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Federal Register · Notice · Jan 14, 1997
The Director is proposing to withdraw approval of NDA 18-949 and NDA 19-664 in accordance with section 505(e)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(e)(2)). … Any other interested person may also submit comments on this notice.
62 FR 1889Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 28, 2021
comment on the guidelines (80 FR 32136, June 5, 2015). … 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.
86 FR 40580Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 31, 2024
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.
89 FR 61485Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Quality System Regulation Amendments
Federal Register · Rule · Feb 2, 2024
The comment period for the proposed rule closed on May 24, 2022. … period of time following publication in the Federal Register .
89 FR 7496Health and Human Services DepartmentFood and Drug AdministrationFood Additives; Threshold of Regulation for Substances Used in Food-Contact Articles
Federal Register · Rule · Jul 17, 1995
Comments on the Proposed Rule The agency provided 60 days for comment on the proposed rule. It received two requests from industry for an extension of the comment period. … The agency granted a 60-day extension of the comment period to February 11, 1994, in a notice published in the Federal Register of December 13, 1993 (58 FR 65139).
60 FR 36582Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jan 21, 2022
Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 21, 2022. … Benefits and Costs in 2020 Dollars Over a 10-Year Time Horizon Category Primary estimate Low estimate High estimate Units Year dollars Discount rate (%) Period
87 FR 3250Health 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 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 · 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 AdministrationAdvisory 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 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 AdministrationFederal Register · Notice · Aug 25, 2000
Moreover, the Conference Report on the Safe Drinking Water Act Amendments of 1996 (H. … contaminant information about bottled water that is updated annually may not represent the contents of any one individual bottle of water but may represent the contaminant history for a specific time period
65 FR 51833Health and Human Services DepartmentFood and Drug AdministrationListing of Color Additives for Coloring Sutures; D&C Violet No. 2
Federal Register · Rule · Jul 28, 2000
in the device comes into direct contact with the body for a significant period of time (section 721(a) of the act). … Thus, the color additive will be in direct contact with the body for a significant period of time.
65 FR 46342Health and Human Services DepartmentFood and Drug AdministrationPrescription Drug User Fee Rates for Fiscal Year 2018
Federal Register · Notice · Sep 14, 2017
that ended on June 30, 2016, and the average number of each of these elements over the most recent 3-year period that ended June 30, 2017. … As table 6 shows, the average number of fee-paying FAEs received annually in the most recent 3-year period is 75.271347 FAEs.
82 FR 43244Health and Human Services DepartmentFood and Drug AdministrationReporting Information Regarding Falsification of Data
Federal Register · Proposed Rule · Feb 19, 2010
Legal Authority FDA is proposing this rule under the authority granted to it by the act (21 U.S.C. 301 et seq. ) and the Public Health Service Act (PHS Act) (42 U.S.C. 201 et seq. ). … Request for Comments In addition to requesting general comments on the proposed rule, FDA has also identified several specific issues on which it invites public comment.
75 FR 7412Health and Human Services DepartmentFood and Drug AdministrationFreedom of Information Regulations
Federal Register · Rule · Jan 5, 1994
Written comments by March 7, 1994. … Request for Comments Interested persons may, on or before March 7, 1994 submit to the Dockets Management Branch (address above) written comments regarding this final rule.
59 FR 531Health 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 AdministrationAdvisory Committees; Notice of Meetings
Federal Register · Notice · Jan 31, 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 … 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.
61 FR 3427Health and Human Services DepartmentFood and Drug AdministrationFood Labeling; Calorie Labeling of Articles of Food in Vending Machines
Federal Register · Rule · Dec 1, 2014
We provided a 90-day comment period that ended on July 5, 2011. We received approximately 250 comments on the proposed rule each containing one or more issues. … The comment did not state how long the phased-in implementation period should be.
79 FR 71259Health and Human Services DepartmentFood and Drug AdministrationModification of Certain Terminology in Title 21
Federal Register · Proposed Rule · May 6, 2026
PHS Act Public Health Service Act. III. Background A. … Act of 1995 (Pub.
91 FR 24380Health and Human Services DepartmentFood and Drug Administration
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