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Briefs, oral arguments, agency decisions and the Federal Register.
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Jason 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 · Jun 30, 2005
This guidance revises recommended deferral periods for such donors, and updates information on component retrieval and quarantine. … Paperwork Reduction Act of 1995 This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995
70 FR 37863Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 15, 2020
FDA intends to review comments received in the docket and periodically assess whether any changes to this policy are warranted. … Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information.
85 FR 65410Health and Human Services DepartmentFood and Drug AdministrationKimberly Schaff Kiehl: Final Debarment Order
Federal Register · Notice · Apr 23, 2026
SUMMARY: The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Kimberly Schaff Kiehl for a period of 10 years from … In proposing a debarment period, FDA weighed the considerations set forth in section 306(c)(3) of the FD&C Act that the Agency considered applicable to Ms.
91 FR 21823Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 9, 2004
(the act). … FDA also believes that this extended period will not impact its ability to receive, review, and respond to prior notice submissions of food, although a time period greater than 10 days may be problematic
69 FR 64959Health and Human Services DepartmentFood and Drug AdministrationGuidance for Industry on ANDA's: Impurities in Drug Substances; Availability
Federal Register · Notice · Dec 3, 1999
On October 19, 1998 (63 FR 55876), in response to requests from the public, the agency reopened the comment period until November 23, 1998. … All comments received during the comment period have been carefully reviewed and the guidance was revised, where appropriate.
64 FR 67917Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Health Claims; D-tagatose and Dental Caries
Federal Register · Rule · Dec 2, 2002
Section 403(r)(7) of the act authorizes us to make proposed regulations issued under section 403(r) of the act effective upon publication pending consideration of public comment and publication of a final … 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.
67 FR 71461Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 23, 2003
DATES: Submit written comments on the collection of information by February 24, 2003. … In the Federal Register of October 4, 2002 (67 FR 62249), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received.
68 FR 3262Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 15, 2015
Paperwork Reduction Act of 1995 The draft 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).
80 FR 27973Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 29, 2021
We invite comment on this assumption. … If a product was not repackaged during a particular reporting period, outsourcing facilities do not need to send an SPL response for that product during that reporting period.
86 FR 22674Health and Human Services DepartmentFood and Drug AdministrationExtralabel Animal Drug Use; Fluoroquinolones and Glycopeptides; Order of Prohibition
Federal Register · Rule · May 22, 1997
The AMDUCA requires that opportunity be given for public comment before a prohibition becomes effective. The regulation provides, at Sec. 530.25, for a public comment period of not less than 60 days. … The order will become effective 90 days from the date of this publication, unless the agency before that time revokes or modifies the order, or extends the period for public comment.
62 FR 27944Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 29, 2011
Recall Status Reports Request that recalling firms provide periodic status reports so FDA can ascertain the progress of the recall. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011-16252 Filed 6-28-11; 8:45 am] BILLING CODE 4160-01-P
76 FR 38184Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · May 21, 2013
Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed order, consideration of any comments received, and a meeting of a device classification … For ECP devices, the preamendments class III devices that are the subject of this proposal, the later of these two time periods is the 90-day period.
78 FR 29672Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 5, 2008
Medical Devices Act of 1990 (SMDA) (Public Law 101-629). … FDA issued tracking orders to 20 additional medical device manufacturers during the time period for FY2002 through FY2004.
73 FR 6729Health and Human Services DepartmentFood and Drug AdministrationAnimal Drug Availability Act; Veterinary Feed Directive
Federal Register · Proposed Rule · Jul 2, 1999
)(6) of the act. … comment period.
64 FR 35966Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 22, 2026
We considered all comments on the draft guidance received during the comment period in finalizing the guidance. … Paperwork Reduction Act of 1995 This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995
91 FR 30318Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 11, 2014
Additionally, the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq) and the Economy Act (31 U.S.C. 1535) require FDA to provide assistance to other Federal, state, and local government bodies … The sample for each data collection period will be evenly distributed among Specialists.
79 FR 73596Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments
Federal Register · Notice · Oct 25, 2019
Additionally, FDA must provide at least a 60-day comment period for any such notice required to be published under section 510(m)(1)(A) of the FD&C Act. … To do so, FDA must publish in the Federal Register a notice of its intent to exempt the device, or of the petition, and provide a 60-day period for public comment.
84 FR 57445Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 4, 2002
This notice solicits comments on the information collection requirements relating to FDA? … There were an estimated 13,938 15-day alert reports, 10,102 periodic reports, and 339 distribution reports submitted to FDA.
67 FR 62249Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 5, 2014
disease specialists, public interest groups, and other members of the public were submitted to the docket via http://www.regulations.gov during the 60-day comment period. … Mandates Reform Act of 1995 (Pub.
79 FR 32464Health and Human Services DepartmentFood and Drug Administration
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