Documents
Briefs, oral arguments, agency decisions and the Federal Register.
5,436 results
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Advisory Committees; Notice of Meetings
Federal Register · Notice · Nov 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 57873Health and Human Services DepartmentFood and Drug AdministrationAdvisory Committees; Notice of Meetings
Federal Register · Notice · Apr 18, 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 19403Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 9, 2018
Agreements Act of 1979 (Pub. … FDA regulates the safety of fish and fishery products, including shellfish, under the FD&C Act, the Public Health Service Act (PHS Act), and our regulations (21 CFR part 123 Fish and Fishery Products
83 FR 10487Health and Human Services DepartmentFood and Drug AdministrationPrescription Drug User Fee Rates for Fiscal Year 2020
Federal Register · Notice · Aug 2, 2019
that ended on June 30, 2018, and the average number of each of these elements over the most recent 3-year period that ended June 30, 2019. … As table 6 shows, the average number of fee-paying FAEs received annually in the most recent 3-year period is 73.036145 FAEs.
84 FR 37882Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Mar 24, 2004
In response to two requests for extension of time to file comments to the final rule, FDA published a document in the Federal Register of July 22, 1996 (61 FR 38046), extending the comment period until … (the act).
69 FR 13717Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 13, 2018
Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to conduct research relating to drugs and other FDA regulated products in carrying out … the provisions of the FD&C Act.
83 FR 10855Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jul 18, 2016
We have not received any new information or comments that would affect our previous determination. VII. Paperwork Reduction Act of 1995 This final rule contains no collection of information. … Section 301( ll ) of the Federal Food, Drug, and Cosmetic Act Our review of this petition was limited to section 409 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 348).
81 FR 46578Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 25, 2004
An FSR and a progress report are also required no later than 90 days after the close of the budget period. … FDA does not guarantee availability to accommodate or explain SPOC comments that are received after the 60-day cutoff. B.
69 FR 35651Health and Human Services DepartmentFood and Drug AdministrationAdvisory Committee; Notice of Meeting
Federal Register · Uncategorized Document · Mar 7, 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. Dated: March 1, 1994.
Health and Human Services DepartmentFood and Drug AdministrationAdvisory Committee; Notice of Meeting
Federal Register · Notice · Jun 6, 1995
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. Dated: May 25, 1995.
60 FR 29854Health and Human Services DepartmentFood and Drug AdministrationAdvisory Committee; Notice of Meeting
Federal Register · Uncategorized Document · Jul 13, 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. Dated: July 7, 1994.
Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 1, 2008
FDA does not guarantee availability to accommodate or explain SPOC comments that are received after the 60 day cut-off. … Reports must be submitted two months prior to the next budget period start date.
73 FR 37466Health and Human Services DepartmentFood and Drug AdministrationAdvisory Committees; Notice of Meetings
Federal Register · Notice · Aug 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 43599Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 9, 2013
information on a variety of topics, including new product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings, proposed regulatory guidances and opportunity to comment … , and other information of interest to patients and patient advocates; and • Hosting of periodic meetings, briefings, and listening sessions between patient advocates and FDA staff.
78 FR 48691Health and Human Services DepartmentFood and Drug AdministrationCrabmeat; Amendment of Common or Usual Name Regulation
Federal Register · Uncategorized Document · Jul 15, 1994
Comments Interested persons may, on or before September 13, 1994, submit to the Dockets Management Branch (address above) written comments regarding this proposal. … Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document.
Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jul 10, 2014
These comments relate to tobacco products that are not currently subject to chapter IX of the FD&C Act. … (Comment 7) One comment recommended that FDA “develop a schedule for periodically reevaluating and adjusting user fee percentage allocations” for tobacco product classes as well as manufacturers and importers
79 FR 39302Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Aug 3, 2020
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (PRA) by September 2, 2020. … Costs, Benefits, and Distributional Effects of the Proposed Rule Category Primary estimate Low estimate High estimate Units Year dollars Discount rate (%) Period
85 FR 46566Health and Human Services DepartmentFood and Drug AdministrationCurrent Good Manufacturing Practice Requirements for Combination Products
Federal Register · Proposed Rule · Sep 23, 2009
under the PHS Act and/or the act. … FDA requests comment on this issue.
74 FR 48423Health and Human Services DepartmentFood and Drug AdministrationList of Bulk Drug Substances That May Be Used in Pharmacy Compounding
Federal Register · Proposed Rule · Jan 7, 1999
DATES: Submit written comments on or before March 23, 1999. … Request for Comments Interested persons may, on or before March 23, 1999, submit to the Dockets Management Branch (address above) written comments regarding this proposal.
64 FR 996Health and Human Services DepartmentFood and Drug AdministrationInternational Harmonization; Policy on Standards
Federal Register · Notice · Oct 11, 1995
The statutory mandates for safeguarding the public health in these product sectors are prescribed in several statutes, notably in the Federal Food, Drug, and Cosmetic Act; the Public Health Service Act … ; and the Fair Packaging and Labeling Act.
60 FR 53078Health and Human Services DepartmentFood and Drug Administration
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