49 CFR 543.6 - Petition: Specific content requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 6 2010-10-01 2010-10-01 false Petition: Specific content requirements. 543.6...; (4) The reasons for the petitioner's belief that the antitheft device will be effective in reducing... petitioner and form a basis for that belief; (5) The reasons for the petitioner's belief that the agency...

49 CFR 543.6 - Petition: Specific content requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 6 2014-10-01 2014-10-01 false Petition: Specific content requirements. 543.6...; (4) The reasons for the petitioner's belief that the antitheft device will be effective in reducing... petitioner and form a basis for that belief; (5) The reasons for the petitioner's belief that the agency...

49 CFR 543.6 - Petition: Specific content requirements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 6 2011-10-01 2011-10-01 false Petition: Specific content requirements. 543.6...; (4) The reasons for the petitioner's belief that the antitheft device will be effective in reducing... petitioner and form a basis for that belief; (5) The reasons for the petitioner's belief that the agency...

49 CFR 543.6 - Petition: Specific content requirements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 6 2012-10-01 2012-10-01 false Petition: Specific content requirements. 543.6...; (4) The reasons for the petitioner's belief that the antitheft device will be effective in reducing... petitioner and form a basis for that belief; (5) The reasons for the petitioner's belief that the agency...

49 CFR 543.6 - Petition: Specific content requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 6 2013-10-01 2013-10-01 false Petition: Specific content requirements. 543.6...; (4) The reasons for the petitioner's belief that the antitheft device will be effective in reducing... petitioner and form a basis for that belief; (5) The reasons for the petitioner's belief that the agency...

Under Lock and Key: Preventing Campus Theft of Electronic Equipment.

ERIC Educational Resources Information Center

Harrison, J. Phil

1996-01-01

A discussion of computer theft prevention on college campuses looks at a variety of elements in electronic equipment security, including the extent of the problem, physical antitheft products, computerized access, control of key access, alarm systems, competent security personnel, lighting, use of layers of protection, and increasing…

78 FR 53498 - Petition for Exemption From the Vehicle Theft Prevention Standard; Fuji Heavy Industries U.S.A...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-29

... identity, design, and location of the components of the antitheft device for the Subaru [confidential.... Additionally, FUSA stated that because the immobilization features are designed and constructed within the... provided a comparative table showing how its device is similar to other manufacturers' devices that have...

Local positioning with sensor-enabled passive multistandard RFID transponders

NASA Astrophysics Data System (ADS)

Heidrich, J.; Brenk, D.; Essel, J.; Schwarzer, S.; Herschmann, R.; Geck, B.; Fischer, G.; Weigel, R.

2010-11-01

RFID is used today in many fields of every day life like access control, anti-theft protection or logistics. Within this article a short overview of the basic RFID principles and the EPC protocol flow is given at first. Afterwards new design approaches for RFID systems within the scope of the research project RFID-S are presented.

78 FR 50489 - Petition for Exemption From the Vehicle Theft Prevention Standard; Volkswagen Group of America, Inc.

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-19

...) petition for exemption of the Audi confidential vehicle line in accordance with 49 CFR part 543, Exemption... 2015 Audi vehicle line. The petition requested an exemption from parts- marking requirement pursuant to... the components of the antitheft device for its Audi vehicle line. Volkswagen will install its...

49 CFR Appendix A-I to Part 541 - Lines With Antitheft Devices Which Are Exempted From the Parts-Marking Requirements of This...

Code of Federal Regulations, 2010 CFR

2010-10-01

... Tribeca. Outback. Suzuki XL-7. Toyota Camry.1 Lexus ES. Lexus GS. Lexus LS. Lexus SC. Volkswagen Audi 5000S. Audi A3. Audi A4. Audi Allroad. Audi A6. Audi Q5. New Beetle. Golf/Rabbit/GTI/R32. Jetta. Passat...

75 FR 31837 - Petition for Exemption From the Vehicle Theft Prevention Standard; Mercedes-Benz

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-04

... agency comparing its proposed device to antitheft devices already installed in the Aston Martin Vantage... effective in contributing to a 63.5% reduction in the theft rate for the Aston Martin Vantage Line... Martin Vantage vehicle line and 0.6784 for the MY 2007. MBUSA also referenced theft data published by the...

78 FR 21189 - Petition for Exemption From the Vehicle Theft Prevention Standard; BMW of North America, LLC

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-09

... must be recognized by the EWS/CAS control unit in order for the vehicle to start. The transponder... in the mechanical keys make the locks almost impossible to pick and the keys impossible to duplicate... description of the antitheft device is necessary in order to notify law enforcement agencies of new vehicle...

System Control Applications of Low-Power Radio Frequency Devices

NASA Astrophysics Data System (ADS)

van Rensburg, Roger

2017-09-01

This paper conceptualizes a low-power wireless sensor network design for application employment to reduce theft of portable computer devices used in educational institutions today. The aim of this study is to design and develop a reliable and robust wireless network that can eradicate accessibility of a device’s human interface. An embedded system supplied by an energy harvesting source, installed on the portable computer device, may represent one of multiple slave nodes which request regular updates from a standalone master station. A portable computer device which is operated in an undesignated area or in a field perimeter where master to slave communication is restricted, indicating a possible theft scenario, will initiate a shutdown of its operating system and render the device unusable. Consequently, an algorithm in the device firmware may ensure the necessary steps are executed to track the device, irrespective whether the device is enabled. Design outcomes thus far indicate that a wireless network using low-power embedded hardware, is feasible for anti-theft applications. By incorporating one of the latest Bluetooth low-energy, ANT+, ZigBee or Thread wireless technologies, an anti-theft system may be implemented that has the potential to reduce major portable computer device theft in institutions of digitized learning.

Anti-theft device staining on banknotes detected by mass spectrometry imaging.

PubMed

Correa, Deleon Nascimento; Zacca, Jorge Jardim; Rocha, Werickson Fortunato de Carvalho; Borges, Rodrigo; de Souza, Wanderley; Augusti, Rodinei; Eberlin, Marcos Nogueira; Vendramini, Pedro Henrique

2016-03-01

We describe the identification and limits of detection of ink staining by mass spectrometry imaging (MSI), as used in anti-theft devices (ATDs). Such ink staining is applied to banknotes during automated teller machine (ATM) explosions. Desorption electrospray ionization (DESI) coupled with high-resolution and high-accuracy orbitrap mass spectrometry (MS) and a moving stage device were applied to obtain 2D molecular images of the major dyes used for staining, that is, 1-methylaminoanthraquinone (MAAQ), rhodamine B (RB) and rhodamine 6G (R6G). MAAQ could not be detected because of its inefficient desorption by DESI from the banknote cellulose surface. By contrast, ATD staining on banknotes is perceptible by the human naked eye only at concentrations higher than 0.2 μg cm(-2), whereas both RB and R6G at concentrations 200 times lower (as low as 0.001 μg cm(-2)) could be easily detected and imaged by DESI-MSI, with selective and specific identification of each analyte and their spatial distribution on samples from suspects. This technique is non-destructive, and no sample preparation is required, which ensures sample preservation for further forensic investigations. Copyright © 2016. Published by Elsevier Ireland Ltd.

49 CFR Appendix A-I to Part 541 - Lines With Antitheft Devices Which Are Exempted From the Parts-Marking Requirements of This...

Code of Federal Regulations, 2013 CFR

2013-10-01

.... X3. X5. Z4. 1 Car Line. 3 Car Line. 4 Car Line.1 5 Car Line. 6 Car Line. 7 Car Line. CHRYSLER 300C... Malibu. Chevrolet Sonic. GMC Terrain. Pontiac G6. Saturn Aura. HONDA Acura TL. Civic.1 HYUNDAI Azera... MY 2013. Manufacturer Subject lines 3. 5. 6. CX-5. CX-7. CX-9. MX-5 Miata. Tribute. MERCEDES-BENZ...

49 CFR Appendix A-I to Part 541 - Lines With Antitheft Devices Which Are Exempted From the Parts-Marking Requirements of This...

Code of Federal Regulations, 2014 CFR

2014-10-01

.... X3. X4.1 X5. Z4. 1 Car Line. 3 Car Line. 4 Car Line. 5 Car Line. 6 Car Line. 7 Car Line. CHRYSLER....1 Civic. Acura TL. HYUNDAI Azera. Genesis. Equus (originally codenamed VI). JAGUAR F-Type. XJ. XK... Quattroporte. MAZDA 2. 3. 5. 6. CX-5. CX-7. CX-9. MX-5 Miata. Tribute. MERCEDES-BENZ smart USA fortwo. SL-Line...

75 FR 6253 - Petition for Exemption From the Federal Motor Vehicle Theft Prevention Standard; Hyundia-Kia...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-08

...This document grants in full the Hyundai-Kia Motors Corporation (HATCI) petition for exemption of the Hyundai VI vehicle line in accordance with 49 CFR part 543, Exemption from Vehicle Theft Prevention Standard. This petition is granted because the agency has determined that the antitheft device to be placed on the line as standard equipment is likely to be as effective in reducing and deterring motor vehicle theft as compliance with the parts-marking requirements of 49 CFR part 541, Federal Motor Vehicle Theft Prevention Standard.

Interference between active implanted medical devices and electromagnetic field emitting devices is rare but real: results of an incidence study in a population of physicians in France.

PubMed

Hours, Martine; Khati, Inès; Hamelin, Joel

2014-03-01

Assessing the behavior of active implanted medical devices (AIMDs) in response to electromagnetic field (EMF) transmitters is a current issue of great importance. Given the numerous telecommunication systems and our lack of knowledge as to the impact of electromagnetic effects, this study investigated the reality of possible AIMD disturbance by EMFs by interviewing health professionals. A self-administered postal questionnaire was sent to almost 5,000 physicians in five specialties: cardiology; endocrinology; ears, nose, and throat; urology; and neurology. It collected data on the existence and annual number of incidents observed and the conditions under which they occurred, the EMF sources involved, and the means of managing the malfunctions. A total of 1,188 physicians agreed to participate. Sixteen percent of participants reported cases of implant failure, three-quarters of whom, mainly in cardiology, reported rates of at least one incident per year-amounting to more than 100 incidents per year in all. Severity appeared to be moderate (discomfort or transient symptoms), but frequently required resetting or, more rarely, replacing the device. Some serious incidents were, however, reported. The sources implicated were basically of two types: electronic security systems (antitheft and airport gates) and medical electromagnetic radiation devices. These incidents were poorly reported within the public health system, preventing follow-up and effective performance of alert and surveillance functions. Although minor, the risk of interference between EMF sources and AIMDs is real and calls for vigilance. It particularly concerns antitheft and airport security gates, though other sources may also cause incidents. ©2013, The Authors. Journal compilation ©2013 Wiley Periodicals, Inc.

75 FR 34946 - Federal Motor Vehicle Theft Prevention Standard; Final Listing of 2011 Light Duty Truck Lines...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-21

...This final rule announces NHTSA's determination that there are no new model year (MY) 2011 light duty truck lines subject to the parts-marking requirements of the Federal motor vehicle theft prevention standard because they have been determined by the agency to be high-theft or because they have a majority of interchangeable parts with those of a passenger motor vehicle line. This final rule also identifies those vehicle lines that have been granted an exemption from the parts-marking requirements because the vehicles are equipped with antitheft devices determined to meet certain statutory criteria.

76 FR 20251 - Federal Motor Vehicle Theft Prevention Standard; Final Listing of 2012 Light Duty Truck Lines...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-12

...This final rule announces NHTSA's determination that there are no new model year (MY) 2012 light duty truck lines subject to the parts-marking requirements of the Federal motor vehicle theft prevention standard because they have been determined by the agency to be high-theft or because they have a majority of interchangeable parts with those of a passenger motor vehicle line. This final rule also identifies those vehicle lines that have been granted an exemption from the parts-marking requirements because the vehicles are equipped with antitheft devices determined to meet certain statutory criteria.

78 FR 44030 - Federal Motor Vehicle Theft Prevention Standard; Final Listing of 2014 Light Duty Truck Lines...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-23

...This final rule announces NHTSA's determination that there are no new model year (MY) 2014 light duty truck lines subject to the parts-marking requirements of the Federal motor vehicle theft prevention standard because they have been determined by the agency to be high-theft or because they have a majority of interchangeable parts with those of a passenger motor vehicle line. This final rule also identifies those vehicle lines that have been granted an exemption from the parts-marking requirements because the vehicles are equipped with antitheft devices determined to meet certain statutory criteria.

78 FR 65030 - Agency Requests for Renewal of a Previously Approved Information Collection(s): Approval of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-30

... Previously Approved Information Collection(s): Approval of Underwriters of Marine Hull Insurance AGENCY...: Approval of Underwriters of Marine Hull Insurance. Form Numbers: None. Type of Review: Renewal of an... approval of marine hull underwriters to insure Maritime Administration program vessels. Foreign and...

49 CFR 236.1031 - Previously approved PTC systems.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 4 2010-10-01 2010-10-01 false Previously approved PTC systems. 236.1031 Section 236.1031 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD....1005 and 236.1007 and otherwise conform to this subpart. (d) Previous approval or recognition of a...

21 CFR 314.160 - Approval of an application or abbreviated application for which approval was previously refused...

Code of Federal Regulations, 2010 CFR

2010-04-01

... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... of an applicant, FDA may, on the basis of new data, approve an application or abbreviated application which it had previously refused, suspended, or withdrawn approval. FDA will publish a notice in the...

21 CFR 314.160 - Approval of an application or abbreviated application for which approval was previously refused...

Code of Federal Regulations, 2012 CFR

2012-04-01

... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... of an applicant, FDA may, on the basis of new data, approve an application or abbreviated application which it had previously refused, suspended, or withdrawn approval. FDA will publish a notice in the...

21 CFR 314.160 - Approval of an application or abbreviated application for which approval was previously refused...

Code of Federal Regulations, 2011 CFR

2011-04-01

... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... of an applicant, FDA may, on the basis of new data, approve an application or abbreviated application which it had previously refused, suspended, or withdrawn approval. FDA will publish a notice in the...

21 CFR 314.160 - Approval of an application or abbreviated application for which approval was previously refused...

Code of Federal Regulations, 2014 CFR

2014-04-01

... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... of an applicant, FDA may, on the basis of new data, approve an application or abbreviated application which it had previously refused, suspended, or withdrawn approval. FDA will publish a notice in the...

21 CFR 314.160 - Approval of an application or abbreviated application for which approval was previously refused...

Code of Federal Regulations, 2013 CFR

2013-04-01

... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... of an applicant, FDA may, on the basis of new data, approve an application or abbreviated application which it had previously refused, suspended, or withdrawn approval. FDA will publish a notice in the...

75 FR 54215 - Agency Request for Approval of a Previously Approved Information Collection(s): Uniform...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-03

... Previously Approved Information Collection(s): Uniform Administrative Requirements for Grants and Cooperative... Higher Education, Hospitals, and Other Nonprofit Organizations AGENCY: Office of the Secretary. ACTION... approved information collection. This information collection involves the use of various forms necessary...

27 CFR 26.55 - Previously approved formulas.

Code of Federal Regulations, 2014 CFR

2014-04-01

... BUREAU, DEPARTMENT OF THE TREASURY ALCOHOL LIQUORS AND ARTICLES FROM PUERTO RICO AND THE VIRGIN ISLANDS Formulas for Products From Puerto Rico § 26.55 Previously approved formulas. Any formula approved on Form...

27 CFR 26.55 - Previously approved formulas.

Code of Federal Regulations, 2010 CFR

2010-04-01

... BUREAU, DEPARTMENT OF THE TREASURY LIQUORS LIQUORS AND ARTICLES FROM PUERTO RICO AND THE VIRGIN ISLANDS Formulas for Products From Puerto Rico § 26.55 Previously approved formulas. Any formula approved on Form...

27 CFR 26.55 - Previously approved formulas.

Code of Federal Regulations, 2013 CFR

2013-04-01

... BUREAU, DEPARTMENT OF THE TREASURY ALCOHOL LIQUORS AND ARTICLES FROM PUERTO RICO AND THE VIRGIN ISLANDS Formulas for Products From Puerto Rico § 26.55 Previously approved formulas. Any formula approved on Form...

27 CFR 26.55 - Previously approved formulas.

Code of Federal Regulations, 2012 CFR

2012-04-01

... BUREAU, DEPARTMENT OF THE TREASURY LIQUORS LIQUORS AND ARTICLES FROM PUERTO RICO AND THE VIRGIN ISLANDS Formulas for Products From Puerto Rico § 26.55 Previously approved formulas. Any formula approved on Form...

27 CFR 26.55 - Previously approved formulas.

Code of Federal Regulations, 2011 CFR

2011-04-01

... BUREAU, DEPARTMENT OF THE TREASURY LIQUORS LIQUORS AND ARTICLES FROM PUERTO RICO AND THE VIRGIN ISLANDS Formulas for Products From Puerto Rico § 26.55 Previously approved formulas. Any formula approved on Form...

The design of infrared information collection circuit based on embedded technology

NASA Astrophysics Data System (ADS)

Liu, Haoting; Zhang, Yicong

2013-07-01

S3C2410 processor is a 16/32 bit RISC embedded processor which based on ARM920T core and AMNA bus, and mainly for handheld devices, and high cost, low-power applications. This design introduces a design plan of the PIR sensor system, circuit and its assembling, debugging. The Application Circuit of the passive PIR alarm uses the invisibility of the infrared radiation well into the alarm system, and in order to achieve the anti-theft alarm and security purposes. When the body goes into the range of PIR sensor detection, sensors will detect heat sources and then the sensor will output a weak signal. The Signal should be amplified, compared and delayed; finally light emitting diodes emit light, playing the role of a police alarm.

Quantitative Accelerated Life Testing of MEMS Accelerometers.

PubMed

Bâzu, Marius; Gălăţeanu, Lucian; Ilian, Virgil Emil; Loicq, Jerome; Habraken, Serge; Collette, Jean-Paul

2007-11-20

Quantitative Accelerated Life Testing (QALT) is a solution for assessing thereliability of Micro Electro Mechanical Systems (MEMS). A procedure for QALT is shownin this paper and an attempt to assess the reliability level for a batch of MEMSaccelerometers is reported. The testing plan is application-driven and contains combinedtests: thermal (high temperature) and mechanical stress. Two variants of mechanical stressare used: vibration (at a fixed frequency) and tilting. Original equipment for testing at tiltingand high temperature is used. Tilting is appropriate as application-driven stress, because thetilt movement is a natural environment for devices used for automotive and aerospaceapplications. Also, tilting is used by MEMS accelerometers for anti-theft systems. The testresults demonstrated the excellent reliability of the studied devices, the failure rate in the"worst case" being smaller than 10 -7 h -1 .

77 FR 69504 - Agency Information Collection Activities; Emergency Reinstatement of Previously Approved Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-19

... MERIT SYSTEMS PROTECTION BOARD Agency Information Collection Activities; Emergency Reinstatement of Previously Approved Collection AGENCY: Merit Systems Protection Board. ACTION: Notice of emergency reinstatement. SUMMARY: The Merit Systems Protection Board (MSPB) is requesting approval from the Office of...

33 CFR 149.421 - What is the requirement for a previously approved fire detection and alarm system on a deepwater...

Code of Federal Regulations, 2010 CFR

2010-07-01

... previously approved fire detection and alarm system on a deepwater port? 149.421 Section 149.421 Navigation... Requirements § 149.421 What is the requirement for a previously approved fire detection and alarm system on a deepwater port? An existing fire detection and alarm system on a deepwater port need not meet the...

33 CFR 149.421 - What is the requirement for a previously approved fire detection and alarm system on a deepwater...

Code of Federal Regulations, 2011 CFR

2011-07-01

... previously approved fire detection and alarm system on a deepwater port? 149.421 Section 149.421 Navigation... Requirements § 149.421 What is the requirement for a previously approved fire detection and alarm system on a deepwater port? An existing fire detection and alarm system on a deepwater port need not meet the...

33 CFR 149.421 - What is the requirement for a previously approved fire detection and alarm system on a deepwater...

Code of Federal Regulations, 2014 CFR

2014-07-01

... previously approved fire detection and alarm system on a deepwater port? 149.421 Section 149.421 Navigation... Requirements § 149.421 What is the requirement for a previously approved fire detection and alarm system on a deepwater port? An existing fire detection and alarm system on a deepwater port need not meet the...

33 CFR 149.421 - What is the requirement for a previously approved fire detection and alarm system on a deepwater...

Code of Federal Regulations, 2012 CFR

2012-07-01

... previously approved fire detection and alarm system on a deepwater port? 149.421 Section 149.421 Navigation... Requirements § 149.421 What is the requirement for a previously approved fire detection and alarm system on a deepwater port? An existing fire detection and alarm system on a deepwater port need not meet the...

33 CFR 149.421 - What is the requirement for a previously approved fire detection and alarm system on a deepwater...

Code of Federal Regulations, 2013 CFR

2013-07-01

... previously approved fire detection and alarm system on a deepwater port? 149.421 Section 149.421 Navigation... Requirements § 149.421 What is the requirement for a previously approved fire detection and alarm system on a deepwater port? An existing fire detection and alarm system on a deepwater port need not meet the...

77 FR 55893 - Agency Requests for Renewal of a Previously Approved Information Collection: Exemptions for Air...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-11

... Previously Approved Information Collection: Exemptions for Air Taxi Operations AGENCY: Office of the... public comments about our intention to request the Office of Management and Budget (OMB)'s approval to..., (202) 366-9721, Office of Aviation Analysis, Office of the Secretary, U.S. Department of Transportation...

46 CFR 162.018-8 - Procedure for approval.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Center, for re-approval. (c) Pre-approval tests. (1) Prior to approval of safety relief valves by the...) Reports of conducted tests on designs of safety relief valves different from those previously approved... approval of a new design or type of safety relief valve shall submit in quadruplicate detail drawings...

46 CFR 162.018-8 - Procedure for approval.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Center, for re-approval. (c) Pre-approval tests. (1) Prior to approval of safety relief valves by the...) Reports of conducted tests on designs of safety relief valves different from those previously approved... approval of a new design or type of safety relief valve shall submit in quadruplicate detail drawings...

46 CFR 162.018-8 - Procedure for approval.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Center, for re-approval. (c) Pre-approval tests. (1) Prior to approval of safety relief valves by the...) Reports of conducted tests on designs of safety relief valves different from those previously approved... approval of a new design or type of safety relief valve shall submit in quadruplicate detail drawings...

46 CFR 162.018-8 - Procedure for approval.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Center, for re-approval. (c) Pre-approval tests. (1) Prior to approval of safety relief valves by the...) Reports of conducted tests on designs of safety relief valves different from those previously approved... approval of a new design or type of safety relief valve shall submit in quadruplicate detail drawings...

46 CFR 162.018-8 - Procedure for approval.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Center, for re-approval. (c) Pre-approval tests. (1) Prior to approval of safety relief valves by the...) Reports of conducted tests on designs of safety relief valves different from those previously approved... approval of a new design or type of safety relief valve shall submit in quadruplicate detail drawings...

Quantitative Accelerated Life Testing of MEMS Accelerometers

PubMed Central

Bâzu, Marius; Gălăţeanu, Lucian; Ilian, Virgil Emil; Loicq, Jerome; Habraken, Serge; Collette, Jean-Paul

2007-01-01

Quantitative Accelerated Life Testing (QALT) is a solution for assessing the reliability of Micro Electro Mechanical Systems (MEMS). A procedure for QALT is shown in this paper and an attempt to assess the reliability level for a batch of MEMS accelerometers is reported. The testing plan is application-driven and contains combined tests: thermal (high temperature) and mechanical stress. Two variants of mechanical stress are used: vibration (at a fixed frequency) and tilting. Original equipment for testing at tilting and high temperature is used. Tilting is appropriate as application-driven stress, because the tilt movement is a natural environment for devices used for automotive and aerospace applications. Also, tilting is used by MEMS accelerometers for anti-theft systems. The test results demonstrated the excellent reliability of the studied devices, the failure rate in the “worst case” being smaller than 10-7h-1. PMID:28903265

36 CFR 1225.24 - When can an agency apply previously approved schedules to electronic records?

Code of Federal Regulations, 2010 CFR

2010-07-01

... may apply a previously approved schedule for hard copy records to electronic versions of the permanent records when the electronic records system replaces a single series of hard copy permanent records or the... have been previously scheduled as permanent in hard copy form, including special media records as...

75 FR 1084 - Agency Information Collection Activities: Proposed Reinstatement With Change of a Previously...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-08

... DEPARTMENT OF JUSTICE Office of Justice Programs [OMB Number 1105-0071] Agency Information Collection Activities: Proposed Reinstatement With Change of a Previously Approved Collection; Comments Requested ACTION: 30[dash]Day notice of information collection under review: extension with change of a previously approved collection national drug...

40 CFR 52.2122 - Approval status.

Code of Federal Regulations, 2010 CFR

2010-07-01

... sources covered by CTGs issued by the previous January. (b) EPA disapproved South Carolina's generic...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) South Carolina § 52.2122 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves South Carolina's plans for...

40 CFR 52.1772 - Approval status.

Code of Federal Regulations, 2010 CFR

2010-07-01

...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) North Carolina § 52.1772 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves North Carolina's plans for... CTGs issued by the previous January. (b) New Source review permits issued pursuant to section 173 of...

EPA Approved Regulations in the Texas SIP

EPA Pesticide Factsheets

changed name to EPA Approved Regulations in the Texas SIP, Add links to:Texas Read Me; Texas SIP History;Current/Previous SIP-Approved Regulations; Delete regulations--now in /node/191099, removed tables

75 FR 69151 - Agency Request for Revision of Previously Approved Information Collections: Uniform...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-10

... Previously Approved Information Collections: Uniform Administrative Requirements for Grants and Cooperative... Higher Education, Hospitals, and Other Nonprofit Organizations AGENCY: Office of the Secretary. ACTION....C. 3501 et seq.), this notice announces that the Information Collection Request (ICR) abstracted...

77 FR 17405 - Notice of Intent To Revise a Previously Approved Information Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-26

... DEPARTMENT OF AGRICULTURE National Agricultural Statistics Service Notice of Intent To Revise a Previously Approved Information Collection AGENCY: National Agricultural Statistics Service, USDA. ACTION... notice announces the intent of the National Agricultural Statistics Service (NASS) to seek reinstatement...

77 FR 71830 - Agency Information Collection Activities: Extension of a Previously Approved Information...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-04

... DEPARTMENT OF JUSTICE [OMB Number 1103-0100] Agency Information Collection Activities: Extension of a Previously Approved Information Collection; Comments Requested Monitoring Information Collections ACTION: 30-Day Notice. The Department of Justice (DOJ) Office of Community Oriented Policing...

A Good Year: FDA Approved Nine New Cancer Drugs in 2014

Cancer.gov

In 2014, the Food and Drug Administration (FDA) approved 41 drugs that had not been approved previously for any indication, the most in nearly 20 years. Of these 41 novel drugs, 9 were approved for the treatment of cancer or cancer-related conditions.

Clone of EPA Approved Regulations in the Texas SIP

EPA Pesticide Factsheets

changed name to EPA Approved Regulations in the Texas SIP, Add links to:Texas Read Me; Texas SIP History;Current/Previous SIP-Approved Regulations; Delete regulations--now in /node/191099, removed tables

75 FR 70067 - Notice of Request for Reinstatement of Previously Approved Information Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-16

... address for which the public should request further information related to the relevant Information... Request for Reinstatement of Previously Approved Information Collection ACTION: Notice; Correction SUMMARY... INFORMATION CONTACT: Robert C. Ashby, Office of the Secretary, Office of Assistant General Counsel for...

40 CFR 52.220 - Identification of plan.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Pollution Control District. (i) Previously approved on September 22, 1972 and now deleted without... and other Legal Documents Pertinent to Air Pollution Control in California”) to chapter 7. (13) El Dorado County Air Pollution Control District. (i) Previously approved on May 31, 1972 in paragraph (b) of...

40 CFR 52.220 - Identification of plan.

Code of Federal Regulations, 2010 CFR

2010-07-01

..., 43, and 44. (5) Ventura County Air Pollution Control District. (i) Previously approved on September... (“State Statutes and other Legal Documents Pertinent to Air Pollution Control in California”) to chapter 7. (13) El Dorado County Air Pollution Control District. (i) Previously approved on May 31, 1972 in...

75 FR 4846 - Agency Information Collection Activities: Extension of a Previously Approved Collection; Comments...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-29

... DEPARTMENT OF JUSTICE Office of Community Oriented Policing Services [OMB Number 1103-0106] Agency Information Collection Activities: Extension of a Previously Approved Collection; Comments Requested ACTION: 30-Day Notice of Information Collection Under Review: COPS Hiring Recovery Program (CHRP) Progress...

76 FR 28458 - Agency Information Collection Activities: Extension of a Previously Approved Collection; Comments...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-17

... DEPARTMENT OF JUSTICE [OMB Number 1103-0094] Agency Information Collection Activities: Extension of a Previously Approved Collection; Comments Requested: Department Annual Progress Report ACTION: 30-Day Notice of Information Collection Under Review. The Department of Justice (DOJ) Office of Community...

78 FR 69129 - Agency Information Collection Activities; Revision of a Previously Approved Collection, With...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-18

... DEPARTMENT OF JUSTICE [OMB Number 1103-0098] Agency Information Collection Activities; Revision of a Previously Approved Collection, With Change; Comments Requested: COPS Application Package ACTION: 60-Day notice. The Department of Justice (DOJ) Office of Community Oriented Policing Services (COPS...

76 FR 61383 - Agency Information Collection Activities: Revision of a Previously Approved Collection, With...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-04

... DEPARTMENT OF JUSTICE [OMB Number 1103-0098] Agency Information Collection Activities: Revision of a Previously Approved Collection, With Change; Comments Requested; COPS Application Package ACTION: 60-Day notice of information collection under review. The Department of Justice (DOJ) Office of...

77 FR 71829 - Agency Information Collection Activities: Revision of a Previously Approved Collection, With...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-04

... DEPARTMENT OF JUSTICE [OMB Number 1103-0098] Agency Information Collection Activities: Revision of a Previously Approved Collection, With Change; Comments Requested COPS Application Package ACTION: 30-Day notice. The Department of Justice (DOJ) Office of Community Oriented Policing Services (COPS...

77 FR 59665 - Agency Information Collection Activities: Revision of a Previously Approved Collection, With...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-28

... DEPARTMENT OF JUSTICE [OMB Number 1103-0098] Agency Information Collection Activities: Revision of a Previously Approved Collection, With Change; Comments Requested COPS Application Package ACTION... public comment until November 27, 2012. This process is conducted in accordance with 5 CFR 1320.10. If...

77 FR 52059 - Agency Information Collection Activities; Revision of a Previously Approved Collection; Comments...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-28

... DEPARTMENT OF JUSTICE [OMB Number 1103-0102] Agency Information Collection Activities; Revision of a Previously Approved Collection; Comments Requested; COPS Progress Report ACTION: 30-Day Notice... 5 CFR 1320.10. If you have comments especially on the estimated public burden or associated response...

76 FR 76761 - Agency Information Collection Activities: Revision of a Previously Approved Collection, With...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-08

... DEPARTMENT OF JUSTICE [OMB Number 1103-0098] Agency Information Collection Activities: Revision of a Previously Approved Collection, With Change; Comments Requested COPS Application Package ACTION.... This process is conducted in accordance with 5 CFR 1320.10. If you have comments, especially on the...

76 FR 61114 - Agency Information Collection Activities: Revision of a Previously Approved Collection, With...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-03

... DEPARTMENT OF JUSTICE [OMB Number 1103-0098] Agency Information Collection Activities: Revision of a Previously Approved Collection, With Change; Comments Requested COPS Application Package ACTION... public comment until December 2, 2011. This process is conducted in accordance with 5 CFR 1320.10. If you...

40 CFR 52.220 - Identification of plan.

Code of Federal Regulations, 2012 CFR

2012-07-01

..., Rules 40, 42, 43, and 44. (5) Ventura County Air Pollution Control District. (i) Previously approved on... contained in appendix II (“State Statutes and other Legal Documents Pertinent to Air Pollution Control in California”) to chapter 7. (13) El Dorado County Air Pollution Control District. (i) Previously approved on...

40 CFR 52.220 - Identification of plan.

Code of Federal Regulations, 2011 CFR

2011-07-01

..., Rules 40, 42, 43, and 44. (5) Ventura County Air Pollution Control District. (i) Previously approved on... (“State Statutes and other Legal Documents Pertinent to Air Pollution Control in California”) to chapter 7. (13) El Dorado County Air Pollution Control District. (i) Previously approved on May 31, 1972 in...

76 FR 69320 - Agency Request for Reinstatement of a Previously Approved Information Collection(s): Aircraft...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-08

... Previously Approved Information Collection(s): Aircraft Accident Liability Insurance AGENCY: Office of the...: Aircraft Accident Liability Insurance. Form Numbers: OST Forms 6410 and 6411. Type of Review: Reinstatement... air carrier accident liability insurance to protect the public from losses. This insurance information...

78 FR 77203 - Agency Requests for Renewal of a Previously Approved Information Collection(s): War Risk...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-20

.... Department of Transportation may provide war risk insurance adequate for the needs of the waterborne commerce... DEPARTMENT OF TRANSPORTATION [Docket No. DOT MARAD-2013-0149] Agency Requests for Renewal of a Previously Approved Information Collection(s): War Risk Insurance, Applications and Related Information...

77 FR 36001 - Agency Information Collection Activities: COPS Progress Report, Revision of a Previously Approved...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-15

... DEPARTMENT OF JUSTICE [OMB Number 1103-0102] Agency Information Collection Activities: COPS Progress Report, Revision of a Previously Approved Collection, With Change; Comments Requested ACTION: 60-Day notice of information collection under review. The Department of Justice (DOJ) Office of Community...

78 FR 16826 - Approval and Promulgation of Air Quality Implementation Plans; Ohio; Cleveland-Akron-Lorain and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-19

...-9790-1] Approval and Promulgation of Air Quality Implementation Plans; Ohio; Cleveland-Akron-Lorain and Columbus 1997 8-Hour Ozone Maintenance Plan Revisions to Approved Motor Vehicle Emissions Budgets AGENCY... quality State Implementation Plans (SIPs) under the Clean Air Act to replace the previously approved motor...

76 FR 10852 - Magnuson-Stevens Act Provisions; Fisheries of the Northeastern United States; Northeast...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-28

..., permitting restrictions, gear restrictions designed to minimize habitat impacts, and reporting requirements... requirement was previously approved for FY 2010 based upon the rationale that this measure was designed to... gillnet gear. This exemption was previously approved for FY 2010 because it is designed to control fishing...

75 FR 12806 - Notice of Request for Renewal of a Previously Approved Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-17

... INFORMATION CONTACT: Lauralyn Remo, Air Carrier Fitness Division (X-56), Office of Aviation Analysis, Office... States Code--(Amended); 14 CFR part 204--Data to Support Fitness Determinations; 14 CFR part 291--Cargo... previously approved collection. Abstract: In order to determine the fitness of persons seeking authority to...

78 FR 69875 - Agency Information Collection Activities; Revision of a Previously Approved Collection, With...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-21

... DEPARTMENT OF JUSTICE Agency Information Collection Activities; Revision of a Previously Approved Collection, With Change; Comments Requested: COPS Progress Report Correction In notice document 2013-25701, appearing on page 64979 in the issue of Wednesday, October 30, 2013, make the following correction: On page 64979, in the second column,...

What is the Process Approvals for Survey Research in the Department of Defense (DoD)

DTIC Science & Technology

2017-04-26

MDW/SGVU SUBJECT: Professional Presentation Approval 11APR 2017 1. Your paper, entitled What is the Process? Approvals for Survey Research in the...approval.) NA 6. TITLE OF MATERIAL TO BE PUBLISHED OR PRESENTED: What is the Process? Approvals for Survey Research in the Department of Defense (DoD...PREVIOUS EDITIONS ARE OBSOLETE 50. DATE I Page 3 of 3 Pages W_hat is the process? Approval of Survey Research in the Department of Defense (DoD

A new kind of universal smart home security safety monitoring system

NASA Astrophysics Data System (ADS)

Li, Biqing; Li, Zhao

2018-04-01

With the current level of social development, improved quality of life, existence and security issues of law and order has become an important issue. This graduation project adopts the form of wireless transmission, to STC89C52 microcontroller as the host control human infrared induction anti-theft monitoring system. The system mainly consists of main control circuit, power supply circuit, activities of the human body detection module, sound and light alarm circuit, record and display circuit. The main function is to achieve exploration activities on the human body, then the information is transmitted to the control panel, according to the system microcontroller program control sound and light alarm circuit, while recording the alarm location and time, and always check the record as required, and ultimately achieve the purpose of monitoring. The advantage of using pyroelectric infrared sensor can be installed in a hidden place, not easy to find, and low cost, good detection results, and has broad prospects for development.

75 FR 1447 - Petition for Exemption From the Vehicle Theft Prevention Standard; Hyundia-Kia America Technical...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-11

...This document grants in full the petition of Hyundai-Kia Motors Corporation (HATCI) in accordance with Sec. 543.9(c)(2) of 49 CFR part 543, Exemption from the Theft Prevention Standard, for the Kia Amanti vehicle line beginning with model year (MY) 2009. This petition is granted because the agency has determined that the antitheft device to be placed on the line as standard equipment is likely to be as effective in reducing and deterring motor vehicle theft as compliance with the parts-marking requirements of the Theft Prevention Standard. HATCI requested confidential treatment for its information and attachments submitted in support of its petition. In a letter dated January 30, 2008, the agency denied HATCI's request for confidential treatment. Subsequently, HATCI requested reconsideration of the determination. In a letter dated September 25, 2008, the agency granted the petitioner's request for reconsideration of confidential treatment of the indicated areas of its petition.

75 FR 82535 - Limitation of Approval of Prevention of Significant Deterioration Provisions Concerning...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-30

...This action is another in a series of steps EPA is taking to implement the Prevention of Significant Deterioration (PSD) program for greenhouse gas (GHG)-emitting sources. EPA is finalizing its proposed rulemaking to narrow its previous approval of State Implementation Plan (SIP) PSD programs in 24 states that apply to GHG-emitting sources. Specifically, EPA is withdrawing its previous approval of those programs to the extent they apply PSD to GHG-emitting sources below the thresholds in the final Tailoring Rule, which EPA promulgated by Federal Register notice dated June 3, 2010. Having narrowed its prior approval, EPA asks that each affected state withdraw from EPA consideration the part of its SIP that is no longer approved. The states for whose SIPs EPA is narrowing approval are: Alabama, California, Colorado, Georgia, Indiana, Iowa, Louisiana, Maine, Maryland, Mississippi, Missouri, New Hampshire, New Mexico, North Carolina, Ohio, Oklahoma, Rhode Island, South Carolina, South Dakota, Tennessee, Utah, Vermont, Virginia, and Wisconsin.

75 FR 71788 - Agency Requests for Renewal of a Previously Approved Information Collection: Uniform Relocation...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-24

... Previously Approved Information Collection: Uniform Relocation Assistance and Real Property Acquisition... present in the United States as required by Public Law 105-117 and 49 CFR 24.208. We are required to publish this notice in the Federal Register by the Paperwork Reduction Act of 1995, Public Law 104-13...

78 FR 3489 - Self-Regulatory Organizations; BATS Exchange, Inc.; Order Granting Approval of Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-16

... on a component by component basis, rather than by sector. Energy components can now be held in long... previously approved, all sectors other than energy could go long and short. Components are set to their..., ``Futures Exchanges''). Previously, the Index and the DCFI were designed such that the energy components...

78 FR 23544 - Proposed Extension of Approval of Information Collection; Comment Request: Recordkeeping...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-19

... Information Collection; Comment Request: Recordkeeping Requirements Under the Safety Standard for Infant...) requests comments on a proposed 3-year extension of approval of information collection for the... and Budget (OMB) previously approved the collection of information under control number 3041-0141. OMB...

78 FR 52893 - Approval and Promulgation of Implementation Plans; State of Iowa

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-27

... (EPA). ACTION: Proposed rule. SUMMARY: EPA is proposing to approve revisions to the State... Board of Health Rules and Regulations. These proposed revisions reflect updates to the Iowa statewide rules previously approved by EPA and will ensure consistency between the applicable local agency rules...

76 FR 49433 - Notice To Request an Extension and Revision of Currently Approved Information Collection and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-10

... Previously Approved Information Collection'' for volunteer workers (73 FR 62949). In accordance with the... request an extension for currently approved information collection, Volunteer Program-Earth Team. This..., for the Volunteer Interest and Placement Summary form and the Time Sheet form. The collected...

77 FR 40884 - Office of the Chief Information Officer; Information Collection; Temporary Contractor Information...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-11

... Management and Budget (OMB) a request to review and approve a previously approved information collection... collection to make determinations on granting unescorted physical access to GSA-controlled facilities. The approval is critical for GSA to continue to make physical access determinations for temporary contractors...

49 CFR 236.1009 - Procedural requirements.

Code of Federal Regulations, 2011 CFR

2011-10-01

..., PTCDP, or Type Approval. (2) After April 16, 2010, a host railroad shall file: (i) A PTCIP if it becomes... develop and submit a PTCIP mutually acceptable to all subject railroads. (b) Type Approval. Each host... unmodified Type Approval previously issued by the Associate Administrator in accordance with § 236.1013 or...

49 CFR 236.1009 - Procedural requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., PTCDP, or Type Approval. (2) After April 16, 2010, a host railroad shall file: (i) A PTCIP if it becomes... develop and submit a PTCIP mutually acceptable to all subject railroads. (b) Type Approval. Each host... unmodified Type Approval previously issued by the Associate Administrator in accordance with § 236.1013 or...

75 FR 33632 - Renewal of Approved Information Collection, OMB Control Number 1004-0179

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-14

... Approved Information Collection, OMB Control Number 1004-0179 AGENCY: Bureau of Land Management, Interior.... This information collection activity was previously approved by the OMB, and assigned control number...: Title: Helium Contracts (43 CFR part 3195). OMB Control Number: 1004-0179. Summary: This collection of...

7 CFR 1724.54 - Requirements for RUS approval of plans and specifications.

Code of Federal Regulations, 2011 CFR

2011-01-01

... specifications for transmission construction projects which are not based on RUS approved line design data or do... section, plans and specifications for transmission construction which use previously approved design data... transformer, and the transmission switchyard at a generating plant. Warehouses and equipment service buildings...

77 FR 58095 - White Pine-Nye Resource Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-19

... person listed For Further Information. SUPPLEMENTARY INFORMATION: The following business will be conducted: Review and approve previous meeting's minutes and business expenses, Review projects approved and...

44 CFR 6.52 - Approval of requests to amend records.

Code of Federal Regulations, 2010 CFR

2010-10-01

... § 6.52 Approval of requests to amend records. If the system manager determines that amendment of a... of disclosure has been maintained, the system manager shall advise all previous recipients of the..., the system manager shall advise the Privacy Appeals Officer that a request to amend has been approved. ...

Brentuximab Approved for Two Rare Lymphomas

Cancer.gov

Brentuximab vedotin (Adcetris®) has been approved for the treatment of adults who have been treated previously for either primary cutaneous anaplastic large cell lymphoma or CD30-expressing mycosis fungoides.

Approval of Community Involvement Plan

EPA Pesticide Factsheets

Contains cover letter from EPA to Walter Coke, Inc. approving Community Involvement Plan (Revision 1.0) (CIP), dated December 21, 2012, and submitted in response to EPA comments on a previous version of this plan.

78 FR 303 - General Services Administration Acquisition Regulation; Information Collection; Proposal To Lease...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-03

... to review and approve an extension of a previously approved information collection requirement for...) evaluate whether the physical attributes of offered properties meet the Government's requirements and (2...

76 FR 44648 - Notice of Availability of a Record of Decision (ROD) and Order for a Written Reevaluation of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-26

... and other associated airport projects are currently undergoing final engineering and design...) has submitted a request to the FAA for approval of the engineering and design refinements that are minor changes to the previously approved project. The ROD and Order approves the engineering and design...

77 FR 62496 - Federal Acquisition Regulation; Submission for OMB Review; Incentive Contracts

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-15

... Management and Budget (OMB) a request to review and approve an extension of a previously approved information... extension of the information collection would violate the fundamental purposes of the Paperwork Reduction...

FDA Expands Approval of Venetoclax for CLL

Cancer.gov

FDA expanded the approval of venetoclax (Venclexta) for people with chronic lymphocytic leukemia (CLL) to include those whose cancer has progressed after previous treatment, regardless of whether their cancer cells have the deletion 17p gene alteration.

33 CFR 331.5 - Criteria.

Code of Federal Regulations, 2010 CFR

2010-07-01

... date of the NAP. (2) Reasons for appeal. The reason(s) for requesting an appeal of an approved JD, a... engineer within 60 days of the date of the NAP; (7) A previously approved JD that has been superceded by...

Living with Fibromyalgia, Drugs Approved to Manage Pain

MedlinePlus

... that can happen in people with diabetes (diabetic peripheral neuropathy) and in those who develop pain following the ... previously approved to treat depression, anxiety, and diabetic peripheral neuropathy. Cymbalta's side effects include nausea, dry mouth, sleepiness, ...

77 FR 43080 - Information Collection; Payments

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-23

... ADMINISTRATION [Docket 2012-0076; Sequence 41; OMB Control No. 9000-0070] Information Collection; Payments... and approve an extension of a previously approved information collection requirement concerning Payments. Public comments are particularly invited on: Whether this collection of information is necessary...

76 FR 52658 - State Program Requirements; Approval of Application for Program Revision to the National...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-23

... (ADEC) in four phases. Phases I-III have been transferred from the EPA to ADEC. In March 2011, ADEC made a submission for approval for a one year extension of the transfer of Phase IV of the APDES program... facilities not previously transferred in Phases I-III. The EPA approved the one year extension for Phase IV...

Annual update: drugs, diagnostics and devices.

PubMed

Berardinelli, Candace; Kupecz, Deborah

2003-03-01

As NPs continue to play an important role in health care as administers of prescriptions, the value of reviewing the latest Food and Drug Administration (FDA) approvals for new drugs and devices is immeasurable. In 2002, the FDA approved several new drugs and devices, as well as monitored previously approved drugs for adverse reactions and untoward events. This article provides a brief review of relevant primary care topics.

75 FR 4565 - General Services Administration Acquisition Regulation; Submission for OMB Review; Industrial...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-28

... Acquisition Regulation; Submission for OMB Review; Industrial Funding Fee and Sales Reporting AGENCY... Management and Budget (OMB) a request to review and approve a reinstatement of a previously approved information collection requirement regarding industrial [[Page 4566

78 FR 18593 - Information Collection; Information Regarding Responsibility Matters

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-27

... ADMINISTRATION [OMB Control No. 9000-0174; Docket 2012-0076; Sequence 64] Information Collection; Information... comments regarding an existing OMB information clearance. SUMMARY: Under the provisions of the Paperwork... request to review and approve an extension of a previously approved information collection requirement...

Sofosbuvir + velpatasvir + voxilaprevir for the treatment of hepatitis C infection.

PubMed

Cory, Theodore J; Mu, Ying; Gong, Yuqing; Kodidela, Sunitha; Kumar, Santosh

2018-05-01

Hepatitis C is a disease with a significant global impact. Over the last several years, the treatment of the disease has been revolutionized. Therapy has transformed over the last several years with the approval of second generation direct acting antivirals, and currently utilized medications for the treatment of hepatitis C are significantly more efficacious with better safety profiles than previously approved treatments. Treatment for individuals who have failed therapy on direct acting antivirals has, until recently, been complex and difficult to treat, but the approval of sofosbuvir/velpatasvir/voxilaprevir represents a new therapeutic option for these individuals. Areas covered: Sofosbuvir/velpatasvir/voxilaprevir is a recently approved therapeutic combination for the treatment of hepatitis C. This article reviews the studies leading to the approval of the combination, and its efficacy and safety profile. Expert opinion: Sofosbuvir/velpatasvir/voxilaprevir fills one of the previously unfilled niches for the treatment of hepatitis C, that of the treatment of individuals who have failed therapy with resistant virus. With the filling of this niche, there appears to be a general slowing of the development of new therapeutics. Although understandable, in the long term, there are considerable risks associated with the decreased development of new drugs to treat hepatitis C.

77 FR 43082 - Federal Acquisition Regulation; Information Collection; Commerce Patent Regulations

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-23

... Proposals: Requesters may obtain a copy of the information collection documents from the General Services...; Information Collection; Commerce Patent Regulations AGENCIES: Department of Defense (DOD), General Services... Budget (OMB) a request to review and approve an extension of a previously approved information collection...

40 CFR 444.12 - Monitoring requirements.

Code of Federal Regulations, 2014 CFR

2014-07-01

... must include requirements to monitor, according to EPA-approved test procedures, each pollutant limited... be accomplished using approved test procedures listed in the table to this paragraph. Most of these test procedures have previously been incorporated by reference at 40 CFR 136.3(a), Table IB. The test...

40 CFR 444.12 - Monitoring requirements.

Code of Federal Regulations, 2013 CFR

2013-07-01

... must include requirements to monitor, according to EPA-approved test procedures, each pollutant limited... be accomplished using approved test procedures listed in the table to this paragraph. Most of these test procedures have previously been incorporated by reference at 40 CFR 136.3(a), Table IB. The test...

78 FR 69086 - Federal Acquisition Regulation; Submission for OMB Review; Preaward Survey Forms (Standard Forms...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-18

.... Standard Form 1408--Preaward Survey of Prospective Contractor Accounting System Respondents: 354. Responses... and approve an extension of a previously approved information collection requirement concerning... not challenge the propriety of this underlying information collection requirement. Response: FAR 9.106...

7 CFR 225.8 - Records and reports.

Code of Federal Regulations, 2010 CFR

2010-01-01

.... (a) Each State agency shall maintain complete and accurate current accounting records of its Program... must also notify the appropriate FNSRO within 5 working days after they approve each private nonprofit... estimated daily attendance that was previously provided; (ii) The hours and type(s) of approved meal service...

21 CFR 514.8 - Supplements and other changes to an approved application.

Code of Federal Regulations, 2013 CFR

2013-04-01

... method(s) or an addition, deletion, or substitution of steps in an aseptic processing operation; (D... solely affecting a natural product, a recombinant DNA-derived protein/polypeptide, or a complex or...) or references to previously approved documentation; (H) For a natural product, a recombinant DNA...

21 CFR 514.8 - Supplements and other changes to an approved application.

Code of Federal Regulations, 2014 CFR

2014-04-01

... method(s) or an addition, deletion, or substitution of steps in an aseptic processing operation; (D... solely affecting a natural product, a recombinant DNA-derived protein/polypeptide, or a complex or...) or references to previously approved documentation; (H) For a natural product, a recombinant DNA...

21 CFR 514.8 - Supplements and other changes to an approved application.

Code of Federal Regulations, 2012 CFR

2012-04-01

... method(s) or an addition, deletion, or substitution of steps in an aseptic processing operation; (D... solely affecting a natural product, a recombinant DNA-derived protein/polypeptide, or a complex or...) or references to previously approved documentation; (H) For a natural product, a recombinant DNA...

78 FR 31551 - Federal Acquisition Regulation; Submission for OMB Review; Commerce Patent Regulations

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-24

... Management and Budget (OMB) a request to review and approve an extension of a previously approved information... comments on or before June 24, 2013. ADDRESSES: Submit comments identified by Information Collection 9000.... Select the link ``Submit a Comment'' that corresponds with ``Information Collection 9000-0095, Commerce...

36 CFR 1254.102 - What requests does NARA not approve?

Code of Federal Regulations, 2011 CFR

2011-07-01

... publication or which relate closely to other documents previously microfilmed or approved for microfilming by... subject to excessive stress and possible damage from special equipment you plan to use, as well as... is in the facility's research room, and such work would disturb researchers. We do not move records...

36 CFR 1254.102 - What requests does NARA not approve?

Code of Federal Regulations, 2012 CFR

2012-07-01

... publication or which relate closely to other documents previously microfilmed or approved for microfilming by... subject to excessive stress and possible damage from special equipment you plan to use, as well as... is in the facility's research room, and such work would disturb researchers. We do not move records...

36 CFR 1254.102 - What requests does NARA not approve?

Code of Federal Regulations, 2014 CFR

2014-07-01

... publication or which relate closely to other documents previously microfilmed or approved for microfilming by... subject to excessive stress and possible damage from special equipment you plan to use, as well as... is in the facility's research room, and such work would disturb researchers. We do not move records...

36 CFR 1254.102 - What requests does NARA not approve?

Code of Federal Regulations, 2010 CFR

2010-07-01

... publication or which relate closely to other documents previously microfilmed or approved for microfilming by... subject to excessive stress and possible damage from special equipment you plan to use, as well as... is in the facility's research room, and such work would disturb researchers. We do not move records...

76 FR 17149 - Renewal of OMB Control Number 1004-0103

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-28

... Control Number 1004-0103 AGENCY: Bureau of Land Management, Interior. ACTION: 60-Day Notice and Request... Management and Budget (OMB) previously approved this information collection activity, and assigned it control... valid OMB control number. Until OMB approves a collection of information, you are not obligated to...

77 FR 70528 - Request for Comments of a Previously Approved Information Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-26

... Approved Information Collection AGENCY: Office of the Secretary, DOT. ACTION: Notice and request for... Office of Management and Budget (OMB) for review and comments. A Federal Register Notice with a 60-day... 26, 2012. FOR FURTHER INFORMATION CONTACT: Vanessa R. Balgobin, (202) 366-9721, Office of Aviation...

77 FR 22497 - Approval and Promulgation of Air Quality Implementation Plans; Illinois; Small Container...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-16

... surface coating operations in the Chicago and Metro-East St. Louis 8-hour ozone nonattainment areas. These... available control technology (RACT) policy. DATES: This direct final rule will be effective June 15, 2012... ``small container exemption'' for pleasure craft surface coating operations. EPA previously approved...

75 FR 6668 - Federal Acquisition Regulation; Submission for OMB Review; Commercial Item Acquisitions

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-10

... ADMINISTRATION [OMB Control No. 9000-0136] Federal Acquisition Regulation; Submission for OMB Review; Commercial... Management and Budget (OMB) a request to review and approve an extension of a previously approved information... online representations and certifications application (ORCA) is activated. DATES: Submit comments on or...

78 FR 27239 - General Services Administration Acquisition Regulation; Submission for OMB Review; Industrial...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-09

... Services Administration Acquisition Regulation; Submission for OMB Review; Industrial Funding Fee and Sales... Budget (OMB) a request to review and approve a reinstatement of a previously approved information collection requirement regarding industrial funding fee and sales reporting. A notice was published in the...

42 CFR 457.150 - CMS review of State plan material.

Code of Federal Regulations, 2013 CFR

2013-10-01

... State plan material. (a) Basis for action. CMS reviews each State plan and plan amendment to determine... on complete plan. CMS approves or disapproves the State plan or plan amendment only in its entirety... disapprove the State plan or plan amendment, or to determine that previously approved material no longer...

78 FR 53761 - Federal Acquisition Regulation; Submission for OMB Review; Commercial Item Acquisitions

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-30

... Management and Budget (OMB) a request to review and approve an extension of a previously approved information... exists; however, its functionality is incorporated into the System for Award Management (SAM). B... fundamental purposes of the Paperwork Reduction Act because of the burden it puts on the entity submitting the...

78 FR 13007 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Allegheny County...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-26

... volatile organic compounds (VOCs) satisfies the RACT requirements set forth by the Clean Air Act (CAA). This SIP revision demonstrates that all requirements for RACT are met either through Certification that..., either through a certification that previously adopted RACT controls in their SIP approved by EPA under...

76 FR 80831 - Clarification of Policy Regarding Approved Training Programs

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-27

... approval multiple curriculums for a particular crewmember position and aircraft make/model/variant. For example, a part 135 certificate holder may have a an initial new-hire curriculum designed to meet the... may then also apply for a reduced new hire curriculum for pilots that have previous experience as a...

77 FR 7010 - Clarification of Policy Regarding Approved Training Programs; Correction

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-10

... approval multiple curriculums for a particular crewmember position and aircraft make/model/variant. For example, a part 135 certificate holder may have a an initial new-hire curriculum designed to meet the... certificate holder may then also apply for a reduced new hire curriculum for pilots that have previous...

76 FR 66964 - Notice of Proposed Information Collection for 1029-0036

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-28

... Requirements for Reclamation and Operation Plan. This information collection activity was previously approved... Requirements for Reclamation and Operation Plan. OSM will request a 3-year term of approval for this... Reclamation and Operation Plan. OMB Control Number: 1029-0036. Summary: Sections 507(b), 508(a), 510(b), 515(b...

36 CFR § 1254.102 - What requests does NARA not approve?

Code of Federal Regulations, 2013 CFR

2013-07-01

... publication or which relate closely to other documents previously microfilmed or approved for microfilming by... subject to excessive stress and possible damage from special equipment you plan to use, as well as... is in the facility's research room, and such work would disturb researchers. We do not move records...

40 CFR 52.1323 - Approval status.

Code of Federal Regulations, 2010 CFR

2010-07-01

... to the work practice manual, pursuant to this rule, must be submitted to EPA for approval as an... previous January. New source review permits issued pursuant to section 173 of the Clean Air Act will not be deemed valid by EPA unless the provisions of Section V of the emission offset interpretive rule published...

49 CFR 213.237 - Inspection of rail.

Code of Federal Regulations, 2014 CFR

2014-10-01

.... (1) To change the designation of a rail inspection segment or to establish a new segment pursuant to... shall remain in effect until the track owner's new designation is approved or conditionally approved by... 25, 2014 has not accumulated more than a total of 30 mgt in previous and new locations since its last...

75 FR 66136 - Agency Information Collection Activities: Reinstatement, With Change, of a Previously Approved...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-27

... Criminal History Information Systems. The Department of Justice (DOJ), Office of Justice Programs, Bureau... collection for which approval has expired. (2) Title of the Form/Collection: Survey of State Criminal History... history records and on the increasing number of operations and services provided by state repositories. (5...

78 FR 75659 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-12

...: (i) To oversee OCC's governance processes; (ii) to approve and oversee OCC's business strategies... place for a number of years, it has not previously submitted those as proposed rule changes pursuant to... accountability, and to align OCC with current best practices in corporate governance. The Board Charter addresses...

Chloroquine, a FDA-approved Drug, Prevents Zika Virus Infection and its Associated Congenital Microcephaly in Mice.

PubMed

Li, Chunfeng; Zhu, Xingliang; Ji, Xue; Quanquin, Natalie; Deng, Yong-Qiang; Tian, Min; Aliyari, Roghiyh; Zuo, Xiangyang; Yuan, Ling; Afridi, Shabbir Khan; Li, Xiao-Feng; Jung, Jae U; Nielsen-Saines, Karin; Qin, Frank Xiao-Feng; Qin, Cheng-Feng; Xu, Zhiheng; Cheng, Genhong

2017-10-01

Zika virus (ZIKV) has become a global public health emergency due to its rapidly expanding range and its ability to cause severe congenital defects such as microcephaly. However, there are no FDA-approved therapies or vaccines against ZIKV infection. Through our screening of viral entry inhibitors, we found that chloroquine (CQ), a commonly used antimalarial and a FDA-approved drug that has also been repurposed against other pathogens, could significantly inhibit ZIKV infection in vitro, by blocking virus internalization. We also demonstrated that CQ attenuates ZIKV-associated morbidity and mortality in mice. Finally, we proved that CQ protects fetal mice from microcephaly caused by ZIKV infection. Our methodology of focusing on previously identified antivirals in screens for effectiveness against ZIKV proved to be a rapid and efficient means of discovering new ZIKV therapeutics. Selecting drugs that were previously FDA-approved, such as CQ, also improves the likelihood that they may more quickly reach stages of clinical testing and use by the public. Copyright © 2017. Published by Elsevier B.V.

77 FR 59242 - Extension of a Previously Approved Collection; Public Charters

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-26

... previous notice. DATES: Comments on this notice should be received by October 26, 2012: attention OMB/OST... operator's advertising, selling or operating the charter. If the prospectus information were not collected...

Perceived approval of friends and parents as mediators of the relationship between self-determination and drinking.

PubMed

Chawla, Neharika; Neighbors, Clayton; Logan, Diane; Lewis, Melissa A; Fossos, Nicole

2009-01-01

Within the context of self-determination theory, individuals vary in the extent to which they are oriented toward autonomy and control. Previous research on the relationship between motivational orientations and drinking behavior among college students has suggested that students who are more autonomously oriented consume less alcohol whereas those who are more control oriented consume more alcohol. This research evaluated the extent to which these relationships are mediated by the perceived approval of friends and parents, both of which are important sources of potential influence on the behavior of college students. First-year students (N = 818, 58% female) who reported one or more heavy drinking episodes in the previous month completed online assessments of their drinking behavior, autonomous and controlled orientations, and perceptions of the approval of drinking (injunctive norms) by important others (friends and parents). The results suggested that controlled orientation was associated with greater alcohol use and that this association was mediated by perceptions of friends being more approving of problematic drinking. In contrast, autonomous orientation was associated with less alcohol use and this association was mediated by perceptions of friends being less supportive of problematic drinking. No support was found for perceptions of parents' approval as a mediator of the associations between either orientation and drinking. The findings highlight the importance of perceptions of friends' approval or disapproval of problematic drinking in understanding the relationship between self-determination and heavy drinking among college students.

Crude glycerol combustion: Particulate, acrolein, other volatile organic emissions

EPA Science Inventory

This STICS entry is for the presentation materials for a peer-reviewed journal manuscript entry by the same title (ORD-000108) previously entered an approved. A Product Description / Abstract for ORD-000108 was previously entered.

78 FR 58460 - Revision of Air Quality Implementation Plan; California; Placer County Air Pollution Control...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-24

...EPA is finalizing a limited approval and limited disapproval of two permitting rules submitted by California as a revision to the Placer County Air Pollution Control District (PCAPCD) and Feather River Air Quality Management District (FRAQMD) portion of the California State Implementation Plan (SIP). These revisions were proposed in the Federal Register on February 22, 2013 and concern construction and modification of stationary sources of air pollution within each District. We are approving local rules that regulate these emission sources under the Clean Air Act as amended in 1990 (CAA). Final approval of these rules makes the rules federally enforceable and corrects program deficiencies identified in a previous EPA rulemaking (76 FR 44809, July 27, 2011). EPA is also making a technical amendment to the Code of Federal Regulations (CFR) to reflect this previous rulemaking, which removed an obsolete provision from the California SIP.

78 FR 20856 - Approval and Promulgation of Air Quality Implementation Plans; Indiana; Redesignation of the...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-08

...EPA is issuing a supplement to its proposed approval of the State of Indiana's request to redesignate the Indianapolis area to attainment for the 1997 annual National Ambient Air Quality Standards (NAAQS or standard) for fine particulate matter (PM2.5). This supplemental proposal revises and expands the basis for proposing approval of the state's request, in light of developments since EPA issued its initial proposal on September 27, 2011. This supplemental proposal addresses four issues, including the effects of two decisions of the United States Court of Appeals for the District of Columbia (D.C. Circuit or Court): the Court's August 21, 2012 decision to vacate and remand to EPA the Cross- State Air Pollution Control Rule (CSAPR) and the Court's January 4, 2013 decision to remand to EPA two final rules implementing the 1997 PM2.5 standard. In this supplemental proposal, EPA is also proposing to approve a supplement to the emission inventories previously submitted by the state. EPA is proposing that the inventories for ammonia and Volatile Organic Compounds (VOC), in conjunction with the inventories for nitrogen oxides (NOX), direct PM2.5, and sulfur dioxide (SO2) that EPA previously proposed to approve, meet the comprehensive emissions inventory requirement of the Clean Air Act (CAA). Finally, this supplemental proposal solicits comment on the state's January 17, 2013 submission of Motor Vehicle Emissions Budgets (MVEBs) developed using EPA's Motor Vehicle Emissions Simulator (MOVES) 2010a emissions model to replace the MOBILE6.2 based MVEBs previously submitted as part of the PM2.5 maintenance plan for the Indianapolis area. EPA is seeking comment only on the issues raised in its supplemental proposal, and is not re-opening for comment other issues raised in its prior proposal.

21 CFR 316.31 - Scope of orphan-drug exclusive approval.

Code of Federal Regulations, 2014 CFR

2014-04-01

... use in the rare disease or condition for which the drug was designated, or for select indication(s) or use(s) within the rare disease or condition for which the drug was designated. Unless FDA previously... indication(s) or uses(s) within the rare disease or condition not protected by the exclusive approval. If the...

21 CFR 558.15 - Antibiotic, nitrofuran, and sulfonamide drugs in the feed of animals.

Code of Federal Regulations, 2011 CFR

2011-04-01

... nitrofuran drugs, if marketing is to continue during the interim. New animal drug entities with antibacterial activity not previously marketed, now pending approval or submitted for approval prior to, on, or following... comply with any of the provisions of paragraph (b) of this section for any of the antibacterial drugs...

21 CFR 558.15 - Antibiotic, nitrofuran, and sulfonamide drugs in the feed of animals.

Code of Federal Regulations, 2013 CFR

2013-04-01

... nitrofuran drugs, if marketing is to continue during the interim. New animal drug entities with antibacterial activity not previously marketed, now pending approval or submitted for approval prior to, on, or following... comply with any of the provisions of paragraph (b) of this section for any of the antibacterial drugs...

21 CFR 558.15 - Antibiotic, nitrofuran, and sulfonamide drugs in the feed of animals.

Code of Federal Regulations, 2010 CFR

2010-04-01

... nitrofuran drugs, if marketing is to continue during the interim. New animal drug entities with antibacterial activity not previously marketed, now pending approval or submitted for approval prior to, on, or following... comply with any of the provisions of paragraph (b) of this section for any of the antibacterial drugs...

21 CFR 558.15 - Antibiotic, nitrofuran, and sulfonamide drugs in the feed of animals.

Code of Federal Regulations, 2014 CFR

2014-04-01

... nitrofuran drugs, if marketing is to continue during the interim. New animal drug entities with antibacterial activity not previously marketed, now pending approval or submitted for approval prior to, on, or following... comply with any of the provisions of paragraph (b) of this section for any of the antibacterial drugs...

21 CFR 558.15 - Antibiotic, nitrofuran, and sulfonamide drugs in the feed of animals.

Code of Federal Regulations, 2012 CFR

2012-04-01

... nitrofuran drugs, if marketing is to continue during the interim. New animal drug entities with antibacterial activity not previously marketed, now pending approval or submitted for approval prior to, on, or following... comply with any of the provisions of paragraph (b) of this section for any of the antibacterial drugs...

78 FR 71705 - Agency Requests for Renewal of a Previously Approved Information Collection(s): Application for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-29

... Register by the Paperwork Reduction Act of 1995, Public Law 104-13. DATES: Written comments should be... . Follow the online instructions for submitting comments. Fax: 1-202-493-2251 Mail or Hand Delivery: Docket... Property. Form Numbers: MA-1047. Type of Review: Renewal of a currently approved information collection...

78 FR 25290 - Notice of Proposed Information Collection: Comment Request; HUD Standard Grant Application Forms...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-30

... submission under the Paperwork Reduction Act; number of respondents is 9,091; frequency of response is on the... previously approved collection for which approval has expired. Authority: PL: Public Law 106-107 468 Name of Law: Federal Financial Assistance Management Improvement Act of 1999. PL: Public Law 109-282 2590 Name...

77 FR 66844 - Federal Acquisition Regulation; Submission for OMB Review; Evaluation of Export Offers

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-07

... Management and Budget (OMB) a request to review and approve an extension of a previously approved information... posted without change to http://www.regulations.gov , including any personal and/or business confidential... United States (CONUS) ports and offers are solicited on a free onboard (f.o.b.) origin or f.o.b...

76 FR 31379 - Notice of Availability of Environmental Assessment and Finding of No Significant Impact for...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-31

... for approval as an addendum to the DP, Revision 2 (Derivation of the Site-Specific Soil DCGLs Addendum Soil DCGLs for Thorium and Radium). The revised DP does not change any previously approved remediation... ensures safety and protection of the public and the environment. Environmental Impacts of the Proposed...

78 FR 9068 - Renewal of Approved Information Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-07

...The Bureau of Land Management (BLM) has submitted an information collection request to the Office of Management and Budget (OMB) to continue the collection of information that enables the BLM to monitor compliance with timber export restrictions. The Office of Management and Budget (OMB) previously approved this information collection activity, and assigned it control number 1004-0058.

77 FR 16509 - Proposed Approval of Revision of Five California Clean Air Act Title V Operating Permits Programs

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-21

... Approval of Revision of Five California Clean Air Act Title V Operating Permits Programs AGENCY... the Operating Permits (Title V) programs of the Monterey Bay Unified Air Pollution Control District... been previously subject to Title V for other reasons to obtain a Title V permit. See ``Prevention of...

FDA Approval: Ibrutinib for Patients with Previously Treated Mantle Cell Lymphoma and Previously Treated Chronic Lymphocytic Leukemia.

PubMed

de Claro, R Angelo; McGinn, Karen M; Verdun, Nicole; Lee, Shwu-Luan; Chiu, Haw-Jyh; Saber, Haleh; Brower, Margaret E; Chang, C J George; Pfuma, Elimika; Habtemariam, Bahru; Bullock, Julie; Wang, Yun; Nie, Lei; Chen, Xiao-Hong; Lu, Donghao Robert; Al-Hakim, Ali; Kane, Robert C; Kaminskas, Edvardas; Justice, Robert; Farrell, Ann T; Pazdur, Richard

2015-08-15

On November 13, 2013, the FDA granted accelerated approval to ibrutinib (IMBRUVICA capsules; Pharmacyclics, Inc.) for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. On February 12, 2014, the FDA granted accelerated approval for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. Ibrutinib is a first-in-class Bruton's tyrosine kinase (BTK) inhibitor that received all four expedited programs of the FDA: Fast-Track designation, Breakthrough Therapy designation, Priority Review, and Accelerated Approval. Both approvals were based on overall response rate (ORR) and duration of response (DOR) in single-arm clinical trials in patients with prior treatment. In MCL (N = 111), the complete and partial response rates were 17.1% and 48.6%, respectively, for an ORR of 65.8% [95% confidence interval (CI), 56.2%-74.5%]. The median DOR was 17.5 months (95% CI, 15.8-not reached). In CLL (N = 48), the ORR was 58.3% (95% CI, 43.2%-72.4%), and the DOR ranged from 5.6 to 24.2 months. The most common adverse reactions (≥ 30% in either trial) were thrombocytopenia, diarrhea, neutropenia, bruising, upper respiratory tract infection, anemia, fatigue, musculoskeletal pain, peripheral edema, and nausea. ©2015 American Association for Cancer Research.

78 FR 38256 - Approval and Promulgation of Air Quality Implementation Plans; Ohio; Redesignation of the Ohio...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-26

...EPA is issuing a supplement to its proposed approval of Ohio's request to redesignate the Ohio portion of the Parkersburg-Marietta, West Virginia-Ohio, area to attainment for the 1997 annual National Ambient Air Quality Standards (NAAQS or standard) for fine particulate matter (PM2.5). This supplemental proposal revises and expands the basis for proposing approval of the state's request, in light of developments since EPA issued its initial proposal on November 30, 2012. This supplemental proposal addresses the effects of a January 4, 2013, decision of the United States Court of Appeals for the District of Columbia (D.C. Circuit or Court) to remand to EPA two final rules implementing the 1997 PM2.5 standard. In this supplemental proposal, EPA is also proposing to approve a supplement to the emission inventories previously submitted by Ohio. EPA is proposing that the inventories for ammonia and volatile organic compounds (VOC), in conjunction with the inventories for nitrogen oxides (NOX), direct PM2.5, and sulfur dioxide (SO2) that EPA previously proposed to approve, meet the comprehensive emissions inventory requirements of the Clean Air Act (CAA or Act). EPA is seeking comment only on the issues raised in its supplemental proposal, and is not re-opening for comment other issues raised in its prior proposal.

78 FR 54346 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Filing and Immediate Effectiveness...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-03

... organization whose market making has not previously been approved by FINRA under the NASD Rule 1000 Series (or... Market Maker or other entity approved by the Exchange to function in a market-making capacity. Member... adopted rules to allow market making on PSX.\\3\\ Rule 910(f) provides that member organizations seeking to...

An update on the clinical evidence that supports biosimilar approvals in Europe.

PubMed

Mielke, Johanna; Jilma, Bernd; Jones, Byron; Koenig, Franz

2018-03-25

Sponsors and regulators have more than 10 years of experience with the development of biosimilars in Europe. However, the regulatory pathway is still evolving. The present article provides an update on biosimilar development in practice by reviewing the clinical development programmes of recently approved biosimilars in Europe. We used the European public assessment reports (EPARs) which are published by the European Medicines Agency (EMA) for a comparison of the clinical development programmes of the 37 approved biosimilars in Europe. Here, we present novel strategies in the development of biosimilars by focusing specifically on the 17 biosimilars that have gained approval in the last year, but we also compare additional key characteristics for all approved biosimilars. The high variability of the clinical development strategies that we found previously was confirmed in the present analysis. Compared with earlier biosimilar applications, more nonstandard development strategies have been used recently. This includes, for example, applications without any studies in patients, and more complex study designs. During this study, we found that the EPARs for biosimilars seem to be improving; however, we identified important details which were still often missing. We provide a proposal for a checklist of the minimum information that should be included in biosimilar EPARs for giving the general public insights into the rationale for the approval of biosimilars. European regulators still seem to be open to consider approaches that differ from the guidelines or previous applications, as long as justification is provided. © 2018 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.

78 FR 68136 - Agency Information Collection Activities; Revision of an Approved Information Collection...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-13

...In accordance with the Paperwork Reduction Act of 1995, FMCSA announces its plan to submit the Information Collection Request (ICR) described below to the Office of Management and Budget (OMB) for its review and approval and invites public comment. FMCSA requests approval to revise an ICR titled ``Practices of Household Brokers'' to no longer include one-time costs previously incurred by brokers to come into compliance with 49 CFR part 371, and to update other wage related costs that have changed since the last approval. This ICR is necessary to support the requirements of subpart B of 49 CFR part 371 and FMCSA's responsibility to ensure consumer protection in the transportation of household goods (HHG).

15 CFR 930.100 - Remedial action for previously reviewed activities.

Code of Federal Regulations, 2010 CFR

2010-01-01

... OCEAN AND COASTAL RESOURCE MANAGEMENT FEDERAL CONSISTENCY WITH APPROVED COASTAL MANAGEMENT PROGRAMS... area involved of any federal assistance activity which the State agency claims was: (1) Previously... conducted or is having an effect on any coastal use or resource substantially different than originally...

Wireless Strain Measurement with a Micromachined Magnetoelastic Resonator Using Ringdown Frequency Locking

PubMed Central

Green, Scott R.; Gianchandani, Yogesh B.

2017-01-01

Resonant magnetoelastic devices are widely used as anti-theft tags and are also being investigated for a range of sensing applications. The vast majority of magnetoelastic devices are operated at resonance, and rely upon an external interface to wirelessly detect the resonant frequency, and other characteristics. For micromachined devices, this detection method must accommodate diminished signal strength and elevated resonant frequencies. Feedthrough of the interrogating stimulus to the detector also presents a significant challenge. This paper describes a method of interrogating wireless magnetoelastic strain sensors using a new frequency-lock approach. Following a brief excitation pulse, the sensor ring-down is analyzed and a feedback loop is used to match the excitation frequency and the resonant frequency. Data acquisition hardware is used in conjunction with custom software to implement the frequency-lock loop. Advantages of the method include temporal isolation of interrogating stimulus from the sensor response and near real-time tracking of resonant frequencies. The method was investigated using a family of wireless strain sensors with resonant frequencies ranging from 120 to 240 kHz. Strain levels extending to 3.5 mstrain and sensitivities up to 14300 ppm/mstrain were measured with response times faster than 0.5 s. The standard deviation of the locked frequency did not exceed 0.1%. PMID:28713873

Comparison of SAR and induced current densities in adults and children exposed to electromagnetic fields from electronic article surveillance devices

NASA Astrophysics Data System (ADS)

Martínez-Búrdalo, M.; Sanchis, A.; Martín, A.; Villar, R.

2010-02-01

Electronic article surveillance (EAS) devices are widely used in most stores as anti-theft systems. In this work, the compliance with international guidelines in the human exposure to these devices is analysed by using the finite-difference time-domain (FDTD) method. Two sets of high resolution numerical phantoms of different size (REMCOM/Hershey and Virtual Family), simulating adult and child bodies, are exposed to a 10 MHz pass-by panel-type EAS consisting of two overlapping current-carrying coils. Two different relative positions between the EAS and the body (frontal and lateral exposures), which imply the exposure of different parts of the body at different distances, have been considered. In all cases, induced current densities in tissues of the central nervous system and specific absorption rates (SARs) are calculated to be compared with the limits from the guidelines. Results show that induced current densities are lower in the case of adult models as compared with those of children in both lateral and frontal exposures. Maximum SAR values calculated in lateral exposure are significantly lower than those calculated in frontal exposure, where the EAS-body distance is shorter. Nevertheless, in all studied cases, with an EAS driving current of 4 A rms, maximum induced current and SAR values are below basic restrictions.

Comparison of SAR and induced current densities in adults and children exposed to electromagnetic fields from electronic article surveillance devices.

PubMed

Martínez-Búrdalo, M; Sanchis, A; Martín, A; Villar, R

2010-02-21

Electronic article surveillance (EAS) devices are widely used in most stores as anti-theft systems. In this work, the compliance with international guidelines in the human exposure to these devices is analysed by using the finite-difference time-domain (FDTD) method. Two sets of high resolution numerical phantoms of different size (REMCOM/Hershey and Virtual Family), simulating adult and child bodies, are exposed to a 10 MHz pass-by panel-type EAS consisting of two overlapping current-carrying coils. Two different relative positions between the EAS and the body (frontal and lateral exposures), which imply the exposure of different parts of the body at different distances, have been considered. In all cases, induced current densities in tissues of the central nervous system and specific absorption rates (SARs) are calculated to be compared with the limits from the guidelines. Results show that induced current densities are lower in the case of adult models as compared with those of children in both lateral and frontal exposures. Maximum SAR values calculated in lateral exposure are significantly lower than those calculated in frontal exposure, where the EAS-body distance is shorter. Nevertheless, in all studied cases, with an EAS driving current of 4 A rms, maximum induced current and SAR values are below basic restrictions.

Transition from Terrorist Event Management to Consequence Management, Executive Summary

DTIC Science & Technology

1982-03-31

8217 "This report has been reviewed in the Federal Emergency Management Agency and approved for puLlication. Approval does not signify that the contents...acts. It describes in general terms what mechanism is in place today. This description is derived from documentation reviewed and information obtained...probabilities was employed in the development of the- values expressed in the matrices. Probabilities were established by a review of several previous

Recent drug approvals from the US FDA and EMEA: what the future holds.

PubMed

Pevarello, Paolo

2009-04-01

The decreased productivity of the pharmaceutical industry in terms of new medical entities approved by the US FDA and the European Medicines Agency (EMEA) on a yearly basis has long been debated. This review will analyze overall new drug applications (NDAs) approved by both the FDA and EMEA in 2007, with the aim of finding trends (also looking at the past) that can be used to predict what the future may be. After a general introduction to the regulatory terminology, NDA approvals in 2007 are divided into categories (new applications of old medicines, metabolites, enantiomers and prodrugs, biological products, natural products and small organic molecule new molecular entities) and discussed. General aspects of the NDA approvals, such as historical trends, the length of the drug-discovery process, geography, differences among therapeutic areas, and the relative role of biotech and pharma industries are also outlined. From this analysis, a perspective is gained on some aspects that will probably influence future drug approvals. The conclusion is that 2007 may represent an inflexion point, in terms of quality if not quantity of new approvals, and that the future may be brighter than previously forecast.

40 CFR 52.220 - Identification of plan.

Code of Federal Regulations, 2014 CFR

2014-07-01

... replacement, Regulation 3, Rules 40, 42, 43, and 44. (5) Ventura County Air Pollution Control District. (i... Control in California”) to chapter 7. (13) El Dorado County Air Pollution Control District. (i) Previously..., 79, and 80. (14) Imperial County Air Pollution Control District. (i) Previously approved on May 31...

12 CFR 1281.13 - Special counting requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

... were previously counted by a Bank under any current or previous housing goal within the five years immediately preceding the current performance year; (10) Purchases of mortgages where the property has not been approved for occupancy; and (11) Any combination of factors in paragraphs (b)(1) through (b)(10...

77 FR 35837 - Conditionally Approved New Animal Drugs for Minor Use and Minor Species; Masitinib

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-15

.... The supplemental CNADA provides for a revised indication for masitinib mesylate tablets in dogs. DATES... in dogs that have not previously received radiotherapy and/or chemotherapy except corticosteroids. In... cell tumors in dogs that have not previously received radiotherapy and/or chemotherapy except...

Innovation in the pharmaceutical industry: New estimates of R&D costs.

PubMed

DiMasi, Joseph A; Grabowski, Henry G; Hansen, Ronald W

2016-05-01

The research and development costs of 106 randomly selected new drugs were obtained from a survey of 10 pharmaceutical firms. These data were used to estimate the average pre-tax cost of new drug and biologics development. The costs of compounds abandoned during testing were linked to the costs of compounds that obtained marketing approval. The estimated average out-of-pocket cost per approved new compound is $1395 million (2013 dollars). Capitalizing out-of-pocket costs to the point of marketing approval at a real discount rate of 10.5% yields a total pre-approval cost estimate of $2558 million (2013 dollars). When compared to the results of the previous study in this series, total capitalized costs were shown to have increased at an annual rate of 8.5% above general price inflation. Adding an estimate of post-approval R&D costs increases the cost estimate to $2870 million (2013 dollars). Copyright © 2016 Elsevier B.V. All rights reserved.

42 CFR 412.273 - Withdrawing an application, terminating an approved 3-year reclassification, or canceling a...

Code of Federal Regulations, 2010 CFR

2010-10-01

... 3-year reclassification, or canceling a previous withdrawal or termination. 412.273 Section 412.273...-year reclassification, or canceling a previous withdrawal or termination. (a) Definitions. For purposes... to the provisions of this section, a hospital (or group of hospitals) may cancel a withdrawal or...

[Local approval procedures act as a brake on RCTs].

PubMed

van der Stok, E P; Huiskens, J; Hemmes, B; Grünhagen, D J; van Gulik, T M; Verhoef, C; Punt, C J A

2016-01-01

Large multicentre randomised controlled trials (RCTs) in the Netherlands are increasingly being impeded by major differences between local approval procedures. However, no national agenda exists as yet to improve this situation. The existence of major local differences in processing time and documentation required has been reported previously but little is known about the costs incurred and whether or not specific certifications and research contracts are mandatory. The current study evaluated these aspects of local procedures for obtaining approval of two oncological multicentre RCTs. Retrospective, descriptive. All local procedures for obtaining approval of two randomised clinical trials were evaluated: the CAIRO5 and CHARISMA trials initiated by the Dutch Colorectal Cancer Group (DCCG). We objectified time between approval by the Medical Ethics Review Committee (METC) and final approval by the Board of Directors (RvB), the type and number of documents needed, and costs charged. The median time interval between the approval by the Medical Ethics Review Committee and the approval by the Board of Directors was 90 days (range 4-312). The number of documents required per centre ranged from 6-20. The costs charged ranged from € 0-€ 1750, and amounted to € 8575 for all procedures combined. No costs were charged by the majority of the centres. The approval procedures for multicentre clinical trials in the Netherlands demonstrate major differences. Processing times, documentation required and costs are unpredictable; greater uniformity is highly desirable in this context.

Drug Discovery Prospect from Untapped Species: Indications from Approved Natural Product Drugs

PubMed Central

Qin, Chu; Tao, Lin; Liu, Xin; Shi, Zhe; Zhang, Cun Long; Tan, Chun Yan; Chen, Yu Zong; Jiang, Yu Yang

2012-01-01

Due to extensive bioprospecting efforts of the past and technology factors, there have been questions about drug discovery prospect from untapped species. We analyzed recent trends of approved drugs derived from previously untapped species, which show no sign of untapped drug-productive species being near extinction and suggest high probability of deriving new drugs from new species in existing drug-productive species families and clusters. Case histories of recently approved drugs reveal useful strategies for deriving new drugs from the scaffolds and pharmacophores of the natural product leads of these untapped species. New technologies such as cryptic gene-cluster exploration may generate novel natural products with highly anticipated potential impact on drug discovery. PMID:22808057

76 FR 56001 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-09

... revenue PFC revenue date date 07-10-C-03-DSM Des Moines, IA... 06/29/11 $9,175,000 $9,547,773 08/01/17 08/01/17 01-04-C-01-MBS Freeland, MI..... 07/11/11 1,999,052 566,875 07/01/06 07/01/06 06-09-C-02-JAX... had previously been approved for collection of PFC revenue in decision 06- 08-C-00-DBQ and for use of...

78 FR 18344 - Federal Acquisition Regulation; Submission for OMB Review; Buy American Act-Free Trade Agreements...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-26

...Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement concerning the Buy American Act--Free Trade Agreements--Israeli Trade Act Certificate. A notice was published in the Federal Register at 77 FR 43081, on July 23, 2012. One comment was received.

[Independent ethics committees for clinical research in Argentina. An evaluation and a system to guarantee their independence].

PubMed

Gonorazky, Sergio E

2008-01-01

The Administración Nacional de Medicamentos, Alimentos y Tecnología Médica de la República Argentina (ANMAT) requires that an independent ethics committee of sponsors and/or researchers must previously evaluate and approve all the new pharmacological research protocols carried out on human beings. However, due to the lucrative nature of the evaluation, and because the selection of the Independent Ethics Committee is carried out by the sponsors and/or researchers, the assumed autonomy of the former can be reduced to merely a relationship of "service provider-customer". The Institutional Review Board of the Mar del Plata s Community Hospital has evaluated, between 2005 and 2006, thirty three research protocols (with their corresponding information sheets for patients and informed consent forms) previously approved by a non-institutional Independent Ethics Committee. The median number of objections made by the Institutional Review Board, which prompted the previously mentioned protocols to be modified in order to be approved, was of three per protocol. In other words, the accreditation of an Independent Ethics Committee requires a system that guarantees actual independence from the sponsors and/or researchers, as well as management control mechanisms that may lead them into an eventual loss of accreditation. Several measures are proposed in order to correct the deficiencies of the present system.

77 FR 45331 - White Pine-Nye Resource Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-31

... INFORMATION CONTACT. SUPPLEMENTARY INFORMATION: The following business will be conducted: Review and approve previous meeting's minutes and business expenses, Recommend funding allocation for proposed projects, and...

78 FR 31947 - National Institutes of Health

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-28

... Certification (previously National Database for Autism Research Data Access Request), 0925-0667, Revision... approval for use of the National Database for Autism Research (NDAR) Data Use Certification (DUC) Form...

76 FR 25298 - White Pine-Nye County Resource Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-04

... person listed FOR FURTHER INFORMATION CONTACT. SUPPLEMENTARY INFORMATION: The following business will be conducted: Review and approve previous meeting's minutes and business expenses, Recommend funding allocation...

29 CFR 1902.18 - Previous hearing or other opportunity for comment on plan.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 5 2010-07-01 2010-07-01 false Previous hearing or other opportunity for comment on plan. 1902.18 Section 1902.18 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR STATE PLANS FOR THE DEVELOPMENT AND ENFORCEMENT OF STATE STANDARDS Procedures for Submission, Approval and...

Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000-2012.

PubMed

Sacks, Leonard V; Shamsuddin, Hala H; Yasinskaya, Yuliya I; Bouri, Khaled; Lanthier, Michael L; Sherman, Rachel E

Some new drug applications fail because of inadequate drug performance and others are not approved because the information submitted to the US Food and Drug Administration (FDA) is unsatisfactory to make that determination. Resubmission of failed applications is costly, delaying marketing approval and the availability of new drugs to patients. To identify the reasons that FDA marketing approval for new drugs was delayed or denied. A retrospective review of FDA documents and extraction of data were performed. We examined all drug applications first submitted to the FDA between 2000 and 2012 for new molecular entities (NMEs), which are active ingredients never before marketed in the United States in any form. Using FDA correspondence and reviews, we investigated the reasons NMEs failed to obtain FDA approval. Reasons for delayed FDA approval or nonapproval of NME applications. Of the 302 identified NME applications, 151 (50%) were approved when first submitted and 222 (73.5%) were ultimately approved. Seventy-one applications required 1 or more resubmissions before approval, with a median delay to approval of 435 days following the first unsuccessful submission. Of the unsuccessful first-time applications, 24 (15.9%) included uncertainties related to dose selection, 20 (13.2%) choice of study end points that failed to adequately reflect a clinically meaningful effect, 20 (13.2%) inconsistent results when different end points were tested, 17 (11.3%) inconsistent results when different trials or study sites were compared, and 20 (13.2%) poor efficacy when compared with the standard of care. The frequency of safety deficiencies was similar among never-approved drugs compared with those with delayed approval (43 of 80 never approved [53.8%] vs 37 of 71 eventually approved [52.1%]; difference, 1.7% [95% CI, -14.86% to 18.05%]; P = .87). However, efficacy deficiencies were significantly more frequent among the never-approved drugs than among those with delayed approvals (61 of 80 never approved [76.3%] vs 28 of 71 eventually approved [39.4%]; difference, 36.9% [95% CI, 20.25% to 50.86%]; P < .001). Several potentially preventable deficiencies, including failure to select optimal drug doses and suitable study end points, accounted for significant delays in the approval of new drugs. Understanding the reasons for previous failures is helpful to improve the efficiency of clinical development for new drugs.

Clinical trial transparency update: an assessment of the disclosure of results of company-sponsored trials associated with new medicines approved in Europe in 2013.

PubMed

Deane, Bryan R; Sivarajah, Jacintha

2017-03-01

The objective of this study was to assess the timely disclosure of results of company-sponsored clinical trials related to all new medicines approved by the European Medicines Agency (EMA) during 2013. This is an extension of two previously reported studies of trials related to all new medicines approved in Europe in 2009, 2010 and 2011, and in 2012. The original study found that over a three year period over three-quarters of all trials were disclosed within 12 months and almost 90% were disclosed by the end of the study. The extension study (2012 approvals) showed an improvement in results disclosure within 12 months to 90%, and an overall disclosure rate of 92% by the end of the study. The methodology used was exactly as previously reported. Various publicly available information sources were searched for both clinical trial registration and disclosure of results. All completed company-sponsored trials related to each new medicine approved for marketing by the EMA in 2013, carried out in patients and recorded on a clinical trials registry and/or included in an EMA European Public Assessment Report (EPAR), were included. Information sources were searched between 1 May and 31 July 2015. The main outcome measure was the proportion of trials for which results had been disclosed on a registry or in the scientific literature either within 12 months of the later of either first regulatory approval or trial completion, or by 31 July 2015 (end of survey). Of the completed trials associated with 34 new medicines licensed to 24 different companies in 2013, results of 90% (484/539) had been disclosed within 12 months, and results of 93% (500/539) had been disclosed by 31 July 2015. The disclosure rate within 12 months of 90% suggests that industry is continuing to achieve disclosure in a timely manner. The overall disclosure rate at study end of 93% indicates that the improvement in transparency amongst company-sponsored trials has been maintained in the trials associated with new medicines approved in 2013.

Clinical trial transparency update: an assessment of the disclosure of results of company-sponsored trials associated with new medicines approved in Europe in 2014.

PubMed

Deane, Bryan R; Porkess, Sheuli

2018-07-01

The objective of this study was to assess the timely disclosure of results of company-sponsored clinical trials related to all new medicines approved by the European Medicines Agency (EMA) during 2014. This is the final extension of three previously reported studies of trials related to all new medicines approved in Europe in 2009, 2010 and 2011, and in 2012 and 2013. The original study found that over a three-year period over three-quarters of all trials were disclosed within 12 months and almost 90% were disclosed by the end of the study (31 January 2013). The extension studies (2012 and 2013 approvals) both showed an improvement in results disclosure within 12 months to 90%, and an overall disclosure rate of 92% and 93% respectively by the end of the studies. The methodology used was exactly as previously reported. Various publicly available information sources were searched for both clinical trial registration and disclosure of results. All completed company-sponsored trials related to each new medicine approved for marketing by the EMA in 2014, carried out in patients and recorded on a clinical trials registry and/or included in an EMA European Public Assessment Report (EPAR), were included. Information sources were searched between 1 May and 31 July 2016. The main outcome measure was the proportion of trials for which results had been disclosed on a registry or in the scientific literature either within 12 months of the later of either first regulatory approval or trial completion, or by 31 July 2016 (end of survey). Of the completed trials associated with 32 new medicines licensed to 22 different companies in 2014, results of 93% (505/542) had been disclosed within 12 months, and results of 96% (518/542) had been disclosed by 31 July 2016. The disclosure rate within 12 months of 93% suggests that industry is continuing to achieve disclosure in a timely manner. The overall disclosure rate at study end of 96% indicates that the improvement in transparency amongst company-sponsored trials has been maintained in the trials associated with new medicines approved in 2014.

40 CFR 52.344 - Visibility protection.

Code of Federal Regulations, 2013 CFR

2013-07-01

... industrial source categories regulated by the NSR and PSD regulations which have previously been approved by EPA. However, Colorado's NSR and PSD regulations have been disapproved for certain sources as listed...

40 CFR 52.344 - Visibility protection.

Code of Federal Regulations, 2014 CFR

2014-07-01

... industrial source categories regulated by the NSR and PSD regulations which have previously been approved by EPA. However, Colorado's NSR and PSD regulations have been disapproved for certain sources as listed...

40 CFR 52.344 - Visibility protection.

Code of Federal Regulations, 2010 CFR

2010-07-01

... industrial source categories regulated by the NSR and PSD regulations which have previously been approved by EPA. However, Colorado's NSR and PSD regulations have been disapproved for certain sources as listed...

40 CFR 52.344 - Visibility protection.

Code of Federal Regulations, 2011 CFR

2011-07-01

... industrial source categories regulated by the NSR and PSD regulations which have previously been approved by EPA. However, Colorado's NSR and PSD regulations have been disapproved for certain sources as listed...

40 CFR 52.344 - Visibility protection.

Code of Federal Regulations, 2012 CFR

2012-07-01

... industrial source categories regulated by the NSR and PSD regulations which have previously been approved by EPA. However, Colorado's NSR and PSD regulations have been disapproved for certain sources as listed...

77 FR 21144 - Extension of a Previously Approved Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-09

... following collection request: Public Charters, 14 CFR part 380. The pre-existing information collection... to the operator's advertising, selling or operating the charter. If the prospectus information were...

75 FR 5144 - Submission for OMB Review: Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-01

... of a previously approved collection. Title of Collection: Personal Protective Equipment (PPE) for... of the workplace to determine if personal protective equipment (PPE) is necessary and to communicate...

Clinical trial transparency: an assessment of the disclosure of results of company-sponsored trials associated with new medicines approved recently in Europe.

PubMed

Rawal, Bina; Deane, Bryan R

2014-03-01

Previous studies have raised concerns around the transparency and disclosure rates of clinical trial results on clinical trial registries and in the scientific literature. The objective of this study was to assess the timely disclosure in the public domain of results of company-sponsored clinical trials related to all new medicines approved by the European Medicines Agency (EMA) over a recent 3 year period. The study surveyed various publicly available information sources for both clinical trial registration and disclosure of results (including clinical trial registries, the International Federation of Pharmaceutical Manufacturers and Associations [IFPMA] Clinical Trials Portal, EMA European Public Assessment Reports and PubMed), searched from 27 December 2012 to 31 January 2013. The study covered all 53 new medicines (except vaccines and fixed-dose combinations) approved for marketing by 34 pharmaceutical companies by the EMA in 2009, 2010 and 2011. It included all completed company-sponsored clinical trials conducted in patients and recorded on a clinical trial registry and/or included in an EPAR. OUTCOME MEASURE AND RESULTS: The main outcome measure was the proportion of trials for which results had been disclosed on a registry or in the scientific literature either within 12 months of the later of either first regulatory approval or trial completion, or by 31 January 2013 (end of survey). Of the completed clinical trials associated with all 53 new medicines approved by the EMA between 2009 and 2011, 77% had results disclosed within 12 months. By 31 January 2013, this had increased to 89%. Rates of results disclosure within 12 months were 71%, 81% and 86% for new medicines approved in 2009, 2010 and 2011 respectively. Disclosure increased to 86%, 93% and 91% respectively by 31 January 2013. Although this was a purely quantitative study which did not aim to assess the content of disclosure against any specific requirements, limitations relating to a number of difficulties in finding all relevant data from multiple sources in the public domain were captured. Results of over three-quarters of all company-sponsored clinical trials related to new medicines recently approved by the EMA were disclosed within a year of completion or regulatory approval, and almost 90% were disclosed by 31 January 2013, suggesting transparency is now better than has sometimes been reported previously.

Synthetic approaches to the 2014 new drugs.

PubMed

Flick, Andrew C; Ding, Hong X; Leverett, Carolyn A; Kyne, Robert E; Liu, Kevin K-C; Fink, Sarah J; O'Donnell, Christopher J

2016-05-01

New drugs introduced to the market every year represent privileged structures for particular biological targets. These new chemical entities (NCEs) provide insight into molecular recognition and also serve as leads for designing future new drugs. This annual review covers the synthesis of thirty-seven NCEs that were approved for the first time in 2014 and one drug which was approved in 2013 and was not covered in a previous edition of this review. Copyright © 2016 Elsevier Ltd. All rights reserved.

Safety and Efficacy of the BrainPort V100 Device in Individuals Blinded by Traumatic Injury

DTIC Science & Technology

2016-12-01

the functional performance of the BrainPort® V200 device, a non-surgical, FDA approved, sensory substitution system, in persons who are profoundly...The BrainPort V200 device is a wearable, non-surgical, FDA approved, prosthetic device intended for people who are profoundly blind. The BrainPort...BrainPort V200 electronic vision aid (described previously) has been developed under this research. FDA clearance to market the V200 in the US is expected

Enhancing the development and approval of acute stroke therapies: Stroke Therapy Academic Industry roundtable.

PubMed

Fisher, Marc; Albers, Gregory W; Donnan, Geoffrey A; Furlan, Anthony J; Grotta, James C; Kidwell, Chelsea S; Sacco, Ralph L; Wechsler, Lawrence R

2005-08-01

Previous Stroke Therapy Academic Industry Roundtable (STAIR) meetings focused on preclinical evidence of drug efficacy and enhancing acute stroke trial design and performance. A fourth (STAIR-IV) was held to discuss relevant issues related to acute stroke drug development and regulatory approval. The STAIR-IV meeting had 3 main focus areas. The first topic was novel approaches to statistical design of acute stroke trials and appropriate outcome measures. The second focus was the need for better cooperation among participants in stroke therapy development that may be addressed through a national consortium of stroke trial centers in the United States and elsewhere. Lastly, regulatory issues related to the approval of novel mono and multiple acute stroke therapies were discussed. The development of additional acute stroke therapies represents a large unmet need with many remaining challenges and also opportunities to incorporate novel approaches to clinical trial design that will lead to regulatory approval. The STAIR-IV meeting explored new concepts of trial methodology and data analysis, initiatives for implementing a US clinical trialist consortium, and pertinent regulatory issues to expedite approval of novel therapies.

Comparison of the new Japanese legislation for expedited approval of regenerative medicine products with the existing systems in the USA and European Union

PubMed Central

Jokura, Yoji; Yano, Kazuo

2017-01-01

Abstract Legislation for expedited‐approval pathways and programmes for drugs, biologics or medical devices has been enacted for rapid commercialization of innovative products in the United States of America (USA) and the European Union (EU). However, less innovative products are increasingly benefitting from these expedited‐approval pathways, and obligations to collect and report post‐marketing data on approved products are being bypassed frequently. The Japanese government recently enacted legislation for a new conditional and time‐limited approval pathway dedicated to regenerative medicine products. The current study examines this new legislation and compares it with existing US and EU regulatory frameworks, with a particular focus on how it addresses the limitations of existing systems. Regulations, guidance documents and approval information were gathered from the websites of the respective authorities in the USA, the EU and Japan, and the systems were categorized through qualitative analysis. The pathways and programmes from each region were categorized into four groups, based on the requirement of pre‐ or post‐marketing clinical data. Expedited‐approval pathways in the USA and the EU provide similar qualification criteria, such as severity of target disease; however, such criteria are not specified for the new pathway in Japan. Only the Japanese pathway stipulates a time limitation on exceptional approval, requiring post‐marketing study for conditional and time‐limited products. Continuous improvement is necessary to solve previously addressed issues within the expedited‐approval pathways and programmes and to ensure that innovative medical products are rigourously screened, but also readily available to patients in need. The time limitation of conditional approval could be a potential solution to some of these problems. Copyright © 2017 The Authors. Tissue Engineering Regenerative Medicine published by John Wiley & Sons, Ltd. PMID:28211195

28 CFR 35.150 - Existing facilities.

Code of Federal Regulations, 2010 CFR

2010-07-01

... public entity to take any action that it can demonstrate would result in a fundamental alteration in the... the previous transition plan. (Approved by the Office of Management and Budget under control number...

24 CFR 891.750 - Selection and admission of tenants.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., creed, religion, sex, handicap, or national origin. (4) Records on applicants and approved eligible families, which provide racial, ethnic, gender and place of previous residency data required by HUD, must...

24 CFR 891.750 - Selection and admission of tenants.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., creed, religion, sex, handicap, or national origin. (4) Records on applicants and approved eligible families, which provide racial, ethnic, gender and place of previous residency data required by HUD, must...

The FDA Unapproved Drugs Initiative: An Observational Study of the Consequences for Drug Prices and Shortages in the United States.

PubMed

Gupta, Ravi; Dhruva, Sanket S; Fox, Erin R; Ross, Joseph S

2017-10-01

Hundreds of drug products are currently marketed in the United States without approval from the FDA. The 2006 Unapproved Drugs Initiative (UDI) requires manufacturers to remove these drug products from the market or obtain FDA approval by demonstrating evidence of safety and efficacy. Once the FDA acts against an unapproved drug, fewer manufacturers remain in the market, potentially enabling drug price increases and greater susceptibility to drug shortages. There is a need for systematic study of the UDI's effect on prices and shortages of all targeted drugs. To examine the clinical evidence for approval and association with prices and shortages of previously unapproved prescription drugs after being addressed by the UDI. Previously unapproved prescription drugs that faced UDI regulatory action or with at least 1 product that received FDA approval through manufacturers' voluntary compliance with the UDI between 2006 and 2015 were identified. The clinical evidence was categorized as either newly conducted clinical trials or use of previously published literature and/or bioequivalence studies to demonstrate safety and efficacy. We determined the change in average wholesale price, presence of shortage, and duration of shortage for each drug during the 2 years before and after UDI regulatory action or approval through voluntary compliance. Between 2006 and 2015, 34 previously unapproved prescription drugs were addressed by the UDI. Nearly 90% of those with a drug product that received FDA approval were supported by literature reviews or bioequivalence studies, not new clinical trial evidence. Among the 26 drugs with available pricing data, average wholesale price during the 2 years before and after voluntary approval or UDI action increased by a median of 37% (interquartile range [IQR] = 23%-204%; P < 0.001). The number of drugs in shortage increased from 17 (50.0%) to 25 (73.5%) during the 2 years before and after, respectively (P = 0.046). The median shortage duration in the 2 years before and after voluntary approval or UDI action increased from 31 days (IQR = 0-339) to 217 days (IQR = 0-406; P = 0.053). The UDI was associated with higher drug prices and more frequent drug shortages when compared with the period before UDI action, while the approval process for these drugs did not necessarily require new clinical evidence to establish safety or efficacy. This project was not supported by any external grants or funds. Gupta was supported by the Yale University School of Medicine Office of Student Research at the time of this study. Dhruva is supported by the Department of Veterans Affairs as part of the Robert Wood Johnson Foundation Clinical Scholars program. Ross reports receiving research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing; from Medtronic and the FDA to develop methods for postmarket surveillance of medical devices; from the FDA to establish the Yale-Mayo Clinic Center of Excellence in Regulatory Science and Innovation; from the Blue Cross Blue Shield Association to better understand medical technology evidence generation; from the Centers for Medicare & Medicaid Services to develop and maintain performance measures that are used for public reporting; and from the Laura and John Arnold Foundation to support the Collaboration on Research Integrity and Transparency at Yale. Fox reports travel support from Oklahoma Society of Health System Pharmacists, Premier Oncology Hematology Management Society, and SEHA-United Arab Emirates. Vizient provides some financial support to the University of Utah Drug Information Service to provide summaries of drug shortage information. Gupta and Ross were responsible for the conception and design of this work, drafted the manuscript, and conducted the statistical analysis. Gupta and Fox were responsible for acquisition of data. Ross provided supervision. All authors participated in the analysis and interpretation of the data and critically revised the manuscript for important intellectual content.

30 CFR 18.61 - Final inspection of complete machine.

Code of Federal Regulations, 2011 CFR

2011-07-01

... substantially modified design of a previously approved one shall be inspected by a qualified representative(s... requirements of this part with respect to joints, lead entrances, and other pertinent features. (2) Wiring...

KCBX Petroleum Coke Storage Pile Sampling Logbook and Photos

EPA Pesticide Factsheets

This documentation of KCBX's petcoke sampling locations and methods demonstrates adherence to the pet coke sampling plan previously submitted and approved by EPA, at both North Terminal and South Terminal stockpiles.

76 FR 13655 - Agency Information Collection Activities: Ship's Store Declaration

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-14

...U.S. Customs and Border Protection (CBP) of the Department of Homeland Security will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act: Ship's Stores Declaration (CBP Form 1303). This is a proposed extension of an information collection that was previously approved. CBP is proposing that this information collection be extended with a change to the burden hours. This document is published to obtain comments from the public and affected agencies. This proposed information collection was previously published in the Federal Register (76 FR 2403) on January 13, 2011, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments. This process is conducted in accordance with 5 CFR 1320.10.

78 FR 27984 - Agency Information Collection Activities: Ship's Store Declaration

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-13

...U.S. Customs and Border Protection (CBP) of the Department of Homeland Security will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act: Ship's Stores Declaration (CBP Form 1303). This is a proposed extension of an information collection that was previously approved. CBP is proposing that this information collection be extended with no change to the burden hours. This document is published to obtain comments from the public and affected agencies. This proposed information collection was previously published in the Federal Register (78 FR 15031) on March 8, 2013, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments. This process is conducted in accordance with 5 CFR 1320.10.

A decade of marketing approval of gene and cell-based therapies in the United States, European Union and Japan: An evaluation of regulatory decision-making.

PubMed

Coppens, D G M; de Wilde, S; Guchelaar, H J; De Bruin, M L; Leufkens, H G M; Meij, P; Hoekman, J

2018-05-02

There is a widely held expectation of clinical advance with the development of gene and cell-based therapies (GCTs). Yet, establishing benefits and risks is highly uncertain. We examine differences in decision-making for GCT approval between jurisdictions by comparing regulatory assessment procedures in the United States (US), European Union (EU) and Japan. A cohort of 18 assessment procedures was analyzed by comparing product characteristics, evidentiary and non-evidentiary factors considered for approval and post-marketing risk management. Product characteristics are very heterogeneous and only three products are marketed in multiple jurisdictions. Almost half of all approved GCTs received an orphan designation. Overall, confirmatory evidence or indications of clinical benefit were evident in US and EU applications, whereas in Japan approval was solely granted based on non-confirmatory evidence. Due to scientific uncertainties and safety risks, substantial post-marketing risk management activities were requested in the EU and Japan. EU and Japanese authorities often took unmet medical needs into consideration in decision-making for approval. These observations underline the effects of implemented legislation in these two jurisdictions that facilitate an adaptive approach to licensing. In the US, the recent assessments of two chimeric antigen receptor-T cell (CAR-T) products are suggestive of a trend toward a more permissive approach for GCT approval under recent reforms, in contrast to a more binary decision-making approach for previous approvals. It indicates that all three regulatory agencies are currently willing to take risks by approving GCTs with scientific uncertainties and safety risks, urging them to pay accurate attention to post-marketing risk management. Copyright © 2018 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

75 FR 54916 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-09

... Web site at http://www.reginfo.gov/public/do/PRAMain or by contacting Michel Smyth on 202- 693-4129... previously approved collection. Title of Collection: Crawler, Locomotive, and Truck Cranes Standard (29 CFR...

24 CFR 880.603 - Selection and admission of assisted tenants.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., creed, religion, sex, or national origin. See 24 CFR part 5 for the informal review provisions for the... applicants and approved eligible families, which provide racial, ethnic, gender and place of previous...

24 CFR 880.603 - Selection and admission of assisted tenants.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., creed, religion, sex, or national origin. See 24 CFR part 5 for the informal review provisions for the... applicants and approved eligible families, which provide racial, ethnic, gender and place of previous...

75 FR 52029 - Agency Information Collection Activities: Reinstatement, With Change, of a Previously Approved...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-24

... Criminal History Information Systems. The Department of Justice (DOJ), Office of Justice Programs, Bureau... State Criminal History Information Systems. (3) Agency form number, if any, and the applicable component...

46 CFR 76.05-20 - Fixed fire extinguishing systems.

Code of Federal Regulations, 2010 CFR

2010-10-01

... all self-propelled vessels and on all barges with sleeping accommodations for more than six persons. Previously approved installations may be retained as long as they are maintained in good condition to the...

46 CFR 76.05-20 - Fixed fire extinguishing systems.

Code of Federal Regulations, 2013 CFR

2013-10-01

... all self-propelled vessels and on all barges with sleeping accommodations for more than six persons. Previously approved installations may be retained as long as they are maintained in good condition to the...

46 CFR 76.05-20 - Fixed fire extinguishing systems.

Code of Federal Regulations, 2011 CFR

2011-10-01

... all self-propelled vessels and on all barges with sleeping accommodations for more than six persons. Previously approved installations may be retained as long as they are maintained in good condition to the...

46 CFR 76.05-20 - Fixed fire extinguishing systems.

Code of Federal Regulations, 2012 CFR

2012-10-01

... all self-propelled vessels and on all barges with sleeping accommodations for more than six persons. Previously approved installations may be retained as long as they are maintained in good condition to the...

46 CFR 76.05-20 - Fixed fire extinguishing systems.

Code of Federal Regulations, 2014 CFR

2014-10-01

... all self-propelled vessels and on all barges with sleeping accommodations for more than six persons. Previously approved installations may be retained as long as they are maintained in good condition to the...

The NCGC Pharmaceutical Collection: A comprehensive resource of clinically approved drugs enabling repurposing and chemical genomics

PubMed Central

Huang, Ruili; Southall, Noel; Wang, Yuhong; Yasgar, Adam; Shinn, Paul; Jadhav, Ajit; Nguyen, Dac-Trung; Austin, Christopher P.

2011-01-01

Small-molecule compounds approved for use as drugs may be “repurposed” for new indications and studied to determine the mechanisms of their beneficial and adverse effects. A comprehensive collection of all small-molecule drugs approved for human use would be invaluable for systematic repurposing across human diseases, particularly for rare and neglected diseases, for which the cost and time required for development of a new chemical entity are often prohibitive. Previous efforts to build such a comprehensive collection have been limited by the complexities, redundancies, and semantic inconsistencies of drug naming within and among regulatory agencies worldwide; a lack of clear conceptualization of what constitutes a drug; and a lack of access to physical samples. We report here the creation of a definitive, complete, and nonredundant list of all approved molecular entities as a freely available electronic resource and a physical collection of small molecules amenable to high-throughput screening. PMID:21525397

The Influence of Confidence on Associations Among Personal Attitudes, Perceived Injunctive Norms, and Alcohol Consumption

PubMed Central

Neighbors, Clayton; Lindgren, Kristen P.; Knee, C. Raymond; Fossos, Nicole; DiBello, Angelo

2011-01-01

Social norms theories hold that perceptions of the degree of approval for a behavior have a strong influence on one’s private attitudes and public behavior. In particular, being more approving of drinking and perceiving peers as more approving of drinking, are strongly associated with one’s own drinking. However, previous research has not considered that students may vary considerably in the confidence in their estimates of peer approval and in the confidence in their estimates of their own approval of drinking. The present research was designed to evaluate confidence as a moderator of associations among perceived injunctive norms, own attitudes, and drinking. We expected perceived injunctive norms and own attitudes would be more strongly associated with drinking among students who felt more confident in their estimates of peer approval and own attitudes. We were also interested in whether this might differ by gender. Injunctive norms and self-reported alcohol consumption were measured in a sample of 708 college students. Findings from negative binomial regression analyses supported moderation hypotheses for confidence and perceived injunction norms but not for personal attitudes. Thus, perceived injunctive norms were more strongly associated with own drinking among students who felt more confident in their estimates of friends’ approval of drinking. A three-way interaction further revealed that this was primarily true among women. Implications for norms and peer influence theories as well as interventions are discussed. PMID:21928864

Barroom Aggression Among Australian Men: Associations With Heavy Episodic Drinking, Conformity to Masculine Norms, and Personal and Perceived Peer Approval of Barroom Aggression.

PubMed

Miller, Peter; Zinkiewicz, Lucy; Hayley, Alexa; Sonderlund, Anders; Litherland, Steven; Medew-Ewen, Tess; Wells, Samantha; Graham, Kathryn

2016-05-01

Research suggests that heavy episodic drinking (HED), perceived peer norms, and personal approval of aggression influence male barroom aggression (MBA). Qualitative research suggests that conformity to hegemonic masculine gender norms also influences MBA; however, quantitative research on the direct and indirect influence of masculinity on MBA is limited. This study tested the relationships between HED, conformity to masculine gender norms, and personal approval and peer approval of MBA on MBA perpetration, as well as the indirect effect of masculine norms on MBA via HED. A convenience sample of Australian men (N = 322; mean age = 21.05 years, SD = 1.95; 76.9% university students) completed an online questionnaire, assessing HED and MBA over the previous year, and subscales of the Beliefs and Attitudes Towards Male Alcohol-Related Aggression Inventory and Conformity to Masculine Norms Inventory-46. Negative binomial regression analyses found that, overall, HED, male peer approval, and personal approval of MBA directly predicted increased risk of verbal and physical MBA perpetration. Greater conformity to specific masculine norms also increased (Power Over Women) and decreased (Emotional Control, Heterosexual Self-Presentation) risk of MBA perpetration. The masculine norms Risk Taking, Playboy, and Emotional Control were found to be indirect predictors of MBA via HED. Risk of MBA perpetration is increased primarily by HED as a direct, but also mediating, predictor. Personal and male peer approval of MBA, and specific masculine norms, further increase this risk whereas other masculine norms appear protective.

75 FR 71067 - Notice of Request for Reinstatement of a Previously Approved Information Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-22

..., disability, religion, sexual orientation, marital or familial status, or because all or part of the..., disability, religion or political beliefs). (Not all bases apply to all programs.) The program discrimination...

76 FR 82306 - Draft Guidance for Industry on Use of Histology in Biomarker Qualification Studies; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-30

... evolution and reversibility of morphologic changes. Because of the many variations in the practice of..., and other forms of information technology. This draft guidance refers to previously approved...

30 CFR 816.106 - Backfilling and grading: Previously mined areas.

Code of Federal Regulations, 2010 CFR

2010-07-01

... operation shall be included within the permit area. (2) The backfill shall be graded to a slope which is compatible with the approved postmining land use and which provides adequate drainage and long-term stability...

30 CFR 817.106 - Backfilling and grading: Previously mined areas.

Code of Federal Regulations, 2010 CFR

2010-07-01

... operation shall be included within the permit area. (2) The backfill shall be graded to a slope which is compatible with the approved postmining land use and which provides adequate drainage and long-term stability...

77 FR 32170 - Notice of Request for Renewal of Previously Approved Collection; Short Term Lending Program...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-31

.... Aging report of receivables and payables; d. Business tax returns; e. Business financial statements; f... submits a monthly status of active guaranteed loans to OSDBU. Respondents: 100. Frequency: Monthly...

75 FR 42473 - Request for Renewal of a Previously Approved Information Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-21

.... Typically, subsidized air carriers are small businesses and operate only aircraft of limited size over a... the Office of Management and Budget, Attention: Desk Officer for the Office of the Secretary of...

78 FR 36576 - Agency Information Collection Activities; Reinstatement of a Previously Approved Collection...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-18

... estimate of the burden of the proposed collection of information, including the validity of the methodology... contacted a second time to participate in reliability testing for selected items. This testing will average...

77 FR 5523 - Notice of Submission of Proposed Information Collection to OMB Emergency Comment Request...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-03

... Burden: 2,360 222 ... 0.698 ... 367,081 Status: Reinstatement, with change, of previously approved... U.S.C. 35, as amended. Dated: January 27, 2012. Colette Pollard, Departmental Reports Management...

Comparison of the new Japanese legislation for expedited approval of regenerative medicine products with the existing systems in the USA and European Union.

PubMed

Jokura, Yoji; Yano, Kazuo; Yamato, Masayuki

2018-02-01

Legislation for expedited-approval pathways and programmes for drugs, biologics or medical devices has been enacted for rapid commercialization of innovative products in the United States of America (USA) and the European Union (EU). However, less innovative products are increasingly benefitting from these expedited-approval pathways, and obligations to collect and report post-marketing data on approved products are being bypassed frequently. The Japanese government recently enacted legislation for a new conditional and time-limited approval pathway dedicated to regenerative medicine products. The current study examines this new legislation and compares it with existing US and EU regulatory frameworks, with a particular focus on how it addresses the limitations of existing systems. Regulations, guidance documents and approval information were gathered from the websites of the respective authorities in the USA, the EU and Japan, and the systems were categorized through qualitative analysis. The pathways and programmes from each region were categorized into four groups, based on the requirement of pre- or post-marketing clinical data. Expedited-approval pathways in the USA and the EU provide similar qualification criteria, such as severity of target disease; however, such criteria are not specified for the new pathway in Japan. Only the Japanese pathway stipulates a time limitation on exceptional approval, requiring post-marketing study for conditional and time-limited products. Continuous improvement is necessary to solve previously addressed issues within the expedited-approval pathways and programmes and to ensure that innovative medical products are rigourously screened, but also readily available to patients in need. The time limitation of conditional approval could be a potential solution to some of these problems. Copyright © 2017 The Authors. Tissue Engineering Regenerative Medicine published by John Wiley & Sons, Ltd. Copyright © 2017 The Authors. Tissue Engineering Regenerative Medicine published by John Wiley & Sons, Ltd.

A Phase 3, multicenter, open-label, switchover trial to assess the safety and efficacy of taliglucerase alfa, a plant cell-expressed recombinant human glucocerebrosidase, in adult and pediatric patients with Gaucher disease previously treated with imiglucerase.

PubMed

Pastores, Gregory M; Petakov, Milan; Giraldo, Pilar; Rosenbaum, Hanna; Szer, Jeffrey; Deegan, Patrick B; Amato, Dominick J; Mengel, Eugen; Tan, Ee Shien; Chertkoff, Raul; Brill-Almon, Einat; Zimran, Ari

2014-12-01

Taliglucerase alfa is a β-glucosidase enzyme replacement therapy (ERT) approved in the US and other countries for the treatment of Gaucher disease (GD) in adults and is approved in pediatric and adult patients in Australia and Canada. It is the first approved plant cell-expressed recombinant human protein. A Phase 3, multicenter, open-label, 9-month study assessed safety and efficacy of switching to taliglucerase alfa in adult and pediatric patients with GD treated with imiglucerase for at least the previous 2years. Patients with stable disease were offered taliglucerase alfa treatment using the same dose (9-60U/kg body weight) and regimen of administration (every 2weeks) as imiglucerase. This report summarizes results from 26 adult and 5 pediatric patients who participated in the trial. Disease parameters (spleen and liver volumes, hemoglobin concentration, platelet count, and biomarker levels) remained stable through 9months of treatment in adults and children following the switch from imiglucerase. All treatment-related adverse events were mild or moderate in severity and transient in nature. Exploratory parameters of linear growth and development showed positive outcomes in pediatric patients. These findings provide evidence of the efficacy and safety profile of taliglucerase alfa as an ERT for GD in patients previously treated with imiglucerase. This trial was registered at www.clinicaltrials.gov as # NCT00712348. Copyright © 2014 Elsevier Inc. All rights reserved.

49 CFR 633.29 - PMP waivers.

Code of Federal Regulations, 2010 CFR

2010-10-01

... TRANSPORTATION PROJECT MANAGEMENT OVERSIGHT Project Management Plans § 633.29 PMP waivers. A waiver will be... element is not necessary for a particular plan; or (b) The requirement of having a new project management... under a previously-approved project management plan. ...

78 FR 48177 - Submission for OMB Review; 30-day Comment Request: National Institute of Mental Health Data...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-07

... Access Request and Use Certification (previously National Database for Autism Research Data Access... approval for use of the National Database for Autism Research (NDAR) Data Use Certification (DUC) Form...

77 FR 70747 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-27

... Statistics to calculate burden costs. Additionally, there is an increase in the total number of annual responses due to a mathematical correction made in the previous ICR. John Moses, Director, Collection...

78 FR 2295 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-10

... Emerging Markets Corporate Bond Fund). Additionally, the Commission has previously approved the listing and... fundamental credit selection process with top down relative value analysis when selecting investment... [[Page 2297

Development of a Mobile Tracer Correlation Method for Assessment of Air Emissions from Landfills and Other Area Sources

EPA Science Inventory

Information form the previously approved extended abstract A standardized area source measurement method based on mobile tracer correlation was used for methane emissions assessment in 52 field deployments...

75 FR 45093 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-02

...: National Oceanic and Atmospheric Administration (NOAA). Title: Marine Recreational Fisheries Statistics... revision of a previously approved information collection. Marine recreational anglers are surveyed for catch and effort data, fish biology data, and angler socioeconomic characteristics. These data are...

49 CFR 633.29 - PMP waivers.

Code of Federal Regulations, 2012 CFR

2012-10-01

... TRANSPORTATION PROJECT MANAGEMENT OVERSIGHT Project Management Plans § 633.29 PMP waivers. A waiver will be... element is not necessary for a particular plan; or (b) The requirement of having a new project management... under a previously-approved project management plan. ...

49 CFR 633.29 - PMP waivers.

Code of Federal Regulations, 2011 CFR

2011-10-01

... TRANSPORTATION PROJECT MANAGEMENT OVERSIGHT Project Management Plans § 633.29 PMP waivers. A waiver will be... element is not necessary for a particular plan; or (b) The requirement of having a new project management... under a previously-approved project management plan. ...

49 CFR 633.29 - PMP waivers.

Code of Federal Regulations, 2014 CFR

2014-10-01

... TRANSPORTATION PROJECT MANAGEMENT OVERSIGHT Project Management Plans § 633.29 PMP waivers. A waiver will be... element is not necessary for a particular plan; or (b) The requirement of having a new project management... under a previously-approved project management plan. ...

49 CFR 633.29 - PMP waivers.

Code of Federal Regulations, 2013 CFR

2013-10-01

... TRANSPORTATION PROJECT MANAGEMENT OVERSIGHT Project Management Plans § 633.29 PMP waivers. A waiver will be... element is not necessary for a particular plan; or (b) The requirement of having a new project management... under a previously-approved project management plan. ...

77 FR 46750 - Agency Information Collection Extension

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-06

... Questionnaire Testing, Evaluation, and Research.'' The proposed collection will utilize qualitative and quantitative methodologies to pretest questionnaires and validate EIA survey forms data quality, including..., Evaluation, and Research; (3) Type of Request: Extension, Without Change, of a Previously Approved Collection...

75 FR 45664 - Agency Information Collection Activities; Proposed Collection; Comments Requested

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-03

... DEPARTMENT OF JUSTICE Justice Management Division [OMB Number 1103-0018] Agency Information Collection Activities; Proposed Collection; Comments Requested ACTION: 30-Day Notice of Information Collection Under Review: Extension of Previously Approved Collection, Department of Justice Procurement...

77 FR 14861 - Approval and Promulgation of Implementation Plans; State of Nevada; Revised Format for Materials...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-13

...EPA is revising the format for materials submitted by the State of Nevada that are incorporated by reference (IBR) into the Nevada State Implementation Plan (SIP). The regulations affected by this format change have all been previously submitted by the State of Nevada and approved by EPA. This format revision will primarily affect the ``Identification of plan'' section, as well as the format of the SIP materials that will be available for public inspection at the National Archives and Records Administration (NARA), the Air and Radiation Docket and Information Center located at EPA Headquarters in Washington, DC, and the EPA Regional Office. EPA is also adding a table in the ``Identification of plan'' section which summarizes the approval actions that EPA has taken on the non-regulatory and quasi-regulatory portions of the Nevada SIP.

Technical Review Report for the Mound 1KW Package Safety Analysis Report for Packaging Waiver for the Use of Modified Primary Containment Vessel (PCV)

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

West, M; Hafner, R

2008-05-05

This Technical Review Report (TRR) documents the review, performed by the Lawrence Livermore National Laboratory (LLNL) staff, at the request of the U.S. Department of Energy (DOE), on the Waiver for the Use of Modified Primary Containment Vessels (PCV). The waiver is to be used to support a limited number of shipments of fuel for the Multi-Mission Radioisotope Thermoelectric Generator (MMRTG) Project in support of the National Aeronautics and Space Administration's (NASA's) Mars Science Laboratory (MSL) mission. Under the waiver, an inventory of existing national security PCVs will be converted to standard PCVs. Both types of PCVs are currently approvedmore » for use by the Office of Nuclear Energy. LLNL has previously reviewed the national security PCVs under Mound 1KW Package Safety Analysis Report for Packaging, Addendum No. 1, Revision c, dated June 2007 (Addendum 1). The safety analysis of the package is documented in the Safety Analysis Report for Packaging (SARP) for the Mound 1KW Package (i.e., the Mound 1KW SARP, or the SARP) where the standard PCVs have been reviewed by LLNL. The Mound 1KW Package is certified by DOE Certificate of Compliance (CoC) number USA/9516/B(U)F-85 for the transportation of Type B quantities of plutonium heat source material. The waiver requests an exemption, claiming safety equivalent to the requirements specified in 10 CFR 71.12, Specific Exemptions, and will lead to a letter amendment to the CoC. Under the waiver, the Office of Radioisotope Power Systems, NE-34, is seeking an exemption from 10 CFR 71.19(d)(1), Previously Approved Package,[5] which states: '(d) NRC will approve modifications to the design and authorized contents of a Type B package, or a fissile material package, previously approved by NRC, provided--(1) The modifications of a Type B package are not significant with respect to the design, operating characteristics, or safe performance of the containment system, when the package is subjected to the tests specified in {section}71.71 and 71.73.' The LLNL staff had previously reviewed a request from Idaho National Laboratory (INL) to reconfigure national security PCVs to standard PCVs. With a nominal 50% reduction in both the height and the volume, the LLNL staff initially deemed the modifications to be significant, which would not be allowed under the provisions of 10 CFR 71.19(d)(1)--see above. As a follow-up, the DOE requested additional clarification from the Nuclear Regulatory Commission (NRC). The NRC concluded that the reconfiguration would be a new fabrication, and that an exemption to the regulations would be required to allow its use, as per the requirements specified in 10 CFR 71.19(c)(1), Previously Approved Package: '(c) A Type B(U) package, a Type B(M) package, or a fissile material package previously approved by the NRC with the designation '-85' in the identification number of the NRC CoC, may be used under the general license of {section}71.17 with the following additional conditions: (1) Fabrication of the package must be satisfactorily completed by December 31, 2006, as demonstrated by application of its model number in accordance with 71.85(c).' Although the preferred approach toward the resolution of this issue would be for the applicant to submit an updated SARP, the applicant has stated that the process of updating the Model Mound 1KW Package SARP is a work that is in progress, but that the updated SARP is not yet ready for submittal. The applicant has to provide a submittal, proving that the package meets the '-96' requirements of International Atomic Energy Agency (IAEA) Safety Standards Series No. TS-R-1, in order to fabricate approved packagings after December 31, 2006. The applicant has further stated that all other packaging features, as described in the currently approved Model Mound 1KW Package SARP, remain unchanged. This report documents the LLNL review of the waiver request. The specific review for each SARP Chapter is documented.« less

77 FR 62273 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-12

... automating regulatory filings and business information processing. We estimate that 10,229 respondents per... Budget (``OMB'') this request for extension of the previously approved collection of information discussed below. The ``Interactive Data'' collection of information requires issuers filing registration...

77 FR 30265 - Submission for OMB Review; Small Business Size Representation

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-22

... Information Collection 9000- 0163, Small Business Size Representation, by any of the following methods... Business Size Representation AGENCY: Department of Defense (DOD), General Services Administration (GSA... of a previously approved information collection requirement regarding small business size...

77 FR 38062 - Proposed Agency Information Collection Activities; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-26

... FEDERAL MEDIATION AND CONCILIATION SERVICE Proposed Agency Information Collection Activities; Comment Request AGENCY: Federal Mediation and Conciliation Service. ACTION: Notice of request for renewal of previously approved collection form FMCS F-7. SUMMARY: The Federal Mediation and Conciliation...

Midwest Guardrail System (MGS) with southern yellow pine posts.

DOT National Transportation Integrated Search

2013-09-01

The Midwest Guardrail System (MGS) has previously been approved for use with various alternative species of wood posts. However, Southern Yellow Pine (SYP) is the most common wood guardrail post material in the United States. The goal of this researc...

77 FR 35473 - Reports, Forms, and Recordkeeping Requirements

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-13

... DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration [U.S. DOT Docket No. NHTSA-2012-0066] Reports, Forms, and Recordkeeping Requirements AGENCY: National Highway Traffic Safety Administration (NHTSA), DOT. ACTION: Request for public comment on proposed revision of the previously approved...

78 FR 26776 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-08

... number EPA-HQ- OECA-2012-0657, to: (1) EPA online, using www.regulations.gov (our preferred method), or... estimates that are attributed to the correction of mathematical discrepancies identified in the previous ICR...

75 FR 52007 - Proposed Information Collection Activity; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-24

...) Community Economic Development (CED) and Job Opportunities for Low-Income Individuals (JOLI) Standard... key information about projects funded through the Community Economic Development (CED) and Job... previously approved questionnaire, Office of Management and Budget (OMB) Control Number: 0970-0317. Questions...

75 FR 30858 - Justice Management Division; Agency Information Collection Activities: Proposed Collection...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-02

... DEPARTMENT OF JUSTICE [OMB Number 1103-0018] Justice Management Division; Agency Information Collection Activities: Proposed Collection: Common Request ACTION: 60-Day Notice of Information Collection Under Review: Extension of Previously Approved Collection; Department of Justice Procurement Blanket...

Review of Studies Concerning Electromagnetic Field (EMF) Exposure Assessment in Europe: Low Frequency Fields (50 Hz–100 kHz)

PubMed Central

Gajšek, Peter; Ravazzani, Paolo; Grellier, James; Samaras, Theodoros; Bakos, József; Thuróczy, György

2016-01-01

We aimed to review the findings of exposure assessment studies done in European countries on the exposure of the general public to low frequency electric and magnetic fields (EMFs) of various frequencies. The study shows that outdoor average extremely low frequency magnetic fields (ELF-MF) in public areas in urban environments range between 0.05 and 0.2 µT in terms of flux densities, but stronger values (of the order of a few µT) may occur directly beneath high-voltage power lines, at the walls of transformer buildings, and at the boundary fences of substations. In the indoor environment, high values have been measured close to several domestic appliances (up to the mT range), some of which are held close to the body, e.g., hair dryers, electric shavers. Common sources of exposure to intermediate frequencies (IF) include induction cookers, compact fluorescent lamps, inductive charging systems for electric cars and security or anti-theft devices. No systematic measurement surveys or personal exposimetry data for the IF range have been carried out and only a few reports on measurements of EMFs around such devices are mentioned. According to the available European exposure assessment studies, three population exposure categories were classified by the authors regarding the possible future risk analysis. This classification should be considered a crucial advancement for exposure assessment, which is a mandatory step in any future health risk assessment of EMFs exposure. PMID:27598182

Bank security dye packs: synthesis, isolation, and characterization of chlorinated products of bleached 1-(methylamino)anthraquinone.

PubMed

Egan, James M; Rickenbach, Michael; Mooney, Kim E; Palenik, Chris S; Golombeck, Rebecca; Mueller, Karl T

2006-11-01

Banknote evidence is often submitted after a suspect has attempted to disguise or remove red dye stain that has been released because of an anti-theft device that activates after banknotes have been unlawfully removed from bank premises. Three chlorinated compounds have been synthesized as forensic chemical standards to indicate bank security dye bleaching as a suspect's intentional method for masking a robbery involving dye pack release on banknotes. A novel, facile synthetic method to provide three chlorinated derivatives of 1-(methylamino)anthraquinone (MAAQ) is presented. The synthetic route involved Ultra Clorox bleach as the chlorine source, iron chloride as the catalyst, and MAAQ as the starting material and resulted in a three-component product mixture. Two mono-chlorinated isomers (2-chloro-1-(methylamino)anthraquinone and 4-chloro-1-(methylamino)anthraquinone) and one di-chlorinated compound (2,4-dichloro-1-(methylamino)anthraquinone) of the MAAQ parent molecule were detected by gas chromatography mass spectrometry (GC-MS), and subsequently isolated by liquid chromatography (LC) with postcolumn fraction collection. Although GC-MS is sensitive enough to detect all of the chlorinated products, it is not definitive enough to identify the structural isomers. Liquid-state nuclear magnetic resonance (NMR) spectroscopy was utilized to elucidate structurally the ortho- and para-mono-chlorinated isomers once enough material was properly isolated. A reaction mechanism involving iron is proposed to explain the presence of chlorinated MAAQ species on stolen banknotes after attempted bleaching.

Review of Studies Concerning Electromagnetic Field (EMF) Exposure Assessment in Europe: Low Frequency Fields (50 Hz-100 kHz).

PubMed

Gajšek, Peter; Ravazzani, Paolo; Grellier, James; Samaras, Theodoros; Bakos, József; Thuróczy, György

2016-09-01

We aimed to review the findings of exposure assessment studies done in European countries on the exposure of the general public to low frequency electric and magnetic fields (EMFs) of various frequencies. The study shows that outdoor average extremely low frequency magnetic fields (ELF-MF) in public areas in urban environments range between 0.05 and 0.2 µT in terms of flux densities, but stronger values (of the order of a few µT) may occur directly beneath high-voltage power lines, at the walls of transformer buildings, and at the boundary fences of substations. In the indoor environment, high values have been measured close to several domestic appliances (up to the mT range), some of which are held close to the body, e.g., hair dryers, electric shavers. Common sources of exposure to intermediate frequencies (IF) include induction cookers, compact fluorescent lamps, inductive charging systems for electric cars and security or anti-theft devices. No systematic measurement surveys or personal exposimetry data for the IF range have been carried out and only a few reports on measurements of EMFs around such devices are mentioned. According to the available European exposure assessment studies, three population exposure categories were classified by the authors regarding the possible future risk analysis. This classification should be considered a crucial advancement for exposure assessment, which is a mandatory step in any future health risk assessment of EMFs exposure.

The relative efficacy of three interventions to favour return to give blood.

PubMed

Myhal, Geneviève; Godin, Gaston; Dubuc, Sophie

2017-09-01

The aim of the study was to test the relative efficacy of action planning and reward distribution to promote retention of whole blood donors. A sample of 7,399 donors was randomised to one of three interventions: "action planning" (n=2,585); "reward" (n=2,397); and "thank you" (n=2,417). Participants in the action planning condition were invited to write the date of their next donation on a post-it note before taking it home at the end of the donation process. Participants in the "reward" condition were given an anti-theft credit card sleeve at the end of the donation process. The "thank you" intervention is the usual condition at the end of the process; it was considered the control condition. The dependent variable was the proportion of donors who registered to give blood at six months. Overall, 4,444 (60.06%) donors registered to give blood at six months. There were no differences between the three interventions in the proportions of donors who registered to give blood (d.f. 2, chi-square=3.72, p<0.15). However, gender modified the effect of the intervention (d.f. 2, chi-square=6.57, p<0.0375); more women registered in the "thank you" condition than in the other two. The results suggest that action planning and the distribution of a reward have no motivational effect on the return to give blood. Nonetheless, women appear to respond more negatively to these interventions at the end of the donation process.

38 CFR 39.32 - Plan preparation.

Code of Federal Regulations, 2011 CFR

2011-07-01

... a previously approved project and there have been no changes. Relevant information may then be shown... having other change or direction between corners) shall be referenced with curve data (including... indicated. The master plan shall analyze all factors affecting the design, including climate, soil...

76 FR 70827 - Proposed Information Collection (Supplier Perception Survey) Activity; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-15

... DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-0751] Proposed Information Collection (Supplier Perception Survey) Activity; Comment Request AGENCY: Office of Acquisition and Logistics... Perception Survey. OMB Control Number: 2900-0751. Type of Review: Extension of previously approved collection...

77 FR 62272 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-12

... securities, the trustee or custodian, and financial statements. The Commission uses the information provided... Copies Available From: Securities and Exchange Commission, Office of Investor Education and Advocacy... (``OMB'') a request for extension of the previously approved collection of information discussed below...

78 FR 15721 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-12

... Bureau of Labor Statistics to calculate respondent burden costs. This ICR also uses updated labor rates.... This increase is due to a mathematical error identified in the previous ICR and is not due to changes...

77 FR 38626 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-28

... Bureau of Labor Statistics to calculate burden costs. There is an increase of one hour in the Agency burden related to a mathematical rounding error in the previous ICR. There is no change in the estimation...

77 FR 56200 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-12

... subject to this standard, and corrections to mathematical errors found in the previous ICR. The growth in... most recent labor rates from the Bureau of Labor Statistics in calculating the labor costs. There is a...

Anual Report of Groundwater Monitoring at Centralia, Kansas, in 2015

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

LaFreniere, Lorraine M.

2016-10-01

The KDHE (2012) agreed to annual sampling at all locations, beginning with the 2013 monitoring documented previously (Argonne 2014a). This present report documents the results of the annual sampling of the approved monitoring well network on September 27-30, 2015.

77 FR 34949 - Draft Guidance on Considerations in Transferring a Previously-Approved Research Project to a New...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-12

... jurisdiction. The agencies wish to stress, however, that our intent was to provide harmonized guidance to IRBs.... FDA and OHRP will continue to work closely in the development of final guidance and appreciate...

76 FR 30405 - Information Collection Request Under OMB Review

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-25

..., the National Agency Check (NAC) Questionnaire for Peace Corps Volunteer Background Investigation (OMB... INFORMATION: The NAC Questionnaire for Peace Corps Volunteer Background Investigation Form is used to conduct... Volunteer Background Investigation. Type of Review: Reinstatement, without change, of a previously approved...

38 CFR 39.8 - Plan preparation.

Code of Federal Regulations, 2010 CFR

2010-07-01

... previously approved project and there have been no changes. Relevant information may then be shown on the.... Boundaries of an unusual nature (curvilinear, off-set, or having other change or direction between corners..., including climate, soil conditions, site boundaries, topography, views, hydrology, environmental constraints...

75 FR 6417 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-09

... Regulatory Affairs, Office of Management and Budget, Room 10102, New Executive Office Building, Washington....), the Securities and Exchange Commission (``Commission'') has submitted to the Office of Management and Budget this request for extension of the previously approved collection of information discussed below...

75 FR 8760 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-25

... Regulatory Affairs, Office of Management and Budget, Room 10102, New Executive Office Building, Washington....), the Securities and Exchange Commission (``Commission'') has submitted to the Office of Management and Budget this request for extension of the previously approved collection of information discussed below...

77 FR 13329 - Information Collection; Small Business Size Representation

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-06

... Collection 9000- 0163, Small Business Size Representation, by any of the following methods: Regulations.gov... ADMINISTRATION [OMB Control No. 9000-0163; Docket 2011-0076; Sequence 6] Information Collection; Small Business... previously approved information collection requirement regarding small business size representation. DATES...

75 FR 54387 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-07

... previously approved collection. Title of Collection: Standard on Ethylene Oxide (29 CFR 1910.1047). OMB... requirements contained in the Standard. The information collection requirements specified in Ethylene Oxide... ethylene oxide. The principal information collection requirements in the EtO Standard include conducting...

75 FR 3236 - Federal Acquisition Regulation; Submission for OMB Review; Cost Accounting Standards Administration

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-20

... Accounting Standards Administration AGENCIES: Department of Defense (DOD), General Services Administration... extension of a previously approved information collection requirement concerning cost accounting standards... include pertinent rules and regulations related to the Cost Accounting Standards along with necessary...

75 FR 70008 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-16

... OMB Review; Comment Request Title: Office of Community Services (OCS) Community Economic Development... funded through the Community Economic Development (CED) and Job Opportunities for Low-Income Individuals... questions in this tool were adapted from a previously approved questionnaire, Office of Management and...

75 FR 8993 - Agency Information Collection Activities: Reinstatement, With Change, of a Previously Approved...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-26

... Publicly Funded Forensic Crime Laboratories. The Department of Justice (DOJ), Bureau of Justice Statistics... of Publicly Funded Forensic Crime Laboratories. (3) Agency form number, if any, and the applicable... perform forensic analyses on criminal evidence. [[Page 8994

77 FR 11937 - Approval and Promulgation of Air Quality Implementation Plans; State of Alabama; Regional Haze...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-28

...EPA is proposing a limited approval of a revision to the Alabama state implementation plan (SIP) submitted by the State of Alabama through the Alabama Department of Environmental Management (ADEM), on July 15, 2008, that addresses regional haze for the first implementation period. This revision addresses the requirements of the Clean Air Act (CAA or Act) and EPA's rules that require states to prevent any future and remedy any existing anthropogenic impairment of visibility in mandatory Class I areas (national parks and wilderness areas) caused by emissions of air pollutants from numerous sources located over a wide geographic area (also referred to as the ``regional haze program''). States are required to assure reasonable progress towards the national goal of achieving natural visibility conditions in Class I areas. EPA is proposing a limited approval of this SIP revision to implement the regional haze requirements for Alabama on the basis that the revision, as a whole, strengthens the Alabama SIP. Additionally, EPA is proposing to rescind the federal regulations previously approved into the Alabama SIP on November 24, 1987, and to rely on the provisions in Alabama's July 15, 2008, SIP submittal to meet the long-term strategy (LTS) requirements for reasonably attributable visibility impairment (RAVI). EPA has previously proposed a limited disapproval of the Alabama regional haze SIP because of deficiencies in the State's regional haze SIP submittal arising from the remand by the U.S. Court of Appeals for the District of Columbia Circuit (DC Circuit) to EPA of the Clean Air Interstate Rule (CAIR). Consequently, EPA is not proposing to take action in this rulemaking to address the State's reliance on CAIR to meet certain regional haze requirements.

Neratinib: First Global Approval.

PubMed

Deeks, Emma D

2017-10-01

Neratinib (Nerlynx™) is an oral, irreversible inhibitor of the human epidermal growth factor receptors HER1 (EGFR), HER2 and HER4. The drug originally arose from research by Wyeth (now Pfizer) and is now being developed by Puma Biotechnology primarily for the treatment of HER2-positive (HER+) breast cancer. Neratinib is approved in the USA for the extended adjuvant treatment of patients with HER2+ early-stage breast cancer who have been previously treated with a trastuzumab-based adjuvant regimen, and is in the preregistration phase for this indication in the EU. Neratinib, as monotherapy and/or combination therapy, is also in phase 3 development for metastatic breast cancer and in phase 1/2 development for advanced breast cancer and other solid tumours, including non-small cell lung cancer, colorectal cancer and glioblastoma. This article summarizes the milestones in the development of neratinib leading to this first approval for breast cancer.

78 FR 68056 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NSPS...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-13

...The Environmental Protection Agency has submitted an information collection request (ICR), ``NSPS for Stationary Gas Turbines (Renewal)'' (EPA ICR No. 1071.11, OMB Control No. 2060-0028), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq). This is a proposed extension of the ICR, which is currently approved through December 31, 2013. Public comments were previously requested via the Federal Register (78 FR 33409) on June 4, 2013, during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

FDA approval of expanded age indication for a tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine.

PubMed

2011-09-23

On July 8, 2011, the Food and Drug Administration (FDA) approved an expanded age indication for the tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap) Boostrix (GlaxoSmithKline Biologicals, Rixensart, Belgium). Originally, Boostrix was licensed in 2005 for persons aged 10 through 18 years, but in 2008, FDA approved an expanded age indication for Boostrix to include persons aged 19 through 64 years. FDA has now expanded the age indication to include persons aged 65 years and older. Boostrix is now licensed for use in persons aged 10 years and older as a single-dose booster vaccination. This notice summarizes the indications for use of Boostrix. Recommendations of the Advisory Committee on Immunization Practices (ACIP) for Tdap vaccines have been published previously. Publication of revised Tdap recommendations within the next year is anticipated.

76 FR 28823 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-18

..., Copies Available From: Securities and Exchange Commission, Office of Investor Education and Advocacy...'') requests for extension of the previously approved collections of information discussed below. Rule 17f-7... ``collection of information'' requirements. An eligible securities depository has to meet minimum standards for...

76 FR 49805 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-11

... request for extension of the previously approved collection of information discussed below. Regulation S-T... submission of documents on the Electronic Data Gathering, Analysis and Retrieval (``EDGAR'') system... any information collection requirements. An agency may not conduct or sponsor, and a person is not...

76 FR 49483 - Federal Acquisition Regulation; Information Collection; Organization and Direction of Work

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-10

...; Information Collection; Organization and Direction of Work AGENCY: Department of Defense (DOD), General... previously approved information collection requirement concerning organization and direction of work. Public... Information Collection 9000- 0064, Organization and Direction of Work, by any of the following methods...

75 FR 45671 - Submission for OMB Review: Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-03

... previously approved collection. Title of Collection: Asbestos in General Industry (29 CFR 1910.1001). OMB... hazardous asbestos exposure. Asbestos exposure results in asbestosis, an emphysema-like condition; lung... requirement to prevent release of airborne asbestos above the time-weighted average and excursion limit. Other...

76 FR 60049 - Federal Acquisition Regulation; Submission for OMB Review; Buy American Act Certificate

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-28

...; Submission for OMB Review; Buy American Act Certificate AGENCIES: Department of Defense (DOD), General... previously approved information collection requirement concerning the Buy American Act certificate. This... the use of appropriate technological collection techniques or other forms of information technology...

Data Analysis and Reporting of the 150 Chevrolet Volt ARRA Demonstration Fleet

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

Richard "Barney" Carlson

This is the final report for the GM Vehicle Demo analysis and reporting. I'd like it to be posted to the AVTA website. It contains no new information than what is in Quarterly reports that were previously approved by GM.

78 FR 57351 - A Reinstatement of a Previously Approved Information Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-18

... collection is necessary in order to provide descriptive information regarding individual research activities... the NIFA Current Research Information System (CRIS). DATES: Written comments on this notice must be... . SUPPLEMENTARY INFORMATION: Title: NIFA Current Research Information System. OMB Number: 0524-0042. Expiration...

76 FR 22708 - Federal Acquisition Regulation; Information Collection; OMB Circular A-119

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-22

... previously approved information collection requirement concerning OMB Circular A-119. Public comments are...; Information Collection; OMB Circular A-119 AGENCIES: Department of Defense (DOD), General Services... public comments regarding an extension to an existing OMB clearance (9000-0153). SUMMARY: Under the...

75 FR 62615 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Order Granting Accelerated...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-12

... Silver Trust \\8\\ and ETFS Gold Trust.\\9\\ The Commission also has previously approved listing on the Exchange of shares of the Sprott Physical Gold Trust, streetTRACKS Gold Trust, and iShares COMEX Gold Trust...

39 CFR 501.10 - Postage Evidencing System modifications.

Code of Federal Regulations, 2010 CFR

2010-07-01

... AND DISTRIBUTE POSTAGE EVIDENCING SYSTEMS § 501.10 Postage Evidencing System modifications. (a) An... 39 Postal Service 1 2010-07-01 2010-07-01 false Postage Evidencing System modifications. 501.10... a previously approved Postage Evidencing System. The notification must include a summary of all...

Evaluation of bicyclopyrone in sweetpotato

USDA-ARS?s Scientific Manuscript database

Bicyclopyrone (BIR) is a new 4-Hydroxyphenylpyruvate dioxygenase (HPPD)-inhibitor that is being evaluated for use in sweetpotato. BIR would be the first HPPD-inhibiting herbicide to be approved for use in sweet potato. Previous studies have shown that sweet potato varieties may differ in their respo...

77 FR 61580 - Federal Acquisition Regulation; Information Collection; Bid Guarantees, Performance and Payment...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-10

..., Performance and Payment Bonds, and Alternative Payment Protections AGENCY: Department of Defense (DOD... previously approved information collection requirement concerning bid guarantees, performance and payment... collection of information is necessary for the proper performance of functions of the Federal Acquisition...

78 FR 25455 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-01

... Assessment Survey, previously approved under information collection number OMB CN: 0970-0379, expires on 7/31... American nonprofit organizations, and Tribal Colleges and Universities. Annual Burden Estimates Number of Average burden Instrument Number of responses per hours per Total burden respondents respondent response...

78 FR 8600 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-06

... Management and Budget, Room 10102, New Executive Office Building, Washington, DC 20503, or by sending an....), the Securities and Exchange Commission (``Commission'') has submitted to the Office of Management and Budget this request for extension of the previously approved collection of information discussed below...

78 FR 9434 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-08

... Information and Regulatory Affairs, Office of Management and Budget, Room 10102, New Executive Office Building....), the Securities and Exchange Commission (``Commission'') has submitted to the Office of Management and Budget this request for extension of the previously approved collection of information discussed below...

Acoustic Differences between Humorous and Sincere Communicative Intentions

ERIC Educational Resources Information Center

Hoicka, Elena; Gattis, Merideth

2012-01-01

Previous studies indicate that the acoustic features of speech discriminate between positive and negative communicative intentions, such as approval and prohibition. Two studies investigated whether acoustic features of speech can discriminate between two positive communicative intentions: humour and sweet-sincerity, where sweet-sincerity involved…

78 FR 14549 - National Contact Center; Information Collection; National Contact Center Customer Evaluation Survey

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-06

...] National Contact Center; Information Collection; National Contact Center Customer Evaluation Survey AGENCY: Contact Center Services, Federal Citizen Information Center, Office of Citizen Services and Innovative... National Contact Center customer evaluation surveys. In this request, the previously approved surveys have...

77 FR 24703 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-25

...-2012-0034, to: (1) EPA online using www.regulations.gov (our preferred method), or by email to docket... decrease in the labor hours in this ICR compared to the previous ICR due to a mathematical error in [[Page...

76 FR 14967 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-18

...- OECA-2010-0374, to (1) EPA online using http://www.regulations.gov (our preferred method), or by email... hours. This is due to a mathematical error in the previous ICR. The increase in cost to Respondents and...

78 FR 23935 - Federal Acquisition Regulation; Information Collection; Contractor Use of Interagency Fleet...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-23

...; Information Collection; Contractor Use of Interagency Fleet Management System Vehicles AGENCY: Department of... previously approved information collection requirement concerning contractor use of interagency fleet... Collection 9000- 0032, Contractor Use of Interagency Fleet Management System Vehicles, by any of the...

78 FR 64499 - Federal Acquisition Regulation; Submission for OMB Review; Contractor Use of Interagency Fleet...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-29

...; Submission for OMB Review; Contractor Use of Interagency Fleet Management System Vehicles AGENCY: Department... previously approved information collection requirement concerning contractor use of interagency fleet... comments identified by Information Collection 9000- 0032, Contractor Use of Interagency Fleet Management...

30 CFR 250.1203 - Gas measurement.

Code of Federal Regulations, 2011 CFR

2011-07-01

... any changes to the previously-approved measurement and/or allocation procedures. Your application... and reflect the same degree of water saturation as in the gas volume. (8) When requested by the Regional Supervisor, submit copies of gas volume statements for each requested gas meter. Show whether gas...

75 FR 75697 - Office of Community Oriented Policing Services; Agency Information Collection Activities...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-06

... DEPARTMENT OF JUSTICE [OMB Number 1103-0098] Office of Community Oriented Policing Services; Agency Information Collection Activities: Revision of a Previously Approved Collection, With Change; Comments Requested ACTION: 60-Day Notice of Information Collection Under Review: COPS Application Package...

78 FR 66953 - Office of Community Oriented Policing Services; Agency Information Collection Activities...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-07

... DEPARTMENT OF JUSTICE [OMB Number 1103-0110] Office of Community Oriented Policing Services; Agency Information Collection Activities: Revision of a Previously Approved Collection, With Change; Comments Requested COPS Grant Status Implementation Facsimile ACTION: 60-Day notice. The Department of...

75 FR 77904 - Office of Community Oriented Policing Services; Agency Information Collection Activities...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-14

... DEPARTMENT OF JUSTICE [OMB Number 1103-0102] Office of Community Oriented Policing Services; Agency Information Collection Activities: Extension of a Previously Approved Collection; Comments Requested ACTION: 60-Day Notice of Information Collection Under Review: COPS Non Hiring Progress Report. The...

75 FR 13573 - Justice Management Division, Office of Attorney Recruitment and Management; Agency Information...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-22

... DEPARTMENT OF JUSTICE [OMB Number 1105-0030] Justice Management Division, Office of Attorney Recruitment and Management; Agency Information Collection Activities: Proposed Renewal of Previously Approved Collection; Comments Requested ACTION: Correction 30-Day Notice of Information Collection Under Review: [[Page 13574

7 CFR 1427.3 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-01-01

..., during the period in which two daily price quotations are available for the growth quoted for M 13/32... other qualities over the available observations during the previous 12 months. Approved cooperative.... Cotton storage deficit area means a State, County, or group of contiguous counties within a State, where...

76 FR 28825 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-18

... likely to use the form each year. Most of the information requested on the form should be readily..., Copies Available From: Securities and Exchange Commission, Office of Investor Education and Advocacy... request for extension of the previously approved collection of information discussed below. Section 17(d...

46 CFR 194.90-1 - Requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 46 Shipping 7 2013-10-01 2013-10-01 false Requirements. 194.90-1 Section 194.90-1 Shipping COAST...-1 Requirements. (a) Vessels contracted for prior to March 1, 1968, shall meet the following requirements: (1) Existing arrangements, materials, and facilities previously approved but not meeting the...

46 CFR 194.90-1 - Requirements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 7 2012-10-01 2012-10-01 false Requirements. 194.90-1 Section 194.90-1 Shipping COAST...-1 Requirements. (a) Vessels contracted for prior to March 1, 1968, shall meet the following requirements: (1) Existing arrangements, materials, and facilities previously approved but not meeting the...

46 CFR 194.90-1 - Requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 7 2010-10-01 2010-10-01 false Requirements. 194.90-1 Section 194.90-1 Shipping COAST...-1 Requirements. (a) Vessels contracted for prior to March 1, 1968, shall meet the following requirements: (1) Existing arrangements, materials, and facilities previously approved but not meeting the...

46 CFR 194.90-1 - Requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 7 2014-10-01 2014-10-01 false Requirements. 194.90-1 Section 194.90-1 Shipping COAST...-1 Requirements. (a) Vessels contracted for prior to March 1, 1968, shall meet the following requirements: (1) Existing arrangements, materials, and facilities previously approved but not meeting the...

7 CFR 3401.8 - Grant awards.

Code of Federal Regulations, 2010 CFR

2010-01-01

... additional support at a future date. This type of research project grant is approved on the basis of peer... previous grant instrument. Such a renewal shall be based upon new application, de novo peer review and..., provided that performance has been satisfactory, appropriations are available for this purpose, and...

78 FR 42974 - Agency Information Collection Activities; Proposed Renewal of Previously Approved Collection...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-18

... of Attorney Recruitment and Management (OARM), will be submitting the following information... until September 16, 2013. This process is conducted in accordance with 5 CFR 1320.10. Written comments... collection: Form Number: 1105-0086. Office of Attorney Recruitment and Management, Justice Management...

78 FR 58347 - Agency Information Collection Activities; Proposed Renewal of Previously Approved Collection...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-23

... of Attorney Recruitment and Management (OARM), will be submitting the following information..., 2013. This process is conducted in accordance with 5 CFR 1320.10. Written comments and/or suggestions... Deana Willis, Assistant Director, Office of Attorney Recruitment and Management, United States...

78 FR 54729 - Reports, Forms, and Record Keeping Requirements

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-05

... information: Title--NHTSA Distracted Driving Survey Project. Type of Request--Revision of previously approved... region, age, and gender. The National Survey on Distracted Driving Attitudes and Behaviors (NSDDAB) will... driving behaviors. The estimated average amount of time to complete the survey is 20 minutes. This...

22 CFR 126.12 - Continuation in force.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Continuation in force. 126.12 Section 126.12... PROVISIONS § 126.12 Continuation in force. All determinations, authorizations, licenses, approvals of... previous provisions of this subchapter, continue in full force and effect until or unless modified, revoked...

7 CFR 3430.14 - Types of applications; types of award instruments.

Code of Federal Regulations, 2011 CFR

2011-01-01

.... 3430.14 Section 3430.14 Agriculture Regulations of the Department of Agriculture (Continued) NATIONAL INSTITUTE OF FOOD AND AGRICULTURE COMPETITIVE AND NONCOMPETITIVE NON-FORMULA FEDERAL ASSISTANCE PROGRAMS... the same program previously but has not been approved for an award under the program. For competitive...

77 FR 12002 - Mount Baker-Snoqualmie National Forest Site-Specific Invasive Plant Treatment Project and Forest...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-28

... these tools, including additional herbicides and application methods to increase treatment effectiveness... organisms than previously approved herbicides and higher effectiveness on particular invasive plants. Thus... examples demonstrate why additional herbicides, methods, and protocols are needed to improve treatment...

10 CFR 52.137 - Contents of applications; technical information.

Code of Federal Regulations, 2012 CFR

2012-01-01

... FOR NUCLEAR POWER PLANTS Standard Design Approvals § 52.137 Contents of applications; technical... power plants similar in design and location to plants for which construction permits have previously... light-water-cooled nuclear power plants, an evaluation of the standard plant design against the Standard...

10 CFR 52.137 - Contents of applications; technical information.

Code of Federal Regulations, 2011 CFR

2011-01-01

... FOR NUCLEAR POWER PLANTS Standard Design Approvals § 52.137 Contents of applications; technical... power plants similar in design and location to plants for which construction permits have previously... light-water-cooled nuclear power plants, an evaluation of the standard plant design against the Standard...

10 CFR 52.137 - Contents of applications; technical information.

Code of Federal Regulations, 2014 CFR

2014-01-01

... FOR NUCLEAR POWER PLANTS Standard Design Approvals § 52.137 Contents of applications; technical... power plants similar in design and location to plants for which construction permits have previously... light-water-cooled nuclear power plants, an evaluation of the standard plant design against the Standard...

10 CFR 52.137 - Contents of applications; technical information.

Code of Federal Regulations, 2013 CFR

2013-01-01

... FOR NUCLEAR POWER PLANTS Standard Design Approvals § 52.137 Contents of applications; technical... power plants similar in design and location to plants for which construction permits have previously... light-water-cooled nuclear power plants, an evaluation of the standard plant design against the Standard...

77 FR 11187 - Request for Comments of a Previously Approved Information Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-24

... similar marketing tools, particularly in international air transportation, had given the Department... name given to a common airline industry marketing practice where, by mutual agreement between.... Arrangements falling into this category are similar to leases of aircraft with crew (wet leases). The...

49 CFR 236.913 - Filing and approval of PSPs.

Code of Federal Regulations, 2012 CFR

2012-10-01

... assessment for the previous condition was conducted using the same methodology as that for operation under the proposed condition; and (viii) If an independent third-party assessment is required or is... outside existing accepted practices (see appendix C); and the PSP describes a locomotive-borne product...

49 CFR 236.913 - Filing and approval of PSPs.

Code of Federal Regulations, 2014 CFR

2014-10-01

... assessment for the previous condition was conducted using the same methodology as that for operation under the proposed condition; and (viii) If an independent third-party assessment is required or is... outside existing accepted practices (see appendix C); and the PSP describes a locomotive-borne product...

49 CFR 236.913 - Filing and approval of PSPs.

Code of Federal Regulations, 2013 CFR

2013-10-01

... assessment for the previous condition was conducted using the same methodology as that for operation under the proposed condition; and (viii) If an independent third-party assessment is required or is... outside existing accepted practices (see appendix C); and the PSP describes a locomotive-borne product...

76 FR 4862 - Notice of Intent To Reinstate a Previously Approved Information Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-27

... countries. Marketing of the increasing volume of distillers by-products to more livestock producers would... quantities of distillers grains, product qualities, volume of sales, pricing, storage facilities, marketing channels, plant services, transportation requirements, species fed, and feed ratios. In its summary report...

77 FR 4862 - Agency Requests for Renewal of a Previously Approved Information Collection: SBTRC Regional Field...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-31

..., marketing, meetings/ conferences, and services to businesses as completed during the quarter. The Quarterly... include business analysis, general management & technical assistance and training, business counseling...) AGENCY: Office of Small and Disadvantaged Business Utilization (OSDBU), Office of the Secretary of...

77 FR 32169 - Agency Requests for Renewal of a Previously Approved Information Collection: Small Business...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-31

... Field Offices include business analysis, general management and technical assistance and training... Collection: Small Business Transportation Resource Center (SBTRC) Regional Field Offices Intake Form (DOT F... Disadvantaged Business Utilization (OSDBU), Office of the Secretary of Transportation (OST), DOT. ACTION: Notice...

78 FR 30303 - National Contact Center; Submission for OMB Review; National Contact Center Customer Evaluation...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-22

...] National Contact Center; Submission for OMB Review; National Contact Center Customer Evaluation Survey AGENCY: Contact Center Services, Federal Citizen Information Center, Office of Citizen Services and... regarding the National Contact Center customer evaluation surveys. In this request, the previously approved...

Chemical Vapor Deposition of Atomically-Thin Molybdenum Disulfide (MoS2)

DTIC Science & Technology

2015-03-01

of the system . All pseudopotentials were tested and resulted in calculated parameters that were in good agreement with previous results. The...UNCLASSIFIED Approved for public release; distribution is unlimited. 7 BIBLIOGRAPHY Soler , J.M., Artacho, E., Gale, J.D., Garcia, A., Junquera, J

30 CFR 585.706 - How do I nominate a CVA for BOEM approval?

Code of Federal Regulations, 2014 CFR

2014-07-01

... technology (including computer programs, hardware, and testing materials and equipment); (5) Ability to perform the CVA functions for the specific project considering current commitments; (6) Previous... facilities; (2) Technical capabilities of the individual or the primary staff for the specific project; (3...

30 CFR 585.706 - How do I nominate a CVA for BOEM approval?

Code of Federal Regulations, 2013 CFR

2013-07-01

... technology (including computer programs, hardware, and testing materials and equipment); (5) Ability to perform the CVA functions for the specific project considering current commitments; (6) Previous... facilities; (2) Technical capabilities of the individual or the primary staff for the specific project; (3...

30 CFR 585.706 - How do I nominate a CVA for BOEM approval?

Code of Federal Regulations, 2012 CFR

2012-07-01

... technology (including computer programs, hardware, and testing materials and equipment); (5) Ability to perform the CVA functions for the specific project considering current commitments; (6) Previous... facilities; (2) Technical capabilities of the individual or the primary staff for the specific project; (3...

75 FR 10267 - Federal Acquisition Regulation; Submission for OMB Review; Contractor Use of Interagency Motor...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-05

... ADMINISTRATION [OMB Control No. 9000-0032] Federal Acquisition Regulation; Submission for OMB Review; Contractor... previously approved information collection requirement concerning contractor use of interagency motor pool... contracting officer may authorize cost-reimbursement contractors to obtain, for official purposes only...

24 CFR 92.50 - Formula allocation.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 24 Housing and Urban Development 1 2010-04-01 2010-04-01 false Formula allocation. 92.50 Section 92.50 Housing and Urban Development Office of the Secretary, Department of Housing and Urban... previous fiscal year, are metropolitan cities, urban counties, or consortia approved under § 92.101; and...

Regulatory approval of new medical devices: cross sectional study.

PubMed

Marcus, Hani J; Payne, Christopher J; Hughes-Hallett, Archie; Marcus, Adam P; Yang, Guang-Zhong; Darzi, Ara; Nandi, Dipankar

2016-05-20

 To investigate the regulatory approval of new medical devices.  Cross sectional study of new medical devices reported in the biomedical literature.  PubMed was searched between 1 January 2000 and 31 December 2004 to identify clinical studies of new medical devices. The search was carried out during this period to allow time for regulatory approval.  Articles were included if they reported a clinical study of a new medical device and there was no evidence of a previous clinical study in the literature. We defined a medical device according to the US Food and Drug Administration as an "instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article."  Type of device, target specialty, and involvement of academia or of industry for each clinical study. The FDA medical databases were then searched for clearance or approval relevant to the device.  5574 titles and abstracts were screened, 493 full text articles assessed for eligibility, and 218 clinical studies of new medical devices included. In all, 99/218 (45%) of the devices described in clinical studies ultimately received regulatory clearance or approval. These included 510(k) clearance for devices determined to be "substantially equivalent" to another legally marketed device (78/99; 79%), premarket approval for high risk devices (17/99; 17%), and others (4/99; 4%). Of these, 43 devices (43/99; 43%) were actually cleared or approved before a clinical study was published.  We identified a multitude of new medical devices in clinical studies, almost half of which received regulatory clearance or approval. The 510(k) pathway was most commonly used, and clearance often preceded the first published clinical study. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

U.S. Food and Drug Administration Approval Summary: Enzalutamide for the Treatment of Patients With Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer.

PubMed

Ning, Yang-Min; Brave, Michael; Maher, V Ellen; Zhang, Lijun; Tang, Shenghui; Sridhara, Rajeshwari; Kim, Geoffrey; Ibrahim, Amna; Pazdur, Richard

2015-08-01

The U.S. Food and Drug Administration approved enzalutamide for the treatment of patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC). At the prespecified interim analysis, a statistically significant improvement in overall survival was demonstrated for patients in the enzalutamide arm compared with patients in the placebo arm. The overall benefit-risk profile supports the expanded indication for enzalutamide. On September 10, 2014, the U.S. Food and Drug Administration approved enzalutamide for the treatment of patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC). Enzalutamide was initially approved in 2012 for use in patients with mCRPC who had previously received docetaxel. The current approval was based on the results of a randomized, placebo-controlled, double-blind trial conducted in 1,717 asymptomatic or minimally symptomatic patients with chemotherapy-naïve mCRPC. Patients were assigned to receive either enzalutamide 160 mg or placebo orally once daily. The coprimary endpoints were overall survival (OS) and radiographic progression-free survival (rPFS), which was assessed by independent central radiology review. At the prespecified interim analysis, a statistically significant improvement in OS was demonstrated for patients in the enzalutamide arm compared with patients in the placebo arm (hazard ratio [HR], 0.71; 95% confidence interval [CI], 0.60-0.84). The median OS was 32.4 and 30.2 months in the enzalutamide and placebo arms, respectively. A statistically significant prolongation of rPFS was observed in patients in the enzalutamide arm (HR, 0.17; 95% CI, 0.14-0.21). In addition, the time to initiation of cytotoxic chemotherapy was prolonged in the enzalutamide arm (HR, 0.35; 95% CI, 0.30-0.40), with median times of 28.0 and 10.8 months in the enzalutamide and placebo arms, respectively. The safety profile was similar to that previously reported for enzalutamide. Adverse reactions of interest included seizure, hypertension, and falls. Enzalutamide should be discontinued if a seizure occurs during treatment. The overall benefit-risk profile supports the expanded indication for enzalutamide. ©AlphaMed Press.

Treatment Paradigms for Advanced Non‐Small Cell Lung Cancer at Academic Medical Centers: Involvement in Clinical Trial Endpoint Design

PubMed Central

Borghaei, Hossein

2017-01-01

Abstract Based on the positive results of various clinical trials, treatment options for non‐small cell lung cancer (NSCLC) have expanded greatly over the last 25 years. While regulatory approvals of chemotherapeutic agents for NSCLC have largely been based on improvements in overall survival, recent approvals of many targeted agents for NSCLC (afatinib, crizotinib, ceritinib, osimertinib) have been based on surrogate endpoints such as progression‐free survival and objective response. As such, selection of appropriate clinical endpoints for examining the efficacy of investigational agents for NSCLC is of vital importance in clinical trial design. This review provides an overview of clinical trial endpoints previously utilized for approved agents for NSCLC and highlights the key efficacy results for these trials. Trends for more recent approvals in NSCLC, including those for the immunotherapeutic agents nivolumab and pembrolizumab, are also discussed. The results of a correlative analysis of endpoints from 18 clinical trials that supported approvals of investigational agents in clinical trials for NSCLC are also presented. Implications for Practice. While improving survival remains the ultimate goal of oncology clinical trials, overall survival may not always be the most feasible or appropriate endpoint to assess patient response. Recently, several investigational agents, both targeted agents and immunotherapies, have gained U.S. Food and Drug Administration approval in non‐small cell lung cancer based on alternate endpoints such as progression‐free survival or response rate. An understanding of the assessment of response and trial endpoint choice is important for future oncology clinical trial design. PMID:28408617

7 CFR 81.8 - Application and approval for participation.

Code of Federal Regulations, 2010 CFR

2010-01-01

... in question, and/or as needed, the statement must show an agreement to participate in the tree... the tree removal. However, obtaining such assent shall be the responsibility of the applicant who... the information appears reliable. (e) As previously indicated, if the number of trees to be removed in...

24 CFR 880.603 - Selection and admission of assisted tenants.

Code of Federal Regulations, 2014 CFR

2014-04-01

... the applicant believes that he or she is being discriminated against on the basis of race, color... applicants and approved eligible families, which provide racial, ethnic, gender and place of previous residency data required by HUD, must be maintained and retained for three years. (c) Reexamination of family...

75 FR 1081 - Justice Management Division; Office of Attorney Recruitment and Management; Agency Information...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-08

... DEPARTMENT OF JUSTICE [OMB Number 1105-0030] Justice Management Division; Office of Attorney Recruitment and Management; Agency Information Collection Activities: Proposed Renewal of Previously Approved Collection; Comments Requested ACTION: 60-Day Notice of Information Collection Under Review: Electronic Applications for the Attorney General's...

77 FR 3265 - Information Collection Being Reviewed by the Federal Communications Commission

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-23

... business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of... of a currently approved collection. Respondents: Business or other for-profit entities. Number of... previous burden estimates. On November 18, 2011, the Commission adopted the USF/ICC Transformation Order...

34 CFR 675.18 - Use of funds.

Code of Federal Regulations, 2014 CFR

2014-07-01

... funds carried forward from the previous year. (c) Carry back funds. An institution may carry back and...'s approval to carry back funds. (d) The institution may use the funds carried forward or carried back under paragraphs (c) and (d) of this section, respectively, for activities described in paragraph...

34 CFR 675.18 - Use of funds.

Code of Federal Regulations, 2011 CFR

2011-07-01

... funds carried forward from the previous year. (c) Carry back funds. An institution may carry back and...'s approval to carry back funds. (d) The institution may use the funds carried forward or carried back under paragraphs (c) and (d) of this section, respectively, for activities described in paragraph...

34 CFR 675.18 - Use of funds.

Code of Federal Regulations, 2012 CFR

2012-07-01

... funds carried forward from the previous year. (c) Carry back funds. An institution may carry back and...'s approval to carry back funds. (d) The institution may use the funds carried forward or carried back under paragraphs (c) and (d) of this section, respectively, for activities described in paragraph...

34 CFR 675.18 - Use of funds.

Code of Federal Regulations, 2013 CFR

2013-07-01

... funds carried forward from the previous year. (c) Carry back funds. An institution may carry back and...'s approval to carry back funds. (d) The institution may use the funds carried forward or carried back under paragraphs (c) and (d) of this section, respectively, for activities described in paragraph...

46 CFR 2.45-25 - Application for approval.

Code of Federal Regulations, 2012 CFR

2012-10-01

...), Office of Design and Engineering Standards, 2100 Second Street SW. Stop 7126, Washington DC 20593-7126... society complies with § 2.45-15; (3) Contain a list of the vessels surveyed by the classification society... vessels the classification society surveys for each of the previous 3 calendar years, including initial...

30 CFR 585.907 - How will BOEM process my decommissioning application?

Code of Federal Regulations, 2014 CFR

2014-07-01

... decommissioning application with the decommissioning general concept in your approved SAP, COP, or GAP to..., COP, or GAP, and BOEM will begin the appropriate NEPA analysis and other regulatory reviews as... change in the impacts previously identified and evaluated in your SAP, COP, or GAP; (2) Require any...

30 CFR 585.907 - How will BOEM process my decommissioning application?

Code of Federal Regulations, 2013 CFR

2013-07-01

... decommissioning application with the decommissioning general concept in your approved SAP, COP, or GAP to..., COP, or GAP, and BOEM will begin the appropriate NEPA analysis and other regulatory reviews as... change in the impacts previously identified and evaluated in your SAP, COP, or GAP; (2) Require any...

76 FR 10065 - Agency Information Collection Activities: Revision of a Previously Approved Collection, With...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-23

... Information Collection Under Review: COPS Application Package. The Department of Justice (DOJ) Office of Community Oriented Policing Services (COPS), will be submitting the following information collection request.../Collection: COPS Application Package. (3) Agency form number, if any, and the applicable component of the...

76 FR 17165 - Submission for OMB Review; Comments Requested

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-28

... customers with copies of their account record information would be approximately $10,688,387 per year (35... (``OMB'') a request for extension of the previously approved collection of information discussed below. The Code of Federal Regulation citation to this collection of information is the following rule: 17...

76 FR 71072 - Agency Information Collection Activities: Extension With Change of a Previously Approved...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-16

...: 30-Day notice. The United States Department of Justice (DOJ), National Drug Intelligence Center (NDIC..., including the validity of the methodology and assumptions used; --Enhance the quality, utility, and clarity... Assessment and other reports and assessments produced by the National Drug Intelligence Center. It provides...

78 FR 69697 - Agency Information Collection Activities: Proposed Collection: Public Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-20

.... Information Collection Request Title: Nurse Faculty Loan Program, Annual Performance Report Financial Data Form OMB No. 0915-0314--REVISION Abstract: This clearance request is for approval of the revised Nurse... previously titled as the Nurse Faculty Loan Program, Annual Operating Report (NFLP-AOR). Need and Proposed...

24 CFR 92.50 - Formula allocation.

Code of Federal Regulations, 2013 CFR

2013-04-01

... per rental unit basis, that amount is capped at twice the national average. (3) To determine the... of funds calculation) exceed twice the national average, on a per rental unit basis, each amount that... previous fiscal year, are metropolitan cities, urban counties, or consortia approved under § 92.101; and...

24 CFR 92.50 - Formula allocation.

Code of Federal Regulations, 2011 CFR

2011-04-01

... per rental unit basis, that amount is capped at twice the national average. (3) To determine the... of funds calculation) exceed twice the national average, on a per rental unit basis, each amount that... previous fiscal year, are metropolitan cities, urban counties, or consortia approved under § 92.101; and...

24 CFR 92.50 - Formula allocation.

Code of Federal Regulations, 2012 CFR

2012-04-01

... per rental unit basis, that amount is capped at twice the national average. (3) To determine the... of funds calculation) exceed twice the national average, on a per rental unit basis, each amount that... previous fiscal year, are metropolitan cities, urban counties, or consortia approved under § 92.101; and...

24 CFR 92.50 - Formula allocation.

Code of Federal Regulations, 2014 CFR

2014-04-01

... per rental unit basis, that amount is capped at twice the national average. (3) To determine the... of funds calculation) exceed twice the national average, on a per rental unit basis, each amount that... previous fiscal year, are metropolitan cities, urban counties, or consortia approved under § 92.101; and...

78 FR 15739 - Agency Information Collection Activities; Proposed Renewal of Previously Approved Collection...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-12

... or more of the following four points: (1) Evaluate whether the proposed collection of information is... respondents (candidates selected for interviews) who will complete a travel survey used to schedule interviews and prepare official Travel Authorizations prior to the interviewees' performing pre-employment...

77 FR 63803 - Federal Acquisition Regulation; Information Collection; Pollution Prevention and Right-to-Know...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-17

...; Information Collection; Pollution Prevention and Right-to-Know Information (FAR 52.223-5) AGENCY: Department... previously approved information collection requirement concerning pollution prevention and right-to-know..., Pollution Prevention and Right-to-Know Information'' on your attached document. Fax: 202-501-4067. Mail...

78 FR 30304 - Federal Acquisition Regulation; Submission for OMB Review; Pollution Prevention and Right-to-Know...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-22

...; Submission for OMB Review; Pollution Prevention and Right-to-Know Information (FAR 52.223-5) AGENCY... previously approved information collection requirement concerning pollution prevention and right-to-know... by Information Collection 9000- 0147, Pollution Prevention and Right-to-Know Information by any of...

75 FR 2547 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-15

... : 0938-0579); Frequency: Reporting--Triennially; Affected Public: Business or other for-profits and Not... change of a previously approved collection; Title of Information Collection: Business Proposal Forms for... contracts. The revised business proposal forms will be useful in a number of important ways. The Government...

78 FR 71712 - Request for Comments of a Previously Approved Information Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-29

... during the operations by the Armed forces of the United States in World War II, Korea, Vietnam, and...: 550. Estimated Completion Time per Response: 1 hour. Frequency of Collection: Annually. ADDRESSES... 49 CFR 1:48. Dated: November 21, 2013. Julie P. Agarwal, Secretary, Maritime Administration. [FR Doc...

75 FR 999 - Records Schedules; Availability and Request for Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-07

... temporary items). Claims, allowances, and individual trusts relating to the World War I alien property... process is available on request. Schedules Pending 1. Department of Agriculture, Agency-wide (N1-16-10-4, 1 item, 1 temporary item). Routine surveillance recordings, which were previously approved for...

77 FR 31910 - Request for Comments of a Previously Approved Information Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-30

... assist wheelchair users and other persons with limited mobility in entering and leaving a vehicle. FMVSS... certification on the owner's manual insert, the installation instructions and the lift operating instruction... insert that is placed in the vehicle owner's manual, installation instructions and one or two labels that...

15 CFR 930.65 - Remedial action for previously reviewed activities.

Code of Federal Regulations, 2010 CFR

2010-01-01

... AND COASTAL RESOURCE MANAGEMENT FEDERAL CONSISTENCY WITH APPROVED COASTAL MANAGEMENT PROGRAMS... representative for the area involved of any federal license or permit activity which the State agency claims was... later maintains is being conducted or is having an effect on any coastal use or resource substantially...

78 FR 48687 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-09

... of Drug Pricing and Network Pharmacy Data from Medicare Prescription Drug Plans (PDPs and MA-PDs) and... children, by age group and basis of Medicaid eligibility, who are provided initial and periodic child... previously approved collection; Title of Information Collection: Collection of Drug Pricing and Network...

75 FR 62857 - Agency Information Collection Activities: Proposed Extension With Change of a Previously Approved...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-13

... DEPARTMENT OF JUSTICE National Drug Intelligence Center [OMB Number 1105-0087] Agency Information... of Justice (DOJ), National Drug Intelligence Center (NDIC), will be submitting the following... technicians, medical examiners); and other specific groups such as drug intelligence analysts. The NDIC has...

75 FR 81313 - Petitions for Modification of Existing Mandatory Safety Standards

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-27

... for methane, oxygen, and carbon monoxide concentrations using an approved hand-held device; (iv) measure air quantity using an appropriately calibrated anemometer. Methane gas or other harmful, noxious... percent methane above the previous reading or a 10 percent unplanned change in the airflow quantity from...

75 FR 43986 - Agency Forms Undergoing Paperwork Reduction Act Review

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-27

.... Proposed Project Aggregate Reports for Tuberculosis Program Evaluation (OMB No. 0920-0457 exp. 5/30/2010... of Tuberculosis Elimination (DTBE) proposes to reinstate with change the Aggregate Reports for Tuberculosis Program Evaluation, previously approved under OMB No. 0920-0457. This request is for a 3-year...

75 FR 17922 - Proposed Data Collections Submitted for Public Comment and Recommendations

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-08

... Reports for Tuberculosis Program Evaluation (OMB No. 0920-0457 exp. 5/31/2010)--Reinstatement--National... for Tuberculosis Program Evaluation, previously approved under OMB No. 0920-0457 after the 5/31/2010... instructions. To ensure the elimination of tuberculosis in the United States, CDC monitors indicators for key...

78 FR 22267 - Proposed Data Collections Submitted for Public Comment and Recommendations

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-15

... this notice. Proposed Project Aggregate Reports for Tuberculosis Program Evaluation (0920-0457-- Exp. 9... extension of the Aggregate Reports for Tuberculosis Program Evaluation, previously approved under OMB No... instructions. To ensure the elimination of tuberculosis in the United States, CDC monitors indicators for key...

75 FR 1112 - Notice of Request for Renewal of a Previously Approved Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-08

... INFORMATION CONTACT: Lauralyn Remo, Air Carrier Fitness Division (X-56), Office of Aviation Analysis, Office... States Code--(Amended); 14 CFR Part 204--Data to Support Fitness Determinations; 14 CFR Part 291--Cargo... fitness of persons seeking authority to engage in air transportation, the Department collects information...

24 CFR 700.145 - Cost distribution.

Code of Federal Regulations, 2014 CFR

2014-04-01

... listed. (iv) The value of services performed by volunteers to CHSP, at the rate of $5.00 an hour. (d..., these previously existing services. The value of these services do not qualify as matching funds. Such... funds with the approval of the Secretary concerned), (ii) The imputed dollar value of other agency or...

24 CFR 700.145 - Cost distribution.

Code of Federal Regulations, 2013 CFR

2013-04-01

... listed. (iv) The value of services performed by volunteers to CHSP, at the rate of $5.00 an hour. (d..., these previously existing services. The value of these services do not qualify as matching funds. Such... funds with the approval of the Secretary concerned), (ii) The imputed dollar value of other agency or...

24 CFR 700.145 - Cost distribution.

Code of Federal Regulations, 2011 CFR

2011-04-01

... listed. (iv) The value of services performed by volunteers to CHSP, at the rate of $5.00 an hour. (d..., these previously existing services. The value of these services do not qualify as matching funds. Such... funds with the approval of the Secretary concerned), (ii) The imputed dollar value of other agency or...

7 CFR 1944.260 - Cost distribution.

Code of Federal Regulations, 2014 CFR

2014-01-01

... listed. (iv) The value of services performed by volunteers to CHSP, at the rate of $5.00 an hour. (d... substitution for, these previously existing services. The value of these services do not qualify as matching... funds with the approval of the Secretary concerned), (ii) The imputed dollar value of other agency or...

7 CFR 1944.260 - Cost distribution.

Code of Federal Regulations, 2013 CFR

2013-01-01

... listed. (iv) The value of services performed by volunteers to CHSP, at the rate of $5.00 an hour. (d... substitution for, these previously existing services. The value of these services do not qualify as matching... funds with the approval of the Secretary concerned), (ii) The imputed dollar value of other agency or...

24 CFR 700.145 - Cost distribution.

Code of Federal Regulations, 2012 CFR

2012-04-01

... listed. (iv) The value of services performed by volunteers to CHSP, at the rate of $5.00 an hour. (d..., these previously existing services. The value of these services do not qualify as matching funds. Such... funds with the approval of the Secretary concerned), (ii) The imputed dollar value of other agency or...

24 CFR 700.145 - Cost distribution.

Code of Federal Regulations, 2010 CFR

2010-04-01

... listed. (iv) The value of services performed by volunteers to CHSP, at the rate of $5.00 an hour. (d..., these previously existing services. The value of these services do not qualify as matching funds. Such... funds with the approval of the Secretary concerned), (ii) The imputed dollar value of other agency or...

7 CFR 1944.260 - Cost distribution.

Code of Federal Regulations, 2011 CFR

2011-01-01

... listed. (iv) The value of services performed by volunteers to CHSP, at the rate of $5.00 an hour. (d... substitution for, these previously existing services. The value of these services do not qualify as matching... funds with the approval of the Secretary concerned), (ii) The imputed dollar value of other agency or...

7 CFR 1944.260 - Cost distribution.

Code of Federal Regulations, 2010 CFR

2010-01-01

... listed. (iv) The value of services performed by volunteers to CHSP, at the rate of $5.00 an hour. (d... substitution for, these previously existing services. The value of these services do not qualify as matching... funds with the approval of the Secretary concerned), (ii) The imputed dollar value of other agency or...

7 CFR 1944.260 - Cost distribution.

Code of Federal Regulations, 2012 CFR

2012-01-01

... listed. (iv) The value of services performed by volunteers to CHSP, at the rate of $5.00 an hour. (d... substitution for, these previously existing services. The value of these services do not qualify as matching... funds with the approval of the Secretary concerned), (ii) The imputed dollar value of other agency or...

40 CFR 52.1870 - Identification of plan.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 20, 1972, by the Ohio Air Pollution Control Board. (2) State provisions for making emissions data... authority for controlling auto emissions. (4) Amendments to air pollution regulations AP-3-11, 12, 13, 14... the control of air pollution and were previously codified and approved as AP-2-01 through 06, 08 and...

ISS Crew Transportation and Services Requirements Document

NASA Technical Reports Server (NTRS)

Bayt, Robert L. (Compiler); Lueders, Kathryn L. (Compiler)

2016-01-01

The ISS Crew Transportation and Services Requirements Document (CCT-REQ-1130) contains all technical, safety, and crew health medical requirements that are mandatory for achieving a Crew Transportation System Certification that will allow for International Space Station delivery and return of NASA crew and limited cargo. Previously approved on TN23183.

40 CFR 444.12 - Monitoring Requirements

Code of Federal Regulations, 2011 CFR

2011-07-01

... requirements to monitor, according to EPA-approved test procedures, each pollutant limited in the permit, the... test procedures listed in the table to this paragraph. Most of these test procedures have previously been incorporated by reference at 40 CFR 136.3(a), Table IB. The test procedures for the regulated...

40 CFR 444.12 - Monitoring Requirements

Code of Federal Regulations, 2012 CFR

2012-07-01

... requirements to monitor, according to EPA-approved test procedures, each pollutant limited in the permit, the... test procedures listed in the table to this paragraph. Most of these test procedures have previously been incorporated by reference at 40 CFR 136.3(a), Table IB. The test procedures for the regulated...

40 CFR 444.12 - Monitoring Requirements

Code of Federal Regulations, 2010 CFR

2010-07-01

... requirements to monitor, according to EPA-approved test procedures, each pollutant limited in the permit, the... test procedures listed in the table to this paragraph. Most of these test procedures have previously been incorporated by reference at 40 CFR 136.3(a), Table IB. The test procedures for the regulated...

78 FR 63181 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-23

... Internal Combustion Engines (Renewal) AGENCY: Environmental Protection Agency (EPA). ACTION: Notice...), ``NESHAP for Stationary Reciprocating Internal Combustion Engines (Renewal)'' (EPA ICR No. 1975.09, OMB... combustion engines (RICE) have been regulated under previous actions. Thus, this final action fulfills the...

76 FR 55389 - Federal Acquisition Regulation; Submission for OMB Review; Architect-Engineer Qualifications (SF...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-07

...; Submission for OMB Review; Architect-Engineer Qualifications (SF 330) AGENCIES: Department of Defense (DOD... extension of a previously approved information collection requirement for the Architect-Engineer... 330, Part I is used by all Executive agencies to obtain information from architect-engineer firms...

75 FR 176 - Agency Information Collection Activities; Request for Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-04

... previously approved information collection consisting of a customer survey form. OSC is required by law to... the proper performance of OSC functions, including whether the information will have practical utility... to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to...

75 FR 9003 - Agency Information Collection Activities; Request for Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-26

... a previously approved information collection consisting of a customer survey form. OSC is required... practical utility; (b) the accuracy of OSC's estimate of the burden of the proposed collections of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d...

77 FR 66881 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-07

... Management and Budget (``OMB'') a request for extension of the previously approved collection of information... advertisements and other sales literature with the Commission as if it were an open-end investment company... by the Commission. The requirement that the fund file advertisements and sales literature as if it...

75 FR 4883 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-29

... Management and Budget a request for extension of the previously approved collection of information discussed.... The fund also must file copies of advertisements and other sales literature with the Commission as if... the fund file advertisements and sales literature as if it were an open-end investment company is...

24 CFR 891.410 - Selection and admission of tenants.

Code of Federal Regulations, 2011 CFR

2011-04-01

... written, chronological waiting list showing the name, race, gender, ethnicity, and date of each person..., color, sex, national origin, familial status, or disability. An Owner may, with the approval of the... provide racial, ethnic, gender and place of previous residency data required by HUD, must be retained for...

24 CFR 891.410 - Selection and admission of tenants.

Code of Federal Regulations, 2010 CFR

2010-04-01

... written, chronological waiting list showing the name, race, gender, ethnicity, and date of each person..., color, sex, national origin, familial status, or disability. An Owner may, with the approval of the... provide racial, ethnic, gender and place of previous residency data required by HUD, must be retained for...

34 CFR 668.16 - Standards of administrative capability.

Code of Federal Regulations, 2011 CFR

2011-07-01

... completion of Title IV, HEA program training provided or approved by the Secretary, and previous experience... participation in a Title IV, HEA program, does not have more than 33 percent of its undergraduate regular... Participation in Title IV, HEA Programs § 668.16 Standards of administrative capability. To begin and to...

34 CFR 668.16 - Standards of administrative capability.

Code of Federal Regulations, 2013 CFR

2013-07-01

... completion of Title IV, HEA program training provided or approved by the Secretary, and previous experience... Participation in Title IV, HEA Programs § 668.16 Standards of administrative capability. To begin and to continue to participate in any Title IV, HEA program, an institution shall demonstrate to the Secretary...

34 CFR 668.16 - Standards of administrative capability.

Code of Federal Regulations, 2014 CFR

2014-07-01

... completion of Title IV, HEA program training provided or approved by the Secretary, and previous experience... Participation in Title IV, HEA Programs § 668.16 Standards of administrative capability. To begin and to continue to participate in any Title IV, HEA program, an institution shall demonstrate to the Secretary...

34 CFR 668.16 - Standards of administrative capability.

Code of Federal Regulations, 2012 CFR

2012-07-01

... completion of Title IV, HEA program training provided or approved by the Secretary, and previous experience... Participation in Title IV, HEA Programs § 668.16 Standards of administrative capability. To begin and to continue to participate in any Title IV, HEA program, an institution shall demonstrate to the Secretary...

78 FR 33076 - Agency Information Collection Activities; Submission to the Office of Management and Budget for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-03

... Career and Technical Education Grant Application (NHCTEP) (1894-0001) AGENCY: Office of Vocational and... previously approved information collection. DATES: Interested persons are invited to submit comments on or... (ICR) that is described below. The Department of Education is especially interested in public comment...

76 FR 15011 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-18

...), the Securities and Exchange Commission (``Commission'') has submitted to the Office of Management and Budget a request for extension of the previously approved collection of information discussed below. Rule 18f-1 (17 CFR 270.18f-1) enables a registered open-end management investment company (``fund'') that...

75 FR 24958 - Proposed Data Collections Submitted for Public Comment and Recommendations

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-06

.... Previously approved were the effectiveness, implementation, and cost surveys with students, school principals... students will participate in the Effectiveness Follow-Up Survey data collection, with 20 teachers and 40... students and interviews with teachers in the urban schools. Data collection staff will use new interview...

77 FR 55864 - Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-11

.... ML111940200), which approved the RBS Cyber Security Plan and associated implementation milestone schedule. The Cyber Security Plan Implementation Schedule contained in the licensee's letter dated April 4, 2011... consequences of an accident previously evaluated? Response: No. The proposed change to the Cyber Security Plan...

76 FR 5207 - Agency Information Collection Activities: Reinstatement With Change of a Previously Approved...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-28

...: Comments Requested Action: 60-Day Notice of Information Collection Under Review: Police Public Contact... instrument with instructions or additional information, please contact Christine Eith, (202) 305-4559, Bureau... Contact Survey. (3) The agency form number, if any, and the applicable component of the Department...

76 FR 42761 - Agency Information Collection Activities: Request for Comments of a Previously Approved...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-19

.... Department of Transportation, 1200 New Jersey Avenue, SE., Room W62-317, Washington, DC 20590; 202-366-3784... variety of service agents. Estimated total number of respondents is 2,620,309. Estimated Number of...-18-11; 8:45 am] BILLING CODE 4910-9-P ...

22 CFR 129.7 - Prior approval (license).

Code of Federal Regulations, 2012 CFR

2012-04-01

... as significant military equipment under this subchapter, for or from any country not a member of the... following factors are present: (i) The value of the significant military equipment is $1,000,000 or more; (ii) The identical significant military equipment has not been previously licensed for export to the...

34 CFR 668.144 - Application for test approval.

Code of Federal Regulations, 2010 CFR

2010-07-01

... the comparability of scores on the current test to scores on the previous test, and data from validity... explanation of the methodology and procedures for measuring the reliability of the test; (ii) Evidence that different forms of the test, including, if applicable, short forms, are comparable in reliability; (iii...

76 FR 23538 - Notice of Intent To Reinstate a Previously Approved Information Collection.

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-27

... management, and conservation practices in order to quantify and assess current impacts of farming practices... (USDA) in 2003 as a multi-agency effort to quantify the environmental effects of conservation practices...) conducted on-site interviews with farmers during 2003-2006 to document tillage and irrigation practices...

9 CFR 95.23 - Previously used meat covers; importations permitted subject to restrictions.

Code of Federal Regulations, 2010 CFR

2010-01-01

... approved for the purpose by the Deputy Administrator, Veterinary Services. (b) The cloth or burlap shall be... inspectors or other persons authorized by the Deputy Administrator, Veterinary Services: Provided, however, That upon permission of the Deputy Administrator, Veterinary Services, such cloth or burlap may be...

9 CFR 95.23 - Previously used meat covers; importations permitted subject to restrictions.

Code of Federal Regulations, 2011 CFR

2011-01-01

... approved for the purpose by the Deputy Administrator, Veterinary Services. (b) The cloth or burlap shall be... inspectors or other persons authorized by the Deputy Administrator, Veterinary Services: Provided, however, That upon permission of the Deputy Administrator, Veterinary Services, such cloth or burlap may be...

21 CFR 314.96 - Amendments to an unapproved abbreviated application.

Code of Federal Regulations, 2011 CFR

2011-04-01

... SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Abbreviated... applicant on the same drug product formulation, unless the information has previously been submitted to FDA... and FDA determines that there may be bioequivalence issues or concerns with the product, FDA may...

21 CFR 314.96 - Amendments to an unapproved abbreviated application.

Code of Federal Regulations, 2012 CFR

2012-04-01

... SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Abbreviated... applicant on the same drug product formulation, unless the information has previously been submitted to FDA... and FDA determines that there may be bioequivalence issues or concerns with the product, FDA may...

77 FR 5832 - Conveyance of Federally-Owned Mineral Interests; Renewal of OMB Control Number

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-06

...] Conveyance of Federally-Owned Mineral Interests; Renewal of OMB Control Number AGENCY: Bureau of Land... Federally-owned mineral interests. The Office of Management and Budget (OMB) previously approved this...: Title: Conveyance of Federally-Owned Mineral Interests (43 CFR Part 2720). OMB Control Number: 1004-0153...

77 FR 60134 - Agency Information Collection Activities; Application for Identification Card

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-02

... previously approved. CBP is proposing that this information collection be extended with no change to the... other technological techniques or other forms of information. Title: Application for Identification Card... with no change to the burden hours or to CBP Form 3078. Type of Review: Extension (without change...

36 CFR 1225.24 - When can an agency apply previously approved schedules to electronic records?

Code of Federal Regulations, 2012 CFR

2012-07-01

... Property NATIONAL ARCHIVES AND RECORDS ADMINISTRATION RECORDS MANAGEMENT SCHEDULING RECORDS § 1225.24 When... must notify the National Archives and Records Administration, Modern Records Programs (NWM), 8601... authority reference; and (v) Format of the records (e.g., database, scanned images, digital photographs, etc...

36 CFR 1225.24 - When can an agency apply previously approved schedules to electronic records?

Code of Federal Regulations, 2011 CFR

2011-07-01

... Property NATIONAL ARCHIVES AND RECORDS ADMINISTRATION RECORDS MANAGEMENT SCHEDULING RECORDS § 1225.24 When... must notify the National Archives and Records Administration, Modern Records Programs (NWM), 8601... authority reference; and (v) Format of the records (e.g., database, scanned images, digital photographs, etc...

36 CFR 1225.24 - When can an agency apply previously approved schedules to electronic records?

Code of Federal Regulations, 2014 CFR

2014-07-01

... Property NATIONAL ARCHIVES AND RECORDS ADMINISTRATION RECORDS MANAGEMENT SCHEDULING RECORDS § 1225.24 When... must notify the National Archives and Records Administration, Modern Records Programs (NWM), 8601... authority reference; and (v) Format of the records (e.g., database, scanned images, digital photographs, etc...

77 FR 14459 - Notice of Request for Renewal of a Previously Approved Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-09

... guarantee applicants. The revised STLP application is a single, consolidated document that is easier to read... other certified Small Businesses (8a, women-owned, small disadvantaged, HUBZone, veteran owned, and... Small Businesses (8a, women-owned, small disadvantaged, HUBZone, veteran owned, and service disabled...

Giving Drugs a Second Chance: Overcoming Regulatory and Financial Hurdles in Repurposing Approved Drugs As Cancer Therapeutics

PubMed Central

Hernandez, J. Javier; Pryszlak, Michael; Smith, Lindsay; Yanchus, Connor; Kurji, Naheed; Shahani, Vijay M.; Molinski, Steven V.

2017-01-01

The repositioning or “repurposing” of existing therapies for alternative disease indications is an attractive approach that can save significant investments of time and money during drug development. For cancer indications, the primary goal of repurposed therapies is on efficacy, with less restriction on safety due to the immediate need to treat this patient population. This report provides a high-level overview of how drug developers pursuing repurposed assets have previously navigated funding efforts, regulatory affairs, and intellectual property laws to commercialize these “new” medicines in oncology. This article provides insight into funding programs (e.g., government grants and philanthropic organizations) that academic and corporate initiatives can leverage to repurpose drugs for cancer. In addition, we highlight previous examples where secondary uses of existing, Food and Drug Administration- or European Medicines Agency-approved therapies have been predicted in silico and successfully validated in vitro and/or in vivo (i.e., animal models and human clinical trials) for certain oncology indications. Finally, we describe the strategies that the pharmaceutical industry has previously employed to navigate regulatory considerations and successfully commercialize their drug products. These factors must be carefully considered when repurposing existing drugs for cancer to best benefit patients and drug developers alike. PMID:29184849

Giving Drugs a Second Chance: Overcoming Regulatory and Financial Hurdles in Repurposing Approved Drugs As Cancer Therapeutics.

PubMed

Hernandez, J Javier; Pryszlak, Michael; Smith, Lindsay; Yanchus, Connor; Kurji, Naheed; Shahani, Vijay M; Molinski, Steven V

2017-01-01

The repositioning or "repurposing" of existing therapies for alternative disease indications is an attractive approach that can save significant investments of time and money during drug development. For cancer indications, the primary goal of repurposed therapies is on efficacy, with less restriction on safety due to the immediate need to treat this patient population. This report provides a high-level overview of how drug developers pursuing repurposed assets have previously navigated funding efforts, regulatory affairs, and intellectual property laws to commercialize these "new" medicines in oncology. This article provides insight into funding programs (e.g., government grants and philanthropic organizations) that academic and corporate initiatives can leverage to repurpose drugs for cancer. In addition, we highlight previous examples where secondary uses of existing, Food and Drug Administration- or European Medicines Agency-approved therapies have been predicted in silico and successfully validated in vitro and/or in vivo (i.e., animal models and human clinical trials) for certain oncology indications. Finally, we describe the strategies that the pharmaceutical industry has previously employed to navigate regulatory considerations and successfully commercialize their drug products. These factors must be carefully considered when repurposing existing drugs for cancer to best benefit patients and drug developers alike.

Managing Innovation to Maximize Value Along the Discovery-Translation-Application Continuum.

PubMed

Waldman, S A; Terzic, A

2017-01-01

Success in pharmaceutical development led to a record 51 drugs approved in the past year, surpassing every previous year since 1950. Technology innovation enabled identification and exploitation of increasingly precise disease targets ensuring next generation diagnostic and therapeutic products for patient management. The expanding biopharmaceutical portfolio stands, however, in contradistinction to the unsustainable costs that reflect remarkable challenges of clinical development programs. This annual Therapeutic Innovations issue juxtaposes advances in translating molecular breakthroughs into transformative therapies with essential considerations for lowering attrition and improving the cost-effectiveness of the drug-development paradigm. Realizing the discovery-translation-application continuum mandates a congruent approval, adoption, and access triad. © 2016 ASCPT.

Managing Innovation to Maximize Value Along the Discovery-Translation-Application Continuum

PubMed Central

Waldman, SA; Terzic, A

2017-01-01

Success in pharmaceutical development led to a record 51 drug approved in the past year, surpassing every previous year since 1950. Technology innovation enabled identification and exploitation of increasingly precise disease targets ensuring a next generation diagnostic and therapeutic products for patient management. The expanding biopharmaceutical portfolio stands however in contradistinction to the unsustainable costs that reflect remarkable challenges of clinical development programs. This annual Therapeutic Innovations issue juxtaposes advances in translating molecular breakthroughs into transformative therapies with essential considerations for lowering attrition and improving the cost-effectiveness of the drug development paradigm. Realizing the discovery-translation-application continuum mandates a congruent approval, adoption and access triad. PMID:27869291

75 FR 82429 - Determinations Concerning Need for Error Correction, Partial Approval and Partial Disapproval...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-30

...EPA is correcting its previous full approval of Texas's Clean Air Act (CAA) Prevention of Significant Deterioration (PSD) program to be a partial approval and partial disapproval. The state did not address, or provide adequate legal authority for, the program's application to all pollutants that would become newly subject to regulation in the future, including non-National Ambient Air Quality Standard (NAAQS) pollutants, among them greenhouse gases (GHGs). Further, EPA is promulgating a federal implementation plan (FIP), as required following the partial disapproval, to establish a PSD permitting program in Texas for GHG-emitting sources. EPA is taking this action through interim final rulemaking, effective upon publication, to ensure the availability of a permitting authority-- EPA--in Texas for GHG-emitting sources when they become subject to PSD on January 2, 2011. This will allow those sources to proceed with plans to construct or expand. This rule will expire on April 30, 2011. EPA is also proposing a notice-and-comment rulemaking that mirrors this rulemaking.

78 FR 43878 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-22

...The Environmental Protection Agency has submitted an information collection request (ICR), ``NESHAP for Stationary Combustion Turbines (40 CFR Part 63, Subpart YYYY) (Renewal)'' (EPA ICR No. 1967.05, OMB Control No. 2060-0540) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq). This is a proposed extension of the ICR, which is currently approved through September 30, 2013. Public comments were previously requested via the Federal Register (77 FR 63813) on October 17, 2012, during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

Bill would establish pilot project for denturism in Kentucky.

PubMed

Campbell, C A

2000-04-01

HB 238 has been reported favorably to the floor of the House of Representatives by the Committee on Licensing and Occupations, but has not yet been acted upon by the full House. When asked whether he thought his legislation would be approved, Representative Burch said he thought the bill had a "50-50" chance of passing the Kentucky legislature this year. Sources within the Kentucky dental laboratory and dental communities disagree on the legislation's chances for passage. Some within the industry feel the legislation simply does not have enough votes to pass the General Assembly, primarily because of opposition from the Kentucky Dental Association. Others speculate that the bill has a better opportunity to be approved this year than it did in the previous years when it was introduced. The Kentucky General Assembly adjourns its session for the year 2000 on April 12, so there will be a quick answer to the question of whether HB 238 will be approved. The May issue of this column will provide details.

78 FR 29381 - Agency Information Collection Activities: Proposed Renewal of Previously Approved Collection...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-20

..., once a year by law students and recent law school graduates (e.g., judicial law clerks) who will be in... (candidates selected for interviews) who will complete a travel survey used to schedule interviews and prepare official Travel Authorizations prior to the interviewees' performing pre-employment interview travel (as...

7 CFR 457.132 - Cranberry crop insurance provisions.

Code of Federal Regulations, 2013 CFR

2013-01-01

.... If you fail to notify us of any circumstance that may affect your yields from previous levels, we... considered acceptable by us; and (d) That are grown on vines that have completed four growing seasons after...: (i) A transfer of coverage and right to an indemnity, or a similar form approved by us, is completed...

7 CFR 457.132 - Cranberry crop insurance provisions.

Code of Federal Regulations, 2012 CFR

2012-01-01

.... If you fail to notify us of any circumstance that may affect your yields from previous levels, we... considered acceptable by us; and (d) That are grown on vines that have completed four growing seasons after...: (i) A transfer of coverage and right to an indemnity, or a similar form approved by us, is completed...

7 CFR 457.132 - Cranberry crop insurance provisions.

Code of Federal Regulations, 2014 CFR

2014-01-01

.... If you fail to notify us of any circumstance that may affect your yields from previous levels, we... considered acceptable by us; and (d) That are grown on vines that have completed four growing seasons after...: (i) A transfer of coverage and right to an indemnity, or a similar form approved by us, is completed...

7 CFR 457.132 - Cranberry crop insurance provisions.

Code of Federal Regulations, 2011 CFR

2011-01-01

.... If you fail to notify us of any circumstance that may affect your yields from previous levels, we... considered acceptable by us; and (d) That are grown on vines that have completed four growing seasons after...: (i) A transfer of coverage and right to an indemnity, or a similar form approved by us, is completed...

76 FR 18033 - Airworthiness Directives; Piper Aircraft, Inc. (Type Certificate Previously Held by The New Piper...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-01

..., any comments received, and other information. The address for the Docket Office (phone: 800-647-5527... INFORMATION CONTACT: Darby Mirocha, Aerospace Engineer, FAA, Atlanta Aircraft Certification Office, 1701... Manager, Atlanta Aircraft Certification Office, FAA, has the authority to approve AMOCs for this AD, if...

75 FR 82329 - Airworthiness Directives; Piper Aircraft, Inc. (Type Certificate Previously Held by The New Piper...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-30

... for the Docket Office (phone: 800-647-5527) is in the ADDRESSES section. Comments will be available in... Engineer, FAA, Atlanta Aircraft Certification Office, 1701 Columbia Avenue, College Park, Georgia 30337... (AMOCs) (h)(1) The Manager, Atlanta Aircraft Certification Office, FAA, has the authority to approve...

78 FR 59335 - Notice of Request for Extension of a Previously Approved Information Collection (Industry...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-26

... information collection concerning industry responses to noncompliance records. There are no changes to the existing information collection. DATES: Comments on this notice must be received on or before November 25... this docket will be made available for public inspection and posted without change, including any...

Effects of Interviewer Behavior on Accuracy of Children's Responses

ERIC Educational Resources Information Center

Sparling, Jessica; Wilder, David A.; Kondash, Jennifer; Boyle, Megan; Compton, Megan

2011-01-01

Previous research has shown that certain interviewer behaviors can evoke inaccurate answers by children. In the current study, we examined the effects of approving and disapproving statements on the accuracy of 3 children's answers to questions in an interview (Experiment 1). We then evaluated 3 questioning techniques that may be used by…

76 FR 62894 - Agency Information Collection Activities: Notice of Request for Renewal of a Previously Approved...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-11

... innovative technologies that will improve safety, reduce congestion due to construction, and improve quality... project, the innovative technologies to be used and a description of how these technologies will improve safety, reduce construction congestion, and improve quality. The collected information will be used by...

Developing and Validating an Instrument for Student Ratings of Teaching

ERIC Educational Resources Information Center

Hunt, Gary; Baldwin, Lyn; Tsui, Ernest; Matthews, Les

2013-01-01

In May 2007, the Thompson Rivers University Faculty of Science established an ad hoc subcommittee to develop a new student ratings of teaching survey. The final survey, approved by the Faculty in February 2011, includes statements categorized in the dimensions of teaching shown in previous studies to be correlated with student achievement. The…

78 FR 64979 - Agency Information Collection Activities; Revision of a Previously Approved Collection, with...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-30

... Collection, with Change; Comments Requested: COPS Progress Report ACTION: 60-Day Notice. The Department of Justice (DOJ) Office of Community Oriented Policing Services (COPS) will be submitting the following...; comments requested. (2) Title of the Form/Collection: COPS Progress Report. (3) Agency form number, if any...

76 FR 10064 - Agency Information Collection Activities: Extension of a Previously Approved Collection; Comments...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-23

... Collection Under Review: COPS Progress Report. The Department of Justice (DOJ) Office of Community Oriented Policing Services (COPS) will be submitting the following information collection request to the Office of... Form/Collection: COPS Progress Report. (3) Agency form number, if any, and the applicable component of...

40 CFR 60.2870 - What are the recordkeeping and reporting requirements for air curtain incinerators?

Code of Federal Regulations, 2012 CFR

2012-07-01

... SOURCES Emissions Guidelines and Compliance Times for Commercial and Industrial Solid Waste Incineration... onsite in either paper copy or electronic format, unless the Administrator approves another format, for... the previous report. (e) Submit initial and annual opacity test reports as electronic or paper copy on...

10 CFR 72.30 - Financial assurance and recordkeeping for decommissioning.

Code of Federal Regulations, 2013 CFR

2013-01-01

... CLASS C WASTE License Application, Form, and Contents § 72.30 Financial assurance and recordkeeping for... review and approval a decommissioning funding plan that must contain: (1) Information on how reasonable... previous cost estimate. (d) If, in surveys made under 10 CFR 20.1501(a), residual radioactivity in soils or...

10 CFR 72.30 - Financial assurance and recordkeeping for decommissioning.

Code of Federal Regulations, 2014 CFR

2014-01-01

... CLASS C WASTE License Application, Form, and Contents § 72.30 Financial assurance and recordkeeping for... review and approval a decommissioning funding plan that must contain: (1) Information on how reasonable... previous cost estimate. (d) If, in surveys made under 10 CFR 20.1501(a), residual radioactivity in soils or...

77 FR 43826 - Agency Information Collection Request. 60-Day Public Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-26

... Discrimination; Health Information Privacy Complaints OMB No. 0990-0269--Extension--Office of Civil Rights. Abstract: The Office for Civil Rights is seeking an extension on an approval for a 3-year clearance on a previous collection. Individuals may file written complaints with the Office for Civil Rights when they...

78 FR 77202 - Request for Comments of a Previously Approved Information Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-20

... below is being forwarded to the Office of Management and Budget (OMB) for review and comments. A Federal... FURTHER INFORMATION CONTACT: Lauren Brand, Director, Office of Marine Highways and Passenger Services, MAR... 20590. Telephone: 202-366-7057; or email lauren.brand@dot.gov . Copies of this collection also can be...

78 FR 71713 - Agency Requests for Renewal of a Previously Approved Information Collection(s): Supplementary...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-29

..., Public Law 104-13. DATES: Written comments should be submitted by January 28, 2014. ADDRESSES: You may... or Hand Delivery: Docket Management Facility, U.S. Department of Transportation, 1200 New Jersey.... Title: Supplementary Training Course Application. Form Numbers: MA-823 Type of Review: Renewal of an...

47 CFR 61.38 - Supporting information to be submitted with letters of transmittal.

Code of Federal Regulations, 2010 CFR

2010-10-01

... economic information to support the changed or new matter. (1) For a tariff change the carrier must submit... located in the respective zones, and receive approval of its proposed plan. (c) Working papers and... previously offered, the Chief, Pricing Policy Division must be provided two sets of working papers containing...

Three Insights About Change

NASA Technical Reports Server (NTRS)

Little, Terry

2002-01-01

Managers need to develop credibility, and need to base it upon new managerial accomplishments rather than previous ones. New and exciting jobs in management are challenging, but can lead to personal growth. Personnel who are afraid of potential negative consequences resulting from administrative changes are a hindrance to projects. An approval-seeking management style almost always fails.

Standard specification for carbon and alloy steel nuts. ASTM standard

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

NONE

This specification is under the jurisdiction of ASTM Committee F-16 on Fasteners and is the responsibility of Subcommittee F16.02 on Steel Bolts, Nuts, Rivets, and Washers. Current edition approved Dec. 10, 1997. Published July 1998. Originally published as A 563-66. Last previous edition A 563-96.

77 FR 65586 - Agency Information Collection Activities; Emergency Reinstatement of Previously Approved Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-29

...) or the Veterans Employment Opportunities Act (VEOA). An explanation of these three types of appeals... Management and Budget (OMB) to reinstate Information Collection Request (ICR) 3124-0009, E-Appeal/US Merit Systems Protection Board Appeal Form which expired on March 31, 2012. This ICR is necessary for...

75 FR 2144 - Public Buildings Service; Submission for OMB Review; Art-in-Architecture Program National Artist...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-14

... art from living American artists. One-half of one percent of the estimated construction cost of new or... for OMB Review; Art-in- Architecture Program National Artist Registry AGENCY: Public Buildings Service... extension of a previously approved information collection requirement regarding Art-in Architecture Program...

76 FR 24876 - Notice of Public Information Collection(s) Being Submitted for Review and Approval to the Office...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-03

... reporting requirements, third party disclosure requirements, and recordkeeping requirement. Obligation To... reporting, recordkeeping and/or third party disclosure requirements. The Commission is reducing its previous... a quarterly report and must also submit an attestation by the chief financial officer (CFO) that the...

30 CFR 250.294 - May I combine the Conceptual Plan and the DWOP?

Code of Federal Regulations, 2012 CFR

2012-07-01

... Information Deepwater Operations Plan (dwop) § 250.294 May I combine the Conceptual Plan and the DWOP? If your development project meets the following criteria, you may submit a combined Conceptual Plan/DWOP on or before... production or completion technology for which you have obtained approval previously. ...

30 CFR 250.294 - May I combine the Conceptual Plan and the DWOP?

Code of Federal Regulations, 2014 CFR

2014-07-01

... Information Deepwater Operations Plan (dwop) § 250.294 May I combine the Conceptual Plan and the DWOP? If your development project meets the following criteria, you may submit a combined Conceptual Plan/DWOP on or before... production or completion technology for which you have obtained approval previously. ...

30 CFR 250.294 - May I combine the Conceptual Plan and the DWOP?

Code of Federal Regulations, 2013 CFR

2013-07-01

... Information Deepwater Operations Plan (dwop) § 250.294 May I combine the Conceptual Plan and the DWOP? If your development project meets the following criteria, you may submit a combined Conceptual Plan/DWOP on or before... production or completion technology for which you have obtained approval previously. ...

78 FR 46404 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-31

... to renew an information collection. This research is important for establishing the scientific basis...: Renewal of an information collection. Background: The data from this research are critically important for... the National Parks Air Tour Management Act of 2000 (NPATMA). The research expands on previous aircraft...

78 FR 63561 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-24

.... 147, page 46404. This research is important for establishing the scientific basis for air tour... information collection. Background: The data from this research are critically important for establishing the... Parks Air Tour Management Act of 2000 (NPATMA). The research expands on previous aircraft noise dose...

78 FR 9035 - Renewal and Revision of a Previously Approved Information Collection; Comment Request; State...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-07

... maximum advertised speed, technology type and spectrum (if applicable) for each broadband provider... funding to collect the maximum advertised speed and technology type to which various classes of Community... businesses use the data to identify where broadband is available, the advertised speeds and other information...

78 FR 69456 - Notice To Reinstate a Previously Approved Information Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-19

... incident occurred on approach, takeoff, or within 3 miles of an airport); ``flight crew member 1... requests information concerning the location and date and time of the accident or incident, the phase of... last inspection, total time on airframe, type of fire extinguishing system, type of reciprocating fuel...

76 FR 79539 - Approval and Promulgation of Air Quality Implementation Plans; West Virginia; Revised Motor...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-22

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [FDMS Docket No. EPA-R03-OAR-2011-0511; FRL-9609-1... Maintenance Areas; Correction AGENCY: Environmental Protection Agency (EPA). ACTION: Direct final rule..., Parkersburg, Weirton, and Wheeling 8-hour ozone maintenance areas. The previous rulemaking amended the...

Primary School Teachers' Opinion on Digital Textbooks

ERIC Educational Resources Information Center

Magdas, Ioana; Drîngu, Maria-Carmen

2016-01-01

Ministry of Education, Research, Youth and Sports of Romania through order no. 3654/29.03.2012 approved the Framework Plan for Primary Education, Preparatory Grade, First and Second Grades. New subjects and syllabuses were introduced. In 2014-2015 school year appeared new school textbooks for first and second grade. Unlike the previous textbooks…

77 FR 38035 - Notice for Request To Reinstate Previously Approved Information Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-26

... participating lenders who make loans to income eligible borrowers in rural areas. The purpose of this program is to promote affordable housing for low- and moderate-income borrowers in rural America. Estimate of Burden: Public reporting burden for this collection of information is estimated to average 49 minutes per...

78 FR 43208 - Proposed Information Collection Activity; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-19

... Information Collection Activity; Comment Request Proposed Projects Title: Income Withholding Order/Notice for...) and 466(b)(6) of the Social Security Act require the use of the Income Withholding for Support (IWO... (8); 42 U.S.C 666(b)(6). The Income Withholding for Support (IWO) form previously approved by the...

77 FR 69924 - Request for Comments on a Renewal of a Previously Approved Information Collection: Production...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-21

...: Kenneth R. Katz, Fuel Economy Division, Office of International Policy, Fuel Economy and Consumer Programs... Parts 531 and 533 Passenger Car Average Fuel Economy Standards--Model Years 2016-2025; Light Truck Average Fuel Economy Standards--Model Years 2016-2025; Production Plan Data. OMB Control Number: 2127-0655...

76 FR 67152 - Federal Acquisition Regulation; Submission for OMB Review; Cost or Pricing Data Requirements and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-31

...; Submission for OMB Review; Cost or Pricing Data Requirements and Information Other Than Cost or Pricing Data... extension of a previously approved information collection requirement concerning cost or pricing data requirements and information other than cost or pricing data. A noticed was published in the Federal Register...

Are We Teaching the IS 2009 Model Curriculum?

ERIC Educational Resources Information Center

Apigian, Charles H.; Gambill, Stanley E.

2010-01-01

This article presents the results of research that gathered data about undergraduate information systems curricula and compared it to previous studies and the IS 2009 working model curriculum which is now named IS 2010 Model Curriculum after final approval. Data was collected from the websites of 240 colleges and universities identified as having…

76 FR 31675 - Agency Information Collection Activities: Notice of Request for Renewal of a Previously Approved...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-01

... Program. Inspections of fracture critical bridges and underwater inspections are also required at... basis for setting initial priorities for the replacement or rehabilitation of bridges under the Highway... rehabilitation. In order to apportion funds for the HBP, the law requires that a cost to replace or rehabilitate...

9 CFR 95.23 - Previously used meat covers; importations permitted subject to restrictions.

Code of Federal Regulations, 2014 CFR

2014-01-01

... permitted subject to restrictions. Cloth or burlap which has been used to cover fresh or frozen meats...-mouth disease exists, shall not be imported except under the following conditions: (a) The cloth or... approved for the purpose by the Deputy Administrator, Veterinary Services. (b) The cloth or burlap shall be...

9 CFR 95.23 - Previously used meat covers; importations permitted subject to restrictions.

Code of Federal Regulations, 2012 CFR

2012-01-01

... permitted subject to restrictions. Cloth or burlap which has been used to cover fresh or frozen meats...-mouth disease exists, shall not be imported except under the following conditions: (a) The cloth or... approved for the purpose by the Deputy Administrator, Veterinary Services. (b) The cloth or burlap shall be...

9 CFR 95.23 - Previously used meat covers; importations permitted subject to restrictions.

Code of Federal Regulations, 2013 CFR

2013-01-01

... permitted subject to restrictions. Cloth or burlap which has been used to cover fresh or frozen meats...-mouth disease exists, shall not be imported except under the following conditions: (a) The cloth or... approved for the purpose by the Deputy Administrator, Veterinary Services. (b) The cloth or burlap shall be...

75 FR 74673 - Approval and Promulgation of Implementation Plans; Georgia: Stage II Vapor Recovery

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-01

... includes multiple modifications to Georgia's Air Quality Rules found at Chapter 391-3-1. Previously, EPA...., Atlanta, Georgia 30303-8960. 5. Hand Delivery or Courier: Ms. Lynorae Benjamin, Regulatory Development... (404) 562-9029. Ms. Spann can also be reached via electronic mail at [email protected]epa.gov . SUPPLEMENTARY...

76 FR 77587 - Agency Information Collection Activities: Notice of Request for Renewal of a Previously Approved...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-13

... accuracy of the estimated burden; (3) ways for the FHWA to enhance the quality, usefulness, and clarity of... electronic technology, without reducing the quality of the collected information. All comments should include..., except Federal holidays. SUPPLEMENTARY INFORMATION: Title: Highways for LIFE Program. Background: Section...

27 CFR 19.735 - Reconsignment while in transit.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Transfer of Spirits Between Alcohol Fuel Plants § 19.735 Reconsignment while in transit. A consignor may... previously approved for the new consignee and must be on file at the alcohol fuel plant. The bond of the new... 27 Alcohol, Tobacco Products and Firearms 1 2011-04-01 2011-04-01 false Reconsignment while in...

75 FR 44791 - Notice of Public Information Collection(s) Being Submitted for Review and Approval to the Office...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-29

... sections that were previously included under OMB Control No. 3060-1007: 47 CFR 25.113, 25.131, 25.154, 25... revisions to this information collection, OMB Control No. 3060-1007 also titled, ``Streamlining and Other...-10- 8:45 am] BILLING CODE 6712-01-S ...

75 FR 59293 - Agency Information Collection Activities: Reinstatement, With Change, of a Previously Approved...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-27

... selection of judicial officers, the governance of the judicial branch, the funding and budgets of state..., information will be collected on the utilization of information technology systems in state courts. All data... Amount of Time Estimated for an Average Respondent to Respond: The State Court Organization (SCO) data...

75 FR 72840 - Agency Information Collection Activities: Reinstatement, With Change of a Previously Approved...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-26

... selection of judicial officers, the governance of the judicial branch, the funding and budgets of state..., information will be collected on the utilization of information technology systems in state courts. All data... Amount of Time Estimated for an Average Respondent to Respond: The State Court Organization (SCO) data...

76 FR 20435 - Notice of Approval of the Supplemental Finding of No Significant Impact and Record of Decision...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-12

.../Record of Decision (FONSI/ROD) for the Supplemental Environmental Assessment (EA) for changes proposed to... previously addressed in the December 2007 environmental assessment FONSI/ROD. The proposed changes include... Supplemental Finding of No Significant Impact and Record of Decision for the Supplemental Environmental...

Effect of dietary monensin on the bacterial population structure of dairy cattle colonic contents

USDA-ARS?s Scientific Manuscript database

Monensin is a carboxylic polyether ionophore antibiotic that is routinely used to improve the performance of beef cattle and was recently approved by the U.S. Food and Drug Administration for the use in dairy cattle to improve milk yields. Previous studies have suggested that monensin improves anima...

77 FR 22766 - Submission for OMB Review; Comment Request; Reporting Executive Compensation and First-Tier...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-17

... additional burden imposed to respond to all three questions posed in the reporting tool is 5,197. DoD, GSA... Request; Reporting Executive Compensation and First-Tier Subcontract Awards AGENCY: Department of Defense... previously approved information collection requirement for Reporting Executive Compensation and First-tier...

75 FR 6227 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-08

....), the Securities and Exchange Commission (``Commission'') has submitted to the Office of Management and Budget this request for extension of the previously approved collection of information discussed below. Schedule 14D-1F (17 CFR 240.14d-102) may be used by any person making a cash tender or exchange offer for...

77 FR 67841 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-14

....), the Securities and Exchange Commission (``Commission'') has submitted to the Office of Management and Budget this request for extension of the previously approved collection of information discussed below. Schedule 14D-1F (17 CFR 240.14d-102) is a form that may be used by any person making a cash tender or...

75 FR 22169 - Self-Regulatory Organizations; New York Stock Exchange LLC; Order Approving Proposed Rule Change...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-27

... election of directors. Under the Corporation's corporate governance guidelines previously adopted by the... resignation to the Nominating and Governance Committee of the Board (or another committee designated by the... resignation would not participate in the recommendation by the Nominating and Governance Committee or the...

30 CFR 203.74 - When will MMS reconsider its determination?

Code of Federal Regulations, 2010 CFR

2010-07-01

... application or if you want your approved royalty suspension volume to change. In these instances, to be... significant new G&G data and you previously have not either requested a redetermination or reapplied for...&G data: (1) Results from drilling new wells or getting new three-dimensional seismic data and...

77 FR 21579 - Agency Information Collection Activities: Transfer of Cargo to a Container Station

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-10

... Activities: Transfer of Cargo to a Container Station AGENCY: U.S. Customs and Border Protection, Department... Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act: Transfer of Cargo to a Container Station. This is a proposed extension of an information collection that was previously...

Controlled Multivariate Evaluation of Open Education: Application of a Critical Model.

ERIC Educational Resources Information Center

Sewell, Alan F.; And Others

This paper continues previous reports of a controlled multivariate evaluation of a junior high school open-education program. A new method of estimating program objectives and implementation is presented, together with the nature and degree of obtained student outcomes. Open-program students were found to approve more highly of their learning…