77 FR 48159 - Draft Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-13

... 510(k)s reviewed in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics... applicable to all devices reviewed through the 510(k) notification process in CDRH and CBER and have been... draft guidance may do so by using the Internet. A search capability for all CDRH guidance documents is...

[Supervision, administration and standard research related to tissue engineered medical products].

PubMed

Xi, Ting-fei; Chen, Liang; Zhao, Peng

2003-11-01

Tissue engineering advance in supplying the reparative and reconstructive medicine with promising tissue engineered medical products(TEMPs) and the new therapy alternative. The related supervision and administration of TEMPs is being developed and the standard research of TEMPs is also in progress. The Food and Drug Administration(FDA) of the United States has treated TEMPs as combined products and supervised them according to the level of risk to patients. Lately, FDA has determined that the Center for Devices and Radiological Health (CDRH) should take charge of examination and approval of TEMPs, with the cooperation of the Center for Biological Evaluations and Research(CBER). The regulatory controls have been established respectively in European Union and Japan. In China, TEMPs are identified as medical devices combined with cells. The Department of Medical Device of the State Food and Drug Administration (SFDA) is responsible for the examination and approval of TEMPs, and National Institute for the Control of Pharmaceutical & Biological Products(NICPBP) is responsible for evaluation tests. The standards of TEMPs are formulated mainly by the American Society of Testing Materials(ASTM) and International Standardization Organization(ISO).

75 FR 22599 - Draft Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-29

... office in processing your request, or fax your request to CDRH to 301-847-8149. See the SUPPLEMENTARY... guidance you are requesting. A search capability for all CDRH guidance documents is available at http://www... Response Responses Response Total Hours CDRH 110 1 110 12 1,320 CBER 4 1 4 12 48 Total 1,368 \\1\\ There are...

The Brazilian wide field imaging camera (WFI) for the China/Brazil earth resources satellite: CBERS 3 and 4

NASA Astrophysics Data System (ADS)

Scaduto, L. C. N.; Carvalho, E. G.; Modugno, R. G.; Cartolano, R.; Evangelista, S. H.; Segoria, D.; Santos, A. G.; Stefani, M. A.; Castro Neto, J. C.

2017-11-01

The purpose of this paper is to present the optical system developed for the Wide Field imaging Camera - WFI that will be integrated to the CBERS 3 and 4 satellites (China Brazil Earth resources Satellite). This camera will be used for remote sensing of the Earth and it is aimed to work at an altitude of 778 km. The optical system is designed for four spectral bands covering the range of wavelengths from blue to near infrared and its field of view is +/-28.63°, which covers 866 km, with a ground resolution of 64 m at nadir. WFI has been developed through a consortium formed by Opto Electrônica S. A. and Equatorial Sistemas. In particular, we will present the optical analysis based on the Modulation Transfer Function (MTF) obtained during the Engineering Model phase (EM) and the optical tests performed to evaluate the requirements. Measurements of the optical system MTF have been performed using an interferometer at the wavelength of 632.8nm and global MTF tests (including the CCD and signal processing electronic) have been performed by using a collimator with a slit target. The obtained results showed that the performance of the optical system meets the requirements of project.

Testing for HIV

MedlinePlus

... and HIV Diagnostic Assays HIV (Human Immunodeficiency Virus) Consumer Information for Patients & Patient Advocates Contact FDA (800) ... 4709 (240) 402-8010 ocod@fda.hhs.gov Consumer Affairs Branch (CBER) Division of Communication and Consumer ...

Land use mapping from CBERS-2 images with open source tools by applying different classification algorithms

NASA Astrophysics Data System (ADS)

Sanhouse-García, Antonio J.; Rangel-Peraza, Jesús Gabriel; Bustos-Terrones, Yaneth; García-Ferrer, Alfonso; Mesas-Carrascosa, Francisco J.

2016-02-01

Land cover classification is often based on different characteristics between their classes, but with great homogeneity within each one of them. This cover is obtained through field work or by mean of processing satellite images. Field work involves high costs; therefore, digital image processing techniques have become an important alternative to perform this task. However, in some developing countries and particularly in Casacoima municipality in Venezuela, there is a lack of geographic information systems due to the lack of updated information and high costs in software license acquisition. This research proposes a low cost methodology to develop thematic mapping of local land use and types of coverage in areas with scarce resources. Thematic mapping was developed from CBERS-2 images and spatial information available on the network using open source tools. The supervised classification method per pixel and per region was applied using different classification algorithms and comparing them among themselves. Classification method per pixel was based on Maxver algorithms (maximum likelihood) and Euclidean distance (minimum distance), while per region classification was based on the Bhattacharya algorithm. Satisfactory results were obtained from per region classification, where overall reliability of 83.93% and kappa index of 0.81% were observed. Maxver algorithm showed a reliability value of 73.36% and kappa index 0.69%, while Euclidean distance obtained values of 67.17% and 0.61% for reliability and kappa index, respectively. It was demonstrated that the proposed methodology was very useful in cartographic processing and updating, which in turn serve as a support to develop management plans and land management. Hence, open source tools showed to be an economically viable alternative not only for forestry organizations, but for the general public, allowing them to develop projects in economically depressed and/or environmentally threatened areas.

US definitions, current use, and FDA stance on use of platelet-rich plasma in sports medicine.

PubMed

Beitzel, Knut; Allen, Donald; Apostolakos, John; Russell, Ryan P; McCarthy, Mary Beth; Gallo, Gregory J; Cote, Mark P; Mazzocca, Augustus D

2015-02-01

With increased utilization of platelet-rich plasma (PRP), it is important for clinicians to understand the United States, the Food and Drug Administration (FDA) regulatory role and stance on PRP. Blood products such as PRP fall under the prevue of FDA's Center for Biologics Evaluation and Research (CBER). CBER is responsible for regulating human cells, tissues, and cellular and tissue-based products. The regulatory process for these products is described in the FDA's 21 CFR 1271 of the Code of Regulations. Under these regulations, certain products including blood products such as PRP are exempt and therefore do not follow the FDA's traditional regulatory pathway that includes animal studies and clinical trials. The 510(k) application is the pathway used to bring PRP preparation systems to the market. The 510(k) application allows devices that are "substantially equivalent" to a currently marketed device to come to the market. There are numerous PRP preparation systems on the market today with FDA clearance; however, nearly all of these systems have 510(k) clearance for producing platelet-rich preparations intended to be used to mix with bone graft materials to enhance bone graft handling properties in orthopedic practices. The use of PRP outside this setting, for example, an office injection, would be considered "off label." Clinicians are free to use a product off-label as long as certain responsibilities are met. Per CBER, when the intent is the practice of medicine, clinicians "have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects." Finally, despite PRP being exempted, the language in 21 CFR 1271 has caused some recent concern over activated PRP; however to date, the FDA has not attempted to regulate activated PRP. Clinicians using activated PRP should be mindful of these concerns and continued to stay informed. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Focus adjustment method for CBERS 3 and 4 satellites Mux camera to be performed in air condition and its experimental verification for best performance in orbital vacuum condition

NASA Astrophysics Data System (ADS)

Scaduto, Lucimara C. N.; Malavolta, Alexandre T.; Modugno, Rodrigo G.; Vales, Luiz F.; Carvalho, Erica G.; Evangelista, Sérgio; Stefani, Mario A.; de Castro Neto, Jarbas C.

2017-11-01

The first Brazilian remote sensing multispectral camera (MUX) is currently under development at Opto Eletronica S.A. It consists of a four-spectral-band sensor covering a 450nm to 890nm wavelength range. This camera will provide images within a 20m ground resolution at nadir. The MUX camera is part of the payload of the upcoming Sino-Brazilian satellites CBERS 3&4 (China-Brazil Earth Resource Satellite). The preliminary alignment between the optical system and the CCD sensor, which is located at the focal plane assembly, was obtained in air condition, clean room environment. A collimator was used for the performance evaluation of the camera. The preliminary performance evaluation of the optical channel was registered by compensating the collimator focus position due to changes in the test environment, as an air-to-vacuum environment transition leads to a defocus process in this camera. Therefore, it is necessary to confirm that the alignment of the camera must always be attained ensuring that its best performance is reached for an orbital vacuum condition. For this reason and as a further step on the development process, the MUX camera Qualification Model was tested and evaluated inside a thermo-vacuum chamber and submitted to an as-orbit vacuum environment. In this study, the influence of temperature fields was neglected. This paper reports on the performance evaluation and discusses the results for this camera when operating within those mentioned test conditions. The overall optical tests and results show that the "in air" adjustment method was suitable to be performed, as a critical activity, to guarantee the equipment according to its design requirements.

Paul Carlson | Center for Cancer Research

Cancer.gov

Paul Carlson, Ph.D. March 28 Principal Investigator Laboratory of Mucosal Pathogens and Cellular Immunology Center for Biologics Evaluation and Research (CBER), FDA Topic:  "Research and Regulation of novel biologic products at the FDA's Center for Biologics Evaluation and Research"

21 CFR 814.100 - Purpose and scope.

Code of Federal Regulations, 2010 CFR

2010-04-01

... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL... public health and safety and with ethical standards, to encourage the discovery and use of devices...), Center for Devices and Radiological Health (CDRH), the Center for Biologics Evaluation and Research (CBER...

21 CFR 312.140 - Address for correspondence.

Code of Federal Regulations, 2012 CFR

2012-04-01

... biological products regulated by CBER. Send the IND submission to the Document Control Center (HFM-99... North VII, 7620 Standish Pl., Rockville, MD 20855. (2) For biological products regulated by CDER. Send the IND submission to the CDER Therapeutic Biological Products Document Room, Center for Drug...

21 CFR 312.140 - Address for correspondence.

Code of Federal Regulations, 2013 CFR

2013-04-01

... biological products regulated by CBER. Send the IND submission to the Document Control Center (HFM-99... North VII, 7620 Standish Pl., Rockville, MD 20855. (2) For biological products regulated by CDER. Send the IND submission to the CDER Therapeutic Biological Products Document Room, Center for Drug...

76 FR 4919 - Regulatory Site Visit Training Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-27

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0046] Regulatory Site Visit Training Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research (CBER) is...

DEVELOPMENT OF FLEXIBLE INSULATION FOR SOLID PROPELLANT ROCKET MOTOR CASES

DTIC Science & Technology

acrylonitrile-phenol furfural -asbestos composition. Other promising materials which are reported are based on two types of liquid butadiene/styrene cbers. The...This material was based on a butadiene/acrylonitrile-phenol furfural -asbestos composition. Other promising materials which are reported are based on two

75 FR 12768 - Blood Products Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-17

...] Blood Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Administration (FDA). At least one portion of the meeting will be closed to the public. Name of Committee: Blood... Biochemistry and Vascular Biology, Division of Hematology, Office of Blood Research and Review, CBER, FDA. FDA...

76 FR 68768 - Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-07

... provides recommendations for the design of clinical trials for cancer vaccines conducted under an IND to... in this notice finalizes the draft guidance of the same title dated September 2009. DATES: Submit...), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike...

21 CFR 312.145 - Guidance documents.

Code of Federal Regulations, 2014 CFR

2014-04-01

... HUMAN USE INVESTIGATIONAL NEW DRUG APPLICATION Miscellaneous § 312.145 Guidance documents. (a) FDA has... of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002. A request for a copy of the CBER list should be directed to...

21 CFR 312.145 - Guidance documents.

Code of Federal Regulations, 2013 CFR

2013-04-01

... HUMAN USE INVESTIGATIONAL NEW DRUG APPLICATION Miscellaneous § 312.145 Guidance documents. (a) FDA has... of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002. A request for a copy of the CBER list should be directed to...

21 CFR 312.145 - Guidance documents.

Code of Federal Regulations, 2012 CFR

2012-04-01

... HUMAN USE INVESTIGATIONAL NEW DRUG APPLICATION Miscellaneous § 312.145 Guidance documents. (a) FDA has... of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002. A request for a copy of the CBER list should be directed to...

21 CFR 312.145 - Guidance documents.

Code of Federal Regulations, 2011 CFR

2011-04-01

... HUMAN USE INVESTIGATIONAL NEW DRUG APPLICATION Miscellaneous § 312.145 Guidance documents. (a) FDA has... of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002. A request for a copy of the CBER list should be directed to...

78 FR 49528 - Consolidation of Wound Care Products Containing Live Cells

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-14

...] Consolidation of Wound Care Products Containing Live Cells AGENCY: Food and Drug Administration, HHS. ACTION... certain wound care products containing live cells from the Center for Devices and Radiological Health... CDRH and CBER. FDA believes that as more wound care products containing live cells are developed such...

21 CFR 601.29 - Guidance documents.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Guidance documents. 601.29 Section 601.29 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS... Register. You may request a copy of the CBER list from the Office of Communication, Training, and...

Multicenter Clinical Trial of Keratin Biomaterial for Peripheral Nerve Regeneration

DTIC Science & Technology

2014-10-01

Evaluation Research (CDER), the Center for Biologics Evaluation Research (CBER), and the Center for Devices and Radiological Health ( CDRH ) to clarify...submitting a new application to the CDRH for a new product. This new product is the material that is produced in the validated manufacturing facility

75 FR 9228 - Draft Guidance for Industry on Non-Inferiority Clinical Trials; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-01

... guidance provides sponsors and review staff in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) with the agency's interpretation of the underlying principles involved in the use of non-inferiority (NI) study designs to provide evidence of the effectiveness...

77 FR 12064 - Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-28

... about last minute modifications that impact a previously announced advisory committee meeting cannot... Agency's Web site and call the appropriate advisory committee hot line/ phone line to learn about... intended for use in the immunologically active cells in blood and other tissues and CBER regulates...

78 FR 44573 - Guidance for Industry on Providing Submissions in Electronic Format-Postmarket Non-Expedited...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-24

... should contact the Center for Drug Evaluation and Research (CDER) or Center for Biologics and Evaluation and Research (CBER) and resubmit their non-expedited ICSRs in a compatible electronic format. \\1\\ For... guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug...

76 FR 18226 - Guidance for Industry on Postmarketing Studies and Clinical Trials-Implementation of Section 505...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-01

... and Development (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug... Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51...

75 FR 54351 - Cell and Gene Therapy Clinical Trials in Pediatric Populations; Public Workshop

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-07

...] Cell and Gene Therapy Clinical Trials in Pediatric Populations; Public Workshop AGENCY: Food and Drug... Biologics Evaluation and Research (CBER) is announcing a public workshop entitled ``Cell and Gene Therapy... regarding best practices related to cell and gene therapy clinical trials in pediatric populations, as well...

77 FR 20025 - Draft Guidance for Industry on Compliance Policy for Reporting Drug Sample Distribution...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-03

... Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD... Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD... Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4288, Silver Spring, MD...

75 FR 54343 - Center for Biologics Evaluation and Research eSubmitter Pilot Evaluation Program for Blood...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0436... That Collect Whole Blood and Blood Components AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) is...

77 FR 41985 - Use of Influenza Disease Models To Quantitatively Evaluate the Benefits and Risks of Vaccines: A...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-17

... Evaluation and Research (CBER) and suggestions for further development. The public workshop will include... Evaluation and Research (HFM-210), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville... models to generate quantitative estimates of the benefits and risks of influenza vaccination. The public...

77 FR 21982 - Request for Notification From Industry Organizations Interested in Participating in the Selection...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-12

... Products Advisory Committee for the Center for Biologics Evaluation and Research (CBER) notify FDA in...). FOR FURTHER INFORMATION CONTACT: Bryan Emery, Center for Biologics Evaluation and Research, Food and... Center for Biologics Evaluation and Research Members are selected by the Commissioner of Food and Drugs...

76 FR 60506 - Request for Notification From Industry Organizations Interested in Participating in the Selection...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-29

... Products Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food... Biological Products Advisory Committee for the Center for Biologics Evaluation and Research (CBER) notify FDA... Evaluation and Research (HFM-71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448...

76 FR 71045 - Center for Biologics Evaluation and Research Report of Scientific and Medical Literature and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-16

... and Development (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug... CONTACT: Paul E. Levine, Jr., Center for Biologics Evaluation and Research (HFM-17), Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0599...

77 FR 35691 - Update to Electronic Common Technical Document Module 1

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-14

... Electronic Common Technical Document (eCTD) Module 1, which is used for electronic submission of... they are received with a limit of 350. SUPPLEMENTARY INFORMATION: The eCTD is an International... Research (CBER) have been receiving submissions in the eCTD format since 2003, and the eCTD has been the...

21 CFR 600.14 - Reporting of biological product deviations by licensed manufacturers.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Reporting of biological product deviations by... § 600.14 Reporting of biological product deviations by licensed manufacturers. (a) Who must report under...) For biological products regulated by the Center for Biologics Evaluation and Research (CBER), send the...

Topographic correction realization based on the CBERS-02B image

NASA Astrophysics Data System (ADS)

Qin, Hui-ping; Yi, Wei-ning; Fang, Yong-hua

2011-08-01

The special topography of mountain terrain will induce the retrieval distortion in same species and surface spectral lines. In order to improve the research accuracy of topographic surface characteristic, many researchers have focused on topographic correction. Topographic correction methods can be statistical-empirical model or physical model, in which the methods based on the digital elevation model data are most popular. Restricted by spatial resolution, previous model mostly corrected topographic effect based on Landsat TM image, whose spatial resolution is 30 meter that can be easily achieved from internet or calculated from digital map. Some researchers have also done topographic correction based on high spatial resolution images, such as Quickbird and Ikonos, but there is little correlative research on the topographic correction of CBERS-02B image. In this study, liao-ning mountain terrain was taken as the objective. The digital elevation model data was interpolated to 2.36 meter by 15 meter original digital elevation model one meter by one meter. The C correction, SCS+C correction, Minnaert correction and Ekstrand-r were executed to correct the topographic effect. Then the corrected results were achieved and compared. The images corrected with C correction, SCS+C correction, Minnaert correction and Ekstrand-r were compared, and the scatter diagrams between image digital number and cosine of solar incidence angel with respect to surface normal were shown. The mean value, standard variance, slope of scatter diagram, and separation factor were statistically calculated. The analysed result shows that the shadow is weakened in corrected images than the original images, and the three-dimensional affect is removed. The absolute slope of fitting lines in scatter diagram is minished. Minnaert correction method has the most effective result. These demonstrate that the former correction methods can be successfully adapted to CBERS-02B images. The DEM data can be interpolated step by step to get the corresponding spatial resolution approximately for the condition that high spatial resolution elevation data is hard to get.

78 FR 70306 - Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-25

... for Devices and Radiological Health (CDRH) Food and Drug Administration, 10903 New Hampshire Ave...''). This guidance is intended to provide the current thinking of CDRH and CBER on when IVD products are... capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/Device...

78 FR 100 - Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-02

... Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research... CDRH and CBER and have been compiled into checklists for use by FDA review staff. In the Federal... do so by using the Internet. A search capability for all CDRH guidance documents is available at http...

National Biocontainment Training Center

DTIC Science & Technology

2015-02-01

develop novel diagnostic platforms to detect drug resistant TB and identification of novel antimicrobial compounds with antibacterial activity against...rCCHFV rescue work in BSL-4. Figure 6. Schematic of the CCHFV M segment fusion with Nanoluc. (a) insert the Nanoluc after the signal peptide , (b...in Dallas, Texas. Trainers: Vickie Jones and Jason Hardcastle. Food and Drug Administration (FDA-CBER) – BSL3 training was provided for faculty and

75 FR 22601 - Draft Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-29

... request, or fax your request to CDRH to 301-847-8149. See the SUPPLEMENTARY INFORMATION section for... capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/Device... Responses Response Total hours CDRH 3601 110 1 110 2 220 CBER 3601 4 1 4 2 8 Total Hours 228 \\1\\ There are...

Multicenter Clinical Trial of Keratin Biomaterial for Peripheral Nerve Regeneration

DTIC Science & Technology

2015-12-01

Radiological Health ( CDRH ) to clarify the designation of the hydrogel. As a result of this meeting, steps required for an IND for the keratin...the Center for Biologics Evaluation Research (CBER), and the Center for Devices and Radiological Health 8 ( CDRH ) to clarify the designation of the...application to the CDRH for a new product. This new product is the material that is produced in the validated manufacturing facility at KeraNetics. This

Combination products regulation at the FDA.

PubMed

Lauritsen, K J; Nguyen, T

2009-05-01

The US Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of drugs, biological products, and medical devices. As single-entity products, drugs are generally regulated by the Center for Drug Evaluation and Research (CDER), devices by the Center for Devices and Radiological Health (CDRH), and biologics by the Center for Biologics Evaluation and Research (CBER). In recent years, technological advances have led to a blurring of the historical lines of separation between the centers.

Application of China-Brazil Earth resources satellite in China

NASA Astrophysics Data System (ADS)

Qiao, Yuliang; Zhao, Shangmin; Zhen, Liu; Bei, Jia

2009-03-01

The launch and successful operation of Chinese-Brazil Earth resources satellite (CBERS-1) in China has accelerated the application of space technology in China. These applications include agriculture, forestry, water conservation, land resources, city planning, environment protection and natural hazards monitoring and so on. The result of these applications provides a scientific basis for government decision making and has created great economic and social benefits in Chinese national economy construction. In this paper we present examples and provide auxiliary documentation of additional applications of the data from Earth resource monitoring.

Analysis of the Education Program Approval Process: A Program Evaluation.

ERIC Educational Resources Information Center

Fountaine, Charles A.; And Others

A study of the education program approval process involving the Veterans Administration (VA) and the State Approving Agencies (SAAs) had the following objectives: to describe the present education program approval process; to determine time and costs associated with the education program approval process; to describe the approval process at…

76 FR 19100 - Maria Carmen Palazzo: Debarment Order

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-06

... development or approval, including the process for development or approval, of any drug product or otherwise... development or approval, including the process for development or approval, of any drug product or otherwise... approval, including the process for development or approval, of any drug product and otherwise relating to...

Safety and Immunogenicity of Cell Culture-Derived A/H3N2 Variant Influenza Vaccines: A Phase I Randomized, Observer-Blind, Dose-Ranging Study.

PubMed

Johnson, Casey; Hohenboken, Matthew; Poling, Terry; Jaehnig, Peter; Kanesa-Thasan, Niranjan

2015-07-01

A/H3N2 variant (H3N2v) influenza may sustain human-to-human transmission, and an available candidate vaccine would be important. In this phase I, randomized, observer-blind, dose-ranging study, 627 healthy subjects ≥ 3 years of age were randomized to receive 2 vaccinations with H3N2c cell-culture-derived vaccine doses containing 3.75 µg, 7.5 µg, or 15 µg hemagglutinin antigen of H3N2v with or without MF59 (registered trademark of Novartis AG) adjuvant (an oil-in-water emulsion). This paper reports Day 43 planned interim data. Single MF59-adjuvanted H3N2c doses elicited immune responses in almost all subjects regardless of antigen and adjuvant dose; the Center for Biologics Evaluation Research and Review (CBER) licensure criteria were met for all groups. Subjects with prevaccination hemagglutination inhibition titers <10 and children 3-<9 years achieve CBER criteria only after receiving 2 doses of nonadjuvanted H3N2c vaccine. Highest antibody titers were observed in the 7.5 µg + 0.25 mL MF59 groups in all age cohorts. MF59-adjuvanted H3N2c vaccines showed the highest rates of solicited local and systemic events, predominately mild or moderate. A single dose of H3N2c vaccine may be immunogenic and supports further development of MF59-adjuvanted H3N2c vaccines, especially for pediatric populations. ClinicalTrials.gov identifier NCT01855945 (http://clinicaltrials.gov/ct2/show/NCT01855945). © The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Results from the Thermal Vacuum Tests of the Chinese-Brazilian Earth Resources Satellite - CBERS FM2

NASA Astrophysics Data System (ADS)

Almeida, J. S.; Garcia, E. C.; Santos, M. B.; Fu, P. Z.

2002-01-01

This paper details the approach adopted and applied on the thermal vacuum tests campaign of the CBERS Flight Model #2 spacecraft, successfully performed at the Integration and Tests Laboratory - LIT, National Institute for Space Research - INPE, in São José dos Campos, SP, from September 7th to 28th, 2001. Measuring approximately 1.8 x 2.0 x 2.2m, weighting 1,500kg and carrying three cameras as the main payload, this spacecraft is scheduled to be launched in China and it will be orbiting the Earth at 778km as part of its remote sensing mission profile. Exploring the capabilities of LIT's 3m x 3m thermal vacuum chamber in terms of appropriately selecting and adjusting its cold shroud temperatures and also some low cost heat input/sink techniques, the spacecraft was adequately disjoined at its service and payload model interface in such a way that each part could physically fit inside the T/V chamber one at a time. Assuring all the necessary functional and test cabling interconnection between the two models through the chamber walls for the proper spacecraft electrical operations as an integrated system, specific thermal test techniques were applied in order to obtain the required hot and cold acceptance levels of temperature at the spacecraft subsystems and structural surfaces, as a consequence of the simulated thermal conditioning from the distinct orbital configurations. These thermal simulation techniques consisted of a combination of skin-heaters, the thermal vacuum chamber main shrouds and dedicated LN2 cold plates, effectively leading to reliable and very satisfactory testing methodology results. Taking more than 350 hours and having 67 people directly involved, including teams from both Brazil and China, this test can be considered as a very important accomplishment in terms of distinct technique of spacecraft testing and also in terms of the satisfactory working relationship between two quite different cultures.

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

Regulating biopharmaceuticals under CDER versus CBER: an insider's perspective.

PubMed

Schwieterman, William D

2006-10-01

The FDA has recently transferred jurisdiction for the regulation of certain biopharmaceuticals from the Center for Biologics, Evaluation and Research to the Center for Drugs, Evaluation and Research, where they will be reviewed in the same FDA divisions as are traditional pharmaceutical agents. With this transfer, sponsors of investigational biopharmaceuticals should expect changes in the regulatory requirements the FDA imposes on the clinical development plans, including an increase in the size and number of pivotal studies; more consistent requirements for conducting preclinical tests in two animal species; increased emphasis on organ structure and function as components of primary endpoints; more emphasis on characterizing dose-ranging and pharmacology; more intense scrutinizing of product advertising; and decreased direct communication with the review team.

10 CFR 1016.8 - Approval for processing access permittees for security facility approval.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 4 2011-01-01 2011-01-01 false Approval for processing access permittees for security facility approval. 1016.8 Section 1016.8 Energy DEPARTMENT OF ENERGY (GENERAL PROVISIONS) SAFEGUARDING OF RESTRICTED DATA Physical Security § 1016.8 Approval for processing access permittees for security facility...

10 CFR 1016.8 - Approval for processing access permittees for security facility approval.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Approval for processing access permittees for security facility approval. 1016.8 Section 1016.8 Energy DEPARTMENT OF ENERGY (GENERAL PROVISIONS) SAFEGUARDING OF RESTRICTED DATA Physical Security § 1016.8 Approval for processing access permittees for security facility...

77 FR 38019 - Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/TRICARE: TRICARE Retail...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-26

... prescriptions approved through the non-formulary special approval process that validates the medical necessity... the process for formulary placement of newly approved drugs; streamline the process for updating... clarify the process for formulary placement of newly approved drugs by the Food and Drug Administration...

44 CFR 78.6 - Flood Mitigation Plan approval process.

Code of Federal Regulations, 2010 CFR

2010-10-01

... approval process. 78.6 Section 78.6 Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT AGENCY... MITIGATION ASSISTANCE § 78.6 Flood Mitigation Plan approval process. The State POC will forward all Flood... reasons for non-approval and offer suggestions for improvement. ...

77 FR 60459 - Notice of Proposed Information Collection; Request for Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-03

... renewed approval for the collection of information for permits and permit processing. This information collection will also seek approval to collect permit processing fees approved under OSM regulations. DATES... and permit processing. OSM is including in this collection a request for OMB approval to collect...

25 CFR 1200.15 - What is the approval process for management plans?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 25 Indians 2 2010-04-01 2010-04-01 false What is the approval process for management plans? 1200... INTERIOR AMERICAN INDIAN TRUST FUND MANAGEMENT REFORM ACT Withdrawing Tribal Funds From Trust § 1200.15 What is the approval process for management plans? The Secretary will approve or disapprove each...

25 CFR 1200.15 - What is the approval process for management plans?

Code of Federal Regulations, 2012 CFR

2012-04-01

... 25 Indians 2 2012-04-01 2012-04-01 false What is the approval process for management plans? 1200... INTERIOR AMERICAN INDIAN TRUST FUND MANAGEMENT REFORM ACT Withdrawing Tribal Funds From Trust § 1200.15 What is the approval process for management plans? The Secretary will approve or disapprove each...

25 CFR 1200.15 - What is the approval process for management plans?

Code of Federal Regulations, 2011 CFR

2011-04-01

... 25 Indians 2 2011-04-01 2011-04-01 false What is the approval process for management plans? 1200... INTERIOR AMERICAN INDIAN TRUST FUND MANAGEMENT REFORM ACT Withdrawing Tribal Funds From Trust § 1200.15 What is the approval process for management plans? The Secretary will approve or disapprove each...

25 CFR 1200.15 - What is the approval process for management plans?

Code of Federal Regulations, 2013 CFR

2013-04-01

... 25 Indians 2 2013-04-01 2013-04-01 false What is the approval process for management plans? 1200... INTERIOR AMERICAN INDIAN TRUST FUND MANAGEMENT REFORM ACT Withdrawing Tribal Funds From Trust § 1200.15 What is the approval process for management plans? The Secretary will approve or disapprove each...

25 CFR 1200.15 - What is the approval process for management plans?

Code of Federal Regulations, 2014 CFR

2014-04-01

... 25 Indians 2 2014-04-01 2014-04-01 false What is the approval process for management plans? 1200... INTERIOR AMERICAN INDIAN TRUST FUND MANAGEMENT REFORM ACT Withdrawing Tribal Funds From Trust § 1200.15 What is the approval process for management plans? The Secretary will approve or disapprove each...

77 FR 56646 - Wayne E. Spencer: Debarment Order

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-13

..., including the process for development or approval, of a drug product under the FD&C Act. Dr. Spencer was..., including the process for development or approval, of a drug product under the FD&C Act. On March 7, 2012... to the development or approval, including the process for development or approval, of a drug product...

Connectivity processes and riparian vegetation of the upper Paraná River, Brazil

NASA Astrophysics Data System (ADS)

Stevaux, José C.; Corradini, Fabrício A.; Aquino, Samia

2013-10-01

In fluvial systems, the relationship between a dominant variable (e.g. flood pulse) and its dependent ones (e.g. riparian vegetation) is called connectivity. This paper analyzes the connectivity elements and processes controlling riparian vegetation for a reach of the upper Paraná River (Brazil) and estimates the future changes in channel-vegetation relationship as a consequence of the managing of a large dam. The studied reach is situated 30 km downstream from the Porto Primavera Dam (construction finished in 1999). Through aerial photography (1:25,000, 1996), RGB-CBERS satellite imagery and a previous field botany survey it was possible to elaborate a map with the five major morpho-vegetation units: 1) Tree-dominated natural levee, 2) Shrubby upper floodplain, 3) Shrub-herbaceous mid floodplain, 4) Grass-herbaceous lower floodplain and 5) Shrub-herbaceous flood runoff channel units. By use of a detailed topographic survey and statistical tools each morpho-vegetation type was analyzed according to its connectivity parameters (frequency, recurrence, permanence, seasonality, potamophase, limnophase and FCQ index) in the pre- and post-dam closure periods of the historical series. Data showed that most of the morpho-vegetation units were predicted to present changes in connectivity parameters values after dam closing and the new regime could affect, in different intensity, the river ecology and particularly the riparian vegetation. The methods used in this study can be useful for dam impact studies in other South American tropical rivers.

How drugs are developed and approved by the FDA: current process and future directions.

PubMed

Ciociola, Arthur A; Cohen, Lawrence B; Kulkarni, Prasad

2014-05-01

This article provides an overview of FDA's regulatory processes for drug development and approval, and the estimated costs associated with the development of a drug, and also examines the issues and challenges facing the FDA in the near future. A literature search was performed using MEDLINE to summarize the current FDA drug approval processes and future directions. MEDLINE was further utilized to search for all cost analysis studies performed to evaluate the pharmaceutical industry R&D productivity and drug development cost estimates. While the drug approval process remains at high risk and spans over multiple years, the FDA drug review and approval process has improved, with the median approval time for new molecular drugs been reduced from 19 months to 10 months. The overall cost to development of a drug remains quite high and has been estimated to range from $868M to $1,241M USD. Several new laws have been enacted, including the FDA Safety and Innovation Act (FDASIA) of 2013, which is designed to improve the drug approval process and enhance access to new medicines. The FDA's improved processes for drug approval and post-market surveillance have achieved the goal of providing patients with timely access to effective drugs while minimizing the risk of drug-related harm. The FDA drug approval process is not without controversy, as a number of well-known gastroenterology drugs have been withdrawn from the US market over the past few years. With the approval of the new FDASIA law, the FDA will continue to improve their processes and, working together with the ACG through the FDA-Related Matters Committee, continue to develop safe and effective drugs for our patients.

14 CFR 21.305 - Approval of materials, parts, processes, and appliances.

Code of Federal Regulations, 2010 CFR

2010-01-01

..., and appliances. 21.305 Section 21.305 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION..., Parts, Processes, and Appliances § 21.305 Approval of materials, parts, processes, and appliances. Whenever a material, part, process, or appliance is required to be approved under this chapter, it may be...

42 CFR 414.917 - Dispute resolution and process for suspension or termination of approved CAP contract and...

Code of Federal Regulations, 2010 CFR

2010-10-01

... quality of a CAP drug supplied by the approved CAP vendor to be unsatisfactory, then the physician may address the issue first through the approved CAP vendor's grievance process, and second through an... approved CAP vendor's service or the quality of a CAP drug supplied by the approved CAP vendor, then the...

10 CFR 1016.9 - Processing security facility approval.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 4 2011-01-01 2011-01-01 false Processing security facility approval. 1016.9 Section 1016... § 1016.9 Processing security facility approval. The following receipt of an acceptable request for... granted pursuant to § 1016.6 of this part. ...

10 CFR 1016.9 - Processing security facility approval.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Processing security facility approval. 1016.9 Section 1016... § 1016.9 Processing security facility approval. The following receipt of an acceptable request for... granted pursuant to § 1016.6 of this part. ...

77 FR 20869 - Self-Regulatory Organizations; NYSE Amex LLC; Order Approving a Proposed Rule Change Amending the...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-06

... Equities Definition of Approved Person To Exclude Foreign Affiliates, Eliminating the Application Process... Equities definition of approved person to exclude foreign affiliates, eliminate the application process for... amend the NYSE Amex Equities definition of ``approved person'' to exclude foreign affiliates, eliminate...

49 CFR 107.709 - Processing of an application for approval, including an application for renewal or modification.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 2 2010-10-01 2010-10-01 false Processing of an application for approval..., Registrations and Submissions § 107.709 Processing of an application for approval, including an application for... before the disposition of an application. (b) At any time during the processing of an application, the...

10 CFR 25.17 - Approval for processing applicants for access authorization.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Approval for processing applicants for access... Authorizations § 25.17 Approval for processing applicants for access authorization. (a) Access authorizations... request by a letter that includes the name, Social Security number and level of access authorization. (c...

77 FR 12637 - Self-Regulatory Organizations; NYSE Amex LLC; Notice of Filing of Proposed Rule Change Amending...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-01

... Equities Definition of Approved Person To Exclude Foreign Affiliates, Eliminating the Application Process..., eliminate the application process for approved persons, and make related technical and conforming changes..., eliminate the application process for approved persons, and make related technical and conforming changes...

77 FR 20870 - Self-Regulatory Organizations; New York Stock Exchange LLC; Order Approving a Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-06

... Definition of Approved Person To Exclude Foreign Affiliates, Eliminating the Application Process for Approved... to exclude foreign affiliates, eliminate the application process for approved persons, and make... Rules 304, 308, and 311. The Exchange also proposed to eliminate use of the Forms AP-1 and AD-G. The...

31 CFR 33.116 - Federal public notice and approval process.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 31 Money and Finance: Treasury 1 2014-07-01 2014-07-01 false Federal public notice and approval process. 33.116 Section 33.116 Money and Finance: Treasury Office of the Secretary of the Treasury WAIVERS FOR STATE INNOVATION § 33.116 Federal public notice and approval process. (a) General. The Federal...

31 CFR 33.116 - Federal public notice and approval process.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 31 Money and Finance: Treasury 1 2013-07-01 2013-07-01 false Federal public notice and approval process. 33.116 Section 33.116 Money and Finance: Treasury Office of the Secretary of the Treasury WAIVERS FOR STATE INNOVATION § 33.116 Federal public notice and approval process. (a) General. The Federal...

31 CFR 33.116 - Federal public notice and approval process.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 31 Money and Finance: Treasury 1 2012-07-01 2012-07-01 false Federal public notice and approval process. 33.116 Section 33.116 Money and Finance: Treasury Office of the Secretary of the Treasury WAIVERS FOR STATE INNOVATION § 33.116 Federal public notice and approval process. (a) General. The Federal...

33 CFR Appendix C to Part 331 - Administrative Appeal Process for Approved Jurisdictional Determinations

Code of Federal Regulations, 2011 CFR

2011-07-01

... Approved Jurisdictional Determinations C Appendix C to Part 331 Navigation and Navigable Waters CORPS OF ENGINEERS, DEPARTMENT OF THE ARMY, DEPARTMENT OF DEFENSE ADMINISTRATIVE APPEAL PROCESS Pt. 331, App. C Appendix C to Part 331—Administrative Appeal Process for Approved Jurisdictional Determinations ER28MR00...

33 CFR Appendix C to Part 331 - Administrative Appeal Process for Approved Jurisdictional Determinations

Code of Federal Regulations, 2013 CFR

2013-07-01

... Approved Jurisdictional Determinations C Appendix C to Part 331 Navigation and Navigable Waters CORPS OF ENGINEERS, DEPARTMENT OF THE ARMY, DEPARTMENT OF DEFENSE ADMINISTRATIVE APPEAL PROCESS Pt. 331, App. C Appendix C to Part 331—Administrative Appeal Process for Approved Jurisdictional Determinations ER28MR00...

33 CFR Appendix C to Part 331 - Administrative Appeal Process for Approved Jurisdictional Determinations

Code of Federal Regulations, 2012 CFR

2012-07-01

... Approved Jurisdictional Determinations C Appendix C to Part 331 Navigation and Navigable Waters CORPS OF ENGINEERS, DEPARTMENT OF THE ARMY, DEPARTMENT OF DEFENSE ADMINISTRATIVE APPEAL PROCESS Pt. 331, App. C Appendix C to Part 331—Administrative Appeal Process for Approved Jurisdictional Determinations ER28MR00...

AOA Approval of ACGME Internship and Residency Training.

PubMed

Duffy, Thomas; Martinez, Bulmaro

2011-04-01

Since the 1970s, the American Osteopathic Association (AOA) has provided a means for osteopathic physicians to apply for approval of their postdoctoral training in programs accredited by the Accreditation Council for Graduate Medical Education (ACGME). Osteopathic physicians who trained in ACGME programs need this approval to meet AOA licensure and board certification requirements. The AOA approves ACGME residency training with several different approval processes. Approval of the first year of postdoctoral training occurs through Resolution 42, specialty approval (for specialties in which the first year of training is part of the residency), or federal or military training approval. For residency training, the AOA verifies successful completion of an ACGME training program before approving the training. The AOA is using customer surveys and online applications to improve the review process for applicants.

[Development of guidance for the approval process of brand-new medical products and regenerative medicine products].

PubMed

Niimi, Shingo

2015-01-01

Ministry of Health, Labour and Weltare has been conducting development of guidance for the approval process of brand-new medical products/development of guidance for medical devices in collaboration with Ministry of Economy, Trade and Industry as part of measures to promote practical use of brand-new medical products since 2005. The objective of this project is to expedite the processes from developmental process of medical devices to approval review and to introduce the medical devices to medical front quickly.. Ministry of Health, Labour and Welfare side has been making guidance for the guide in approval process of brand-new medical products and regeneration medicine products to aim at acceleration and facilitation of development and approval process of innovative medical products. Twenty-two of the guidance have been issued as director of the evaluation and licensing division. The evaluation index about safety and efficacy required for medical devices and regenerative medicine products in progress were put together in these guidance and useful for medical devices developer to understand the point at the approved review. Therefore, I think that the evaluation index could also contribute to the efficient product development. The guidance about implantable artificial heart is issued as the representative example which was useful in the approved review.

25 CFR 162.565 - What is the approval process for a WSR lease?

Code of Federal Regulations, 2013 CFR

2013-04-01

... PERMITS Wind and Solar Resource Leases Wsr Lease Approval § 162.565 What is the approval process for a WSR... environmental laws, land use laws, and ordinances; (3) If the lease is being approved under 25 U.S.C. 415... other Federal or tribal land use requirements. (b) Upon receiving a WSR lease package, we will promptly...

25 CFR 162.565 - What is the approval process for a WSR lease?

Code of Federal Regulations, 2014 CFR

2014-04-01

... PERMITS Wind and Solar Resource Leases Wsr Lease Approval § 162.565 What is the approval process for a WSR... environmental laws, land use laws, and ordinances; (3) If the lease is being approved under 25 U.S.C. 415... other Federal or tribal land use requirements. (b) Upon receiving a WSR lease package, we will promptly...

75 FR 69150 - Self-Regulatory Organizations; The Depository Trust Company; Order Approving Proposed Rule Change...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-10

... Process in Providing Trustee Access to the Security Position Report Service November 4, 2010. I.... The current review process to approve a trustee's access to the SPR service for a security is done... a trustee's access to DTC's SPR service for an issue with an automated approval process, DTC will be...

Multi-resource data-based research on remote sensing monitoring over the green tide in the Yellow Sea

NASA Astrophysics Data System (ADS)

Gao, Zhiqiang; Xu, Fuxiang; Song, Debin; Zheng, Xiangyu; Chen, Maosi

2017-09-01

This paper conducted dynamic monitoring over the green tide (large green alga—Ulva prolifera) occurred in the Yellow Sea in 2014 to 2016 by the use of multi-source remote sensing data, including GF-1 WFV, HJ-1A/1B CCD, CBERS-04 WFI, Landsat-7 ETM+ and Landsta-8 OLI, and by the combination of VB-FAH (index of Virtual-Baseline Floating macroAlgae Height) with manual assisted interpretation based on remote sensing and geographic information system technologies. The result shows that unmanned aerial vehicle (UAV) and shipborne platform could accurately monitor the distribution of Ulva prolifera in small spaces, and therefore provide validation data for the result of remote sensing monitoring over Ulva prolifera. The result of this research can provide effective information support for the prevention and control of Ulva prolifera.

An overview of in-orbit radiometric calibration of typical satellite sensors

NASA Astrophysics Data System (ADS)

Zhou, G. Q.; Li, C. Y.; Yue, T.; Jiang, L. J.; Liu, N.; Sun, Y.; Li, M. Y.

2015-06-01

This paper reviews the development of in-orbit radiometric calibration methods in the past 40 years. It summarizes the development of in-orbit radiometric calibration technology of typical satellite sensors in the visible/near-infrared bands and the thermal infrared band. Focuses on the visible/near-infrared bands radiometric calibration method including: Lamp calibration and solar radiationbased calibration. Summarizes the calibration technology of Landsat series satellite sensors including MSS, TM, ETM+, OLI, TIRS; SPOT series satellite sensors including HRV, HRS. In addition to the above sensors, there are also summarizing ALI which was equipped on EO-1, IRMSS which was equipped on CBERS series satellite. Comparing the in-orbit radiometric calibration technology of different periods but the same type satellite sensors analyzes the similarities and differences of calibration technology. Meanwhile summarizes the in-orbit radiometric calibration technology in the same periods but different country satellite sensors advantages and disadvantages of calibration technology.

Certification of ICI 1012 optical data storage tape

NASA Technical Reports Server (NTRS)

Howell, J. M.

1993-01-01

ICI has developed a unique and novel method of certifying a Terabyte optical tape. The tape quality is guaranteed as a statistical upper limit on the probability of uncorrectable errors. This is called the Corrected Byte Error Rate or CBER. We developed this probabilistic method because of two reasons why error rate cannot be measured directly. Firstly, written data is indelible, so one cannot employ write/read tests such as used for magnetic tape. Secondly, the anticipated error rates need impractically large samples to measure accurately. For example, a rate of 1E-12 implies only one byte in error per tape. The archivability of ICI 1012 Data Storage Tape in general is well characterized and understood. Nevertheless, customers expect performance guarantees to be supported by test results on individual tapes. In particular, they need assurance that data is retrievable after decades in archive. This paper describes the mathematical basis, measurement apparatus and applicability of the certification method.

14 CFR 21.303 - Approval of materials, parts, processes, and appliances.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 1 2011-01-01 2011-01-01 false Approval of materials, parts, processes, and appliances. 21.303 Section 21.303 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT CERTIFICATION PROCEDURES FOR PRODUCTS AND PARTS Approval of Materials...

44 CFR 78.9 - Planning grant approval process.

Code of Federal Regulations, 2012 CFR

2012-10-01

..., DEPARTMENT OF HOMELAND SECURITY INSURANCE AND HAZARD MITIGATION National Flood Insurance Program FLOOD MITIGATION ASSISTANCE § 78.9 Planning grant approval process. The State POC will evaluate and approve applications for Planning Grants. Funds will be provided only for the flood portion of any mitigation plan, and...

44 CFR 78.9 - Planning grant approval process.

Code of Federal Regulations, 2014 CFR

2014-10-01

..., DEPARTMENT OF HOMELAND SECURITY INSURANCE AND HAZARD MITIGATION National Flood Insurance Program FLOOD MITIGATION ASSISTANCE § 78.9 Planning grant approval process. The State POC will evaluate and approve applications for Planning Grants. Funds will be provided only for the flood portion of any mitigation plan, and...

44 CFR 78.9 - Planning grant approval process.

Code of Federal Regulations, 2013 CFR

2013-10-01

..., DEPARTMENT OF HOMELAND SECURITY INSURANCE AND HAZARD MITIGATION National Flood Insurance Program FLOOD MITIGATION ASSISTANCE § 78.9 Planning grant approval process. The State POC will evaluate and approve applications for Planning Grants. Funds will be provided only for the flood portion of any mitigation plan, and...

44 CFR 78.9 - Planning grant approval process.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., DEPARTMENT OF HOMELAND SECURITY INSURANCE AND HAZARD MITIGATION National Flood Insurance Program FLOOD MITIGATION ASSISTANCE § 78.9 Planning grant approval process. The State POC will evaluate and approve applications for Planning Grants. Funds will be provided only for the flood portion of any mitigation plan, and...

44 CFR 78.9 - Planning grant approval process.

Code of Federal Regulations, 2011 CFR

2011-10-01

..., DEPARTMENT OF HOMELAND SECURITY INSURANCE AND HAZARD MITIGATION National Flood Insurance Program FLOOD MITIGATION ASSISTANCE § 78.9 Planning grant approval process. The State POC will evaluate and approve applications for Planning Grants. Funds will be provided only for the flood portion of any mitigation plan, and...

44 CFR 78.6 - Flood Mitigation Plan approval process.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 44 Emergency Management and Assistance 1 2012-10-01 2011-10-01 true Flood Mitigation Plan approval..., DEPARTMENT OF HOMELAND SECURITY INSURANCE AND HAZARD MITIGATION National Flood Insurance Program FLOOD MITIGATION ASSISTANCE § 78.6 Flood Mitigation Plan approval process. The State POC will forward all Flood...

77 FR 21143 - Projects Approved for Consumptive Uses of Water

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-09

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

78 FR 11947 - Projects Approved for Consumptive Uses of Water

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-20

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

78 FR 17281 - Projects Approved for Consumptive Uses of Water

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-20

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

78 FR 2315 - Projects Approved for Consumptive Uses of Water

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-10

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

78 FR 15402 - Projects Approved for Consumptive Uses of Water

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-11

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

77 FR 55892 - Projects Approved for Consumptive Uses of Water

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-11

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

77 FR 55891 - Projects Approved for Consumptive Uses of Water

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-11

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

77 FR 59239 - Projects Approved for Consumptive Uses of Water

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-26

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

77 FR 16317 - Projects Approved for Consumptive Uses of Water

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-20

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

77 FR 34455 - Projects Approved for Consumptive Uses of Water

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-11

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

Drug approval processes in Australian Paediatric Hospitals.

PubMed

Sinha, Y K; Craig, J C; Barclay, P; Taitz, J; South, M; Coulthard, K; Pearson, C; Erickson, S; Brien, J E

2010-09-01

To describe and evaluate the decision-making processes for drug approval in Australian paediatric hospitals. Multicentre descriptive study involving face-to-face interviews of drug and therapeutics committee chairs and secretaries, review of committee documents and drug submissions for all Australian paediatric hospital drug and therapeutics committees over a 1-year period. All eight paediatric hospitals in Australia. Eight committee chairs and seven secretaries or delegates. Total drug expenditure, number of formulary submissions, individual-patient use approvals and approval rates for each hospital from 1 July 2006 to 30 June 2007, stratified by therapeutic class. Qualitative description of the approval processes. Total drug expenditure varied from $A1.7 million (US$1.5 million) to $A11.1 million (US$9.8 million) per hospital. The number of formulary submissions also varied, from 7 to 21, but approval rate was high (76%-100%) and not significantly different among hospitals (p=0.17). Several committees approved identical submissions for five drugs. The number of individual-patient use applications varied considerably, ranging from 10 to 456 per hospital. Where estimable, individual-patient use approval was 76%-100% and variable (p=0.03). Quality of evidence relating to safety and efficacy of drugs being considered was regarded as the most important factors influencing decision making, with the cost less important. Most committees had poor infrastructural support for approval processes. No committee formally included a pharmaco-economic evaluation. Most drug submissions in tertiary paediatric hospitals are approved; however, workload, drug expenditure and individual-patient use schemes vary considerably. Duplication of effort occurs, and few committees are resourced sufficiently given their terms of reference.

Immunogenicity and safety of an AS03-adjuvanted H7N1 vaccine in healthy adults: A phase I/II, observer-blind, randomized, controlled trial.

PubMed

Madan, Anuradha; Ferguson, Murdo; Sheldon, Eric; Segall, Nathan; Chu, Laurence; Toma, Azhar; Rheault, Paul; Friel, Damien; Soni, Jyoti; Li, Ping; Innis, Bruce L; Schuind, Anne

2017-03-07

H7 influenza strains have pandemic potential. AS03-adjuvanted H7N1 A/mallard/Netherlands/12/2000 split-virion vaccine formulations were evaluated as model H7-subtype vaccine and tested after H7N9 emerged in China, and caused severe human disease with high mortality. In this phase I/II, observer-blind, randomized trial in US and Canada, 420 healthy adults (21-64years) were randomized to receive 1 of 4 H7N1 vaccine formulations (3.75 or 7.5μg hemagglutinin adjuvanted with either AS03 A or AS03 B ), 15μg unadjuvanted H7N1 hemagglutinin, or saline placebo, given as 2-dose series. Immunogenicity was assessed using hemagglutination-inhibition (HI) and microneutralization (MN) assays, at day 42 (21days post-dose 2), month 6, and month 12 (HI only) for the per-protocol cohorts (398, 379 and 368 participants, respectively). Safety is reported up to month 12. Beneficial AS03 adjuvant effect was demonstrated. Committee for Medical Products for Human Use, and Center for Biologics Evaluation and Research (CBER) criteria were met for all adjuvanted formulations at day 42 (H7N1 HI assay); seroprotection (SPR) and seroconversion rates (SCR) were 88.5-94.8%, mean geometric increase (MGI) 19.2-34.9, and geometric mean titers (GMT) 98.3-180.7. Unadjuvanted H7N1 vaccine did not meet CBER criteria. In adjuvanted groups, antibody titers decreased over time; month 12 SPRs and GMTs were low (2.0-18.8% and 8.1-12.2). MN antibodies showed similar kinetics, with titers persisting at higher range than HI at month 6. All adjuvanted groups showed cross-reactivity against H7N9, with HI responses similar to H7N1. The most frequent solicited symptom in adjuvanted groups was injection site pain (71.2-86.7%); grade 3 solicited symptoms were infrequent. Nine participants reported 17 serious adverse events; none were considered causally related to vaccination. Adjuvanted H7N1 vaccine formulations had an acceptable safety profile and induced an antibody response after 2 doses with cross-reactivity to H7N9. ClinicalTrials.gov: NCT01934127. Copyright © 2017. Published by Elsevier Ltd.

26th Space Simulation Conference Proceedings. Environmental Testing: The Path Forward

NASA Technical Reports Server (NTRS)

Packard, Edward A.

2010-01-01

Topics covered include: A Multifunctional Space Environment Simulation Facility for Accelerated Spacecraft Materials Testing; Exposure of Spacecraft Surface Coatings in a Simulated GEO Radiation Environment; Gravity-Offloading System for Large-Displacement Ground Testing of Spacecraft Mechanisms; Microscopic Shutters Controlled by cRIO in Sounding Rocket; Application of a Physics-Based Stabilization Criterion to Flight System Thermal Testing; Upgrade of a Thermal Vacuum Chamber for 20 Kelvin Operations; A New Approach to Improve the Uniformity of Solar Simulator; A Perfect Space Simulation Storm; A Planetary Environmental Simulator/Test Facility; Collimation Mirror Segment Refurbishment inside ESA s Large Space; Space Simulation of the CBERS 3 and 4 Satellite Thermal Model in the New Brazilian 6x8m Thermal Vacuum Chamber; The Certification of Environmental Chambers for Testing Flight Hardware; Space Systems Environmental Test Facility Database (SSETFD), Website Development Status; Wallops Flight Facility: Current and Future Test Capabilities for Suborbital and Orbital Projects; Force Limited Vibration Testing of JWST NIRSpec Instrument Using Strain Gages; Investigation of Acoustic Field Uniformity in Direct Field Acoustic Testing; Recent Developments in Direct Field Acoustic Testing; Assembly, Integration and Test Centre in Malaysia: Integration between Building Construction Works and Equipment Installation; Complex Ground Support Equipment for Satellite Thermal Vacuum Test; Effect of Charging Electron Exposure on 1064nm Transmission through Bare Sapphire Optics and SiO2 over HfO2 AR-Coated Sapphire Optics; Environmental Testing Activities and Capabilities for Turkish Space Industry; Integrated Circuit Reliability Simulation in Space Environments; Micrometeoroid Impacts and Optical Scatter in Space Environment; Overcoming Unintended Consequences of Ambient Pressure Thermal Cycling Environmental Tests; Performance and Functionality Improvements to Next Generation Thermal Vacuum Control System; Robotic Lunar Lander Development Project: Three-Dimensional Dynamic Stability Testing and Analysis; Thermal Physical Properties of Thermal Coatings for Spacecraft in Wide Range of Environmental Conditions: Experimental and Theoretical Study; Molecular Contamination Generated in Thermal Vacuum Chambers; Preventing Cross Contamination of Hardware in Thermal Vacuum Chambers; Towards Validation of Particulate Transport Code; Updated Trends in Materials' Outgassing Technology; Electrical Power and Data Acquisition Setup for the CBER 3 and 4 Satellite TBT; Method of Obtaining High Resolution Intrinsic Wire Boom Damping Parameters for Multi-Body Dynamics Simulations; and Thermal Vacuum Testing with Scalable Software Developed In-House.

Petitioning process for irradiated foods and animal feeds in North America

NASA Astrophysics Data System (ADS)

Marcotte, Michelle; Kunstadt, Peter

1993-07-01

The lack of sufficient regulatory approvals continues to delay the commercial application of food irradiation in several countries. Often, the regulatory approval process itself appears too challenging and approvals are not even requested. We believe that petitions can be successful and want to encourage interested parties to submit good quality approval petitions to the regulatory authorities. The objective of this paper is to review petition requirements so that researchers and companies in other countries will be able to prepare petitions requesting approval for the import and sale of irradiated foods into North America.

25 CFR 162.530 - What is the approval process for a WEEL?

Code of Federal Regulations, 2014 CFR

2014-04-01

... Wind and Solar Resource Leases Weel Approval § 162.530 What is the approval process for a WEEL? (a... potential environmental impacts and ensure compliance with all applicable environmental laws, land use laws... mitigation measures necessary to satisfy any requirements including any other Federal or tribal land use...

25 CFR 162.530 - What is the approval process for a WEEL?

Code of Federal Regulations, 2013 CFR

2013-04-01

... Wind and Solar Resource Leases Weel Approval § 162.530 What is the approval process for a WEEL? (a... potential environmental impacts and ensure compliance with all applicable environmental laws, land use laws... mitigation measures necessary to satisfy any requirements including any other Federal or tribal land use...

18 CFR 1304.4 - Application review and approval process.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 18 Conservation of Power and Water Resources 2 2010-04-01 2010-04-01 false Application review and... ALTERATIONS Procedures for Approval of Construction § 1304.4 Application review and approval process. (a) TVA... the application as appropriate. (b) If a hearing is held for any of the reasons described in paragraph...

Approving for a community aged care package: experiences and perceptions of six metropolitan aged care assessment service teams.

PubMed

Stephens, Delwyne; Wells, Yvonne; Gardner, Ian

2011-06-01

To establish whether the experiences and perceptions of different metropolitan Aged Care Assessment Service (ACAS) teams when approving people for Community Aged Care Packages (CACPs) were similar. Six semi-structured 30-minute group interviews were completed. ACAS team approval processes for CACPs were similar. The primary criterion for approval was need for case management. Many factors, however, impinged on the approval process. Barriers to making approvals included long waiting times, a lack of confidence in the priority rating system, and consideration of whether a person was better off with Home and Community Care services because of the impact of the Australian Government's Cost Recovery policy. ACAS teams have competing considerations when approving a person for a CACP. In particular, structural barriers, such as cost recovery policies, can have a significant negative impact on approval decisions. © 2010 The Authors. Journal compilation © 2010 ACOTA.

[Results of certification audit in Mexican hospitals, a review from 2009 to 2012].

PubMed

Galván-García, Ángel Fernando; Vértiz-Ramírez, José de Jesús; Sauceda-Valenzuela, Alma Lucila; Poblano-Verástegui, Ofelia; Ruelas-Barajas, Enrique; Sánchez-Domínguez, Mario Salvador

2018-01-01

To analyze the participation of Mexican hospitals in the certification process (equivalent to accreditation in other countries). Crosssectional study that analyzes results of 136 establishments audited between 2009 and 2012. Standards with an excellent rating (9.0-10.0), approving (6-8.9) and non-approving (0-5.9) were identified. With a multinomial model, the probability of obtaining non-approving, approving and excellent qualification was calculated. The general average score was 7.72, higher in ambulatory surgery centers (9.10), than in general hospitals (7.30) and specialty hospitals (7.99). All public establishments obtained an approval score. Hospitals audited in 2011 had a higher risk of obtaining an approval (RRR= 4.6, p<0.05) and excellent (RRR= 6.6, p<0.05) rating. The scope of the certification process in Mexico has been limited, with greater participation of the private sector. The evaluation certificate applied in 2011 favored the achievement of approval and excellence results. We recommend homologating the entire process with that of the Joint Commission International JCI.

The New Drug Conditional Approval Process in China: Challenges and Opportunities.

PubMed

Yao, Xuefang; Ding, Jinxi; Liu, Yingfang; Li, Penghui

2017-05-01

Our aim was to characterize the newly established new drug conditional approval process in China and discuss the challenges and opportunities with respect to new drug research and development and registration. We examined the new approval program through literature review, law analysis, and data analysis. Data were derived from published materials, such as journal articles, government publications, press releases, and news articles, along with statistical data from INSIGHT-China Pharma Databases, the China Food and Drug Administration website, the Center for Drug Evaluation website, the US Food and Drug Administration website, and search results published by Google. Currently, there is a large backlog of New Drug Applications in China, mainly because of the prolonged review time at the China Food and Drug Administration, resulting in a lag in drug approvals. In 2015, the Chinese government implemented the drug review and registration system reform and tackled this issue through various approaches, such as setting up a drug review fee system, adjusting the drug registration classification, and establishing innovative review pathways, including the conditional approval process. In Europe and the United States, programs comparable to the conditional approval program in China have been well developed. The conditional approval program recently established in China is an expedited new drug approval process that is expected to affect new drug development at home and abroad and profoundly influence the public health and the pharmaceutical industry in China. Like any program in its initial stage, the conditional approval program is facing several challenges, including setting up a robust system, formatting new drug clinical research requirements, and improving the regulatory agency's function for drug review and approval. The program is expected to evolve and improve as part of the government mandate of the drug registration system reform. Copyright © 2017 Elsevier HS Journals, Inc. All rights reserved.

Applying for ethical approval for research: the main issues.

PubMed

Gelling, Leslie

2016-01-13

The need to obtain research ethical approval is common to all research involving human participants. This approval must be obtained before research participants can be approached and before data collection can begin. The process of ethical review is one way that research participants can be confident that possible risks have been considered, minimised and deemed acceptable. This article outlines some of the main issues researchers should consider when planning an application for research ethical approval by answering the following six questions: 'Do I need research ethical approval?', 'How many applications will I need to make?', 'Where should I apply for research ethical approval?', 'What do I need to include in my application?', 'What do research ethics committees look for?' and 'What other approvals might I need?' Answering these questions will enable researchers to navigate the ethical review process.

Some key techniques of SPOT-5 image processing in new national land and resources investigation project

NASA Astrophysics Data System (ADS)

Xue, Changsheng; Li, Qingquan; Li, Deren

2004-02-01

In 1988, the detail information on land resource was investigated in China. Fourteen years later, it has changed a lot. It is necessary that the second land resource detailed investigation should be implemented. On this condition, the New National Land and Resources Investigation Project in China, which will last 12 years, has been started since 1999. The project is directly under the administration of the Ministry of Land and Resource (MLR). It was organized and implemented By China Geological, China Land Surveying and Planning Institute (CLSPI) and Information Center of MLR. It is a grand and cross century project supported by the Central Finance, based on State and public interests and strategic characteristics. Up to now, "Land Use Dynamic Monitoring By Remote Sensing," "Arable Land Resource Investigation," "Rural Collective Land Property Right Investgiation," "Establishment of Public Consulting Standardization of Cadastral Information," "Land Resource Fundamental Maps and Data Updating," "Urban Land Price Investigation and Intensive Utilization Potential Capacity Evaluation," "Farmland Classification, Gradation, and Evaluation," "Land Use Database Construction at City or County Level" 8 subprojects have had the preliminary achievements. In this project, SPOT-1/2/4 and Landsat-7 TM data were always applied to monitor land use dynamic change as the main data resource. Certainly, IRS, CBERS-2, and IKONOS data also were tested in small areas. In 2002, the SPOT-5 data, whose spatial resolution of the panchromatic image is 2.5 meters and the spectral one is 10 meters, were applied into update the land use base map at the 1:10000 scale in 26 Chinese cities. The purpose in this paper is to communicate the experience of SPOT-5 image processing with the colleagues.

Global burned-land estimation in Latin America using MODIS composite data.

PubMed

Chuvieco, Emilio; Opazo, Sergio; Sione, Walter; Del Valle, Hector; Anaya, Jesús; Di Bella, Carlos; Cruz, Isabel; Manzo, Lilia; López, Gerardo; Mari, Nicolas; González-Alonso, Federico; Morelli, Fabiano; Setzer, Alberto; Csiszar, Ivan; Kanpandegi, Jon Ander; Bastarrika, Aitor; Libonati, Renata

2008-01-01

This paper presents results of the AQL2004 project, which has been develope within the GOFC-GOLD Latin American network of remote sensing and forest fires (RedLatif). The project intended to obtain monthly burned-land maps of the entire region, from Mexico to Patagonia, using MODIS (moderate-resolution imaging spectroradiometer) reflectance data. The project has been organized in three different phases: acquisition and preprocessing of satellite data; discrimination of burned pixels; and validation of results. In the first phase, input data consisting of 32-day composites of MODIS 500-m reflectance data generated by the Global Land Cover Facility (GLCF) of the University of Maryland (College Park, Maryland, U.S.A.) were collected and processed. The discrimination of burned areas was addressed in two steps: searching for "burned core" pixels using postfire spectral indices and multitemporal change detection and mapping of burned scars using contextual techniques. The validation phase was based on visual analysis of Landsat and CBERS (China-Brazil Earth Resources Satellite) images. Validation of the burned-land category showed an agreement ranging from 30% to 60%, depending on the ecosystem and vegetation species present. The total burned area for the entire year was estimated to be 153 215 km2. The most affected countries in relation to their territory were Cuba, Colombia, Bolivia, and Venezuela. Burned areas were found in most land covers; herbaceous vegetation (savannas and grasslands) presented the highest proportions of burned area, while perennial forest had the lowest proportions. The importance of croplands in the total burned area should be taken with reserve, since this cover presented the highest commission errors. The importance of generating systematic products of burned land areas for different ecological processes is emphasized.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-03

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

18 CFR 5.8 - Notice of commencement of proceeding and scoping document, or of approval to use traditional...

Code of Federal Regulations, 2011 CFR

2011-04-01

... of proceeding and scoping document, or of approval to use traditional licensing process or... PROCESS § 5.8 Notice of commencement of proceeding and scoping document, or of approval to use traditional... required under § 5.5, filing of the pre-application document pursuant to § 5.6, and filing of any request...

Development of Electro-Optical Standard Processes for Application

DTIC Science & Technology

2011-11-01

AERONAUTICS AND SPACE ADMINISTRATION DISTRIBUTION A: APPROVED FOR PUBLIC RELEASE DISTRIBUTION IS UNLIMITED Report Documentation Page Form ApprovedOMB No...0704-0188 Public reporting burden for the collection of information is estimated to average 1 hour per response, including the time for reviewing...DISTRIBUTION/AVAILABILITY STATEMENT Approved for public release; distribution unlimited 13. SUPPLEMENTARY NOTES 14. ABSTRACT Defines the process of

44 CFR 78.10 - Project grant approval process.

Code of Federal Regulations, 2012 CFR

2012-10-01

..., DEPARTMENT OF HOMELAND SECURITY INSURANCE AND HAZARD MITIGATION National Flood Insurance Program FLOOD MITIGATION ASSISTANCE § 78.10 Project grant approval process. The State POC will solicit applications from...

44 CFR 78.10 - Project grant approval process.

Code of Federal Regulations, 2013 CFR

2013-10-01

..., DEPARTMENT OF HOMELAND SECURITY INSURANCE AND HAZARD MITIGATION National Flood Insurance Program FLOOD MITIGATION ASSISTANCE § 78.10 Project grant approval process. The State POC will solicit applications from...

44 CFR 78.10 - Project grant approval process.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., DEPARTMENT OF HOMELAND SECURITY INSURANCE AND HAZARD MITIGATION National Flood Insurance Program FLOOD MITIGATION ASSISTANCE § 78.10 Project grant approval process. The State POC will solicit applications from...

44 CFR 78.10 - Project grant approval process.

Code of Federal Regulations, 2011 CFR

2011-10-01

..., DEPARTMENT OF HOMELAND SECURITY INSURANCE AND HAZARD MITIGATION National Flood Insurance Program FLOOD MITIGATION ASSISTANCE § 78.10 Project grant approval process. The State POC will solicit applications from...

44 CFR 78.10 - Project grant approval process.

Code of Federal Regulations, 2014 CFR

2014-10-01

..., DEPARTMENT OF HOMELAND SECURITY INSURANCE AND HAZARD MITIGATION National Flood Insurance Program FLOOD MITIGATION ASSISTANCE § 78.10 Project grant approval process. The State POC will solicit applications from...

Physicians' Trust in the FDA's Use of Product-Specific Pathways for Generic Drug Approval.

PubMed

Kesselheim, Aaron S; Eddings, Wesley; Raj, Tara; Campbell, Eric G; Franklin, Jessica M; Ross, Kathryn M; Fulchino, Lisa A; Avorn, Jerry; Gagne, Joshua J

2016-01-01

Generic drugs are cost-effective versions of brand-name drugs approved by the Food and Drug Administration (FDA) following proof of pharmaceutical equivalence and bioequivalence. Generic drugs are widely prescribed by physicians, although there is disagreement over the clinical comparability of generic drugs to brand-name drugs within the physician community. The objective of this survey was to assess physicians' perceptions of generic drugs and the generic drug approval process. A survey was administered to a national sample of primary care internists and specialists between August 2014 and January 2015. In total, 1,152 physicians comprising of internists with no reported specialty certification and those with specialty certification in hematology, infectious diseases, and endocrinology were surveyed. The survey assessed physicians' perceptions of the FDA's generic drug approval process, as well as their experiences prescribing six generic drugs approved between 2008 and 2012 using product-specific approval pathways and selected comparator drugs. Among 718 respondents (62% response rate), a majority were comfortable with the FDA's process in ensuring the safety and effectiveness of generic drugs overall (91%) and with letting the FDA determine which tests were necessary to determine bioequivalence in a particular drug (92%). A minority (13-26%) still reported being uncomfortable prescribing generic drugs approved using product-specific pathways. Overall, few physicians heard reports of concerns about generic versions of the study drugs or their comparators, with no differences between the two groups. Physicians tended to hear about concerns about the safety or effectiveness of generic drugs from patients, pharmacists, and physician colleagues. Physicians hold largely positive views of the FDA's generic drug approval process even when some questioned the performance of certain generic drugs in comparison to brand-name drugs. Better education about the generic drug approval process and standards may alleviate concerns among the physician community and support the delivery of cost-effective health care.

How IPCC Science-Policy Interactions Shape Its Policymaker Summaries

NASA Astrophysics Data System (ADS)

Mach, K. J.; Freeman, P. T.; Mastrandrea, M.; Field, C. B.

2016-12-01

Government approval is a defining feature of the Intergovernmental Panel on Climate Change (IPCC) assessment process. In plenary sessions with scientist authors, IPCC member governments discuss and agree each sentence of every report's summary for policymakers (SPM). This consensus-based approval builds joint ownership of scientific knowledge by both scientists and governments. The approval process and its resulting SPM revisions have received extensive attention in published anecdotes and perspectives, but without comprehensive evaluation to date. We present the results of an in-depth analysis of IPCC SPM revisions, providing an evidence basis for understanding a complex science-policy interaction. Revisions resulting from governmental review and approval expand SPMs. SPM text lengthens by 17 to 53% in recent assessment summaries. Political sensitivities and associated failures of consensus have led to prominent exceptions resulting in SPM contractions. Contrasting recent assertions, we find IPCC SPMs to be as readable as other professionally edited assessment summaries, for multiple measures of reading ease. Across metrics, some SPMs, but not all, become more readable through the revision process. We additionally examine each revision in an SPM for which we have deep familiarity. Most of the SPM's revisions occur prior to the in-person government-approval session, and they emphasize different purposes compared to revisions made during the approval session. Revisions prior to the in-person session largely pertain to clarity, scientific rigor, and explanation, whereas the subsequent in-person government-approval revisions place more emphasis on policy relevance, comprehensiveness of examples, and nuances of expert judgment. The value added in the IPCC government-approval process emerges through multiple stages of revision and approval, as scientists and governments together navigate a complex science-policy interaction.

33 CFR Appendix C to Part 331 - Administrative Appeal Process for Approved Jurisdictional Determinations

Code of Federal Regulations, 2010 CFR

2010-07-01

... 33 Navigation and Navigable Waters 3 2010-07-01 2010-07-01 false Administrative Appeal Process for... ENGINEERS, DEPARTMENT OF THE ARMY, DEPARTMENT OF DEFENSE ADMINISTRATIVE APPEAL PROCESS Pt. 331, App. C Appendix C to Part 331—Administrative Appeal Process for Approved Jurisdictional Determinations ER28MR00...

25 CFR 293.15 - When does an approved or considered-to-have-been-approved compact or amendment take effect?

Code of Federal Regulations, 2010 CFR

2010-04-01

... compact or amendment take effect? 293.15 Section 293.15 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR ECONOMIC ENTERPRISES CLASS III TRIBAL STATE GAMING COMPACT PROCESS § 293.15 When does an approved or considered-to-have-been-approved compact or amendment take effect? (a) An approved or...

Orthopaedic Device Approval Through the Premarket Approval Process: A Financial Feasibility Analysis for a Single Center.

PubMed

Yang, Brian W; Iorio, Matthew L; Day, Charles S

2017-03-15

The 2 main routes of medical device approval through the U.S. Food and Drug Administration are the premarket approval (PMA) process, which requires clinical trials, and the 510(k) premarket notification, which exempts devices from clinical trials if they are substantially equivalent to an existing device. Recently, there has been growing concern regarding the safety of devices approved through the 510(k) premarket notification. The PMA process decreases the potential for device recall; however, it is substantially more costly and time-consuming. Investors and medical device companies are only willing to invest in devices if they can expect to recoup their investment within a timeline of roughly 7 years. Our study utilizes financial modeling to assess the financial feasibility of approving various orthopaedic medical devices through the 510(k) and PMA processes. The expected time to recoup investment through the 510(k) process ranged from 0.585 years to 7.715 years, with an average time of 2.4 years; the expected time to recoup investment through the PMA route ranged from 2.9 years to 24.5 years, with an average time of 8.5 years. Six of the 13 orthopaedic device systems that we analyzed would require longer than our 7-year benchmark to recoup the investment costs of the PMA process. With the 510(k) premarket notification, only 1 device system would take longer than 7 years to recoup its investment costs. Although the 510(k) premarket notification has demonstrated safety concerns, broad requirements for PMA authorization may limit device innovation for less-prevalent orthopaedic conditions. As a result, new approval frameworks may be beneficial. Our report demonstrates how current regulatory policies can potentially influence orthopaedic device innovation.

Monitoring desertification using the integrated CA GIS and RS with AHP-derived weights: a case study of Beijing and its neighboring areas in recent 20 years

NASA Astrophysics Data System (ADS)

Wang, Gongwen; Chen, Jianping; Li, Qing; Ding, Huoping

2007-06-01

This paper aims to monitor desertification evolution of different stages and assess its factors using remote sensing (RS) data and cellular automata (CA)-geographical information system (GIS) with an adaptive analytic hierarchy process (AHP) to derive weights of desertification factors. The study areas (114°E to 117°E and 39.5°to 42.2°N) are one of the important agro-pastoral transitional zone, located in Beijing and its neighboring areas, marginal desertified areas in North China. Desertification information including NDVI and desertification area were derived from the satellite images of 1987TM, 1996TM (with a resolution of 28.5), and 2006 CBERS-(with a resolution of 19.5 m) in study areas. The ancillary data in terms of meteorology, geology, 30m-DEM, hydrography can be statistical analyzed with GIS technology. A CA model based on the desertification factors with AHP-derived weights was built by AML program in ArcGIS workstation to assess the evolution of desertification in different stages (from 1987 to 1996, and from 1996 to 2006). The research results show that desertified areas was increased by 3.28% per year from 1987 to 1996, so was 0.51% per year from 1996 to 2006. Although the weights of desertification factors have some changes in different stages, the main factors including climate, NDVI, and terrain did not change except the values in study areas.

75 FR 71177 - Notice of Projects Approved for Consumptive Uses of Water

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-22

... SUSQUEHANNA RIVER BASIN COMMISSION Notice of Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice of approved projects. SUMMARY: This notice... for the consumptive use of water pursuant to the Commission's approval by rule process set forth in 18...

75 FR 23837 - Notice of Projects Approved for Consumptive Uses of Water

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-04

... SUSQUEHANNA RIVER BASIN COMMISSION Notice of Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice of approved projects. SUMMARY: This notice... consumptive use of water pursuant to the Commission's approval by rule process set forth in 18 CFR 806.22(e...

75 FR 38591 - Notice of Projects Approved for Consumptive Uses of Water

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-02

... SUSQUEHANNA RIVER BASIN COMMISSION Notice of Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice of Approved Projects. SUMMARY: This notice... consumptive use of water pursuant to the Commission's approval by rule process set forth in and 18 CFR 806.22...

49 CFR 22.43 - Approval or denial.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 1 2010-10-01 2010-10-01 false Approval or denial. 22.43 Section 22.43 Transportation Office of the Secretary of Transportation SHORT-TERM LENDING PROGRAM (STLP) Loan Application Process § 22.43 Approval or denial. If a loan guarantee is approved by DOT OSDBU, a Guarantee Agreement...

Examination of the relationship between oncology drug labeling revision frequency and FDA product categorization.

PubMed

Berlin, Robert J

2009-09-01

I examined the relationship between the Food and Drug Administration's (FDA's) use of special regulatory designations and the frequency with which labels of oncology drugs are revised to explore how the FDA's designation of products relates to product development and refinement. One hundred oncology drugs, designated by the FDA as accelerated approval, priority review, orphan drug, or traditional review, were identified from publicly available information. Drug information for each product was evaluated to assess the rate at which manufacturers revised product labeling. Rates were compared between specially categorized products and traditional review products (e.g., orphan vs nonorphan drugs) to produce revision rate ratios for each special category. Labeling for accelerated approval and priority review products are revised significantly more frequently than are labels for traditional products. Accelerated approval products are approved based on surrogate endpoints; this approval process anticipates subsequent labeling refinement. Priority review products, however, are approved through a process that is ostensibly as rigorous as traditional review. Their higher than expected label revision rate may suggest deficiencies in the FDA's current priority review evaluation processes.

Capability approval programme for Microwave Hybrid Integrated Circuits (MHICS)

NASA Astrophysics Data System (ADS)

1990-11-01

The general requirements for capability approval of a manufacturing line for Microwave Hybrid Integrated Circuits (MHICs) are defined. ESA approval mandate will be exercized upon conclusion of the evaluation phase and at the end of the program. Before the evaluation phase can commence, the manufacturer must define the capability approval domain by specifying the processes, materials and technology for which approval is sought.

FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012.

PubMed

Rome, Benjamin N; Kramer, Daniel B; Kesselheim, Aaron S

The US Food and Drug Administration (FDA) evaluates high-risk medical devices such as cardiac implantable electronic devices (CIEDs), including pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy devices, via the premarket approval (PMA) process, during which manufacturers submit clinical data demonstrating safety and effectiveness. Subsequent changes to approved high-risk devices are implemented via "supplements," which may not require additional clinical testing. To characterize the prevalence and characteristics of changes to CIEDs made through the PMA supplement process. Using the FDA's PMA database, we reviewed all CIEDs approved as original PMAs or supplements from 1979 through 2012. For each supplement, we collected the date approved, type of supplement (panel-track, 180-day, real-time, special, and 30-day notice), and the nature of the changes. We calculated the number of supplements approved per PMA and analyzed trends relating to different supplement regulatory categories over time. For supplements approved via the 180-day regulatory pathway, which often involve significant design changes, from 2010-2012, we identified how often additional clinical data were collected. From 1979-2012, the FDA approved 77 original and 5829 supplement PMA applications for CIEDs, with a median of 50 supplements per original PMA (interquartile range [IQR], 23-87). Excluding manufacturing changes that do not alter device design, the number of supplements approved each year was stable around a mean (SD) of 2.6 (0.9) supplements per PMA per year. Premarket approvals remained active via successive supplements over a median period of 15 years (IQR, 8-20), and 79% of the 77 original PMAs approved during our study period were the subject of at least 1 supplement in 2012. Thirty-seven percent of approved supplements involved a change to the device's design. Among 180-day supplements approved from 2010-2012, 23% (15/64) included new clinical data to support safety and effectiveness. Many CIED models currently used by clinicians were approved via the PMA supplement process, not as original PMAs. Most new device models are deemed safe and effective without requiring new clinical data, reinforcing the importance of rigorous postapproval surveillance of these devices.

9 CFR 590.680 - Approval of labeling for egg products processed in exempted egg products processing plants.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Approval of labeling for egg products processed in exempted egg products processing plants. 590.680 Section 590.680 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION INSPECTION OF...

9 CFR 590.680 - Approval of labeling for egg products processed in exempted egg products processing plants.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Approval of labeling for egg products processed in exempted egg products processing plants. 590.680 Section 590.680 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION INSPECTION OF...

75 FR 15413 - Approval for Processing Authority, Foreign-Trade Zone 196, ATC Logistics & Electronics (Personal...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-29

... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1671] Approval for Processing Authority, Foreign-Trade Zone 196, ATC Logistics & Electronics (Personal Navigation Devices), Fort Worth... & Electronics, an operator of Foreign-Trade Zone 196, has requested processing authority within FTZ 196 in Fort...

42 CFR 410.143 - Requirements for approved accreditation organizations.

Code of Federal Regulations, 2013 CFR

2013-10-01

...) Notice of any proposed changes in its accreditation standards and requirements or evaluation process. If... enforcement of its standards to a set of quality standards (described in § 410.144) and processes when any of the following conditions exist: (i) CMS imposes new requirements or changes its process for approving...

Operative planning of functional sessions for multisatellite observation and communication systems

NASA Astrophysics Data System (ADS)

Darnopykh, Valeriy V.; Malyshev, Veniamin V.

2012-04-01

An important control aspect of modern satellite observation and communication systems is the control of the functional processes. Functional sessions proceed under conditions of restricted technical ability, large amounts or information to be processed by the on-board equipment, practice inequality of the received information, intentions of system management and operators, interests of customers and other factors. A large number of spacecrafts (SC) in orbital constellation is one of the most important factors affecting the functional process also. Besides that some modern projects of satellite systems are multifunctional that is mixed operations of observation and communication. Therefore the functioning of SC on-board equipment must be accurately co-ordinate. That is why the problem of operative planning the functioning of these systems, while directly affecting the efficiency of the system, is very complex and actual at present. A methodical approach and software package for operative planning of functional processes for satellite observation and communication systems, including multifunctional projects, are considered in the paper. The base scheme of this approach consists of four main stages: stage 1—modeling of SC orbital kinematics and dynamics; stage 2—modeling of system functional processes with all kind of restrictions and criterion function values; stage 3—solving an optimization tasks by numerical applicable algorithms and constructing the optimal (or accuracy) plans; stage 4—repeated plan optimization (different variants) and analyzing. Such scheme is the result of authors practical research which have been realized during last 15 years by the operative planning as for any kinds of single SC as for satellite systems with different structure of orbital constellation. The research helps to unify the procedure of operative planning, to formulate basic principles and approaches for its solving, to develop special software package. The main aspects of the approach proposed are illustrated in the paper. The results of the calculations of applied planning problems are presented. The objects of research in these problems are: projects of CBERS observation systems (1-3 SC) and projects of Iridium (66 SC) global communication system.

7 CFR 58.705 - Meaning of words.

Code of Federal Regulations, 2014 CFR

2014-01-01

..., GENERAL SPECIFICATIONS FOR APPROVED PLANTS AND STANDARDS FOR GRADES OF DAIRY PRODUCTS 1 General Specifications for Dairy Plants Approved for USDA Inspection and Grading Service 1 Supplemental Specifications for Plants Manufacturing, Processing and Packaging Pasteurized Process Cheese and Related Products...

7 CFR 58.705 - Meaning of words.

Code of Federal Regulations, 2012 CFR

2012-01-01

..., GENERAL SPECIFICATIONS FOR APPROVED PLANTS AND STANDARDS FOR GRADES OF DAIRY PRODUCTS 1 General Specifications for Dairy Plants Approved for USDA Inspection and Grading Service 1 Supplemental Specifications for Plants Manufacturing, Processing and Packaging Pasteurized Process Cheese and Related Products...

7 CFR 58.705 - Meaning of words.

Code of Federal Regulations, 2013 CFR

2013-01-01

..., GENERAL SPECIFICATIONS FOR APPROVED PLANTS AND STANDARDS FOR GRADES OF DAIRY PRODUCTS 1 General Specifications for Dairy Plants Approved for USDA Inspection and Grading Service 1 Supplemental Specifications for Plants Manufacturing, Processing and Packaging Pasteurized Process Cheese and Related Products...

7 CFR 58.705 - Meaning of words.

Code of Federal Regulations, 2011 CFR

2011-01-01

..., GENERAL SPECIFICATIONS FOR APPROVED PLANTS AND STANDARDS FOR GRADES OF DAIRY PRODUCTS 1 General Specifications for Dairy Plants Approved for USDA Inspection and Grading Service 1 Supplemental Specifications for Plants Manufacturing, Processing and Packaging Pasteurized Process Cheese and Related Products...

Notification: Evaluation of EPA’s Approval Process for Air Quality Dispersion Models

EPA Pesticide Factsheets

Project #OPE-FY17-0016, June 5, 2017. The EPA OIG plans to begin preliminary research to assess the effectiveness of EPA's process for reviewing and approving air quality dispersion models it recommends for use.

77 FR 38033 - Notice of Establishment of a Commodity Import Approval Process Web Site

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-26

... Process Web Site AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Notice. SUMMARY: We are announcing the creation of a new Plant Protection and Quarantine Web site that will provide stakeholders with... comment on draft risk assessments. This Web site will make the commodity import approval process more...

Ensuring Effective Curriculum Approval Processes: A Guide for Local Senates

ERIC Educational Resources Information Center

Academic Senate for California Community Colleges, 2016

2016-01-01

Curriculum is the heart of the mission of every college. College curriculum approval processes have been established to ensure that rigorous, high quality curriculum is offered that meets the needs of students. While some concerns may exist regarding the effectiveness and efficiency of local curriculum processes, all participants in the process…

78 FR 53149 - Medicare and Medicaid Programs: Continued Approval of American Osteopathic Association/Healthcare...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-28

...) survey review and decision-making process for accreditation. The comparison of AOA/HFAP's accreditation... September 25, 2013. II. Application Approval Process Section 1865(a)(3)(A) of the Act provides a statutory... survey process to: ++ Determine the composition of the survey team, surveyor qualifications, and AOA/HFAP...

7 CFR 58.734 - Official identification.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Specifications for Dairy Plants Approved for USDA Inspection and Grading Service 1 Requirements for Processed Cheese Products Bearing Usda Official Identification § 58.734 Official identification. Only process... to be in compliance with these requirements may be identified with official USDA Quality Approved...

A multistage crucible of revision and approval shapes IPCC policymaker summaries.

PubMed

Mach, Katharine J; Freeman, Patrick T; Mastrandrea, Michael D; Field, Christopher B

2016-08-01

Intergovernmental Panel on Climate Change (IPCC) member governments approve each report's summary for policymakers (SPM) by consensus, discussing and agreeing on each sentence in a plenary session with scientist authors. A defining feature of IPCC assessment, the governmental approval process builds joint ownership of current knowledge by scientists and governments. The resulting SPM revisions have been extensively discussed in anecdotes, interviews, and perspectives, but they have not been comprehensively analyzed. We provide an in-depth evaluation of IPCC SPM revisions, establishing an evidential basis for understanding their nature. Revisions associated with governmental review and approval generally expand SPMs, with SPM text growing by 17 to 53% across recent assessment reports. Cases of high political sensitivity and failure to reach consensus are notable exceptions, resulting in SPM contractions. In contrast to recent claims, we find that IPCC SPMs are as readable, for multiple metrics of reading ease, as other professionally edited assessment summaries. Across reading-ease metrics, some SPMs become more readable through governmental review and approval, whereas others do not. In an SPM examined through the entire revision process, most revisions associated with governmental review and approval occurred before the start of the government-approval plenary session. These author revisions emphasize clarity, scientific rigor, and explanation. In contrast, the subsequent plenary revisions place greater emphasis especially on policy relevance, comprehensiveness of examples, and nuances of expert judgment. Overall, the value added by the IPCC process emerges in a multistage crucible of revision and approval, as individuals together navigate complex science-policy terrain.

Ethical approval for research involving geographically dispersed subjects: unsuitability of the UK MREC/LREC system and relevance to uncommon genetic disorders.

PubMed

Lewis, J C; Tomkins, S; Sampson, J R

2001-10-01

To assess the process involved in obtaining ethical approval for a single-centre study involving geographically dispersed subjects with an uncommon genetic disorder. Observational data of the application process to 53 local research ethics committees (LRECs) throughout Wales, England and Scotland. The Multicentre Research Ethics Committee (MREC) for Wales had already granted approval. Application to the 53 LRECs required 24,552 sheets of paper and took two months of the researcher's time. The median time taken for approval was 39 days with only seven (13%) of committees responding within the recommended 21 days. In at least nineteen cases (36%) a subcommittee considered the application. Thirty-three committees (62%) accepted the proposal without amendments but, of the remainder, four (8%) requested changes outside of the remit of LRECs. Difficulties still exist with the system for obtaining ethical approval for studies involving a single centre but with patients at multiple sites, as is often required for genetic observational research. As such studies differ from true multicentre studies, it may be advantageous to develop a separate and specific process of application to ensure that resources are not unnecessarily expended in the quest for ethical approval.

75 FR 60158 - Self-Regulatory Organizations; The Depository Trust Company; Notice of Filing of a Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-29

... Process in Providing Trustee Access to the Security Position Report Service September 24, 2010. Pursuant...'') service with an automated approval process. II. Self-Regulatory Organization's Statement of the Purpose of... approve a Trustee's access to the SPR service for a security is done manually, and the process is...

47 CFR 69.119 - Basic service element expedited approval process.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 47 Telecommunication 3 2010-10-01 2010-10-01 false Basic service element expedited approval process. 69.119 Section 69.119 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) COMMON CARRIER SERVICES (CONTINUED) ACCESS CHARGES Computation of Charges § 69.119 Basic service element...

21 CFR 530.13 - Extralabel use from compounding of approved new animal and approved human drugs.

Code of Federal Regulations, 2013 CFR

2013-04-01

... of a product from approved animal or human drugs by a veterinarian or a pharmacist on the order of a... pharmacist or veterinarian within the scope of a professional practice; (4) Adequate procedures and processes...

21 CFR 530.13 - Extralabel use from compounding of approved new animal and approved human drugs.

Code of Federal Regulations, 2010 CFR

2010-04-01

... of a product from approved animal or human drugs by a veterinarian or a pharmacist on the order of a... pharmacist or veterinarian within the scope of a professional practice; (4) Adequate procedures and processes...

21 CFR 530.13 - Extralabel use from compounding of approved new animal and approved human drugs.

Code of Federal Regulations, 2014 CFR

2014-04-01

... of a product from approved animal or human drugs by a veterinarian or a pharmacist on the order of a... pharmacist or veterinarian within the scope of a professional practice; (4) Adequate procedures and processes...

21 CFR 530.13 - Extralabel use from compounding of approved new animal and approved human drugs.

Code of Federal Regulations, 2011 CFR

2011-04-01

... of a product from approved animal or human drugs by a veterinarian or a pharmacist on the order of a... pharmacist or veterinarian within the scope of a professional practice; (4) Adequate procedures and processes...

21 CFR 530.13 - Extralabel use from compounding of approved new animal and approved human drugs.

Code of Federal Regulations, 2012 CFR

2012-04-01

... of a product from approved animal or human drugs by a veterinarian or a pharmacist on the order of a... pharmacist or veterinarian within the scope of a professional practice; (4) Adequate procedures and processes...

36 CFR 9.86 - Application review process and approval standards.

Code of Federal Regulations, 2014 CFR

2014-07-01

... review process and approval standards. (a) The Regional Director will review applications submitted... applicable laws, Executive Orders and regulations, the Regional Director will promptly notify the AMRAP agency coordinator of the anticipated date of a final decision. (b) The Regional Director is responsible...

36 CFR 9.86 - Application review process and approval standards.

Code of Federal Regulations, 2012 CFR

2012-07-01

... review process and approval standards. (a) The Regional Director will review applications submitted... applicable laws, Executive Orders and regulations, the Regional Director will promptly notify the AMRAP agency coordinator of the anticipated date of a final decision. (b) The Regional Director is responsible...

76 FR 66344 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-26

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change... 31, 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National Association of... consolidation process, see Information Notice, March 12, 2008 (Rulebook Consolidation Process). For convenience...

77 FR 36983 - Processed Raspberry Promotion, Research and Information Program; Request for Extension and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-20

... DEPARTMENT OF AGRICULTURE Agricultural Marketing Service [Doc. No. AMS-FV-12-0021] Processed... Approved Information Collection AGENCY: Agricultural Marketing Service, USDA. ACTION: Request for comments... announces the Agricultural Marketing Service's (AMS) intention to request approval, from the Office of...

Approving cancer treatments based on endpoints other than overall survival: an analysis of historical data using the PACE Continuous Innovation Indicators™ (CII).

PubMed

Brooks, Neon; Campone, Mario; Paddock, Silvia; Shortenhaus, Scott; Grainger, David; Zummo, Jacqueline; Thomas, Samuel; Li, Rose

2017-01-01

There is an active debate about the role that endpoints other than overall survival (OS) should play in the drug approval process. Yet the term 'surrogate endpoint' implies that OS is the only critical metric for regulatory approval of cancer treatments. We systematically analyzed the relationship between U.S. Food and Drug Administration (FDA) approval and publication of OS evidence to understand better the risks and benefits of delaying approval until OS evidence is available. Using the PACE Continuous Innovation Indicators (CII) platform, we analyzed the effects of cancer type, treatment goal, and year of approval on the lag time between FDA approval and publication of first significant OS finding for 53 treatments approved between 1952 and 2016 for 10 cancer types (n = 71 approved indications). Greater than 59% of treatments were approved before significant OS data for the approved indication were published. Of the drugs in the sample, 31% had lags between approval and first published OS evidence of 4 years or longer. The average number of years between approval and first OS evidence varied by cancer type and did not reliably predict the eventual amount of OS evidence accumulated. Striking the right balance between early access and minimizing risk is a central challenge for regulators worldwide. We illustrate that endpoints other than OS have long helped to provide timely access to new medicines, including many current standards of care. We found that many critical drugs are approved many years before OS data are published, and that OS may not be the most appropriate endpoint in some treatment contexts. Our examination of approved treatments without significant OS data suggests contexts where OS may not be the most relevant endpoint and highlights the importance of using a wide variety of fit-for-purpose evidence types in the approval process.

78 FR 55238 - Notice of Request for New Approval of Information Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-10

... Agricultural Service (FAS) intends to request the approval of a new information collection process involving... DEPARTMENT OF AGRICULTURE Foreign Agricultural Service Notice of Request for New Approval of Information Collection AGENCY: Foreign Agricultural Service, USDA. ACTION: Notice and request for comments...

75 FR 51464 - Medicare and Medicaid Programs; Approval of the American Association for Accreditation of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-20

... Surgery Facilities for Continued Deeming Authority for Ambulatory Surgical Centers AGENCY: Centers for... to approve without condition the American Association for Accreditation of Ambulatory Surgery... of Ambulatory Surgery Facilities on November 27, 2009. II. Deeming Applications Approval Process...

The safety review and approval process for space nuclear power sources

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

Bennett, G.L.

1991-01-01

Over the past 30 yr. the U.S. Government has evolved a process for the safety review and launch approval of nuclear power sources (NPSs) proposed for launch into space. This process, which involves a number of governmental agencies, ensures that the various postulated accident scenarios are considered, that the responses of the NPSs to the accident environments are assessed, and that appropriate elements of the Federal Government are involved in the launch approval. This process has worked very well in the successful launches of 37 radioisotope thermoelectric generators and 1 reactor by the United States since 1961. Particular attention willmore » be focused on the recent launch of the Galileo spacecraft. 19 refs., 12 figs., 4 tabs.« less

A multistage crucible of revision and approval shapes IPCC policymaker summaries

PubMed Central

Mach, Katharine J.; Freeman, Patrick T.; Mastrandrea, Michael D.; Field, Christopher B.

2016-01-01

Intergovernmental Panel on Climate Change (IPCC) member governments approve each report’s summary for policymakers (SPM) by consensus, discussing and agreeing on each sentence in a plenary session with scientist authors. A defining feature of IPCC assessment, the governmental approval process builds joint ownership of current knowledge by scientists and governments. The resulting SPM revisions have been extensively discussed in anecdotes, interviews, and perspectives, but they have not been comprehensively analyzed. We provide an in-depth evaluation of IPCC SPM revisions, establishing an evidential basis for understanding their nature. Revisions associated with governmental review and approval generally expand SPMs, with SPM text growing by 17 to 53% across recent assessment reports. Cases of high political sensitivity and failure to reach consensus are notable exceptions, resulting in SPM contractions. In contrast to recent claims, we find that IPCC SPMs are as readable, for multiple metrics of reading ease, as other professionally edited assessment summaries. Across reading-ease metrics, some SPMs become more readable through governmental review and approval, whereas others do not. In an SPM examined through the entire revision process, most revisions associated with governmental review and approval occurred before the start of the government-approval plenary session. These author revisions emphasize clarity, scientific rigor, and explanation. In contrast, the subsequent plenary revisions place greater emphasis especially on policy relevance, comprehensiveness of examples, and nuances of expert judgment. Overall, the value added by the IPCC process emerges in a multistage crucible of revision and approval, as individuals together navigate complex science-policy terrain. PMID:27532046

34 CFR 668.156 - Approved State process.

Code of Federal Regulations, 2010 CFR

2010-07-01

... student's eligibility for Title IV, HEA program funds must apply to the Secretary for approval of that... than a single standardized test; (3) Tutoring in basic verbal and quantitative skills, if appropriate... program completion. (d) A State process must— (1) Monitor on an annual basis each participating...

42 CFR 410.142 - CMS process for approving national accreditation organizations.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Diabetes Self-Management Training and Diabetes Outcome Measurements § 410.142 CMS process for approving... diabetes to accredit entities to furnish training. (b) Required information and materials. An organization... outpatient diabetes self-management training program and procedures to monitor the correction of those...

42 CFR 410.142 - CMS process for approving national accreditation organizations.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Diabetes Self-Management Training and Diabetes Outcome Measurements § 410.142 CMS process for approving... diabetes to accredit entities to furnish training. (b) Required information and materials. An organization... outpatient diabetes self-management training program and procedures to monitor the correction of those...

42 CFR 410.142 - CMS process for approving national accreditation organizations.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Diabetes Self-Management Training and Diabetes Outcome Measurements § 410.142 CMS process for approving... diabetes to accredit entities to furnish training. (b) Required information and materials. An organization... outpatient diabetes self-management training program and procedures to monitor the correction of those...

42 CFR 410.142 - CMS process for approving national accreditation organizations.

Code of Federal Regulations, 2010 CFR

2010-10-01

.... (5) A description of the organization's data management and analysis system for its accreditation... organizations. 410.142 Section 410.142 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF... Diabetes Self-Management Training and Diabetes Outcome Measurements § 410.142 CMS process for approving...

42 CFR 410.142 - CMS process for approving national accreditation organizations.

Code of Federal Regulations, 2011 CFR

2011-10-01

.... (5) A description of the organization's data management and analysis system for its accreditation... organizations. 410.142 Section 410.142 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF... Diabetes Self-Management Training and Diabetes Outcome Measurements § 410.142 CMS process for approving...

77 FR 45688 - Electronic Prescriptions for Controlled Substances Notice of Approved Certification Process

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-01

... Comprehensive Drug Abuse Prevention and Control Act of 1970, often referred to as the Controlled Substances Act... substances, particularly Schedule II controlled substances, which have a significant potential for abuse... Prescriptions for Controlled Substances Notice of Approved Certification Process AGENCY: Drug Enforcement...

36 CFR 72.53 - Preapplication process for Rehabilitation and Innovation grants.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Rehabilitation and Innovation grants. 72.53 Section 72.53 Parks, Forests, and Public Property NATIONAL PARK..., Approval and Administration § 72.53 Preapplication process for Rehabilitation and Innovation grants. To... to submission and approval of Rehabilitation and Innovation proposals. (1) Preapplications shall be...

36 CFR 72.53 - Preapplication process for Rehabilitation and Innovation grants.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Rehabilitation and Innovation grants. 72.53 Section 72.53 Parks, Forests, and Public Property NATIONAL PARK..., Approval and Administration § 72.53 Preapplication process for Rehabilitation and Innovation grants. To... to submission and approval of Rehabilitation and Innovation proposals. (1) Preapplications shall be...

36 CFR 72.53 - Preapplication process for Rehabilitation and Innovation grants.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Rehabilitation and Innovation grants. 72.53 Section 72.53 Parks, Forests, and Public Property NATIONAL PARK..., Approval and Administration § 72.53 Preapplication process for Rehabilitation and Innovation grants. To... to submission and approval of Rehabilitation and Innovation proposals. (1) Preapplications shall be...

36 CFR 72.53 - Preapplication process for Rehabilitation and Innovation grants.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Rehabilitation and Innovation grants. 72.53 Section 72.53 Parks, Forests, and Public Property NATIONAL PARK..., Approval and Administration § 72.53 Preapplication process for Rehabilitation and Innovation grants. To... to submission and approval of Rehabilitation and Innovation proposals. (1) Preapplications shall be...

36 CFR 72.53 - Preapplication process for Rehabilitation and Innovation grants.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Rehabilitation and Innovation grants. 72.53 Section 72.53 Parks, Forests, and Public Property NATIONAL PARK..., Approval and Administration § 72.53 Preapplication process for Rehabilitation and Innovation grants. To... to submission and approval of Rehabilitation and Innovation proposals. (1) Preapplications shall be...

16 CFR 312.12 - Voluntary Commission Approval Processes.

Code of Federal Regulations, 2014 CFR

2014-01-01

... CONGRESS CHILDREN'S ONLINE PRIVACY PROTECTION RULE § 312.12 Voluntary Commission Approval Processes. (a...; and (b) Support for internal operations of the Web site or online service. An interested party may... potential effects on children's online privacy. The request shall be filed with the Commission's Office of...

21 CFR 211.100 - Written procedures; deviations.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Process Controls § 211.100 Written procedures; deviations. (a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality... approved by the appropriate organizational units and reviewed and approved by the quality control unit. (b...

21 CFR 211.100 - Written procedures; deviations.

Code of Federal Regulations, 2014 CFR

2014-04-01

... Process Controls § 211.100 Written procedures; deviations. (a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality... approved by the appropriate organizational units and reviewed and approved by the quality control unit. (b...

21 CFR 211.100 - Written procedures; deviations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Process Controls § 211.100 Written procedures; deviations. (a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality... approved by the appropriate organizational units and reviewed and approved by the quality control unit. (b...

21 CFR 211.100 - Written procedures; deviations.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Process Controls § 211.100 Written procedures; deviations. (a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality... approved by the appropriate organizational units and reviewed and approved by the quality control unit. (b...

21 CFR 211.100 - Written procedures; deviations.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Process Controls § 211.100 Written procedures; deviations. (a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality... approved by the appropriate organizational units and reviewed and approved by the quality control unit. (b...

44 CFR 78.6 - Flood Mitigation Plan approval process.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 44 Emergency Management and Assistance 1 2011-10-01 2011-10-01 false Flood Mitigation Plan..., DEPARTMENT OF HOMELAND SECURITY INSURANCE AND HAZARD MITIGATION National Flood Insurance Program FLOOD MITIGATION ASSISTANCE § 78.6 Flood Mitigation Plan approval process. The State POC will forward all Flood...

44 CFR 78.6 - Flood Mitigation Plan approval process.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 44 Emergency Management and Assistance 1 2013-10-01 2013-10-01 false Flood Mitigation Plan..., DEPARTMENT OF HOMELAND SECURITY INSURANCE AND HAZARD MITIGATION National Flood Insurance Program FLOOD MITIGATION ASSISTANCE § 78.6 Flood Mitigation Plan approval process. The State POC will forward all Flood...

44 CFR 78.6 - Flood Mitigation Plan approval process.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 44 Emergency Management and Assistance 1 2014-10-01 2014-10-01 false Flood Mitigation Plan..., DEPARTMENT OF HOMELAND SECURITY INSURANCE AND HAZARD MITIGATION National Flood Insurance Program FLOOD MITIGATION ASSISTANCE § 78.6 Flood Mitigation Plan approval process. The State POC will forward all Flood...

PDA Single-Use Systems Cross-Organizational Workshop-Meeting Summary, May 14, 2014-PDA Global Headquarters, Bethesda, MD.

PubMed

Repetto, Robert; Levy, Richard

2015-01-01

The application of single-use systems, or disposables, has increased dramatically in the past 10 years. Although some elements of the pharmaceutical and biotech manufacturing process were single-use and therefore disposable and not reused, the majority of the process equipment and fluid path was cleaned and reused by end users. Today, much more of the manufacturing process is composed of single-use systems, and there are some biotech plants that use single-use systems exclusively. Because of this increasing reliance on suppliers, there is an urgent need for more formal standards specifically for single-use system technology. The objective of this PDA-sponsored workshop held on May 14, 2014 was twofold: (1) to promote a harmonized approach to supporting single-use system activities within the industry and in so doing to minimize duplication of efforts, and (2) to communicate ongoing single-use system initiatives among the group. Representatives of ASME, ASTM, BPOG, BPSA, ELSIE, PDA, PQRI, and USP, as well as representatives of CBER and CDER of FDA, attended. Today, the majority of pharmaceutical and biotech drug manufacturing equipment is cleaned and reused. However, in the past 10 years, the use of disposable manufacturing systems has increased dramatically; there are even some biotech-derived drugs that are manufactured entirely using single-use technology. This movement toward disposables has placed increased reliance on disposable equipment suppliers, each of which manufactures its products independently to meet customer needs. This fact has led to non-uniformity in design for connectors and similar sub-processes, and has made the need for more formal industry standards. The objective of this PDA-sponsored workshop held on May 14, 2014 was twofold: (1) to promote a harmonized approach to supporting single-use system projects within the industry and in so doing to minimize duplication of efforts, and (2) to communicate ongoing single-use system initiatives among the group. Representatives of industry associations and standard-setting organizations, as well as representatives of the U.S. Food and Drug Administration, attended. © PDA, Inc. 2015.

78 FR 54813 - Approval and Promulgation of Air Quality Implementation Plans; Colorado; Construction Permit...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-06

...] Approval and Promulgation of Air Quality Implementation Plans; Colorado; Construction Permit Program Fee Increases; Construction Permit Regulation of PM 2.5 ; Regulation 3 AGENCY: Environmental Protection Agency... construction permit processing fees. EPA proposes approval of Colorado's May 25, 2011 submittal, which...

Regulatory Challenges for Cartilage Repair Technologies.

PubMed

McGowan, Kevin B; Stiegman, Glenn

2013-01-01

In the United States, few Food and Drug Administration (FDA)-approved options exist for the treatment of focal cartilage and osteochondral lesions. Developers of products for cartilage repair face many challenges to obtain marketing approval from the FDA. The objective of this review is to discuss the necessary steps for FDA application and approval for a new cartilage repair product. FDA Guidance Documents, FDA Panel Meetings, scientific organization recommendations, and clinicaltrials.gov were reviewed to demonstrate the current thinking of FDA and the scientific community on the regulatory process for cartilage repair therapies. Cartilage repair therapies can receive market approval from FDA as medical devices, drugs, or biologics, and the specific classification of product can affect the nonclinical, clinical, and regulatory strategy to bring the product to market. Recent FDA guidance gives an outline of the required elements to bring a cartilage repair product to market, although these standards are often very general. As a result, companies have to carefully craft their study patient population, comparator group, and clinical endpoint to best showcase their product's attributes. In addition, regulatory strategy and manufacturing process validation need to be considered early in the clinical study process to allow for timely product approval following the completion of clinical study. Although the path to regulatory approval for a cartilage repair therapy is challenging and time-consuming, proper clinical trial planning and attention to the details can eventually save companies time and money by bringing a product to the market in the most expeditious process possible.

Regulatory Challenges for Cartilage Repair Technologies

PubMed Central

Stiegman, Glenn

2013-01-01

In the United States, few Food and Drug Administration (FDA)–approved options exist for the treatment of focal cartilage and osteochondral lesions. Developers of products for cartilage repair face many challenges to obtain marketing approval from the FDA. The objective of this review is to discuss the necessary steps for FDA application and approval for a new cartilage repair product. FDA Guidance Documents, FDA Panel Meetings, scientific organization recommendations, and clinicaltrials.gov were reviewed to demonstrate the current thinking of FDA and the scientific community on the regulatory process for cartilage repair therapies. Cartilage repair therapies can receive market approval from FDA as medical devices, drugs, or biologics, and the specific classification of product can affect the nonclinical, clinical, and regulatory strategy to bring the product to market. Recent FDA guidance gives an outline of the required elements to bring a cartilage repair product to market, although these standards are often very general. As a result, companies have to carefully craft their study patient population, comparator group, and clinical endpoint to best showcase their product’s attributes. In addition, regulatory strategy and manufacturing process validation need to be considered early in the clinical study process to allow for timely product approval following the completion of clinical study. Although the path to regulatory approval for a cartilage repair therapy is challenging and time-consuming, proper clinical trial planning and attention to the details can eventually save companies time and money by bringing a product to the market in the most expeditious process possible. PMID:26069647

A drug's life: the pathway to drug approval.

PubMed

Keng, Michael K; Wenzell, Candice M; Sekeres, Mikkael A

2013-10-01

In the United States, drugs and medical devices are regulated by the US Food and Drug Administration (FDA). A drug must undergo rigorous testing prior to marketing to and medical use by the general public. The FDA grants marketing approval for drug products based on a comprehensive review of safety and efficacy data. This review article explains the history behind the establishment of the FDA and examines the historical legislation and approval processes for drugs, specifically in the fields of medical oncology and hematology. The agents imatinib (Gleevec, Novartis) and decitabine (Dacogen, Eisai) are used to illustrate both the current FDA regulatory process-specifically the orphan drug designation and accelerated approval process-and why decitabine failed to gain an indication for acute myeloid leukemia. The purpose and construct of the Oncologic Drugs Advisory Committee are also discussed, along with examples of 2 renal cell cancer drugs-axitinib (Inlyta, Pfizer) and tivozanib-that used progression-free survival as an endpoint. Regulatory approval of oncology drugs is the cornerstone of the development of new treatment agents and modalities, which lead to improvements in the standard of cancer care. The future landscape of drug development and regulatory approval will be influenced by the new breakthrough therapy designation, and choice of drug will be guided by genomic insights.

Ethical approval for research involving geographically dispersed subjects: unsuitability of the UK MREC/LREC system and relevance to uncommon genetic disorders

PubMed Central

Lewis, J C; Tomkins, S; Sampson, J R

2001-01-01

Objectives—To assess the process involved in obtaining ethical approval for a single-centre study involving geographically dispersed subjects with an uncommon genetic disorder. Design—Observational data of the application process to 53 local research ethics committees (LRECs) throughout Wales, England and Scotland. The Multicentre Research Ethics Committee (MREC) for Wales had already granted approval. Results—Application to the 53 LRECs required 24,552 sheets of paper and took two months of the researcher's time. The median time taken for approval was 39 days with only seven (13%) of committees responding within the recommended 21 days. In at least nineteen cases (36%) a subcommittee considered the application. Thirty-three committees (62%) accepted the proposal without amendments but, of the remainder, four (8%) requested changes outside of the remit of LRECs. Discussion—Difficulties still exist with the system for obtaining ethical approval for studies involving a single centre but with patients at multiple sites, as is often required for genetic observational research. As such studies differ from true multicentre studies, it may be advantageous to develop a separate and specific process of application to ensure that resources are not unnecessarily expended in the quest for ethical approval. Key Words: Research ethics • MREC • LREC PMID:11579194

76 FR 79703 - Notice of Submission for Extension of a Currently Approved Information Collection to OMB; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-22

... Special Claims Processing. Description of Information Collection: This is an extension of a currently... Extension of a Currently Approved Information Collection to OMB; Comment Request Applications for Housing Assistance Payments and Special Claims Processing AGENCY: Office of Program Systems Management. ACTION...

76 FR 77823 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-14

... technology and systems for the purposes of collecting, validating, and verifying information, processing and... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OECA-2011-0218; FRL-9501-2] Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request; NSPS for Metallic Mineral Processing...

Ozone processing of foods and beverages

USDA-ARS?s Scientific Manuscript database

Ozone has a long history of use as a disinfectant in food and beverage processing. In the United States, the application of ozone to disinfect bottled water was approved as Generally Recognized As Safe (GRAS) in 1982. Later it was approved as a sanitizing agent for bottled water treatment lines. Ozo...

17 CFR 202.190 - Public Company Accounting Oversight Board budget approval process.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 17 Commodity and Securities Exchanges 2 2011-04-01 2011-04-01 false Public Company Accounting... SECURITIES AND EXCHANGE COMMISSION INFORMAL AND OTHER PROCEDURES Public Company Accounting Oversight Board (Regulation P) § 202.190 Public Company Accounting Oversight Board budget approval process. (a) Purpose. These...

17 CFR 202.190 - Public Company Accounting Oversight Board budget approval process.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 17 Commodity and Securities Exchanges 2 2012-04-01 2012-04-01 false Public Company Accounting... SECURITIES AND EXCHANGE COMMISSION INFORMAL AND OTHER PROCEDURES Public Company Accounting Oversight Board (Regulation P) § 202.190 Public Company Accounting Oversight Board budget approval process. (a) Purpose. These...

77 FR 61787 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Agreement...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-11

... for OMB Review; Comment Request; Agreement Approval Process for Use of Functional Affirmative Action..., ``Agreement Approval Process for Use of Functional Affirmative Action Programs,'' to the Office of Management... 11246 permit Federal supply and service contractors to develop affirmative action programs (AAPs) that...

17 CFR 202.11 - Public Company Accounting Oversight Board budget approval process.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 17 Commodity and Securities Exchanges 2 2010-04-01 2010-04-01 false Public Company Accounting Oversight Board budget approval process. 202.11 Section 202.11 Commodity and Securities Exchanges SECURITIES AND EXCHANGE COMMISSION INFORMAL AND OTHER PROCEDURES § 202.11 Public Company Accounting Oversight...

76 FR 31856 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Adoption of Control...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-02

... Flat Wood Paneling Surface Coating Processes AGENCY: Environmental Protection Agency (EPA). ACTION... by EPA's Control Techniques Guidelines (CTG) standards for flat wood paneling surface coating processes. EPA is approving this revision concerning the adoption of the EPA CTG requirements for flat wood...

32 CFR 199.21 - Pharmacy benefits program.

Code of Federal Regulations, 2012 CFR

2012-07-01

... limited to: (1) Approval of a new pharmaceutical agent by the U.S. Food and Drug Administration; (2) Approval of a new indication for an existing pharmaceutical agent; (3) Changes in the clinical use of... the new formulary management process, the processes established by this section shall apply. (h...

32 CFR 199.21 - Pharmacy benefits program.

Code of Federal Regulations, 2011 CFR

2011-07-01

... limited to: (1) Approval of a new pharmaceutical agent by the U.S. Food and Drug Administration; (2) Approval of a new indication for an existing pharmaceutical agent; (3) Changes in the clinical use of... the new formulary management process, the processes established by this section shall apply. (h...

32 CFR 199.21 - Pharmacy benefits program.

Code of Federal Regulations, 2013 CFR

2013-07-01

... limited to: (1) Approval of a new pharmaceutical agent by the U.S. Food and Drug Administration; (2) Approval of a new indication for an existing pharmaceutical agent; (3) Changes in the clinical use of... the new formulary management process, the processes established by this section shall apply. (h...

32 CFR 199.21 - TRICARE Pharmacy Benefits Program.

Code of Federal Regulations, 2014 CFR

2014-07-01

... limited to: (1) Approval of a new pharmaceutical agent by the U.S. Food and Drug Administration; (2) Approval of a new indication for an existing pharmaceutical agent; (3) Changes in the clinical use of... the new formulary management process, the processes established by this section shall apply. (h...

PubMed

Ríos, Pedro Rizo; Rivera, Aurora González; Oropeza, Itzel Rivas; Rivas Bocanegra, Ruth E

2013-12-01

The high costs generated by the current epidemiological profile and the introduction of new technologies, impact on public health systems, this situation is complicated when the health budget is low and causes the drug to be paid by the patient's pocket. In this situation it is necessary to design strategies that strengthen the approval of drugs that will be used in public health institutions in Mexico. To describe the results of the drug approval process for use in public health institutions to ensure the efficacy, safety, and efficiency of health technologies used in public health institutions in Mexico. We conducted a cross-sectional drug approval process, from September 2011 to December 2012, with a descriptive analysis for each stage in the process considered. Of the 394 applications received for approval of health technology, 244 (62%) were for drugs; of these, 151 (62%) met the requirements for evaluation (32% and 68% were modifications inclusions), finally was approved of 42% (61% of the changes and 33% of inclusions). The 73% of the applications were for consensus approval, 12% were conditioned at low price and 6% were approved by majority vote. The main reasons for refusal were lack of clinical evidence (31%) and methodological problems in the economic evaluation (27%). The strengthening of the process was conducted with methodological rigor based on critical analysis of scientific evidence, with transparency and legitimacy under a legal framework to promote resource optimization. The highest percentage of requests was for drugs which are the most commonly used therapeutic technology; for this reason it requires a proper selection process to ensure greater health benefit that ensures efficient use of economic resources. The economic evaluation was a support tool to consider in addition to price, the value of health determined by the quality of evidence, establishing a GDP per capita as a threshold to define a drug as an efficient alternative. © 2013 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Published by International Society for Pharmacoeconomics and Outcomes Research (ISPOR) All rights reserved.

Permethrin Exposure Dosimetry: Biomarkers and Modifiable Factors

DTIC Science & Technology

2015-08-01

ongoing communication with the US Army Center for Initial Military Training (CIMT) has taken place, initiating in August 2014. The PI briefed the DCG ...2016, ongoing communication with National Guard Bureau has taken place, initiating in April 2015. o With DCG -IMT approval (see Task 3 below...September 2015. TASK 3 Study 1 site approval [COMPLETE] o DCG -IMT Approval Memorandum, 1 June 2015. Approval process identified Ft. Sill as the location

77 FR 10621 - Changes to the In-Bond Process

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-22

... submit in-bond applications electronically using a CBP-approved electronic data interchange (EDI) system... electronically submit the in-bond application to CBP via a CBP-approved EDI system. \\6\\ Due to the unique... as the CBP-approved EDI system for submitting the in-bond application and other information that is...

42 CFR 433.117 - Initial approval of replacement systems.

Code of Federal Regulations, 2010 CFR

2010-10-01

... and Information Retrieval Systems § 433.117 Initial approval of replacement systems. (a) A replacement system must meet all conditions of initial approval of a mechanized claims processing and information retrieval system. (b) The agency must submit a APD that includes— (1) The date the replacement system will...

76 FR 50536 - Projects Approved or Rescinded for Consumptive Uses of Water

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-15

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved or Rescinded for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects... the consumptive use of water pursuant to the Commission's approval by rule process set forth in 18 CFR...

76 FR 20802 - Projects Approved or Rescinded for Consumptive Uses of Water

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-13

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved or Rescinded for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects... the consumptive use of water pursuant to the Commission's approval by rule process set forth in 18 CFR...

47 CFR 69.119 - Basic service element expedited approval process.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 47 Telecommunication 3 2011-10-01 2011-10-01 false Basic service element expedited approval... CARRIER SERVICES (CONTINUED) ACCESS CHARGES Computation of Charges § 69.119 Basic service element... approval of new basic service elements are those indicated in § 1.45 of the rules, except as specified...

47 CFR 69.119 - Basic service element expedited approval process.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 47 Telecommunication 3 2013-10-01 2013-10-01 false Basic service element expedited approval... CARRIER SERVICES (CONTINUED) ACCESS CHARGES Computation of Charges § 69.119 Basic service element... approval of new basic service elements are those indicated in § 1.45 of the rules, except as specified...

47 CFR 69.119 - Basic service element expedited approval process.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 47 Telecommunication 3 2014-10-01 2014-10-01 false Basic service element expedited approval... CARRIER SERVICES (CONTINUED) ACCESS CHARGES Computation of Charges § 69.119 Basic service element... approval of new basic service elements are those indicated in § 1.45 of the rules, except as specified...

47 CFR 69.119 - Basic service element expedited approval process.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 47 Telecommunication 3 2012-10-01 2012-10-01 false Basic service element expedited approval... CARRIER SERVICES (CONTINUED) ACCESS CHARGES Computation of Charges § 69.119 Basic service element... approval of new basic service elements are those indicated in § 1.45 of the rules, except as specified...

1 CFR 19.2 - Routing and approval of drafts.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 1 General Provisions 1 2014-01-01 2012-01-01 true Routing and approval of drafts. 19.2 Section 19.2 General Provisions ADMINISTRATIVE COMMITTEE OF THE FEDERAL REGISTER PREPARATION, TRANSMITTAL, AND PROCESSING OF DOCUMENTS EXECUTIVE ORDERS AND PRESIDENTIAL PROCLAMATIONS § 19.2 Routing and approval of drafts...

1 CFR 19.2 - Routing and approval of drafts.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 1 General Provisions 1 2010-01-01 2010-01-01 false Routing and approval of drafts. 19.2 Section 19.2 General Provisions ADMINISTRATIVE COMMITTEE OF THE FEDERAL REGISTER PREPARATION, TRANSMITTAL, AND PROCESSING OF DOCUMENTS EXECUTIVE ORDERS AND PRESIDENTIAL PROCLAMATIONS § 19.2 Routing and approval of drafts...

1 CFR 19.2 - Routing and approval of drafts.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 1 General Provisions 1 2011-01-01 2011-01-01 false Routing and approval of drafts. 19.2 Section 19.2 General Provisions ADMINISTRATIVE COMMITTEE OF THE FEDERAL REGISTER PREPARATION, TRANSMITTAL, AND PROCESSING OF DOCUMENTS EXECUTIVE ORDERS AND PRESIDENTIAL PROCLAMATIONS § 19.2 Routing and approval of drafts...

1 CFR 19.2 - Routing and approval of drafts.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 1 General Provisions 1 2012-01-01 2012-01-01 false Routing and approval of drafts. 19.2 Section 19.2 General Provisions ADMINISTRATIVE COMMITTEE OF THE FEDERAL REGISTER PREPARATION, TRANSMITTAL, AND PROCESSING OF DOCUMENTS EXECUTIVE ORDERS AND PRESIDENTIAL PROCLAMATIONS § 19.2 Routing and approval of drafts...

1 CFR 19.2 - Routing and approval of drafts.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 1 General Provisions 1 2013-01-01 2012-01-01 true Routing and approval of drafts. 19.2 Section 19.2 General Provisions ADMINISTRATIVE COMMITTEE OF THE FEDERAL REGISTER PREPARATION, TRANSMITTAL, AND PROCESSING OF DOCUMENTS EXECUTIVE ORDERS AND PRESIDENTIAL PROCLAMATIONS § 19.2 Routing and approval of drafts...

41 CFR 102-38.110 - Who approves our determinations to conduct negotiated sales?

Code of Federal Regulations, 2013 CFR

2013-07-01

... 41 Public Contracts and Property Management 3 2013-07-01 2013-07-01 false Who approves our... Management Federal Property Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATION PERSONAL PROPERTY 38-SALE OF PERSONAL PROPERTY Sales Process Negotiated Sales § 102-38.110 Who approves our...

41 CFR 102-38.110 - Who approves our determinations to conduct negotiated sales?

Code of Federal Regulations, 2012 CFR

2012-01-01

... 41 Public Contracts and Property Management 3 2012-01-01 2012-01-01 false Who approves our... Management Federal Property Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATION PERSONAL PROPERTY 38-SALE OF PERSONAL PROPERTY Sales Process Negotiated Sales § 102-38.110 Who approves our...

41 CFR 102-38.110 - Who approves our determinations to conduct negotiated sales?

Code of Federal Regulations, 2014 CFR

2014-01-01

... 41 Public Contracts and Property Management 3 2014-01-01 2014-01-01 false Who approves our... Management Federal Property Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATION PERSONAL PROPERTY 38-SALE OF PERSONAL PROPERTY Sales Process Negotiated Sales § 102-38.110 Who approves our...

41 CFR 102-38.110 - Who approves our determinations to conduct negotiated sales?

Code of Federal Regulations, 2010 CFR

2010-07-01

... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Who approves our... Management Federal Property Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATION PERSONAL PROPERTY 38-SALE OF PERSONAL PROPERTY Sales Process Negotiated Sales § 102-38.110 Who approves our...

41 CFR 102-38.110 - Who approves our determinations to conduct negotiated sales?

Code of Federal Regulations, 2011 CFR

2011-01-01

... 41 Public Contracts and Property Management 3 2011-01-01 2011-01-01 false Who approves our... Management Federal Property Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATION PERSONAL PROPERTY 38-SALE OF PERSONAL PROPERTY Sales Process Negotiated Sales § 102-38.110 Who approves our...

7 CFR 1717.901 - Early approval.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 11 2011-01-01 2011-01-01 false Early approval. 1717.901 Section 1717.901 Agriculture... for Supplemental Financing Required by 7 CFR 1710.110 § 1717.901 Early approval. (a) Conditions. If... supplemental financing early in the process, before funding is available for the concurrent RUS insured loan...

76 FR 53528 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-26

... Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Advanced... about our intention to request the Office of Management and Budget (OMB) approval for to renew an... Advanced Qualification Program (AQP) incorporates data driven quality control processes for validating and...

78 FR 75670 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-12

... Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Advanced... about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. The Advanced Qualification Program uses data driven quality control processes for...

7 CFR 1710.209 - Approval requirements for load forecast work plans.

Code of Federal Regulations, 2010 CFR

2010-01-01

... cooperate in the preparation of and submittal of the load forecast work plan of their power supply borrower. (b) An approved load forecast work plan establishes the process for the preparation and maintenance... approved load forecast work plan must outline the coordination and preparation requirements for both the...

44 CFR 350.12 - FEMA Headquarters review and approval.

Code of Federal Regulations, 2010 CFR

2010-10-01

... assistance that may be needed in the FEMA review and approval process. (b) If, after formal submission of the... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false FEMA Headquarters review and approval. 350.12 Section 350.12 Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT AGENCY...

75 FR 47599 - Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Food and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-06

... premarket notification and review process. FDA's regulations governing application for agency approval to...-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each... collection of information, before submitting the collection to OMB for approval. To comply with this...

Effects of local institutional review board review on participation in national practice-based research network studies.

PubMed

Finch, Stacia A; Barkin, Shari L; Wasserman, Richard C; Dhepyasuwan, Niramol; Slora, Eric J; Sege, Robert D

2009-12-01

To describe the process and outcomes of local institutional review board (IRB) review for 2 Pediatric Research in Office Settings (PROS) studies. Pediatric Research in Office Settings conducted 2 national studies concerning sensitive topics: (1) Child Abuse Recognition Experience Study (CARES), an observational study of physician decision making, and (2) Safety Check, a violence prevention intervention trial. Institutional review board approval was secured by investigators' sites, the American Academy of Pediatrics, and practices with local IRBs. Practices were queried about IRB rules at PROS enrollment and study recruitment. Pediatric Research in Office Settings practices in 29 states. Eighty-eight PROS practices (75 IRBs). Main Exposure Local IRB presence. Local IRB presence, level of PROS assistance, IRB process, study participation, data collection completion, and minority enrollment. Practices requiring additional local IRB approval agreed to participate less than those that did not (CARES: 33% vs 52%; Safety Check: 41% vs 56%). Of the 88 practices requiring local IRB approval, 55 received approval, with nearly 50% needing active PROS help, many requiring consent changes (eg, contact name additions, local IRB approval stamps), and 87% beginning data collection. Median days to obtain approval were 81 (CARES) and 109 (Safety Check). Practices requiring local IRB approval were less likely to complete data collection but more likely to enroll minority patients. Local IRB review was associated with lower participation rates, substantial effort navigating the process (with approval universally granted without substantive changes), and data collection delays. When considering future reforms, the national human subject protections system should consider the potential redundancy and effect on generalizability, particularly regarding enrollment of poor urban children, related to local IRB review.

Data Collection Satellite Application in Precision Agriculture

NASA Astrophysics Data System (ADS)

Durào, O.

2002-01-01

Agricultural Instrumentation Research Center, Brazilian Agricultural Research Corporation; Space Programs Brazil launched in 1993 its first satellite partially built and entirely designed, integrated, tested and operated in the country. It was the SCD-1 satellite, a small (115 kg. and an octagonal prism with 80 cm. height and an external diameter of 100 cm.) with a payload transponder that receives data from ground platforms spread all over the country (including its sea shore). These data are then retransmitted to a receiving station at every satellite pass. Data collected and received are processed at Data Collection Mission Center for distribution via internet at most 30 min after the satellite pass. The ground platforms are called PCD's and differ in the parameters measured according to its purpose and location. Thus, they are able to measure temperature, rain level, wind direction, solar radiation, carbon monoxide as well as many others, beyond its own location. SCD- 1 had a nominal designed life of one year, but is still functioning. It is a LEO satellite with inclination of 25°. In 1998, the country launched SCD-2, with the same purpose, but in phase with SCD-1 . Other differences were a higher index of Brazilian made components and an active attitude control subsystem for the spin rate provided by the magnetic torque coils (these in accordance with a development strategy previously planned). In 1999 the country launched in cooperation with China a remote sensing satellite (mass of 1.4 ton.) called CBERS-1. This satellite is sun synchronous (98° inclination) and also carries a transponder for data collection/transmission as a secondary payload. Thus, the country has now three satellites with data collection/transmission capabilities, two in low inclination phased orbits and one in polar orbit, providing a nice coverage both geographical and temporal not only to its territory but also to other regions of the world.. At first there were not too many PCD's over Brazilian territory. There were 25 platforms when SCD-1 was launched. However this number is growing rapidly to 400 platforms, at first for measurements of water reservoir levels as well as other hydrology applications (The Brazilian Electricity Regulatory Agency - ANEEL is the customer), and for many other different applications such as meteorology, oceanography, environmental monitoring sciences, and people and animal tracking. The clear feeling is that users are discovering a satellite system whose benefits were not previously well understood when launched and being able to propose and come up with different and useful applications. A new field in the country that has a great potential to benefit from this system is agriculture. Per se, this is a very important sector of the Brazilian economy and its international trade. Combining it with space technology may justify the investment of new and low cost dedicated satellites. This paper describes a new proposal for use of the SCD-1,2,CBERS-1 satellite system for precision agriculture. New PCD's would be developed for measurements of chemical content of the soil, such as, for example, Nitrogen and others, beyond humidity and solar incidence. This can lead to a more efficient fertilization, harvesting and even the spray of chemical defensives, with the consequence of environment protection. The PCD's ground network so established, along with the information network already available, combined with the space segment of such a system may, as previously said, be able to justify the investment in low cost satellites with this sole purpose.

15 CFR 400.32 - Procedure for review of request for approval of manufacturing or processing.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 15 Commerce and Foreign Trade 2 2010-01-01 2010-01-01 false Procedure for review of request for approval of manufacturing or processing. 400.32 Section 400.32 Commerce and Foreign Trade Regulations Relating to Commerce and Foreign Trade (Continued) FOREIGN-TRADE ZONES BOARD, DEPARTMENT OF COMMERCE...

75 FR 69121 - Information Collection Sent to the Office of Management and Budget (OMB) for Approval; OMB...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-10

... Office of Management and Budget (OMB) for Approval; OMB Control Number 1024-0252; The Interagency Access and Senior Pass Application Processes AGENCY: National Park Service, Interior. ACTION: Notice; request.... Title: The Interagency Access and Senior Pass Application Processes. Form Number: None. Type of Request...

25 CFR 170.426 - What is the approval process for the IRRTIP?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 25 Indians 1 2010-04-01 2010-04-01 false What is the approval process for the IRRTIP? 170.426 Section 170.426 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR LAND AND WATER INDIAN RESERVATION ROADS PROGRAM Planning, Design, and Construction of Indian Reservation Roads Program Facilities...

48 CFR 1819.7203 - Mentor approval process.

Code of Federal Regulations, 2013 CFR

2013-10-01

... by NASA OSBP. (f) A template of the mentor application is available at: http://www.osbp.nasa.gov. ... ADMINISTRATION SOCIOECONOMIC PROGRAMS SMALL BUSINESS PROGRAMS NASA Mentor-Protégé Program 1819.7203 Mentor approval process. (a) An entity seeking to participate as a mentor must apply to the NASA Headquarters...

48 CFR 1819.7203 - Mentor approval process.

Code of Federal Regulations, 2014 CFR

2014-10-01

... by NASA OSBP. (f) A template of the mentor application is available at: http://www.osbp.nasa.gov. ... ADMINISTRATION SOCIOECONOMIC PROGRAMS SMALL BUSINESS PROGRAMS NASA Mentor-Protégé Program 1819.7203 Mentor approval process. (a) An entity seeking to participate as a mentor must apply to the NASA Headquarters...

48 CFR 1819.7203 - Mentor approval process.

Code of Federal Regulations, 2012 CFR

2012-10-01

... by NASA OSBP. (f) A template of the mentor application is available at: http://www.osbp.nasa.gov. ... ADMINISTRATION SOCIOECONOMIC PROGRAMS SMALL BUSINESS PROGRAMS NASA Mentor-Protégé Program 1819.7203 Mentor approval process. (a) An entity seeking to participate as a mentor must apply to the NASA Headquarters...

48 CFR 1819.7203 - Mentor approval process.

Code of Federal Regulations, 2011 CFR

2011-10-01

... by NASA OSBP. (f) A template of the mentor application is available at: http://www.osbp.nasa.gov. ... ADMINISTRATION SOCIOECONOMIC PROGRAMS SMALL BUSINESS PROGRAMS NASA Mentor-Protégé Program 1819.7203 Mentor approval process. (a) An entity seeking to participate as a mentor must apply to the NASA Headquarters...

48 CFR 1819.7203 - Mentor approval process.

Code of Federal Regulations, 2010 CFR

2010-10-01

... by NASA OSBP. (f) A template of the mentor application is available at: http://www.osbp.nasa.gov. ... ADMINISTRATION SOCIOECONOMIC PROGRAMS SMALL BUSINESS PROGRAMS NASA Mentor-Protégé Program 1819.7203 Mentor approval process. (a) An entity seeking to participate as a mentor must apply to the NASA Headquarters...

77 FR 13294 - Announcing Approval of Federal Information Processing Standard (FIPS) Publication 180-4, Secure...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-06

... hash algorithms in many computer network applications. On February 11, 2011, NIST published a notice in... Information Security Management Act (FISMA) of 2002 (Pub. L. 107-347), the Secretary of Commerce is authorized to approve Federal Information Processing Standards (FIPS). NIST activities to develop computer...

Overview of U.S. nuclear launch safety approval process, supporting launch vehicle databook and probabilistic risk assessment methods

NASA Technical Reports Server (NTRS)

Reinhart, L. E.

2001-01-01

This paper provides an overview of the U.S. space nuclear power system launch approval process as defined by the two separate requirements of the National Environmental Policy Act (NEPA) and Presidential Directive/National Security Council Memorandum No. 25 (PD/NSC-25).

25 CFR 273.17 - Programs approved by Indian Education Committee.

Code of Federal Regulations, 2011 CFR

2011-04-01

...) Programs developed or approved by the Indian Education Committee pursuant to this part may, at the option... 25 Indians 1 2011-04-01 2011-04-01 false Programs approved by Indian Education Committee. 273.17... EDUCATION ASSISTANCE ACT PROGRAM EDUCATION CONTRACTS UNDER JOHNSON-O'MALLEY ACT Application Process § 273.17...

25 CFR 273.17 - Programs approved by Indian Education Committee.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) Programs developed or approved by the Indian Education Committee pursuant to this part may, at the option... 25 Indians 1 2010-04-01 2010-04-01 false Programs approved by Indian Education Committee. 273.17... EDUCATION ASSISTANCE ACT PROGRAM EDUCATION CONTRACTS UNDER JOHNSON-O'MALLEY ACT Application Process § 273.17...

76 FR 40624 - Approval and Promulgation of Implementation Plans; State of Kansas

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-11

... in the proposal, as supplemented by this notice, as its rationale for the final rule. No public... approved emissions limits with limited public process or without requiring further approval by EPA, that... on proposals for three states in Region 5). EPA notes that these public comments on another proposal...

76 FR 40619 - Approval and Promulgation of Implementation Plans; State of Missouri

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-11

... in the proposal as supplemented by this rule, as its rationale for the final rule. No public comments... approved emissions limits with limited public process or without requiring further approval by EPA, that... for three states in Region 5). EPA notes that these public comments on another proposal are not...

78 FR 11808 - Approval and Promulgation of Implementation Plans; Tennessee: Approve Knox County Supplemental...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-20

... INFORMATION: On December 18, 2012, EPA proposed to approve, through parallel processing, a draft revision to... County to account for changes in the emissions model and vehicle miles traveled projection model. EPA is... submit comments. FOR FURTHER INFORMATION CONTACT: Kelly Sheckler, Air Quality Modeling and Transportation...

78 FR 77686 - Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-24

... and review process. FDA's regulations governing application for Agency approval to market a new drug... Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of... submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of...

Ethics review as a component of institutional approval for a multicentre continuous quality improvement project: the investigator's perspective.

PubMed

Ezzat, Hanna; Ross, Sue; von Dadelszen, Peter; Morris, Tara; Liston, Robert; Magee, Laura A

2010-07-30

For ethical approval of a multicentre study in Canada, investigators must apply separately to individual Research Ethics Boards (REBs). In principle, the protection of human research subjects is of utmost importance. However, in practice, the process of multicentre ethics review can be time consuming and costly, requiring duplication of effort for researchers and REBs. We used our experience with ethical review of The Canadian Perinatal Network (CPN), to gain insight into the Canadian system. The applications forms of 16 different REBs were abstracted for a list of standardized items. The application process across sites was compared. Correspondence between the REB and the investigators was documented in order to construct a timeline to approval, identify the specific issues raised by each board, and describe how they were resolved. Each REB had a different application form. Most (n = 9) had a two or three step application process. Overall, it took a median of 31 days (range 2-174 days) to receive an initial response from the REB. Approval took a median of 42 days (range 4-443 days). Privacy and consent were the two major issues raised. Several additional minor or administrative issues were raised which delayed approval. For CPN, the Canadian REB process of ethical review proved challenging. REBs acted independently and without unified application forms or submission procedures. We call for a critical examination of the ethical, privacy and institutional review processes in Canada, to determine the best way to undertake multicentre review.

[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.

Spatial forecast of landslides in three gorges based on spatial data mining.

PubMed

Wang, Xianmin; Niu, Ruiqing

2009-01-01

The Three Gorges is a region with a very high landslide distribution density and a concentrated population. In Three Gorges there are often landslide disasters, and the potential risk of landslides is tremendous. In this paper, focusing on Three Gorges, which has a complicated landform, spatial forecasting of landslides is studied by establishing 20 forecast factors (spectra, texture, vegetation coverage, water level of reservoir, slope structure, engineering rock group, elevation, slope, aspect, etc). China-Brazil Earth Resources Satellite (Cbers) images were adopted based on C4.5 decision tree to mine spatial forecast landslide criteria in Guojiaba Town (Zhigui County) in Three Gorges and based on this knowledge, perform intelligent spatial landslide forecasts for Guojiaba Town. All landslides lie in the dangerous and unstable regions, so the forecast result is good. The method proposed in the paper is compared with seven other methods: IsoData, K-Means, Mahalanobis Distance, Maximum Likelihood, Minimum Distance, Parallelepiped and Information Content Model. The experimental results show that the method proposed in this paper has a high forecast precision, noticeably higher than that of the other seven methods.

A lake data set for the Tibetan Plateau from the 1960s, 2005, and 2014

PubMed Central

Wan, Wei; Long, Di; Hong, Yang; Ma, Yingzhao; Yuan, Yuan; Xiao, Pengfeng; Duan, Hongtao; Han, Zhongying; Gu, Xingfa

2016-01-01

Long-term datasets of number and size of lakes over the Tibetan Plateau (TP) are among the most critical components for better understanding the interactions among the cryosphere, hydrosphere, and atmosphere at regional and global scales. Due to the harsh environment and the scarcity of data over the TP, data accumulation and sharing become more valuable for scientists worldwide to make new discoveries in this region. This paper, for the first time, presents a comprehensive and freely available data set of lakes’ status (name, location, shape, area, perimeter, etc.) over the TP region dating back to the 1960s, including three time series, i.e., the 1960s, 2005, and 2014, derived from ground survey (the 1960s) or high-spatial-resolution satellite images from the China-Brazil Earth Resources Satellite (CBERS) (2005) and China’s newly launched GaoFen-1 (GF-1, which means high-resolution images in Chinese) satellite (2014). The data set could provide scientists with useful information for revealing environmental changes and mechanisms over the TP region. PMID:27328160

Spatial Forecast of Landslides in Three Gorges Based On Spatial Data Mining

PubMed Central

Wang, Xianmin; Niu, Ruiqing

2009-01-01

The Three Gorges is a region with a very high landslide distribution density and a concentrated population. In Three Gorges there are often landslide disasters, and the potential risk of landslides is tremendous. In this paper, focusing on Three Gorges, which has a complicated landform, spatial forecasting of landslides is studied by establishing 20 forecast factors (spectra, texture, vegetation coverage, water level of reservoir, slope structure, engineering rock group, elevation, slope, aspect, etc). China-Brazil Earth Resources Satellite (Cbers) images were adopted based on C4.5 decision tree to mine spatial forecast landslide criteria in Guojiaba Town (Zhigui County) in Three Gorges and based on this knowledge, perform intelligent spatial landslide forecasts for Guojiaba Town. All landslides lie in the dangerous and unstable regions, so the forecast result is good. The method proposed in the paper is compared with seven other methods: IsoData, K-Means, Mahalanobis Distance, Maximum Likelihood, Minimum Distance, Parallelepiped and Information Content Model. The experimental results show that the method proposed in this paper has a high forecast precision, noticeably higher than that of the other seven methods. PMID:22573999

A lake data set for the Tibetan Plateau from the 1960s, 2005, and 2014.

PubMed

Wan, Wei; Long, Di; Hong, Yang; Ma, Yingzhao; Yuan, Yuan; Xiao, Pengfeng; Duan, Hongtao; Han, Zhongying; Gu, Xingfa

2016-06-21

Long-term datasets of number and size of lakes over the Tibetan Plateau (TP) are among the most critical components for better understanding the interactions among the cryosphere, hydrosphere, and atmosphere at regional and global scales. Due to the harsh environment and the scarcity of data over the TP, data accumulation and sharing become more valuable for scientists worldwide to make new discoveries in this region. This paper, for the first time, presents a comprehensive and freely available data set of lakes' status (name, location, shape, area, perimeter, etc.) over the TP region dating back to the 1960s, including three time series, i.e., the 1960s, 2005, and 2014, derived from ground survey (the 1960s) or high-spatial-resolution satellite images from the China-Brazil Earth Resources Satellite (CBERS) (2005) and China's newly launched GaoFen-1 (GF-1, which means high-resolution images in Chinese) satellite (2014). The data set could provide scientists with useful information for revealing environmental changes and mechanisms over the TP region.

Out of the frying pan? Streamlining the ethics review process of multisite qualitative research projects.

PubMed

Iedema, Rick A M; Allen, Suellen; Britton, Kate; Hor, Suyin

2013-05-01

This paper describes the ethics approval processes for two multicentre, nationwide, qualitative health service research projects. The paper explains that the advent of the National Ethics Application Form has brought many improvements, but that attendant processes put in place at local health network and Human Research Ethics Committee levels may have become significantly more complicated, particularly for innovative qualitative research projects. The paper raises several questions based on its analysis of ethics application processes currently in place. WHAT IS KNOWN ABOUT THE TOPIC? The complexity of multicentre research ethics applications for research in health services has been addressed by the introduction of the National Ethics Application Form. Uptake of the form across the country's human research ethics committees has been uneven. WHAT DOES THIS PAPER ADD? This paper adds detailed insight into the ethics application process as it is currently enacted across the country. The paper details this process with reference to difficulties faced by multisite and qualitative studies in negotiating access to research sites, ethics committees' relative unfamiliarity with qualitative research , and apparent tensions between harmonisation and local sites' autonomy in approving research. WHAT ARE THE IMPLICATIONS FOR PRACTITIONERS? Practitioners aiming to engage in research need to be aware that ethics approval takes place in an uneven procedural landscape, made up of variable levels of ethics approval harmonization and intricate governance or site-specific assessment processes.

Evaluation of sensor, environment and operational factors impacting the use of multiple sensor constellations for long term resource monitoring

NASA Astrophysics Data System (ADS)

Rengarajan, Rajagopalan

Moderate resolution remote sensing data offers the potential to monitor the long and short term trends in the condition of the Earth's resources at finer spatial scales and over longer time periods. While improved calibration (radiometric and geometric), free access (Landsat, Sentinel, CBERS), and higher level products in reflectance units have made it easier for the science community to derive the biophysical parameters from these remotely sensed data, a number of issues still affect the analysis of multi-temporal datasets. These are primarily due to sources that are inherent in the process of imaging from single or multiple sensors. Some of these undesired or uncompensated sources of variation include variation in the view angles, illumination angles, atmospheric effects, and sensor effects such as Relative Spectral Response (RSR) variation between different sensors. The complex interaction of these sources of variation would make their study extremely difficult if not impossible with real data, and therefore, a simulated analysis approach is used in this study. A synthetic forest canopy is produced using the Digital Imaging and Remote Sensing Image Generation (DIRSIG) model and its measured BRDFs are modeled using the RossLi canopy BRDF model. The simulated BRDF matches the real data to within 2% of the reflectance in the red and the NIR spectral bands studied. The BRDF modeling process is extended to model and characterize the defoliation of a forest, which is used in factor sensitivity studies to estimate the effect of each factor for varying environment and sensor conditions. Finally, a factorial experiment is designed to understand the significance of the sources of variation, and regression based analysis are performed to understand the relative importance of the factors. The design of experiment and the sensitivity analysis conclude that the atmospheric attenuation and variations due to the illumination angles are the dominant sources impacting the at-sensor radiance.

48 CFR 819.7108 - Application process.

Code of Federal Regulations, 2010 CFR

2010-10-01

... SOCIOECONOMIC PROGRAMS SMALL BUSINESS PROGRAMS VA Mentor-Protégé Program 819.7108 Application process. (a) Firms interested in becoming approved mentor-protégé participants must submit a joint written VA Mentor-Protégé Agreement to the VA OSDBU for review and approval. The proposed Mentor-Protégé Agreement will be...

75 FR 64248 - Approval for Processing Authority Foreign-Trade Zones 73 and 74; The Belt's Corporation (Kitting...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-19

... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1713] Approval for Processing Authority Foreign-Trade Zones 73 and 74; The Belt's Corporation (Kitting of Liquor Gift Sets), Elkridge and Baltimore, MD Pursuant to its authority under the Foreign-Trade Zones Act of June 18, 1934, as amended (19 U...

Evaluation Processes of Regional and National Education Accrediting Agencies: Implications for Redesigning an Evaluation Process in California.

ERIC Educational Resources Information Center

Bernhardt, Victoria L.

Colleges and universities in California may be accredited or approved by four different agencies to offer approved programs of teacher education: the State Department of Education's Office of Private Postsecondary Education (OPPE) (for private institutions); the Western Association of Schools and Colleges (WASC); the Commission on Teacher…

Cutting the Cost of New Community College Facilities: Streamlining the Facilities Approval Process. Commission on Innovation Policy Discussion Paper Number 3.

ERIC Educational Resources Information Center

BW Associates, Berkeley, CA.

Intended to provide background information and preliminary options for the California Community Colleges' Commission on Innovation, this document proposes that approval processes for new facilities be simplified and that restrictions on the lease or purchase of off-campus facilities be eased. Following introductory materials detailing the…

Free Schools in the Big Society: The Motivations, Aims and Demography of Free School Proposers

ERIC Educational Resources Information Center

Higham, Rob

2014-01-01

Free school policy claims to partly decentralise to local proposers decisions over who provides a free school, where and for what reasons, within the constraints of a government approval process. This article analyses empirically the people and organisations doing the proposing and their interactions with the approval process. The article begins…

Medical Device Regulation: A Comparison of the United States and the European Union.

PubMed

Maak, Travis G; Wylie, James D

2016-08-01

Medical device regulation is a controversial topic in both the United States and the European Union. Many physicians and innovators in the United States cite a restrictive US FDA regulatory process as the reason for earlier and more rapid clinical advances in Europe. The FDA approval process mandates that a device be proved efficacious compared with a control or be substantially equivalent to a predicate device, whereas the European Union approval process mandates that the device perform its intended function. Stringent, peer-reviewed safety data have not been reported. However, after recent high-profile device failures, political pressure in both the United States and the European Union has favored more restrictive approval processes. Substantial reforms of the European Union process within the next 5 to 10 years will result in a more stringent approach to device regulation, similar to that of the FDA. Changes in the FDA regulatory process have been suggested but are not imminent.

49 CFR 611.7 - Relation to planning and project development processes.

Code of Federal Regulations, 2010 CFR

2010-10-01

...) Preliminary Engineering. Consistent with 49 USC 5309(e)(6) and 5328(a)(2), FTA will approve/disapprove entry... rating of “recommended” to be approved for entry into preliminary engineering. (4) This part does not in... 5328(a)(3), FTA will approve/disapprove entry of a proposed project into final design within 120 days...

49 CFR 272.103 - Submission of critical incident stress plan for approval by the Federal Railroad Administration.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 4 2014-10-01 2014-10-01 false Submission of critical incident stress plan for... CRITICAL INCIDENT STRESS PLANS Plan Components and Approval Process § 272.103 Submission of critical incident stress plan for approval by the Federal Railroad Administration. (a) Each railroad subject to this...

36 CFR 223.203 - Indirect substitution exception for National Forest System timber from within Washington State.

Code of Federal Regulations, 2010 CFR

2010-07-01

... unprocessed timber was limited to whichever is less: (i) The higher of the applicant's actual purchase.... (b) Application, review and approval process. To obtain a share of the 50 million board feet exempted.... Applicants were notified of the approving official's decision by letter. If approved, the amount of the...

REF Onida Approval

EPA Pesticide Factsheets

This update August 9, 2016 letter from EPA approves, with modifications, the petition from Ring-neck Energy & Feed, LLC, REF Onida facility, with modifications, regarding non-grandfathered ethanol produced through a dry mill process

Industry funding of the FDA: effects of PDUFA on approval times and withdrawal rates.

PubMed

Berndt, Ernst R; Gottschalk, Adrian H B; Philipson, Tomas J; Strobeck, Matthew W

2005-07-01

The development of new therapies is a crucial component of efforts to improve healthcare. Because drug development and FDA regulatory review have historically been lengthy and costly processes, the US Congress passed a series of legislative acts, beginning in 1992, known collectively as the Prescription Drug User Fee Acts (PDUFA), which sought to expedite the FDA drug-review process. Here, we review data on drug approvals and drug-approval times, both as a whole and by therapeutic class, which demonstrate that implementation of the PDUFAs led to substantial incremental reductions in approval times beyond what would have been observed in the absence of these legislative acts. In addition, our preliminary examination of the trends in the number of new molecular entity withdrawals, frequently used as a proxy to assess the FDA's safety record, suggests that the proportion of approvals ultimately leading to safety withdrawals prior to PDUFA and during PDUFA I and II were not statistically different.

RAT Requisition Approval Team - A L6S Initiative

NASA Technical Reports Server (NTRS)

Hall, Valerie

2004-01-01

L6S Project Description - Problem: The current cycle time for generating and approving Requisitions does not meet "Best-In-Class." . Scope: Only looking at the Florida Requisition Approval process for Orbiter (ORBF & ORBG) and Ground (GFAC) stocked items. This includes the time from when a requirement is generated by Logistics Planning and Supportability in Florida until it is approved and received by Procurement. Requisitions generated at other sites or for non stocked items will be out of scope of this Project

A planning support system to optimize approval of private housing development projects

NASA Astrophysics Data System (ADS)

Hussnain, M. Q.; Wakil, K.; Waheed, A.; Tahir, A.

2016-06-01

Out of 182 million population of Pakistan, 38% reside in urban areas having an average growth rate of 1.6%, raising the urban housing demand significantly. Poor state response to fulfil the housing needs has resulted in a mushroom growth of private housing schemes (PHS) over the years. Consequently, only in five major cities of Punjab, there are 383 legal and 150 illegal private housing development projects against 120 public sector housing schemes. A major factor behind the cancerous growth of unapproved PHS is the prolonged and delayed approval process in concerned approval authorities requiring 13 months on average. Currently, manual and paper-based approaches are used for vetting and for granting the permission which is highly subjective and non-transparent. This study aims to design a flexible planning support system (PSS) to optimize the vetting process of PHS projects under any development authority in Pakistan by reducing time and cost required for site and documents investigations. Relying on the review of regulatory documents and interviews with professional planners and land developers, this study describes the structure of a PSS developed using open- source geo-spatial tools such as OpenGeo Suite, PHP, and PostgreSQL. It highlights the development of a Knowledge Module (based on regulatory documents) containing equations related to scheme type, size (area), location, access road, components of layout plan, planning standards and other related approval checks. Furthermore, it presents the architecture of the database module and system data requirements categorized as base datasets (built-in part of PSS) and input datasets (related to the housing project under approval). It is practically demonstrated that developing a customized PSS to optimize PHS approval process in Pakistan is achievable with geospatial technology. With the provision of such a system, the approval process for private housing schemes not only becomes quicker and user-friendly but also transparent.

7 CFR 1775.19 - Grant cancellation or major changes.

Code of Federal Regulations, 2010 CFR

2010-01-01

..., DEPARTMENT OF AGRICULTURE (CONTINUED) TECHNICAL ASSISTANCE GRANTS Grant Application Processing § 1775.19... and approved by the approval official by written amendment to RUS Guide 1775-1. Any change not...

Ethics review as a component of institutional approval for a multicentre continuous quality improvement project: the investigator's perspective

PubMed Central

2010-01-01

Background For ethical approval of a multicentre study in Canada, investigators must apply separately to individual Research Ethics Boards (REBs). In principle, the protection of human research subjects is of utmost importance. However, in practice, the process of multicentre ethics review can be time consuming and costly, requiring duplication of effort for researchers and REBs. We used our experience with ethical review of The Canadian Perinatal Network (CPN), to gain insight into the Canadian system. Methods The applications forms of 16 different REBs were abstracted for a list of standardized items. The application process across sites was compared. Correspondence between the REB and the investigators was documented in order to construct a timeline to approval, identify the specific issues raised by each board, and describe how they were resolved. Results Each REB had a different application form. Most (n = 9) had a two or three step application process. Overall, it took a median of 31 days (range 2-174 days) to receive an initial response from the REB. Approval took a median of 42 days (range 4-443 days). Privacy and consent were the two major issues raised. Several additional minor or administrative issues were raised which delayed approval. Conclusions For CPN, the Canadian REB process of ethical review proved challenging. REBs acted independently and without unified application forms or submission procedures. We call for a critical examination of the ethical, privacy and institutional review processes in Canada, to determine the best way to undertake multicentre review. PMID:20673343

Streamlining the Capstone Process: A Time-Saving Approval System for Graduate Theses/Projects

ERIC Educational Resources Information Center

Grooms, James; Kline, Douglas; Cummings, Jeffrey

2016-01-01

Capstones have become an integral part of many information systems programs, both at the undergraduate and graduate level. One of the challenges can be tracking the process from the start of the capstone to completion. This paper describes the analysis, design and implementation of a web application for the approval workflow of a master's program…

In-Network Processing on Low-Cost IOT Nodes for Maritime Surveillance

DTIC Science & Technology

2017-03-01

NAVAL POSTGRADUATE SCHOOL MONTEREY, CALIFORNIA THESIS Approved for public release. Distribution is unlimited. IN-NETWORK...PROCESSING ON LOW- COST IOT NODES FOR MARITIME SURVEILLANCE by Andrew R. Belding March 2017 Thesis Advisor: Gurminder Singh Co-Advisor: John H...Gibson THIS PAGE INTENTIONALLY LEFT BLANK i REPORT DOCUMENTATION PAGE Form Approved OMB No. 0704-0188 Public reporting burden for this

Spatial Data from Transportation Studies and Surveys | Transportation

Science.gov Websites

transportation studies and surveys, submit an application for approval to connect to a restricted secure portal environment. For a list of studies and surveys, see cleansed data. Application Process For accessing spatial data, learn about the application and approval process. If you'd like to apply to access the spatial

Poet North Manchester Approval

EPA Pesticide Factsheets

This update August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-North Manchester, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable

Poet Marion Approval

EPA Pesticide Factsheets

This update August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-North Manchester, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable

Poet Portland Approval

EPA Pesticide Factsheets

This update August 9, 2016 letter from EPA approves the petition, with modifications, from Poet Biorefining-Portland, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel

Poet Laddonia Approval

EPA Pesticide Factsheets

This update Auugust 9, 2016 letter from EPA approves with modifications, the petition from Poet Biorefining Laddonia, Poet Laddonia Facility, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act f

Poet Alexandria Approval

EPA Pesticide Factsheets

This update August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-Alexandria, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel

[The legal question of the obtention of human stem cells for biomedical research. Legislation policy considerations].

PubMed

Romeo Casabona, Carlos María

2006-01-01

The future Law on Biomedical Research, whose draft bill has been approved by the Council of Ministers and that will soon begin its parliamentary process of approval, will regulate, among other matters, the research with embryos. Likewise, it will make a pronouncement on the so-called therapeutic cloning. This report makes a detailed analysis of different matters that must be borne in mind by the legislator in order to face the process of evaluation and approval of said Law in relation with the aforementioned matters. It makes a special analysis of the legal texts of an international nature to which Spain is unavoidably subjected to, in such a way that the legislative text that will finally be approved is not contrary to the dispositions that are within such.

New orthopedic devices and the FDA.

PubMed

Sheth, Ujash; Nguyen, Nhu-An; Gaines, Sean; Bhandari, Mohit; Mehlman, Charles T; Klein, Guy

2009-01-01

Each year the field of orthopedics is introduced to an influx of new medical devices. Each of these medical devices has faced certain hurdles prior to being approved for marketing by the U.S. Food and Drug Administration (FDA). Among the regulatory pathways available, the 510(k) premarket notification is by far the one most commonly used. The 510(k) premarket notification allows the manufacturer to receive prompt approval of their device by demonstrating that it is "substantially equivalent" to an existing legally marketed device. In most instances, this proof of substantial equivalence allows manufacturers of medical devices to bypass the use of clinical trials, which are a hallmark of the approval process for new drugs. As a result, most medical devices are approved without demonstrating safety or effectiveness. This article reviews the regulatory processes used by the FDA to evaluate new orthopedic devices.

FDA, CE mark or something else?-Thinking fast and slow.

PubMed

Mishra, Sundeep

There is a robust debate going on among the Medical Device stake-holders whether FDA is better or CE mark or something else. Currently process of obtaining an FDA approval is bogged down by ever-increasing unpredictability, inconsistency, prolonged time, and huge expense but CE mark has its own problems. Historically, the Japanese review process has tended to be the slowest among the big three but recently with the introduction of accelerated review process there has been a significant progress. While the goal of an innovator/manufacturer is to develop, manufacture and market a medical device that addresses an unmet clinical need, the requisite regulatory approval process can be very confusing. Not only there is a whole lot of jargon tossed around by regulatory affair professionals: "substantial equivalence," "PMDA," "CE mark," "Notified body," "510K" and "PMA" but the actual approval process can also be very tardy, inconsistent and expensive. Copyright © 2016 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

Development trends for new cancer therapeutics and vaccines.

PubMed

Reichert, Janice M; Wenger, Julia B

2008-01-01

Global commercial development of cancer treatments has dramatically increased over the past 15 years. To assess trends in the process, we analyzed data for 1111 candidates that entered clinical study during 1990-2006. Our results show that although the average number of therapeutic candidates entering clinical study per year more than doubled, the US approval success rate was low (8%) during the period. The therapeutics took seven years on average to go through the clinical and US approval phases, but cancer vaccines have yet to gain any US approvals. These results indicate that improvement in the efficiency of the development process for innovative cancer treatments is needed.

Poet Fostoria Approval

EPA Pesticide Factsheets

This August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-Fostoria, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6)

Poet Leipsic Approval

EPA Pesticide Factsheets

This August 9, 2016 letter from EPA approves,wtih modifications, the petition from Poet Biorefining-Leipsic, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs

Kansas Ethanol Lyons Approval

EPA Pesticide Factsheets

This update August 9, 2016 letter from EPA approves, with modifications, the petition from Kansas Ethanol, LLC, Lyons facility, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel

Joule Unlimited Technologies Approval

EPA Pesticide Factsheets

This March 29 letter from EPA approves the petition from Joule Unlimited Technologies, Inc. regarding ethanol produced through the Joule Helioculture Process under the Clean Air Act for renewable fuel [D-code 5] RINs under the RFS program.

9 CFR 590.540 - Spray process drying facilities.

Code of Federal Regulations, 2010 CFR

2010-01-01

... equipped with approved air intake filters. (d) Air shall be drawn into the drier from sources free from..., if used, shall be equipped with approved air filters at blower intake. (f) High-pressure pump heads...

9 CFR 590.540 - Spray process drying facilities.

Code of Federal Regulations, 2011 CFR

2011-01-01

... equipped with approved air intake filters. (d) Air shall be drawn into the drier from sources free from..., if used, shall be equipped with approved air filters at blower intake. (f) High-pressure pump heads...

25 CFR 162.580 - What is the approval process for a sublease of a WSR lease?

Code of Federal Regulations, 2013 CFR

2013-04-01

... 25 Indians 1 2013-04-01 2013-04-01 false What is the approval process for a sublease of a WSR lease? 162.580 Section 162.580 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR LAND AND WATER LEASES AND PERMITS Wind and Solar Resource Leases Wsr Lease Subleases § 162.580 What is the...

25 CFR 162.572 - What is the approval process for an amendment to a WSR lease?

Code of Federal Regulations, 2014 CFR

2014-04-01

... 25 Indians 1 2014-04-01 2014-04-01 false What is the approval process for an amendment to a WSR lease? 162.572 Section 162.572 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR LAND AND WATER LEASES AND PERMITS Wind and Solar Resource Leases Wsr Lease Amendments § 162.572 What is the...

25 CFR 162.576 - What is the approval process for an assignment of a WSR lease?

Code of Federal Regulations, 2014 CFR

2014-04-01

... 25 Indians 1 2014-04-01 2014-04-01 false What is the approval process for an assignment of a WSR lease? 162.576 Section 162.576 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR LAND AND WATER LEASES AND PERMITS Wind and Solar Resource Leases Wsr Lease Assignments § 162.576 What is the...

25 CFR 162.576 - What is the approval process for an assignment of a WSR lease?

Code of Federal Regulations, 2013 CFR

2013-04-01

... 25 Indians 1 2013-04-01 2013-04-01 false What is the approval process for an assignment of a WSR lease? 162.576 Section 162.576 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR LAND AND WATER LEASES AND PERMITS Wind and Solar Resource Leases Wsr Lease Assignments § 162.576 What is the...

25 CFR 162.572 - What is the approval process for an amendment to a WSR lease?

Code of Federal Regulations, 2013 CFR

2013-04-01

... 25 Indians 1 2013-04-01 2013-04-01 false What is the approval process for an amendment to a WSR lease? 162.572 Section 162.572 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR LAND AND WATER LEASES AND PERMITS Wind and Solar Resource Leases Wsr Lease Amendments § 162.572 What is the...

25 CFR 162.584 - What is the approval process for a leasehold mortgage of a WSR lease?

Code of Federal Regulations, 2013 CFR

2013-04-01

... 25 Indians 1 2013-04-01 2013-04-01 false What is the approval process for a leasehold mortgage of a WSR lease? 162.584 Section 162.584 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR LAND AND WATER LEASES AND PERMITS Wind and Solar Resource Leases Wsr Leasehold Mortgages § 162.584 What...

25 CFR 162.584 - What is the approval process for a leasehold mortgage of a WSR lease?

Code of Federal Regulations, 2014 CFR

2014-04-01

... 25 Indians 1 2014-04-01 2014-04-01 false What is the approval process for a leasehold mortgage of a WSR lease? 162.584 Section 162.584 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR LAND AND WATER LEASES AND PERMITS Wind and Solar Resource Leases Wsr Leasehold Mortgages § 162.584 What...

25 CFR 162.580 - What is the approval process for a sublease of a WSR lease?

Code of Federal Regulations, 2014 CFR

2014-04-01

... 25 Indians 1 2014-04-01 2014-04-01 false What is the approval process for a sublease of a WSR lease? 162.580 Section 162.580 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR LAND AND WATER LEASES AND PERMITS Wind and Solar Resource Leases Wsr Lease Subleases § 162.580 What is the...

RECENT DEVELOPMENTS IN HYDROWEB DATABASE Water level time series on lakes and reservoirs (Invited)

NASA Astrophysics Data System (ADS)

Cretaux, J.; Arsen, A.; Calmant, S.

2013-12-01

We present the current state of the Hydroweb database as well as developments in progress. It provides offline water level time series on rivers, reservoirs and lakes based on altimetry data from several satellites (Topex/Poseidon, ERS, Jason-1&2, GFO and ENVISAT). The major developments in Hydroweb concerns the development of an operational data centre with automatic acquisition and processing of IGDR data for updating time series in near real time (both for lakes & rivers) and also use of additional remote sensing data, like satellite imagery allowing the calculation of lake's surfaces. A lake data centre is under development at the Legos in coordination with Hydrolare Project leaded by SHI (State Hydrological Institute of the Russian Academy of Science). It will provide the level-surface-volume variations of about 230 lakes and reservoirs, calculated through combination of various satellite images (Modis, Asar, Landsat, Cbers) and radar altimetry (Topex / Poseidon, Jason-1 & 2, GFO, Envisat, ERS2, AltiKa). The final objective is to propose a data centre fully based on remote sensing technique and controlled by in situ infrastructure for the Global Terrestrial Network for Lakes (GTN-L) under the supervision of WMO and GCOS. In a longer perspective, the Hydroweb database will integrate data from future missions (Jason-3, Jason-CS, Sentinel-3A/B) and finally will serve for the design of the SWOT mission. The products of hydroweb will be used as input data for simulation of the SWOT products (water height and surface variations of lakes and rivers). In the future, the SWOT mission will allow to monitor on a sub-monthly basis the worldwide lakes and reservoirs bigger than 250 * 250 m and Hydroweb will host water level and extent products from this

HEPA Filter Disposal Write-Up 10/19/16

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

Loll, C.

Process knowledge (PK) collection on HEPA filters is handled via the same process as other waste streams at LLNL. The Field technician or Characterization point of contact creates an information gathering document (IGD) in the IGD database, with input provided from the generator, and submits it for electronic approval. This document is essentially a waste generation profile, detailing the physical, chemical as well as radiological characteristics, and hazards, of a waste stream. It will typically contain a general, but sometimes detailed, description of the work processes which generated the waste. It will contain PK as well as radiological and industrialmore » hygiene analytical swipe results, and any other analytical or other supporting knowledge related to characterization. The IGD goes through an electronic approval process to formalize the characterization and to ensure the waste has an appropriate disposal path. The waste generator is responsible for providing initial process knowledge information, and approves the IGD before it routed to chemical and radiological waste characterization professionals. This is the standard characterization process for LLNL-generated HEPA Filters.« less

9 CFR 590.546 - Albumen flake process drying facilities.

Code of Federal Regulations, 2011 CFR

2011-01-01

... be equipped with approved intake filters. (b) The intake air source shall be free from foul odors, dust, and dirt. (c) Premix-type burners, if used, shall be equipped with approved air filters at blower...

9 CFR 590.546 - Albumen flake process drying facilities.

Code of Federal Regulations, 2010 CFR

2010-01-01

... be equipped with approved intake filters. (b) The intake air source shall be free from foul odors, dust, and dirt. (c) Premix-type burners, if used, shall be equipped with approved air filters at blower...

7 CFR 58.736 - Pasteurized process cheese.

Code of Federal Regulations, 2012 CFR

2012-01-01

..., GENERAL SPECIFICATIONS FOR APPROVED PLANTS AND STANDARDS FOR GRADES OF DAIRY PRODUCTS 1 General Specifications for Dairy Plants Approved for USDA Inspection and Grading Service 1 Quality Specifications for..., and be completely sealed and not broken or soiled. ...

7 CFR 58.736 - Pasteurized process cheese.

Code of Federal Regulations, 2013 CFR

2013-01-01

..., GENERAL SPECIFICATIONS FOR APPROVED PLANTS AND STANDARDS FOR GRADES OF DAIRY PRODUCTS 1 General Specifications for Dairy Plants Approved for USDA Inspection and Grading Service 1 Quality Specifications for..., and be completely sealed and not broken or soiled. ...

7 CFR 58.736 - Pasteurized process cheese.

Code of Federal Regulations, 2014 CFR

2014-01-01

..., GENERAL SPECIFICATIONS FOR APPROVED PLANTS AND STANDARDS FOR GRADES OF DAIRY PRODUCTS 1 General Specifications for Dairy Plants Approved for USDA Inspection and Grading Service 1 Quality Specifications for..., and be completely sealed and not broken or soiled. ...

14 CFR 121.405 - Training program and revision: Initial and final approval.

Code of Federal Regulations, 2014 CFR

2014-01-01

... aids, devices, methods, and procedures listed in the certificate holder's curriculum as set forth in § 121.403 that increase the quality and effectiveness of the teaching-learning process. If approval of...

14 CFR 121.405 - Training program and revision: Initial and final approval.

Code of Federal Regulations, 2011 CFR

2011-01-01

... aids, devices, methods, and procedures listed in the certificate holder's curriculum as set forth in § 121.403 that increase the quality and effectiveness of the teaching-learning process. If approval of...

14 CFR 121.405 - Training program and revision: Initial and final approval.

Code of Federal Regulations, 2010 CFR

2010-01-01

... aids, devices, methods, and procedures listed in the certificate holder's curriculum as set forth in § 121.403 that increase the quality and effectiveness of the teaching-learning process. If approval of...

14 CFR 121.405 - Training program and revision: Initial and final approval.

Code of Federal Regulations, 2013 CFR

2013-01-01

... aids, devices, methods, and procedures listed in the certificate holder's curriculum as set forth in § 121.403 that increase the quality and effectiveness of the teaching-learning process. If approval of...

Didion Cambria Approval

EPA Pesticide Factsheets

This May 9, 2016 letter from EPA approves the petition from Didion Ethanol, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs under the RFS program.

Poet Lake Crystal Approval

EPA Pesticide Factsheets

This September 19, 2016 letter from EPA approves the petition from Poet Biorefining-Lake Crystal, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs under the RFS

14 CFR 21.301 - Applicability.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT CERTIFICATION PROCEDURES FOR PRODUCTS AND PARTS Approval of Materials, Parts, Processes, and Appliances § 21.301 Applicability. This subpart prescribes procedural requirements for the approval of certain materials, parts...

14 CFR 21.301 - Applicability.

Code of Federal Regulations, 2011 CFR

2011-01-01

... Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT CERTIFICATION PROCEDURES FOR PRODUCTS AND PARTS Approval of Materials, Parts, Processes, and Appliances § 21.301 Applicability. This subpart prescribes procedural requirements for the approval of certain materials, parts...

The Use of Model-Driven Methodologies and Processes in Aegis Development

DTIC Science & Technology

2011-05-17

Jamie.Durbin@lmco.com Christopher.M.Thompson@lmco.com May 17, 2011 Distribution Statement A: Approved for Public Release. Distribution is unlimited...Report Documentation Page Form ApprovedOMB No. 0704-0188 Public reporting burden for the collection of information is estimated to average 1 hour per...AVAILABILITY STATEMENT Approved for public release; distribution unlimited 13. SUPPLEMENTARY NOTES Presented at the 23rd Systems and Software

Negotiating the Nation in History: the Swedish State Approval Scheme for Textbooks and Teaching Aids from 1945 to 1983

ERIC Educational Resources Information Center

Elmersjö, Henrik Åström

2016-01-01

This article explores the discussions concerning history textbooks that occurred within the Swedish State Approval Scheme for Textbooks (Statens läroboksnämnd) from 1945 to 1983. By focusing on the negotiation of nationhood and the process of textbook approval as an arena for the renegotiation of ways in which history was taught in schools, the…

Enhancing stewardship of community-engaged research through governance.

PubMed

Oetzel, John G; Villegas, Malia; Zenone, Heather; White Hat, Emily R; Wallerstein, Nina; Duran, Bonnie

2015-06-01

We explored the relationship of community-engaged research final approval type (tribal government, health board, or public health office (TG/HB); agency staff or advisory board; or individual or no community approval) with governance processes, productivity, and perceived outcomes. We identified 294 federally funded community-engaged research projects in 2009 from the National Institutes of Health's Research Portfolio Online Reporting Tools, Centers for Disease Control and Prevention's Prevention Research Centers, and Native American Research Centers for Health databases. Two hundred (68.0%) investigators completed a survey about governance processes and productivity measures; 312 partners (77.2% of 404 invited) and 138 investigators (69.0% of 200 invited) completed a survey about perceived outcomes. Projects with TG/HB approval had increased likelihood of community control of resources (odds ratios [ORs] ≥ 4.80). Projects with other approvals had decreased likelihood of development or revision of institutional review board policies (ORs ≤ 0.37), having written agreements (ORs ≤ 0.17), and agreements about publishing (ORs ≤ 0.28), data use (ORs ≤ 0.17), and publishing approval (ORs ≤ 0.14). Community-engaged research projects with TG/HB approval had strong stewardship of project resources and agreements. Governance as stewardship protects community interests; thus, is an ethical imperative for communities, especially native communities, to adopt.

Ethics and privacy issues of a practice-based surveillance system: need for a national-level institutional research ethics board and consent standards.

PubMed

Kotecha, Jyoti A; Manca, Donna; Lambert-Lanning, Anita; Keshavjee, Karim; Drummond, Neil; Godwin, Marshall; Greiver, Michelle; Putnam, Wayne; Lussier, Marie-Thérèse; Birtwhistle, Richard

2011-10-01

To describe the challenges the Canadian Primary Care Sentinel Surveillance Network (CPCSSN) experienced with institutional research ethics boards (IREBs) when seeking approvals across jurisdictions and to provide recommendations for overcoming challenges of ethical review for multisite and multijurisdictional surveillance and research. The CPCSSN project collects and validates longitudinal primary care health information (relating to hypertension, diabetes, depression, chronic obstructive lung disease, and osteoarthritis) from electronic medical records across Canada. Privacy and data storage security policies and processes have been developed to protect participants' privacy and confidentiality, and IREB approval is obtained in each participating jurisdiction. Inconsistent interpretation and application of privacy and ethical issues by IREBs delays and impedes research programs that could better inform us about chronic disease. The CPCSSN project's experience with gaining approval from IREBs highlights the difficulty of conducting pan-Canadian health surveillance and multicentre research. Inconsistent IREB approvals to waive explicit individual informed consent produced particular challenges for researchers. The CPCSSN experience highlights the need to develop a better process for researchers to obtain timely and consistent IREB approvals for multicentre surveillance and research. We suggest developing a specialized, national, centralized IREB responsible for approving multisite studies related to population health research.

Montana Advanced Biofuels Great Falls Approval

EPA Pesticide Factsheets

This November 20, 2015 letter from EPA approves the petition from Montana Advanced Biofuels, LLC, Great Falls facility, regarding ethanol produced through a dry mill process, qualifying under the Clean Air Act for advanced biofuel (D-code 5) and renewable

14 CFR 121.405 - Training program and revision: Initial and final approval.

Code of Federal Regulations, 2012 CFR

2012-01-01

... § 121.403 that increase the quality and effectiveness of the teaching-learning process. If approval of... transportation, he may, upon a statement of the reasons, require a change effective without stay. (f) Each...

75 FR 60341 - Licenses, Certifications, and Approvals for Material Licensees; Reopening of Comment Period

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-30

... approval processes for byproduct, source and special nuclear material licenses, and irradiators to clarify... proposed rule, which closed on September 27, 2010, is reopened and will remain open until November 29, 2010...

77 FR 33363 - Approval and Promulgation of Implementation Plans; Kentucky; Approval of Revisions to the...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-06

... facilities that produce ethanol through a natural fermentation process from the definition of ``chemical..., modeling and attainment demonstrations, NSR, and the impact to reformulated gas for the 1997 8- hour ozone...

CORN, LP Goldfield Approval

EPA Pesticide Factsheets

This November 19, 2015 letter from EPA approves the petition from CORN, LP, Goldfield facility, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs under the RFS pro

Monsanto may bypass NIH in microbe test.

PubMed

Sun, Marjorie

1985-01-11

The Monsanto Company is planning to ask the Environmental Protection Agency for clearance to field test a genetically engineered microbial pesticide, bypassing the traditional approval process of the National Institutes of Health. Although only federally funded institutions are required to obtain NIH approval for genetic engineering tests, Monsanto is the first company to bypass the NIH regulatory process, which has become mired in a lawsuit brought by Jeremy Rifkin.

Why should ethics approval be required prior to publication of health promotion research?

PubMed

Newson, Ainsley J; Lipworth, Wendy

2015-12-01

Most academic journals that publish studies involving human participants require evidence that the research has been approved by a human research ethics committee (HREC). Yet journals continue to receive submissions from authors who have failed to obtain such approval. In this paper, we provide an ethical justification of why journals should not, in general, publish articles describing research that has no ethics approval, with particular attention to the health promotion context. Using theoretical bioethical reasoning and drawing on a case study, we first rebut some potential criticisms of the need for research ethics approval. We then outline four positive claims to justify a presumption that research should, in most instances, be published only if it has been undertaken with HREC approval. We present four justifications for requiring ethics approval before publication: (1) HREC approval adds legitimacy to the research; (2) the process of obtaining HREC approval can improve the quality of an intervention being investigated; (3) obtaining HREC approval can help mitigate harm; and (4) obtaining HREC approval demonstrates respect for persons. This paper provides a systematic and comprehensive assessment of why research ethics approval should generally be obtained before publishing in the health promotion context. So what? Journals such as the Health Promotion Journal of Australia have recently begun to require research ethics approval for publishing research. Health promotion researchers will be interested in learning the ethical justification for this change.

Development of pediatric vaccine recommendations and policies.

PubMed

Pickering, Larry K; Orenstein, Walter A

2002-07-01

A significant decrease in each vaccine-preventable disease has occurred since the introduction of the respective immunizations now included in the recommended childhood immunization schedule. The process through which a vaccine must travel from development to approval and implementation is complex. Hurdles include receiving approval from several advisory committees, government agencies, and professional organizations. At each step in the process, data regarding safety, immunogenicity, and efficacy are evaluated continuously and rigorously. Once a vaccine is approved by the Food and Drug Administration (FDA) and incorporated into the recommended childhood immunization schedule, continuing issues include those that deal with supply, safety, effectiveness, and financing. The logistics of development and implementation of pediatric vaccine recommendations and policies are reviewed.

Translation of proteomic biomarkers into FDA approved cancer diagnostics: issues and challenges

PubMed Central

2013-01-01

Tremendous efforts have been made over the past few decades to discover novel cancer biomarkers for use in clinical practice. However, a striking discrepancy exists between the effort directed toward biomarker discovery and the number of markers that make it into clinical practice. One of the confounding issues in translating a novel discovery into clinical practice is that quite often the scientists working on biomarker discovery have limited knowledge of the analytical, diagnostic, and regulatory requirements for a clinical assay. This review provides an introduction to such considerations with the aim of generating more extensive discussion for study design, assay performance, and regulatory approval in the process of translating new proteomic biomarkers from discovery into cancer diagnostics. We first describe the analytical requirements for a robust clinical biomarker assay, including concepts of precision, trueness, specificity and analytical interference, and carryover. We next introduce the clinical considerations of diagnostic accuracy, receiver operating characteristic analysis, positive and negative predictive values, and clinical utility. We finish the review by describing components of the FDA approval process for protein-based biomarkers, including classification of biomarker assays as medical devices, analytical and clinical performance requirements, and the approval process workflow. While we recognize that the road from biomarker discovery, validation, and regulatory approval to the translation into the clinical setting could be long and difficult, the reward for patients, clinicians and scientists could be rather significant. PMID:24088261

Introduction of Biosimilar Therapeutics Into Nephrology Practice in the United States: Report of a Scientific Workshop Sponsored by the National Kidney Foundation.

PubMed

Wish, Jay B; Charytan, Chaim; Chertow, Glenn M; Kalantar-Zadeh, Kamyar; Kliger, Alan S; Rubin, Robert J; Yee, Jerry; Fishbane, Steven

2016-12-01

Biosimilars are biologic medicines highly similar to the reference product with no meaningful clinical differences in terms of safety, purity, and potency. All biologic medicines are produced by living cells, resulting in an inherent heterogeneity in their higher order structures and post-translational modifications. In 2010, the US Congress enacted legislation to streamline the approval process for biosimilars of products losing patent protection, with the goal of decreasing costs and improving patient access to therapeutically important but expensive biologic agents. In 2015, the US Food and Drug Administration approved the first biosimilar agent through this pathway. Approval of additional biosimilar agents in the United States, including those used by nephrologists, is anticipated. Given the relative lack of knowledge regarding biosimilars and their approval process and a lack of trust by the nephrology community regarding their safety and efficacy, the National Kidney Foundation conducted a symposium, Introduction of Biosimilar Therapeutics Into Nephrology Practice in the U.S., September 17 to 18, 2015. Issues related to manufacturing, the regulatory approval process, interchangeability, substitution/switching, nomenclature, and clinician and patient awareness and acceptance were examined. This report summarizes the main discussions at the symposium, highlights several controversies, and makes recommendations related to public policy, professional and patient education, and research needs. Copyright © 2016 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

An Unfulfilled Promise: Changes Needed to the Drug Approval Process to Make Personalized Medicine a Reality.

PubMed

Riley, Margaret Foster

2015-01-01

The widespread availability of drugs for personalized medicine has been an aspiration since before the human genome was sequenced. Recently, there is renewed interest; personalized medicine is much in the news. Legislation has been considered with the goal of smoothing, shortening and incentivizing the approval process for therapeutic products. President Obama mentioned the need for new initiatives to achieve such goals in the State of the Union address. But most of these initiatives do not consider the fundamental changes that personalized medicine demands. It requires a statutory structure designed for the development of products applicable for small subpopulations that is very different from our current model which is designed for the development of products for large populations. The current approval process is purposely not designed to consider individual efficacy. It is designed to incentivize reduced variation in clinical trials rather than embracing variation. In addition, it is based on twentieth-century notions of disease focused on phenotype rather than on pathophysiologic pathways. Current foci on the development of companion diagnostics, orphan drugs and post-approval study are important but insufficient. FDA does not have the authority to require the type of standardization, clinical trial design and extensive data reporting and sharing that. is needed to achieve the goals for personalized medicine. In addition, FDA's current drug approval process is too lengthy and cumbersome to deal with the iterative responses personalized medicine entails. If we are serious about wanting to achieve these goals, we will need to entertain such fundamental changes in authority.

TA-55 change control manual

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

Blum, T.W.; Selvage, R.D.; Courtney, K.H.

This manual is the guide for initiating change at the Plutonium Facility, which handles the processing of plutonium as well as research on plutonium metallurgy. It describes the change and work control processes employed at TA-55 to ensure that all proposed changes are properly identified, reviewed, approved, implemented, tested, and documented so that operations are maintained within the approved safety envelope. All Laboratory groups, their contractors, and subcontractors doing work at TA-55 follow requirements set forth herein. This manual applies to all new and modified processes and experiments inside the TA-55 Plutonium Facility; general plant project (GPP) and line itemmore » funded construction projects at TA-55; temporary and permanent changes that directly or indirectly affect structures, systems, or components (SSCs) as described in the safety analysis, including Facility Control System (FCS) software; and major modifications to procedures. This manual does not apply to maintenance performed on process equipment or facility SSCs or the replacement of SSCs or equipment with documented approved equivalents.« less

78 FR 39704 - Agency Information Collection Activities: Revision of Approved Information Collection; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-02

... use of automated data processing (ADP) and information retrieval systems to administer SNAP. Section... DEPARTMENT OF AGRICULTURE Food and Nutrition Service Agency Information Collection Activities: Revision of Approved Information Collection; Comment Request--Supplemental Nutrition Assistance Program...

14 CFR 1214.304 - Process.

Code of Federal Regulations, 2010 CFR

2010-01-01

... conducted at the Johnson Space Center by certified examiners approved by the Director, Life Sciences... examination will be conducted at Johnson Space Center by certified examiners approved by the Director, Life Sciences Division, NASA Headquarters). (iv) Submitting its recommendations for payload specialists through...

14 CFR § 1214.304 - Process.

Code of Federal Regulations, 2014 CFR

2014-01-01

... conducted at the Johnson Space Center by certified examiners approved by the Director, Life Sciences... examination will be conducted at Johnson Space Center by certified examiners approved by the Director, Life Sciences Division, NASA Headquarters). (iv) Submitting its recommendations for payload specialists through...

14 CFR 1214.304 - Process.

Code of Federal Regulations, 2013 CFR

2013-01-01

... conducted at the Johnson Space Center by certified examiners approved by the Director, Life Sciences... examination will be conducted at Johnson Space Center by certified examiners approved by the Director, Life Sciences Division, NASA Headquarters). (iv) Submitting its recommendations for payload specialists through...

14 CFR 1214.304 - Process.

Code of Federal Regulations, 2011 CFR

2011-01-01

... conducted at the Johnson Space Center by certified examiners approved by the Director, Life Sciences... examination will be conducted at Johnson Space Center by certified examiners approved by the Director, Life Sciences Division, NASA Headquarters). (iv) Submitting its recommendations for payload specialists through...

14 CFR 1214.304 - Process.

Code of Federal Regulations, 2012 CFR

2012-01-01

... conducted at the Johnson Space Center by certified examiners approved by the Director, Life Sciences... examination will be conducted at Johnson Space Center by certified examiners approved by the Director, Life Sciences Division, NASA Headquarters). (iv) Submitting its recommendations for payload specialists through...

New aquaculture drugs under FDA review

USGS Publications Warehouse

Bowker, James D.; Gaikowski, Mark P.

2012-01-01

Only eight active pharmaceutical ingredients available in 18 drug products have been approved by the U.S. Food and Drug Administration for use in aquaculture. The approval process can be lengthy and expensive, but several new drugs and label claims are under review. Progress has been made on approvals for Halamid (chloramine-T), Aquaflor (florfenicol) and 35% PeroxAid (hydrogen peroxide) as therapeutic drugs. Data are also being generated for AQUI-S 20E, a fish sedative.

Joint Service Solvent Substitution (JS3)

DTIC Science & Technology

2012-05-01

Process Evaluation Acceptance Criteria Market Research Demonstration Plan Demonstration Validate Implementation Approval Start Approval...PRF-63460D Mg (AZ 31B-H24) mg/cm^2 0.7 Mg (SAE AMS 4377) “ Al (AMS-QQ-A-250) “ Al (7075-T6) “ 0.49 Ti (AMS 4911, 6AL- 4V ...properties – Evaluation of vendor test results – Industry experience – DOD Aerospace & Shipbuilding NESHAP experience Market Research 21 Approved for

Accelerated approval of oncology products: a decade of experience.

PubMed

Dagher, Ramzi; Johnson, John; Williams, Grant; Keegan, Patricia; Pazdur, Richard

2004-10-20

We review the regulatory history of the accelerated approval process and summarize the U.S. Food and Drug Administration experience with accelerated approvals in oncology. The accelerated approval regulations, promulgated in 1992, allow approval of drugs for serious or life-threatening diseases on the basis of a surrogate endpoint that is reasonably likely to predict clinical benefit, such as survival or symptom benefit, pending completion of studies designed to confirm clinical benefit, referred to as phase 4 commitments, which are required to be conducted with due diligence. From 1992 to 2004, 22 applications involving anticancer drugs or biologics were approved. Of these 22 applications, accelerated approval was granted to 15 on the basis of findings from studies without an active comparator (i.e., single-arm studies or studies comparing two dose levels) and to the remaining seven on the basis of one or more randomized studies. Of the 22 approved applications, six (i.e., applications for dexrazoxane, irinotecan, capecitabine, docetaxel, imatinib mesylate, and oxaliplatin) have had one or more indications converted to regular approval. This review reports information that was presented at an Oncologic Drugs Advisory Committee meeting held in March 2003; it also presents a discussion of accelerated approval study designs, the study populations evaluated in the accelerated approval and confirmatory settings, and the integration of accelerated approval into a comprehensive drug development plan.

Declassifying coverage. New guidance documents issued by the CMS may clarify the great unknown of Medicare coverage determination.

PubMed

Barr, Paul

2005-03-21

Heard of Section 731 of the Medicare Modernization Act? The provision, meant to clear up the generally murky and unwieldy Medicare reimbursement approval process, could quicken the national approval process for medical procedures and devices. The changes will create a more definable approach to OK'ing new technologies. "I like the idea of bringing more science to bear," says Richard Pico, left.

Variability of the institutional review board process within a national research network.

PubMed

Khan, Muhammad A; Barratt, Michelle S; Krugman, Scott D; Serwint, Janet R; Dumont-Driscoll, Marilyn

2014-06-01

To determine the variability of the institutional review board (IRB) process for a minimal risk multicenter study. Participants included 24 Continuity Research Network (CORNET) sites of the Academic Pediatric Association that participated in a cross-sectional study. Each site obtained individual institutional IRB approval. An anonymous questionnaire went to site investigators about the IRB process at their institution. Twenty-two of 24 sites (92%) responded. Preparation time ranged from 1 to 20 hours, mean of 7.1 hours. Individuals submitting ≤3 IRB applications/year required more time for completion than those submitting >3/year (P < .05). Thirteen of 22 (59%) study sites received approval with "exempt" status, and 6 (27%) approved as "expedited" studies. IRB experiences were highly variable across study sites. These findings indicate that multicenter research projects should anticipate barriers to timely study implementation. Improved IRB standardization or centralization for multicenter clinical studies would facilitate this type of practice-based clinical research.

21 CFR 515.22 - Suspension and/or revocation of approval of a medicated feed mill license.

Code of Federal Regulations, 2014 CFR

2014-04-01

... mill license approved under section 512(m)(2) of the Federal Food, Drug, and Cosmetic Act (the act) and... controls used for, the manufacture, processing, packing, and holding of such animal feed are inadequate to...

21 CFR 515.22 - Suspension and/or revocation of approval of a medicated feed mill license.

Code of Federal Regulations, 2013 CFR

2013-04-01

... mill license approved under section 512(m)(2) of the Federal Food, Drug, and Cosmetic Act (the act) and... controls used for, the manufacture, processing, packing, and holding of such animal feed are inadequate to...

14 CFR 414.11 - Application.

Code of Federal Regulations, 2012 CFR

2012-01-01

... the safety element for which the safety approval is sought. (ii) Engineering design and analyses that... TRANSPORTATION LICENSING SAFETY APPROVALS Application Procedures § 414.11 Application. (a) The application must...) Safety element (i.e., launch vehicle, reentry vehicle, safety system, process, service, or any identified...

14 CFR 414.11 - Application.

Code of Federal Regulations, 2013 CFR

2013-01-01

... the safety element for which the safety approval is sought. (ii) Engineering design and analyses that... TRANSPORTATION LICENSING SAFETY APPROVALS Application Procedures § 414.11 Application. (a) The application must...) Safety element (i.e., launch vehicle, reentry vehicle, safety system, process, service, or any identified...

14 CFR 414.11 - Application.

Code of Federal Regulations, 2014 CFR

2014-01-01

... the safety element for which the safety approval is sought. (ii) Engineering design and analyses that... TRANSPORTATION LICENSING SAFETY APPROVALS Application Procedures § 414.11 Application. (a) The application must...) Safety element (i.e., launch vehicle, reentry vehicle, safety system, process, service, or any identified...

Processing Benefits of Resonance Acoustic Mixing on High Performance Propellants and Explosives

DTIC Science & Technology

2012-02-01

slightly greater stress Modulus similar Dewetting Distribution Statement A: Approved for Public Release Tensile Comparison File: NAVAIR Brief 18...greater stress Modulus similar Dewetting Distribution Statement A: Approved for Public Release Resodyn Mixed Explosive 19 File: NAVAIR Brief

24 CFR 214.105 - Preliminary application process.

Code of Federal Regulations, 2012 CFR

2012-04-01

... AUTHORITIES HOUSING COUNSELING PROGRAM Approval and Disapproval of Housing Counseling Agencies § 214.105... which the parent entity exercises control over the quality and type of housing counseling services... required to submit an application for HUD approval. However, to participate in HUD's Housing Counseling...

24 CFR 214.105 - Preliminary application process.

Code of Federal Regulations, 2013 CFR

2013-04-01

... AUTHORITIES HOUSING COUNSELING PROGRAM Approval and Disapproval of Housing Counseling Agencies § 214.105... which the parent entity exercises control over the quality and type of housing counseling services... required to submit an application for HUD approval. However, to participate in HUD's Housing Counseling...

24 CFR 214.105 - Preliminary application process.

Code of Federal Regulations, 2010 CFR

2010-04-01

... AUTHORITIES HOUSING COUNSELING PROGRAM Approval and Disapproval of Housing Counseling Agencies § 214.105... which the parent entity exercises control over the quality and type of housing counseling services... required to submit an application for HUD approval. However, to participate in HUD's Housing Counseling...

24 CFR 3280.4 - Incorporation by reference.

Code of Federal Regulations, 2014 CFR

2014-04-01

..., Processes, and Services, IBR approved for §§ 3280.403(e) and 3280.405(e). (22) ANSI Z97.1-2004, Standard for... § 3280.604(b). (18) ANSI/ASME B1.20.1-1983, Pipe Threads, General Purpose (Inch), IBR approved for...

7 CFR 1780.36 - Approving official review.

Code of Federal Regulations, 2010 CFR

2010-01-01

... funding sources, the approval official, after consultation with applicant, may submit a request for an... be used to determine the applications selected for further development and funding. After completing... priority scores for further processing. When authorizing the development of an application for funding, the...

7 CFR 52.2 - Terms defined.

Code of Federal Regulations, 2010 CFR

2010-01-01

... this part, setting forth in addition to appropriate descriptive information relative to a processed... plant facilities, sanitation, and methods of operation have been surveyed and approved for specific... have been surveyed and approved for specific product(s) by the Administrator as suitable and adequate...

7 CFR 52.2 - Terms defined.

Code of Federal Regulations, 2014 CFR

2014-01-01

... this part, setting forth in addition to appropriate descriptive information relative to a processed... plant facilities, sanitation, and methods of operation have been surveyed and approved for specific... have been surveyed and approved for specific product(s) by the Administrator as suitable and adequate...

7 CFR 52.2 - Terms defined.

Code of Federal Regulations, 2012 CFR

2012-01-01

... this part, setting forth in addition to appropriate descriptive information relative to a processed... plant facilities, sanitation, and methods of operation have been surveyed and approved for specific... have been surveyed and approved for specific product(s) by the Administrator as suitable and adequate...

7 CFR 52.2 - Terms defined.

Code of Federal Regulations, 2013 CFR

2013-01-01

... this part, setting forth in addition to appropriate descriptive information relative to a processed... plant facilities, sanitation, and methods of operation have been surveyed and approved for specific... have been surveyed and approved for specific product(s) by the Administrator as suitable and adequate...

7 CFR 52.2 - Terms defined.

Code of Federal Regulations, 2011 CFR

2011-01-01

... this part, setting forth in addition to appropriate descriptive information relative to a processed... plant facilities, sanitation, and methods of operation have been surveyed and approved for specific... have been surveyed and approved for specific product(s) by the Administrator as suitable and adequate...

Demystifying the U.S. Food and Drug Administration: I. Understanding agency structure and function.

PubMed

Levi, Benjamin; Lisiecki, Jeffrey; Rubin, Peter; D'Amico, Richard A; Hume, Keith M; Seward, Bill; Cederna, Paul S

2014-06-01

The U.S. Food and Drug Administration is the government agency responsible for oversight of the safety and efficacy of pharmaceuticals and devices, including biologics and devices that combine biologics with other materials. Within the U.S. Food and Drug Administration, the Center for Biologics Evaluation and Research is specifically responsible for the evaluation and approval of biological products. This department of the U.S. Food and Drug Administration has a series of mechanisms in place to aid researchers in the process of developing new biologics. This article outlines the study phases involved in developing new biologics and how the Center for Biologics Evaluation and Research and investigators can work together to facilitate this process. It also discusses issues specific to biologics that have been encountered in the past and that investigators should consider when developing and obtaining approval for new biologics. The equivalent center within the U.S. Food and Drug Administration for approving medical devices is the Center for Devices and Radiological Health. The equivalent process of development and approval of medical devices is similarly discussed. Finally, essential contacts for investigators within the Center for Biologics Evaluation and Research and the Center for Devices and Radiological Health are provided.

Rule-based land use/land cover classification in coastal areas using seasonal remote sensing imagery: a case study from Lianyungang City, China.

PubMed

Yang, Xiaoyan; Chen, Longgao; Li, Yingkui; Xi, Wenjia; Chen, Longqian

2015-07-01

Land use/land cover (LULC) inventory provides an important dataset in regional planning and environmental assessment. To efficiently obtain the LULC inventory, we compared the LULC classifications based on single satellite imagery with a rule-based classification based on multi-seasonal imagery in Lianyungang City, a coastal city in China, using CBERS-02 (the 2nd China-Brazil Environmental Resource Satellites) images. The overall accuracies of the classification based on single imagery are 78.9, 82.8, and 82.0% in winter, early summer, and autumn, respectively. The rule-based classification improves the accuracy to 87.9% (kappa 0.85), suggesting that combining multi-seasonal images can considerably improve the classification accuracy over any single image-based classification. This method could also be used to analyze seasonal changes of LULC types, especially for those associated with tidal changes in coastal areas. The distribution and inventory of LULC types with an overall accuracy of 87.9% and a spatial resolution of 19.5 m can assist regional planning and environmental assessment efficiently in Lianyungang City. This rule-based classification provides a guidance to improve accuracy for coastal areas with distinct LULC temporal spectral features.

Characterization of Land Surfaces with Satellite-borne Sensor

NASA Astrophysics Data System (ADS)

Qiao, Y.

Hot groundwater is a kind of valuable natural resources to be explored utilized. Shanxi Province, located in the eastern Loess Plateau of China, is rich in geothermal resources, most of which was found in irrigation well drilling or geological survey. Basic study is weak. Now new developed Remote Sensing technique provides geothermal study with an advanced way. Air-RS information of thermal infrared and dada from thermal channel of Meteorological Landset AVHRR has been used widely. A thermal infrared channel (TM6) was installed in the U.S. second Landset, Its resolving power of space is as high as 120m, 10 times more than one of AVHRR. A Landset earth recourses launched by China and Brazil (CBERS-1) in 1999, including a spectrum of thermal infrared. It is paid a great interested and attention to survey geothermal resources using thermal infrared. This article is a brief introduction of finding hot groundwater with on the bases of differences of thermal radiation of objects reflected by thermal infrared in the Landset, and treated with HIS colors changes. This study provides an advanced way widely used to exploit hot groundwater and to promote the development of tourism and geothermal medical in China.

A primary study on finding hot groundwater using infrared remote sensing

NASA Astrophysics Data System (ADS)

Qiao, Y.; Wu, Q.

Hot groundwater is a kind of valuable natural resources to be explored utilized. Shanxi Province, located in the eastern Loess Plateau of China, is rich in geothermal resources, most of which was found in irrigation well drilling or geological survey. Basic study is weak. Now new developed Remote Sensing technique provides geothermal study with an advanced way. Air-RS information of thermal infrared and dada from thermal channel of Meteorological Landset AVHRR has been used widely. A thermal infrared channel (TM6) was installed in the U. S. second Landset, Its resolving power of space is as high as 120 m, 10 times more t an one ofh AVHRR. A Landset earth recourses launched by China and Brazil (CBERS-1) in 1999, including a spectrum of thermal infrared. It is paid a great interested and attention to survey geothermal resources using thermal infrared. This article is a brief introduction of finding hot groundwater with on the bases of differences of thermal radiation of objects reflected by thermal infrared in the Landset, and treated with HIS colors changes. This study provides an advanced way widely used to exploit hot groundwater and to promote the development of tourism and geothermal medical in China.

International Conference on Harmonisation; Electronic Transmission of Postmarket Individual Case Safety Reports for Drugs and Biologics, Excluding Vaccines; Availability of Food and Drug Administration Regional Implementation Specifications for ICH E2B(R3) Reporting to the Food and Drug Administration Adverse Event Reporting System. Notice of Availability.

PubMed

2016-06-23

The Food and Drug Administration (FDA) is announcing the availability of its FDA Adverse Event Reporting System (FAERS) Regional Implementation Specifications for the International Conference on Harmonisation (ICH) E2B(R3) Specification. FDA is making this technical specifications document available to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and ICSR attachments) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This document, entitled "FDA Regional Implementation Specifications for ICH E2B(R3) Implementation: Postmarket Submission of Individual Case Safety Reports (ICSRs) for Drugs and Biologics, Excluding Vaccines" supplements the "E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide--Data Elements and Message Specification" final guidance for industry and describes FDA's technical approach for receiving ICSRs, for incorporating regionally controlled terminology, and for adding region-specific data elements when reporting to FAERS.

Research ethics board approval for an international thromboprophylaxis trial.

PubMed

Lutz, Kristina; Wilton, Kelly; Zytaruk, Nicole; Julien, Lisa; Hall, Richard; Harvey, Johanne; Skrobik, Yoanna; Vlahakis, Nicholas; Meade, Laurie; Matte, Andrea; Meade, Maureen; Burns, Karen; Albert, Martin; Cash, Bronwyn Barlow; Vallance, Shirley; Klinger, James; Heels-Ansdell, Diane; Cook, Deborah

2012-06-01

Research ethics board (REB) review of scientific protocols is essential, ensuring participants' dignity, safety, and rights. The objectives of this study were to examine the time from submission to approval, to analyze predictors of approval time, and to describe the scope of conditions from REBs evaluating an international thromboprophylaxis trial. We generated survey items through literature review and investigators' discussions, creating 4 domains: respondent and institutional demographics, the REB application process, and alternate consent models. We conducted a document analysis that involved duplicate assessment of themes from REB critique of the protocol and informed consent forms (ICF). Approval was granted from 65 REB institutions, requiring 58 unique applications. We analyzed 44 (75.9%) of 58 documents and surveys. Survey respondents completing the applications had 8 (5-12) years of experience; 77% completed 4 or more REB applications in previous 5 years. Critical care personnel were represented on 54% of REBs. The time to approval was a median (interquartile range) of 75 (42, 150) days, taking longer for sites with national research consortium membership (89.1 vs 31.0 days, P = .03). Document analysis of the application process and ICF yielded 5 themes: methodology, data management, consent procedures, cataloguing, and miscellaneous. Protocol-specific themes focused on trial implementation, external critiques, and budget. The only theme specific to the ICF was risks and benefits. The most frequent comments on the protocol and ICF were about methodology and miscellaneous issues; ICF comments also addressed study risks and benefits. More studies on methods to enhance efficiency and consistency of the REB approval processes for clinical trials are needed while still maintaining high ethical standards. Copyright © 2012 Elsevier Inc. All rights reserved.

Incorporating consideration of health impacts into land use development approval processes: Development of a Health Background Study Framework.

PubMed

Moloughney, Brent W; Bursey, Gayle E; Neumann, Jana; Leeming, Daniel H; Gutmann, Christine E; Sivanand, Bhavna; Mowat, David L

2014-09-12

This project involved development of a Health Background Study (HBS) Framework to support consideration of health impacts within municipalities' approval process for land use development. Peel Public Health and Toronto Public Health led the project with the participation of planners, urban designers, engineers, public health staff and development industry representatives. Historical growth in the Region of Peel and suburban Toronto has resulted in extensive low-density development, creating car-dependent communities with disconnected streets and segregated land uses. The inclusion of an HBS in developers' applications to municipalities is one approach by which health-related expectations for the built environment can be established within the approval process. Development of the HBS Framework used the six core elements of the built environment with the strongest evidence for impact on health and was informed by analysis of the provincial and local policy contexts, practices of other municipalities and stakeholder interviews. The Framework's contents were refined according to feedback from multidisciplinary stakeholder workshops. The HBS Framework identifies minimum standards for built environment core elements that developers need to address in their applications. The Framework was created to be simple and instructive with applicability to a range of development locations and scales, and to various stages of the development approval process. Peel Public Health is leading several initiatives to support the use of the HBS as a part of the development application process. The HBS Framework is a tool that public health and planning can use to support the consideration of health impacts within municipalities' land use development processes.

40 CFR 501.31 - Review and approval procedures.

Code of Federal Regulations, 2010 CFR

2010-07-01

... SLUDGE MANAGEMENT PROGRAM REGULATIONS Program Approval, Revision and Withdrawal § 501.31 Review and... sludge management program within 90 days after receiving a complete program submission. (b) Within 30... questions; and (6) Briefly outline the fundamental aspects of the State's proposed program, and the process...

78 FR 27471 - Projects Rescinded for Consumptive Uses of Water

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-10

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Rescinded for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the approved by rule projects..., being rescinded for the consumptive use of water pursuant to the Commission's approval by rule process...

12 CFR 1815.105 - Major decision points.

Code of Federal Regulations, 2012 CFR

2012-01-01

... ENVIRONMENTAL QUALITY § 1815.105 Major decision points. (a) The possible environmental effects of an Application... decisionmaking process: (1) Preliminary approval stage, at which point applications are selected for funding; and (2) Final approval and funding stage. (b) Environmental review shall be integrated into the...

12 CFR 1815.105 - Major decision points.

Code of Federal Regulations, 2010 CFR

2010-01-01

... ENVIRONMENTAL QUALITY § 1815.105 Major decision points. (a) The possible environmental effects of an Application... decisionmaking process: (1) Preliminary approval stage, at which point applications are selected for funding; and (2) Final approval and funding stage. (b) Environmental review shall be integrated into the...

12 CFR 1815.105 - Major decision points.

Code of Federal Regulations, 2014 CFR

2014-01-01

... ENVIRONMENTAL QUALITY § 1815.105 Major decision points. (a) The possible environmental effects of an Application... decisionmaking process: (1) Preliminary approval stage, at which point applications are selected for funding; and (2) Final approval and funding stage. (b) Environmental review shall be integrated into the...

20 CFR 656.32 - Revocation of approved labor certifications.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false Revocation of approved labor certifications. 656.32 Section 656.32 Employees' Benefits EMPLOYMENT AND TRAINING ADMINISTRATION, DEPARTMENT OF LABOR LABOR CERTIFICATION PROCESS FOR PERMANENT EMPLOYMENT OF ALIENS IN THE UNITED STATES Labor Certification...

Validation of source approval of HMA surface mix aggregate : final report.

DOT National Transportation Integrated Search

2016-04-01

The main focus of this research project was to develop methodologies for the validation of source approval of hot : mix asphalt surface mix aggregate. In order to further enhance the validation process, a secondary focus was also to : create a spectr...

76 FR 70352 - Approval and Promulgation of Implementation Plans; Reasonably Available Control Technology for...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-14

... controlling oxides of nitrogen from the stationary reciprocating, diesel fuel fired, internal combustion... County. The facility contains two stationary reciprocating, diesel fuel fired, internal combustion... Conditions of Approval specify the NO X emissions limits, combustion process adjustments mentioned above...

14 CFR 414.11 - Application.

Code of Federal Regulations, 2011 CFR

2011-01-01

...) Safety element (i.e., launch vehicle, reentry vehicle, safety system, process, service, or any identified... operating limits for which the safety approval is sought. (3) The following as applicable: (i) Information... the safety element for which the safety approval is sought. (ii) Engineering design and analyses that...

14 CFR 414.11 - Application.

Code of Federal Regulations, 2010 CFR

2010-01-01

...) Safety element (i.e., launch vehicle, reentry vehicle, safety system, process, service, or any identified... operating limits for which the safety approval is sought. (3) The following as applicable: (i) Information... the safety element for which the safety approval is sought. (ii) Engineering design and analyses that...

Navigating the IRB: The Ethics of SoTL

ERIC Educational Resources Information Center

Martin, Ryan C.

2013-01-01

This chapter discusses Institutional Review Boards (IRBs) as they apply to the SoTL. Specifically, it describes when SoTL projects must receive IRB approval, why they must get IRB approval, the review process, and some special issues of concern with regard to SoTL.

Enhancing Stewardship of Community-Engaged Research Through Governance

PubMed Central

Villegas, Malia; Zenone, Heather; White Hat, Emily R.; Wallerstein, Nina; Duran, Bonnie

2015-01-01

Objectives. We explored the relationship of community-engaged research final approval type (tribal government, health board, or public health office (TG/HB); agency staff or advisory board; or individual or no community approval) with governance processes, productivity, and perceived outcomes. Methods. We identified 294 federally funded community-engaged research projects in 2009 from the National Institutes of Health’s Research Portfolio Online Reporting Tools, Centers for Disease Control and Prevention’s Prevention Research Centers, and Native American Research Centers for Health databases. Two hundred (68.0%) investigators completed a survey about governance processes and productivity measures; 312 partners (77.2% of 404 invited) and 138 investigators (69.0% of 200 invited) completed a survey about perceived outcomes. Results. Projects with TG/HB approval had increased likelihood of community control of resources (odds ratios [ORs] ≥ 4.80). Projects with other approvals had decreased likelihood of development or revision of institutional review board policies (ORs ≤ 0.37), having written agreements (ORs ≤ 0.17), and agreements about publishing (ORs ≤ 0.28), data use (ORs ≤ 0.17), and publishing approval (ORs ≤ 0.14). Conclusions. Community-engaged research projects with TG/HB approval had strong stewardship of project resources and agreements. Governance as stewardship protects community interests; thus, is an ethical imperative for communities, especially native communities, to adopt. PMID:25880952

Follow-on biologics: competition in the biopharmaceutical marketplace.

PubMed

Devine, Joshua W; Cline, Richard R; Farley, Joel F

2006-01-01

To describe the implications of a follow-on biologic approval process with focus on current stakeholders, implications of the status quo, and recommendations for future policy. A search using Medline, International Pharmaceutical Abstracts, Med Ad News, F-D-C Reports/Pink Sheets, and Google index directories was conducted with terms such as biologic, biopharmaceutical, generic, and follow-on. Articles pertaining to the follow-on biologic debate. By the authors. Over the past decade, the biopharmaceutical market has experienced substantial growth in the number of product approvals and sales. In contrast with prescription medications, biologic agents currently lack an abbreviated regulatory approval process. Evidence from the Drug Price Competition and Patent Term Restoration Act of 1984 suggests that reducing barriers to generic competition in the pharmaceutical market successfully increases generic market penetration and reduces overall prices to consumers. Although scientific and regulatory dissimilarities between biopharmaceuticals and other medications exist, a follow-on biologic approval process has the potential to play an important role in containing growth in pharmaceutical spending. In addition to biopharmaceutical and generic biopharmaceutical manufacturers, stakeholders with a vested interest in this debate include individual consumers who continue to bear the burden of spending increases in the pharmaceutical market. The debate over a follow-on process likely will be difficult as parties seek a balance between incentives for biopharmaceutical innovation, consumer safety, and affordability of existing biologic products.

Foregone benefits of important food crop improvements in Sub-Saharan Africa

PubMed Central

2017-01-01

A number of new crops have been developed that address important traits of particular relevance for smallholder farmers in Africa. Scientists, policy makers, and other stakeholders have raised concerns that the approval process for these new crops causes delays that are often scientifically unjustified. This article develops a real option model for the optimal regulation of a risky technology that enhances economic welfare and reduces malnutrition. We consider gradual adoption of the technology and show that delaying approval reduces uncertainty about perceived risks of the technology. Optimal conditions for approval incorporate parameters of the stochastic processes governing the dynamics of risk. The model is applied to three cases of improved crops, which either are, or are expected to be, delayed by the regulatory process. The benefits and costs of the crops are presented in a partial equilibrium that considers changes in adoption over time and the foregone benefits caused by a delay in approval under irreversibility and uncertainty. We derive the equilibrium conditions where the net-benefits of the technology equal the costs that would justify a delay. The sooner information about the safety of the technology arrive, the lower the costs for justifying a delay need to be i.e. it pays more to delay. The costs of a delay can be substantial: e.g. a one year delay in approval of the pod-borer resistant cowpea in Nigeria will cost the country about 33 million USD to 46 million USD and between 100 and 3,000 lives. PMID:28749984

Companion diagnostics: a regulatory perspective from the last 5 years of molecular companion diagnostic approvals.

PubMed

Roscoe, Donna M; Hu, Yun-Fu; Philip, Reena

2015-01-01

Companion diagnostics are essential for the safe and effective use of the corresponding therapeutic products. The US FDA has approved a number of companion diagnostics used to select cancer patients for treatment with contemporaneously approved novel therapeutics. The processes of co-development and co-approval of a therapeutic product and its companion diagnostic have been a learning experience that continues to evolve. Using several companion diagnostics as examples, this article describes the challenges associated with the scientific, clinical and regulatory hurdles faced by FDA and industry alike. Taken together, this discussion is intended to assist manufacturers toward a successful companion diagnostics development plan.

STS safety approval process for small self-contained payloads

NASA Technical Reports Server (NTRS)

Gum, Mary A.

1988-01-01

The safety approval process established by the National Aeronautics and Space Administration for Get Away Special (GAS) payloads is described. Although the designing organization is ultimately responsible for the safe operation of its payload, the Get Away Special team at the Goddard Space Flight Center will act as advisors while iterative safety analyses are performed and the Safety Data Package inputs are submitted. This four phase communications process will ultimately give NASA confidence that the GAS payload is safe, and successful completion of the Phase 3 package and review will clear the way for flight aboard the Space Transportation System orbiter.

78 FR 42947 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-18

... collecting, validating and verifying information, processing and maintaining information, and disclosing and... Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request AGENCY... Services, has submitted an Information Collection Request (ICR), described below, to the Office of...

77 FR 71425 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-30

..., and verifying information; processing and maintaining information; and disclosing and providing... Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request AGENCY... Services Administration (HRSA) will submit an Information Collection Request (ICR) to the Office of...

78 FR 2274 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-10

... verifying information, processing and maintaining information, and disclosing and providing information, to... Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request ACTION....C. Chapter 35), the Health Resources and Services Administration (HRSA) will submit an Information...

75 FR 13204 - Notice of Petition for Approval

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-18

... different railroad territory type configurations. Consequently, ETMS and the PSP has evolved over time as... configuration types. The revised PSP provides descriptions of: The ETMS itself, ETMS safety process and analyses... written information or comments pertinent to FRA's consideration of the above petition for approval of a...

25 CFR 273.22 - Application approval officials.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 25 Indians 1 2011-04-01 2011-04-01 false Application approval officials. 273.22 Section 273.22 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR INDIAN SELF-DETERMINATION AND EDUCATION ASSISTANCE ACT PROGRAM EDUCATION CONTRACTS UNDER JOHNSON-O'MALLEY ACT Application Process § 273.22...

25 CFR 273.22 - Application approval officials.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 25 Indians 1 2012-04-01 2011-04-01 true Application approval officials. 273.22 Section 273.22 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR INDIAN SELF-DETERMINATION AND EDUCATION ASSISTANCE ACT PROGRAM EDUCATION CONTRACTS UNDER JOHNSON-O'MALLEY ACT Application Process § 273.22...

25 CFR 273.22 - Application approval officials.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 25 Indians 1 2014-04-01 2014-04-01 false Application approval officials. 273.22 Section 273.22 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR INDIAN SELF-DETERMINATION AND EDUCATION ASSISTANCE ACT PROGRAM EDUCATION CONTRACTS UNDER JOHNSON-O'MALLEY ACT Application Process § 273.22...

25 CFR 273.22 - Application approval officials.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 25 Indians 1 2013-04-01 2013-04-01 false Application approval officials. 273.22 Section 273.22 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR INDIAN SELF-DETERMINATION AND EDUCATION ASSISTANCE ACT PROGRAM EDUCATION CONTRACTS UNDER JOHNSON-O'MALLEY ACT Application Process § 273.22...

25 CFR 273.22 - Application approval officials.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 25 Indians 1 2010-04-01 2010-04-01 false Application approval officials. 273.22 Section 273.22 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR INDIAN SELF-DETERMINATION AND EDUCATION ASSISTANCE ACT PROGRAM EDUCATION CONTRACTS UNDER JOHNSON-O'MALLEY ACT Application Process § 273.22...

75 FR 59710 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-28

... Approval; Comment Request; Aerospace Manufacturing and Rework Industry Information Collection AGENCY... electronic docket, go to http://www.regulations.gov . Title: Aerospace Manufacturing and Rework Industry... manufacturing and rework facilities and has been tailored to the processes at aerospace facilities. Respondents...

Ethics in Higher Education Research

ERIC Educational Resources Information Center

Parsell, Mitch; Ambler, Trudy; Jacenyik-Trawoger, Christa

2014-01-01

Many educational researchers have experienced challenges in obtaining ethics approval. This article explores some of the reasons why this is the case, looking specifically at the participatory action research methodology. The authors' experience of seeking ethics approval for a project intended to introduce peer review as an enhancement process is…

Validation of source approval of HMA surface mix aggregate using spectrometer : final report.

DOT National Transportation Integrated Search

2016-04-01

The main focus of this research project was to develop methodologies for the validation of source approval of hot : mix asphalt surface mix aggregate. In order to further enhance the validation process, a secondary focus was also to : create a spectr...

Connected Vehicle Pilot Deployment Program Phase 1 : Human Use Approval Summary : New York City

DOT National Transportation Integrated Search

2016-08-04

The New York City (NYC) Connected Vehicle (CV) Pilot Deployment will be the largest deployment of connected vehicle technology to date. The purpose of the human use approval activity is to apply the Institutional Review Board (IRB) process to the NYC...

7 CFR 1940.316 - Responsible officials for the environmental review process.

Code of Federal Regulations, 2010 CFR

2010-01-01

... submitted to the approval official for final determinations. The SEC will review the assessment and provide... adequacy of the assessment or the recommendations reached, the State Director, whether or not the approving... Law 103-354 official responsible for executing the environmental impact determination and...

Document Concurrence System

NASA Technical Reports Server (NTRS)

Muhsin, Mansour; Walters, Ian

2004-01-01

The Document Concurrence System is a combination of software modules for routing users expressions of concurrence with documents. This system enables determination of the current status of concurrences and eliminates the need for the prior practice of manually delivering paper documents to all persons whose approvals were required. This system runs on a server, and participants gain access via personal computers equipped with Web-browser and electronic-mail software. A user can begin a concurrence routing process by logging onto an administration module, naming the approvers and stating the sequence for routing among them, and attaching documents. The server then sends a message to the first person on the list. Upon concurrence by the first person, the system sends a message to the second person, and so forth. A person on the list indicates approval, places the documents on hold, or indicates disapproval, via a Web-based module. When the last person on the list has concurred, a message is sent to the initiator, who can then finalize the process through the administration module. A background process running on the server identifies concurrence processes that are overdue and sends reminders to the appropriate persons.

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

Newman, J.R.; Maltby, J.H.

The purpose of this presentation was to discuss the emerging role of financial entities in determining environmental requirements for international power projects. The paper outlines the following: emerging conditions; examples of announced privatization energy projects by country; types of government and international financial entity sources; problems for IPPs; similarity and differences between the World Bank and the USEPA; comparison of the international standards and regulations for power plants; recent trends/issues involving international power project approval; and recommendations for understanding/expediting the financial entities` environmental approval process and how to expedite this process.

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...

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...

78 FR 25750 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-02

... technology and systems for the purpose of collecting, validating and verifying information, processing and... Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request ACTION....C. Chapter 35), the Health Resources and Services Administration (HRSA) will submit an Information...

78 FR 63980 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-25

... verifying information, processing and maintaining information, and disclosing and providing information, to...-30D] Agency Information Collection Activities; Submission to OMB for Review and Approval; Public... Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the...

78 FR 63979 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-25

... technology and systems for the purpose of collecting, validating and verifying information, processing and...-30D] Agency Information Collection Activities; Submission to OMB for Review and Approval; Public... Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the...

78 FR 70308 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-25

..., validating and verifying information, processing and maintaining information, and disclosing and providing... Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request AGENCY... (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB...

78 FR 42951 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-18

..., processing and maintaining information, and disclosing and providing information, to train personnel and to... Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request AGENCY... Services, has submitted an Information Collection Request (ICR), described below, to the Office of...

77 FR 70443 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-26

..., processing and maintaining information, and disclosing and providing information, to train personnel and to...-30D] Agency Information Collection Activities; Submission to OMB for Review and Approval; Public... and Human Services, has submitted an Information Collection Request (ICR), described below, to the...

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...

40 CFR 763.173 - Exemptions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... prohibitions imposed by § 763.165, § 763.167, or § 763.169 may file an application for an exemption. Persons whose exemption applications are approved by the Agency may manufacture, import, process, or distribute in commerce the banned product as specified in the Agency's approval of the application. No applicant...

10 CFR 725.15 - Requirements for approval of applications.

Code of Federal Regulations, 2010 CFR

2010-01-01

... and/or operation of production or manufacturing facilities and offers reasonable assurance of adequacy... Production will be approved only if the application demonstrates also that the applicant: (i) Is directly engaged in a substantial effort to develop, design, build or operate a chemical processing plant or other...

78 FR 54891 - Information Collection Request Submitted to OMB for Review and Approval: Comment Request; Great...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-06

... Submitted to OMB for Review and Approval: Comment Request; Great Lakes Accountability System (Reinstatement... Agency has submitted an information collection request (ICR), Great Lakes Accountability System... legislation called for increased accountability for the GLRI and directed EPA to implement a process to track...

9 CFR 590.640 - Application for exemption; approval.

Code of Federal Regulations, 2010 CFR

2010-01-01

... AGRICULTURE EGG PRODUCTS INSPECTION INSPECTION OF EGGS AND EGG PRODUCTS (EGG PRODUCTS INSPECTION ACT) Exempted Egg Products Plants § 590.640 Application for exemption; approval. Any person desiring to process egg..., a Supervisory Egg Products Inspector will make a survey and inspection of the premises and plant to...

Connected vehicle pilot deployment program phase 1 : human use approval summary – Tampa.

DOT National Transportation Integrated Search

2016-07-18

This document presents the Human Use Approval (HUA) Summary for the THEA Connected Vehicle (CV) Pilot Deployment. The purpose of this report is to document the process used by THEA in the Tampa CV Pilot Deployment as required in Phase 1, Task 8 in pr...

40 CFR 153.155 - Seed treatment products.

Code of Federal Regulations, 2013 CFR

2013-07-01

... products. (a) Pesticide products intended for use in treating seeds must contain an EPA-approved dye to... established under the Federal Food, Drug and Cosmetic Act for residues of the pesticide. (b) The following... the user to add an EPA-approved dye with the pesticide during the seed treatment process. (2) Products...

40 CFR 153.155 - Seed treatment products.

Code of Federal Regulations, 2014 CFR

2014-07-01

... products. (a) Pesticide products intended for use in treating seeds must contain an EPA-approved dye to... established under the Federal Food, Drug and Cosmetic Act for residues of the pesticide. (b) The following... the user to add an EPA-approved dye with the pesticide during the seed treatment process. (2) Products...

40 CFR 153.155 - Seed treatment products.

Code of Federal Regulations, 2012 CFR

2012-07-01

... products. (a) Pesticide products intended for use in treating seeds must contain an EPA-approved dye to... established under the Federal Food, Drug and Cosmetic Act for residues of the pesticide. (b) The following... the user to add an EPA-approved dye with the pesticide during the seed treatment process. (2) Products...

75 FR 5157 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-01

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change... Consolidated FINRA Rulebook January 25, 2010. On December 2, 2009, the Financial Industry Regulatory Authority... later in the rulebook consolidation process. It is therefore ordered, pursuant to Section 19(b)(2) of...

75 FR 43588 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-26

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a Proposed Rule... FINRA Rule 4320 in the Consolidated FINRA Rulebook July 20, 2010. On May 21, 2010, the Financial... application by their terms. For more information about the rulebook consolidation process, see Information...

76 FR 31272 - Permanent Certification Program for Health Information Technology; Revisions to ONC-Approved...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-31

... Permanent Certification Program for Health Information Technology; Revisions to ONC-Approved Accreditor Processes AGENCY: Office of the National Coordinator for Health Information Technology (ONC), Department of... Coordinator for Health Information Technology (the National Coordinator) by section 3001(c)(5) of the Public...

76 FR 72636 - Permanent Certification Program for Health Information Technology; Revisions to ONC-Approved...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-25

... Permanent Certification Program for Health Information Technology; Revisions to ONC-Approved Accreditor Processes AGENCY: Office of the National Coordinator for Health Information Technology (ONC), Department of... Coordinator for Health Information Technology by section 3001(c)(5) of the Public Health Service Act (PHSA) as...

22 CFR 172.4 - Testimony and production of documents prohibited unless approved by appropriate Department...

Code of Federal Regulations, 2010 CFR

2010-04-01

... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Testimony and production of documents... DEPARTMENT OF STATE ACCESS TO INFORMATION SERVICE OF PROCESS; PRODUCTION OR DISCLOSURE OF OFFICIAL... § 172.4 Testimony and production of documents prohibited unless approved by appropriate Department...

78 FR 22877 - Agency Information Collection Activities; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-17

... Bank has developed an electronic disbursement approval processing system for guaranteed lenders with... authorized by Ex-Im Bank and legal documentation has been completed, the lender will obtain and review the... application system (ExIm Online). Ex-Im Bank's action (approved or declined) will be posted on the lender's...

78 FR 10169 - Agency Information Collection Activities: Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-13

... Bank has developed an electronic disbursement approval processing system for guaranteed lenders with... authorized by Ex-Im Bank and legal documentation has been completed, the lender will obtain and review the... application system (ExIm Online). Ex-Im Bank's action (approved or declined) will be posted on the lender's...

78 FR 5859 - Agency Information Collection Activities: Requests for Comments; Clearance of New Approval of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-28

... about our intention to request the Office of Management and Budget (OMB) approval for a new information... propeller critical parts by the manufacturer, and establish engineering, manufacture, and maintenance... their manuals to record engineering, manufacture, and maintenance processes for propeller critical parts...

40 CFR 35.940-3 - Costs allowable, if approved.

Code of Federal Regulations, 2014 CFR

2014-07-01

... the treatment process, or that will be used for ultimate disposal of residues resulting from such... of compost residues which result from wastewater treatment, if EPA has approved a program for use of the compost. (d) Acquisition of an operable portion of a treatment works. This type of acquisition is...

40 CFR 35.940-3 - Costs allowable, if approved.

Code of Federal Regulations, 2012 CFR

2012-07-01

... the treatment process, or that will be used for ultimate disposal of residues resulting from such... of compost residues which result from wastewater treatment, if EPA has approved a program for use of the compost. (d) Acquisition of an operable portion of a treatment works. This type of acquisition is...

40 CFR 35.940-3 - Costs allowable, if approved.

Code of Federal Regulations, 2013 CFR

2013-07-01

... the treatment process, or that will be used for ultimate disposal of residues resulting from such... of compost residues which result from wastewater treatment, if EPA has approved a program for use of the compost. (d) Acquisition of an operable portion of a treatment works. This type of acquisition is...

7 CFR 1717.901 - Early approval.

Code of Federal Regulations, 2010 CFR

2010-01-01

... for Supplemental Financing Required by 7 CFR 1710.110 § 1717.901 Early approval. (a) Conditions. If... supplemental financing early in the process, before funding is available for the concurrent RUS insured loan... commitment from the private lender to provide a loan for the remaining amount of financing required, with...

76 FR 13976 - Notice of Request for Revision of a Currently Approved Information Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-15

.... SUPPLEMENTARY INFORMATION: Title: Form RD 1951-65, Customer Initiated Payments (CIP) Enrollment Form; Form RD... Initiated Payments [CIP], FedWire, and Preauthorized Debits [PAD]) for receiving and processing loan... approved forms for collecting bank routing information for CIP, FedWire, and PAD. Estimate of Burden...

Reflections on the Ethics-Approval Process

ERIC Educational Resources Information Center

Murray, Lee; Pushor, Debbie; Renihan, Pat

2012-01-01

It is sometimes a difficult journey receiving ethics approval for research involving vulnerable populations, research involving our own children, or innovative research methodologies such as autoethnography. This autoethnographical account is a story about one student who wanted to write a PhD dissertation in a very different way and also the…

78 FR 72626 - Notice of Request for Renewal of a Currently Approved Information Collection (Pathogen Reduction...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-03

... reduction and Hazard Analysis and Critical Control Point (HACCP) Systems requirements because OMB approval... February 28, 2014. FSIS has established requirements applicable to meat and poultry establishments designed.... coli by slaughter establishments to verify the adequacy of the establishment's process controls for the...

75 FR 37376 - Notice of Request for Revision of a Currently Approved Information Collection (Pathogen Reduction...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-29

... Control Point (HACCP) Systems requirements because OMB approval will expire on December 31, 2010, and to... collection. FSIS has established requirements applicable to meat and poultry establishments designed to... by slaughter establishments to verify the adequacy of the establishment's process controls for the...

10 CFR 70.23 - Requirements for the approval of applications.

Code of Federal Regulations, 2014 CFR

2014-01-01

... and use special nuclear material in a plutonium processing and fuel fabrication plant. 3 The criteria... Section 70.23 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) DOMESTIC LICENSING OF SPECIAL NUCLEAR... a license will be approved if the Commission determines that: (1) The special nuclear material is to...

10 CFR 70.23 - Requirements for the approval of applications.

Code of Federal Regulations, 2012 CFR

2012-01-01

... and use special nuclear material in a plutonium processing and fuel fabrication plant. 3 The criteria... Section 70.23 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) DOMESTIC LICENSING OF SPECIAL NUCLEAR... a license will be approved if the Commission determines that: (1) The special nuclear material is to...

10 CFR 70.23 - Requirements for the approval of applications.

Code of Federal Regulations, 2011 CFR

2011-01-01

... to possess and use special nuclear material in a plutonium processing and fuel fabrication plant. 3... Section 70.23 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) DOMESTIC LICENSING OF SPECIAL NUCLEAR... a license will be approved if the Commission determines that: (1) The special nuclear material is to...

10 CFR 70.23 - Requirements for the approval of applications.

Code of Federal Regulations, 2013 CFR

2013-01-01

... and use special nuclear material in a plutonium processing and fuel fabrication plant. 3 The criteria... Section 70.23 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) DOMESTIC LICENSING OF SPECIAL NUCLEAR... a license will be approved if the Commission determines that: (1) The special nuclear material is to...

14 CFR 21.316 - Responsibility of holder.

Code of Federal Regulations, 2010 CFR

2010-01-01

... CERTIFICATION PROCEDURES FOR PRODUCTS AND PARTS Approval of Materials, Parts, Processes, and Appliances § 21.316... conforms to its approved design and is in a condition for safe operation; (d) Mark the PMA article for...) Have access to design data necessary to determine conformity and airworthiness for each article...

76 FR 63833 - Commission Approval of Divestiture Agreements

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-14

... example, ``immaterial'' may have a specific meaning under contract law that is not fully consistent with... process for approval of ministerial and other minor contract modifications that will not diminish the... competition laws and any other provisions in the order. This evaluation includes review of the purchase and...

77 FR 53241 - Self-Regulatory Organizations; Options Clearing Corporation; Order Approving Proposed Rule Change...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-31

... Organizations; Options Clearing Corporation; Order Approving Proposed Rule Change Relating to the Auction Process Under Options Clearing Corporation Rule 1104 August 27, 2012. I. Introduction On July 3, 2012, the Options Clearing Corporation (``OCC'') filed with the Securities and Exchange Commission (``Commission...

77 FR 11677 - Medicaid Program; Review and Approval Process for Section 1115 Demonstrations

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-27

... experimental, pilot, and demonstration projects approved under section 1115 of the Social Security Act relating... selected provisions of section 1902 of the Act for experimental, pilot, or demonstration projects... application, and recommended that CMS allow the State to not post a complete application. The commenters noted...

77 FR 50499 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-21

... recovery and/or recovery and recycling equipment (hereafter referred to as ``refrigerant handling equipment... systems for the purposes of collecting, validating, and verifying information, processing and maintaining... approved refrigerant reclaimed by owners of refrigerant recycling equipment certified under 40 CFR 82.36(a...

75 FR 53457 - Lifesaving Equipment: Production Testing and Harmonization With International Standards

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-31

... approval process for all lifesaving equipment required under the various vessel and facility regulations in... buoyant apparatuses. If the proposed rule is made final, all equipment approved after the effective date... Equipment: Production Testing and Harmonization With International Standards; Proposed Rule #0;#0;Federal...

76 FR 78706 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-19

... incorporated NYSE Rule 2A (Jurisdiction) as part of the process of developing a consolidated rulebook..., among other things, rulemaking, examinations, disciplinary actions, and listing applications. NYSE Rule... executives, employees and approved persons in connection with their conduct of the business of member...

76 FR 30092 - Notice of Request for Extension of Approval of an Information Collection; Select Agent Registration

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-24

...] Notice of Request for Extension of Approval of an Information Collection; Select Agent Registration... . FOR FURTHER INFORMATION CONTACT: For information regarding the select agent registration process... Dr. Charles Divan, Branch Chief, Agriculture Select Agent Program, RIPPS, PPQ, APHIS, 4700 River Road...

9 CFR 590.640 - Application for exemption; approval.

Code of Federal Regulations, 2011 CFR

2011-01-01

... AGRICULTURE EGG PRODUCTS INSPECTION INSPECTION OF EGGS AND EGG PRODUCTS (EGG PRODUCTS INSPECTION ACT) Exempted Egg Products Plants § 590.640 Application for exemption; approval. Any person desiring to process egg..., a Supervisory Egg Products Inspector will make a survey and inspection of the premises and plant to...

42 CFR 403.802 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-10-01

..., alcohol swabs, and gauze; a vaccine licensed under section 351 of the Public Health Service Act; or any... organization means an entity applying for approval to enter into a new contract with CMS to offer a new... enrollment form or other approved process for enrolling individuals into an endorsed program that...

42 CFR 403.802 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-10-01

..., alcohol swabs, and gauze; a vaccine licensed under section 351 of the Public Health Service Act; or any... organization means an entity applying for approval to enter into a new contract with CMS to offer a new... enrollment form or other approved process for enrolling individuals into an endorsed program that...

42 CFR 403.802 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-10-01

..., alcohol swabs, and gauze; a vaccine licensed under section 351 of the Public Health Service Act; or any... organization means an entity applying for approval to enter into a new contract with CMS to offer a new... enrollment form or other approved process for enrolling individuals into an endorsed program that...

Improving the postmarket surveillance of total joint arthroplasty devices.

PubMed

Mahomed, Nizar N; Syed, Khalid; Sledge, Clement B; Brennan, Troyen A; Liang, Matthew H

2008-01-01

To evaluate the FDA's approval process and postmarket surveillance strategies for THR devices. The FDA Center for Devices and Radiological Health (CDRH) 510k releasable database was used to document approved THR devices. The CDRH Medical Device Reporting data files were used to study the efficiency of the FDA's post-market surveillance system. Manufacturers were contacted to supply information regarding their implants. Medline was searched between 1966-1996 to determine the percentage of THR devices with published data on clinical outcomes. Between 1976 and 1996, 701 new THR devices were approved by the Substantial Equivalent (SE) route and 34 were approved on the basis of Premarket Approval PMA. The number of approvals doubled between 1991-1995 compared to 1976-1990. Seventy-four different manufacturers obtained approval to market THR devices. Only four manufacturers obtained approval via the PMA application. Under Mandatory Device Reporting all revision arthroplasties should be reported. Using data from 2 independent services for which we had US hospital discharge data in 1993 we estimate that only 3% of all revision THR were reported to the FDA. Manufacturers of hip implants failed to provide useful information. Medline search revealed only 15% of the approved THR devices had published data on outcomes. Current FDA premarket approval and postmarket surveillance strategies fail to provide information for evidence-based selection of THR devices. Recommendations are made to avert problems with device failures.

Working with the U.S. Food and Drug Administration to obtain approval of products under the Animal Rule.

PubMed

Park, Glen D; Mitchel, Jules T

2016-06-01

While the development of medical products and approval by the U.S. Food and Drug Administration (FDA) is well known, the development of countermeasures against exposure to toxic levels of radiation, chemicals, and infectious agents requires special consideration, and there has been, to date, little experience in working with the FDA to obtain approval of these products. The FDA has published a regulation entitled "Approval of Biological Products when Human Efficacy Studies are not Ethical or Feasible." This regulation, known simply as the "Animal Rule," was designed to permit approval or licensing of drugs and biologics when efficacy studies in humans are not ethical or feasible. To date, 12 products have been approved under the Animal Rule. It is highly recommended that sponsors of products that are to be developed under the Animal Rule meet with the FDA and other government entities early in the development process to ensure that the efficacy and safety studies that are planned will meet the FDA's requirements for approval of the product. © 2016 New York Academy of Sciences.

SSI/SSDI Outreach, Access, and Recovery (SOAR): Disability Application Outcomes Among Homeless Adults.

PubMed

Lowder, Evan M; Desmarais, Sarah L; Neupert, Shevaun D; Truelove, Melissa A

2017-11-01

The SSI/SSDI Outreach, Access, and Recovery (SOAR) program has been shown to increase access to Supplemental Security Income and Social Security Disability Insurance benefits among homeless adults. However, little empirical data exist on how or for whom SOAR achieves successful application outcomes. This study investigated applicant and application characteristics associated with disability application outcomes among homeless adults. Secondary data on 6,361 SOAR-assisted applications were obtained. Multilevel models investigated between-applicant differences in application processing time and decision as a function of applicant and application characteristics. Older age and living in an institution were associated with greater odds of application approval. Female gender and receipt of public assistance were associated with longer processing time and lower odds of approval. Except for quality review, SOAR critical components were associated with greater odds of approval. Women and adults receiving public assistance appear disadvantaged in the SOAR application process. SOAR critical components promote successful disability application outcomes.

The manager and equipment decisions: the capital budget.

PubMed

McConnell, Charles R

2011-01-01

As part of his or her role in preparing a departmental budget, a manager must often become involved in budgeting for capital expenditures, those purchases that are of a type and sufficient dollar value to be capitalized and depreciated. Depending on the value of a proposed purchase, the department manager may have only a partial voice in the process; some significant purchases will require administrative approval, whereas some major acquisitions will require approval by the board of directors. Planning for possible capital purchases should begin well before the start of the annual budget exercise. Listing a capital item in the department's budget request does not imply approval; often, there are many more "needs" than there are capital funds available. Therefore, there must be a consistent process for identifying the proposed purchases that will be funded, such process necessarily including detailed specification of the need for a particular capital purchase, identification of all reasonable alternatives, consideration of any constraints, detailed financial comparison of alternatives, assessment of intangible factors, and a recommended choice.

Compounding and Extralabel Use of Drugs in Exotic Animal Medicine.

PubMed

Powers, Lauren V; Davidson, Gigi

2018-05-01

Extralabel drug use is the use of a Food and Drug Administration (FDA)-approved drug in a manner different from what is stipulated on the approved label. Compounding is the process of preparing a medication in a manner not indicated on the label to create a formulation specifically tailored to the needs of an individual patient. Extralabel drug use and compounding are vital aspects of safe and effective drug delivery to patients in exotic animal practice. There are few FDA-approved drugs for exotic animal species, and many approved drugs for other species are not available in suitable formulations for use in exotic animals. Copyright © 2018 Elsevier Inc. All rights reserved.

Capacity for ethical and regulatory review of herbal trials in developing countries: a case study of Moringa oleifera research in HIV-infected patients.

PubMed

Monera-Penduka, Tsitsi G; Maponga, Charles C; Morse, Gene D; Nhachi, Charles F B

2017-01-01

Lack of regulatory capacity limits the conduct of ethical and rigorous trials of herbal medicines in developing countries. Sharing ethical and regulatory experiences of successful herbal trials may accelerate the field while assuring human subjects protection. The methods and timelines for the ethical and regulatory review processes for the first drug regulatory authority approved herbal trial in Zimbabwe are described in this report. The national drug regulatory authority and ethics committee were engaged for pre-submission discussions. Six applications were submitted. Application procedures and communications with the various regulatory and ethics review boards were reviewed. Key issues raised and timelines for communications were summarized. There was no special framework for the approval of herbal trials. One local institutional review committee granted an exemption. Key issues raised for revision were around pre-clinical efficacy and safety data, standardization and quality assurance of the intervention as well as consenting procedures. Approval timelines ranged between eight and 72 weeks. In the absence of a defined framework for review of herbal trials, approval processes can be delayed. Dialogue between researchers and regulators is important for successful and efficient protocol approval for herbal trials in developing countries. The study was registered prospectively on August 3, 2011 with clinicaltrials.gov (NCT01410058).

Era of faster FDA drug approval has also seen increased black-box warnings and market withdrawals.

PubMed

Frank, Cassie; Himmelstein, David U; Woolhandler, Steffie; Bor, David H; Wolfe, Sidney M; Heymann, Orlaith; Zallman, Leah; Lasser, Karen E

2014-08-01

After approval, many prescription medications that patients rely on subsequently receive new black-box warnings or are withdrawn from the market because of safety concerns. We examined whether the frequency of these safety problems has increased since 1992, when the Prescription Drug User Fee Act, legislation designed to accelerate the drug approval process at the Food and Drug Administration, was passed. We found that drugs approved after the act's passage were more likely to receive a new black-box warning or be withdrawn than drugs approved before its passage (26.7 per 100.0 drugs versus 21.2 per 100.0 drugs at up to sixteen years of follow-up). We could not establish causality, however. Our findings suggest the need for reforms to reduce patients' exposure to unsafe drugs, such as a statement or symbol in the labeling, medication guides for patients, and marketing materials indicating that a drug was approved only recently. Project HOPE—The People-to-People Health Foundation, Inc.

Mapping Impervious Surface Expansion using Medium-resolution Satellite Image Time Series: A Case Study in the Yangtze River Delta, China

NASA Technical Reports Server (NTRS)

Gao, Feng; DeColstoun, Eric Brown; Ma, Ronghua; Weng, Qihao; Masek, Jeffrey G.; Chen, Jin; Pan, Yaozhong; Song, Conghe

2012-01-01

Cities have been expanding rapidly worldwide, especially over the past few decades. Mapping the dynamic expansion of impervious surface in both space and time is essential for an improved understanding of the urbanization process, land-cover and land-use change, and their impacts on the environment. Landsat and other medium-resolution satellites provide the necessary spatial details and temporal frequency for mapping impervious surface expansion over the past four decades. Since the US Geological Survey opened the historical record of the Landsat image archive for free access in 2008, the decades-old bottleneck of data limitation has gone. Remote-sensing scientists are now rich with data, and the challenge is how to make best use of this precious resource. In this article, we develop an efficient algorithm to map the continuous expansion of impervious surface using a time series of four decades of medium-resolution satellite images. The algorithm is based on a supervised classification of the time-series image stack using a decision tree. Each imerpervious class represents urbanization starting in a different image. The algorithm also allows us to remove inconsistent training samples because impervious expansion is not reversible during the study period. The objective is to extract a time series of complete and consistent impervious surface maps from a corresponding times series of images collected from multiple sensors, and with a minimal amount of image preprocessing effort. The approach was tested in the lower Yangtze River Delta region, one of the fastest urban growth areas in China. Results from nearly four decades of medium-resolution satellite data from the Landsat Multispectral Scanner (MSS), Thematic Mapper (TM), Enhanced Thematic Mapper plus (ETM+) and China-Brazil Earth Resources Satellite (CBERS) show a consistent urbanization process that is consistent with economic development plans and policies. The time-series impervious spatial extent maps derived from this study agree well with an existing urban extent polygon data set that was previously developed independently. The overall mapping accuracy was estimated at about 92.5% with 3% commission error and 12% omission error for the impervious type from all images regardless of image quality and initial spatial resolution.

75 FR 73017 - Approval and Promulgation of Implementation Plans; Georgia: Prevention of Significant...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-29

... produce ethanol through a natural fermentation process from the definition of ``chemical process plants... facilities that produce ethanol through a natural fermentation process from the definition of ``chemical...

78 FR 11754 - Approval and Promulgation of Implementation Plans; Tennessee: Knox County Supplement Motor...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-20

... December 18, 2012, (77 FR 74820), EPA proposed to approve through parallel processing Tennessee's October... well as changes to future vehicle mix assumptions, that influence the emission estimations. TDEC has... 2014. \\2\\ A safety margin is the difference between the attainment level of emissions from all source...

77 FR 64508 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-22

... Activities; Submission to OMB for Review and Approval; Comment Request; NESHAP for Mercury (Renewal) AGENCY... further information about the electronic docket, go to www.regulations.gov . Title: NESHAP for Mercury (40... process mercury ore to recover mercury Estimated Number of Respondents: 107. Frequency of Response...

25 CFR 273.17 - Programs approved by Indian Education Committee.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 25 Indians 1 2012-04-01 2011-04-01 true Programs approved by Indian Education Committee. 273.17 Section 273.17 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR INDIAN SELF-DETERMINATION AND EDUCATION ASSISTANCE ACT PROGRAM EDUCATION CONTRACTS UNDER JOHNSON-O'MALLEY ACT Application Process § 273.17...

25 CFR 273.17 - Programs approved by Indian Education Committee.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 25 Indians 1 2013-04-01 2013-04-01 false Programs approved by Indian Education Committee. 273.17 Section 273.17 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR INDIAN SELF-DETERMINATION AND EDUCATION ASSISTANCE ACT PROGRAM EDUCATION CONTRACTS UNDER JOHNSON-O'MALLEY ACT Application Process § 273.17...

25 CFR 273.17 - Programs approved by Indian Education Committee.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 25 Indians 1 2014-04-01 2014-04-01 false Programs approved by Indian Education Committee. 273.17 Section 273.17 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR INDIAN SELF-DETERMINATION AND EDUCATION ASSISTANCE ACT PROGRAM EDUCATION CONTRACTS UNDER JOHNSON-O'MALLEY ACT Application Process § 273.17...

78 FR 13625 - Approval of Subzone Status; Sea World, Inc.; Guaynabo, Puerto Rico

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-28

... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [S-138-2012] Approval of Subzone Status; Sea World, Inc.; Guaynabo, Puerto Rico On December 12, 2012, the Executive Secretary of the Foreign-Trade... Sea World, Inc., in Guaynabo, Puerto Rico. The application was processed in accordance with the FTZ...

30 CFR 227.107 - When will the MMS Director decide whether to approve a State's delegation proposal?

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 2 2010-07-01 2010-07-01 false When will the MMS Director decide whether to approve a State's delegation proposal? 227.107 Section 227.107 Mineral Resources MINERALS MANAGEMENT SERVICE, DEPARTMENT OF THE INTERIOR MINERALS REVENUE MANAGEMENT DELEGATION TO STATES Delegation Process...

School Site Selection and Approval Guide.

ERIC Educational Resources Information Center

California State Dept. of Education, Sacramento. Div. of School Facilities Planning.

This guide is designed to assist school districts in selecting school sites that provide both a safe and supportive environment for the instructional program and the learning process, and gain state approval for the selected sites. The guide includes a set of selection criteria that have proven helpful to site selection teams, information about…

GI Course Approvals.

ERIC Educational Resources Information Center

Orlans, Harold; And Others

The process by which institutions and courses are approved for veterans educational benefits is examined in this study mandated by Public Law 95-202. The legislative background of the investigation is described as well as the history of the Servicemen's Readjustment Act of 1944, the Korean Bill of 1952, and P.L. 94-502 of 1976. A summary guide to…

38 CFR 74.11 - How does CVE process applications for VetBiz VIP Verification Program?

Code of Federal Regulations, 2012 CFR

2012-07-01

... electronic means. (The Office of Management and Budget has approved the information collection requirements... Veterans Enterprise, is authorized to approve or deny applications for VetBiz VIP Verification. The CVE... complete and suitable for evaluation and, if not, what additional information or clarification is required...

38 CFR 74.11 - How does CVE process applications for VetBiz VIP Verification Program?

Code of Federal Regulations, 2010 CFR

2010-07-01

... electronic means. (The Office of Management and Budget has approved the information collection requirements... Veterans Enterprise, is authorized to approve or deny applications for VetBiz VIP Verification. The CVE... complete and suitable for evaluation and, if not, what additional information or clarification is required...

38 CFR 74.11 - How does CVE process applications for VetBiz VIP Verification Program?

Code of Federal Regulations, 2011 CFR

2011-07-01

... electronic means. (The Office of Management and Budget has approved the information collection requirements... Veterans Enterprise, is authorized to approve or deny applications for VetBiz VIP Verification. The CVE... complete and suitable for evaluation and, if not, what additional information or clarification is required...

38 CFR 74.11 - How does CVE process applications for VetBiz VIP Verification Program?

Code of Federal Regulations, 2014 CFR

2014-07-01

... electronic means. (The Office of Management and Budget has approved the information collection requirements... Veterans Enterprise, is authorized to approve or deny applications for VetBiz VIP Verification. The CVE... complete and suitable for evaluation and, if not, what additional information or clarification is required...

38 CFR 74.11 - How does CVE process applications for VetBiz VIP Verification Program?

Code of Federal Regulations, 2013 CFR

2013-07-01

... electronic means. (The Office of Management and Budget has approved the information collection requirements... Veterans Enterprise, is authorized to approve or deny applications for VetBiz VIP Verification. The CVE... complete and suitable for evaluation and, if not, what additional information or clarification is required...

75 FR 6422 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-09

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change... Incorporated NYSE Rule 411(a)(ii)(5) as Part of the Process of Developing the Consolidated FINRA Rulebook February 2, 2010. On December 4, 2009, the Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a...

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...

77 FR 68784 - Standard Test Procedures Approval Process for Respirators To Be Used in Wildland Fire-Fighting...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-16

... regulations allow. Because manufacturers have not yet developed respiratory protection for this occupational...-approved filtering facepiece respirators which are not designed for this use, or no respiratory protection... respiratory protective devices designed for the inhalation hazards of this occupational setting. On July 10...

The Ethics and Politics of Ethics Approval

ERIC Educational Resources Information Center

Battin, Tim; Riley, Dan; Avery, Alan

2014-01-01

The regulatory scope of Human Research Ethics Committees can be problematic for a variety of reasons. Some scholars have argued the ethics approval process, for example, is antithetical to certain disciplines in the humanities and social sciences, while others are willing to give it qualified support. This article uses a case study to cast the…

Bacteria-eating virus approved as food additive.

PubMed

Bren, Linda

2007-01-01

Not all viruses harm people. The Food and Drug Administration has approved a mixture of viruses as a food additive to protect people. The additive can be used in processing plants for spraying onto ready-to-eat meat and poultry products to protect consumers from the potentially life-threatening bacterium Listeria monocytogenes (L. monocytogenes).

78 FR 68705 - Premerger Notification; Reporting and Waiting Period Requirements

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-15

....\\6\\ An exclusive license is substantively the same as buying the patent or part of the patent... through the FDA approval process, nor to effectively market or promote it in drug form after FDA approval... promotion of the drug. There is a great deal of uncertainty involved because the transfer takes place very...

77 FR 64339 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-19

... development of a model notice of privacy practices (NPP). Need and Proposed Use of the Information: 45 CFR 164... verifying information, processing and maintaining information, and disclosing and providing information, to...-30D] Agency Information Collection Activities; Submission to OMB for Review and Approval; Public...