Documents
Briefs, oral arguments, agency decisions and the Federal Register.
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Advisory 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 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 · Rule · Dec 19, 2016
Section 403(r)(7) of the FD&C Act authorizes us to make proposed regulations issued under section 403(r) of the FD&C Act effective upon publication pending consideration of public comment and publication … We invite public comment on this interim final rule. We will consider modifications to this interim final rule based on comments made during the comment period.
81 FR 91716Health and Human Services DepartmentFood and Drug AdministrationAdvisory Committee; Notice of Meeting
Federal Register · Uncategorized Document · Feb 1, 1994
brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time required to make their comments … 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.
Health and Human Services DepartmentFood and Drug AdministrationDevices Proposed for a New Use With an Approved, Marketed Drug; Public Hearing; Request for Comments
Federal Register · Notice · Sep 26, 2017
the approved, marketed drug is low; changes to the drug are unlikely to raise safety or effectiveness issues with respect to the conditions of use with the drug as described in the DRD labeling; and periodic … To the extent that the conditions for the hearing, as described in this notice, conflict with any provisions set out in part 15, this notice acts as a waiver of those provisions as specified in § 15.30
82 FR 44803Health 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 · Proposed Rule · Apr 5, 2010
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. … Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one copy.
75 FR 17093Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 3, 2020
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.
85 FR 46666Health and Human Services DepartmentFood and Drug AdministrationAdvisory Committees; Notice of Meetings
Federal Register · Notice · Sep 27, 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 50828Health and Human Services DepartmentFood and Drug Administration
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