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Federal 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 · Nov 15, 2016
Evaluation of FDA's Point-of-Sale Public Education Campaign OMB Control Number—0910-NEW The 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. … This outcome evaluation study will consist of three longitudinal data collection periods each lasting 3-4 months at 4 month intervals between data collection periods, with the first survey (Wave 1) occurring
81 FR 80075Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Hearing Aids; Technical Data Amendments; Confirmation of Effective Date
Federal Register · Rule · Feb 25, 2000
FDA stated that the effective date of the direct final rule would be on March 17, 2000, 60 days after the end of the comment period, unless any significant adverse comment was submitted to FDA during the … comment period.
65 FR 10012Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 18, 1998
After the comment period, comments may be submitted to one of the centers at the address below. FOR FURTHER INFORMATION CONTACT: Andrea C. … FDA is, therefore, emphasizing that it is soliciting comment from all interested persons and is providing a 90-day comment period and establishing a docket for receipt of comments.
63 FR 64093Health 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 AdministrationFederal Register · Notice · Apr 7, 2014
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 … There were an estimated 92,470 15-day Alert reports, 132,667 periodic reports, and 334 lot distribution reports submitted to FDA.
79 FR 19097Health and Human Services DepartmentFood and Drug AdministrationBiological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review
Federal Register · Rule · Jan 5, 2004
During the comment period for the December 1985 proposal, FDA received no comments opposing the placement of AVA into Category I 2 . 2 On October 12, 2001, a group of individuals filed a … Flexibility Act (5 U.S.C 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).
69 FR 255Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 29, 2012
(42 U.S.C. 262 and 264) and the provisions of the Federal Food, Drug, and Cosmetic Act that apply to drugs (21 U.S.C. 301 et seq. ). … FDA received one comment from the public.
77 FR 65560Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 10, 2003
U.S.C. 262 and 264) and the provisions of the Federal Food, Drug, and Cosmetic Act that apply to drugs (21 U.S.C. 301 et seq. ). … These characteristics include long latency periods and the ability to establish persistent infections.
68 FR 41153Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 22, 2006
U.S.C. 262 and 264) and the provisions of the Federal Food, Drug, and Cosmetic Act that apply to drugs (21 U.S.C. 301 et seq. ). … These characteristics include long latency periods and the ability to establish persistent infections.
71 FR 35911Health 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 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 · Aug 17, 2026
This notification is a periodic proposal pursuant to section 513(f)(6)(D)(i) of the FD&C Act, and FDA is seeking feedback on this proposal through public comment. … Once the comment period ends, FDA will consider the comments and publish in the Federal Register a final action distinctly classifying suitable accessories into class I, if any. III.
91 FR 53205Health 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 · Sep 10, 2018
Some comments requested up to 7 days to provide the notification, but several others suggested that FDA revise the notification period to 3 business days. … Most comments on the 2013 draft 503A guidance said this period was too short, but did not recommend a specific alternative.
83 FR 45631Health and Human Services DepartmentFood and Drug AdministrationFood Additives: Food Contact Substance Notification That Is No Longer Effective
Federal Register · Proposed Rule · Jan 26, 2022
Submit written comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 by March 28, 2022. … Act of 1995 (Pub.
87 FR 3949Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 21, 2020
New Animal Drugs for Investigational Use—21 CFR Part 511 OMB Control Number 0910-0117—Extension FDA has the authority under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to approve new animal drugs … Section 512(j) of the FD&C Act authorizes us to issue regulations relating to the investigational use of new animal drugs.
85 FR 83092Health and Human Services DepartmentFood and Drug AdministrationLaboratory Accreditation for Analyses of Foods
Federal Register · Proposed Rule · Nov 4, 2019
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by March 3, 2020 (see the “Paperwork Reduction Act of 1995” section of this document). … period.
84 FR 59452Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 23, 2015
Other comments supported a time-based deferral policy shorter than 1year, or no deferral period at all, because of advances in blood donor testing technologies that permit earlier detection of new HIV … Paperwork Reduction Act of 1995 The guidance refers to previously approved collections of information found in FDA regulations.
80 FR 79913Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jan 16, 2018
(FD&C Act). … (FD&C Act).
83 FR 2092Health and Human Services DepartmentFood and Drug Administration
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