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Federal Register · Rule · Nov 27, 2015
In response to several requests, we extended the proposed rule comment period until January 27, 2014. D. … Some comments contend that 10 days is insufficient time, and instead request a period of 3 months.
80 FR 74570Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 16, 2008
Postmarketing Adverse Drug Experience Reporting—21 CFR 310.305 and 314.80 (OMB Control Number 0910-0230)—Extension Sections 201, 502, 505, and 701 of the Federal Food, Drug, and Cosmetic Act (the act) … Under § 314.80(c)(2), applicants must provide periodic reports of adverse drug experiences.
73 FR 76358Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 19, 2017
Records are maintained on file at each testing facility and examined there periodically by FDA inspectors. … In response to requests, the comment period was extended to January 21, 2017 (81 FR 75351, October 31, 2016).
82 FR 60203Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 12, 2004
Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed … Recall Status Reports Requests that recalling firms provide periodic status reports so FDA can ascertain the progress of the recall.
69 FR 60630Health and Human Services DepartmentFood and Drug AdministrationNicole Shelby Randall: Final Debarment Order
Federal Register · Notice · Nov 25, 2025
SUMMARY: The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Nicole Shelby Randall for a period of 5 years from … In proposing a debarment period, FDA weighed the considerations set forth in section 306(c)(3) of the FD&C Act that the Agency considered applicable to Ms.
90 FR 53327Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 8, 2019
DATES: Fax written comments on the collection of information by June 7, 2019. … The report must cover the period of the preceding calendar year and include separate information for each month of the calendar year.
84 FR 20142Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 2, 2022
Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. … Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required for this guidance.
87 FR 11712Health and Human Services DepartmentFood and Drug AdministrationRequirements for Submission of In Vivo Bioequivalence Data; Proposed Rule
Federal Register · Proposed Rule · Oct 29, 2003
Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. … Regulatory Fairness Act of 1996 (Public Law 104-121))), and the Unfunded Mandates Reform Act (Public Law 104-4).
68 FR 61640Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 23, 2011
Recall Status Reports Request that recalling firms provide periodic status reports so FDA can ascertain the progress of the recall. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011-30146 Filed 11-22-11; 8:45 am] BILLING CODE 4160-01-P
76 FR 72420Health and Human Services DepartmentFood and Drug AdministrationGuidance Documents Related to Coronavirus Disease 2019; Availability
Federal Register · Notice · Apr 22, 2022
Therefore, FDA will issue COVID-19-related guidances for immediate implementation without prior public comment (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)(1) … availability of certain COVID-19-related guidances that FDA issued during the relevant period, as included in table 1.
87 FR 24172Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 15, 2022
The guidance provides recommendations on conducting relative BA studies during the investigational period for an NDA and bioequivalence (BE) studies during the postapproval period for certain changes to … Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information.
87 FR 22537Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Sep 12, 2018
Paperwork Reduction Act of 1995 I. … When FDA conducts rulemaking, it normally does so using notice-and-comment procedures established under the Administrative Procedure Act (APA) and FDA regulations.
83 FR 46104Health and Human Services DepartmentFood and Drug AdministrationPremarket Notification for Food Contact Substances; Public Meeting
Federal Register · Notice · Feb 22, 1999
Section 309 of FDAMA amended section 409 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 348) to establish a notification process for food contact substances. … There will be an open question and answer period for FDA to answer questions from participants regarding these matters.
64 FR 8577Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 18, 2016
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by May 18, 2016. … that the licensed pharmacist or licensed physician selected ( i.e., a 30-day period within the last year).
81 FR 22617Health and Human Services DepartmentFood and Drug AdministrationExports: Notification and Recordkeeping Requirements
Federal Register · Proposed Rule · Apr 2, 1999
DATES: Submit written comments by June 16, 1999. Submit written comments on the information collection requirements by May 3, 1999. … period would increase the likelihood of records being lost or destroyed before FDA could inspect an exporting firm.
64 FR 15944Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 1, 2018
The report must cover the period of the preceding calendar year and include separate information for each month of the calendar year. … Animal drug manufacturers are already required to maintain distribution records for their animal drug products to comply with FDA's current good manufacturing regulations for periodic drug reports under
83 FR 49395Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Sep 17, 2026
FDA must publish in the Federal Register a notice of its intent to exempt the device, or of the petition, and provide a 60-calendar-day period for public comment. … The comment period closed on February 27, 2026.
91 FR 58817Health and Human Services DepartmentFood and Drug AdministrationTyler Jordan Hall: Final Debarment Order
Federal Register · Notice · Jan 23, 2026
SUMMARY: The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Tyler Jordan Hall for a period of 5 years from importing … In proposing a debarment period, FDA weighed the considerations set forth in section 306(c)(3) of the FD&C Act that the Agency considered applicable to Mr.
91 FR 2940Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 7, 2011
Manufacturers keep infant formula distribution records for the prescribed period as a matter of routine business practice. … Manufacturers keep infant formula distribution records for the prescribed period as a matter of routine business practice. Dated: June 1, 2011.
76 FR 32976Health and Human Services DepartmentFood and Drug AdministrationShanif Abdul Punjani: Final Debarment Order
Federal Register · Notice · Jun 3, 2024
SUMMARY: The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Shanif Abdul Punjani for a period of 5 years from importing or offering … In proposing a debarment period, FDA weighed the considerations set forth in section 306(c)(3) of the FD&C Act that it considered applicable to Mr.
89 FR 47565Health and Human Services DepartmentFood and Drug Administration
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