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Federal Register · Notice · Jun 25, 1999
Submit written comments at any time. … The comments in the docket will be periodically reviewed, and, where appropriate, the guidance will be amended.
64 FR 34259Health and Human Services DepartmentFood and Drug AdministrationBiological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Withdrawal
Federal Register · Rule · Dec 29, 2004
period. … AUTHORITY : Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, the final rule and final order published on January 5, 2004
69 FR 78280Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 21, 2016
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 (the FD&C Act) (21 U.S.C. 360d).
81 FR 64917Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities: Proposed Collection
Federal Register · Notice · Nov 25, 1997
DATES: Submit written comments on the collection of information by January 26, 1998. … The regulations contain no periodic reporting requirements.
62 FR 62773Health 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 · Jan 30, 2023
510(k) of the FD&C Act, must be accompanied by a certification. … ) 1 1 1 30 30 Subpart E—Postapproval Requirements: Postapproval requirements (814.82(a)(9)) 121 1 121 135 16,335 Periodic reports (814.84(b)) 764 1 764 10
88 FR 5888Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 26, 1995
Any other interested person may also submit comments on this notice. … of section 505(e) of the act.
60 FR 32982Health and Human Services DepartmentFood and Drug AdministrationDesignation of Official Names and Proper Names for Certain Biological Products
Federal Register · Proposed Rule · Aug 28, 2015
During FDA's implementation of the BPCI Act, the Agency has opened several dockets to solicit comments on issues related to the naming of biological products licensed under section 351(k) of the PHS Act … We invite comment on the best means of coordinating with external stakeholders that play a role in drug naming and listing to achieve this objective considering, among other things, any transition period
80 FR 52224Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Mar 20, 2024
MRC formulations are complex because they are required to release a specified amount of active ingredient over a specified period of time for a given therapy. … MRCs are designed to release a specified amount of active ingredient to a specific region of the GI tract over a specified period of time, for a given therapy.
89 FR 19776Health and Human Services DepartmentFood and Drug AdministrationRevocation of Certain Regulations Affecting Food
Federal Register · Rule · Jun 3, 1996
After it published the October 1995 proposal, but before the close of the comment period in this rulemaking, FDA published the December 1995 ANPRM (60 FR 67492 at 67493) that announced the agency's intent … One comment acknowledged that, technically, this terminology constitutes misbranding under section 403 of the act.
61 FR 27771Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 28, 2023
under section 351(k) of the Public Health Service Act as amended by the Biologics Price Competition and Innovation Act of 2009. … The reporting period for this information collection renewal includes the 3 years of the COVID-19 pandemic.
88 FR 66853Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Dec 19, 2007
(the act). … One comment contended that in the Van Damme et al. study, subjects averaged 3.6 coital acts a day, with a mean of 70 sexual acts a month, which is atypical of the sexual activity for the majority of women
72 FR 71769Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 26, 2017
This notice solicits comments on an extension of the time period for the outcome evaluation of FDA's multicultural youth tobacco public education campaign, the addition of two rounds of data collection … (Tobacco Control Act) (Pub.
82 FR 61003Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 24, 2020
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 . … The records of processing information are periodically reviewed during factory inspections by FDA to verify fulfillment of the requirements in parts 113 or 114.
85 FR 44905Health 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 · Proposed Rule · Jun 12, 1996
The requirements for comments are found in section 572.603 of Title 46 of the Code of Federal Regulations. … The parties have requested a shortened review period. Agreement No.: 224-200989. Title: Port of Galveston/Suderman Contracting Stevedores, Inc. Terminal Agreement.
61 FR 29701Health 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 · 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 AdministrationFederal Register · Notice · Apr 10, 2026
510(k) of the FD&C Act, must be accompanied by a certification. … ) 4 1 4 30 120 Subpart E—Postapproval Requirements: Postapproval requirements (814.82(a)(9)) 14 1 14 135 1890 Periodic reports (814.84(b)) 860 2 1,720 10
91 FR 18468Health 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 Administration
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