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Briefs, oral arguments, agency decisions and the Federal Register.
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Federal Register · Notice · Jan 19, 2017
Act of 1997 (Pub. … The comment period will be reopened for 90 days, until January 19, 2017.
82 FR 6568Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Mar 20, 2002
Background In response to requirements of the Nutrition Labeling and Education Act of 1990 (the 1990 amendments) (Public Law 101-135), which amended the Federal Food, Drug, and Cosmetic Act (the act … The 1996 final rule had a 1-year compliance period.
67 FR 12918Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 30, 2019
FDA is establishing the electronic format requirements described in this guidance under the Federal Food, Drug, and Cosmetic Act (FD&C Act). … The collection of information for submitting periodic adverse drug experience reports has been approved under OMB control number 0910-0230.
84 FR 58158Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 3, 2012
(the FD&C Act). … Submit electronic comments on the draft guidance, including comments on the proposed collection of information to http://www.regulations.gov.
77 FR 20030Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 20, 2016
of the Animal Generic Drug User Fee Act (AGDUFA). … The meeting and written comments submitted to the docket will provide critical input as the Agency prepares for reauthorization discussions.
81 FR 23304Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 11, 2026
The meeting and written comments submitted to the docket will provide critical input as the Agency prepares for reauthorization discussions. … Notification of Intent To Participate in Periodic Stakeholder Consultation Meetings If you intend to participate in continued periodic stakeholder consultation meetings regarding AGDUFA reauthorization
91 FR 25577Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 21, 1999
Act). … The agency is providing a 60-day comment period and is establishing a docket for the receipt of comments.
64 FR 3301Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Exemptions From Premarket Notification; Class II Devices
Federal Register · Notice · Dec 15, 2000
FDA is publishing this notice in order to obtain comments on this petition in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA). … 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.
65 FR 78494Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 1, 2014
In the Federal Register of June 10, 2014 (79 FR 33197), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. … 80 8,960 Notification of withdrawal of an HDE—814.116(e)(3) 8 1 8 1 8 Notification of withdrawal of institutional review board approval—814.124(b) 3 1 3 2 6 Periodic
79 FR 71110Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 25, 2024
Medical Device Recall Authority OMB Control Number 0910-0432—Extension This collection of information helps to implement section 518(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C … FDA issued part 810 to implement the provisions of section 518 of the FD&C Act.
89 FR 78313Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 18, 2015
The Biologics Price Competition and Innovation Act of 2009 amended the Public Health Service Act (PHS Act) and other statutes to create an abbreviated licensure pathway in section 351(k) of the PHS Act … All comments received during the comment period for the draft guidance have been reviewed and, where appropriate, incorporated into this guidance.
80 FR 72069Health and Human Services DepartmentFood and Drug AdministrationMark Moffett; Denial of Hearing; Final Debarment Order
Federal Register · Notice · Jan 25, 2023
Moffett, in any capacity during his period of debarment, will be subject to civil money penalties (section 307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))). If Mr. … 7) of the FD&C Act).
88 FR 4826Health and Human Services DepartmentFood and Drug AdministrationPersonal Blood Storage of Memphis, Inc.; Revocation of U.S. License No. 1131
Federal Register · Notice · Aug 5, 1997
The notice provided other interested persons with 60 days to submit written comments on the proposed revocation. … No other interested persons submitted written comments on the proposed revocation within the 60-day time period.
62 FR 42134Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Aug 4, 1999
ACTION: Notice of public meeting; reopening of comment period; correction. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is correcting … Dotzel, Acting Associate Commissioner for Policy. [FR Doc. 99-19790 Filed 8-3-99; 8:45 am] BILLING CODE 4160-01-F
64 FR 42277Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 18, 2010
(Comment) Some of the comments related to the placement of information in the draft guidance. … FDA based these estimates on the number of original HDE applications that the Center for Devices and Radiological Health (CDRH) received for the period October 1, 2004, through September 30, 2007.
75 FR 7270Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jul 24, 2015
The comment period on that proposed rule closed on January 27, 2014, and FDA is currently working on the final rule, which will respond to the comments submitted. … During the period that an AB's recognition is suspended, the AB would not be permitted to accredit additional CBs for participation in FDA's program.
80 FR 43987Health and Human Services DepartmentFood and Drug AdministrationGuidance Documents Related to Coronavirus Disease 2019; Availability
Federal Register · Notice · Apr 23, 2021
availability of certain COVID-19-related guidances that FDA issued during the relevant period, as included in table 1. … Paperwork Reduction Act of 1995 A.
86 FR 21744Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 11, 2008
finalizing the guidance, FDA is issuing this revised draft guidance to notify industry that it intends to exercise enforcement discretion with regard to these labeling requirements for an additional 1-year period … Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy.
73 FR 75436Health and Human Services DepartmentFood and Drug AdministrationThird Annual Animal Drug User Fee Educational Conference; Public Meeting
Federal Register · Notice · Jun 3, 2026
Background The Animal Drug User Fee Act (Pub. L. 108-130) (ADUFA or the Act) was originally signed into law in 2003 and was subsequently reauthorized by Congress in 2008, 2013, 2018, and 2023. … “The Animal Drug User Fee Act Reauthorization Performance Goals and Procedures Fiscal Years 2024 Through 2028” (Performance Goals Letter) sets forth the Agency's performance goals for the period covered
91 FR 33176Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 18, 2001
The regulations further provide that fish and fishery products are adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 342(a)(4)) if their processor fails … The provision in question, § 123.9(b)(3), allows a processor to store records offsite under two circumstances: (1) The facility is closed for prolonged periods between seasonal packs, or (2) the facility
66 FR 37482Health and Human Services DepartmentFood and Drug Administration
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