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Federal Register · Rule · Jul 21, 2020
regulatory requirements for certain HCT/Ps; this time period will run through May 31, 2021, instead of November 30, 2020. … Paperwork Reduction Act of 1995 This guidance contains no collection of information.
85 FR 43989Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 3, 2011
This notice solicits comments on the requirement established by Title II of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Pub. … Section 222 of FDAAA amends sections 510(b) of the FD&C Act to require domestic establishments to register annually during the period beginning October 1 and ending December 31 of each year.
76 FR 68195Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 22, 2010
FDA-2010-N-0447] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices Third-Party Review Under the Food and Drug Administration Modernization Act AGENCY … Third-party reviewers should maintain records of their 510(k) reviews and a copy of the 510(k) for a reasonable period of time, usually a period of 3 years.
75 FR 57801Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 1, 2019
The Food and Drug Administration Amendments Act of 2007 created section 505-1 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355-1), which authorizes FDA to require a REMS for certain … When appropriate, the data should be reported for the reporting period and cumulatively, and trends in performance compared to previous periods should be reported and discussed; (9) a discussion including
84 FR 1153Health and Human Services DepartmentFood and Drug AdministrationReauthorization of the Generic Drug User Fee Amendments; Public Meeting; Request for Comments
Federal Register · Notice · Aug 11, 2026
The FD&C Act directs FDA, following negotiations with the regulated industry and periodic consultations with other stakeholders, to present recommendations for reauthorization of the GDUFA program to the … This notice, the 30-day comment period, and the public meeting described in this notice will satisfy certain of these statutory requirements.
91 FR 51718Health and Human Services DepartmentFood and Drug AdministrationPhibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Revocation of Approved Method
Federal Register · Notice · Nov 7, 2023
The comments defended the use of the 30 ppb QCA tolerance and 42-day withdrawal period as sufficient to protect human and animal safety. The sponsor alternatively suggested use of the U.S. … Without an adequate method, the drug cannot meet the provisions of section 512(d)(1)(I) of the FD&C Act. Comments on process to develop a new method.
88 FR 76760Health and Human Services DepartmentFood and Drug AdministrationNonclinical Testing Terminology
Federal Register · Proposed Rule · Sep 22, 2026
The comment period for this companion proposed rule runs concurrently with the comment period for the direct final rule. … The comment period for this companion proposed rule runs concurrently with the comment period for the direct final rule.
91 FR 60036Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 28, 2022
Submissions under section 904(c) of the FD&C Act are for any new product that is not yet on the market ( e.g., if on the market due to deeming compliance period), deemed product manufacturers should … as most of these submissions are expected to be for products subject to the deeming compliance period.
87 FR 4622Health and Human Services DepartmentFood and Drug AdministrationAdministrative Actions for Noncompliance; Lesser Administrative Actions
Federal Register · Proposed Rule · Apr 4, 2016
period ends. … The comment period for this companion proposed rule runs concurrently with the direct final rule's comment period.
81 FR 19066Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Sep 28, 2010
FDA stated that the effective date of the direct final rule would be on December 7, 2009, 60 days after the end of the comment period, unless any significant adverse comment was submitted to FDA during … the comment period.
75 FR 59611Health and Human Services DepartmentFood and Drug AdministrationRemoval of Regulations Regarding Certification of Antibiotic Drugs; Confirmation of Effective Date
Federal Register · Rule · Sep 11, 1998
SUPPLEMENTARY INFORMATION: FDA solicited comments concerning the direct final rule for a 75-day period ending July 27, 1998. … the comment period.
63 FR 48576Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 7, 1999
All comments received during the comment period have been carefully reviewed and incorporated in this revised guidance where appropriate. … As a result of public input during the comment period, the final guidance is clearer and more concise than the draft version.
64 FR 36694Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 5, 2004
Several provisions of this act affect the PMA process, such as section 515(d)(6) of the act. … FDA has determined respondents meeting the criteria of § 814.84 will submit reports on a periodic basis.
69 FR 17689Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 8, 2001
Several provisions of this act affect the PMA process, such as section 515(d)(6) of the act. … FDA has determined respondents meeting the criteria of § 814.84 will submit reports on a periodic basis.
66 FR 9582Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 16, 2001
Several provisions of this act affect the PMA process, such as section 515(d)(6) of the act. … In the Federal Register of February 8, 2001 (66 FR 9582), the agency requested comments on the proposed collection of information. No comments were received.
66 FR 27147Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 24, 2019
Panel of Experts—Section 515(c)(3) of the FD&C Act. … Day 100 Meeting—Section 515(d)(3) of the FD&C Act.
84 FR 57030Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities: Proposed Collection; Comment Request
Federal Register · Notice · May 28, 1998
Applications for FDA Approval to Market a New Drug--21 CFR Part 314--(OMB Control Number 0910-0001)--Reinstatement Under section 505(a) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C … Other interested persons may also submit comments on the notice.
63 FR 29229Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Mar 26, 2024
FDORA Food and Drug Omnibus Reform Act of 2022. FONSI Finding of No Significant Impact. FD&C Act Federal Food, Drug, and Cosmetic Act. … FDA invites comments and submission of data concerning the EA and FONSI. X. Paperwork Reduction Act of 1995 FDA tentatively concludes that this proposed rule contains no collection of information.
89 FR 20882Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 7, 2023
The withdrawal period for the use of this drug combination is 70 days (§ 558.115(d)(3)(ii)). … The withdrawal period for the use of this animal drug combination is 42 days (§ 558.115(d)(4); § 558.450(e)(3)(iii)). II.
88 FR 76756Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 8, 2018
DATES: Fax written comments on the collection of information by February 7, 2018. … In the Federal Register of July 18, 2017 (82 FR 32836), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
83 FR 819Health and Human Services DepartmentFood and Drug Administration
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