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Federal Register · Notice · Apr 30, 2024
FDA Recall Regulations—21 CFR Part 7 OMB Control Number 0910-0249—Extension This information collection helps support implementation of section 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C … Similarly, during the same period, 6,385 recalls were terminated, for an average of 2,128 recall terminations annually, and we assume an average of 10 hours is needed for the corresponding information
89 FR 34256Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 19, 2023
2019 (COVID-19) Public Health Emergency” guidance to exercise certain enforcement policies for certain devices beyond the expiration of the COVID-19 PHE (which expired on May 11, 2023) and the 180-day period … the FD&C Act (21 U.S.C. 371(h)(1)(C)) and § 10.115(g)(2) (21 CFR 10.115(g)(2)).
88 FR 72080Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities: Proposed Collection; Comment Request
Federal Register · Notice · Dec 23, 1997
This notice solicits comments on the recordkeeping requirements for manufacturers of medicated animal feeds. DATES: Submit written comments on the collection of information by February 23, 1998. … A license is required when the manufacturer of a medicated feed involves the use of a drug or drugs which FDA has determined requires more control because of the need for a withdrawal period before slaughter
62 FR 67076Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 26, 2003
FDA plans to conduct the STED pilot program for a period of 1 year. The pilot will begin on the date of publication of the final FDA guidance document. … The comment period ended on September 24, 2001. FDA received comments from five parties; in some instances the parties submitted multiple comments.
68 FR 38068Health 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 · Proposed Rule · Apr 25, 2016
the FD&C Act (21 U.S.C. 360j(g)). … The comments submitted by JRC question the effectiveness of positive behavioral interventions, citing three case review studies of “positive-only” approaches covering successive time periods.
81 FR 24386Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 16, 2000
Section 702 of the act (21 U.S.C. 372) authorizes investigational powers to FDA for enforcement of the act. … As both the 3500 instructions and 3500A instructions can be updated periodically based on questions/comments from stakeholders and statutory/regulatory changes, changing the forms themselves is not seen
65 FR 69314Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 13, 2016
The Agency did not receive any comments on that draft guidance during the public comment period. The current guidance finalizes that draft guidance. … The Paperwork Reduction Act of 1995 This guidance contains an information collection that is subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44
81 FR 62908Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Health Claims; Soluble Fiber From Certain Foods and Risk of Coronary Heart Disease
Federal Register · Rule · Feb 25, 2008
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.
73 FR 9938Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities; Submission for OMB Review; Comment Request
Federal Register · Notice · Jul 16, 1997
DATES: Submit written comments on the collection of information by August 15, 1997. … Under Sec. 895.21(d), any interested person may request an informal hearing and submit written comments.
62 FR 38095Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 2, 2024
On April 13, 2017, we published a notice announcing the extension of the comment period to June 19, 2017 (82 FR 17844). … Moreover, section 740(d)(4)(B) of the Federal Food, Drug, and Cosmetic Act uses this term (21 U.S.C. 379j-12(d)(4)(B)).
89 FR 35832Health and Human Services DepartmentFood and Drug AdministrationFood and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications
Federal Register · Proposed Rule · Apr 4, 2016
FDA is proposing to issue a final rule within 912 days (generally 30 months) of the closing of the comment period for the proposed rule. … During this 912-day time period, FDA will review and consider any new data, information, and public comments submitted to the docket and draft and publish a final regulation.
81 FR 19069Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Dec 20, 2017
FD&C Act (21 U.S.C. 352). … Mandates Reform Act of 1995 (Pub.
82 FR 60474Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Mar 8, 1999
Interested persons were given until August 10, 1998, to comment on the proposed rule. … During the comment period, FDA received one comment that raised the following three issues about the nasal dilator: (1) The comment suggested that the intended use of the external nasal dilator be
64 FR 10947Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Exemptions From Premarket Notification; Surgical Lamps
Federal Register · Notice · Dec 4, 1998
This section requires FDA to publish in the Federal Register a notice of intent to exempt a device, or of the petition, and to provide a 30-day comment period. … FDA received no comments.
63 FR 67075Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 10, 2009
The Food and Drug Administration Amendments Act of 2007 (FDAAA) includes a requirement that FDA identify and periodically update susceptibility test interpretive criteria for antibacterial drug products … No comments were received.
74 FR 6634Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 20, 2010
If you wish to make an oral presentation during the open comment period at the workshop, you must indicate this at the time of registration. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010-20659 Filed 8-19-10; 8:45 am] BILLING CODE 4160-01-S
75 FR 51467Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 25, 2019
Background Section 3011 of the 21st Century Cures Act (Pub. L. 114-255) added a new section 507 to the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 357). … The BEST glossary is meant to be a resource that will be periodically updated with additional terms and clarifying information.
84 FR 35868Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 17, 2001
providing guidance regarding further distribution, giving instructions as to what to do with the product, providing recipients with a ready means of reporting to the recalling firm (§ 7.49); and submitting periodic … One comment was received on the information collection.
66 FR 43263Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 30, 2004
The comment period for the proposed information collection provisions closed on December 29, 2003. FDA received seven comments from manufacturers on the draft 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
69 FR 69606Health and Human Services DepartmentFood and Drug Administration
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