to supply a current required for its ZVS operation.

Power-processing unit

NASA Technical Reports Server (NTRS)

Wessel, Frank J. (Inventor); Hancock, Donald J. (Inventor)

1987-01-01

Power-processing unit uses AC buses (30, 32) to supply all current dependent needs such as connections (54, 56) to an ion thruster through an inductor (88) and the primary of a transformer (90), to assure limited currents to such loads. Where temperature control is also required, such as to the main discharge vaporizer heater connection (36, 38), switches (100, 102) are serially connected with inductor (96) and the primary of transformer (98). Temperature sensor (104) controls the switches (100, 102) for temperature regulation.

Tropomodulin Capping of Actin Filaments in Striated Muscle Development and Physiology

PubMed Central

Gokhin, David S.; Fowler, Velia M.

2011-01-01

Efficient striated muscle contraction requires precise assembly and regulation of diverse actin filament systems, most notably the sarcomeric thin filaments of the contractile apparatus. By capping the pointed ends of actin filaments, tropomodulins (Tmods) regulate actin filament assembly, lengths, and stability. Here, we explore the current understanding of the expression patterns, localizations, and functions of Tmods in both cardiac and skeletal muscle. We first describe the mechanisms by which Tmods regulate myofibril assembly and thin filament lengths, as well as the roles of closely related Tmod family variants, the leiomodins (Lmods), in these processes. We also discuss emerging functions for Tmods in the sarcoplasmic reticulum. This paper provides abundant evidence that Tmods are key structural regulators of striated muscle cytoarchitecture and physiology. PMID:22013379

Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs; revision of certain labeling controls--FDA. Final rule.

PubMed

1993-08-03

The Food and Drug Administration (FDA) is amending the current good manufacturing practice (CGMP) regulations for human and veterinary drug products to revise certain labeling control provisions. Specifically, the final rule defines the term "gang-printed labeling," specifies conditions for the use of gang-printed or cut labeling, exempts manufacturers that employ automated 100-percent labeling inspection systems from CGMP labeling reconciliation requirements, and requires manufacturers to identify filled drug product containers that are set aside and held in an unlabeled condition for future labeling operations. These changes are intended to reduce the frequency of drug product mislabeling and associated drug product recalls.

Human Immunodeficiency Virus Type 1 (HIV-1) Viral Protein R (Vpr)-Mediated Cell Cycle Arrest: An Analysis of Current Mechanistic Models

DTIC Science & Technology

2006-06-08

entices speculation on Vpr-mediated modulation of cellular stress responses. The major human small Hsp, HSP27 , represents an important point of...intersection for the two eukaryotic stress response mechanisms, i.e. HSF-mediated HSP expression induction and SAPK cascade activation. While HSP27 ...expression up-regulation requires HSF activation, functional activation of HSP27 requires MK2-catalyzed phosphorylation, and, therefore, p38 pathway

The proposed EU-regulation on clinical trials on medicinal products: an unethical proposal?

PubMed

Heringa, Jilles; Dute, Joseph

2013-09-01

The Commission has proposed a regulation 'on clinical trials on medicinal products for human use' to introduce one regulatory framework for clinical trials in the European Union. This regulation should replace the current clinical trials directive (2001/20/EC). In this article we describe and critically review the main provisions of the proposed regulation. We assess the consequences for a sound authorisation procedure of clinical trials and the level of protection for human subjects. We note that the proposed regulation is inconsistent with applicable international legal documents, such as the Biomedicine Convention and the Declaration of Helsinki. We conclude that the proposed regulation does not ensure a "high level of human health protection"--required by its legal basis in the TFEU--because it may force Member States concerned to accept a reporting Member States' approval of--in their estimation--an unethical clinical trial.

Series-Connected Buck Boost Regulators

NASA Technical Reports Server (NTRS)

Birchenough, Arthur G.

2005-01-01

A series-connected buck boost regulator (SCBBR) is an electronic circuit that bucks a power-supply voltage to a lower regulated value or boosts it to a higher regulated value. The concept of the SCBBR is a generalization of the concept of the SCBR, which was reported in "Series-Connected Boost Regulators" (LEW-15918), NASA Tech Briefs, Vol. 23, No. 7 (July 1997), page 42. Relative to prior DC-voltage-regulator concepts, the SCBBR concept can yield significant reductions in weight and increases in power-conversion efficiency in many applications in which input/output voltage ratios are relatively small and isolation is not required, as solar-array regulation or battery charging with DC-bus regulation. Usually, a DC voltage regulator is designed to include a DC-to-DC converter to reduce its power loss, size, and weight. Advances in components, increases in operating frequencies, and improved circuit topologies have led to continual increases in efficiency and/or decreases in the sizes and weights of DC voltage regulators. The primary source of inefficiency in the DC-to-DC converter portion of a voltage regulator is the conduction loss and, especially at high frequencies, the switching loss. Although improved components and topology can reduce the switching loss, the reduction is limited by the fact that the converter generally switches all the power being regulated. Like the SCBR concept, the SCBBR concept involves a circuit configuration in which only a fraction of the power is switched, so that the switching loss is reduced by an amount that is largely independent of the specific components and circuit topology used. In an SCBBR, the amount of power switched by the DC-to-DC converter is only the amount needed to make up the difference between the input and output bus voltage. The remaining majority of the power passes through the converter without being switched. The weight and power loss of a DC-to-DC converter are determined primarily by the amount of power processed. In the SCBBR, the unswitched majority of the power is passed through with very little power loss, and little if any increase in the sizes of the converter components is needed to enable the components to handle the unswitched power. As a result, the power-conversion efficiency of the regulator can be very high, as shown in the example of Figure 1. A basic SCBBR includes a DC-to-DC converter (see Figure 2). The switches and primary winding of a transformer in the converter is connected across the input bus, while the secondary winding and switches are connected in series with the output bus, so that the output voltage is the sum of the input voltage and the secondary voltage of the converter. In the breadboard SCBBR, the input voltage applied to the primary winding is switched by use of metal oxide/semiconductor field-effect transistors (MOSFETs) in a full bridge circuit; the secondary winding is center-tapped, with two MOSFET switches and diode rectifiers connected in opposed series in each leg. The sets of opposed switches and rectifiers are what enable operation in either a boost or a buck mode. In the boost mode, input voltage and current, and the output voltage and current are all positive; that is, the secondary voltage is added to the input voltage and the net output voltage can be regulated at a value equal or greater than the input voltage. In the buck mode, input voltage is still positive and the current still flows in the same direction in the secondary, but the switches are controlled such that some power flows from the secondary to the primary. The voltage across the secondary and the current into the primary are reversed. The result is that the output voltage is lower than the input voltage, and some power is recirculated from the converter secondary back to the input. Quantitatively, the advantage of an SCBBR is a direct function of the regulation range required. If, for example, a regulation range of 20 percent is required for a 500-W supply, th it suffices to design the DC-to-DC converter in the SCBBR for a power rating of only 100 W. The switching loss and size are much smaller than those of a conventional regulator that must be rated for switching of all 500 W. The reduction in size and the increase in efficiency are not directly proportional to switched-power ratio of 5:1 because the additional switches contribute some conduction loss and the input and output filters must be larger than those typically required for a 100-W converter. Nevertheless, the power loss and the size can be much smaller than those of a 500-W converter.

Gap Junctions

PubMed Central

Nielsen, Morten Schak; Axelsen, Lene Nygaard; Sorgen, Paul L.; Verma, Vandana; Delmar, Mario; Holstein-Rathlou, Niels-Henrik

2013-01-01

Gap junctions are essential to the function of multicellular animals, which require a high degree of coordination between cells. In vertebrates, gap junctions comprise connexins and currently 21 connexins are known in humans. The functions of gap junctions are highly diverse and include exchange of metabolites and electrical signals between cells, as well as functions, which are apparently unrelated to intercellular communication. Given the diversity of gap junction physiology, regulation of gap junction activity is complex. The structure of the various connexins is known to some extent; and structural rearrangements and intramolecular interactions are important for regulation of channel function. Intercellular coupling is further regulated by the number and activity of channels present in gap junctional plaques. The number of connexins in cell-cell channels is regulated by controlling transcription, translation, trafficking, and degradation; and all of these processes are under strict control. Once in the membrane, channel activity is determined by the conductive properties of the connexin involved, which can be regulated by voltage and chemical gating, as well as a large number of posttranslational modifications. The aim of the present article is to review our current knowledge on the structure, regulation, function, and pharmacology of gap junctions. This will be supported by examples of how different connexins and their regulation act in concert to achieve appropriate physiological control, and how disturbances of connexin function can lead to disease. © 2012 American Physiological Society. Compr Physiol 2:1981-2035, 2012. PMID:23723031

Conceptual Design for CLIC Gun Pulser

DOE Office of Scientific and Technical Information (OSTI.GOV)

Tang, Tao

The Compact Linear Collider (CLIC) is a proposed future electron-positron collider, designed to perform collisions at energies from 0.5 to 5 TeV, with a nominal design optimized for 3 TeV (Dannheim, 2012). The Drive Beam Accelerator consists of a thermionic DC gun, bunching section and an accelerating section. The thermionic gun needs deliver a long (~143us) pulse of current into the buncher. A pulser is needed to drive grid of the gun to generate a stable current output. This report explores the requirements of the gun pulser and potential solutions to regulate grid current.

Techniques to improve maneuver stability characteristics of a nonlinear wide-body transport airplane in cruise flight

NASA Technical Reports Server (NTRS)

Grantham, William D.; Person, Lee H., Jr.; Bailey, Melvin L.; Tingas, Stephen A.

1994-01-01

The maneuver control stability characteristics of an aircraft are a flying qualities parameter of critical importance, to ensure structural protection as well as adequate predictability to the pilot. Currently, however, maneuver stability characteristics are not uniquely addressed in the Federal Aviation Regulations (FAR) Part 25, for transport aircraft. In past transport category certification programs, the Federal Aviation Administration (FAA) has used a combination of requirements (longitudinal control, vibration and buffeting, high-speed characteristics, and out-of-trim characteristics) to ensure safe and controllable maneuver stability characteristics over a range of flight conditions and airplane configurations. Controversies exist regarding each of these regulations, however, and considerable expenditures in terms of design studies and testing time have resulted from the requirements. It is also recognized that additional engineering guidance is needed for identifying acceptable nonlinear maneuver stability characteristics, particularly as they relate to relaxed stability, highly augmented transport configurations. The current trend in large aircraft design is toward relaxed, or even negative, static margins for improved fuel efficiency. The advanced flight control systems developed for these aircraft, in many instances, have rendered current aforementioned maneuver stability criteria either too stringent or of little practical use. Current design requirements do not account for these advanced designs. The objective was to evaluate a broad spectrum of linear and nonlinear longitudinal stability characteristics to generate data for defining satisfactory and unacceptable maneuver characteristics, as defined by pilot opinion. Primary emphasis was placed on two techniques of varying column force per normal acceleration. This study was a joint venture with four pilots participating; one from NASA, one from the FAA, and two from industry.

78 FR 36122 - Fisheries of the Exclusive Economic Zone Off Alaska; Bering Sea and Aleutian Islands Crab...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-17

... the harvesting and processing sectors'' and to monitor the ``economic stability for harvesters.... 120806311-3530-02] RIN 0648-BC25 Fisheries of the Exclusive Economic Zone Off Alaska; Bering Sea and... Tanner Crabs (FMP). These regulations revise the annual economic data reports (EDRs) currently required...

Do you know the fair market value of quality?

PubMed

Johnson, Jen

2009-10-01

To develop a physician compensation package that includes fair-market-value incentive payments for their efforts to improve healthcare quality, a hospital first needs to: Evaluate current market data on quality incentive payments. Be familiar with the existing regulatory guidelines related to paying for quality. Understand the requirements for complying with the regulations.

75 FR 44163 - Antidumping and Countervailing Duty Proceedings: Electronic Filing Procedures; Administrative...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-28

... Central Records Unit. Any questions concerning file formatting, document conversion, access on the Web, or... manually, a party need only submit one hard copy of the submission with the Department. The Department's regulations currently require parties to submit one hard copy original and five hard copies of a public...

76 FR 66715 - Agency Information Collection Activities; Proposed Collection; Comment Request; Monthly Progress...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-27

... ``anonymous access'' system, which means EPA will not know your identity or contact information unless you...-OARM-2011-0748, which is available for online viewing at http://www.regulations.gov , or in person... a person is not required to respond to, a collection of information, unless it displays a currently...

Creating Cultures of Integrity: Ethics Education in UK Business Schools

ERIC Educational Resources Information Center

Bell, Emma; Caulfield, Paul; Hibbert, Paul; Jennings, Paul

2014-01-01

Recent corporate scandals and responses by regulators have created an environment in which there is a heightened awareness of business ethics. This report presents a series of case studies exploring how the current curricula in UK business schools could be scoped differently to give new business leaders the tools required for strong ethical…

(PRESENTED IN ALBERTA, CANADA) A PERFORMANCE EVALUATION OF THE 2004 RELEASE OF MODELS-3 CMAQ

EPA Science Inventory

The Clean Air Act and its Amendments require that the U.S. Environmental Protection Agency (EPA) establish National Ambient Air Quality Standards for O₃ and particulate matter and to assess current and future air quality regulations designed to protect human health and...

78 FR 51046 - Registration of Mortgage Loan Originators

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-20

... Federal Register.\\10\\ Instead of substantively amending the current regulations, the CFPB has made only... State or territory that does not have one in place that meets the requirements of the S.A.F.E. Act. \\10... CFR part 1007 will now govern the registration of residential mortgage loan originators at FCS...

78 FR 16919 - Proposed Collection; Comment Request for Regulation Project

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-19

... through the use of automated collection techniques or other forms of information technology; and (e... on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning...

76 FR 68792 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-07

...: Submission for the Office of Management and Budget (OMB) Review; Comment Request AGENCY: Nuclear Regulatory... Control and Accounting of Special Nuclear Material. 3. Current OMB approval number: 3150-0123. 4. The form... requirements for material control and accounting of SNM, and specific performance-based regulations for...

76 FR 77817 - Agency Information Collection Activities; Proposed Renewal of Several Currently Approved...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-14

... manufacturing). Abstract: The Customs and Border Protection (CBP) regulations at 19 CFR 12.112 require that an... agricultural and chemical manufacturing). Abstract: This ICR renewal will allow EPA to collect necessary data... Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act (FQPA) of...

Word Processing and Its Implications for Business Communications Courses.

ERIC Educational Resources Information Center

Kruk, Leonard B.

Word processing, a systematic approach to office work, is currently based on the use of sophisticated dictating and typing machines. The word processing market is rapidly increasing with the paper explosion brought on by such factors as increasing governmental regulation, Internal Revenue Service requirements, and the need for stockholders to be…

A simulated approach to estimating PM10 and PM2.5 concentrations downwind from cotton gins

USDA-ARS?s Scientific Manuscript database

Cotton gins are required to obtain operating permits from state air pollution regulatory agencies (SAPRA), which regulate the amount of particulate matter that can be emitted. Industrial Source Complex Short Term version 3 (ISCST3) is the Gaussian dispersion model currently used by some SAPRAs to pr...

75 FR 40030 - Proposed Collection: Comment Request for Regulation Project

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-13

... required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently... Write-off of Certain Tax Preferences. DATES: Written comments should be received on or before September... . SUPPLEMENTARY INFORMATION: Title: Optional 10-Year Write-off of Certain Tax Preferences. OMB Number: 1545-1903...

Drinking Water Disinfection By-Product Rules and Climate Change Effects - A Glimpse of Current and Future Trends

EPA Science Inventory

"Drinking water quality at the consumer's tap is the center piece of U.S. drinking water regulations to protect people's health. Recently promulgated Stage II DBP rules are an example, which requires a system approach in a multi-barrier strategy for compliance and risk managemen...

76 FR 36623 - Proposed Collection; Comment Request for Regulation Project

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-22

... 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning requirements respecting the adoption or change of accounting method; extensions of time to make elections... or Change of Accounting Method; Extensions of Time to Make Elections. OMB Number: 1545-1488...

77 FR 48112 - Pipeline Safety: Administrative Procedures; Updates and Technical Corrections

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-13

...This Notice of Proposed Rulemaking updates the administrative civil penalty maximums for violation of the pipeline safety regulations to conform to current law, updates the informal hearing and adjudication process for pipeline enforcement matters to conform to current law, amends other administrative procedures used by PHMSA personnel, and makes other technical corrections and updates to certain administrative procedures. The proposed amendments do not impose any new operating, maintenance, or other substantive requirements on pipeline owners or operators.

The Structure and Function of the Rous Sarcoma virus RNA Stability Element

PubMed Central

Withers, Johanna B.; Beemon, Karen L.

2013-01-01

For simple retroviruses, such as the Rous sarcoma virus (RSV), post-transcriptional control elements regulate viral RNA splicing, export, stability, and packaging into virions. These RNA sequences interact with cellular host proteins to regulate and facilitate productive viral infections. One such element, known as the RSV stability element (RSE), is required for maintaining stability of the full-length unspliced RNA. This viral RNA serves as the mRNA for the Gag and Pol proteins and also as the genome packaged in progeny virions. When the RSE is deleted from the viral RNA, the unspliced RNA becomes unstable and is degraded in a Upf1-dependent manner. Current evidence suggests that the RSE inhibits recognition of the viral gag termination codon by the nonsense-mediated mRNA decay (NMD) pathway. We believe that the RSE acts as an insulator to NMD, thereby preventing at least one of the required functional steps that target an mRNA for degradation. Here, we discuss the history of the RSE and the current model of how the RSE is interacting with cellular NMD factors. PMID:21769913

Biology as a Key Technological Foundation for Settlement Beyond Earth

NASA Technical Reports Server (NTRS)

Rothschild, L. J.; Navarrete, J.; Kent, R. E.; McCutcheon, G.; Pless, E.; Paulino-Lima, I. G.

2017-01-01

Moving materials beyond Earth, whether spacecraft, living organisms, or both, is limited by mass constraints. Yet human survival requires an extensive infrastructure, from environmental regulation to life support. In practice this means habitats, food, oxygen, waste recycling, medicine and so on. Thus, there is a mismatch between what will be required in transit and at destination to fulfill dreams of human settlements and what can realistically moved there. Further, settlement off planet with current transportation systems requires the ability to operate independently of the Earth for prolonged periods of time, requiring long-term storage of supplies and the flexibilityto satisfy new needs.

[Guideline-conform psychiatric psychotherapeutic treatment for patients with schizophrenia : A normative evaluation of necessary personnel requirements].

PubMed

Mehl, S; Falkai, P; Berger, M; Löhr, M; Rujescu, D; Wolff, J; Kircher, T

2016-03-01

Although national treatment guidelines and current publications of the German Federal Joint Committee (Gemeinsamer Bundesausschuss) recommend cognitive behavior therapy for all patients with schizophrenia, the implementation of these recommendations in current inpatient and outpatient treatment is only rudimentary. The aim of this study was to systematically search randomized controlled studies (RCTs), meta-analyses and the guidelines of the German Association for Psychiatry and Psychotherapy, Psychosomatics and Neurology (DGPPN) and the British National Institute for Health and Clinical Excellence (NICE) in order to assess the number of personnel necessary for psychiatric and therapeutic inpatient treatment in line with present guidelines. Moreover, the number of staff required was compared with the personnel resources designated by the German psychiatry personnel regulations (Psych-PV). The German and NICE guidelines, RCTs and meta-analyses were analyzed and an adequate weekly treatment plan for an inpatient unit was developed. Moreover, the number of personnel necessary to realize the treatment plan was calculated. In order to realize adequate inpatient treatment approximately 107 min extra for medical psychotherapeutic personnel per patient and week (of which 72 min for psychotherapy) and another 60 min for nursing staff per patient and week are required in addition to the current Psych-PV regulations. Thus, implementation in an open ward with 20 inpatients would require 3.62 positions for physicians, 0.7 positions in psychology and 12.85 positions for nursing staff (including management positions and night shifts). These evidence-based recommendations for precise specifications of inpatient treatment should lead to improved inpatient treatment in line with present guidelines. Moreover, outpatients and day patients could be included in this treatment model. The results should be considered in the construction of the future prospective payment system for inpatient psychiatric healthcare in Germany.

Microbial biocatalyst developments to upgrade fossil fuels.

PubMed

Kilbane, John J

2006-06-01

Steady increases in the average sulfur content of petroleum and stricter environmental regulations concerning the sulfur content have promoted studies of bioprocessing to upgrade fossil fuels. Bioprocesses can potentially provide a solution to the need for improved and expanded fuel upgrading worldwide, because bioprocesses for fuel upgrading do not require hydrogen and produce far less carbon dioxide than thermochemical processes. Recent advances have demonstrated that biodesulfurization is capable of removing sulfur from hydrotreated diesel to yield a product with an ultra-low sulfur concentration that meets current environmental regulations. However, the technology has not yet progressed beyond laboratory-scale testing, as more efficient biocatalysts are needed. Genetic studies to obtain improved biocatalysts for the selective removal of sulfur and nitrogen from petroleum provide the focus of current research efforts.

¿Es tiempo de exigir publicidad basada en la evidencia?

PubMed

Macías-Hernández, Salvador Israel; Morones-Alba, Juan Daniel

2017-01-01

Claims made in current advertising for medical products is not necessarily scientifically proven, yet at the same time clinicians are required to adopt evidence-based practices and undergo periodic certifications. This is a clear contradiction. It is crucial to begin to reflect on the need to regulate information presented in the media and to place greater emphasis on patient well-being and safety instead of on third-party interests. The medical community must demand stricter regulations and evidence-based advertising policies. Copyright: © 2017 SecretarÍa de Salud.

Regulation of stem cell-based therapies in Canada: current issues and concerns.

PubMed

von Tigerstrom, Barbara; Nguyen, Thu Minh; Knoppers, Bartha Maria

2012-09-01

Stem cell therapies offer enormous potential for the treatment of a wide range of diseases and conditions. Despite the excitement over such advances, regulators are faced with the challenge of determining criteria to ensure stem cells and their products are safe and effective for human use. However, stem cell-based products and therapies present unique regulatory challenges because standard drug development models do not wholly apply given the complexity and diversity of these products and therapies. As a result, regulatory requirements are often unclear and ambiguous creating unnecessary barriers for research. In order to better understand the barriers that might affect Canadian stem cell researchers, we sought feedback from stakeholders regarding areas of uncertainty or concern about existing regulatory oversight of cell therapies. A selection of Canadian researchers and clinicians working in the area of stem cell research were interviewed to assess certain key questions: 1) whether current regulatory requirements are easily accessible and well understood; 2) whether regulatory requirements create important challenges or barriers; and 3) whether there is a need for further guidance on the issue. The results of this survey are summarized and compared to issues and concerns experienced in other countries, as reported in the literature, to identify challenges which may be on the horizon and to provide possible solutions for regulatory reform.

How four U.S. states are regulating recreational marijuana edibles.

PubMed

Gourdet, Camille; Giombi, Kristen C; Kosa, Katherine; Wiley, Jenny; Cates, Sheryl

2017-05-01

Sales of edible marijuana products have been strong in Colorado and Washington State since the legalization of recreational marijuana. Initially, these states did not have comprehensive labelling or packaging requirements in place. In response to increases in marijuana-related emergency room visits and poison control centre calls, additional regulations were implemented. Currently, Alaska, Colorado, Oregon, and Washington each have passed into law various labelling and packaging requirements for edibles. This article presents the primary legal research findings of relevant statutes and regulations for edibles in Alaska, Colorado, Oregon, and Washington. These laws were identified by using Boolean terms and connectors searches in these states' legal databases in LexisNexis. Alaska, Colorado, Oregon, and Washington vary greatly in how they regulate labelling and packaging. Colorado, Oregon and Washington require a Universal Symbol to be affixed to edibles, but only Oregon and Washington require that the use of pesticides be disclosed on the label. Only Colorado and Oregon require that the packaging for edibles bear a Nutrition Facts Panel on the label. Δ 9 -Tetrahydracannabinol (THC) in a single serving or single edible product as Alaska and Oregon. All four states prohibit the manufacture or packaging of edibles that appeal to youth. State laws governing recreational marijuana edibles have evolved since the first recreational edible products were available for sale. Alaska, Colorado, Oregon, and Washington now require edible product labels to disclose a variety of product information, including risk factors associated with consumption. However, there still remain concerns about the regulatory gaps that exist in each of these states, inherent difficulties in enforcing laws around the labelling, packaging, and manufacturing of edibles, and the outstanding question of whether these edible laws are actually informing consumers and keeping the public safe. Copyright © 2017 Elsevier B.V. All rights reserved.

Carbachol-induced colonic mucus formation requires transport via NKCC1, K+ channels and CFTR

PubMed Central

Lindén, Sara K.; Alwan, Ala H.; Scholte, Bob J.; Hansson, Gunnar C.; Sjövall, Henrik

2016-01-01

The colonic mucosa protects itself from the luminal content by secreting mucus that keeps the bacteria at a distance from the epithelium. For this barrier to be effective, the mucus has to be constantly replenished which involves exocytosis and expansion of the secreted mucins. Mechanisms involved in regulation of mucus exocytosis and expansion are poorly understood, and the aim of this study was to investigate whether epithelial anion secretion regulates mucus formation in the colon. The muscarinic agonist carbachol was used to induce parallel secretion of anions and mucus, and by using established inhibitors of ion transport, we studied how inhibition of epithelial transport affected mucus formation in mouse colon. Anion secretion and mucin exocytosis were measured by changes in membrane current and epithelial capacitance, respectively. Mucus thickness measurements were used to determine the carbachol effect on mucus growth. The results showed that the carbachol-induced increase in membrane current was dependent on NKCC1 co-transport, basolateral K+ channels and Cftr activity. In contrast, the carbachol-induced increase in capacitance was partially dependent on NKCC1 and K+ channel activity, but did not require Cftr activity. Carbachol also induced an increase in mucus thickness that was inhibited by the NKCC1 blocker bumetanide. However, mice that lacked a functional Cftr channel did not respond to carbachol with an increase in mucus thickness, suggesting that carbachol-induced mucin expansion requires Cftr channel activity. In conclusion, these findings suggest that colonic epithelial transport regulates mucus formation by affecting both exocytosis and expansion of the mucin molecules. PMID:25139191

Carbachol-induced colonic mucus formation requires transport via NKCC1, K⁺ channels and CFTR.

PubMed

Gustafsson, Jenny K; Lindén, Sara K; Alwan, Ala H; Scholte, Bob J; Hansson, Gunnar C; Sjövall, Henrik

2015-07-01

The colonic mucosa protects itself from the luminal content by secreting mucus that keeps the bacteria at a distance from the epithelium. For this barrier to be effective, the mucus has to be constantly replenished which involves exocytosis and expansion of the secreted mucins. Mechanisms involved in regulation of mucus exocytosis and expansion are poorly understood, and the aim of this study was to investigate whether epithelial anion secretion regulates mucus formation in the colon. The muscarinic agonist carbachol was used to induce parallel secretion of anions and mucus, and by using established inhibitors of ion transport, we studied how inhibition of epithelial transport affected mucus formation in mouse colon. Anion secretion and mucin exocytosis were measured by changes in membrane current and epithelial capacitance, respectively. Mucus thickness measurements were used to determine the carbachol effect on mucus growth. The results showed that the carbachol-induced increase in membrane current was dependent on NKCC1 co-transport, basolateral K(+) channels and Cftr activity. In contrast, the carbachol-induced increase in capacitance was partially dependent on NKCC1 and K(+) channel activity, but did not require Cftr activity. Carbachol also induced an increase in mucus thickness that was inhibited by the NKCC1 blocker bumetanide. However, mice that lacked a functional Cftr channel did not respond to carbachol with an increase in mucus thickness, suggesting that carbachol-induced mucin expansion requires Cftr channel activity. In conclusion, these findings suggest that colonic epithelial transport regulates mucus formation by affecting both exocytosis and expansion of the mucin molecules.

Infection prevention and control standards in assisted living facilities: are residents' needs being met?

PubMed

Kossover, Rachel A; Chi, Carolyn J; Wise, Matthew E; Tran, Alvin H; Chande, Neha D; Perz, Joseph F

2014-01-01

Assisted living facilities (ALFs) provide housing and care to persons unable to live independently, and who often have increasing medical needs. Disease outbreaks illustrate challenges of maintaining adequate resident protections in these facilities. Describe current state laws on assisted living admissions criteria, medical oversight, medication administration, vaccination requirements, and standards for infection control training. We abstracted laws and regulations governing assisted living facilities for the 50 states using a structured abstraction tool. Selected characteristics were compared according to the time period in which the regulation took effect. Selected state health departments were queried regarding outbreaks identified in assisted living facilities. Of the 50 states, 84% specify health-based admissions criteria to assisted living facilities; 60% require licensed health care professionals to oversee medical care; 88% specifically allow subcontracting with outside entities to provide routine medical services onsite; 64% address medication administration by assisted living facility staff; 54% specify requirements for some form of initial infection control training for all staff; 50% require reporting of disease outbreaks to the health department; 18% specify requirements to offer or require vaccines to staff; 30% specify requirements to offer or require vaccines to residents. Twelve states identified approximately 1600 outbreaks from 2010 to 2013, with influenza or norovirus infections predominating. There is wide variation in how assisted living facilities are regulated in the United States. States may wish to consider regulatory changes that ensure safe health care delivery, and minimize risks of infections, outbreaks of disease, and other forms of harm among assisted living residents. Published by Elsevier Inc.

Revision of Import and Export Requirements for Controlled Substances, Listed Chemicals, and Tableting and Encapsulating Machines, Including Changes To Implement the International Trade Data System (ITDS); Revision of Reporting Requirements for Domestic Transactions in Listed Chemicals and Tableting and Encapsulating Machines; and Technical Amendments. Final rule.

PubMed

2016-12-30

The Drug Enforcement Administration is updating its regulations for the import and export of tableting and encapsulating machines, controlled substances, and listed chemicals, and its regulations relating to reports required for domestic transactions in listed chemicals, gamma-hydroxybutyric acid, and tableting and encapsulating machines. In accordance with Executive Order 13563, the Drug Enforcement Administration has reviewed its import and export regulations and reporting requirements for domestic transactions in listed chemicals (and gamma-hydroxybutyric acid) and tableting and encapsulating machines, and evaluated them for clarity, consistency, continued accuracy, and effectiveness. The amendments clarify certain policies and reflect current procedures and technological advancements. The amendments also allow for the implementation, as applicable to tableting and encapsulating machines, controlled substances, and listed chemicals, of the President's Executive Order 13659 on streamlining the export/import process and requiring the government-wide utilization of the International Trade Data System (ITDS). This rule additionally contains amendments that implement recent changes to the Controlled Substances Import and Export Act (CSIEA) for reexportation of controlled substances among members of the European Economic Area made by the Improving Regulatory Transparency for New Medical Therapies Act. The rule also includes additional substantive and technical and stylistic amendments.

A Sensorless Predictive Current Controlled Boost Converter by Using an EKF with Load Variation Effect Elimination Function

PubMed Central

Tong, Qiaoling; Chen, Chen; Zhang, Qiao; Zou, Xuecheng

2015-01-01

To realize accurate current control for a boost converter, a precise measurement of the inductor current is required to achieve high resolution current regulating. Current sensors are widely used to measure the inductor current. However, the current sensors and their processing circuits significantly contribute extra hardware cost, delay and noise to the system. They can also harm the system reliability. Therefore, current sensorless control techniques can bring cost effective and reliable solutions for various boost converter applications. According to the derived accurate model, which contains a number of parasitics, the boost converter is a nonlinear system. An Extended Kalman Filter (EKF) is proposed for inductor current estimation and output voltage filtering. With this approach, the system can have the same advantages as sensored current control mode. To implement EKF, the load value is necessary. However, the load may vary from time to time. This can lead to errors of current estimation and filtered output voltage. To solve this issue, a load variation elimination effect elimination (LVEE) module is added. In addition, a predictive average current controller is used to regulate the current. Compared with conventional voltage controlled system, the transient response is greatly improved since it only takes two switching cycles for the current to reach its reference. Finally, experimental results are presented to verify the stable operation and output tracking capability for large-signal transients of the proposed algorithm. PMID:25928061

MEDIATOR25 Acts as an Integrative Hub for the Regulation of Jasmonate-Responsive Gene Expression in Arabidopsis1[C][W

PubMed Central

Çevik, Volkan; Kidd, Brendan N.; Zhang, Peijun; Hill, Claire; Kiddle, Steve; Denby, Katherine J.; Holub, Eric B.; Cahill, David M.; Manners, John M.; Schenk, Peer M.; Beynon, Jim; Kazan, Kemal

2012-01-01

The PHYTOCHROME AND FLOWERING TIME1 gene encoding the MEDIATOR25 (MED25) subunit of the eukaryotic Mediator complex is a positive regulator of jasmonate (JA)-responsive gene expression in Arabidopsis (Arabidopsis thaliana). Based on the function of the Mediator complex as a bridge between DNA-bound transcriptional activators and the RNA polymerase II complex, MED25 has been hypothesized to function in association with transcriptional regulators of the JA pathway. However, it is currently not known mechanistically how MED25 functions to regulate JA-responsive gene expression. In this study, we show that MED25 physically interacts with several key transcriptional regulators of the JA signaling pathway, including the APETALA2 (AP2)/ETHYLENE RESPONSE FACTOR (ERF) transcription factors OCTADECANOID-RESPONSIVE ARABIDOPSIS AP2/ERF59 and ERF1 as well as the master regulator MYC2. Physical interaction detected between MED25 and four group IX AP2/ERF transcription factors was shown to require the activator interaction domain of MED25 as well as the recently discovered Conserved Motif IX-1/EDLL transcription activation motif of MED25-interacting AP2/ERFs. Using transcriptional activation experiments, we also show that OCTADECANOID-RESPONSIVE ARABIDOPSIS AP2/ERF59- and ERF1-dependent activation of PLANT DEFENSIN1.2 as well as MYC2-dependent activation of VEGETATIVE STORAGE PROTEIN1 requires a functional MED25. In addition, MED25 is required for MYC2-dependent repression of pathogen defense genes. These results suggest an important role for MED25 as an integrative hub within the Mediator complex during the regulation of JA-associated gene expression. PMID:22822211

Complex regulation of AprA metalloprotease in Pseudomonas fluorescens M114: evidence for the involvement of iron, the ECF sigma factor, PbrA and pseudobactin M114 siderophore.

PubMed

Maunsell, Bláithín; Adams, Claire; O'Gara, Fergal

2006-01-01

In the soil bacterium Pseudomonas fluorescens M114, extracellular proteolytic activity and fluorescent siderophore (pseudobactin M114) production were previously shown to be co-ordinately negatively regulated in response to environmental iron levels. An iron-starvation extracytoplasmic function sigma factor, PbrA, required for the transcription of siderophore biosynthetic genes, was also implicated in M114 protease regulation. The current study centred on the characterization and genetic regulation of the gene(s) responsible for protease production in M114. A serralysin-type metalloprotease gene, aprA, was identified and found to encode the major, if not only, extracellular protease produced by this strain. The expression of aprA and its protein product were found to be subject to complex regulation. Transcription analysis confirmed that PbrA was required for full aprA transcription under low iron conditions, while the ferric uptake regulator, Fur, was implicated in aprA repression under high iron conditions. Interestingly, the iron regulation of AprA was dependent on culture conditions, with PbrA-independent AprA-mediated proteolytic activity observed on skim milk agar supplemented with yeast extract, when supplied with iron or purified pseudobactin M114. These effects were not observed on skim milk agar without yeast extract. PbrA-independent aprA expression was also observed from a truncated transcriptional fusion when grown in sucrose asparagine tryptone broth supplied with iron or purified pseudobactin M114. Thus, experimental evidence suggested that iron mediated its effects via transcriptional activation by PbrA under low iron conditions, while an as-yet-unidentified sigma factor(s) may be required for the PbrA-independent aprA expression and AprA proteolytic activity induced by siderophore and iron.

Ego depletion and attention regulation under pressure: is a temporary loss of self-control strength indeed related to impaired attention regulation?

PubMed

Englert, Chris; Zwemmer, Kris; Bertrams, Alex; Oudejans, Raôul R

2015-04-01

In the current study we investigated whether ego depletion negatively affects attention regulation under pressure in sports by assessing participants' dart throwing performance and accompanying gaze behavior. According to the strength model of self-control, the most important aspect of self-control is attention regulation. Because higher levels of state anxiety are associated with impaired attention regulation, we chose a mixed design with ego depletion (yes vs. no) as between-subjects and anxiety level (high vs. low) as within-subjects factor. Participants performed a perceptual-motor task requiring selective attention, namely, dart throwing. In line with our expectations, depleted participants in the high-anxiety condition performed worse and displayed a shorter final fixation on bull's eye, demonstrating that when one's self-control strength is depleted, attention regulation under pressure cannot be maintained. This is the first study that directly supports the general assumption that ego depletion is a major factor in influencing attention regulation under pressure.

The chloroplast ATP synthase features the characteristic redox regulation machinery.

PubMed

Hisabori, Toru; Sunamura, Ei-Ichiro; Kim, Yusung; Konno, Hiroki

2013-11-20

Regulation of the activity of the chloroplast ATP synthase is largely accomplished by the chloroplast thioredoxin system, the main redox regulation system in chloroplasts, which is directly coupled to the photosynthetic reaction. We review the current understanding of the redox regulation system of the chloroplast ATP synthase. The thioredoxin-targeted portion of the ATP synthase consists of two cysteines located on the central axis subunit γ. The redox state of these two cysteines is under the influence of chloroplast thioredoxin, which directly controls rotation during catalysis by inducing a conformational change in this subunit. The molecular mechanism of redox regulation of the chloroplast ATP synthase has recently been determined. Regulation of the activity of the chloroplast ATP synthase is critical in driving efficiency into the ATP synthesis reaction in chloroplasts. The molecular architecture of the chloroplast ATP synthase, which confers redox regulatory properties requires further investigation, in light of the molecular structure of the enzyme complex as well as the physiological significance of the regulation system.

Implicit emotion regulation affects outcome evaluation

PubMed Central

Yang, Qiwei; Tang, Ping; Luo, Wenbo; Luo, Yue-jia

2015-01-01

Efficient implicit emotion regulation processes, which run without awareness, are important for human well-being. In this study, to investigate the influence of implicit emotion regulation on psychological and electrophysiological responses to gains and losses, participants were required to select between two Chinese four-character idioms to match the meaning of the third one before they performed a monetary gambling task. According to whether their meanings were related to emotion regulation, the idioms fell into two categories. Event-related potentials and self-rating emotional experiences to outcome feedback were recorded during the task. Priming emotion regulation reduced subjective emotional experience to both gains and losses and the amplitudes of the feedback-related negativity, while the P3 component was not influenced. According to these results, we suggest that the application of implicit emotion regulation effectively modulated the subjective emotional experience and the motivational salience of current outcomes without the cost of cognitive resources. This study implicates the potential significance of implicit emotion regulation in decision-making processes. PMID:25332404

Ethical aspects of clinical research with minors.

PubMed

Bos, Wendy; Tromp, Krista; Tibboel, Dick; Pinxten, Wim

2013-07-01

Over the past decades, clinical research has increasingly been subjected to ethical requirements and legal regulation. The specific focus of ethical and legal frameworks on competent adults (which serve as the paradigmatic research subject), however, has created an ambivalent attitude towards pediatric clinical research. On one hand, minors are regarded as a vulnerable population that deserves additional protection against the risks and burdens involved in clinical research. On the other hand, the population of minors should not be denied (or not get timely) access to the benefits of clinical research. In this paper, we will explore the legal regulation and ethical guidance that currently governs pediatric clinical research in the European Union and discuss the future challenges in this field. In addition, we will discuss major ethical concerns in pediatric clinical research, with a focus on the acceptability of research risks and the informed consent process. In the discussion, we will address key concerns in both regulating pediatric clinical research and implementing ethical and legal requirement in the actual pediatric research conduct.

CD55 regulates self-renewal and cisplatin resistance in endometrioid tumors

PubMed Central

Wiechert, Andrew; Rao, Vinay S.; Alluri, Ravi; Thiagarajan, Praveena S.; Hale, James S.; Chumakova, Anastasia; Jarrar, Awad; Parker, Yvonne; Lindner, Daniel J.; Nagaraj, Anil Belur; DiFeo, Analisa; Abdul-Karim, Fadi W.; Rose, Peter G.; DeBernardo, Robert; Mahdi, Haider; McCrae, Keith R.; Lin, Feng

2017-01-01

Effective targeting of cancer stem cells (CSCs) requires neutralization of self-renewal and chemoresistance, but these phenotypes are often regulated by distinct molecular mechanisms. Here we report the ability to target both of these phenotypes via CD55, an intrinsic cell surface complement inhibitor, which was identified in a comparative analysis between CSCs and non-CSCs in endometrioid cancer models. In this context, CD55 functions in a complement-independent manner and required lipid raft localization for CSC maintenance and cisplatin resistance. CD55 regulated self-renewal and core pluripotency genes via ROR2/JNK signaling and in parallel cisplatin resistance via lymphocyte-specific protein tyrosine kinase (LCK) signaling, which induced DNA repair genes. Targeting LCK signaling via saracatinib, an inhibitor currently undergoing clinical evaluation, sensitized chemoresistant cells to cisplatin. Collectively, our findings identify CD55 as a unique signaling node that drives self-renewal and therapeutic resistance through a bifurcating signaling axis and provides an opportunity to target both signaling pathways in endometrioid tumors. PMID:28838952

Allograft update: the current status of tissue regulation, procurement, processing, and sterilization.

PubMed

McAllister, David R; Joyce, Michael J; Mann, Barton J; Vangsness, C Thomas

2007-12-01

Allografts are commonly used during sports medicine surgical procedures in the United States, and their frequency of use is increasing. Based on surgeon reports, it is estimated that more than 60 000 allografts were used in knee surgeries by members of the American Orthopaedic Society for Sports Medicine in 2005. In the United States, there are governmental agencies and other regulatory bodies involved in the oversight of tissue banks. In 2005, the Food and Drug Administration finalized its requirements for current good tissue practice and has mandated new rules regarding the "manufacture" of allogenic tissue. In response to well-publicized infections associated with the implantation of allograft tissue, some tissue banks have developed methods to sterilize allograft tissue. Although many surgeons have significant concerns about the safety of allografts, the majority believe that sterilized allografts are safe but that the sterilization process negatively affects tissue biology and biomechanics. However, most know very little about the principles of sterilization and the proprietary processes currently used in tissue banking. This article will review the current status of allograft tissue regulation, procurement, processing, and sterilization in the United States.

MCK1 is a novel regulator of myo-inositol phosphate synthase (MIPS) that is required for inhibition of inositol synthesis by the mood stabilizer valproate

PubMed Central

Yu, Wenxi; Daniel, Joshua; Mehta, Dhara; Maddipati, Krishna Rao

2017-01-01

Myo-inositol, the precursor of all inositol compounds, is essential for the viability of eukaryotes. Identifying the factors that regulate inositol homeostasis is of obvious importance to understanding cell function and the pathologies underlying neurological and metabolic resulting from perturbation of inositol metabolism. The current study identifies Mck1, a GSK3 homolog, as a novel positive regulator of inositol de novo synthesis in yeast. Mck1 was required for normal activity of myo-inositol phosphate synthase (MIPS), which catalyzes the rate-limiting step of inositol synthesis. mck1Δ cells exhibited a 50% decrease in MIPS activity and a decreased rate of incorporation of [13C6]glucose into [13C6]-inositol-3-phosphate and [13C6]-inositol compared to WT cells. mck1Δ cells also exhibited decreased growth in the presence of the inositol depleting drug valproate (VPA), which was rescued by supplementation of inositol. However, in contrast to wild type cells, which exhibited more than a 40% decrease in MIPS activity in the presence of VPA, the drug did not significantly decrease MIPS activity in mck1Δ cells. These findings indicate that VPA-induced MIPS inhibition is Mck1-dependent, and suggest a model that unifies two current hypotheses of the mechanism of action of VPA—inositol depletion and GSK3 inhibition. PMID:28817575

MCK1 is a novel regulator of myo-inositol phosphate synthase (MIPS) that is required for inhibition of inositol synthesis by the mood stabilizer valproate.

PubMed

Yu, Wenxi; Daniel, Joshua; Mehta, Dhara; Maddipati, Krishna Rao; Greenberg, Miriam L

2017-01-01

Myo-inositol, the precursor of all inositol compounds, is essential for the viability of eukaryotes. Identifying the factors that regulate inositol homeostasis is of obvious importance to understanding cell function and the pathologies underlying neurological and metabolic resulting from perturbation of inositol metabolism. The current study identifies Mck1, a GSK3 homolog, as a novel positive regulator of inositol de novo synthesis in yeast. Mck1 was required for normal activity of myo-inositol phosphate synthase (MIPS), which catalyzes the rate-limiting step of inositol synthesis. mck1Δ cells exhibited a 50% decrease in MIPS activity and a decreased rate of incorporation of [13C6]glucose into [13C6]-inositol-3-phosphate and [13C6]-inositol compared to WT cells. mck1Δ cells also exhibited decreased growth in the presence of the inositol depleting drug valproate (VPA), which was rescued by supplementation of inositol. However, in contrast to wild type cells, which exhibited more than a 40% decrease in MIPS activity in the presence of VPA, the drug did not significantly decrease MIPS activity in mck1Δ cells. These findings indicate that VPA-induced MIPS inhibition is Mck1-dependent, and suggest a model that unifies two current hypotheses of the mechanism of action of VPA-inositol depletion and GSK3 inhibition.

The AKAP Cypher/Zasp contributes to β-adrenergic/PKA stimulation of cardiac CaV1.2 calcium channels.

PubMed

Yu, Haijie; Yuan, Can; Westenbroek, Ruth E; Catterall, William A

2018-06-04

Stimulation of the L-type Ca 2+ current conducted by Ca V 1.2 channels in cardiac myocytes by the β-adrenergic/protein kinase A (PKA) signaling pathway requires anchoring of PKA to the Ca V 1.2 channel by an A-kinase anchoring protein (AKAP). However, the AKAP(s) responsible for regulation in vivo remain unknown. Here, we test the role of the AKAP Cypher/Zasp in β-adrenergic regulation of Ca V 1.2 channels using physiological studies of cardiac ventricular myocytes from young-adult mice lacking the long form of Cypher/Zasp (LCyphKO mice). These myocytes have increased protein levels of Ca V 1.2, PKA, and calcineurin. In contrast, the cell surface density of Ca V 1.2 channels and the basal Ca 2+ current conducted by Ca V 1.2 channels are significantly reduced without substantial changes to kinetics or voltage dependence. β-adrenergic regulation of these L-type Ca 2+ currents is also significantly reduced in myocytes from LCyphKO mice, whether calculated as a stimulation ratio or as net-stimulated Ca 2+ current. At 100 nM isoproterenol, the net β-adrenergic-Ca 2+ current conducted by Ca V 1.2 channels was reduced to 39 ± 12% of wild type. However, concentration-response curves for β-adrenergic stimulation of myocytes from LCyphKO mice have concentrations that give a half-maximal response similar to those for wild-type mice. These results identify Cypher/Zasp as an important AKAP for β-adrenergic regulation of cardiac Ca V 1.2 channels. Other AKAPs may work cooperatively with Cypher/Zasp to give the full magnitude of β-adrenergic regulation of Ca V 1.2 channels observed in vivo. This is a work of the U.S. Government and is not subject to copyright protection in the United States. Foreign copyrights may apply.

Environmental permitting in Thailand

DOE Office of Scientific and Technical Information (OSTI.GOV)

Byers, A.C.

Thailand's 1992 enhancement and Conservation of Environmental Quality Act and regulations require any entry proposing to construct a thermal power plant with a capacity greater that 10 MW to perform various environmental studies and prepare an environmental Impact Assessment (EIA) report in accordance with the guidelines issued by the office of Environmental Policy and Planning (OEPP). Approval of the EIA is a prerequisite to the issuance of most other construction permits. Applicable environmental standards and regulation are promulgated by the Pollution Control Department (PCD), a wholly separate agency for the OEPP. The PCD is a fairly new organization and, asmore » a result, their staff is still gaining understanding of the multiple environmental aspects of power generation. Accordingly, the PCD is still in process of drafting key regulations applicable to the power industry. This paper examines the current guidelines, practices, procedures and legal requirements regarding environmental licensing of a thermal power plant in Thailand. The requisite scope and content of the EIA report will be identified, as well as the current procedure for its official review and approval by the OEPP. The paper will address the challenges of working with local consultants and identify potential pitfalls in the report preparation process. Areas of particular interest in the EIA review will be identified based on recent examples of OEPP comments on previous SPP and IPP projects. Additionally, the development of applicable environmental standards by the PCD will be identified along with their plans for implementing these standards. The paper will also examine the relationship of the OEPP and PCD, and reflect upon trends for environmental regulation in Thailand in the near future.« less

The Food and Drug Administration and pragmatic clinical trials of marketed medical products

PubMed Central

Anderson, Monique L; Griffin, Joseph; Goldkind, Sara F; Zeitler, Emily P; Wing, Liz; Al-Khatib, Sana M; Sherman, Rachel E

2015-01-01

Pragmatic clinical trials (PCTs) can help answer questions of comparative effectiveness for interventions routinely used in medical practice. PCTs may examine outcomes of one or more marketed medical products, and they are heterogeneous in design and risk. The Food and Drug Administration (FDA) is charged with protecting the rights, safety, and welfare of individuals enrolled in clinical investigations, as well as assuring the integrity upon which approval of medical products are made. The FDA has broad jurisdiction over drugs and medical devices (whether or not they are approved for marketing), and as such, clinical investigations of these products are subject to applicable FDA regulations. While many PCTs will meet the criteria for an exemption from the requirements for an investigational new drug application (IND) or investigational device exemption (IDE), in general all clinical investigations of medical products that fall under FDA jurisdiction must adhere to regulations for informed consent and review by an institutional review board (IRB). We are concerned that current FDA requirements for obtaining individual informed consent may deter or delay the conduct of PCTs intended to develop reliable evidence of comparative safety and effectiveness of approved medical products that are regulated by the FDA. Under current regulations, there are no described mechanisms to alter or waive informed consent to make it less burdensome or more practicable for low-risk PCTs. We recommend that the FDA establish a risk-based approach to obtaining informed consent in PCTs that would facilitate the conduct of PCTs without compromising the protection of enrolled individuals or the integrity of the resulting data. PMID:26374684

Federal employees health benefits: payment of premiums for periods of leave without pay or insufficient pay. Final rule.

PubMed

2007-02-05

The Office of Personnel Management (OPM) is issuing final regulations to rewrite certain sections of the Federal regulations in plain language. These final regulations require Federal agencies to provide employees entering leave without pay (LWOP) status, or whose pay is insufficient to cover their Federal Employees Health Benefits (FEHB) premium payments, written notice of their opportunity to continue their FEHB coverage. Employees who want to continue their enrollment must sign a form agreeing to pay their premiums directly to their agency on a current basis, or to incur a debt to be withheld from their future salary. The purpose of this final regulation is to rewrite the existing regulations to ensure that employees who are entering LWOP status, or whose pay is insufficient to pay their FEHB premiums, are fully informed when they decide whether or not to continue their FEHB coverage.

Requirements to the procedure and stages of innovative fuel development

NASA Astrophysics Data System (ADS)

Troyanov, V.; Zabudko, L.; Grachyov, A.; Zhdanova, O.

2016-04-01

According to the accepted current understanding under the nuclear fuel we will consider the assembled active zone unit (Fuel assembly) with its structural elements, fuel rods, pellet column, structural materials of fuel rods and fuel assemblies. The licensing process includes justification of safe application of the proposed modifications, including design-basis and experimental justification of the modified items under normal operating conditions and in violation of normal conditions, including accidents as well. Besides the justification of modified units itself, it is required to show the influence of modifications on the performance and safety of the other Reactor Unit’ and Nuclear Plant’ elements (e.g. burst can detection system, transportation and processing operations during fuel handling), as well as to justify the new standards of fuel storage etc. Finally, the modified fuel should comply with the applicable regulations, which often becomes a very difficult task, if only because those regulations, such as the NP-082-07, are not covered modification issues. Making amendments into regulations can be considered as the only solution, but the process is complicated and requires deep grounds for amendments. Some aspects of licensing new nuclear fuel are considered the example of mixed nitride uranium -plutonium fuel application for the BREST reactor unit.

Evaluation of US rear underride guard regulation for large trucks using real-world crashes.

PubMed

Brumbelow, Matthew L; Blanar, Laura

2010-11-01

Current requirements for rear underride guards on large trucks are set by the National Highway Traffic Safety Administration in Federal Motor Vehicle Safety Standards (FMVSS) 223 and 224. The standards have been in place since 1998, but their adequacy has not been evaluated apart from two series of controlled crash tests. The current study used detailed reviews of real-world crashes from the Large Truck Crash Causation Study to assess the ability of guards that comply with certain aspects of the regulation to mitigate passenger vehicle underride. It also evaluated the dangers posed by underride of large trucks that are exempt from guard requirements. For the 115 cases meeting the inclusion criteria, coded data, case narratives, photographs, and measurements were used to examine the interaction between study vehicles. The presence and type of underride guard was determined, and its performance in mitigating underride was categorized. Overall, almost one-half of the passenger vehicles had underride damage classified as severe or catastrophic. These vehicles accounted for 23 of the 28 in which occupants were killed. For the cases involving trailers with underride guards compliant with one or both FMVSS, guard deformation or complete failure was frequent and most commonly due to weak attachments, buckling of the trailer chassis, or bending of the lateral end of the guard under narrow overlap loading. Most of the truck units studied qualified for at least one of the FMVSS exemptions. The two largest groups were trailers with small wheel setbacks and single-unit straight trucks. Dump trucks represented a particularly hazardous category of straight truck. The current study suggests several weaknesses in the rear underride guard regulation. The standard allows too much ground clearance, the quasi-static test conditions allow guard designs that fail in narrow overlap crashes, and certifying guards independent of trailers leads to systems with inadequate attachment and chassis strength. Additionally, the regulation should be expanded to cover a higher percentage of the large truck fleet.

77 FR 5201 - Drawbridge Operation Regulation; Bear Creek, Dundalk, MD

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-02

... bridge opening to a 48-hour advance notice requirement for a bridge opening. Due to the lack of openings... this bridge has had fewer than 12 openings every year since 2008. The majority of these openings have... it difficult, logistically, to arrive at the bridge site for an opening within the current four hour...

No harm done? Assessing risk of harm under the federal breach notification rule.

PubMed

Dimick, Chris

2010-08-01

Provisions within the HITECH Act require that covered entities notify individuals if their protected health information is breached. However, the current regulation allows an exemption if the risk of harm is slight. Assessing risk can be subjective, and privacy officers have been working to create methods to conduct and document their analyses.

78 FR 5244 - Proposed Collection; Comment Request for Regulation Project

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-24

...: REG-106511-00. Abstract: Section 6075(a) of the Internal Revenue Code (the Code) requires the executor...; however, except in the case of executors who are abroad, no such extension may be for more than 6 months. Executors currently request an extension of time to file Form 706 by filing Form 4768, ``Application for...

78 FR 21338 - Notice of Request for Extension of a Currently Approved Information Collection (Registration...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-10

...In accordance with the Paperwork Reduction Act of 1995 and Office of Management and Budget (OMB) regulations, the Food Safety and Inspection Service (FSIS) is announcing its intention to request extension of an information collection for business registration requirements because the information collection approval is scheduled to expire on June 30, 2013.

Organic and inorganic amendments affect vegetation growth on an acidic minesoil

Treesearch

William T. Plass

1982-01-01

Organic amendments can be included in minesoil revegetation treatments to produce high-density ground covers or increase the yield of pasture and forage crops. They may provide an alternative to the "topsoiling" requirements under current surface-mining laws and regulations. In this study, shredded hardwood bark, composted municipal waste, and a tannery waste...

75 FR 76185 - Federal Motor Vehicle Safety Standard, Rearview Mirrors; Federal Motor Vehicle Safety Standard...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-07

... Simulation D. Comparative Regulatory Requirements i. Current FMVSS No. 111 ii. Relevant European Regulations... specifically-defined type of incident in which a non-occupant of a vehicle (most commonly, a pedestrian, but it...-speed vehicle or trailer, designed to carry 10 persons or less which is constructed either on a truck...

75 FR 28319 - Yokohama Tire Corporation, Receipt of Petition for Decision of Inconsequential Noncompliance

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-20

... tires include the full Tire Identification Number (TIN) on one sidewall but omits the partial serial... failure incidents. The TIN becomes important in the event of a safety campaign and enables the owners to... with the current FMVSS No. 139 sidewall marking regulation that requires a full TIN on the sidewall and...

Inactivation of E. coli O157:H7 and nonpathogenic E. coli in strawberry juice by pulsed electric field, sodium benzoate, potassium sorbate, and citric acid

USDA-ARS?s Scientific Manuscript database

Introduction: Current regulations require that juice processors effect a 5 log CFU/ml reduction of a target pathogen prior to distributing products. Whereas thermal pasteurization reduces the sensory characteristics of juice by altering flavor components, pulsed electric field (PEF) treatment may ...

77 FR 53237 - Submission for Review; Information Collection: Freedom of Information/Privacy Act Record Request...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-31

... of data elements specific to FOIA and Privacy Act record requests submitted to FIS. Current FOIA and... consistent with the published regulations at 5 CFR 294 and 297, respectively. Often the requests are missing data elements which require contact with the requester via mail, thereby adding time to the access...

75 FR 38180 - Proposed Collection; Comment Request for Regulation Project

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-01

... Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting... tax-exempt status under section 501(e) of the Internal Revenue Code. Such an organization must keep records in order to show its cooperative nature and to establish compliance with other requirements in...

75 FR 38867 - Proposed Collection; Comment Request for Regulation Project

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-06

... employment taxes (and to employers) and are needed to ensure proper compliance with the Code. Upon... required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently... Retirement Tax Act; 26 CFR 31.6001-5, Additional records in connection with collection of income tax at...

78 FR 36117 - Fisheries Off West Coast States; Coastal Pelagic Species Fisheries; Annual Specifications

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-17

... regulations require NMFS to set these annual catch levels for the Pacific sardine fishery based on the annual... HG, the primary management target for the fishery, for the current fishing season. The HG is based... Fisheries Science Center and the resulting Pacific sardine biomass estimate of 659,539 mt. Based on the...

76 FR 37996 - West Virginia Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-29

... Regulations (CSR) to provide for the establishment of a minimum incremental bonding rate as authorized by... minimum incremental bonding rate of $10,000 per increment at CSR 38-2-11.4.a.2. Because these revisions... at CSR 38-2-11.4.a.2. Section 22-3-11(a) of WVSCMRA currently requires mining operators to furnish a...

LEGAL BASES FOR DISCLOSING CONFIDENTIAL PATIENT INFORMATION FOR PUBLIC HEALTH: DISTINGUISHING BETWEEN HEALTH PROTECTION AND HEALTH IMPROVEMENT

PubMed Central

Taylor, Mark J.

2015-01-01

The disclosure of confidential patient data without an individual's explicit consent should be for purposes that persons have reason to both expect and accept. We do not currently have the required level of clarity or consistency in understanding regarding the disclosure of confidential patient information for public health purposes to support effective public dialogue. The Health Service (Control of Patient Information) Regulations 2002 establish a legal basis in England and Wales for data to be disclosed for public health purposes without patient consent. Under the Regulations, there is more than one potential route towards lawful processing: Data may be processed for public health purposes under both Regulations 3 and 5. The alternatives have different safeguards and conditions attached, and their respective applicability to processing for purposes of public health improvement is currently unclear and subject to review. Beyond the need for clarity regarding the safeguards applicable to processing for particular public health purposes, there are reasons to prefer recognition that Regulation 5 is the most appropriate legal basis for disclosure when the purpose is public health improvement rather than public health protection. Where health improvement, rather than protection, is the aim, there is no justification for discarding the additional safeguards associated with processing under Regulation 5. PMID:25995294

Development and regulation of biosimilars: current status and future challenges.

PubMed

Tsiftsoglou, Asterios S; Ruiz, Sol; Schneider, Christian K

2013-06-01

Biologic medicinal products developed via rDNA technology as recombinant protein-based medicines that have been in clinical use since the early 1980s as original biopharmaceuticals have greatly contributed to the therapy of severe metabolic and degenerative diseases. The recent expiration of the data protection or patents for most of them created opportunities for the development of copy versions of original biopharmaceuticals with similar biologic activity (termed biosimilars). Production of these new products is expected to meet worldwide demand, promote market competition, maintain the incentives for innovation, and sustain the healthcare systems. The licencing of these products, however, relies on the experience gained with the original biopharmaceuticals. Critical issues related to this class of medicinal products include their terminology (to avoid confusion with generics and non-innovator copy versions that have not been tested according to the biosimilar guidelines), manufacturing, and regulation. The European Union (EU) has been the first to establish a regulatory framework for marketing authorization application (MAA) and has named these products biosimilars, a term also recently adopted by the US FDA. Unlike the conventional, more common small molecular weight human medicines and chemical generics, protein-based medicines exhibit higher molecular weight, complexity in structure and function that can be affected by changes in the manufacturing process. Therefore, biosimilars represent a relatively heterogeneous class of medicinal products that make their regulation quite challenging. According to the current understanding in the EU, a biosimilar is a copy version of an already authorized biopharmaceutical (or reference product) with similar biologic activity, physicochemical characteristics, efficacy, and safety, based on a full comparability exercise at quality, preclinical and clinical level to ensure similar efficacy and safety. Guidance has been provided through several Committee for Medicinal Products for Human Use (CHMP) guidelines as well as individual scientific advice requested from the European Medicines Agency (EMA) by various companies for the development and regulation of biosimilars. This review is mainly focused on the current status of regulation of biosimilars in the EU as well as on future challenges lying ahead for the improvement of the requirements needed for the marketing authorization of biosimilars. Emphasis is given on the quality requirements concerning these medicinal products (biologics).

Federal environmental and occupational toxicology regulations and reporting requirements: a practical approach to what the medical toxicologist needs to know, part 1.

PubMed

Schwartz, Michael D; Dell'Aglio, Damon M; Nickle, Richard; Hornsby-Myers, Jennifer

2014-09-01

Toxicologists are often called upon to assist in environmental, industrial, occupational and public health assessments. Accordingly, medical toxicologists may find it prudent to be aware of applicable federal toxicological regulations and reporting requirements and of the roles of relevant federal agencies. These regulations are numerous, complex, and have evolved and expanded over time, making it difficult for toxicologists to sustain a current knowledge base. This article reviews the pertinent federal toxicological reporting requirements with regard to the Toxic Substances Control Act (TSCA), the Atomic Energy Act (AEA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Resource Conservation and Recovery Act (RCRA), the Clean Air Act, the Clean Water Act, the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), the Emergency Planning and Community Right to Know Act (EPCRA), the Occupational Safety and Health Act, the Department of Transportation, and information about the National Response Center. We reference internet-based government resources and offer direct links to applicable websites in an attempt to offer rapid and current sources of practical information. The format of the article is a series of hypothetical scenarios followed by commentary. Discussions of the Safe Drinking Water Act, the Food, Drug, and Cosmetic Act, and the Dietary Supplement Health and Education Act are beyond the scope of this paper. For those desiring a more in-depth discussion of the relevant federal environmental laws and statutes and applicable case law, the reader is directed to resources such as the Environmental Law Handbook, the websites of individual laws found at www.epa.gov and the decisions of individual courts of appeal. It is our hope that this article provides not only useful practical information for the practicing toxicologist but also serves as a key reference for medical toxicology core content on environmental laws and regulations.

Federal environmental and occupational toxicology regulations and reporting requirements: a practical approach to what the medical toxicologist needs to know, part 2.

PubMed

Schwartz, Michael D; Dell'Aglio, Damon M; Nickle, Richard; Hornsby-Myers, Jennifer

2014-12-01

Toxicologists are often called upon to assist in environmental, industrial, occupational and public health assessments. Accordingly, medical toxicologists may find it prudent to be aware of applicable federal toxicological regulations and reporting requirements and of the roles of relevant federal agencies. These regulations are numerous, complex, and have evolved and expanded over time, making it difficult for toxicologists to sustain a current knowledge base. This article reviews the pertinent federal toxicological reporting requirements with regards to the Toxic Substances Control Act (TSCA), the Atomic Energy Act (AEA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Resource Conservation and Recovery Act (RCRA), the Clean Air Act, the Clean Water Act, the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), the Emergency Planning and Community Right to Know Act (EPCRA), the Occupational Safety and Health Act, the Department of Transportation, and information about the National Response Center. We reference internet-based government resources and offer direct links to applicable websites in an attempt to offer rapid and current sources of practical information. The format of the article is a series of hypothetical scenarios followed by commentary. Discussions of the Safe Drinking Water Act and the Food, Drug, and Cosmetic Act and the Dietary Supplement Health and Education Act are beyond the scope of this paper. For those desiring a more in depth discussion of the relevant federal environmental laws and statutes, and applicable case law, the reader is directed to resources such as the Environmental Law Handbook, the websites of individual laws found at www.epa.gov and the decisions of individual courts of appeal. It is our hope that this article provides not only useful practical information for the practicing toxicologist, but also serves as a key reference for Medical Toxicology core content on environmental laws and regulations.

[Quality of hospital discharge reports in terms of current legislation and expert recommendations].

PubMed

Zambrana-García, José Luis; Rivas-Ruiz, Francisco

2013-01-01

To determine the quality of hospital discharge reports (HDRs) taking into account current legislation and the conclusions of the consensus on hospital discharge reports in medical specialities in 11 community hospitals in Andalusia (Spain). A cross-sectional study of 1,708 HDRs was carried out. We determined the presence or absence of the various items required by current legislation and by the recommendations of the above-mentioned consensus. A total of 97.4% (95% confidence interval [95% CI]: 96.5-98.2) of the HDRs were classified as satisfactory according to the stipulations of current legislation. However, when the assessment was based on the consensus, the rate of adequacy fell to 72.1% (95% CI: 70.0-74.3). A notable finding was the absence of the duration of treatment after hospital discharge in 39.4% of the HDRs. HDRs show an excellent level of compliance with the data required by current regulations, but their intrinsic quality needs to be improved. Copyright © 2012 SESPAS. Published by Elsevier Espana. All rights reserved.

Underground storage tank management plan

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

1994-09-01

The Underground Storage Tank (UST) Management Program at the Oak Ridge Y-12 Plant was established to locate UST systems in operation at the facility, to ensure that all operating UST systems are free of leaks, and to establish a program for the removal of unnecessary UST systems and upgrade of UST systems that continue to be needed. The program implements an integrated approach to the management of UST systems, with each system evaluated against the same requirements and regulations. A common approach is employed, in accordance with Tennessee Department of Environment and Conservation (TDEC) regulations and guidance, when corrective actionmore » is mandated. This Management Plan outlines the compliance issues that must be addressed by the UST Management Program, reviews the current UST inventory and compliance approach, and presents the status and planned activities associated with each UST system. The UST Management Plan provides guidance for implementing TDEC regulations and guidelines for petroleum UST systems. (There are no underground radioactive waste UST systems located at Y-12.) The plan is divided into four major sections: (1) regulatory requirements, (2) implementation requirements, (3) Y-12 Plant UST Program inventory sites, and (4) UST waste management practices. These sections describe in detail the applicable regulatory drivers, the UST sites addressed under the Management Program, and the procedures and guidance used for compliance with applicable regulations.« less

Cosmetic websites Scotland: legal or lurid.

PubMed

Gunn, Eilidh G M; Loh, Charles Yuen Yung; Athanassopoulos, Thanassi

2014-08-01

The provision of cosmetic interventions and their advertising have recently come under intense scrutiny in the wake of the PIP scandal and Keogh report. A study of Scottish websites offering esthetic procedures was conducted to determine adherence to the advertising standards and regulations currently in place. Regulations are provided by the Advertising Standards Authority, Committee on Advertising Practice, Independent Healthcare Advisory Services and General Medical Council. An Internet search was then conducted to search for providers of non-surgical and surgical cosmetic procedures. Overall 125 websites were reviewed. 109 local and 16 national with 17 websites associated with cosmetic surgeons. 26 websites failed to adhere to regulations. Failure was related to advertising of POM on the homepage or dropdown menu (20), offering enticements inappropriately (6). 26.6% of websites did not display qualifications of the practitioners. Only 16.6% of websites described the specific and the non-specific side effects of "anti-wrinkle injections" and only 12.5% mentioned alternative treatments. The majority of websites reviewed adhered to current advertising standards. Plastic surgeons provide a small percentage of cosmetic procedures. Greater regulation at the point of product entry and of all esthetic practitioners is required. Crown Copyright © 2014. Published by Elsevier Ltd. All rights reserved.

Past Strategies and Future Directions for Identifying AMP-Activated Protein Kinase (AMPK) Modulators

PubMed Central

Sinnett, Sarah E.; Brenman, Jay E.

2014-01-01

AMP-activated protein kinase (AMPK) is a promising therapeutic target for cancer, type II diabetes, and other illnesses characterized by abnormal energy utilization. During the last decade, numerous labs have published a range of methods for identifying novel AMPK modulators. The current understanding of AMPK structure and regulation, however, has propelled a paradigm shift in which many researchers now consider ADP to be an additional regulatory nucleotide of AMPK. How can the AMPK community apply this new understanding of AMPK signaling to translational research? Recent insights into AMPK structure, regulation, and holoenzyme-sensitive signaling may provide the hindsight needed to clearly evaluate the strengths and weaknesses of past AMPK drug discovery efforts. Improving future strategies for AMPK drug discovery will require pairing the current understanding of AMPK signaling with improved experimental designs. PMID:24583089

Current good tissue practice for human cell, tissue, and cellular and tissue-based product establishments; inspection and enforcement. Final rule.

PubMed

2004-11-24

The Food and Drug Administration (FDA) is requiring human cell, tissue, and cellular and tissue-based product (HCT/P) establishments to follow current good tissue practice (CGTP), which governs the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps; recordkeeping; and the establishment of a quality program. The agency is also issuing new regulations pertaining to labeling, reporting, inspections, and enforcement that will apply to manufacturers of those HCT/Ps regulated solely under the authority of the Public Health Service Act (PHS Act), and not as drugs, devices, and/or biological products. The agency's actions are intended to improve protection of the public health while keeping regulatory burden to a minimum, which in turn would encourage significant innovation.

Compensation of research-related injuries in the European Union.

PubMed

Avilds, Miguelangel Ramiro

2014-12-01

The planned reform of the Clinical Trials Directive has re-opened the debate over how to implement and interpret research-related injuries regulation. In the European Union (EU), clinical trials are currently regulated by Directive 2001/20/EC, which establishes the provision of mandatory insurance before clinical trials commence but is silent on the system of liability. The proposed new Regulation will impact biomedical research assurance in all EU Member States because it points to insurance costs as being one of the causes of the fall in the number of clinical trials carried out in the EU. Despite the adoption of a risk-balance approach, the proposed new Regulation does not include a no-fault compensation system to protect subjects participating in clinical trials. An adequate protection of the rights and wellbeing of trial subjects would require not only mandatory insurance for clinical trials but also a no-fault compensation system. The new regulation should include a general clause requiring mandatory insurance and establishing liability insurance based on no-fault compensation; an exception clause, enabling the performance of clinical trials without insurance in the case of low-risk interventions or non-commercial clinical trials; and an exclusion clause, excluding compensation when there is no causal connection between injuries and clinical trial.

Tobacco Regulation and Cost-Benefit Analysis: How Should We Value Foregone Consumer Surplus?

PubMed

Levy, Helen G; Norton, Edward C; Smith, Jeffrey A

2018-01-01

Recent tobacco regulations proposed by the Food and Drug Administration have raised a thorny question: how should the cost-benefit analysis accompanying such policies value foregone consumer surplus associated with regulation-induced reductions in smoking? In a model with rational and fully informed consumers, this question is straightforward. There is disagreement, however, about whether consumers are rational and fully informed, and the literature offers little practical guidance about what approach the FDA should use if they are not. In this paper, we outline the history of the FDA's recent attempts to regulate cigarettes and other tobacco products and how they have valued foregone consumer surplus in cost-benefit analyses. We advocate replacing the approach used in most of this literature, which first calculates health gains associated with regulation and then "offsets" them by some factor reflecting consumer surplus losses, with a more general behavioral public finance framework for welfare analysis. This framework applies standard tools of welfare analysis to consumer demand that may be "biased" (that is, not necessarily rational and fully informed) without requiring specific assumptions about the reason for the bias. This framework would require estimates of both biased and unbiased consumer demand; we sketch an agenda to help develop these in the context of smoking. The use of this framework would substantially reduce the confusion currently surrounding welfare analysis of tobacco regulation.

Tobacco Regulation and Cost-Benefit Analysis: How Should We Value Foregone Consumer Surplus?

PubMed Central

Levy, Helen G.; Norton, Edward C.; Smith, Jeffrey A.

2016-01-01

Recent tobacco regulations proposed by the Food and Drug Administration have raised a thorny question: how should the cost-benefit analysis accompanying such policies value foregone consumer surplus associated with regulation-induced reductions in smoking? In a model with rational and fully informed consumers, this question is straightforward. There is disagreement, however, about whether consumers are rational and fully informed, and the literature offers little practical guidance about what approach the FDA should use if they are not. In this paper, we outline the history of the FDA’s recent attempts to regulate cigarettes and other tobacco products and how they have valued foregone consumer surplus in cost-benefit analyses. We advocate replacing the approach used in most of this literature, which first calculates health gains associated with regulation and then “offsets” them by some factor reflecting consumer surplus losses, with a more general behavioral public finance framework for welfare analysis. This framework applies standard tools of welfare analysis to consumer demand that may be “biased” (that is, not necessarily rational and fully informed) without requiring specific assumptions about the reason for the bias. This framework would require estimates of both biased and unbiased consumer demand; we sketch an agenda to help develop these in the context of smoking. The use of this framework would substantially reduce the confusion currently surrounding welfare analysis of tobacco regulation. PMID:29404381

Regulatory and quality considerations for continuous manufacturing. May 20-21, 2014 Continuous Manufacturing Symposium.

PubMed

Allison, Gretchen; Cain, Yanxi Tan; Cooney, Charles; Garcia, Tom; Bizjak, Tara Gooen; Holte, Oyvind; Jagota, Nirdosh; Komas, Bekki; Korakianiti, Evdokia; Kourti, Dora; Madurawe, Rapti; Morefield, Elaine; Montgomery, Frank; Nasr, Moheb; Randolph, William; Robert, Jean-Louis; Rudd, Dave; Zezza, Diane

2015-03-01

This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including continuous manufacturing process description and control strategy in regulatory files, process validation, and key Good Manufacturing Practice (GMP) requirements. In addition, the paper identifies regulatory gaps and challenges and proposes a way forward to facilitate implementation. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

Phospholipase C δ4 regulates cold sensitivity in mice.

PubMed

Yudin, Yevgen; Lutz, Brianna; Tao, Yuan-Xiang; Rohacs, Tibor

2016-07-01

The cold- and menthol-activated transient receptor potential melastatin 8 (TRPM8) channels are thought to be regulated by phospholipase C (PLC), but neither the specific PLC isoform nor the in vivo relevance of this regulation has been established. Here we identify PLCδ4 as the key PLC isoform involved in regulation of TRPM8 channels in vivo. We show that in small PLCδ4(-/-) TRPM8-positive dorsal root ganglion neurons cold, menthol and WS-12, a selective TRPM8 agonist, evoked significantly larger currents than in wild-type neurons, and action potential frequencies induced by menthol or by current injections were also higher in PLCδ4(-/-) neurons. PLCδ4(-/-) mice showed increased behavioural responses to evaporative cooling, and this effect was inhibited by a TRPM8 antagonist; behavioural responses to heat and mechanical stimuli were not altered. We provide evidence for the involvement of a specific PLC isoform in the regulation of cold sensitivity in mice by regulating TRPM8 activity. The transient receptor potential melastatin 8 (TRPM8) ion channel is a major sensor of environmental low temperatures. Ca(2+) -induced activation of phospholipase C (PLC) has been implied in the regulation of TRPM8 channels during menthol- and cold-induced desensitization in vitro. Here we identify PLCδ4 as the key PLC isoform involved in regulation of TRPM8 in sensory dorsal root ganglion (DRG) neurons. We identified two TRPM8-positive neuronal subpopulations, based on their cell body size. Most TRPM8-positive small neurons also responded to capsaicin, and had significantly larger menthol-induced inward current densities than medium-large cells, most of which did not respond to capsaicin. Small, but not medium-large, PLCδ4(-/-) neurons showed significantly larger currents induced by cold, menthol or WS-12, a specific TRPM8 agonist, compared to wild-type (WT) neurons, but TRPM8 protein levels were not different between the two groups. In current-clamp experiments small neurons had more depolarized resting membrane potentials, and required smaller current injections to generate action potentials (APs) than medium-large cells. In small PLCδ4(-/-) neurons, menthol application induced larger depolarizations and generation of APs with frequencies significantly higher compared to WT neurons. In behavioural experiments PLCδ4(-/-) mice showed greater sensitivity to evaporative cooling by acetone than control animals. Pretreatment with the TRPM8 antagonist PBMC reduced cold-induced responses, and the effect was more pronounced in the PLCδ4(-/-) group. Heat and mechanical sensitivity of the PLCδ4(-/-) mice was not different from WT animals. Our data support the involvement of PLCδ4 in the regulation of TRPM8 channel activity in vivo. © 2016 The Authors. The Journal of Physiology © 2016 The Physiological Society.

Signal-activated phospholipase regulation of leukocyte chemotaxis.

PubMed

Cathcart, Martha K

2009-04-01

Signal-activated phospholipases are a recent focus of the rapidly growing field of lipid signaling. The extent of their impact on the pathways regulating diverse cell functions is beginning to be appreciated. A critical step in inflammation is the attraction of leukocytes to injured or diseased tissue. Chemotaxis of leukocytes, a requisite process for monocyte and neutrophil extravasation from the blood into tissues, is a critical step for initiating and maintaining inflammation in both acute and chronic settings. Recent studies have identified new important and required roles for two signal-activated phospholipases A2 (PLA2) in regulating chemotaxis. The two intracellular phospholipases, cPLA2alpha (Group IVA) and iPLA2beta (Group VIA), act in parallel to provide distinct lipid mediators at different intracellular sites that are both required for leukocytes to migrate toward the chemokine monocyte chemoattractant protein-1. This review will summarize the separate roles of these phospholipases as well as what is currently known about the influence of two other classes of intracellular signal-activated phospholipases, phospholipase C and phospholipase D, in regulating chemotaxis in eukaryotic cells, but particularly in human monocytes. The contributions of these phospholipases to chemotaxis both in vitro and in vivo will be highlighted.

Commercial treatability study capabilities for application to the US Department of Energy`s anticipated mixed waste streams. Revision 1

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

1996-09-01

US DOE mixed low-level and mixed transuranic waste inventory was estimated at 181,000 cubic meters (about 2,000 waste streams). Treatability studies may be used as part of DOE`s mixed waste management program. Commercial treatability study suppliers have been identified that either have current capability in their own facilities or have access to licensed facilities. Numerous federal and state regulations, as well as DOE Order 5820.2A, impact the performance of treatability studies. Generators, transporters, and treatability study facilities are subject to regulation. From a mixed- waste standpoint, a key requirement is that the treatability study facility must have an NRC ormore » state license that allows it to possess radioactive materials. From a RCRA perspective, the facility must support treatability study activities with the applicable plans, reports, and documentation. If PCBs are present in the waste, TSCA will also be an issue. CERCLA requirements may apply, and both DOE and NRC regulations will impact the transportation of DOE mixed waste to an off-site treatment facility. DOE waste managers will need to be cognizant of all applicable regulations as mixed-waste treatability study programs are initiated.« less

Energy drinks: an emerging public health hazard for youth.

PubMed

Pomeranz, Jennifer L; Munsell, Christina R; Harris, Jennifer L

2013-05-01

Energy drinks are emerging as a public health threat and are increasingly consumed by youth internationally. Energy drinks contain high levels of caffeine, sugar, and novel ingredients, and are often marketed through youth-oriented media and venues. We review these practices and the current inconsistent state of labeling. We also examine international support for regulation of these products, including a survey showing that 85 per cent of United States parents agreed that regulations requiring caffeine content disclosure and warning labels on energy drinks are warranted. We then examine the regulatory structure for energy drinks in the United States, analyzing legal and self-regulatory strategies to protect consumers, especially youth, from these potentially dangerous products. Recommended government interventions include revised labeling requirements, addressing problematic ingredients, and enacting retail restrictions. We conclude by identifying areas for future research.

Considerations of nano-QSAR/QSPR models for nanopesticide risk assessment within the European legislative framework.

PubMed

Villaverde, Juan José; Sevilla-Morán, Beatriz; López-Goti, Carmen; Alonso-Prados, José Luis; Sandín-España, Pilar

2018-09-01

The European market for pesticides is currently legislated through the well-developed Regulation (EC) No. 1107/2009. This regulation promotes the competitiveness of European agriculture, recognizing the necessity of safe pesticides for human and animal health and the environment to protect crops against pests, diseases and weeds. In this sense, nanotechnology can provide a tremendous opportunity to achieve a more rational use of pesticides. However, the lack of information regarding nanopesticides and their fate and behavior in the environment and their effects on human and animal health is inhibiting rapid nanopesticide incorporation into European Union agriculture. This review analyzes the recent state of knowledge on nanopesticide risk assessment, highlighting the challenges that need to be overcame to accelerate the arrival of these new tools for plant protection to European agricultural professionals. Novel nano-Quantitative Structure-Activity/Structure-Property Relationship (nano-QSAR/QSPR) tools for risk assessment are analyzed, including modeling methods and validation procedures towards the potential of these computational instruments to meet the current requirements for authorization of nanoformulations. Future trends on these issues, of pressing importance within the context of the current European pesticide legislative framework, are also discussed. Standard protocols to make high-quality and well-described datasets for the series of related but differently sized nanoparticles/nanopesticides are required. Copyright © 2018 Elsevier B.V. All rights reserved.

Psychophysiological correlates of emotion regulation training in adolescent anxiety: Evidence from the novel PIER task.

PubMed

De Witte, Nele A J; Sütterlin, Stefan; Braet, Caroline; Mueller, Sven C

2017-05-01

Anxiety disorders are the leading cause of mental illness in adolescence. While anxious adolescents show impairments in emotion processing and deficits in emotion regulation, few studies have attempted to improve emotion regulation within these populations. This study used a multi-method design to test a newly developed emotion regulation training aimed at improving insight into emotions and instructing cognitive reappraisal. The efficacy of cognitive reappraisal was investigated in 27 clinically anxious youth (Age: M=12.36, SD=2.59) and 43 healthy controls (Age: M=13.07, SD=2.19) using psychophysiological measures. Specifically, heart rate variability, pupil dilation, and visual fixations were recorded while youth had to up- or downregulate their emotions in response to affective pictures in the Psychophysiological Indicators of Emotion Regulation (PIER) task. The novel training effectively improved self-reported emotion regulation and momentary anxiety in both groups. Moreover, initial group differences in emotional reactivity mostly disappeared when participants were instructed to apply emotion regulation in the task. However, pupil dilation data suggested that participants with anxiety disorders required more cognitive resources for the upregulation of negative affect to counteract this effect. The relatively small sample size and large age range could hamper detection of additional group differences that may exist. The current study provides evidence that anxious youth can apply cognitive reappraisal to a similar extent as healthy adolescents after emotion regulation training but may need to exert more effort to do so. This training could be a valuable addition to current treatment programs. Copyright © 2017 Elsevier B.V. All rights reserved.

In Defense of a Social Value Requirement for Clinical Research

PubMed Central

Wendler, David; Rid, Annette

2017-01-01

Many guidelines and commentators endorse the view that clinical research is ethically acceptable only when it has social value, in the sense of collecting data which might be used to improve health. A version of this social value requirement is included in the Declaration of Helsinki and the Nuremberg Code, and is codified in many national research regulations. At the same time, there have been no systematic analyses of why social value is an ethical requirement for clinical research. Recognizing this gap in the literature, recent articles by Alan Wertheimer and David Resnik argue that the extant justifications for the social value requirement are unpersuasive. Both authors conclude, contrary to almost all current guidelines and regulations, that it can be acceptable across a broad range of cases to conduct clinical research which is known prospectively to have no social value. The present paper assesses this conclusion by critically evaluating the ethical and policy considerations relevant to the claim that clinical research must have social value. This analysis supports the standard view that social value is an ethical requirement for the vast majority of clinical research studies and should be mandated by applicable guidelines and policies. PMID:28060427

In Defense of a Social Value Requirement for Clinical Research.

PubMed

Wendler, David; Rid, Annette

2017-02-01

Many guidelines and commentators endorse the view that clinical research is ethically acceptable only when it has social value, in the sense of collecting data which might be used to improve health. A version of this social value requirement is included in the Declaration of Helsinki and the Nuremberg Code, and is codified in many national research regulations. At the same time, there have been no systematic analyses of why social value is an ethical requirement for clinical research. Recognizing this gap in the literature, recent articles by Alan Wertheimer and David Resnik argue that the extant justifications for the social value requirement are unpersuasive. Both authors conclude, contrary to almost all current guidelines and regulations, that it can be acceptable across a broad range of cases to conduct clinical research which is known prospectively to have no social value. The present article assesses this conclusion by critically evaluating the ethical and policy considerations relevant to the claim that clinical research must have social value. This analysis supports the standard view that social value is an ethical requirement for the vast majority of clinical research studies and should be mandated by applicable guidelines and policies. © 2017 John Wiley & Sons Ltd.

Template for updating regulations in QA manuals

DOE Office of Scientific and Technical Information (OSTI.GOV)

White, M.G.; Banerjee, B.

1992-01-01

Recently, the U.S. Department of Energy (DOE) issued new quality assurance (QA) orders to reflect current policies for conduct and operation of DOE-authorized programs and facilities. Establishing traceability to new QA criteria and requirements from former multidraft orders, QA manuals, and guidance documentation for DOE-funded work can be confusing. Identified critical considerations still must be addressed. Most of the newly stated QA criteria can be cross referenced, where applicable, to former QA plans and manuals. Where additional criteria occur, new procedures may be required, together with revisions in QA plans and manuals.

Nutritional Biochemistry of Space Flight

NASA Technical Reports Server (NTRS)

Smith, Scott M.

2000-01-01

Adequate nutrition is critical for maintenance of crew health during and after extended-duration space flight. The impact of weightlessness on human physiology is profound, with effects on many systems related to nutrition, including bone, muscle, hematology, fluid and electrolyte regulation. Additionally, we have much to learn regarding the impact of weightlessness on absorption, mtabolism , and excretion of nutrients, and this will ultimately determine the nutrient requirements for extended-duration space flight. Existing nutritional requirements for extended-duration space flight have been formulated based on limited flight research, and extrapolation from ground-based research. NASA's Nutritional Biochemistry Laboratory is charged with defining the nutritional requirements for space flight. This is accomplished through both operational and research projects. A nutritional status assessment program is included operationally for all International Space Station astronauts. This medical requirement includes biochemical and dietary assessments, and is completed before, during, and after the missions. This program will provide information about crew health and nutritional status, and will also provide assessments of countermeasure efficacy. Ongoing research projects include studies of calcium and bone metabolism, and iron absorption and metabolism. The calcium studies include measurements of endocrine regulation of calcium homeostasis, biochemical marker of bone metabolism, and tracer kinetic studies of calcium movement in the body. These calcium kinetic studies allow for estimation of intestinal absorption, urinary excretion, and perhaps most importantly - deposition and resorption of calcium from bone. The Calcium Kinetics experiment is currently being prepared for flight on the Space Shuttle in 2001, and potentially for subsequent Shuttle and International Space Station missions. The iron study is intended to assess whether iron absorption is down-regulated dUl1ng space flight. This is critical due to the red blood cell changes which occur, and the increase in iron storage that has been observed after space flight. The Iron Absorption and Metabolism experiment is currently planned for long-term flights on the International Space Station.

Current reprogramming systems in regenerative medicine: from somatic cells to induced pluripotent stem cells.

PubMed

Hu, Chenxia; Li, Lanjuan

2016-01-01

Induced pluripotent stem cells (iPSCs) paved the way for research fields including cell therapy, drug screening, disease modeling and the mechanism of embryonic development. Although iPSC technology has been improved by various delivery systems, direct transduction and small molecule regulation, low reprogramming efficiency and genomic modification steps still inhibit its clinical use. Improvements in current vectors and the exploration of novel vectors are required to balance efficiency and genomic modification for reprogramming. Herein, we set out a comprehensive analysis of current reprogramming systems for the generation of iPSCs from somatic cells. By clarifying advantages and disadvantages of the current reprogramming systems, we are striding toward an effective route to generate clinical grade iPSCs.

78 FR 6772 - Failure To File Gain Recognition Agreements and Other Required Filings

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-31

... regulations that would amend the existing rules governing the consequences to U.S. persons for failing to file... current law, if a U.S. transferor fails to timely file an initial GRA, or fails to comply in any material... fails to timely file an annual certification), the U.S. transferor is subject to full gain recognition...

78 FR 27336 - Drawbridge Operation Regulation; Wolf River, Gills Landing and Winneconne, WI

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-10

... clearance allows most of the vessel traffic to pass under the bridge without an opening. The Canadian... boat. A 12- hours advance notice from October 16 to April 19 would be required for openings. Currently...-hour advance notice of arrival for openings from May 1 to October 31 between the hours of 11 p.m. to 7...

c-Rel, an NF-[kappa]B Family Transcription Factor, Is Required for Hippocampal Long-Term Synaptic Plasticity and Memory Formation

ERIC Educational Resources Information Center

Ahn, Hyung Jin; Hernandez, Caterina M.; Levenson, Jonathan M.; Lubin, Farah D.; Liou, Hsiou-Chi; Sweatt, J. David

2008-01-01

Transcription is a critical component for consolidation of long-term memory. However, relatively few transcriptional mechanisms have been identified for the regulation of gene expression in memory formation. In the current study, we investigated the activity of one specific member of the NF-[kappa]B transcription factor family, c-Rel, during…

COMPARISON OF THE RECOVERIES OF ESCHERICHIA COLI AND TOTAL COLIFORMS FROM DRINKING WATER BY THE MI AGAR METHOD AND THE U.S. ENVIRONMENTAL PROTECTION AGENCY-APPROVED MEMBRANE FILTER METHOD

EPA Science Inventory

Drinking water regulations under the Final Coliform Rule require that total coliform-positive drinking water samples be examined for the presence of Escherichia coli or fecal coliforms. The current U.S. Environmental Protection Agency-approved membrane filter (MF) method for E. c...

78 FR 4307 - Current Good Manufacturing Practice Requirements for Combination Products

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-22

.... Rationale for the Rulemaking B. The Proposed Rule C. The Final Rule II. Comments on the Proposed Rule A. General B. What is the scope of this subpart? (Sec. 4.1) C. How does FDA define key terms and phrases in... Act (the PHS Act) (42 U.S.C. 262). All biological products regulated under the PHS Act meet the...

77 FR 29575 - Amendment to the International Traffic in Arms Regulations: Revision of U.S. Munitions List...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-18

... while the newly revised categories would follow a completely different numbering structure. In order to... under ECCN 0A617.e. Paragraph (c) is removed and placed in reserve; the articles currently controlled... opinion that this rule is exempt from the rulemaking provisions of 5 U.S.C. 553, it does not require...

Effectiveness of the Civil Aviation Security Program.

DTIC Science & Technology

1977-10-31

searches. Perhaps the best evidence of the effectiveness of airline and airport security measures is the number of hijackings and related crimes...revision of the regulation that established basic airport security requirements is currently underway. One of the more significant revisions under study... airport security procedures cannot be determined with certainty. Nowever, the number of firearms detected at passenger screening points under suspicious

75 FR 76666 - Reporting, Recordkeeping, and Daily Trading Records Requirements for Swap Dealers and Major Swap...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-09

... Commission \\11\\ and by the Autorit[eacute] des March[eacute]s Financiers in France,\\12\\ and have been... Securities and Futures Commission para. 3.9 (2010) (H.K.). \\12\\ General Regulation of the Autorit[eacute] des... it displays a currently valid control number. The OMB has not yet assigned this collection a control...

The Regulatory Structure Supporting Basic Education in Indonesia: Analysis Covering 1989 to Present. Working Paper.

ERIC Educational Resources Information Center

Cohen, Joseph

This report examines the legal and regulatory structure of basic education in Indonesia beginning in 1989, when Education Law Number 2 was enacted (from which all current regulations, policies, and procedures can be traced). In 1999, two key laws (Number 22 and Number 25) were passed that required the decentralization of many government functions.…

Harnessing the potential of lung stem cells for regenerative medicine.

PubMed

McQualter, Jonathan L; Anthony, Desiree; Bozinovski, Steven; Prêle, Cecilia M; Laurent, Geoffrey J

2014-11-01

In response to recurrent exposure to environmental insults such as allergens, pollution, irritants, smoke and viral/bacterial infection, the epithelium of the lung is continually damaged. Homeostasis of the lung requires a balance between immune regulation and promotion of tissue regeneration, which requires the co-ordinated proliferation and differentiation of stem and progenitor cells. In this review we reflect on the current understanding of lung epithelial stem and progenitor cells and advocate a model hierarchy in which self-renewing multipotent lung epithelial stem cells give rise to lineage restricted progenitor cells that repopulate airway and alveolar epithelial cell lineages during homeostasis and repair. We also discuss the role of mesenchymal progenitor cells in maintaining the structural integrity of the lung and propose a model in which mesenchymal cells act as the quintessential architects of lung regeneration by providing molecular signals, such as FGF-10, to regulate the fate and specificity of epithelial stem and progenitor cells. Moreover, we discuss the current status and future prospects for translating lung stem cell therapies to the clinic to replace, repair, or regenerate diseased lung tissue. This article is part of a directed issue entitled: Regenerative Medicine: the challenge of translation. Copyright © 2014 Elsevier Ltd. All rights reserved.

Transcription Factors and Plants Response to Drought Stress: Current Understanding and Future Directions

PubMed Central

Joshi, Rohit; Wani, Shabir H.; Singh, Balwant; Bohra, Abhishek; Dar, Zahoor A.; Lone, Ajaz A.; Pareek, Ashwani; Singla-Pareek, Sneh L.

2016-01-01

Increasing vulnerability of plants to a variety of stresses such as drought, salt and extreme temperatures poses a global threat to sustained growth and productivity of major crops. Of these stresses, drought represents a considerable threat to plant growth and development. In view of this, developing staple food cultivars with improved drought tolerance emerges as the most sustainable solution toward improving crop productivity in a scenario of climate change. In parallel, unraveling the genetic architecture and the targeted identification of molecular networks using modern “OMICS” analyses, that can underpin drought tolerance mechanisms, is urgently required. Importantly, integrated studies intending to elucidate complex mechanisms can bridge the gap existing in our current knowledge about drought stress tolerance in plants. It is now well established that drought tolerance is regulated by several genes, including transcription factors (TFs) that enable plants to withstand unfavorable conditions, and these remain potential genomic candidates for their wide application in crop breeding. These TFs represent the key molecular switches orchestrating the regulation of plant developmental processes in response to a variety of stresses. The current review aims to offer a deeper understanding of TFs engaged in regulating plant’s response under drought stress and to devise potential strategies to improve plant tolerance against drought. PMID:27471513

The Effectiveness of Taiwan Building Energy Regulation under the influence of Future Climate

NASA Astrophysics Data System (ADS)

Weng, Yu-Teng; Huang, Kuo-Tsang

2017-04-01

Building energy consumption comprises circa 40% of the national annual energy usage in Taiwan, and the majority proportion is attributed to the cooling apparatus usage. As cooling energy is closely related to the outdoor climate, it is expected that the future global climate change would amplify its demand. Considering the building energy regulation criteria are the minimum requirements that the building has to be complied with, this study tried to investigate whether the current building energy regulation in Taiwan, initiated in 2013, would still be capable of maintaining the energy use in the future as today's level. The research adopted EnergyPlus to simulate the annual cooling energy use of several virtual office building cases with the constructed hourly future weather data under future climate change scenarios of RCP45 and RCP85 defined by IPCC. The virtual building cases are generated by a structured orthogonal array with each case is constituted by 10 building design parameters. The results revealed that the building energy consumption based on the current regulation criteria failed to maintain at the same level in the future as oppose to nowadays. By comparing to the current cooling energy usage, it would rise by 13% and 22% in RCP45 and RCP85, respectively, at the end of this century. This research further parametrically studied the potential cooling energy mitigation strategies and proposed effective building envelope design schemes in order to neutralize the future building energy increase.

Regulation of neuronal excitability by interaction of fragile X mental retardation protein with slack potassium channels.

PubMed

Zhang, Yalan; Brown, Maile R; Hyland, Callen; Chen, Yi; Kronengold, Jack; Fleming, Matthew R; Kohn, Andrea B; Moroz, Leonid L; Kaczmarek, Leonard K

2012-10-31

Loss of the RNA-binding protein fragile X mental retardation protein (FMRP) represents the most common form of inherited intellectual disability. Studies with heterologous expression systems indicate that FMRP interacts directly with Slack Na(+)-activated K(+) channels (K(Na)), producing an enhancement of channel activity. We have now used Aplysia bag cell (BC) neurons, which regulate reproductive behaviors, to examine the effects of Slack and FMRP on excitability. FMRP and Slack immunoreactivity were colocalized at the periphery of isolated BC neurons, and the two proteins could be reciprocally coimmunoprecipitated. Intracellular injection of FMRP lacking its mRNA binding domain rapidly induced a biphasic outward current, with an early transient tetrodotoxin-sensitive component followed by a slowly activating sustained component. The properties of this current matched that of the native Slack potassium current, which was identified using an siRNA approach. Addition of FMRP to inside-out patches containing native Aplysia Slack channels increased channel opening and, in current-clamp recordings, produced narrowing of action potentials. Suppression of Slack expression did not alter the ability of BC neurons to undergo a characteristic prolonged discharge in response to synaptic stimulation, but prevented recovery from a prolonged inhibitory period that normally follows the discharge. Recovery from the inhibited period was also inhibited by the protein synthesis inhibitor anisomycin. Our studies indicate that, in BC neurons, Slack channels are required for prolonged changes in neuronal excitability that require new protein synthesis, and raise the possibility that channel-FMRP interactions may link changes in neuronal firing to changes in protein translation.

Involvement of Small RNAs in Phosphorus and Sulfur Sensing, Signaling and Stress: Current Update

PubMed Central

Kumar, Smita; Verma, Saurabh; Trivedi, Prabodh K.

2017-01-01

Plants require several essential mineral nutrients for their growth and development. These nutrients are required to maintain physiological processes and structural integrity in plants. The root architecture has evolved to absorb nutrients from soil and transport them to other parts of the plant. Nutrient deficiency affects several physiological and biological processes in plants and leads to reduction in crop productivity and yield. To compensate this adversity, plants have developed adaptive mechanisms to enhance the acquisition, conservation, and mobilization of these nutrients under deficient or adverse conditions. In addition, plants have evolved an intricate nexus of complex signaling cascades, which help in nutrient sensing and uptake as well as to maintain nutrient homeostasis. In recent years, small non-coding RNAs such as micro RNAs (miRNAs) and endogenous small interfering RNAs have emerged as important component in regulating plant stress responses. A set of these small RNAs (sRNAs) have been implicated in regulating various processes involved in nutrient uptake, assimilation, and deficiency. In response to phosphorus (P) and sulphur (S) deficiencies, role of sRNAs, miR395 and miR399, have been identified to be instrumental; however, many more miRNAs might be involved in regulating the plant response to these nutrient stresses. These sRNAs modulate expression of target genes in response to P and S deficiencies and regulate their uptake and utilization for proper growth and development of the plant. This review summarizes the current understanding of uptake, sensing, and signaling of P and S and highlights the regulatory role of sRNAs in adaptive responses to these nutrient stresses in plants. PMID:28344582

76 FR 53381 - Endangered and Threatened Wildlife and Plants; Termination of the Southern Sea Otter...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-26

...We, the U.S. Fish and Wildlife Service (Service), propose to remove the regulations that govern the southern sea otter (Enhydra lutris nereis) translocation program, including the establishment of an experimental population of southern sea otters, and all associated management actions. We are also proposing to amend the Authority citation for 50 CFR part 17 by removing the reference to Public Law 99- 625, the statute that authorized the Secretary to promulgate regulations establishing the southern sea otter translocation program. Removal of the regulations will terminate the program. We are proposing this action because we believe that the southern sea otter translocation program has failed to fulfill its purpose, as outlined in the southern sea otter translocation plan, and that our recovery and management goals for the species cannot be met by continuing the program. Our conclusion is based, in part, on an evaluation of the program against specific failure criteria established at the program's inception. This proposed action would terminate the designation of the experimental population of southern sea otters, abolish the southern sea otter translocation and management zones, and eliminate the current requirement to remove southern sea otters from San Nicolas Island and the management zone. This proposed rule would also eliminate future actions, required under the current regulations, to capture and relocate southern sea otters for the purpose of establishing an experimental population, and to remove southern sea otters in perpetuity from an ``otter-free'' management zone. As a result, it would allow southern sea otters to expand their range naturally into southern California waters. We have prepared a revised draft supplemental environmental impact statement (SEIS) and an initial regulatory flexibility analysis (IRFA) to accompany this proposed rule.

Implicit emotion regulation affects outcome evaluation.

PubMed

Yang, Qiwei; Tang, Ping; Gu, Ruolei; Luo, Wenbo; Luo, Yue-jia

2015-06-01

Efficient implicit emotion regulation processes, which run without awareness, are important for human well-being. In this study, to investigate the influence of implicit emotion regulation on psychological and electrophysiological responses to gains and losses, participants were required to select between two Chinese four-character idioms to match the meaning of the third one before they performed a monetary gambling task. According to whether their meanings were related to emotion regulation, the idioms fell into two categories. Event-related potentials and self-rating emotional experiences to outcome feedback were recorded during the task. Priming emotion regulation reduced subjective emotional experience to both gains and losses and the amplitudes of the feedback-related negativity, while the P3 component was not influenced. According to these results, we suggest that the application of implicit emotion regulation effectively modulated the subjective emotional experience and the motivational salience of current outcomes without the cost of cognitive resources. This study implicates the potential significance of implicit emotion regulation in decision-making processes. © The Author (2014). Published by Oxford University Press. For Permissions, please email: journals.permissions@oup.com.

The Chloroplast ATP Synthase Features the Characteristic Redox Regulation Machinery

PubMed Central

Sunamura, Ei-Ichiro; Kim, Yusung; Konno, Hiroki

2013-01-01

Abstract Significance: Regulation of the activity of the chloroplast ATP synthase is largely accomplished by the chloroplast thioredoxin system, the main redox regulation system in chloroplasts, which is directly coupled to the photosynthetic reaction. We review the current understanding of the redox regulation system of the chloroplast ATP synthase. Recent Advances: The thioredoxin-targeted portion of the ATP synthase consists of two cysteines located on the central axis subunit γ. The redox state of these two cysteines is under the influence of chloroplast thioredoxin, which directly controls rotation during catalysis by inducing a conformational change in this subunit. The molecular mechanism of redox regulation of the chloroplast ATP synthase has recently been determined. Critical Issues: Regulation of the activity of the chloroplast ATP synthase is critical in driving efficiency into the ATP synthesis reaction in chloroplasts. Future Directions: The molecular architecture of the chloroplast ATP synthase, which confers redox regulatory properties requires further investigation, in light of the molecular structure of the enzyme complex as well as the physiological significance of the regulation system. Antioxid. Redox Signal. 19, 1846–1854. PMID:23145525

A study of Schwarz converters for nuclear powered spacecraft

NASA Technical Reports Server (NTRS)

Stuart, Thomas A.; Schwarze, Gene E.

1987-01-01

High power space systems which use low dc voltage, high current sources such as thermoelectric generators, will most likely require high voltage conversion for transmission purposes. This study considers the use of the Schwarz resonant converter for use as the basic building block to accomplish this low-to-high voltage conversion for either a dc or an ac spacecraft bus. The Schwarz converter has the important assets of both inherent fault tolerance and resonant operation; parallel operation in modular form is possible. A regulated dc spacecraft bus requires only a single stage converter while a constant frequency ac bus requires a cascaded Schwarz converter configuration. If the power system requires constant output power from the dc generator, then a second converter is required to route unneeded power to a ballast load.

Differential regulation of ASICs and TRPV1 by zinc in rat bronchopulmonary sensory neurons.

PubMed

Vysotskaya, Zhanna V; Moss, Charles R; Gu, Qihai

2014-12-01

Zinc has been known to act as a signaling molecule that regulates a variety of neuronal functions. In this study, we aimed to study the effect of zinc on two populations of acid-sensitive ion channels, acid-sensing ion channels (ASICs), and transient receptor potential vanilloid receptor-1 (TRPV1), in vagal bronchopulmonary sensory neurons. Rat vagal sensory neurons innervating lungs and airways were retrogradely labeled with a fluorescent tracer. Whole-cell perforated patch-clamp recordings were carried out in primarily cultured bronchopulmonary sensory neurons. The acid-evoked ASIC and TRPV1 currents were measured and compared between before and after the zinc pretreatment. ASIC currents were induced by a pH drop from 7.4 to 6.8 or 6.5 in the presence of capsazepine (10 µM), a specific TRPV1 antagonist. Pretreatment with zinc (50 or 300 µM, 2 min) displayed different effects on the two distinct phenotypes of ASIC currents: a marked potentiation on ASIC channels with fast kinetics of activation and inactivation or no significant effect on ASIC currents with slow activation and inactivation. On the other hand, pretreatment with zinc significantly inhibited the acid (pH 5.5 or 5.3)-induced TRPV1 currents. The inhibition was abolished by intracellular chelation of zinc by TPEN (25 µM), indicating that intracellular accumulation of zinc was likely required for its inhibitory effect on TRPV1 channels. Our study showed that zinc differentially regulates the activities of ASICs and TRPV1 channels in rat vagal bronchopulmonary sensory neurons.

Proteolytic cleavage and PKA phosphorylation of α1C subunit are not required for adrenergic regulation of CaV1.2 in the heart.

PubMed

Katchman, Alexander; Yang, Lin; Zakharov, Sergey I; Kushner, Jared; Abrams, Jeffrey; Chen, Bi-Xing; Liu, Guoxia; Pitt, Geoffrey S; Colecraft, Henry M; Marx, Steven O

2017-08-22

Calcium influx through the voltage-dependent L-type calcium channel (Ca V 1.2) rapidly increases in the heart during "fight or flight" through activation of the β-adrenergic and protein kinase A (PKA) signaling pathway. The precise molecular mechanisms of β-adrenergic activation of cardiac Ca V 1.2, however, are incompletely known, but are presumed to require phosphorylation of residues in α 1C and C-terminal proteolytic cleavage of the α 1C subunit. We generated transgenic mice expressing an α 1C with alanine substitutions of all conserved serine or threonine, which is predicted to be a potential PKA phosphorylation site by at least one prediction tool, while sparing the residues previously shown to be phosphorylated but shown individually not to be required for β-adrenergic regulation of Ca V 1.2 current (17-mutant). A second line included these 17 putative sites plus the five previously identified phosphoregulatory sites (22-mutant), thus allowing us to query whether regulation requires their contribution in combination. We determined that acute β-adrenergic regulation does not require any combination of potential PKA phosphorylation sites conserved in human, guinea pig, rabbit, rat, and mouse α 1C subunits. We separately generated transgenic mice with inducible expression of proteolytic-resistant α 1C Prevention of C-terminal cleavage did not alter β-adrenergic stimulation of Ca V 1.2 in the heart. These studies definitively rule out a role for all conserved consensus PKA phosphorylation sites in α 1C in β-adrenergic stimulation of Ca V 1.2, and show that phosphoregulatory sites on α 1C are not redundant and do not each fractionally contribute to the net stimulatory effect of β-adrenergic stimulation. Further, proteolytic cleavage of α 1C is not required for β-adrenergic stimulation of Ca V 1.2.

Role of IκB kinase β in regulating the remodeling of the CARMA1-Bcl10-MALT1 complex.

PubMed

Karim, Zubair A; Hensch, Nicole R; Qasim, Hanan; Alshbool, Fatima Z; Khasawneh, Fadi T

2018-06-02

The current work investigates the notion that inducible clustering of signaling mediators of the IKK pathway is important for platelet activation. Thus, while the CARMA1, Bcl10, and MALT1 (CBM) complex is essential for triggering IKK/NF-κB activation upon platelet stimulation, the signals that elicit its formation and downstream effector activation remain elusive. We demonstrate herein that IKKβ is involved in membrane fusion, and serves as a critical protein kinase required for initial formation and the regulation of the CARMA1/MALT1/Bcl10/CBM complex in platelets. We also show that IKKβ regulates these processes via modulation of phosphorylation of Bcl10 and IKKγ polyubiquitination. Collectively, our data demonstrate that IKKβ regulates membrane fusion and the remodeling of the CBM complex formation. Copyright © 2018 Elsevier Inc. All rights reserved.

Proteases for Processing Proneuropeptides into Peptide Neurotransmitters and Hormones

PubMed Central

Hook, Vivian; Funkelstein, Lydiane; Lu, Douglas; Bark, Steven; Wegrzyn, Jill; Hwang, Shin-Rong

2009-01-01

Peptide neurotransmitters and peptide hormones, collectively known as neuropeptides, are required for cell-cell communication in neurotransmission and for regulation of endocrine functions. Neuropeptides are synthesized from protein precursors (termed proneuropeptides or prohormones) that require proteolytic processing primarily within secretory vesicles that store and secrete the mature neuropeptides to control target cellular and organ systems. This review describes interdisciplinary strategies that have elucidated two primary protease pathways for prohormone processing consisting of the cysteine protease pathway mediated by secretory vesicle cathepsin L and the well-known subtilisin-like proprotein convertase pathway that together support neuropeptide biosynthesis. Importantly, this review discusses important areas of current and future biomedical neuropeptide research with respect to biological regulation, inhibitors, structural features of proneuropeptide and protease interactions, and peptidomics combined with proteomics for systems biological approaches. Future studies that gain in-depth understanding of protease mechanisms for generating active neuropeptides will be instrumental for translational research to develop pharmacological strategies for regulation of neuropeptide functions. Pharmacological applications for neuropeptide research may provide valuable therapeutics in health and disease. PMID:18184105

R-spondin 1 is required for specification of hematopoietic stem cells through Wnt16 and Vegfa signaling pathways

PubMed Central

2017-01-01

Hematopoietic stem cells (HSCs) are the therapeutic component of bone marrow transplants, but finding immune-compatible donors limits treatment availability and efficacy. Recapitulation of endogenous specification during development is a promising approach to directing HSC specification in vitro, but current protocols are not capable of generating authentic HSCs with high efficiency. Across phyla, HSCs arise from hemogenic endothelium in the ventral floor of the dorsal aorta concurrent with arteriovenous specification and intersegmental vessel (ISV) sprouting, processes regulated by Notch and Wnt. We hypothesized that coordination of HSC specification with vessel patterning might involve modulatory regulatory factors such as R-spondin 1 (Rspo1), an extracellular protein that enhances β-catenin-dependent Wnt signaling and has previously been shown to regulate ISV patterning. We find that Rspo1 is required for HSC specification through control of parallel signaling pathways controlling HSC specification: Wnt16/DeltaC/DeltaD and Vegfa/Tgfβ1. Our results define Rspo1 as a key upstream regulator of two crucial pathways necessary for HSC specification. PMID:28087636

Autonomous vehicles' disengagements: Trends, triggers, and regulatory limitations.

PubMed

Favarò, Francesca; Eurich, Sky; Nader, Nazanin

2018-01-01

Autonomous Vehicle (AV) technology is quickly becoming a reality on US roads. Testing on public roads is currently undergoing, with many AV makers located and testing in Silicon Valley, California. The California Department of Motor Vehicles (CA DMV) currently mandates that any vehicle tested on California public roads be retrofitted to account for a back-up human driver, and that data related to disengagements of the AV technology be publicly available. Disengagements data is analyzed in this work, given the safety-critical role of AV disengagements, which require the control of the vehicle to be handed back to the human driver in a safe and timely manner. This study provides a comprehensive overview of the fragmented data obtained from AV manufacturers testing on California public roads from 2014 to 2017. Trends of disengagement reporting, associated frequencies, average mileage driven before failure, and an analysis of triggers and contributory factors are here presented. The analysis of the disengagements data also highlights several shortcomings of the current regulations. The results presented thus constitute an important starting point for improvements on the current drafts of the testing and deployment regulations for autonomous vehicles on public roads. Copyright © 2017 Elsevier Ltd. All rights reserved.

If it looks like a duck and quacks like a duck…: Energy "shots" should be regulated as energy drinks in Canada.

PubMed

Hammond, David; Reid, Jessica L

2016-06-27

In 2012, Health Canada transitioned caffeinated energy drinks from Natural Health Product to Food and Drug classification and regulations, implementing temporary guidelines with requirements such as caffeine content limits, mandatory cautionary labelling, and restrictions on health claims. "Energy shots" often contain as much or more caffeine compared to energy drinks and have been associated with a similar number of adverse health events. However, current requirements for energy drinks do not apply to energy shots, which remain classified as "natural health products" on the basis that they are "not consumed or perceived as foods" in the same way as energy drinks. An online survey was conducted with Canadian youth and young adults aged 12-24 years (N = 2040) in October 2014 to examine perceptions of energy shots. Respondents viewed an image of a popular energy shot and were asked which term best described it, with six randomly-ordered options. The vast majority (78.8%) perceived the energy shot as an "energy drink" (vs. "supplement", "vitamin drink", "natural health product", "soft drink" or "food product"). Given consumer perceptions and the similarity in product constituents, there is little basis for regulating energy shots differently from energy drinks; these products should be subject to similar labelling and health warning requirements.

Characterization of the evolution of the pharmaceutical regulatory environment.

PubMed

Shafiei, Nader; Ford, James L; Morecroft, Charles W; Lisboa, Paulo J; Taylor, Mark J

2013-01-01

This paper is part of a research study that is intended to identify pharmaceutical quality risks induced by the ongoing transformation in the industry. This study establishes the current regulatory context by characterizing the development of the pharmaceutical regulatory environment. The regulatory environment is one of the most important external factors that affects a company's organization, processes, and technological strategy. This is especially the case with the pharmaceutical industry, where its products affect the quality of life of the consumers. The quantitative analysis of regulatory events since 1813 and review of the associated literature resulted in identification of six factors influencing the regulatory environment, namely public health protection, public health promotion, crisis management, harmonization, innovation, and modernization. From 1813 to the 1970s the focus of regulators was centered on crisis management and public health protection-a basic mission that has remained consistent over the years. Since the 1980s a gradual move in the regulatory environment towards a greater focus on public health promotion, international harmonization, innovation, and agency modernization may be seen. The pharmaceutical industry is currently going through changes that affect the way it performs its research, manufacturing, and regulatory activities. The impact of these changes on the approaches to quality risk management requires more understanding. The authors are engaged in research to identify elements of the changes that influence pharmaceutical quality. As quality requirements are an integral part of the pharmaceutical regulations, a comprehensive understanding of these regulations is seen as the first step. The results of this study show that (i) public health protection, public health promotion, crisis management, harmonization, innovation, and modernization are factors that affect regulations in the pharmaceutical industry; (ii) the regulators' main mission of public health protection has remained a constant feature over the years; and (iii) since the 1970s other factors such as public health promotion, international harmonization, innovation, and agency modernization are playing more important role in regulatory agency thinking and actions.

[The EU Portal: Implementation, importance, and features].

PubMed

von Aschen, Harald; Krafft, Hartmut

2017-08-01

The European Medicines Agency (EMA) is developing a web-based EU portal with a database "at Union level as a single entry point for the submission of data and information relating to clinical trials in accordance with" the new EU regulation No. 536/2014. The specifications are mostly published, but some documents are still missing. Because the project is integrated and has dependencies on other projects, this could result in other specification upgrades. The IT solution is under ongoing development until project completion in quarter III of 2019. The EU Portal and the database will be audited. If the audit is successful, the new regulation will come into force in October 2018. The use of the EU Portal will then be mandatory with some transition rules. The software development of the portal is restricted to the regulation and the derived requirements. It is not possible to implement any national requirements. We describe in this paper the current key functionalities of the portal and try to derive requirements for a national IT system.On 16.06.2017 the EMA Management Board announced that the development of the new portal has been delayed and it is foreseen that the new regulation can come into effect in 2019 at the earliest. The press release can be found here: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/06/news_detail_002764.jsp%26mid=WC0b01ac058004d5c1 (accessed: 12.07.2017).

The impact of regulations, safety considerations and physical limitations on research progress at maximum biocontainment.

PubMed

Shurtleff, Amy C; Garza, Nicole; Lackemeyer, Matthew; Carrion, Ricardo; Griffiths, Anthony; Patterson, Jean; Edwin, Samuel S; Bavari, Sina

2012-12-01

We describe herein, limitations on research at biosafety level 4 (BSL-4) containment laboratories, with regard to biosecurity regulations, safety considerations, research space limitations, and physical constraints in executing experimental procedures. These limitations can severely impact the number of collaborations and size of research projects investigating microbial pathogens of biodefense concern. Acquisition, use, storage, and transfer of biological select agents and toxins (BSAT) are highly regulated due to their potential to pose a severe threat to public health and safety. All federal, state, city, and local regulations must be followed to obtain and maintain registration for the institution to conduct research involving BSAT. These include initial screening and continuous monitoring of personnel, controlled access to containment laboratories, accurate and current BSAT inventory records. Safety considerations are paramount in BSL-4 containment laboratories while considering the types of research tools, workflow and time required for conducting both in vivo and in vitro experiments in limited space. Required use of a positive-pressure encapsulating suit imposes tremendous physical limitations on the researcher. Successful mitigation of these constraints requires additional time, effort, good communication, and creative solutions. Test and evaluation of novel vaccines and therapeutics conducted under good laboratory practice (GLP) conditions for FDA approval are prioritized and frequently share the same physical space with important ongoing basic research studies. The possibilities and limitations of biomedical research involving microbial pathogens of biodefense concern in BSL-4 containment laboratories are explored in this review.

The Impact of Regulations, Safety Considerations and Physical Limitations on Research Progress at Maximum Biocontainment

PubMed Central

Shurtleff, Amy C.; Garza, Nicole; Lackemeyer, Matthew; Carrion, Ricardo; Griffiths, Anthony; Patterson, Jean; Edwin, Samuel S.; Bavari, Sina

2012-01-01

We describe herein, limitations on research at biosafety level 4 (BSL-4) containment laboratories, with regard to biosecurity regulations, safety considerations, research space limitations, and physical constraints in executing experimental procedures. These limitations can severely impact the number of collaborations and size of research projects investigating microbial pathogens of biodefense concern. Acquisition, use, storage, and transfer of biological select agents and toxins (BSAT) are highly regulated due to their potential to pose a severe threat to public health and safety. All federal, state, city, and local regulations must be followed to obtain and maintain registration for the institution to conduct research involving BSAT. These include initial screening and continuous monitoring of personnel, controlled access to containment laboratories, accurate and current BSAT inventory records. Safety considerations are paramount in BSL-4 containment laboratories while considering the types of research tools, workflow and time required for conducting both in vivo and in vitro experiments in limited space. Required use of a positive-pressure encapsulating suit imposes tremendous physical limitations on the researcher. Successful mitigation of these constraints requires additional time, effort, good communication, and creative solutions. Test and evaluation of novel vaccines and therapeutics conducted under good laboratory practice (GLP) conditions for FDA approval are prioritized and frequently share the same physical space with important ongoing basic research studies. The possibilities and limitations of biomedical research involving microbial pathogens of biodefense concern in BSL-4 containment laboratories are explored in this review. PMID:23342380

Triggering HIV polyprotein processing by light using rapid photodegradation of a tight-binding protease inhibitor.

PubMed

Schimer, Jiří; Pávová, Marcela; Anders, Maria; Pachl, Petr; Šácha, Pavel; Cígler, Petr; Weber, Jan; Majer, Pavel; Řezáčová, Pavlína; Kräusslich, Hans-Georg; Müller, Barbara; Konvalinka, Jan

2015-03-09

HIV protease (PR) is required for proteolytic maturation in the late phase of HIV replication and represents a prime therapeutic target. The regulation and kinetics of viral polyprotein processing and maturation are currently not understood in detail. Here we design, synthesize, validate and apply a potent, photodegradable HIV PR inhibitor to achieve synchronized induction of proteolysis. The compound exhibits subnanomolar inhibition in vitro. Its photolabile moiety is released on light irradiation, reducing the inhibitory potential by 4 orders of magnitude. We determine the structure of the PR-inhibitor complex, analyze its photolytic products, and show that the enzymatic activity of inhibited PR can be fully restored on inhibitor photolysis. We also demonstrate that proteolysis of immature HIV particles produced in the presence of the inhibitor can be rapidly triggered by light enabling thus to analyze the timing, regulation and spatial requirements of viral processing in real time.

Understanding the role of growth factors in embryonic development: insights from the lens

PubMed Central

Lovicu, F. J.; McAvoy, J. W.; de Iongh, R. U.

2011-01-01

Growth factors play key roles in influencing cell fate and behaviour during development. The epithelial cells and fibre cells that arise from the lens vesicle during lens morphogenesis are bathed by aqueous and vitreous, respectively. Vitreous has been shown to generate a high level of fibroblast growth factor (FGF) signalling that is required for secondary lens fibre differentiation. However, studies also show that FGF signalling is not sufficient and roles have been identified for transforming growth factor-β and Wnt/Frizzled families in regulating aspects of fibre differentiation. In the case of the epithelium, key roles for Wnt/β-catenin and Notch signalling have been demonstrated in embryonic development, but it is not known if other factors are required for its formation and maintenance. This review provides an overview of current knowledge about growth factor regulation of differentiation and maintenance of lens cells. It also highlights areas that warrant future study. PMID:21402581

Triggering HIV polyprotein processing by light using rapid photodegradation of a tight-binding protease inhibitor

PubMed Central

Schimer, Jiří; Pávová, Marcela; Anders, Maria; Pachl, Petr; Šácha, Pavel; Cígler, Petr; Weber, Jan; Majer, Pavel; Řezáčová, Pavlína; Kräusslich, Hans-Georg; Müller, Barbara; Konvalinka, Jan

2015-01-01

HIV protease (PR) is required for proteolytic maturation in the late phase of HIV replication and represents a prime therapeutic target. The regulation and kinetics of viral polyprotein processing and maturation are currently not understood in detail. Here we design, synthesize, validate and apply a potent, photodegradable HIV PR inhibitor to achieve synchronized induction of proteolysis. The compound exhibits subnanomolar inhibition in vitro. Its photolabile moiety is released on light irradiation, reducing the inhibitory potential by 4 orders of magnitude. We determine the structure of the PR-inhibitor complex, analyze its photolytic products, and show that the enzymatic activity of inhibited PR can be fully restored on inhibitor photolysis. We also demonstrate that proteolysis of immature HIV particles produced in the presence of the inhibitor can be rapidly triggered by light enabling thus to analyze the timing, regulation and spatial requirements of viral processing in real time. PMID:25751579

Epigenetic regulation of female puberty.

PubMed

Lomniczi, Alejandro; Wright, Hollis; Ojeda, Sergio R

2015-01-01

Substantial progress has been made in recent years toward deciphering the molecular and genetic underpinnings of the pubertal process. The availability of powerful new methods to interrogate the human genome has led to the identification of genes that are essential for puberty to occur. Evidence has also emerged suggesting that the initiation of puberty requires the coordinated activity of gene sets organized into functional networks. At a cellular level, it is currently thought that loss of transsynaptic inhibition, accompanied by an increase in excitatory inputs, results in the pubertal activation of GnRH release. This concept notwithstanding, a mechanism of epigenetic repression targeting genes required for the pubertal activation of GnRH neurons was recently identified as a core component of the molecular machinery underlying the central restraint of puberty. In this chapter we will discuss the potential contribution of various mechanisms of epigenetic regulation to the hypothalamic control of female puberty. Copyright © 2014 Elsevier Inc. All rights reserved.

Applying Quality by Design Concepts to Pharmacy Compounding.

PubMed

Timko, Robert J

2015-01-01

Compounding of medications is an important part of the practice of the pharmacy profession. Because compounded medications do not have U.S. Food and Drug Administration approval, a pharmacist has the responsibility to ensure that compounded medications are of suitable quality, safety, and efficacy. The Federal Government and numerous states have updated their laws and regulations regarding pharmacy compounding as a result of recent quality issues. Compounding pharmacists are expected to follow good preparation prodecures in their compounding practices in much the same way pharmaceutical manufacturers are required to follow Current Good Manufacturing Procedures as detailed in the United States Code of Federal Regulations. Application of Quality by Design concepts to the preparation process for a compounded medication can help in understanding the potential pitfalls and the means to mitigate their impact. The goal is to build quality into the compounding process to ensure that the resultant compounded prescription meets the human or animal patients' requirements.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Spencer, Barry B.; Bruffey, Stephanie H.; Jordan, Jacob A.

US regulations will require the removal of iodine and tritium, along with other volatile and semi-volatile radionuclides, from the off-gas streams of nuclear fuel reprocessing plants. Advanced tritium pretreatment (TPT) is an additional head-end operation that could be incorporated within nuclear fuel reprocessing plants. It utilizes nitrogen dioxide (NOR2R) as an oxidant to convert UOR2R to UR3ROR8R prior to traditional aqueous dissolution. Advanced TPT can result in the quantitative volatilization of both tritium and iodine. Up-front removal of iodine is of significant advantage because otherwise it distributes to several unit operations and the associated off-gas streams. The off-gas streams willmore » then require treatment to comply with US regulations. Advanced TPT is currently under development at Oak Ridge National Laboratory, and a kilogram-scale hot cell demonstration with used nuclear fuel (UNF) is planned for fiscal year (FY) 2018.« less

Stakeholders' perception of the nutrition and health claim regulation.

PubMed

de Boer, Alie; Bast, Aalt

2015-05-01

In 2007, the Nutrition and Health Claim Regulation (NHCR) entered into force, which required scientific substantiation of health claims. In the field of antioxidants, most proposed claims were negatively assessed by the European Food Safety Authority (EFSA). This study reviews the perception of the NHCR of 14 Dutch stakeholders to unravel the grounds for disproving the putative health claims. Most claims are shown to be refused based on the quality of scientific substantiation, due to usage of scientific methods on which no consensus has been reached and the differences in expectations and requirements. Three themes exemplify the need for improvement in applying the NHCR: (i) enforcement; (ii) methodology; and (iii) perceived impact of the NHCR. With highly diverging perceptions of stakeholders, the current effectiveness of the NHCR can be questioned. The views of different stakeholders on these themes help to focus the discussion on the NCHR in capturing health effects.

Comparison of food colour regulations in the EU and the US: a review of current provisions.

PubMed

Lehto, Sari; Buchweitz, Maria; Klimm, Alexandra; Straßburger, Raphaela; Bechtold, Cato; Ulberth, Franz

2017-03-01

This review describes the European Union and the US regulations applicable to food colours. Despite the different regulatory frameworks, the overall approach is similar, based on well-established risk-assessment procedures and risk-management measures. However, differences impacting free movement of goods can be found in the details and implementation of regulations. Using additives approved only in the US or in the EU implies that producers aiming to export need to adjust their product composition to the export market. Failure to comply may give rise to claims of adulteration, misbranding or non-compliance and rejection at the border or recall from the market. A careful comparison of the level of protection provided by the two sets of regulations, the criteria of good manufacturing practice (GMP) inspections and the certification requirements could be key to aligning the rules and to negotiating mutual recognition agreements. This review provides an extensive overview of the similarities and differences in regulating food colours in the EU and the US.

Sodium benzoate, potassium sorbate, and citric acid induce sublethal injury and enhance pulsed electric field inactivation of E. coli O157:H7 and nonpathogenic surrogate E. coli in strawberry juice

USDA-ARS?s Scientific Manuscript database

Current FDA regulations require that juice processors effect a 5 log CFU/ml reduction of a target pathogen prior to distributing products. Whereas thermal pasteurization reduces the sensory characteristics of juice by altering flavor components, pulsed electric field (PEF) treatment can be conducte...

Thematic mapper flight model preshipment review data package. Volume 4: Appendix. Part C: Power supply data

NASA Technical Reports Server (NTRS)

1982-01-01

The acceptance test data package for the thematic mapper flight model power supply was reviewed and the data compared to the relevant specification. The power supply was found to be within specification. Final test data for outut voltage regulation and ripple, efficiency, over and undervoltage protection, telemetry, impedances, turn-on requirements, and input current limits are presented.

7 CFR Exhibit C to Subpart C of... - Checklist of Visual Exhibits and Documentation for RRH, RCH, and LH Proposals

Code of Federal Regulations, 2010 CFR

2010-01-01

... RRH, RCH, and LH Proposals C Exhibit C to Subpart C of Part 1924 Agriculture Regulations of the... REPAIR Planning and Performing Site Development Work Pt. 1924, Subpt. C, Exh. C Exhibit C to Subpart C of... the required information will be sufficient. C. Property Survey Map. A current survey map of the...

Ethics and regulation in organ procurement research.

PubMed

Ackerman, Terrence F; Winsett, Rebecca P

2002-12-01

This article explores the role of ethics and regulation in human research conducted by organ procurement agencies; basic ethical principles for human research are outlined. Organ procurement agencies are not required to observe federal regulations; however, voluntary adherence will ensure that procurement research is conducted according to current standards of ethical practice. Although most organ procurement research will qualify for exempt status, this determination should be made by an institutional review board. Even if studies qualify for exempt status, there is a moral presumption that informed consent should be sought, unless certain narrow conditions for waiver of consent are satisfied. Finally, when future research utilizing organ procurement records is anticipated, procurement coordinators should provide sufficiently detailed information to families about such plans to permit their advance informed consent to research activities.

Uncovering the Role of RNA-Binding Proteins in Gene Expression in the Immune System.

PubMed

Díaz-Muñoz, Manuel D; Turner, Martin

2018-01-01

Fighting external pathogens requires an ever-changing immune system that relies on tight regulation of gene expression. Transcriptional control is the first step to build efficient responses while preventing immunodeficiencies and autoimmunity. Post-transcriptional regulation of RNA editing, location, stability, and translation are the other key steps for final gene expression, and they are all controlled by RNA-binding proteins (RBPs). Nowadays we have a deep understanding of how transcription factors control the immune system but recent evidences suggest that post-transcriptional regulation by RBPs is equally important for both development and activation of immune responses. Here, we review current knowledge about how post-transcriptional control by RBPs shapes our immune system and discuss the perspective of RBPs being the key players of a hidden immune cell epitranscriptome.

Dendritic protein synthesis in the normal and diseased brain

PubMed Central

Swanger, Sharon A.; Bassell, Gary J.

2015-01-01

Synaptic activity is a spatially-limited process that requires a precise, yet dynamic, complement of proteins within the synaptic micro-domain. The maintenance and regulation of these synaptic proteins is regulated, in part, by local mRNA translation in dendrites. Protein synthesis within the postsynaptic compartment allows neurons tight spatial and temporal control of synaptic protein expression, which is critical for proper functioning of synapses and neural circuits. In this review, we discuss the identity of proteins synthesized within dendrites, the receptor-mediated mechanisms regulating their synthesis, and the possible roles for these locally synthesized proteins. We also explore how our current understanding of dendritic protein synthesis in the hippocampus can be applied to new brain regions and to understanding the pathological mechanisms underlying varied neurological diseases. PMID:23262237

Employee Retirement Income Security Act of 1974; rules and regulations for administration and enforcement; claims procedure. Final regulation; delay of applicability date.

PubMed

2001-07-09

This action delays for at least six months and not more than one year the applicability date for the regulation governing minimum requirements for benefit claims procedures of group health plans covered by Title I of the Employee Retirement Income Security Act. As published on November 21, 2000, the benefit claims procedure would be applicable to claims filed on or after January 1, 2002. The current action amends the regulation so that it will apply to group health claims filed on or after the first day of the first plan year beginning on or after July 1, 2002, but in no event later than January 1, 2003. This action provides a limited additional period within which group health plan sponsors, administrators, and service providers can bring their claims processing systems into compliance with the new requirements. A postponement of the applicability date with respect to group health claims will allow a more orderly transition to the new standards and will avoid the confusion and additional expense that would be caused if certain pending Congressional bills are enacted before or soon after the original applicability date. This action does not apply to pension plans or plans providing disability or welfare benefits (other than group health). For these plans, the regulation will continue to be applicable to claims filed on or after January 1, 2002.

White Paper: Landscape on Technical and Conceptual Requirements and Competence Framework in Drug/Disease Modeling and Simulation

PubMed Central

Vlasakakis, G; Comets, E; Keunecke, A; Gueorguieva, I; Magni, P; Terranova, N; Della Pasqua, O; de Lange, E C; Kloft, C

2013-01-01

Pharmaceutical sciences experts and regulators acknowledge that pharmaceutical development as well as drug usage requires more than scientific advancements to cope with current attrition rates/therapeutic failures. Drug disease modeling and simulation (DDM&S) creates a paradigm to enable an integrated and higher-level understanding of drugs, (diseased)systems, and their interactions (systems pharmacology) through mathematical/statistical models (pharmacometrics)1—hence facilitating decision making during drug development and therapeutic usage of medicines. To identify gaps and challenges in DDM&S, an inventory of skills and competencies currently available in academia, industry, and clinical practice was obtained through survey. The survey outcomes revealed benefits, weaknesses, and hurdles for the implementation of DDM&S. In addition, the survey indicated that no consensus exists about the knowledge, skills, and attributes required to perform DDM&S activities effectively. Hence, a landscape of technical and conceptual requirements for DDM&S was identified and serves as a basis for developing a framework of competencies to guide future education and training in DDM&S. PMID:23887723

Cartilage tissue engineering: recent advances and perspectives from gene regulation/therapy.

PubMed

Li, Kuei-Chang; Hu, Yu-Chen

2015-05-01

Diseases in articular cartilages affect millions of people. Despite the relatively simple biochemical and cellular composition of articular cartilages, the self-repair ability of cartilage is limited. Successful cartilage tissue engineering requires intricately coordinated interactions between matrerials, cells, biological factors, and phycial/mechanical factors, and still faces a multitude of challenges. This article presents an overview of the cartilage biology, current treatments, recent advances in the materials, biological factors, and cells used in cartilage tissue engineering/regeneration, with strong emphasis on the perspectives of gene regulation (e.g., microRNA) and gene therapy. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

76 FR 63763 - National Environmental Policy Act Implementing Procedures

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-13

...The U.S. Department of Energy (DOE or the Department) is revising its National Environmental Policy Act (NEPA) Implementing Procedures. The majority of the changes are being made to the categorical exclusion provisions. These revisions are intended to better align the Department's regulations, particularly its categorical exclusions, with DOE's current activities and recent experiences, and to update the provisions with respect to current technologies and regulatory requirements. DOE is establishing 20 new categorical exclusions and removing two categorical exclusion categories, one environmental assessment category, and three environmental impact statement categories. Other changes modify and clarify DOE's existing provisions.

Regulatory and Quality Considerations for Continuous Manufacturing May 20-21, 2014 Continuous Manufacturing Symposium.

PubMed

Allison, Gretchen; Cain, Yanxi Tan; Cooney, Charles; Garcia, Tom; Bizjak, Tara Gooen; Holte, Oyvind; Jagota, Nirdosh; Komas, Bekki; Korakianiti, Evdokia; Kourti, Dora; Madurawe, Rapti; Morefield, Elaine; Montgomery, Frank; Nasr, Moheb; Randolph, William; Robert, Jean-Louis; Rudd, Dave; Zezza, Diane

2015-03-01

This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including continuous manufacturing process description and control strategy in regulatory files, process validation, and key Good Manufacturing Practice (GMP) requirements. In addition, the paper identifies regulatory gaps and challenges and proposes a way forward to facilitate implementation. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

Consumers' preferences for the communication of risk information in drug advertising.

PubMed

Davis, Joel J

2007-01-01

Research was conducted to identify consumers' preferences regarding the form, content, and placement of drug side-effect information in direct-to-consumer (DTC) advertising. Specific questions explored preferences for the presence or absence of numeric information, the use of placebo and discontinuation groups as a context for understanding drug risk, the sequence in which side effects are presented, and the placement of side-effect statements on DTC Web sites. Consumers prefer detailed, readily accessible risk information--preferences that are a major departure from current advertiser practices and from what current and proposed Food and Drug Administration (FDA) regulations require.

The current status of orphan drug development in Europe and the US.

PubMed

Hall, Anthony K; Carlson, Marilyn R

2014-02-01

Orphan drug legislation has been introduced in a number of countries in order to stimulate the development of treatments for rare diseases by introducing commercial incentives for companies wishing to undertake that development. In order to navigate the maze of regulatory regulations and procedures so that companies can make proper use of the orphan drug incentives, specialist knowledge is required. This article will review the current status of orphan drug development in the EU and the US, explain the incentives and procedures, and touch on the role of patient organisations in the process.

Unity Power Factor Operated PFC Converter Based Power Supply for Computers

NASA Astrophysics Data System (ADS)

Singh, Shikha; Singh, Bhim; Bhuvaneswari, G.; Bist, Vashist

2017-11-01

Power Supplies (PSs) employed in personal computers pollute the single phase ac mains by drawing distorted current at a substandard Power Factor (PF). The harmonic distortion of the supply current in these personal computers are observed 75% to 90% with the Crest Factor (CF) being very high which escalates losses in the distribution system. To find a tangible solution to these issues, a non-isolated PFC converter is employed at the input of isolated converter that is capable of improving the input power quality apart from regulating the dc voltage at its output. This is given to the isolated stage that yields completely isolated and stiffly regulated multiple output voltages which is the prime requirement of computer PS. The operation of the proposed PS is evaluated under various operating conditions and the results show improved performance depicting nearly unity PF and low input current harmonics. The prototype of this PS is developed in laboratory environment and test results are recorded which corroborate the power quality improvement observed in simulation results under various operating conditions.

Awareness and perceptions of Vermont's prescribed product gift ban and disclosure law by prescribers and pharmacists.

PubMed

Kennedy, Amanda G; Possidente, Carl J; Pinckney, Richard G

2013-02-01

Vermont law strictly regulates the interactions between pharmaceutical manufacturers and health care providers, including gifts, meals, and medication samples. The purpose of this study was to describe providers' awareness and perceptions of current requirements. An online survey was completed by Vermont providers, including prescribers and pharmacists. The survey asked providers about their awareness of 15 different legal requirements and about their level of agreement with these requirements. Four hundred and eleven providers completed the survey (61% male, mean age 52 years, and 71% physicians). Awareness of the 15 requirements ranged from 28.4% to 93.8%. Most providers agreed or had no strong opinions. Responses at significance levels of P < .001 were noted in 8 of 15 requirements when perceptions were stratified by providers who had any interactions with pharmaceutical representatives in the past year (N = 227, 55.4%) versus providers who reported no interactions (N = 183; 44.6%). A high proportion of Vermont providers are unaware of the current law. Most agreed or had no strong opinions about the requirements; however, at least a quarter disagreed with banning small gifts and meals. Having any interaction with pharmaceutical representatives changed how providers perceived the requirements. These data may be useful for other states considering similar laws.

Protein kinase A stimulates Kv7.1 surface expression by regulating Nedd4-2-dependent endocytic trafficking.

PubMed

Andersen, Martin N; Hefting, Louise L; Steffensen, Annette B; Schmitt, Nicole; Olesen, Søren-Peter; Olsen, Jesper V; Lundby, Alicia; Rasmussen, Hanne B

2015-11-15

The potassium channel Kv7.1 plays critical physiological roles in both heart and epithelial tissues. In heart, Kv7.1 and the accessory subunit KCNE1 forms the slowly activating delayed-rectifier potassium current current, which is enhanced by protein kinase A (PKA)-mediated phosphorylation. The observed current increase requires both phosphorylation of Kv7.1 and the presence of KCNE1. However, PKA also stimulates Kv7.1 currents in epithelial tissues, such as colon, where the channel does not coassemble with KCNE1. Here, we demonstrate that PKA activity significantly impacts the subcellular localization of Kv7.1 in Madin-Darby canine kidney cells. While PKA inhibition reduced the fraction of channels at the cell surface, PKA activation increased it. We show that PKA inhibition led to intracellular accumulation of Kv7.1 in late endosomes/lysosomes. By mass spectroscopy we identified eight phosphorylated residues on Kv7.1, however, none appeared to play a role in the observed response. Instead, we found that PKA acted by regulating endocytic trafficking involving the ubiquitin ligase Nedd4-2. We show that a Nedd4-2-resistant Kv7.1-mutant displayed significantly reduced intracellular accumulation upon PKA inhibition. Similar effects were observed upon siRNA knockdown of Nedd4-2. However, although Nedd4-2 is known to regulate Kv7.1 by ubiquitylation, biochemical analyses demonstrated that PKA did not influence the amount of Nedd4-2 bound to Kv7.1 or the ubiquitylation level of the channel. This suggests that PKA influences Nedd4-2-dependent Kv7.1 transport though a different molecular mechanism. In summary, we identify a novel mechanism whereby PKA can increase Kv7.1 current levels, namely by regulating Nedd4-2-dependent Kv7.1 transport. Copyright © 2015 the American Physiological Society.

Protein kinase A stimulates Kv7.1 surface expression by regulating Nedd4-2-dependent endocytic trafficking

PubMed Central

Andersen, Martin N.; Hefting, Louise L.; Steffensen, Annette B.; Schmitt, Nicole; Olesen, Søren-Peter; Olsen, Jesper V.; Lundby, Alicia

2015-01-01

The potassium channel Kv7.1 plays critical physiological roles in both heart and epithelial tissues. In heart, Kv7.1 and the accessory subunit KCNE1 forms the slowly activating delayed-rectifier potassium current current, which is enhanced by protein kinase A (PKA)-mediated phosphorylation. The observed current increase requires both phosphorylation of Kv7.1 and the presence of KCNE1. However, PKA also stimulates Kv7.1 currents in epithelial tissues, such as colon, where the channel does not coassemble with KCNE1. Here, we demonstrate that PKA activity significantly impacts the subcellular localization of Kv7.1 in Madin-Darby canine kidney cells. While PKA inhibition reduced the fraction of channels at the cell surface, PKA activation increased it. We show that PKA inhibition led to intracellular accumulation of Kv7.1 in late endosomes/lysosomes. By mass spectroscopy we identified eight phosphorylated residues on Kv7.1, however, none appeared to play a role in the observed response. Instead, we found that PKA acted by regulating endocytic trafficking involving the ubiquitin ligase Nedd4-2. We show that a Nedd4-2-resistant Kv7.1-mutant displayed significantly reduced intracellular accumulation upon PKA inhibition. Similar effects were observed upon siRNA knockdown of Nedd4-2. However, although Nedd4-2 is known to regulate Kv7.1 by ubiquitylation, biochemical analyses demonstrated that PKA did not influence the amount of Nedd4-2 bound to Kv7.1 or the ubiquitylation level of the channel. This suggests that PKA influences Nedd4-2-dependent Kv7.1 transport though a different molecular mechanism. In summary, we identify a novel mechanism whereby PKA can increase Kv7.1 current levels, namely by regulating Nedd4-2-dependent Kv7.1 transport. PMID:26405101

Nitrogen-responsive Regulation of GATA Protein Family Activators Gln3 and Gat1 Occurs by Two Distinct Pathways, One Inhibited by Rapamycin and the Other by Methionine Sulfoximine*

PubMed Central

Georis, Isabelle; Tate, Jennifer J.; Cooper, Terrance G.; Dubois, Evelyne

2011-01-01

Nitrogen availability regulates the transcription of genes required to degrade non-preferentially utilized nitrogen sources by governing the localization and function of transcription activators, Gln3 and Gat1. TorC1 inhibitor, rapamycin (Rap), and glutamine synthetase inhibitor, methionine sulfoximine (Msx), elicit responses grossly similar to those of limiting nitrogen, implicating both glutamine synthesis and TorC1 in the regulation of Gln3 and Gat1. To better understand this regulation, we compared Msx- versus Rap-elicited Gln3 and Gat1 localization, their DNA binding, nitrogen catabolite repression-sensitive gene expression, and the TorC1 pathway phosphatase requirements for these responses. Using this information we queried whether Rap and Msx inhibit sequential steps in a single, linear cascade connecting glutamine availability to Gln3 and Gat1 control as currently accepted or alternatively inhibit steps in two distinct parallel pathways. We find that Rap most strongly elicits nuclear Gat1 localization and expression of genes whose transcription is most Gat1-dependent. Msx, on the other hand, elicits nuclear Gln3 but not Gat1 localization and expression of genes that are most Gln3-dependent. Importantly, Rap-elicited nuclear Gln3 localization is absolutely Sit4-dependent, but that elicited by Msx is not. PP2A, although not always required for nuclear GATA factor localization, is highly required for GATA factor binding to nitrogen-responsive promoters and subsequent transcription irrespective of the gene GATA factor specificities. Collectively, our data support the existence of two different nitrogen-responsive regulatory pathways, one inhibited by Msx and the other by rapamycin. PMID:22039046

Nitrogen-responsive regulation of GATA protein family activators Gln3 and Gat1 occurs by two distinct pathways, one inhibited by rapamycin and the other by methionine sulfoximine.

PubMed

Georis, Isabelle; Tate, Jennifer J; Cooper, Terrance G; Dubois, Evelyne

2011-12-30

Nitrogen availability regulates the transcription of genes required to degrade non-preferentially utilized nitrogen sources by governing the localization and function of transcription activators, Gln3 and Gat1. TorC1 inhibitor, rapamycin (Rap), and glutamine synthetase inhibitor, methionine sulfoximine (Msx), elicit responses grossly similar to those of limiting nitrogen, implicating both glutamine synthesis and TorC1 in the regulation of Gln3 and Gat1. To better understand this regulation, we compared Msx- versus Rap-elicited Gln3 and Gat1 localization, their DNA binding, nitrogen catabolite repression-sensitive gene expression, and the TorC1 pathway phosphatase requirements for these responses. Using this information we queried whether Rap and Msx inhibit sequential steps in a single, linear cascade connecting glutamine availability to Gln3 and Gat1 control as currently accepted or alternatively inhibit steps in two distinct parallel pathways. We find that Rap most strongly elicits nuclear Gat1 localization and expression of genes whose transcription is most Gat1-dependent. Msx, on the other hand, elicits nuclear Gln3 but not Gat1 localization and expression of genes that are most Gln3-dependent. Importantly, Rap-elicited nuclear Gln3 localization is absolutely Sit4-dependent, but that elicited by Msx is not. PP2A, although not always required for nuclear GATA factor localization, is highly required for GATA factor binding to nitrogen-responsive promoters and subsequent transcription irrespective of the gene GATA factor specificities. Collectively, our data support the existence of two different nitrogen-responsive regulatory pathways, one inhibited by Msx and the other by rapamycin.

Validation of Minimum Display Requirements for a UAS Detect and Avoid System

NASA Technical Reports Server (NTRS)

Rorie, Conrad; Fern, Lisa; Roberts, Zach; Monk, Kevin; Santiago, Confesor; Shively, Jay

2017-01-01

The full integration of Unmanned Aircraft Systems (UAS) into the National Airspace System (NAS), a prerequisite for enabling a broad range of public and commercial UAS operations, presents several technical challenges to UAS developers, operators and regulators. A primary barrier is the inability for UAS pilots (situated at a ground control station, or GCS) to comply with Title 14 Code of Federal Regulations sections 91.111 and 91.113, which require pilots to see and avoid other aircraft in order to maintain well clear. The present study is the final in a series of human-in-the-loop experiments designed to explore and test the various display and alerting requirements being incorporated into the minimum operational performance standards (MOPS) for a UAS-specific detect and avoid system that would replace the see and avoid function required of manned aircraft. Two display configurations were tested - an integrated display and a standalone display - and their impact on pilot response times and ability to maintain DAA well clear were compared. Results indicated that the current draft of the MOPS result in high-level performance and did not meaningfully differ by display configuration.

California Groundwater Management During Drought: Existing and Future Regulatory Approaches

NASA Astrophysics Data System (ADS)

Ekdahl, E.; Boland-Brien, S.; Vanderburgh, B.; Landau, K.; Bean, J.; Peltier, T.

2015-12-01

Groundwater has served as an effective buffer to California's crippling drought of 2012-2015, allowing continued agricultural production in many areas where surface water deliveries have been curtailed. However, over-reliance on groundwater has caused plummeting groundwater levels in much of the state's heavily agricultural regions, with annual groundwater overdraft state-wide estimated in the millions of acre-feet per year. Prior to 2015, California water law did not allow for the effective monitoring or assessment of groundwater use; passage of new state regulations will require development of locally-managed plans that, for the first time, require comprehensive groundwater management and groundwater basin sustainability. Because these plans are not required to be implemented for another 25 years, groundwater levels will likely continue to decrease. Some communities that are 100-percent reliant on groundwater as a source of municipal supply may face shortages and supply issues, which may exacerbate known water quality concerns. Examination of community water systems that are reliant on groundwater, their existing water quality issues, and their response to the current drought (through existing mandatory conservation requirements imposed by California state regulators) can identify areas that are particularly susceptible to continued groundwater overdraft.

Do Performance-Based Codes Support Universal Design in Architecture?

PubMed

Grangaard, Sidse; Frandsen, Anne Kathrine

2016-01-01

The research project 'An analysis of the accessibility requirements' studies how Danish architectural firms experience the accessibility requirements of the Danish Building Regulations and it examines their opinions on how future regulative models can support innovative and inclusive design - Universal Design (UD). The empirical material consists of input from six workshops to which all 700 Danish Architectural firms were invited, as well as eight group interviews. The analysis shows that the current prescriptive requirements are criticized for being too homogenous and possibilities for differentiation and zoning are required. Therefore, a majority of professionals are interested in a performance-based model because they think that such a model will support 'accessibility zoning', achieving flexibility because of different levels of accessibility in a building due to its performance. The common understanding of accessibility and UD is directly related to buildings like hospitals and care centers. When the objective is both innovative and inclusive architecture, the request of a performance-based model should be followed up by a knowledge enhancement effort in the building sector. Bloom's taxonomy of educational objectives is suggested as a tool for such a boost. The research project has been financed by the Danish Transport and Construction Agency.

Risk for hepatitis B and C virus transmission in nail salons and barbershops and state regulatory requirements to prevent such transmission in the United States.

PubMed

Yang, Jun; Hall, Keri; Nuriddin, Azizeh; Woolard, Diane

2014-01-01

The potential for hepatitis B and C virus (HBV/HCV) transmission in nail salons and barbershops has been reported, but a systematic review has not been conducted. These businesses are regulated by state cosmetology or barbering boards, but adequacy of sanitary requirements has not been evaluated. To conduct literature review to assess risk for HBV/HCV transmission in nail salons and barbershops and to evaluate sanitary requirements in HBV/HCV prevention in these businesses in 50 states and District of Columbia. Several search engines were used for literature search. Studies that quantified risks associated with manicuring, pedicuring, or barbering were included. State requirements for disinfection and sterilization were reviewed and evaluated. For literature review, odds ratios, 95% confidence intervals, and confounding adjustment were extracted and evaluated. For regulation review, requirements for disinfection or sterilization for multiuse items in nail salons and barbershops were assessed according to the US federal guidelines. Forty-six studies were identified and 36 were included in this study. Overall, the results were not consistent on risk for HBV/HCV transmission in nail salons and barbershops. For sanitary requirements, disinfection with an Environmental Protection Agency-registered disinfectant is required in 39 states for nail salons and in 26 states for barbershops. Sterilization was described in 15 states for nail salons and in 11 states for barbershops, but the majority of these states listed it as an optional approach. Sanitary requirements are consistent in states where 1 board regulates both businesses but are substantially discrepant in states with separate boards. Current literature cannot confirm or exclude the risk for HBV/HCV transmission in nail salons and barbershops. Existing sanitary requirements are adequate in the majority of states, but compliance is needed to prevent HBV/HCV transmission in these businesses.

Put on a happy face! Inhibitory control and socioemotional knowledge predict emotion regulation in 5- to 7-year-olds.

PubMed

Hudson, Amanda; Jacques, Sophie

2014-07-01

Children's developing capacity to regulate emotions may depend on individual characteristics and other abilities, including age, sex, inhibitory control, theory of mind, and emotion and display rule knowledge. In the current study, we examined the relations between these variables and children's (N=107) regulation of emotion in a disappointing gift paradigm as well as their relations with the amount of effort to control emotion children exhibited after receiving the disappointing gift. Regression analyses were also conducted to identify unique predictors. Children's understanding of others' emotions and emotion display rules, as well as their inhibitory control skills, emerged as significant correlates of emotion regulation and predicted children's responses to the disappointing gift even after controlling for other relevant variables. Age and inhibitory control significantly predicted the amount of overt effort that went into regulating emotions, as did emotion knowledge (albeit only marginally). Together, findings suggest that effectively regulating emotions requires (a) knowledge of context-appropriate emotions along with (b) inhibitory skills to implement that knowledge. Copyright © 2014 Elsevier Inc. All rights reserved.

The integration of the risk management process with the lifecycle of medical device software.

PubMed

Pecoraro, F; Luzi, D

2014-01-01

The application of software in the Medical Device (MD) domain has become central to the improvement of diagnoses and treatments. The new European regulations that specifically address software as an important component of MD, require complex procedures to make software compliant with safety requirements, introducing thereby new challenges in the qualification and classification of MD software as well as in the performance of risk management activities. Under this perspective, the aim of this paper is to propose an integrated framework that combines the activities to be carried out by the manufacturer to develop safe software within the development lifecycle based on the regulatory requirements reported in US and European regulations as well as in the relevant standards and guidelines. A comparative analysis was carried out to identify the main issues related to the application of the current new regulations. In addition, standards and guidelines recently released to harmonise procedures for the validation of MD software have been used to define the risk management activities to be carried out by the manufacturer during the software development process. This paper highlights the main issues related to the qualification and classification of MD software, providing an analysis of the different regulations applied in Europe and the US. A model that integrates the risk management process within the software development lifecycle has been proposed too. It is based on regulatory requirements and considers software risk analysis as a central input to be managed by the manufacturer already at the initial stages of the software design, in order to prevent MD failures. Relevant changes in the process of MD development have been introduced with the recognition of software being an important component of MDs as stated in regulations and standards. This implies the performance of highly iterative processes that have to integrate the risk management in the framework of software development. It also makes it necessary to involve both medical and software engineering competences to safeguard patient and user safety.

Thermal regulation of tightly packed solid-state photodetectors in a 1 mm3 resolution clinical PET system

PubMed Central

Vandenbroucke, A.; Innes, D.; Lau, F. W. Y.; Hsu, D. F. C.; Reynolds, P. D.; Levin, Craig S.

2015-01-01

Purpose: Silicon photodetectors are of significant interest for use in positron emission tomography (PET) systems due to their compact size, insensitivity to magnetic fields, and high quantum efficiency. However, one of their main disadvantages is fluctuations in temperature cause strong shifts in gain of the devices. PET system designs with high photodetector density suffer both increased thermal density and constrained options for thermally regulating the devices. This paper proposes a method of thermally regulating densely packed silicon photodetectors in the context of a 1 mm3 resolution, high-sensitivity PET camera dedicated to breast imaging. Methods: The PET camera under construction consists of 2304 units, each containing two 8 × 8 arrays of 1 mm3 LYSO crystals coupled to two position sensitive avalanche photodiodes (PSAPD). A subsection of the proposed camera with 512 PSAPDs has been constructed. The proposed thermal regulation design uses water-cooled heat sinks, thermoelectric elements, and thermistors to measure and regulate the temperature of the PSAPDs in a novel manner. Active cooling elements, placed at the edge of the detector stack due to limited access, are controlled based on collective leakage current and temperature measurements in order to keep all the PSAPDs at a consistent temperature. This thermal regulation design is characterized for the temperature profile across the camera and for the time required for cooling changes to propagate across the camera. These properties guide the implementation of a software-based, cascaded proportional-integral-derivative control loop that controls the current through the Peltier elements by monitoring thermistor temperature and leakage current. The stability of leakage current, temperature within the system using this control loop is tested over a period of 14 h. The energy resolution is then measured over a period of 8.66 h. Finally, the consistency of PSAPD gain between independent operations of the camera over 10 days is tested. Results: The PET camera maintains a temperature of 18.00 ± 0.05 °C over the course of 12 h while the ambient temperature varied 0.61 °C, from 22.83 to 23.44 °C. The 511 keV photopeak energy resolution over a period of 8.66 h is measured to be 11.3% FWHM with a maximum photopeak fluctuation of 4 keV. Between measurements of PSAPD gain separated by at least 2 day, the maximum photopeak shift was 6 keV. Conclusions: The proposed thermal regulation scheme for tightly packed silicon photodetectors provides for stable operation of the constructed subsection of a PET camera over long durations of time. The energy resolution of the system is not degraded despite shifts in ambient temperature and photodetector heat generation. The thermal regulation scheme also provides a consistent operating environment between separate runs of the camera over different days. Inter-run consistency allows for reuse of system calibration parameters from study to study, reducing the time required to calibrate the system and hence to obtain a reconstructed image. PMID:25563270

Thermal regulation of tightly packed solid-state photodetectors in a 1 mm{sup 3} resolution clinical PET system

DOE Office of Scientific and Technical Information (OSTI.GOV)

Freese, D. L.; Vandenbroucke, A.; Innes, D.

2015-01-15

Purpose: Silicon photodetectors are of significant interest for use in positron emission tomography (PET) systems due to their compact size, insensitivity to magnetic fields, and high quantum efficiency. However, one of their main disadvantages is fluctuations in temperature cause strong shifts in gain of the devices. PET system designs with high photodetector density suffer both increased thermal density and constrained options for thermally regulating the devices. This paper proposes a method of thermally regulating densely packed silicon photodetectors in the context of a 1 mm{sup 3} resolution, high-sensitivity PET camera dedicated to breast imaging. Methods: The PET camera under constructionmore » consists of 2304 units, each containing two 8 × 8 arrays of 1 mm{sup 3} LYSO crystals coupled to two position sensitive avalanche photodiodes (PSAPD). A subsection of the proposed camera with 512 PSAPDs has been constructed. The proposed thermal regulation design uses water-cooled heat sinks, thermoelectric elements, and thermistors to measure and regulate the temperature of the PSAPDs in a novel manner. Active cooling elements, placed at the edge of the detector stack due to limited access, are controlled based on collective leakage current and temperature measurements in order to keep all the PSAPDs at a consistent temperature. This thermal regulation design is characterized for the temperature profile across the camera and for the time required for cooling changes to propagate across the camera. These properties guide the implementation of a software-based, cascaded proportional-integral-derivative control loop that controls the current through the Peltier elements by monitoring thermistor temperature and leakage current. The stability of leakage current, temperature within the system using this control loop is tested over a period of 14 h. The energy resolution is then measured over a period of 8.66 h. Finally, the consistency of PSAPD gain between independent operations of the camera over 10 days is tested. Results: The PET camera maintains a temperature of 18.00 ± 0.05 °C over the course of 12 h while the ambient temperature varied 0.61 °C, from 22.83 to 23.44 °C. The 511 keV photopeak energy resolution over a period of 8.66 h is measured to be 11.3% FWHM with a maximum photopeak fluctuation of 4 keV. Between measurements of PSAPD gain separated by at least 2 day, the maximum photopeak shift was 6 keV. Conclusions: The proposed thermal regulation scheme for tightly packed silicon photodetectors provides for stable operation of the constructed subsection of a PET camera over long durations of time. The energy resolution of the system is not degraded despite shifts in ambient temperature and photodetector heat generation. The thermal regulation scheme also provides a consistent operating environment between separate runs of the camera over different days. Inter-run consistency allows for reuse of system calibration parameters from study to study, reducing the time required to calibrate the system and hence to obtain a reconstructed image.« less

Design and Testing of a Variable Pressure Regulator for the Constellation Space Suit

NASA Technical Reports Server (NTRS)

Gill, Larry; Campbell, Colin

2008-01-01

The next generation space suit requires additional capabilities for controlling and adjusting internal pressure than previous design suits. Next generation suit pressures will range from slight pressure, for astronaut prebreath comfort, to hyperbaric pressure levels for emergency medical treatment. Carleton was awarded a contract in 2008 to design and build a proof of concept bench top demonstrator regulator having five setpoints which are selectable using input electronic signaling. Although the basic regulator architecture is very similar to the existing SOP regulator used in the current EMU, the major difference is the electrical selectivity of multiple setpoints rather than the mechanical On/Off feature found on the SOP regulator. The concept regulator employs a linear actuator stepper motor combination to provide variable compression to a custom design main regulator spring. This concept allows for a continuously adjustable outlet pressures from 8.2 psid (maximum) down to "firm" zero thus effectively allowing it to serve as a shutoff valve. This paper details the regulator design and presents test results on regulation band width, command set point accuracy; slue rate and regulation stability, particularly when the set point is being slued. Projections for a flight configuration version are also offered for performance, architectural layout and weight.

Status of the NRC Decommissioning Program

DOE Office of Scientific and Technical Information (OSTI.GOV)

Orlando, D. A.; Camper, L.; Buckley, J.

2003-02-24

On July 21, 1997, the U.S. Nuclear Regulatory Commission (NRC) published the final rule on Radiological Criteria for License Termination (the License Termination Rule or LTR) as Subpart E to 10 CFR Part 20. NRC regulations require that materials licensees submit Decommissioning Plans to support the decommissioning of its facility if it is required by license condition, or if the procedures and activities necessary to carry out the decommissioning have not been approved by NRC and these procedures could increase the potential health and safety impacts to the workers or the public. NRC regulations also require that reactor licensees submitmore » Post-shutdown Decommissioning Activities Reports and License Termination Plans to support the decommissioning of nuclear power facilities. This paper provides an update on the status of the NRC's decommissioning program that was presented during WM'02. It discusses the staff's current efforts to streamline the decommissioning process, current issues being faced in the decommissioning program, such as partial site release and restricted release of sites, as well as the status of the decommissioning of complex sites and those listed in the Site Decommissioning Management Plan. The paper discusses the status of permanently shut-down commercial power reactors and the transfer of complex decommissioning sites and sites listed on the SDMP to Agreement States. Finally the paper provides an update of the status of various tools and guidance the NRC is developing to assist licensees during decommissioning, including an effort to consolidate and risk-inform decommissioning guidance.« less

Refinery evaluation of optical imaging to locate fugitive emissions.

PubMed

Robinson, Donald R; Luke-Boone, Ronke; Aggarwal, Vineet; Harris, Buzz; Anderson, Eric; Ranum, David; Kulp, Thomas J; Armstrong, Karla; Sommers, Ricky; McRae, Thomas G; Ritter, Karin; Siegell, Jeffrey H; Van Pelt, Doug; Smylie, Mike

2007-07-01

Fugitive emissions account for approximately 50% of total hydrocarbon emissions from process plants. Federal and state regulations aiming at controlling these emissions require refineries and petrochemical plants in the United States to implement a Leak Detection and Repair Program (LDAR). The current regulatory work practice, U.S. Environment Protection Agency Method 21, requires designated components to be monitored individually at regular intervals. The annual costs of these LDAR programs in a typical refinery can exceed US$1,000,000. Previous studies have shown that a majority of controllable fugitive emissions come from a very small fraction of components. The Smart LDAR program aims to find cost-effective methods to monitor and reduce emissions from these large leakers. Optical gas imaging has been identified as one such technology that can help achieve this objective. This paper discusses a refinery evaluation of an instrument based on backscatter absorption gas imaging technology. This portable camera allows an operator to scan components more quickly and image gas leaks in real time. During the evaluation, the instrument was able to identify leaking components that were the source of 97% of the total mass emissions from leaks detected. More than 27,000 components were monitored. This was achieved in far less time than it would have taken using Method 21. In addition, the instrument was able to find leaks from components that are not required to be monitored by the current LDAR regulations. The technology principles and the parameters that affect instrument performance are also discussed in the paper.

Revitalising primary healthcare requires an equitable global economic system - now more than ever.

PubMed

Sanders, David; Baum, Fran E; Benos, Alexis; Legge, David

2011-08-01

The promised revitalisation of primary healthcare (PHC) is happening at a time when the contradictions and unfairness of the global economic system have become clear, suggesting that the current system is unsustainable. In the past two decades, one of the most significant impediments to the implementation of comprehensive PHC has been neoliberal economic policies and their imposition globally. This article questions what will be required for PHC to flourish. PHC incorporates five key principles: equitable provision of services, comprehensive care, intersectoral action, community involvement and appropriate technology. This article considers intersectoral action and comprehensiveness and their potential to be implemented in the current global environment. It highlights the constraints to intersectoral action through a case study of nutrition in the context of globalisation of the food chain. It also explores the challenges to implementing a comprehensive approach to health that are posed by neoliberal health sector reforms and donor practices. The paper concludes that even well-designed health systems based on PHC have little influence over the broader economic forces that shape their operation and their ability to improve health. Reforming these economic forces will require greater regulation of the national and global economic environment to emphasise people's health rather than private profit, and action to address climate change. Revitalisation of PHC and progress towards health equity are unlikely without strong regulation of the market. The further development and strengthening of social movements for health will be key to successful advocacy action.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Rosenberg, Michael; Jonlin, Duane; Nadel, Steven

Today’s building energy codes focus on prescriptive requirements for features of buildings that are directly controlled by the design and construction teams and verifiable by municipal inspectors. Although these code requirements have had a significant impact, they fail to influence a large slice of the building energy use pie – including not only miscellaneous plug loads, cooking equipment and commercial/industrial processes, but the maintenance and optimization of the code-mandated systems as well. Currently, code compliance is verified only through the end of construction, and there are no limits or consequences for the actual energy use in an occupied building. Inmore » the future, our suite of energy regulations will likely expand to include building efficiency, energy use or carbon emission budgets over their full life cycle. Intelligent building systems, extensive renewable energy, and a transition from fossil fuel to electric heating systems will likely be required to meet ultra-low-energy targets. This paper lays out the authors’ perspectives on how buildings may evolve over the course of the 21st century and the roles that codes and regulations will play in shaping those buildings of the future.« less

Children's exposure assessment: a review of factors influencing Children's exposure, and the data available to characterize and assess that exposure.

PubMed Central

Cohen Hubal, E A; Sheldon, L S; Burke, J M; McCurdy, T R; Berry, M R; Rigas, M L; Zartarian, V G; Freeman, N C

2000-01-01

We review the factors influencing children's exposure to environmental contaminants and the data available to characterize and assess that exposure. Children's activity pattern data requirements are demonstrated in the context of the algorithms used to estimate exposure by inhalation, dermal contact, and ingestion. Currently, data on children's exposures and activities are insufficient to adequately assess multimedia exposures to environmental contaminants. As a result, regulators use a series of default assumptions and exposure factors when conducting exposure assessments. Data to reduce uncertainty in the assumptions and exposure estimates are needed to ensure chemicals are regulated appropriately to protect children's health. To improve the database, advancement in the following general areas of research is required: identification of appropriate age/developmental benchmarks for categorizing children in exposure assessment; development and improvement of methods for monitoring children's exposures and activities; collection of activity pattern data for children (especially young children) required to assess exposure by all routes; collection of data on concentrations of environmental contaminants, biomarkers, and transfer coefficients that can be used as inputs to aggregate exposure models. PMID:10856019

Preimplantation diagnosis to create 'saviour siblings': a critical discussion of the current and future legal frameworks in South Africa.

PubMed

Strode, Ann; Soni, Sheetal

2011-12-14

Pre-implantation genetic diagnosis (PGD) is a technology used in conjunction with in vitro fertilisation to screen embryos for genetic conditions prior to transfer. It was initially developed to screen mutations for severe, irreversible, genetic conditions. Currently, PGD makes it possible to select against more than 100 different genetic conditions. It has been proposed as a method for creating a tissue-matched child who can in turn serve as a compatible stem cell donor to save a sick sibling in need of a stem cell transplant. The advantage of this method is that it provides genetic information before implantation of an embryo into the womb, making it possible to ensure that only tissue-matched embryos are transferred to the uterus. A couple can therefore avoid the difficult choice of either terminating the pregnancy at a later point if the fetus is not a match, or extending their family again in the hope that their next child will be tissue compatible. Many people have expressed disapproval of the use of PGD for this purpose, and it is associated with many conflicting interests including religion, ethics as well as legal regulation. In order to manage these issues some jurisdictions have created legal frameworks to regulate the use of this technology. Many of these are modelled on the UK's Human Fertilisation and Embryology Authority and its guardian legislation. This paper critiques the current and future South African legal framework to establish whether it is able to adequately regulate the use of PGD as well as guard against misuse of the technology. It concludes that changes are required to the future framework in order to ensure that it regulates the circumstances in which PGD may occur and that the Minister of Health should act expediently in finalising draft regulations which will regulate PGD in the future.

Requiring School Districts to Spend Comparable Amounts on Title I Schools Is Pushing on a String. Evidence Speaks Reports, Vol 1, #21

ERIC Educational Resources Information Center

Dynarski, Mark; Kainz, Kirsten

2016-01-01

Of all the rules that the U.S. Department of Education will have to formulate for the Every Student Succeeds Act, the proposed regulations to monitor that states and districts spend comparable amounts for schools eligible and not eligible to use Title I funds are attracting the most attention. Currently, districts can show comparability based on…

Nurse prescribing ethics and medical marketing.

PubMed

Adams, J

This article suggests that nurse prescribers require an awareness of key concepts in ethics, such as deontology and utilitarianism to reflect on current debates and contribute to them. The principles of biomedical ethics have also been influential in the development of professional codes of conduct. Attention is drawn to the importance of the Association of the British Pharmaceutical Industry's code of practice for the pharmaceutical industry in regulating marketing aimed at prescribers.

Waste Characterization Methods

DOE Office of Scientific and Technical Information (OSTI.GOV)

Vigil-Holterman, Luciana R.; Naranjo, Felicia Danielle

2016-02-02

This report discusses ways to classify waste as outlined by LANL. Waste Generators must make a waste determination and characterize regulated waste by appropriate analytical testing or use of acceptable knowledge (AK). Use of AK for characterization requires several source documents. Waste characterization documentation must be accurate, sufficient, and current (i.e., updated); relevant and traceable to the waste stream’s generation, characterization, and management; and not merely a list of information sources.

Citron kinase controls abscission through RhoA and anillin

PubMed Central

Gai, Marta; Camera, Paola; Dema, Alessandro; Bianchi, Federico; Berto, Gaia; Scarpa, Elena; Germena, Giulia; Di Cunto, Ferdinando

2011-01-01

The small GTPase RhoA plays a crucial role in the different stages of cytokinesis, including contractile ring formation, cleavage furrow ingression, and midbody abscission. Citron kinase (CIT-K), a protein required for cytokinesis and conserved from insects to mammals, is currently considered a cytokinesis-specific effector of active RhoA. In agreement with previous observations, we show here that, as in Drosophila cells, CIT-K is specifically required for abscission in mammalian cells. However, in contrast with the current view, we provide evidence that CIT-K is an upstream regulator rather than a downstream effector of RhoA during late cytokinesis. In addition, we show that CIT-K is capable of physically and functionally interacting with the actin-binding protein anillin. Active RhoA and anillin are displaced from the midbody in CIT-K-depleted cells, while only anillin, but not CIT-K, is affected if RhoA is inactivated in late cytokinesis. The overexpression of CIT-K and of anillin leads to abscission delay. However, the delay produced by CIT-K overexpression can be reversed by RhoA inactivation, while the delay produced by anillin overexpression is RhoA-independent. Altogether, these results indicate that CIT-K is a crucial abscission regulator that may promote midbody stability through active RhoA and anillin. PMID:21849473

Recent Findings in the Genetics of Blood Pressure: How to Apply in Practice or Is a Moonshot Required?

PubMed

Padmanabhan, Sandosh; Aman, Alisha; Dominiczak, Anna F

2018-06-07

Hypertension is recognised as the biggest contributor to the global burden of disease, but it is controlled in less than a fifth of patients worldwide, despite being relatively easy to detect and the availability of inexpensive safe generic drugs. Blood pressure is regulated by a complex network of physiologic pathways with currently available drugs targeting key receptors or enzymes in the top pathways. Major advances in the dissection of both monogenic and polygenic determinants of blood pressure regulation and variation have not resulted in rapid translation of these discoveries into clinical applications or precision medicine. Uromodulin is an example of a novel gene for hypertension identified from genome-wide association studies, currently the basis of a clinical trial to reposition loop diuretics in hypertension management. Gene-editing studies have established a genome-wide association studies (GWAS) SNP in chromosome 6p24, implicated in six conditions including hypertension, as a distal regulator of the endothelin-1 gene around 3000 base pairs away. Genomics of aldosterone-producing adenomas bring to focus the paradox in genomic medicine where availability of cheap generic drugs may render precision medicine uneconomical. The speed of technology-driven genomic discoveries and the sluggish traditional pathways of drug development and translation need harmonisation to make a timely and early impact on global public health. This requires a directed collaborative effort for which we propose a hypertension moonshot to make a quantum leap in hypertension management and cardiovascular risk reduction by bringing together traditional bioscience, omics, engineering, digital technology and data science.

Ribosomal S6K1 in POMC and AgRP Neurons Regulates Glucose Homeostasis but Not Feeding Behavior in Mice

PubMed Central

Smith, Mark A.; Katsouri, Loukia; Irvine, Elaine E.; Hankir, Mohammed K.; Pedroni, Silvia M.A.; Voshol, Peter J.; Gordon, Matthew W.; Choudhury, Agharul I.; Woods, Angela; Vidal-Puig, Antonio; Carling, David; Withers, Dominic J.

2015-01-01

Summary Hypothalamic ribosomal S6K1 has been suggested as a point of convergence for hormonal and nutrient signals in the regulation of feeding behavior, bodyweight, and glucose metabolism. However, the long-term effects of manipulating hypothalamic S6K1 signaling on energy homeostasis and the cellular mechanisms underlying these roles are unclear. We therefore inactivated S6K1 in pro-opiomelanocortin (POMC) and agouti-related protein (AgRP) neurons, key regulators of energy homeostasis, but in contrast to the current view, we found no evidence that S6K1 regulates food intake and bodyweight. In contrast, S6K1 signaling in POMC neurons regulated hepatic glucose production and peripheral lipid metabolism and modulated neuronal excitability. S6K1 signaling in AgRP neurons regulated skeletal muscle insulin sensitivity and was required for glucose sensing by these neurons. Our findings suggest that S6K1 signaling is not a general integrator of energy homeostasis in the mediobasal hypothalamus but has distinct roles in the regulation of glucose homeostasis by POMC and AgRP neurons. PMID:25865886

Ribosomal S6K1 in POMC and AgRP Neurons Regulates Glucose Homeostasis but Not Feeding Behavior in Mice.

PubMed

Smith, Mark A; Katsouri, Loukia; Irvine, Elaine E; Hankir, Mohammed K; Pedroni, Silvia M A; Voshol, Peter J; Gordon, Matthew W; Choudhury, Agharul I; Woods, Angela; Vidal-Puig, Antonio; Carling, David; Withers, Dominic J

2015-04-21

Hypothalamic ribosomal S6K1 has been suggested as a point of convergence for hormonal and nutrient signals in the regulation of feeding behavior, bodyweight, and glucose metabolism. However, the long-term effects of manipulating hypothalamic S6K1 signaling on energy homeostasis and the cellular mechanisms underlying these roles are unclear. We therefore inactivated S6K1 in pro-opiomelanocortin (POMC) and agouti-related protein (AgRP) neurons, key regulators of energy homeostasis, but in contrast to the current view, we found no evidence that S6K1 regulates food intake and bodyweight. In contrast, S6K1 signaling in POMC neurons regulated hepatic glucose production and peripheral lipid metabolism and modulated neuronal excitability. S6K1 signaling in AgRP neurons regulated skeletal muscle insulin sensitivity and was required for glucose sensing by these neurons. Our findings suggest that S6K1 signaling is not a general integrator of energy homeostasis in the mediobasal hypothalamus but has distinct roles in the regulation of glucose homeostasis by POMC and AgRP neurons. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Emotional competence and extrinsic emotion regulation directed toward an ostracized person.

PubMed

Nozaki, Yuki

2015-12-01

Positive interpersonal relationships hinge on individuals' competence in regulating others' emotions as well as their own. Nevertheless, little is known about the relationship between emotional competence and specific interpersonal behaviors. In particular, it is unclear which situations require emotional competence for extrinsic emotion regulation and whether emotionally competent individuals actually attempt to regulate others' emotions. To clarify these issues, the current investigation examined the relationship between emotional competence and extrinsic emotion regulation directed toward an ostracized person. The results of Study 1 (N = 39) indicated that interpersonal emotional competence (competence related to others' emotions) was positively associated with participants' efforts to relieve the ostracized person's sadness. In Study 2 (N = 120), this relationship was moderated by the ostracized person's emotional expression. In particular, participants with high interpersonal emotional competence were more likely to attempt to regulate the sadness of ostracized individuals who expressed neutral affect. In contrast, when the ostracized person expressed sadness, there were no significant relationships between high or low interpersonal emotional competence and extrinsic emotion regulation behavior. These results offer novel insight into how emotionally competent individuals use their competence to benefit others. (c) 2015 APA, all rights reserved).

Uncovering the Role of RNA-Binding Proteins in Gene Expression in the Immune System

PubMed Central

Díaz-Muñoz, Manuel D.; Turner, Martin

2018-01-01

Fighting external pathogens requires an ever-changing immune system that relies on tight regulation of gene expression. Transcriptional control is the first step to build efficient responses while preventing immunodeficiencies and autoimmunity. Post-transcriptional regulation of RNA editing, location, stability, and translation are the other key steps for final gene expression, and they are all controlled by RNA-binding proteins (RBPs). Nowadays we have a deep understanding of how transcription factors control the immune system but recent evidences suggest that post-transcriptional regulation by RBPs is equally important for both development and activation of immune responses. Here, we review current knowledge about how post-transcriptional control by RBPs shapes our immune system and discuss the perspective of RBPs being the key players of a hidden immune cell epitranscriptome. PMID:29875770

Examination of the expanding pathways for the regulation of p21 expression and activity.

PubMed

Jung, Yong-Sam; Qian, Yingjuan; Chen, Xinbin

2010-07-01

p21(Waf1/Cip1/Sdi1) was originally identified as an inhibitor of cyclin-dependent kinases, a mediator of p53 in growth suppression and a marker of cellular senescence. p21 is required for proper cell cycle progression and plays a role in cell death, DNA repair, senescence and aging, and induced pluripotent stem cell reprogramming. Although transcriptional regulation is considered to be the initial control point for p21 expression, there is growing evidence that post-transcriptional and post-translational regulations play a critical role in p21 expression and activity. This review will briefly discuss the activity of p21 and focus on current knowledge of the determinants that control p21 transcription, mRNA stability and translation, and protein stability and activity. (c) 2010 Elsevier Inc. All rights reserved.

Structural integrity and containment aspects of small gas turbine engines

NASA Astrophysics Data System (ADS)

Gupta, S. S.; Gomuc, R.

1994-03-01

Structural integrity of rotating components in gas turbine engines is very crucial since their failure implies high impact energy, which, if uncontained, could mean damage to aircraft structures, controls, and so forth, and, in the worst scenario, even loss of lives. This final consequence has led to very stringent airworthiness regulations for engine/aircraft certifications. This paper discusses the historical statistics of noncontainment events in turbofans, turboprops, and turboshafts and shows how the damage severity varies between different applications and how changes to regulations are continuing in order to improve the reliability of aircraft/rotorcraft. The paper also presents design challenges resulting from the analysis complexity of containment/noncontainment event and the way Pratt & Whitney Canada design/analysis/test system caters to all the requirements. The weight and cost impact of possible changes to current regulations are also presented.

Environmental regulation of plant gene expression: an RT-qPCR laboratory project for an upper-level undergraduate biochemistry or molecular biology course.

PubMed

Eickelberg, Garrett J; Fisher, Alison J

2013-01-01

We present a novel laboratory project employing "real-time" RT-qPCR to measure the effect of environment on the expression of the FLOWERING LOCUS C gene, a key regulator of floral timing in Arabidopsis thaliana plants. The project requires four 3-hr laboratory sessions and is aimed at upper-level undergraduate students in biochemistry or molecular biology courses. The project provides students with hands-on experience with RT-qPCR, the current "gold standard" for gene expression analysis, including detailed data analysis using the common 2-ΔΔCT method. Moreover, it provides a convenient starting point for many inquiry-driven projects addressing diverse questions concerning ecological biochemistry, naturally occurring genetic variation, developmental biology, and the regulation of gene expression in nature. Copyright © 2013 Wiley Periodicals, Inc.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Taylor, Margaret; Fujita, K. Sydny

Regulatory impact assessment is formally required by the U.S. and many other nations in order to help governments weigh the costs and benefits of proposed regulations, particularly as they compare to those of alternative actions and other government priorities. 1 One of the “best practices” of regulatory impact assessments, as established by the OECD, is to use estimates of costs that are grounded in economic theory. Economic theory indicates that changes in compliance costs should be expected over time as a result of factors related to technological innovation. But many U.S. regulatory impact assessments have traditionally employed a practice thatmore » is in conflict with this expectation: they take current estimates of the costs of complying with a proposed regulation and project that those costs will remain unchanged over the full time period that the regulation would be in effect.« less

Medical cannabis: considerations for the anesthesiologist and pain physician.

PubMed

Beaulieu, Pierre; Boulanger, Aline; Desroches, Julie; Clark, Alexander J

2016-05-01

New regulations are in place at the federal and provincial levels in Canada regarding the way medical cannabis is to be controlled. We present them together with guidance for the safe use of medical cannabis and recent clinical trials on cannabis and pain. The new Canadian regulations on the use of medical cannabis, the provincial regulations, and the various cannabis products available from the Canadian Licensed Producers were reviewed from Health Canada, provincial licensing authorities, and the licensed producers website, respectively. Recent clinical trials on cannabis and pain were reviewed from the existing literature. Health Canada has approved a new regulation on medical marijuana/cannabis, the Marihuana for Medical Purposes Regulations: The production of medical cannabis by individuals is illegal. Health Canada, however, has licensed authorized producers across the country, limiting the production to specific licenses of certain cannabis products. There are currently 26 authorized licensed producers from seven Canadian provinces offering more than 200 strains of marijuana. We provide guidance for the safe use of medical cannabis. The recent literature indicates that currently available cannabinoids are modestly effective analgesics that provide a safe, reasonable therapeutic option for managing chronic non-cancer-related pain. The science of medical cannabis and the need for education of healthcare professionals and patients require continued effort. Although cannabinoids work to decrease pain, there is still a need to confirm these beneficial effects clinically and to exploit them with acceptable benefit-to-risk ratios.

Current good manufacturing practice regulation and investigational new drugs. Direct final rule.

PubMed

2006-01-17

The Food and Drug Administration (FDA) is amending its current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most investigational "Phase 1" drugs from complying with the requirements in FDA's regulations. FDA will instead exercise oversight of production of these drugs under the agency's general statutory CGMP authority and investigational new drug application (IND) authority. In addition, FDA is making available simultaneously with the publication of this direct final rule, a guidance document setting forth recommendations on approaches to CGMP compliance for the exempted Phase 1 drugs. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule, under FDA's usual procedure for notice-and-comment rulemaking, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comments and withdraws this direct final rule. The companion proposed rule and direct final rule are substantively identical. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance for industry entitled "INDs--Approaches to Complying With CGMP During Phase 1" to provide further guidance on the subject.

[Guideline-adherent inpatient psychiatric psychotherapeutic treatment of obsessive-compulsive disorder : Normative definition of personnel requirements].

PubMed

Klein, J P; Zurowski, B; Wolff, J; Godemann, F; Herpertz, S C; Berger, M; Heuft, G; Hohagen, F

2016-07-01

Guideline-oriented inpatient psychiatric and psychotherapeutic treatment of patients with obsessive-compulsive disorder (OCD) is an important part of the care available for these patients. It may not be adequately reflected in the current personnel resources available according to the German psychiatry personnel regulation (Psych-PV). The goal of this work was to assess the personnel resources necessary for a guideline-oriented inpatient psychiatric and psychotherapeutic treatment of patients with OCD and compare the necessary resources with the resources available according to Psych-PV. Based on the German national guidelines for OCD and a meta-analysis on treatment intensity, we formulated a normative weekly treatment plan. Based on this plan we calculated the necessary personnel resources and compared these with the resources available according to Psych-PV category A1 (standard care). The weekly treatment time for a guideline-oriented inpatient psychiatric and psychotherapeutic treatment of patients with OCD is 23.5 h per week. This corresponds to a weekly personnel requirement of 20.9 h. This requirement is only partly reflected in the Psych-PV (17.3 h, 82.8 %). The coverage of personnel resources by Psych-PV is even lower for psychotherapy provided by psychiatrist and psychologists (38.3 %, i. e. 183 min in the normative plan versus 70 min in Psych-PV). The current paper shows that the personal resources required for a guideline-oriented inpatient psychiatric and psychotherapeutic treatment of patients with OCD is not adequately reflected in the German psychiatry personnel regulation (Psych-PV). The actual shortage may be underestimated in our paper.

Eccrine sweat gland development and sweat secretion

PubMed Central

Cui, Chang-Yi; Schlessinger, David

2017-01-01

Eccrine sweat glands help to maintain homoeostasis, primarily by stabilizing body temperature. Derived from embryonic ectoderm, millions of eccrine glands are distributed across human skin and secrete litres of sweat per day. Their easy accessibility has facilitated the start of analyses of their development and function. Mouse genetic models find sweat gland development regulated sequentially by Wnt, Eda and Shh pathways, although precise subpathways and additional regulators require further elucidation. Mature glands have two secretory cell types, clear and dark cells, whose comparative development and functional interactions remain largely unknown. Clear cells have long been known as the major secretory cells, but recent studies suggest that dark cells are also indispensable for sweat secretion. Dark cell-specific Foxa1 expression was shown to regulate a Ca2+-dependent Best2 anion channel that is the candidate driver for the required ion currents. Overall, it was shown that cholinergic impulses trigger sweat secretion in mature glands through second messengers – for example InsP3 and Ca2+ – and downstream ion channels/transporters in the framework of a Na+-K+-Cl− cotransporter model. Notably, the microenvironment surrounding secretory cells, including acid–base balance, was implicated to be important for proper sweat secretion, which requires further clarification. Furthermore, multiple ion channels have been shown to be expressed in clear and dark cells, but the degree to which various ion channels function redundantly or indispensably also remains to be determined. PMID:26014472

An Evaluation of a High Pressure Regulator for NASA's Robotic Lunar Lander Spacecraft

NASA Technical Reports Server (NTRS)

Burnside, Christopher G.; Trinh, Huu P.; Pedersen, Kevin W.

2013-01-01

The Robotic Lunar Lander (RLL) development project office at NASA Marshall Space Flight Center is currently studying several lunar surface science mission concepts. The focus is on spacecraft carrying multiple science instruments and power systems that will allow extended operations on the lunar surface or other air-less bodies in the solar system. Initial trade studies of launch vehicle options indicate the spacecraft will be significantly mass and volume constrained. Because of the investment by the DOD in low mass, highly volume efficient components, NASA has investigated the potential integration of some of these technologies in space science applications. A 10,000 psig helium pressure regulator test activity has been conducted as part of the overall risk reduction testing for the RLL spacecraft. The regulator was subjected to typical NASA acceptance testing to assess the regulator response to the expected RLL mission requirements. The test results show the regulator can supply helium at a stable outlet pressure of 740 psig within a +/- 5% tolerance band and maintain a lock-up pressure less than the +5% above nominal outlet pressure for all tests conducted. Numerous leak tests demonstrated leakage less than 10-3 standard cubic centimeters per second (SCCS) for the internal seat leakage at lock-up and less than 10-5 SCCS for external leakage through the regulator body. The successful test has shown the potential for 10,000 psig helium systems in NASA spacecraft and has reduced risk associated with hardware availability and hardware ability to meet RLL mission requirements.

PI controller design for indirect vector controlled induction motor: A decoupling approach.

PubMed

Jain, Jitendra Kr; Ghosh, Sandip; Maity, Somnath; Dworak, Pawel

2017-09-01

Decoupling of the stator currents is important for smoother torque response of indirect vector controlled induction motors. Typically, feedforward decoupling is used to take care of current coupling that requires exact knowledge of motor parameters, additional circuitry and signal processing. In this paper, a method is proposed to design the regulating proportional-integral gains that minimize coupling without any requirement of the additional decoupler. The variation of the coupling terms for change in load torque is considered as the performance measure. An iterative linear matrix inequality based H ∞ control design approach is used to obtain the controller gains. A comparison between the feedforward and the proposed decoupling schemes is presented through simulation and experimental results. The results show that the proposed scheme is simple yet effective even without additional block or burden on signal processing. Copyright © 2017 ISA. Published by Elsevier Ltd. All rights reserved.

Kv4.2 Mediates Histamine Modulation of Preoptic Neuron Activity and Body Temperature

PubMed Central

Sethi, Jasmine; Sanchez-Alavez, Manuel; Tabarean, Iustin V.

2011-01-01

Histamine regulates arousal, circadian rhythms, and thermoregulation. Activation of H3 histamine receptors expressed by preoptic GABAergic neurons results in a decrease of their firing rate and hyperthermia. Here we report that an increase in the A-type K+ current in preoptic GABAergic neurons in response to activation of H3 histamine receptors results in decreased firing rate and hyperthermia in mice. The Kv4.2 subunit is required for these actions in spite of the fact that Kv4.2−/− preoptic GABAergic neurons display A-type currents and firing characteristics similar to those of wild-type neurons. This electrical remodeling is achieved by robust upregulation of the expression of the Kv4.1 subunit and of a delayed rectifier current. Dynamic clamp experiments indicate that enhancement of the A-type current by a similar amount to that induced by histamine is sufficient to mimic its robust effect on firing rates. These data indicate a central role played by the Kv4.2 subunit in histamine regulation of body temperature and its interaction with pERK1/2 downstream of the H3 receptor. We also reveal that this pathway provides a mechanism for selective modulation of body temperature at the beginning of the active phase of the circadian cycle. PMID:22220205

[Electromagnetic hazards from electrosurgery--assessment of occupational exposure to electromagnetic field and currents induceed in the body].

PubMed

Gryz, Krzysztof; Karpowicz, Jolanta

2006-01-01

The investigation of the occupational exposure to electromagnetic fields from electrosurgery devices were done (according to the requirements of Polish Standard PN-T-06580:2002). The exposure was evaluated following the criteria established by occupational safety and health regulations. The measurements and evaluation of the currents flowing through the exposed workers body were also conducted following the method and criteria published by IEEE standard and European Directive 2004/40/EC. It was found that in the vicinity of electrosurgical devices, the area of electromagnetic fields to which only workers operating the source of field should be exposed can exist up to the distance of 70 cm from the active electrode and supplying cables. In the case when the cables are placed directly on the surgeon body or long duration of the daily exposure the overexposure of workers can appear (referring to Polish regulations). The current flowing through the arm of surgeon keeping the electrode with electric field of the maximum strength (app. 1000 V/m or higher) can exceed permissible value of 40 mA established by the Directive 2004/40/EC for contact current. The reduction of the surgeon exposure can be reached by the proper positioning of the cables supplying monopolar electrode or by the use of bipolar electrode.

75 FR 68911 - Regulations Under the Genetic Information Nondiscrimination Act of 2008

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-09

...The Equal Employment Opportunity Commission (``EEOC'' or ``Commission'') is issuing a final rule to implement Title II of the Genetic Information Nondiscrimination Act of 2008 (``GINA''). Congress enacted Title II of GINA to protect job applicants, current and former employees, labor union members, and apprentices and trainees from discrimination based on their genetic information. Title II of GINA requires the EEOC to issue implementing regulations. The Commission issued a proposed rule in the Federal Register on March 2, 2009, for a sixty-day notice and comment period that ended on May 1, 2009. After consideration of the public comments, the Commission has revised portions of both the final rule and the preamble.

Membrane-trafficking sorting hubs: cooperation between PI4P and small GTPases at the trans-Golgi Network

PubMed Central

Santiago-Tirado, Felipe H.; Bretscher, Anthony

2011-01-01

Cell polarity in eukaryotes requires constant sorting, packaging, and transport of membrane-bound cargo within the cell. These processes occur in two sorting hubs: the recycling endosome for incoming material, and the trans-Golgi Network for outgoing. Phosphatidylinositol 3-phosphate and 4–5 phosphate are enriched at the endocytic and exocytic sorting hubs, respectively, where they act together with small GTPases to recruit factors to segregate cargo and regulate carrier formation and transport. In this review, we summarize the current understanding of how these lipids and GTPases directly regulate membrane trafficking, emphasizing the recent discoveries of phosphatidylinositol 4-phosphate functions at the trans-Golgi Network. PMID:21764313

Financial reporting practices: a comprehensive evaluation.

PubMed

Godwin, Norman H; Mueller, Jennifer M

2005-01-01

A distinguishing characteristic of high performance organizations is a strong internal control structure-controls that ensure patient care, compliance with regulations, internal efficiencies, and financial reporting. It is controls on financial reporting that are receiving a great deal of attention under a new law, the Sarbanes-Oxley Act of 2002. Public companies are now required by law to document controls over financial reporting, in order to fully address exposures and the effectiveness of current controls. Though many healthcare organizations are not directly affected by the law, regulatory agencies could follow suit and require similar compliance. In fact, several states have introduced bills that require nonprofit organizations to adhere to portions of the act. This article provides a guide for organizations desiring to stay ahead of the curve.

48 CFR 6.501 - Requirement.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 48 Federal Acquisition Regulations System 1 2013-10-01 2013-10-01 false Requirement. 6.501 Section 6.501 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION ACQUISITION PLANNING COMPETITION REQUIREMENTS Competition Advocates 6.501 Requirement. As required by section 20 of the Office of...

48 CFR 6.501 - Requirement.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Requirement. 6.501 Section 6.501 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION ACQUISITION PLANNING COMPETITION REQUIREMENTS Competition Advocates 6.501 Requirement. As required by section 20 of the Office of...

48 CFR 6.501 - Requirement.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 1 2011-10-01 2011-10-01 false Requirement. 6.501 Section 6.501 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION ACQUISITION PLANNING COMPETITION REQUIREMENTS Competition Advocates 6.501 Requirement. As required by section 20 of the Office of...

Considerations on Directive 98/8 of the European Commission - the biocide directive.

PubMed

Patryn, Rafał; Jarosz, Mirosław J; Włoszczak-Szubzda, Anna; Sak, Jarosław; Pawlikowski, Jakub

2011-01-01

Nowadays, versatile human activity requires the development of technologies in the chemical and biological industries that ultimately enable an increase in human activity, and help create the living conditions in the domain of human civilization. Increasing this activity very frequently requires the implementation of new technologies concerning the active elimination of numerous threats and obstacles which are found in the human and natural environment. The concept of so-called biocidal products has been introduced into the European legislation as long as ten years ago, defining them as various types of 'chemical substances or microorganisms which can deter, render harmless, or exert a controlling eff ect on any harmful organism, by chemical or biological means'. They can be added to other materials (typically liquids) to protect them against biological infestation and growth. Biocidal products - due to their specificity, toxicity and composition - create a serious risk for human and animal life and health, as well as for the natural environment, it is therefore fully justified to have legal regulations concerning such biocides. Because biocidal products are intended to kill living organisms, and as such, many biocidal products pose a significant risk to human health and welfare, and have significant adverse eff ects on the natural environment. Great care is required when handling biocides and appropriate protective clothing and equipment should be used. Currently, Directive 98/8/EC is a comprehensive set of legal regulations concerning biocidal products, their specificity, principles relating to their placing on the market, and guidelines for their control. It is worth emphasizing that Directive 98/8/EC implements the clampdown on poisoning cases with biocides, the duty of which was passed to the so-called Centres of Consultation and Toxicological Information. These centres provide round-the-clock (24-hour) medical consultation and assistance in cases of poisonings with these products. The presented study constitutes an in-depth presentation and analysis of the European law concerning biocides and the current regulations applying to them.

A Symphony of Regulations Centered on p63 to Control Development of Ectoderm-Derived Structures

PubMed Central

Guerrini, Luisa; Costanzo, Antonio; Merlo, Giorgio R.

2011-01-01

The p53-related transcription factor p63 is critically important for basic cellular functions during development of the ectoderm and derived structure and tissues, including skin, limb, palate, and hair. On the one side, p63 is required to sustain the proliferation of keratinocyte progenitors, while on the other side it is required for cell stratification, commitment to differentiate, cell adhesion, and epithelial-mesenchymal signaling. Molecules that are components or regulators of the p63 pathway(s) are rapidly being identified, and it comes with no surprise that alterations in the p63 pathway lead to congenital conditions in which the skin and other ectoderm-derived structures are affected. In this paper, we summarize the current knowledge of the molecular and cellular regulations centered on p63, derived from the comprehension of p63-linked human diseases and the corresponding animal models, as well as from cellular models and high-throughput molecular approaches. We point out common themes and features, that allow to speculate on the possible role of p63 downstream events and their potential exploitation in future attempts to correct the congenital defect in preclinical studies. PMID:21716671

75 FR 4227 - Phytosanitary Treatments; Location of and Process for Updating Treatment Schedules

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-26

...We are amending the phytosanitary treatment regulations in 7 CFR part 305 by removing the lists of approved treatments and treatment schedules from the regulations, while retaining the general requirements for performing treatments and certifying or approving treatment facilities. We are removing treatment schedules from other places where they are currently found in 7 CFR chapter III as well. Approved treatment schedules will instead be found in the Plant Protection and Quarantine Treatment Manual, which is available on the Internet. We are also establishing a new process to provide the public with notice and the opportunity to comment on changes to treatment schedules. Finally, we are harmonizing and combining the requirements for performing irradiation treatment for imported articles, articles moved interstate from Hawaii and U.S. territories, and articles moved interstate from an area quarantined for fruit flies. These changes will simplify and expedite our processes for adding, changing, and removing treatment schedules while continuing to provide for public participation in the process. These changes will also simplify our presentation of treatments to the public by consolidating all treatments into one document and eliminating redundant text from the regulations.

48 CFR 6.501 - Requirement.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 48 Federal Acquisition Regulations System 1 2014-10-01 2014-10-01 false Requirement. 6.501 Section 6.501 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION ACQUISITION PLANNING COMPETITION REQUIREMENTS Advocates for Competition 6.501 Requirement. As required by 41 U.S.C. 1705, the head...

Thermal analyses of power subsystem components

NASA Technical Reports Server (NTRS)

Morehouse, Jeffrey H.

1990-01-01

The hiatus in the Space Shuttle (Orbiter) program provided time for an in-depth examination of all the subsystems and their past performance. Specifically, problems with reliability and/or operating limits were and continue to be of major engineering concern. The Orbiter Auxiliary Power Unit (APU) currently operates with electric resistance line heaters which are controlled with thermostats. A design option simplification of this heater subsystem is being considered which would use self-regulating heaters. A determination of the properties and thermal operating characteristics of these self-regulating heaters was needed. The Orbiter fuel cells are cooled with a freon loop. During a loss of external heat exchanger coolant flow, the single pump circulating the freon is to be left running. It was unknown what temperature and flow rate transient conditions of the freon would provide the required fuel cell cooling and for how long. The overall objective was the development of the thermal characterization and subsequent analysis of both the proposed self-regulating APU heater and the fuel cell coolant loop subsystem. The specific objective of the APU subsystem effort was to determine the feasibility of replacing the current heater and thermostat arrangement with a self-regulating heater. The specific objective of the fuel cell coolant subsystem work was to determine the tranient coolant temperature and associated flow rates during a loss-of-external heat exchanger flow.

Border control: selectivity of chloroplast protein import and regulation at the TOC-complex

PubMed Central

Demarsy, Emilie; Lakshmanan, Ashok M.; Kessler, Felix

2014-01-01

Plants have evolved complex and sophisticated molecular mechanisms to regulate their development and adapt to their surrounding environment. Particularly the development of their specific organelles, chloroplasts and other plastid-types, is finely tuned in accordance with the metabolic needs of the cell. The normal development and functioning of plastids require import of particular subsets of nuclear encoded proteins. Most preproteins contain a cleavable sequence at their N terminal (transit peptide) serving as a signal for targeting to the organelle and recognition by the translocation machinery TOC–TIC (translocon of outer membrane complex–translocon of inner membrane complex) spanning the dual membrane envelope. The plastid proteome needs constant remodeling in response to developmental and environmental factors. Therefore selective regulation of preprotein import plays a crucial role in plant development. In this review we describe the diversity of transit peptides and TOC receptor complexes, and summarize the current knowledge and potential directions for future research concerning regulation of the different Toc isoforms. PMID:25278954

Border control: selectivity of chloroplast protein import and regulation at the TOC-complex.

PubMed

Demarsy, Emilie; Lakshmanan, Ashok M; Kessler, Felix

2014-01-01

Plants have evolved complex and sophisticated molecular mechanisms to regulate their development and adapt to their surrounding environment. Particularly the development of their specific organelles, chloroplasts and other plastid-types, is finely tuned in accordance with the metabolic needs of the cell. The normal development and functioning of plastids require import of particular subsets of nuclear encoded proteins. Most preproteins contain a cleavable sequence at their N terminal (transit peptide) serving as a signal for targeting to the organelle and recognition by the translocation machinery TOC-TIC (translocon of outer membrane complex-translocon of inner membrane complex) spanning the dual membrane envelope. The plastid proteome needs constant remodeling in response to developmental and environmental factors. Therefore selective regulation of preprotein import plays a crucial role in plant development. In this review we describe the diversity of transit peptides and TOC receptor complexes, and summarize the current knowledge and potential directions for future research concerning regulation of the different Toc isoforms.

Quality management system in radiotherapy in the light of regulations applicable in Poland

PubMed Central

2012-01-01

The need to establish conditions for safe irradiation was noted in Poland back in 1986 in the Atomic Law, but for over 16 years no regulations regarding this aspect were passed. The radiological incident in Bialystok (Poland) in 2001 undeniably accelerated the implementation of new legal regulations. Nevertheless, in the absence of national guidelines until 2002, most health care institutions resorted to the quality management system (QMS) model proposed by the ISO norm 9001:2000. Eventually, practice proved the theory and the aforementioned model was also implemented into Polish acts of law defining basic requirements for QMS in radiotherapy. The aim of this work is to review current national regulations regarding QMS in radiotherapy, in particular those referring to standard procedures, the establishment of a commission for procedures and performance of external and internal clinical audits in oncological radiotherapy, as well as to present the process of their implementation into the practice of health care institutions. PMID:23788867

Metabolic Regulation of Manganese Superoxide Dismutase Expression via Essential Amino Acid Deprivation*

PubMed Central

Aiken, Kimberly J.; Bickford, Justin S.; Kilberg, Michael S.; Nick, Harry S.

2008-01-01

Organisms respond to available nutrient levels by rapidly adjusting metabolic flux, in part through changes in gene expression. A consequence of adaptations in metabolic rate is the production of mitochondria-derived reactive oxygen species. Therefore, we hypothesized that nutrient sensing could regulate the synthesis of the primary defense of the cell against superoxide radicals, manganese superoxide dismutase. Our data establish a novel nutrient-sensing pathway for manganese superoxide dismutase expression mediated through essential amino acid depletion concurrent with an increase in cellular viability. Most relevantly, our results are divergent from current mechanisms governing amino acid-dependent gene regulation. This pathway requires the presence of glutamine, signaling via the tricarboxylic acid cycle/electron transport chain, an intact mitochondrial membrane potential, and the activity of both the MEK/ERK and mammalian target of rapamycin kinases. Our results provide evidence for convergence of metabolic cues with nutrient control of antioxidant gene regulation, revealing a potential signaling strategy that impacts free radical-mediated mutations with implications in cancer and aging. PMID:18187411

Metabolic regulation of manganese superoxide dismutase expression via essential amino acid deprivation.

PubMed

Aiken, Kimberly J; Bickford, Justin S; Kilberg, Michael S; Nick, Harry S

2008-04-18

Organisms respond to available nutrient levels by rapidly adjusting metabolic flux, in part through changes in gene expression. A consequence of adaptations in metabolic rate is the production of mitochondria-derived reactive oxygen species. Therefore, we hypothesized that nutrient sensing could regulate the synthesis of the primary defense of the cell against superoxide radicals, manganese superoxide dismutase. Our data establish a novel nutrient-sensing pathway for manganese superoxide dismutase expression mediated through essential amino acid depletion concurrent with an increase in cellular viability. Most relevantly, our results are divergent from current mechanisms governing amino acid-dependent gene regulation. This pathway requires the presence of glutamine, signaling via the tricarboxylic acid cycle/electron transport chain, an intact mitochondrial membrane potential, and the activity of both the MEK/ERK and mammalian target of rapamycin kinases. Our results provide evidence for convergence of metabolic cues with nutrient control of antioxidant gene regulation, revealing a potential signaling strategy that impacts free radical-mediated mutations with implications in cancer and aging.

Considerations for the use of human participants in vector biology research: a tool for investigators and regulators.

PubMed

Achee, Nicole L; Youngblood, Laura; Bangs, Michael J; Lavery, James V; James, Stephanie

2015-02-01

A thorough search of the existing literature has revealed that there are currently no published recommendations or guidelines for the interpretation of US regulations on the use of human participants in vector biology research (VBR). An informal survey of vector biologists has indicated that issues related to human participation in vector research have been largely debated by academic, national, and local Institutional Review Boards (IRBs) in the countries where the research is being conducted, and that interpretations and subsequent requirements made by these IRBs have varied widely. This document is intended to provide investigators and corresponding scientific and ethical review committee members an introduction to VBR methods involving human participation and the legal and ethical framework in which such studies are conducted with a focus on US Federal Regulations. It is also intended to provide a common perspective for guiding researchers, IRB members, and other interested parties (i.e., public health officials conducting routine entomological surveillance) in the interpretation of human subjects regulations pertaining to VBR.

Outstanding Questions In First Amendment Law Related To Food Labeling Disclosure Requirements For Health.

PubMed

Pomeranz, Jennifer L

2015-11-01

The federal and state governments are increasingly focusing on food labeling as a method to support good health. Many such laws are opposed by the food industry and may be challenged in court, raising the question of what is legally feasible. This article analyzes outstanding questions in First Amendment law related to commercial disclosure requirements and conducts legal analysis and policy evaluation for three current policies. These include the Food and Drug Administration's draft regulation requiring an added sugar disclosure on the Nutrition Facts panel, California's proposed sugar-sweetened beverage safety warning label bill, and Vermont's law requiring labels of genetically engineered food to disclose this information. I recommend several methods for policy makers to enact food labeling laws within First Amendment parameters, including imposing factual commercial disclosure requirements, disclosing the government entity issuing a warning, collecting evidence, and identifying legitimate governmental interests. Project HOPE—The People-to-People Health Foundation, Inc.

A Sodium Leak Current Regulates Pacemaker Activity of Adult Central Pattern Generator Neurons in Lymnaea Stagnalis

PubMed Central

Lu, Tom Z.; Feng, Zhong-Ping

2011-01-01

The resting membrane potential of the pacemaker neurons is one of the essential mechanisms underlying rhythm generation. In this study, we described the biophysical properties of an uncharacterized channel (U-type channel) and investigated the role of the channel in the rhythmic activity of a respiratory pacemaker neuron and the respiratory behaviour in adult freshwater snail Lymnaea stagnalis. Our results show that the channel conducts an inward leak current carried by Na+ (ILeak-Na). The ILeak-Na contributed to the resting membrane potential and was required for maintaining rhythmic action potential bursting activity of the identified pacemaker RPeD1 neurons. Partial knockdown of the U-type channel suppressed the aerial respiratory behaviour of the adult snail in vivo. These findings identified the Na+ leak conductance via the U-type channel, likely a NALCN-like channel, as one of the fundamental mechanisms regulating rhythm activity of pacemaker neurons and respiratory behaviour in adult animals. PMID:21526173

Analysis of Transcription Factors Key for Mouse Pancreatic Development Establishes NKX2-2 and MNX1 Mutations as Causes of Neonatal Diabetes in Man

PubMed Central

Flanagan, Sarah E.; De Franco, Elisa; Lango Allen, Hana; Zerah, Michele; Abdul-Rasoul, Majedah M.; Edge, Julie A.; Stewart, Helen; Alamiri, Elham; Hussain, Khalid; Wallis, Sam; de Vries, Liat; Rubio-Cabezas, Oscar; Houghton, Jayne A.L.; Edghill, Emma L.; Patch, Ann-Marie; Ellard, Sian; Hattersley, Andrew T.

2014-01-01

Summary Understanding transcriptional regulation of pancreatic development is required to advance current efforts in developing beta cell replacement therapies for patients with diabetes. Current knowledge of key transcriptional regulators has predominantly come from mouse studies, with rare, naturally occurring mutations establishing their relevance in man. This study used a combination of homozygosity analysis and Sanger sequencing in 37 consanguineous patients with permanent neonatal diabetes to search for homozygous mutations in 29 transcription factor genes important for murine pancreatic development. We identified homozygous mutations in 7 different genes in 11 unrelated patients and show that NKX2-2 and MNX1 are etiological genes for neonatal diabetes, thus confirming their key role in development of the human pancreas. The similar phenotype of the patients with recessive mutations and mice with inactivation of a transcription factor gene support there being common steps critical for pancreatic development and validate the use of rodent models for beta cell development. PMID:24411943

Myristoylated peptides potentiate the funny current (If) in sinoatrial myocytes

PubMed Central

Liao, Zhandi; St Clair, Joshua R; Larson, Eric D

2011-01-01

The funny current, If, in sinoatrial myocytes is thought to contribute to the sympathetic fight-or-flight increase in heart rate. If is produced by hyperpolarization-activated cyclic nucleotide sensitive-4 (HCN4) channels, and it is widely believed that sympathetic regulation of If occurs via direct binding of cAMP to HCN4, independent of phosphorylation. However, we have recently shown that Protein Kinase A (PKA) activity is required for sympathetic regulation of If, and that PKA can directly phosphorylate HCN4.1 In the present study, we examined the effects of a myristoylated PKA inhibitory peptide (myr-PKI) on If in mouse sinoatrial myocytes. We found that myr-PKI and another myristoylated peptide potently and specifically potentiated If via a mechanism that did not involve PKA inhibition and that was independent of the peptide sequence, Protein Kinase C or phosphatidylinositol-4,5-bisphosphate. The off-target activation of If by myristoylated peptides limits their usefulness for studies of pacemaker mechanisms in sinoatrial myocytes. PMID:21150293

Subcutaneous white adipocytes express a light sensitive signaling pathway mediated via a melanopsin/TRPC channel axis.

PubMed

Ondrusova, Katarina; Fatehi, Mohammad; Barr, Amy; Czarnecka, Zofia; Long, Wentong; Suzuki, Kunimasa; Campbell, Scott; Philippaert, Koenraad; Hubert, Matthew; Tredget, Edward; Kwan, Peter; Touret, Nicolas; Wabitsch, Martin; Lee, Kevin Y; Light, Peter E

2017-11-27

Subcutaneous white adipose tissue (scWAT) is the major fat depot in humans and is a central player in regulating whole body metabolism. Skin exposure to UV wavelengths from sunlight is required for Vitamin D synthesis and pigmentation, although it is plausible that longer visible wavelengths that penetrate the skin may regulate scWAT function. In this regard, we discovered a novel blue light-sensitive current in human scWAT that is mediated by melanopsin coupled to transient receptor potential canonical cation channels. This pathway is activated at physiological intensities of light that penetrate the skin on a sunny day. Daily exposure of differentiated adipocytes to blue light resulted in decreased lipid droplet size, increased basal lipolytic rate and alterations in adiponectin and leptin secretion. Our results suggest that scWAT function may be directly under the influence of ambient sunlight exposure and may have important implications for our current understanding of adipocyte biology. (150 words).

Aero acoustic analysis and community noise. HSCT climb to cruise noise assessment

NASA Technical Reports Server (NTRS)

Mortlock, Alan K.

1992-01-01

The widely accepted industry High Speed Civil Transport (HSCT) design goal for exterior noise is to achieve Federal Aviation Regulation (FAR) Part 36 Stage 3 noise limits currently required for new subsonic aircraft. The three phases of the concern are as follows: (1) airport noise abatement at communities close to the airport, (2) climb power opening-up procedures, and (3) the climb to cruise phase affecting communities far from the airport.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

This Reference Book contains a current copy of the Clean Water Act (excluding Section 404) and those regulations that implement the statutes and appear to be most relevant to US Department of Energy (DOE) activities. The document is provided to DOE and contractor staff for informational purposes only and should not be interpreted as legal guidance. Updates that include important new requirements will be provided periodically. Questions concerning this Reference Book may be directed to Mark Petts, EH-231 (202/586-2609).

Stress-induced self-cannibalism: on the regulation of autophagy by endoplasmic reticulum stress.

PubMed

Deegan, Shane; Saveljeva, Svetlana; Gorman, Adrienne M; Samali, Afshin

2013-07-01

Macroautophagy (autophagy) is a cellular catabolic process which can be described as a self-cannibalism. It serves as an essential protective response during conditions of endoplasmic reticulum (ER) stress through the bulk removal and degradation of unfolded proteins and damaged organelles; in particular, mitochondria (mitophagy) and ER (reticulophagy). Autophagy is genetically regulated and the autophagic machinery facilitates removal of damaged cell components and proteins; however, if the cell stress is acute or irreversible, cell death ensues. Despite these advances in the field, very little is known about how autophagy is initiated and how the autophagy machinery is transcriptionally regulated in response to ER stress. Some three dozen autophagy genes have been shown to be required for the correct assembly and function of the autophagic machinery; however; very little is known about how these genes are regulated by cellular stress. Here, we will review current knowledge regarding how ER stress and the unfolded protein response (UPR) induce autophagy, including description of the different autophagy-related genes which are regulated by the UPR.

Regulation of transport processes across the tonoplast

PubMed Central

Neuhaus, H. Ekkehard; Trentmann, Oliver

2014-01-01

In plants, the vacuole builds up the cellular turgor and represents an important component in cellular responses to diverse stress stimuli. Rapid volume changes of cells, particularly of motor cells, like guard cells, are caused by variation of osmolytes and consequently of the water contents in the vacuole. Moreover, directed solute uptake into or release out of the large central vacuole allows adaptation of cytosolic metabolite levels according to the current physiological requirements and specific cellular demands. Therefore, solute passage across the vacuolar membrane, the tonoplast, has to be tightly regulated. Important principles in vacuolar transport regulation are changes of tonoplast transport protein abundances by differential expression of genes or changes of their activities, e.g., due to post-translational modification or by interacting proteins. Because vacuolar transport is in most cases driven by an electro-chemical gradient altered activities of tonoplast proton pumps significantly influence vacuolar transport capacities. Intense studies on individual tonoplast proteins but also unbiased system biological approaches have provided important insights into the regulation of vacuolar transport. This short review refers to selected examples of tonoplast proteins and their regulation, with special focus on protein phosphorylation. PMID:25309559

Molecular and epigenetic regulations and functions of the LAFL transcriptional regulators that control seed development.

PubMed

Lepiniec, L; Devic, M; Roscoe, T J; Bouyer, D; Zhou, D-X; Boulard, C; Baud, S; Dubreucq, B

2018-05-24

The LAFL (i.e. LEC1, ABI3, FUS3, and LEC2) master transcriptional regulators interact to form different complexes that induce embryo development and maturation, and inhibit seed germination and vegetative growth in Arabidopsis. Orthologous genes involved in similar regulatory processes have been described in various angiosperms including important crop species. Consistent with a prominent role of the LAFL regulators in triggering and maintaining embryonic cell fate, their expression appears finely tuned in different tissues during seed development and tightly repressed in vegetative tissues by a surprisingly high number of genetic and epigenetic factors. Partial functional redundancies and intricate feedback regulations of the LAFL have hampered the elucidation of the underpinning molecular mechanisms. Nevertheless, genetic, genomic, cellular, molecular, and biochemical analyses implemented during the last years have greatly improved our knowledge of the LALF network. Here we summarize and discuss recent progress, together with current issues required to gain a comprehensive insight into the network, including the emerging function of LEC1 and possibly LEC2 as pioneer transcription factors.

UK: the current state of regulation of complementary and alternative medicine.

PubMed

Walker, L A; Budd, S

2002-03-01

There is no legislation that restricts the practice of CAM in the UK apart from the practice of chiropractic and osteopathy and limits on advertising the treatments of certain conditions such as cancer and tuberculosis. The UK government has increasingly recognised the need for comprehensive regulation of CAM, though it abandoned its original plan for a single overarching regulatory body. Initiatives to examine and hasten the process of regulation have included setting up a central, well-recognised charitable body to facilitate progress for individual professions, and an authoritative survey of the existing professional organisations. One pathway open to individual professions is statutory self-regulation, which requires a single governing body, a systematic corpus of knowledge, recognised training courses and demonstrated efficacy. The other pathway is voluntary self-regulation. Chiropractic and osteopathy have adopted statutory self-regulation, though this has proved expensive for individual members of these professions. A recent House of Lords report on CAM has recommended that the herbal medicine and acupuncture professions should also develop a system of statutory regulation. Other professions, such as aromatherapy, are in the process of establishing single professional bodies as a first step towards self-regulation. Among the issues that remain to be resolved is the relationship between the CAM professions and statutory registered practitioners who also practise CAM.

A new digital pulse power supply in heavy ion research facility in Lanzhou

NASA Astrophysics Data System (ADS)

Wang, Rongkun; Chen, Youxin; Huang, Yuzhen; Gao, Daqing; Zhou, Zhongzu; Yan, Huaihai; Zhao, Jiang; Shi, Chunfeng; Wu, Fengjun; Yan, Hongbin; Xia, Jiawen; Yuan, Youjin

2013-11-01

To meet the increasing requirements of the Heavy Ion Research Facility in Lanzhou-Cooler Storage Ring (HIRFL-CSR), a new digital pulse power supply, which employs multi-level converter, was designed. This power supply was applied with a multi H-bridge converters series-parallel connection topology. A new control model named digital power supply regulator system (DPSRS) was proposed, and a pulse power supply prototype based on DPSRS has been built and tested. The experimental results indicate that tracking error and ripple current meet the requirements of this design. The achievement of prototype provides a perfect model for HIRFL-CSR power supply system.

Revision of certification standards for aviation maintenance personnel

NASA Technical Reports Server (NTRS)

Vipond, Leslie K.

1992-01-01

Part 65, Subparts D and E, of the Federal Aviation Regulations (FAR) identify the certification requirements for aviation mechanics and aviation repairmen. The training, experience, privileges, ratings, recordkeeping, and currency requirements for aviation maintenance personnel are also addressed by those parts of the FAR. The recent emergence of the aging fleet problem and the introduction of new technologies, aircraft, engines, and aeronautical products has caused certain portions of these rules to become obsolete. Further, international political arrangements, such as bilateral airworthiness and maintenance agreements, International Civil Aviation Organization (ICAO) standards, certain international agreements for maintenance personnel training, and mechanic certificate reciprocity, have all impacted on the current regulatory policy.

Novel aspects of plasma control in ITER

DOE Office of Scientific and Technical Information (OSTI.GOV)

Humphreys, D.; Jackson, G.; Walker, M.

2015-02-15

ITER plasma control design solutions and performance requirements are strongly driven by its nuclear mission, aggressive commissioning constraints, and limited number of operational discharges. In addition, high plasma energy content, heat fluxes, neutron fluxes, and very long pulse operation place novel demands on control performance in many areas ranging from plasma boundary and divertor regulation to plasma kinetics and stability control. Both commissioning and experimental operations schedules provide limited time for tuning of control algorithms relative to operating devices. Although many aspects of the control solutions required by ITER have been well-demonstrated in present devices and even designed satisfactorily formore » ITER application, many elements unique to ITER including various crucial integration issues are presently under development. We describe selected novel aspects of plasma control in ITER, identifying unique parts of the control problem and highlighting some key areas of research remaining. Novel control areas described include control physics understanding (e.g., current profile regulation, tearing mode (TM) suppression), control mathematics (e.g., algorithmic and simulation approaches to high confidence robust performance), and integration solutions (e.g., methods for management of highly subscribed control resources). We identify unique aspects of the ITER TM suppression scheme, which will pulse gyrotrons to drive current within a magnetic island, and turn the drive off following suppression in order to minimize use of auxiliary power and maximize fusion gain. The potential role of active current profile control and approaches to design in ITER are discussed. Issues and approaches to fault handling algorithms are described, along with novel aspects of actuator sharing in ITER.« less

A review of nondestructive examination technology for polyethylene pipe in nuclear power plant

NASA Astrophysics Data System (ADS)

Zheng, Jinyang; Zhang, Yue; Hou, Dongsheng; Qin, Yinkang; Guo, Weican; Zhang, Chuck; Shi, Jianfeng

2018-05-01

Polyethylene (PE) pipe, particularly high-density polyethylene (HDPE) pipe, has been successfully utilized to transport cooling water for both non-safety- and safety-related applications in nuclear power plant (NPP). Though ASME Code Case N755, which is the first code case related to NPP HDPE pipe, requires a thorough nondestructive examination (NDE) of HDPE joints. However, no executable regulations presently exist because of the lack of a feasible NDE technique for HDPE pipe in NPP. This work presents a review of current developments in NDE technology for both HDPE pipe in NPP with a diameter of less than 400 mm and that of a larger size. For the former category, phased array ultrasonic technique is proven effective for inspecting typical defects in HDPE pipe, and is thus used in Chinese national standards GB/T 29460 and GB/T 29461. A defect-recognition technique is developed based on pattern recognition, and a safety assessment principle is summarized from the database of destructive testing. On the other hand, recent research and practical studies reveal that in current ultrasonic-inspection technology, the absence of effective ultrasonic inspection for large size was lack of consideration of the viscoelasticity effect of PE on acoustic wave propagation in current ultrasonic inspection technology. Furthermore, main technical problems were analyzed in the paper to achieve an effective ultrasonic test method in accordance to the safety and efficiency requirements of related regulations and standards. Finally, the development trend and challenges of NDE test technology for HDPE in NPP are discussed.

Novel aspects of plasma control in ITER

DOE PAGES

Humphreys, David; Ambrosino, G.; de Vries, Peter; ...

2015-02-12

ITER plasma control design solutions and performance requirements are strongly driven by its nuclear mission, aggressive commissioning constraints, and limited number of operational discharges. In addition, high plasma energy content, heat fluxes, neutron fluxes, and very long pulse operation place novel demands on control performance in many areas ranging from plasma boundary and divertor regulation to plasma kinetics and stability control. Both commissioning and experimental operations schedules provide limited time for tuning of control algorithms relative to operating devices. Although many aspects of the control solutions required by ITER have been well-demonstrated in present devices and even designed satisfactorily formore » ITER application, many elements unique to ITER including various crucial integration issues are presently under development. We describe selected novel aspects of plasma control in ITER, identifying unique parts of the control problem and highlighting some key areas of research remaining. Novel control areas described include control physics understanding (e.g. current profile regulation, tearing mode suppression (TM)), control mathematics (e.g. algorithmic and simulation approaches to high confidence robust performance), and integration solutions (e.g. methods for management of highly-subscribed control resources). We identify unique aspects of the ITER TM suppression scheme, which will pulse gyrotrons to drive current within a magnetic island, and turn the drive off following suppression in order to minimize use of auxiliary power and maximize fusion gain. The potential role of active current profile control and approaches to design in ITER are discussed. Finally, issues and approaches to fault handling algorithms are described, along with novel aspects of actuator sharing in ITER.« less

48 CFR 3406.501 - Requirement.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 48 Federal Acquisition Regulations System 7 2014-10-01 2014-10-01 false Requirement. 3406.501 Section 3406.501 Federal Acquisition Regulations System DEPARTMENT OF EDUCATION ACQUISITION REGULATION COMPETITION AND ACQUISITION PLANNING COMPETITION REQUIREMENTS Competition Advocates 3406.501 Requirement. The...

48 CFR 3406.501 - Requirement.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 48 Federal Acquisition Regulations System 7 2013-10-01 2012-10-01 true Requirement. 3406.501 Section 3406.501 Federal Acquisition Regulations System DEPARTMENT OF EDUCATION ACQUISITION REGULATION COMPETITION AND ACQUISITION PLANNING COMPETITION REQUIREMENTS Competition Advocates 3406.501 Requirement. The...

48 CFR 3406.501 - Requirement.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 48 Federal Acquisition Regulations System 7 2012-10-01 2012-10-01 false Requirement. 3406.501 Section 3406.501 Federal Acquisition Regulations System DEPARTMENT OF EDUCATION ACQUISITION REGULATION COMPETITION AND ACQUISITION PLANNING COMPETITION REQUIREMENTS Competition Advocates 3406.501 Requirement. The...

How clinical medical students perceive others to influence their self-regulated learning.

PubMed

Berkhout, Joris J; Helmich, Esther; Teunissen, Pim W; van der Vleuten, Cees P M; Jaarsma, A Debbie C

2017-03-01

Undergraduate medical students are prone to struggle with learning in clinical environments. One of the reasons may be that they are expected to self-regulate their learning, which often turns out to be difficult. Students' self-regulated learning is an interactive process between person and context, making a supportive context imperative. From a socio-cultural perspective, learning takes place in social practice, and therefore teachers and other hospital staff present are vital for students' self-regulated learning in a given context. Therefore, in this study we were interested in how others in a clinical environment influence clinical students' self-regulated learning. We conducted a qualitative study borrowing methods from grounded theory methodology, using semi-structured interviews facilitated by the visual Pictor technique. Fourteen medical students were purposively sampled based on age, gender, experience and current clerkship to ensure maximum variety in the data. The interviews were transcribed verbatim and were, together with the Pictor charts, analysed iteratively, using constant comparison and open, axial and interpretive coding. Others could influence students' self-regulated learning through role clarification, goal setting, learning opportunities, self-reflection and coping with emotions. We found large differences in students' self-regulated learning and their perceptions of the roles of peers, supervisors and other hospital staff. Novice students require others, mainly residents and peers, to actively help them to navigate and understand their new learning environment. Experienced students who feel settled in a clinical environment are less susceptible to the influence of others and are better able to use others to their advantage. Undergraduate medical students' self-regulated learning requires context-specific support. This is especially important for more novice students learning in a clinical environment. Their learning is influenced most heavily by peers and residents. Supporting novice students' self-regulated learning may be improved by better equipping residents and peers for this role. © 2016 The Authors. Medical Education Published by John Wiley & Sons Ltd and The Association for the Study of Medical Education.

Hippo pathway coactivators Yap and Taz are required to coordinate mammalian liver regeneration

PubMed Central

Lu, Li; Finegold, Milton J; Johnson, Randy L

2018-01-01

The mammalian liver has a remarkable capacity for repair following injury. Removal of up to two-third of liver mass results in a series of events that include extracellular matrix remodeling, coordinated hepatic cell cycle re-entry, restoration of liver mass and tissue remodeling to return the damaged liver to its normal state. Although there has been considerable advancement of our knowledge concerning the regenerative capacity of the mammalian liver, many outstanding questions remaining, such as: how does the regenerating liver stop proliferating when appropriate mass is restored and how do these mechanisms relate to normal regulation of organ size during development? Hippo pathway has been proposed to be central in mediating both events: organ size control during development and following regeneration. In this report, we examined the role of Yap and Taz, key components of the Hippo pathway in liver organ size regulation, both in the context of development and homeostasis. Our studies reveal that contrary to the current paradigms that Yap/Taz are not required for developmental regulation of liver size but are required for proper liver regeneration. In livers depleted of Yap and Taz, liver mass is elevated in neonates and adults. However, Yap/Taz-depleted livers exhibit profound defects in liver regeneration, including an inability to restore liver mass and to properly coordinate cell cycle entry. Taken together, our results highlight requirements for the Hippo pathway during liver regeneration and indicate that there are additional pathways that cooperate with Hippo signaling to control liver size during development and in the adult. PMID:29303509

Fatigue Risk Management: A Maritime Framework

PubMed Central

Grech, Michelle Rita

2016-01-01

It is evident that despite efforts directed at mitigating the risk of fatigue through the adoption of hours of work and rest regulations and development of codes and guidelines, fatigue still remains a concern in shipping. Lack of fatigue management has been identified as a contributory factor in a number of recent accidents. This is further substantiated through research reports with shortfalls highlighted in current fatigue management approaches. These approaches mainly focus on prescriptive hours of work and rest and include an individualistic approach to managing fatigue. The expectation is that seafarers are responsible to manage and tolerate fatigue as part of their working life at sea. This attitude is an accepted part of a seafarer’s role. Poor compliance is one manifest of this problem with shipboard demands making it hard for seafarers to follow hours of work and rest regulations, forcing them into this “poor compliance” trap. This makes current fatigue management approaches ineffective. This paper proposes a risk based approach and way forward for the implementation of a fatigue risk management framework for shipping, aiming to support the hours of work and rest requirements. This forms part of the work currently underway to review and update the International Maritime Organization, Guidelines on Fatigue. PMID:26840326

Informed consent in human subject research: a comparison of current international and Nigerian guidelines.

PubMed

Fadare, Joseph O; Porteri, Corinna

2010-03-01

Informed consent is a basic requirement for the conduct of ethical research involving human subjects. Currently, the Helsinki Declaration of the World Medical Association and the International Ethical Guidelines for Biomedical Research of the Council for International Organizations of Medical Sciences (CIOMS) are widely accepted as international codes regulating human subject research and the informed consent sections of these documents are quite important. Debates on the applicability of these guidelines in different socio-cultural settings are ongoing and many workers have advocated the need for national or regional guidelines. Nigeria, a developing country, has recently adopted its national guideline regulating human subject research: the National Health Research Ethics Committee (NHREC) code. A content analysis of the three guidelines was done to see if the Nigerian guidelines confer any additional protection for research subjects. The concept of a Community Advisory Committee in the Nigerian guideline is a novel one that emphasizes research as a community burden and should promote a form of "research friendship" to foster the welfare of research participants. There is also the need for a regular update of the NHREC code so as to address some issues that were not considered in its current version.

Fatigue Risk Management: A Maritime Framework.

PubMed

Grech, Michelle Rita

2016-01-29

It is evident that despite efforts directed at mitigating the risk of fatigue through the adoption of hours of work and rest regulations and development of codes and guidelines, fatigue still remains a concern in shipping. Lack of fatigue management has been identified as a contributory factor in a number of recent accidents. This is further substantiated through research reports with shortfalls highlighted in current fatigue management approaches. These approaches mainly focus on prescriptive hours of work and rest and include an individualistic approach to managing fatigue. The expectation is that seafarers are responsible to manage and tolerate fatigue as part of their working life at sea. This attitude is an accepted part of a seafarer's role. Poor compliance is one manifest of this problem with shipboard demands making it hard for seafarers to follow hours of work and rest regulations, forcing them into this "poor compliance" trap. This makes current fatigue management approaches ineffective. This paper proposes a risk based approach and way forward for the implementation of a fatigue risk management framework for shipping, aiming to support the hours of work and rest requirements. This forms part of the work currently underway to review and update the International Maritime Organization, Guidelines on Fatigue.

Supporting the Use of Unmanned Aircraft Systems(UAS) for Global Science Observations in Civil and Segregated Airspace

NASA Technical Reports Server (NTRS)

Mulac, B. L.; Reider. K/

2010-01-01

Unmanned Aircraft Systems (UAS) are growing more popular within the earth science community as a way to augment measurements currently made with manned aircraft. UAS arc uniquely suited for applications that require long dwell times and/or in locations that are generally too dangerous for manned aircraft. Environmental monitoring in areas like the Arctic or obtaining data within a hurricane are just a couple of examples of many applications to which UAS are ideally suited. However, UAS are not without their challenges. Most unmanned aircraft are unable to meet current airspace regulations that are in place for manned aircraft, and specific airspace standards and regulations for unmanned aircraft do not exist. As a result, gaining access to civil airspace for flights is very difficult around the world. Under Term of Reference 48 within the ISPRS Commission 1, WGI/I: Standardization of Aircraft Interfaces, efforts have been made to understand and quantify the current state of UAS airspace access on a global scale. The results of these efforts will be presented along with examples of successful science missions that have been conducted internationally during the past year.

Measurement of attitudes toward commercial development of geothermal energy in Federal Region IX. Final report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1981-06-01

A survey was conducted of ten target study groups and subgroups for Klamath Falls, Oregon, and Susanville, California: local government, current and potential industry at the site, relocators to the site, current and potential financial community, regulators, and current and potential promoters and developers. The results of benchmark attitudinal measurement is presented separately for each target group. A literature review was conducted and Macro-environmental attitudes of a sample of local government and industry personnel at the sites were assessed. An assessment of capabilities was made which involved two measurements. The first was a measurement of a sample of promoters, developers,more » and industrial service companies active at the site to determine infrastructure capabilities required by industry for geothermal plants. The second measurement involved analyzing a sample of industry management in the area and defining their requirements for plant retrofit and expansion. Finally, the processes used by the study group to analyze information to reach commitment and regulatory decisions that significantly impact on geothermal energy projects at the site were identified and defined.« less

Algorithm of dynamic regulation of a system of duct, for a high accuracy climatic system

NASA Astrophysics Data System (ADS)

Arbatskiy, A. A.; Afonina, G. N.; Glazov, V. S.

2017-11-01

Currently, major part of climatic system, are stationary in projected mode only. At the same time, many modern industrial sites, require constant or periodical changes in technological process. That is 80% of the time, the industrial site is not require ventilation system in projected mode and high precision of climatic parameters must maintain. While that not constantly is in use for climatic systems, which use in parallel for different rooms, we will be have a problem for balance of duct system. For this problem, was created the algorithm for quantity regulation, with minimal changes. Dynamic duct system: Developed of parallel control system of air balance, with high precision of climatic parameters. The Algorithm provide a permanent pressure in main duct, in different a flow of air. Therefore, the ending devises air flow have only one parameter for regulation - flaps open area. Precision of regulation increase and the climatic system provide high precision for temperature and humidity (0,5C for temperature, 5% for relative humidity). Result: The research has been made in CFD-system - PHOENICS. Results for velocity of air in duct, for pressure of air in duct for different operation mode, has been obtained. Equation for air valves positions, with different parameters for climate in room’s, has been obtained. Energy saving potential for dynamic duct system, for different types of a rooms, has been calculated.

Methods, systems and apparatus for synchronous current regulation of a five-phase machine

DOEpatents

Gallegos-Lopez, Gabriel; Perisic, Milun

2012-10-09

Methods, systems and apparatus are provided for controlling operation of and regulating current provided to a five-phase machine when one or more phases has experienced a fault or has failed. In one implementation, the disclosed embodiments can be used to synchronously regulate current in a vector controlled motor drive system that includes a five-phase AC machine, a five-phase inverter module coupled to the five-phase AC machine, and a synchronous current regulator.

Micropropagation of African violet (Saintpaulia ionantha Wendl.).

PubMed

Shukla, Mukund; Sullivan, J Alan; Jain, Shri Mohan; Murch, Susan J; Saxena, Praveen K

2013-01-01

Micropropagation is an important tool for rapid multiplication and the creation of genetic variability in African violets (Saintpaulia ionantha Wendl.). Successful in vitro propagation depends on the specific requirements and precise manipulation of various factors such as the type of explants used, physiological state of the mother plant, plant growth regulators in the culture medium, and growth conditions. Development of cost-effective protocols with a high rate of multiplication is a crucial requirement for commercial application of micropropagation. The current chapter describes an optimized protocol for micropropagation of African violets using leaf explants obtained from in vitro grown plants. In this process, plant regeneration occurs via both somatic embryogenesis and shoot organogenesis simultaneously in the explants induced with the growth regulator thidiazuron (TDZ; N-phenyl-N'-1,2,3-thidiazol-5-ylurea). The protocol is simple, rapid, and efficient for large-scale propagation of African violet and the dual routes of regeneration allow for multiple applications of the technology from simple clonal propagation to induction or selection of variants to the production of synthetic seeds.

Regulation of Clinical Trials with Advanced Therapy Medicinal Products in Germany.

PubMed

Renner, Matthias; Anliker, Brigitte; Sanzenbacher, Ralf; Schuele, Silke

2015-01-01

In the European Union, clinical trials for Advanced Therapy Medicinal Products are regulated at the national level, in contrast to the situation for a Marketing Authorisation Application, in which a centralised procedure is foreseen for these medicinal products. Although based on a common understanding regarding the regulatory requirement to be fulfilled before conduct of a clinical trial with an Advanced Therapy Investigational Medicinal Product, the procedures and partly the scientific requirements for approval of a clinical trial application differ between the European Union Member States. This chapter will thus give an overview about the path to be followed for a clinical trial application and the subsequent approval process for an Advanced Therapy Investigational Medicinal Product in Germany and will describe the role of the stakeholders that are involved. In addition, important aspects of manufacturing, quality control and non-clinical testing of Advanced Therapy Medicinal Products in the clinical development phase are discussed. Finally, current and future approaches for harmonisation of clinical trial authorisation between European Union Member States are summarised.

A Comprehensive Review of Spirit Drink Safety Standards and Regulations from an International Perspective.

PubMed

Pang, Xiao-Na; Li, Zhao-Jie; Chen, Jing-Yu; Gao, Li-Juan; Han, Bei-Zhong

2017-03-01

Standards and regulations related to spirit drinks have been established by different countries and international organizations to ensure the safety and quality of spirits. Here, we introduce the principles of food safety and quality standards for alcoholic beverages and then compare the key indicators used in the distinct standards of the Codex Alimentarius Commission, the European Union, the People's Republic of China, the United States, Canada, and Australia. We also discuss in detail the "maximum level" of the following main contaminants of spirit drinks: methanol, higher alcohols, ethyl carbamate, hydrocyanic acid, heavy metals, mycotoxins, phthalates, and aldehydes. Furthermore, the control measures used for potential hazards are introduced. Harmonization of the current requirements based on comprehensive scope analysis and the risk assessment approach will enhance both the trade and quality of distilled spirits. This review article provides valuable information that will enable producers, traders, governments, and researchers to increase their knowledge of spirit drink safety requirements, control measures, and research trends.

Transcriptome and proteome analysis of Salmonella enterica serovar Typhimurium systemic infection of wild type and immune-deficient mice

PubMed Central

Oshota, Olusegun; Fookes, Maria; Schreiber, Fernanda; Chaudhuri, Roy R.; Yu, Lu; Clare, Simon; Choudhary, Jyoti; Thomson, Nicholas R.; Lio, Pietro

2017-01-01

Salmonella enterica are a threat to public health. Current vaccines are not fully effective. The ability to grow in infected tissues within phagocytes is required for S. enterica virulence in systemic disease. As the infection progresses the bacteria are exposed to a complex host immune response. Consequently, in order to continue growing in the tissues, S. enterica requires the coordinated regulation of fitness genes. Bacterial gene regulation has so far been investigated largely using exposure to artificial environmental conditions or to in vitro cultured cells, and little information is available on how S. enterica adapts in vivo to sustain cell division and survival. We have studied the transcriptome, proteome and metabolic flux of Salmonella, and the transcriptome of the host during infection of wild type C57BL/6 and immune-deficient gp91-/-phox mice. Our analyses advance the understanding of how S. enterica and the host behaves during infection to a more sophisticated level than has previously been reported. PMID:28796780

Drosophila Perlecan Regulates Intestinal Stem Cell Activity via Cell-Matrix Attachment

PubMed Central

You, Jia; Zhang, Yan; Li, Zhouhua; Lou, Zhefeng; Jin, Longjin; Lin, Xinhua

2014-01-01

Summary Stem cells require specialized local microenvironments, termed niches, for normal retention, proliferation, and multipotency. Niches are composed of cells together with their associated extracellular matrix (ECM). Currently, the roles of ECM in regulating niche functions are poorly understood. Here, we demonstrate that Perlecan (Pcan), a highly conserved ECM component, controls intestinal stem cell (ISC) activities and ISC-ECM attachment in Drosophila adult posterior midgut. Loss of Pcan from ISCs, but not other surrounding cells, causes ISCs to detach from underlying ECM, lose their identity, and fail to proliferate. These defects are not a result of a loss of epidermal growth factor receptor (EGFR) or Janus kinase/signal transducer and activator of transcription (JAK/STAT) signaling activity but partially depend on integrin signaling activity. We propose that Pcan secreted by ISCs confers niche properties to the adjacent ECM that is required for ISC maintenance of stem cell identity, activity, and anchorage to the niche. PMID:24936464

Regulation of solid waste management at Brazilian ports: analysis and proposals for Brazil in light of the European experience.

PubMed

Jaccoud, Cristiane; Magrini, Alessandra

2014-02-15

With a coastline of 8500 km, Brazil has 34 public ports and various private terminals, which together in 2012 handled 809 million tonnes of goods. The solid wastes produced (from port activities, ships and cargoes) pose a highly relevant problem, both due to the quantity and diversity, requiring a complex and integrated set of practices resulting from legal requirements and proactive initiatives. The main Brazilian law on solid waste management is recent (Law 12,305/2010) and the specific rules on solid waste in ports are badly in need of revision to meet the challenges caused by expansion of the sector and to harmonize them with the best global practices. This paper analyzes the current legal/regulatory framework for solid waste management at Brazilian ports and compares this structure with the practice in Europe. At the end, we suggest initiatives to improve the regulation of solid wastes at Brazilian ports. Copyright © 2014 Elsevier Ltd. All rights reserved.