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Federal Register · Notice · Apr 28, 2003
Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d … Extension of time period for the transition statement. 28 H. General Hospital/ General Plastic Surgery Old Item No.
68 FR 22391Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 10, 2023
The AOAC Method permits the calculation of a PER as the ratio of the average animal body weight gain per gram of protein consumed of a test protein versus casein after a 28-day feeding period. … Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection
88 FR 8868Health and Human Services DepartmentFood and Drug AdministrationAdvisory Committees; Notice of Meetings
Federal Register · Notice · Jul 24, 1996
emphasized, however, that the 1 hour time limit for an open public hearing represents a minimum rather than a maximum time for public participation, and an open public hearing may last for whatever longer period … This notice is issued under section 10(a)(1) and (2) of the Federal Advisory Committee Act (5 U.S.C. app. 2), and FDA's regulations (21 CFR part 14) on advisory committees.
61 FR 38453Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Aug 16, 2024
Submit written comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 by October 15, 2024. … The estimated annualized costs of this rulemaking over a 10-year period would range from $0.002 million to $0.007 million at a 2 percent discount rate, with a primary estimate of $0.005 million.
89 FR 66647Health and Human Services DepartmentFood and Drug AdministrationAdvisory Committees; Notice of Meetings
Federal Register · Notice · Mar 22, 1995
emphasized, however, that the 1 hour time limit for an open public hearing represents a minimum rather than a maximum time for public participation, and an open public hearing may last for whatever longer period … The Federal Advisory Committee Act (FACA) (5 U.S.C. app. 2, 10(d)), permits such closed advisory committee meetings in certain circumstances.
60 FR 15147Health and Human Services DepartmentFood and Drug AdministrationLabel Requirement for Food That Has Been Refused Admission Into the United States
Federal Register · Proposed Rule · Sep 28, 2018
As directed by section 304 of the FDA Food Safety Modernization Act (Pub. … Should we decide to undertake such a rulemaking in the future, we will re-propose the action and provide a new opportunity for comment.
83 FR 49022Health and Human Services DepartmentFood and Drug AdministrationMutual Recognition of Pharmaceutical Good Manufacturing Practices Annex; Public Meeting
Federal Register · Rule · Oct 27, 1999
In the preamble to the final rule, FDA stated that it plans to hold periodic meetings with interested parties and make public summaries of key meetings held with its EU counterparts concerning implementation … Dotzel, Acting Associate Commissioner for Policy. [FR Doc. 99-27973 Filed 10-26-99; 8:45 am] BILLING CODE 4160-01-F
64 FR 57776Health and Human Services DepartmentFood and Drug AdministrationAdvisory Committees; Notice of Meetings
Federal Register · Notice · May 21, 1997
emphasized, however, that the 1 hour time limit for an open public hearing represents a minimum rather than a maximum time for public participation, and an open public hearing may last for whatever longer period … The Federal Advisory Committee Act (FACA) (5 U.S.C. app. 2, 10(d)), permits such closed advisory committee meetings in certain circumstances.
62 FR 27769Health and Human Services DepartmentFood and Drug AdministrationAdvisory Committees; Notice of Meetings
Federal Register · Notice · Jun 25, 1996
emphasized, however, that the 1 hour time limit for an open public hearing represents a minimum rather than a maximum time for public participation, and an open public hearing may last for whatever longer period … The Federal Advisory Committee Act (FACA) (5 U.S.C. app. 2, 10(d)), permits such closed advisory committee meetings in certain circumstances.
61 FR 32829Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 29, 2018
A covered drug product is: (1) Subject to an approved application under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or under section 351 of the Public Health Service Act (42 … Paperwork Reduction Act of 1995 This notice refers to previously approved collections of information found in FDA regulations.
83 FR 30748Health and Human Services DepartmentFood and Drug AdministrationListing of Color Additives Exempt From Certification; Mica-Based Pearlescent Pigments
Federal Register · Rule · Jun 8, 2015
Follow the instructions for submitting comments. … We have not received any new information or comments that would affect our previous determinations. VI. Paperwork Reduction Act of 1995 This final rule contains no collection of information.
80 FR 32303Health and Human Services DepartmentFood and Drug AdministrationTermination of Listing of Color Additives Exempt From Certification; Lead Acetate
Federal Register · Rule · Oct 8, 2021
The intended use of lead acetate is as a color additive and as such we are acting under sections 721(d) and 601(e) (21 U.S.C. 361(e)) of the FD&C Act. … (Response to Objection 19) We addressed this consideration in the final rule in our response to Combe's comment (see 83 FR 54665 at 54672).
86 FR 56183Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Health Claims; Soluble Fiber from Certain Foods and Risk of Coronary Heart Disease
Federal Register · Rule · May 1, 2008
(the petitioner) on November 7, 2005, under section 403(r)(4) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 343(r)(4)). … FDA solicited comments on the proposed rule. The comment period closed on April 23, 2007. The agency received eight responses, each containing one or more comments, to the proposed rule.
73 FR 23947Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Nov 17, 2011
Individuals aged 12 and above who had smoked within the past month were asked about their usual brand choice during that time period. … Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. VIII. Requests for Comments FDA is requesting comments on this proposed rule.
76 FR 71281Health and Human Services DepartmentFood and Drug AdministrationAdvisory Committees; Notice of Meetings
Federal Register · Notice · May 24, 1995
emphasized, however, that the 1 hour time limit for an open public hearing represents a minimum rather than a maximum time for public participation, and an open public hearing may last for whatever longer period … The Federal Advisory Committee Act (FACA) (5 U.S.C. app. 2, 10(d)), permits [[Page 27532]] such closed advisory committee meetings in certain circumstances.
60 FR 27530Health and Human Services DepartmentFood and Drug AdministrationAdvisory Committees; Notice of Meetings
Federal Register · Notice · Oct 25, 1996
emphasized, however, that the 1 hour time limit for an open public hearing represents a minimum rather than a maximum time for public participation, and an open public hearing may last for whatever longer period … The Federal Advisory Committee Act (FACA) (5 U.S.C. app. 2, 10(d)), permits such closed advisory committee meetings in certain circumstances.
61 FR 55306Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 7, 2010
As each submission is completed, the users will be asked to comment on the eSubmitter program. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010-22167 Filed 9-3-10; 8:45 am] BILLING CODE 4160-01-S
75 FR 54343Health and Human Services DepartmentFood and Drug AdministrationFood Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3
Federal Register · Rule · Jun 22, 2005
Follow the instructions for submitting comments. • Agency Web site: http://www.fda.gov/dockets/ecomments . Follow the instructions for submitting comments on the agency Web site. … Objections and Requests for a Hearing Section 409(f) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 348(f)), provides that, within 30 days after publication of an order relating to a
70 FR 36021Health and Human Services DepartmentFood and Drug AdministrationFinancial Disclosure by Clinical Investigators
Federal Register · Rule · Dec 31, 1998
As discussed in section V of this document, PhRMA had also submitted a comment under the Paperwork Reduction Act of 1995 (the PRA) on the information collection provisions of the rule. … Analysis of Impact FDA has examined the impacts of the final rule under Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act (Pub.
63 FR 72171Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Revision of the Nutrition and Supplement Facts Labels
Federal Register · Proposed Rule · Mar 3, 2014
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by April 2, 2014 (see the “Paperwork Reduction Act of 1995” section of this document). … On April 19, 2004 (69 FR 20838), we extended the comment period for the 2003 ANPRM to receive comments that considered the information in the 2004 meeting of the Nutrition Subcommittee of the Food Advisory
79 FR 11880Health and Human Services DepartmentFood and Drug Administration
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