Documents
Briefs, oral arguments, agency decisions and the Federal Register.
5,436 results
0.46s
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 · Jul 18, 2000
During that same period, nearly 2,000 510(k) submissions from approximately 800 companies were eligible for third party review. … The pilot will begin after FDA reviews comments and finalizes the guidance entitled “Guidance for Staff, Industry and Third Parties: Implementation of Third Party Programs under the FDA Modernization Act
65 FR 44540Health 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 · Dec 20, 2006
The interim final rule established a 75-day comment period. … notice system, FDA reopened the comment period for 30 days on April 14, 2004 (69 FR 19763), and for an additional 60 days on May 18, 2004 (69 FR 28060), for a total of 165 days.
71 FR 76344Health 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 AdministrationFederal Register · Proposed Rule · Jul 11, 2003
1999 proposal (November 2002 reopening of the comment period) to solicit comments on a proposed footnote statement that would be used in place of a % DV for trans fat on the nutrition label. … A few comments to the November 2002 reopening of the comment period supported the proposed footnote statement, “Intake of trans fat should be as low as possible,” with or without some modification
68 FR 41507Health 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 · Notice · Sep 5, 2019
. 4 See section 514(d)(2)(A)-(B) of the FD&C Act. … For example, a participating accreditation body or testing laboratory agrees to attend training, regularly communicate with FDA, and support periodic FDA audits.
84 FR 46737Health 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 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 · Jun 25, 2021
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 and to allow 60 days for … Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021-13580 Filed 6-24-21; 8:45 am] BILLING CODE 4164-01-P
86 FR 33708Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 7, 2018
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 … A source previously found to contain E. coli will be considered negative for E. coli after five samples collected over a 24-hour period from the same sampling site are tested and found to be
83 FR 55726Health 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 Administration
Ask Donna what matters in the record.
She can read the source against your case and show you exactly where the answer came from.