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Briefs, oral arguments, agency decisions and the Federal Register.
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Food Labeling: Health Claims; Soluble Fiber From Certain Foods and Risk of Coronary Heart Disease
Federal Register · Rule · Feb 25, 2008
Section 403(r)(7) of the act authorizes us to make proposed regulations issued under section 403(r) of the act effective upon publication pending consideration of public comment and publication of a final … FDA invites public comment on this interim final rule. The agency will consider modifications to this interim final rule based on comments made during the comment period.
73 FR 9938Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities; Submission for OMB Review; Comment Request
Federal Register · Notice · Jul 16, 1997
DATES: Submit written comments on the collection of information by August 15, 1997. … Under Sec. 895.21(d), any interested person may request an informal hearing and submit written comments.
62 FR 38095Health and Human Services DepartmentFood and Drug AdministrationFood and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications
Federal Register · Proposed Rule · Apr 4, 2016
FDA is proposing to issue a final rule within 912 days (generally 30 months) of the closing of the comment period for the proposed rule. … During this 912-day time period, FDA will review and consider any new data, information, and public comments submitted to the docket and draft and publish a final regulation.
81 FR 19069Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 10, 2009
The Food and Drug Administration Amendments Act of 2007 (FDAAA) includes a requirement that FDA identify and periodically update susceptibility test interpretive criteria for antibacterial drug products … No comments were received.
74 FR 6634Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 20, 2010
If you wish to make an oral presentation during the open comment period at the workshop, you must indicate this at the time of registration. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010-20659 Filed 8-19-10; 8:45 am] BILLING CODE 4160-01-S
75 FR 51467Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 25, 2019
Background Section 3011 of the 21st Century Cures Act (Pub. L. 114-255) added a new section 507 to the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 357). … The BEST glossary is meant to be a resource that will be periodically updated with additional terms and clarifying information.
84 FR 35868Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 17, 2001
providing guidance regarding further distribution, giving instructions as to what to do with the product, providing recipients with a ready means of reporting to the recalling firm (§ 7.49); and submitting periodic … One comment was received on the information collection.
66 FR 43263Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Dec 16, 2019
(Response 4) FDA agrees with the commenter that this rule should apply to all premarket regulatory submissions that are specified in section 745A(b) of the FD&C Act. … Act of 1995 (Pub.
84 FR 68334Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 5, 2023
The Federal Food, Drug, and Cosmetic Act (FD&C Act) directs that FDA consult with the public as part of the OMUFA reauthorization process. … This notice, the public meeting, the 30-day comment period after the meeting, and the posting of the comments on the FDA website will help satisfy these requirements.
88 FR 60688Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 25, 2013
The comment period closed on April 6, 2009. Three sets of comments were received and reviewed by FDA. The guidance was updated to address comments where appropriate. … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations and guidance documents.
78 FR 24425Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 15, 2006
Paperwork Reduction Act of 1995 This guidance document refers to previously approved collections of information found in FDA regulations. … FDA will periodically review the comments in the docket and, where appropriate, will amend the guidance.
71 FR 34625Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 23, 2019
The Pilot Accreditation Scheme for Conformity Assessment Program (hereafter referred to as the ASCA Pilot) is authorized under the Federal Food, Drug, and Cosmetic Act (FD&C Act). … Paperwork Reduction Act of 1995 In the Federal Register of September 5, 2019 (84 FR 46737), FDA requested public comment on the collections of information associated with the ASCA Pilot.
84 FR 49741Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 3, 2025
period to allow interested parties to provide comments about issues of fact, law, and policy raised by the rules postponed under this memorandum”; and consider further delaying such rules “where necessary … the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)(1)(C)).
90 FR 8802Health and Human Services DepartmentFood and Drug AdministrationProduct-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Federal Register · Notice · Aug 22, 2023
Under that process, draft guidances are posted on FDA's website and announced periodically in the Federal Register . … Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. V.
88 FR 57116Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · May 30, 2008
By notice published in the Federal Register of March 10, 1992 (57 FR 8462), FDA extended the reporting period to March 31, 1992. … Subsequently, as permitted by section 520(l)(5)(C) of the act, in the Federal Register of November 30, 1992 (57 FR 56586), the agency published a notice extending the period for issuing such regulations
73 FR 31027Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 9, 2006
regulations (40 CFR part 1500 and 21 CFR part 25) and under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(d)). … FDA will periodically review the comments in the docket and, where appropriate, will amend the guidance.
71 FR 1434Health and Human Services DepartmentFood and Drug AdministrationReauthorization of the Generic Drug User Fee Amendments; Public Meeting; Request for Comments
Federal Register · Notice · May 19, 2025
The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that before FDA begins negotiations with the regulated industry on GDUFA reauthorization, we publish a notice in the Federal Register requesting … Goals and Program Enhancements Fiscal Years 2023-2027 ( i.e., the GDUFA III Commitment Letter) ( https://www.fda.gov/industry/generic-drug-user-fee-amendments/gdufa-iii-reauthorization ); provide a period
90 FR 21313Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 17, 2014
of 2002 (the Bioterrorism Act) added section 414 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 350c), which requires that persons who manufacture, process, pack, hold, receive, … Existing records may be used if they contain all of the required information and are retained for the required time period. Section 101 of the FDA Food Safety Modernization Act (FSMA) (Pub.
79 FR 21767Health and Human Services DepartmentFood and Drug AdministrationRevocation of Certain Regulations; General
Federal Register · Rule · Jul 23, 1997
FDA received one comment on this provision, and the comment expressed no objection to revoking this provision. Consequently, Sec. 1.31 is revoked. … only as a result of internal Agency deliberation * * * if this policy is to be modified, it should be done so only in accordance with standard rule-making procedures, with a public comment period on the
62 FR 39439Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Oct 3, 1996
The agency requests specific comment on whether OTC marketing experience should be considered solely from countries listed or designated under the new section 802(b)(1) of the act or whether experience … (3) Comment No. CP1, Docket No. 78N-0038, Dockets Management Branch. (4) Comment No. CP2, Docket No. 78N-0038, Dockets Management Branch. (5) Comment No.
61 FR 51625Health and Human Services DepartmentFood and Drug Administration
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