Documents
Briefs, oral arguments, agency decisions and the Federal Register.
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Federal Register · Notice · Sep 29, 2011
SUMMARY: The Food and Drug Administration (FDA) is opening a comment period for the notice of public workshop published in the Federal Register of July 28, 2011 (76 FR 45268). … FDA is opening a comment period in light of public interest in this topic and in order to gain additional insight about the causes and impact of drug shortages, and possible strategies for preventing or
76 FR 60505Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 11, 2024
For draft guidance documents issued after October 1, 2014, CDRH committed to finalize, withdraw, reopen the comment period, or issue new draft guidance on the topic for 80 percent of the documents within … 3 years of the close of the comment period and for the remaining 20 percent, within 5 years.
89 FR 82612Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Mar 20, 2017
(the FD&C Act). … to the intended use provisions, the new comment period should provide additional opportunity to comment on FDA's approach, including a fair opportunity to comment on the language chosen in the final rule
82 FR 14319Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 5, 2022
ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. … The report must cover the period of the preceding calendar year and include separate information for each month of the calendar year.
87 FR 26764Health and Human Services DepartmentFood and Drug AdministrationKevin Sheng Hsiang Fang: Final Debarment Order
Federal Register · Notice · Nov 19, 2024
SUMMARY: The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Kevin Sheng Hsiang Fang for a period of 5 years from importing articles … In proposing a debarment period, FDA weighed the considerations set forth in section 306(c)(3) of the FD&C Act that it considered applicable to Mr.
89 FR 91408Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Health Claims; Plant Sterol/Stanol Esters and Coronary Heart Disease
Federal Register · Rule · Sep 8, 2000
comment. … FDA invites public comment on this interim final rule. The agency will consider modifications to this interim final rule based on comments made during the comment period.
65 FR 54686Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jan 10, 2001
If no timely significant comments were submitted to FDA during the comment period, FDA intended to publish a document in the Federal Register within 30 days after the comment period ended, confirming … notice and comment procedures.
66 FR 1834Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities; Submission for OMB Review; Comment Request
Federal Register · Notice · Mar 23, 1998
DATES: Submit written comments on the collection of information by April 22, 1998. … In the Federal Register of December 11, 1997 (62 FR 65273), the agency invited comments on the collections of information. No significant comments were received.
63 FR 13865Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 21, 2000
DATES: Submit written comments on the collection of information by October 23, 2000. … However, animals held for this period may still be sent for slaughter.
65 FR 57193Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 9, 2016
As part of FDA's performance commitments, FDA is providing a period for public comment on the final assessment of the Program. … FDA will hold an open public comment period to give the public an opportunity to comment during the public meeting.
81 FR 89109Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Health Claims; Oats and Coronary Heart Disease
Federal Register · Proposed Rule · Jan 4, 1996
This new law amended the Federal Food, Drug, and Cosmetic Act (the act) in a number of important ways. … Comments Interested persons may, on or before April 3, 1996, submit to the Dockets Management Branch (address above) written comments regarding this proposal.
61 FR 295Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 16, 2008
DATES: Fax written comments on the collection of information by June 16, 2008. … There were an estimated 23,835 15-day Alert reports, 21,872 periodic reports, and 179 lot distribution reports submitted to FDA.
73 FR 28486Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jan 23, 2002
(the act). … There is a comment period for interested persons to comment on the agency's proposal, during which interim marketing would not be permitted.
67 FR 3060Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 10, 2017
Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. … These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
82 FR 3002Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 24, 2022
DATES: Fax written comments on the collection of information by July 25, 2022. … In the Federal Register of February 8, 2022 (87 FR 7187), we published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
87 FR 37859Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Mar 26, 2020
Paperwork Reduction Act of 1995 This guidance refers to previously approved FDA collections of information. … These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).
85 FR 17008Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 2, 2019
FDA is also reopening the comment period on this draft guidance for comments to be submitted for consideration before we finish work on the final version of the guidance. … FDA is also reopening the comment period on this draft guidance for comments to be submitted for consideration before it finishes work on the final version of the guidance.
84 FR 12621Health and Human Services DepartmentFood and Drug AdministrationJason Oppenheimer: Final Debarment Order
Federal Register · Notice · Oct 1, 2025
SUMMARY: The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Jason Oppenheimer for a period of 5 years from importing or offering … In proposing a debarment period, FDA weighed the considerations set forth in section 306(c)(3) of the FD&C Act that it considered applicable to Mr.
90 FR 47310Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 3, 2022
ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. … Administrative Detention and Banned Medical Devices OMB Control Number 0910-0114—Extension FDA has the statutory authority under section 304(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
87 FR 26208Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 3, 2019
(Tobacco Control Act) (Pub. … Because youth age over the study period, the age range of youth and young adults among whom we collect data over the study period are aged 11 to 18.
84 FR 46021Health and Human Services DepartmentFood and Drug Administration
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