Agency: Food and Drug Administration

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[FR Doc E9-20248] 76. Agency Information Collection Activities: Proposed Collection; Comment

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, and to allow 60 days

Published: 2009-08-24 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-20119] 77. Revision of the Requirements for Publication of License Revocation;

The Food and Drug Administration (FDA) is confirming the effective date of September 17, 2009, for the direct final rule that appeared in the Federal Register of May 5, 2009 (74 FR 20583). The direct final rule amends the biologics regulations to clarify the regulatory procedures for notifying the public about the revocation of a biologics

Published: 2009-08-21 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-20084] 78. Clinical Investigator Training Course

The Food and Drug Administration's (FDA's) Office of Critical Path Programs and the Clinical Trials Transformation Initiative (CTTI) are cosponsoring a 3day training course for clinical investigators on scientific, ethical, and regulatory aspects of clinical trials. This training course is intended to provide investigators with expertise in the

Published: 2009-08-21 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-20083] 79. Prescription Drug User Fee Act IV Information Technology Assessment

In the last decade, the Food and Drug Adminstration (FDA) has achieved great success in reforming and modernizing its regulatory processes and responsibilities as a result of changes and improvements driven by the requirements of the Prescription Drug User Fee Act (PDUFA), the 1997 FDA Modernization Act (FDAMA), and other legislation. PDUFA was

Published: 2009-08-21 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-19972] 80.Agency Information Collection Activities; Announcement of Office of Management

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Investigational New Drug Regulations'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Published: 2009-08-20 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-19980] 81.Agency Information Collection Activities; Announcement of Office of Management

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``MedWatch: Food and Drug Administration Medical Products Reporting Program'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Published: 2009-08-20 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-19782] 82.Agency Information Collection Activities; Submission for Office of Management

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Published: 2009-08-18 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-19784] 83.Agency Information Collection Activities; Announcement of Office of Management

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Recommendations for Early Food Safety Evaluation of New NonPesticidal Proteins Produced by New Plant Varieties Intended for Food Use'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Published: 2009-08-18 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc 09-19785] 84.Agency Information Collection Activities; Announcement of Office of Management

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Irradiation in the Production, Processing, and Handling of Food'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Published: 2009-08-18 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-19787] 85.Agency Information Collection Activities; Announcement of Office of Management

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Mental Models Study of Farmers' Understanding and Implementation of Good Agricultural Practices'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Published: 2009-08-18 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-19788] 86.Agency Information Collection Activities; Announcement of Office of Management

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Financial Disclosure by Clinical Investigators'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Published: 2009-08-18 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-19779] 87.Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2010;

The Food and Drug Administration is correcting a notice entitled that appeared in the Federal Register of August 3, 2009 (74 FR 38429). The document announced the Fiscal Year 2010 fee rates for the Animal Drug User Fee Act. The document was published with a typographical error. This document corrects that error.

Published: 2009-08-18 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-19680] 88.Office of the Commissioner Reorganization; Statement of Organizations,

The Food and Drug Administration (FDA) has reorganized the Office of the Commissioner (OC). This reorganization includes the organizations and their substructure components as listed in this document. This reorganization includes the realignment of four Deputy level offices within the Office of the Commissioner: the Office of the Chief Scientist; the

Published: 2009-08-18 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-19522] 89. International Conference on Harmonisation; Draft Guidance on Q4B Evaluation

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 10: Polyacrylamide Gel Electrophoresis General Chapter.'' The draft guidance was prepared under the auspices of the International Conference on

Published: 2009-08-14 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-19297] 90. Use of Ozone-Depleting Substances; Epinephrine

CFR Correction

In Title 21 of the Code of Federal Regulations, parts 1 to 99, revised as of Apr. 1, 2009, on page 66, Sec. 2.125(e)(2)(v) is reinstated as follows:
Sec. 2.125 Use of ozonedepleting substances in foods, drugs, devices, or cosmetics.
* * * * *
(e) * * *
(2) * * *
(v) Epinephrine.
* * * * *
[FR Doc. E919297 Filed

Published: 2009-08-11 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-19107] 91. Review of Post-Inspection Responses

The Food and Drug Administration (FDA) is announcing a program to support public health protection by facilitating the timely issuance of warning letters. The program establishes a timeframe for the submission and agency review of postinspection responses to inspectional
[[Page 40212]]
observations that are communicated to a firm through issuance

Published: 2009-08-11 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-18952] 92. Guidance for Industry on Pharmaceutical Components at Risk for Melamine

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Pharmaceutical Components at Risk for Melamine Contamination.'' This guidance provides recommendations that will help pharmaceutical manufacturers of finished products, repackers, other suppliers, and pharmacists who engage in drug

Published: 2009-08-07 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-18532] 93. Agency Information Collection Activities; Announcement of Office of

The Food and Drug Administration (FDA) is announcing that a collection of information entitled Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of

Published: 2009-08-04 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-18569] 94. Authorization of Emergency Use of Certain In Vitro Diagnostic Devices;

The Food and Drug Administration (FDA) is announcing the issuance of two Emergency Use Authorizations (EUAs) (the
Authorizations), one of which was amended, for certain in vitro diagnostic devices. FDA is issuing the Authorizations under the Federal Food, Drug, and Cosmetic Act (the act), as requested by the Centers for Disease Control and

Published: 2009-08-04 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-18570] 95. Authorization of Emergency Use of Certain Personal Respiratory Protection

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization), as amended, for certain personal respiratory protection devices.\1\ FDA is issuing this Authorization under the Federal Food, Drug, and Cosmetic Act (the act), as requested by the Centers for Disease Control and Prevention

Published: 2009-08-04 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-18533] 96. Cooperative Agreement Between the Food and Drug Administration and the

The Food and Drug Administration (FDA) is announcing its intention to receive and consider a single source application for the award of a cooperative agreement in fiscal year 2009 (FY09) to the Dauphin Island Sea Lab (DISL). The goal of the DISL is marine science education, basic and applied marine science research, coastal zone management policy

Published: 2009-08-04 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-18416] 97. Seafood Hazard Analysis and Critical Control Points Alliance for Education

The Food and Drug Administration (FDA) is announcing its intention to receive and consider a single source application for the award of a cooperative agreement in fiscal year 2009 (FY09) to the University of Florida for the support of the Seafood Hazard Analysis and Critical Control Points (HACCP) Alliance for Education and Training. The goal of

Published: 2009-08-03 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-18459] 98. Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2010

The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2010 animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Animal Drug User Fee Act of 2003 (ADUFA) and the Animal Drug User Fee Amendments of 2008 (ADUFA II), authorizes FDA to collect user fees for

Published: 2009-08-03 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-18458] 99. Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year

The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2010 generic new animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Animal Generic Drug User Fee Act of 2008 (AGDUFA), authorizes FDA to collect user fees for certain abbreviated applications for

Published: 2009-08-03 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-18456] 100. Medical Device User Fee Rates for Fiscal Year 2010

The Food and Drug Administration (FDA) is announcing the [[Page 38445]]
fee rates and payment procedures for medical device user fees for fiscal year (FY) 2010. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), the Medical Device User Fee Stabilization Act of 2005

Published: 2009-08-03 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

Years: 2000200120022003200420052006200720082009

Pages: «23456>»