Documents
Briefs, oral arguments, agency decisions and the Federal Register.
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Advisory 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 AdministrationListing of Color Additives Exempt From Certification; Calcium Carbonate
Federal Register · Rule · Nov 7, 2017
The IOM considers the UL as the highest average daily intake level of a nutrient that poses no risk of adverse effects when the nutrient is consumed over long periods of time. … We have not received any new information or comments that would affect our previous determination. VIII. Paperwork Reduction Act of 1995 This final rule contains no collection of information.
82 FR 51554Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 28, 2023
As required by section 743(b)(2)(B)(iii) of the FD&C Act, FDA previously published a set of guidelines in consideration of the burden of the VQIP fee on small businesses and provided for a period of public … Consistent with section 743(b)(2)(B)(iii) of the FD&C Act, we will adjust the fee schedule for small businesses only through notice and comment rulemaking.
88 FR 48893Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 28, 2014
DATES: Fax written comments on the collection of information by June 27, 2014. … Enrolled jurisdictions must conduct the work described in tables 1, 2, and 3 over a 5-year period.
79 FR 30616Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 27, 2015
On November 21, 1997, the President signed into law the FDA Modernization Act (FDAMA) (Pub. L. 105-115). Section 206 of FDAMA, in part, added a new section 510(m) to the FD&C Act. … This section requires FDA to publish in the Federal Register a notice of intent to exempt a device, or of the petition, and to provide a 30-day comment period.
80 FR 65774Health 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 · Apr 14, 2003
Drug products covered by this notice (i.e., estrogen-androgen combination drugs) are regarded as new drugs (section 201(p) of the Federal Food, Drug, and Cosmetic Act (the act) 21 U.S.C. 321(p)). … Any other interested person may also submit comments on this notice.
68 FR 17953Health 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 AdministrationMedical Device Classification Procedures
Federal Register · Proposed Rule · Mar 25, 2014
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (the PRA) by April 24, 2014. ADDRESSES: You may submit comments, identified by Docket No. … Paperwork Reduction Act of 1995 VIII. Proposed Effective Date IX. Comments SUPPLEMENTARY INFORMATION: I.
79 FR 16252Health and Human Services DepartmentFood and Drug AdministrationAdvisory Committees; Notice of Meetings
Federal Register · Uncategorized Document · Aug 16, 1994
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.
Health and Human Services DepartmentFood and Drug AdministrationFood Additives Permitted in Feed and Drinking Water of Animals; Formaldehyde
Federal Register · Rule · Oct 6, 1998
The notice of filing provided for a 30-day comment period on the petitioner's environmental assessment. No comments have been received. … The label also contains a statement that ``Formaldehyde is subject to SARA Title III, Section 313 reporting'' (Superfund Amendments and Reauthorization Act (SARA), and the Occupational Safety and Health
63 FR 53579Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 25, 2007
of the same proposed DTC television advertisement, after receipt of FDA advisory comments on the initial submission. … For example, assuming 150 submissions in FY 2008, FDA will review and provide advisory comments to the sponsor within 45 days on 50 percent of the 150 original submissions.
72 FR 60677Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Dec 8, 2021
This section requires FDA to publish in the Federal Register a notice of intent to exempt a device, or of the petition, and to provide a 60-day period for public comment. … FDA received one comment that is unrelated to the petition and, thus, outside the scope of this final order.
86 FR 69583Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 24, 2019
Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d). … Such standards are those that FDA has recognized by notice published in the Federal Register or that FDA has decided to recognize but for which recognition is pending (because a periodic notice has
84 FR 57034Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jul 2, 2019
Introduction We received various comments from a trade organization and an individual on the proposed rule by the close of the comment period; however, only one commenter provided comments on issues relevant … (Comment 2) A comment requested that FDA expand the definition of significant decision as set forth in section 517A of the FD&C Act by including: (1) a grant or denial of Clinical Laboratory Improvement
84 FR 31471Health and Human Services DepartmentFood and Drug AdministrationCertain Requirements Regarding Prescription Drug Marketing
Federal Register · Proposed Rule · Feb 4, 2022
DATES: Submit either electronic or written comments on the proposed rule by April 5, 2022. ADDRESSES: You may submit comments as follows. … relationship means an association that exists when a manufacturer and a distributor enter into a written agreement under which the distributor is authorized to distribute the manufacturer's drug samples for a period
87 FR 6443Health and Human Services DepartmentFood and Drug AdministrationConsumer-Directed Promotion of Regulated Medical Products; Public Hearing
Federal Register · Notice · Sep 13, 2005
Comments about the meeting or comments after the meeting should be submitted to http://www.fda.gov/dockets/ecomments . … This includes, for example, “advertisements in published journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television, and telephone communication
70 FR 54054Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Nov 28, 1997
Background The 1984 amendments included a provision, codified under section 505(j)(4)(B)(iv) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(j)(4)(B)(iv)), granting 180 days of … The regulations in Sec. 314.107(c) were issued through notice and comment rulemaking with the active participation of the pharmaceutical industry and consumer groups.
62 FR 63268Health 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 Administration
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