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Briefs, oral arguments, agency decisions and the Federal Register.
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Federal Register · Notice · Sep 9, 2022
Paperwork Reduction Act of 1995 This draft guidance refers to proposed collections of information described in FDA's 60-day notice requesting public comment on the proposed collection of information … required by the PRA, FDA has published an analysis of these information collection provisions elsewhere in this edition of the Federal Register and will submit them for OMB approval following the period
87 FR 55438Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 21, 2016
The comment period for the draft guidance closed on August 27, 2013. … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations.
81 FR 3432Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 11, 2014
In the GDUFA Commitment Letter, FDA committed to review and act on a certain percentage of PASs within a specified time period from the date of submission for receipts in fiscal years (FY) 2015-2017. … Reduction Act of 1995 (44 U.S.C. 3501-3520).
79 FR 40112Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 16, 2017
Under section 520(m) of the FD&C Act, FDA is authorized to exempt an HUD from the effectiveness requirements of sections 514 and 515 of the FD&C Act (21 U.S.C. 360d and 360e) provided that the device … 80 8,800 Notification of withdrawal of an HDE—814.116(e)(3) 1 1 1 1 1 Notification of withdrawal of Institutional Review Board approval—814.124(b) 1 1 1 2 2 Periodic
82 FR 48096Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 1, 2012
FDA is accepting comments to this document and intends to consider such comments in its continued implementation of these fees. Submit either electronic or written comments by October 31, 2012. … The comment period for this request ended November 30, 2011.
77 FR 45636Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities: Proposed Collection; Comment Request
Federal Register · Notice · Aug 4, 1998
This notice solicits comments on the Third-Party Review Pilot Program established by FDA's Center for Devices and Radiological Health (CDRH) under the FDA Modernization Act of 1997 (FDAMA). … Third-party reviewers should maintain records of their 510(k) reviews and a copy of the 510(k) for a reasonable period of time.
63 FR 41575Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 5, 2014
diagnostic testing of the donor indicating T. cruzi infection, we recommend that the establishment notify consignees of all previously distributed blood and blood components collected during the “lookback” period … Peter Lurie, Acting Associate Commissioner for Policy and Planning. [FR Doc. 2014-04776 Filed 3-4-14; 8:45 am] BILLING CODE 4160-01-P
79 FR 12506Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 8, 2016
In the Federal Register of April 28, 2016 (81 FR 25409), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. … Changes to PS plan for a device that is no longer marketed (§ 822.28) 80 1 80 8 640 Waiver (§ 822.29) 1 1 1 40 40 Exemption request (§ 822.30) 16 1 16 40 640 Periodic
81 FR 62142Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 11, 2013
In the Federal Register of May 16, 2013 (78 FR 28853), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. … Changes to PS plan for a device that is no longer marketed (§ 822.28) 80 1 80 8 640 Waiver (§ 822.29) 1 1 1 40 40 Exemption request (§ 822.30) 16 1 16 40 640 Periodic
78 FR 55723Health and Human Services DepartmentFood and Drug AdministrationRefuse To Accept Procedures for Premarket Tobacco Product Submissions; Withdrawal
Federal Register · Rule · Nov 16, 2016
The comment period closed October 24, 2016. FDA is withdrawing the direct final rule because the Agency received significant adverse comment. … FDA will consider the comments we received on the direct final rule to be comments on the companion proposed rule published at 81 FR 52371 (August 8, 2016).
81 FR 80567Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 22, 1999
The Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act (the PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each … Dotzel, Acting Associate Commissioner for Policy Coordination. [FR Doc. 99-15754 Filed 6-21-99; 8:45 am] BILLING CODE 4160-01-F
64 FR 33309Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 18, 2021
Under the Safe Medical Devices Act of 1990 (Pub. … (FD&C Act) (21 U.S.C. 360(k)) clearance.
86 FR 10108Health and Human Services DepartmentFood and Drug AdministrationRevocation of Certain Regulations; General
Federal Register · Rule · Jul 23, 1997
FDA received one comment on this provision, and the comment expressed no objection to revoking this provision. Consequently, Sec. 1.31 is revoked. … only as a result of internal Agency deliberation * * * if this policy is to be modified, it should be done so only in accordance with standard rule-making procedures, with a public comment period on the
62 FR 39439Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 19, 2022
The Food and Drug Administration Safety and Innovation Act (Pub. … The application review period will take a minimum of 2 months after 11:59 p.m. eastern time on October 19, 2022.
87 FR 57203Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 9, 2024
The Food and Drug Administration Safety and Innovation Act (Pub. … The application review period will take a minimum of 2 months after 11:59 p.m. Eastern Time on August 8, 2024.
89 FR 56393Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 14, 2023
The Food and Drug Administration Safety and Innovation Act (Pub. … The application review period will take a minimum of 2 months after 11:59 p.m. Eastern Time on August 14, 2023.
88 FR 45223Health and Human Services DepartmentFood and Drug AdministrationReauthorization of the Generic Drug User Fee Amendments; Public Meeting; Request for Comments
Federal Register · Notice · May 19, 2025
The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that before FDA begins negotiations with the regulated industry on GDUFA reauthorization, we publish a notice in the Federal Register requesting … Goals and Program Enhancements Fiscal Years 2023-2027 ( i.e., the GDUFA III Commitment Letter) ( https://www.fda.gov/industry/generic-drug-user-fee-amendments/gdufa-iii-reauthorization ); provide a period
90 FR 21313Health and Human Services DepartmentFood and Drug AdministrationProduct-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Federal Register · Notice · Aug 22, 2023
Under that process, draft guidances are posted on FDA's website and announced periodically in the Federal Register . … Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. V.
88 FR 57116Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 9, 2021
(Tobacco Control Act) (Pub. … unique circumstances of the COVID-19 pandemic), applications for deemed new tobacco products on the market at that time were due to FDA by September 9, 2020. 2 The court order also provided a 1-year period
86 FR 70139Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 7, 2025
In the Federal Register of April 6, 2023 (88 FR 20525), we announced that we were reopening the comment period until May 8, 2023, to allow interested parties additional time to submit comments. … Paperwork Reduction Act of 1995 This guidance contains no collection of information.
90 FR 1135Health and Human Services DepartmentFood and Drug Administration
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