Agency: Food and Drug Administration
Years: 20002001200220032004200520062007200820092010201120122013[FR Doc 2010-32344] 1. Substances Generally Recognized as Safe; Reopening of the Comment Period
The Food and Drug Administration (FDA) is reopening the comment period for the proposed rule published in the Federal Register of April 17, 1997 (the 1997 proposed rule). The 1997 proposed rule would replace the voluntary petition process to affirm the generally recognized as safe (GRAS) status of a substance intended for use in food for humans or
Published: 2010-12-28 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 2010-32249] 2. Draft Compliance Policy Guide Sec. 510.800 Beverages--Serving Size Labeling;
The Food and Drug Administration (FDA) is announcing the availability of draft ``Compliance Policy Guide Sec. 510.800 BeveragesServing Size Labeling'' (the draft CPG). The draft CPG, when finalized, will provide guidance for FDA staff on FDA's exercise of enforcement discretion related to serving size labeling for certain beverages that are
Published: 2010-12-23 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 2010-31952] 3. New Animal Drugs; Change of Sponsor's Address
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of address for Intervet, Inc., a sponsor of approved new animal drug applications.
Published: 2010-12-21 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 2010-31888] 4. Good Laboratory Practice for Nonclinical Laboratory Studies
The Food and Drug Administration (FDA) is seeking comment on whether to amend the regulations governing good laboratory practices (GLPs). The Agency decided that to require a GLP quality system for all facilities/laboratories, as well as to more completely address nonclinical studies as they are presently conducted, the Agency would need to modify
Published: 2010-12-21 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 2010-31889] 5. Unapproved Animal Drugs
The Food and Drug Administration (FDA, the Agency) is soliciting comments from stakeholders on strategies to address the prevalence of animal drug products marketed in the United States without approval or other legal marketing status. FDA is concerned that the safety and effectiveness of these activelymarketed products has not been demonstrated.
Published: 2010-12-20 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 2010-31382] 6. Uniform Compliance Date for Food Labeling Regulations
The Food and Drug Administration (FDA) is establishing January 1, 2014, as the uniform compliance date for food labeling regulations that are issued between January 1, 2011, and December 31, 2012. FDA periodically announces uniform compliance dates for new food labeling requirements to minimize the economic impact of label changes. On December 8,
Published: 2010-12-15 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 2010-31383] 7. Statement of Organization, Functions and Delegations of Authority
The Food and Drug Administration (FDA) has reorganized its Center for Tobacco Products (CTP) by establishing two new offices: Office of Health Communication and Education and the Office of Compliance and Enforcement. In addition, CTP has made improvements to the current offices' functional statements. This organizational change is intended to fill
Published: 2010-12-15 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 2010-30992] 8. Determination of Regulatory Review Period for Purposes of Patent Extension;
The Food and Drug Administration (FDA) has determined the regulatory review period for ILARIS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which
Published: 2010-12-09 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 2010-30991] 9. Determination of Regulatory Review Period for Purposes of Patent Extension;
The Food and Drug Administration (FDA) has determined the regulatory review period for BEPREVE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which
Published: 2010-12-09 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 2010-30995] 10. Determination of Regulatory Review Period for Purposes of Patent Extension;
The Food and Drug Administration (FDA) has determined the regulatory review period for SABRIL and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which
Published: 2010-12-09 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 2010-30685] 11. Required Warnings for Cigarette Packages and Advertisements; Research Report
The Food and Drug Administration (FDA) is announcing that it has added a document to the docket for the proposed rulemaking concerning required textual warnings and accompanying graphics to be displayed on cigarette packages and in cigarette advertisements. The document is a report entitled ``Report: Experimental Study of Graphic Cigarette Warning
Published: 2010-12-07 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 2010-30623] 12. Annual Guidance Agenda
The Food and Drug Administration (FDA) is publishing its annual guidance document agenda. This list is being published under FDA's good guidance practices (GGPs) regulations. It is intended to seek public comment on possible topics for future guidance document development or revisions of existing ones.
Published: 2010-12-07 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 2010-30387] 13. Draft Guidance for Industry on Residual Solvents in Animal Drug Products;
The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry
Published: 2010-12-03 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 2010-30039] 14. Amendments to General Regulations of the Food and Drug Administration
The Food and Drug Administration (FDA) is amending certain of its general regulations to include tobacco products, where appropriate, in light of FDA's authority to regulate these products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). With these amendments, tobacco products will be subject to the same general
Published: 2010-11-30 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 2010-30040] 15. Amendments to General Regulations of the Food and Drug Administration
The Food and Drug Administration (FDA) is proposing to amend certain of its general regulations to include tobacco products, where appropriate, in light of FDA's authority to regulate these products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). With these amendments, tobacco products will be subject to the same
Published: 2010-11-30 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 2010-29927] 16. Clinical Development Programs for Sedation Products; Request for Assistance
The Food and Drug Administration (FDA) is seeking information on a variety of issues related to the clinical development and use of sedation products in adult and pediatric age groups. FDA is inviting any interested party, or parties, to facilitate an evaluation of critical fundamentals of the science related to sedation products by conducting and
Published: 2010-11-29 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 2010-29150] 17.Office of the Secretary
Office of the Commissioner of Food and Drugs; Delegation of Authority
Notice is hereby given that I have delegated to the Commissioner of Food and Drugs the authorities vested in the Secretary of Health and Human Services under section 4 of the Federal Cigarette Labeling and Advertising Act (FCLAA)(15 U.S.C. 1333), as amended by the Family
Published: 2010-11-19 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 2010-28550] 18. New Animal Drugs for Minor Use and Minor Species
The Food and Drug Administration (FDA) is amending its regulations regarding new animal drugs for minor use and minor species to update language and to clarify the regulations consistent with the explanations in the preambles to the proposed and final rules establishing them. This action is being taken to ensure accuracy and clarity in the
Published: 2010-11-15 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 2010-28551] 19. New Animal Drugs for Minor Use and Minor Species
The Food and Drug Administration (FDA) is proposing to amend its regulations regarding new animal drugs for minor use and minor species to update language and to clarify the regulations consistent with the explanations in the preambles to the proposed and final rules establishing them. This action is being taken to ensure accuracy and clarity in
Published: 2010-11-15 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 2010-28307] 20. New Animal Drugs; Change of Sponsor's Name
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from North American Nutrition Companies, Inc., to Provimi North America, Inc.
Published: 2010-11-10 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 2010-28357] 21. Prescription Drug User Fee Act; Reopening of the Comment Period
The Food and Drug Administration (FDA) is reopening until October 31, 2011, the comment period for the notice of public meeting that published in the Federal Register of March 16, 2010 (75 FR 12555). In the notice, FDA announced a public meeting to solicit input on the reauthorization of the Prescription Drug User Fee Act (PDUFA) program. The
Published: 2010-11-10 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 2010-28193] 22. Report on the Performance of Drug and Biologics Firms in Conducting
Under the Food and Drug Administration Modernization Act of 1997 (Modernization Act), the Food and Drug Administration (FDA) is required to report annually in the Federal Register on the status of postmarketing requirements and commitments required of, or agreed upon by, holders of approved drug and biological products. This notice is the Agency's
Published: 2010-11-09 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 2010-27824] 23. Generic Drug User Fee; Notice of Public Meeting; Reopening of the Comment
The Food and Drug Administration (FDA) is reopening until December 6, 2010, the comment period for the notice of public meeting entitled Generic Drug User Fee; Public Meeting; Request for Comments, published in the Federal Register of August 9, 2010 (75 FR 47820). In that notice, FDA announced a public meeting that took place on September 17,
Published: 2010-11-04 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 2010-27448] 24. Draft Compliance Policy Guide Sec. 690.800 Salmonella in Animal Feed;
The Food and Drug Administration (FDA) is extending to December 31, 2010, the comment period for a notice of availability of a draft compliance policy guide (CPG) that appeared in the Federal Register of August 2, 2010 (75 FR 45130). In the document, FDA requested comments on its proposal that certain criteria should be considered in recommending
Published: 2010-10-29 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 2010-25687] 25. Cooperative Agreement To Support Building Global Capacity for the
The Food and Drug Administration (FDA) is announcing its intention to accept and consider a single source application for award of a cooperative agreement to the World Health Organization (WHO) in support of building a global surveillance and monitoring system for combating counterfeit/falsified medicines and risks and breaches in the supply.
Published: 2010-10-13 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
Years: 20002001200220032004200520062007200820092010201120122013