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Briefs, oral arguments, agency decisions and the Federal Register.
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Animal Food Labeling; Declaration of Certifiable Color Additives
Federal Register · Rule · Nov 17, 2011
FDA is issuing a final regulation in response to the Nutrition Labeling and Education Act of 1990 (the 1990 amendments), which amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by requiring … Act of 1995 (Pub.
76 FR 71248Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jan 17, 2025
The comment period closed December 4, 2024. FDA is withdrawing the direct final rule because the Agency received significant adverse comment. … SUPPLEMENTARY INFORMATION: Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, the direct final rule published on September
90 FR 5590Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · May 7, 2018
The comment period closed April 11, 2018. FDA is withdrawing the direct final rule because the Agency received significant adverse comment. … SUPPLEMENTARY INFORMATION: Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, the direct final rule published on January 26
83 FR 19936Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 17, 2011
However, this one-time testing will need to be conducted within 2 years after publication of the 2011 final rule (§ 201.327), which is within the period addressed in the PRA notice for that regulation. … It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments.
76 FR 35665Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 14, 2000
For hospital reprocessors, FDA intends to establish a 1-year phase in for active enforcement of the Federal Food, Drug, and Cosmetic Act's (the act's) nonpremarket requirements (e.g., registration, listing … The agency will use the 1-year period following issuance of this final guidance document to educate hospitals about their regulatory obligations.
65 FR 49583Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 14, 2010
GRAS affirmation petition process still exists, FDA has not received a GRAS affirmation petition since the establishment of the voluntary GRAS notification program and is not expecting any during the period … and other specific labeling acts administered by FDA.
75 FR 33624Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Dec 16, 2016
To this end, FDA has been periodically meeting with USP and discussing the 503A Bulks List (Refs. 5 and 6). … Paperwork Reduction Act of 1995 The submission of comments on this proposed rule would be submissions in response to a Federal Register notice, in the form of comments, which are excluded from the
81 FR 91071Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 11, 2026
ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. … Existing records may be used if they contain all the required information and are retained for the required time period.
91 FR 35486Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 29, 2025
The public can submit comments on the roundtable topics during the open comment period; the request for comments is not limited to small tobacco product manufacturers. … (FD&C Act).
90 FR 60715Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 11, 1999
This notice is issued under the Controlled Substances Act. … The short time period for the submission of comments and requests for a public meeting is needed to assure that HHS may, in a timely fashion, carry out the required action and be responsive to the United
64 FR 1629Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 3, 2020
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 … DATES: Fax written comments on the collection of information by March 4, 2020.
85 FR 5965Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jul 8, 1999
FDA is also reopening, until August 4, 1999, the comment period for the proposed rule, to allow interested persons to comment on the issues raised in this document. … Under Federal Food, Drug, and Cosmetic Act (the act), as amended by the Dietary Supplement Health and Education Act of 1994 (DSHEA), a dietary supplement may carry a statement that describes ``the role
64 FR 36824Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Exemption From Premarket Notification: Class II Devices; Surgical Apparel
Federal Register · Rule · May 17, 2018
To do so, FDA must publish in the Federal Register notice of its intent to exempt the device, or of the petition, and provide a 60-calendar day period for public comment. … Three commenters supported the implementation of the MOU with the CDC, acting through NIOSH, regarding oversight of N95s and exemption from 510(k) for this device type.
83 FR 22846Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 1, 2025
Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information including each proposed extension … entity; §§ 1.506(d)(3) 1.511(c)(5)(iii) 11,701 2 23,402 0.33 (20 minutes) 7,723 Conduct/review audits; § 1.506(e)(1)(i), 1.511(c)(6)(i)(A) 11,701 2 23,402 3 70,206 Conduct periodic
90 FR 18682Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 27, 2012
The comment period closed June 6, 2012. FDA is withdrawing the direct final rule because the Agency received significant adverse comment. … Authority: Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, the direct final rule published in the Federal Register
77 FR 38173Health and Human Services DepartmentFood and Drug AdministrationIrradiation in the Production, Processing and Handling of Food
Federal Register · Rule · Dec 3, 1997
The comments illustrate, however, a heightened public awareness of the health threat posed by pathogens in or on meat. … \13\ Following publication of the final rule, FDA received several letters and two submissions within the 30-day objection period.
62 FR 64107Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 20, 2010
Drug, and Cosmetic Act (the act). … Description : Section 228 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), amended section 704(g)(7) of the Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 374(g)(7)) to add the
75 FR 28257Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Mar 19, 2010
Background The Tobacco Control Act was enacted on June 22, 2009, amending the Federal Food, Drug, and Cosmetic Act (act) and providing FDA with the authority to regulate tobacco products (Public Law 111 … The 1995 proposed rule provided a 90-day comment period (extended to 144 days in the Federal Register of October 16, 1995 (60 FR 53560)).
75 FR 13225Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 26, 2009
Act of 1995 (the PRA) (44 U.S.C. 3501-3520). … for exposure in an endemic area, or medical diagnostic testing of the donor, the establishment notify consignees of all previously distributed blood and blood components collected during the lookback period
74 FR 13211Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Aug 22, 2008
Several comments referred to the recently enacted Food and Drug Administration Amendments Act of 2007 (FDAAA) in support of this position. … (Comment 15) One comment requested that FDA clarify that sponsors may not use the CBE process to submit labeling changes for drugs or biological products under section 505(o) of the act.
73 FR 49603Health and Human Services DepartmentFood and Drug Administration
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