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Federal Register · Notice · Feb 19, 2026
Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed … The regulations were issued under FDA's statutory authority to regulate food safety, including section 402(a)(1) and (4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(1) and (4)).
91 FR 8010Health and Human Services DepartmentFood and Drug AdministrationReview of General Biologics and Licensing Regulations
Federal Register · Uncategorized Document · Jun 3, 1994
This review is part of FDA's program to periodically review existing significant regulations. … Under Executive Order 12866, the Paperwork Reduction Act of 1980 (Pub. L. 96-511), and the Regulatory Flexibility Act (Pub.
Health and Human Services DepartmentFood and Drug AdministrationPediatric Studies of Ampicillin Conducted in Accordance With the Public Health Service Act
Federal Register · Notice · Apr 25, 2017
This notice is to announce the 30-day open public comment period on the report. DATES: Submit either electronic or written comments by May 25, 2017. … Availability of Report for Public Comment FDA is announcing the 30-day open public comment period for the report of the pediatric studies of ampicillin that were conducted in accordance with section
82 FR 19065Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 31, 2006
DATES: Fax written comments on the collection of information by November 30, 2006. … ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer
71 FR 63768Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Nov 30, 2007
Analysis of Comments on the Proposed Rule and FDA's Response FDA received one comment on the proposed rule. … Any subsequent change to the device within this 3-year reporting period requiring the submission of a premarket notification in accordance with section 510(k) of the act should be included in the annual
72 FR 67640Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 1, 2026
FDA will review any comments submitted within the 60-day comment period and will further consider whether the exemption described in this notice should be modified prior to publication of its final determination … FDA must publish in the Federal Register a notice of its intent to exempt the device, or of the petition, and provide a 60-calendar-day period for public comment.
91 FR 23427Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jul 6, 1999
The Unfunded Mandates Reform Act of 1995 (Pub. … The Small Business Regulatory Enforcement Fairness Act of 1996 (Pub.
64 FR 36516Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 12, 2017
Application for FDA Approval To Market a New Drug OMB Control Number 0910-0001—Extension Under section 505(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(a)), a new drug … Other interested persons may also submit comments on the notice.
82 FR 58403Health and Human Services DepartmentFood and Drug AdministrationAn Evaluation of the Prescription Drug User Fee Act Workload Adjuster; Request for Comments
Federal Register · Notice · May 6, 2013
FDA-2013-N-0418] An Evaluation of the Prescription Drug User Fee Act Workload Adjuster; Request for Comments AGENCY: Food and Drug Administration, HHS. … SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on an assessment of the Prescription Drug User Fee Act (PDUFA) Workload Adjuster conducted by an independent
78 FR 26374Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 11, 2008
The comment period closed on November 13, 2000. We received a small number of comments, and FDA has made some changes to the final guidance document based on these comments. … One comment indicated that the risk of detention is greater for high-volume manufacturers because they have many shipments and many FDA analyses in a 24-month period and, therefore, a greater cumulative
73 FR 39969Health and Human Services DepartmentFood and Drug AdministrationDavid Winne: Grant of Special Termination; Final Order Terminating Debarment
Federal Register · Notice · Nov 1, 2023
ADDRESSES: Submit comments electronically at https://www.regulations.gov. … Under section 306(d)(4)(D) of the FD&C Act, the period of debarment of an individual who qualifies for special termination may be limited to less than permanent but to no less than 1 year. Mr.
88 FR 74999Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 22, 2021
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 … This written appeal could include a request for an informal hearing as defined in section 201(y) of the FD&C Act (21 U.S.C. 321(y)).
86 FR 66315Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 20, 2009
L. 109-462; Section 761(b)(1) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 379aa-1(b)(1)) M CFSAN/Center for Veterinary Medicine (CVM) 1 None This notice solicits comments … (Comment 17) Another comment suggested that questions on the rational questionnaire should be prioritized to capture the most important questions and information first in a shorter period of time.
74 FR 23721Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 27, 2004
(the act) designed to assure the adequate labeling of prescription (Rx) drugs. … Under section 502(a) of the act (21 U.S.C. 352(a)), a drug product is misbranded if its labeling is false or misleading in any particular, and under section 201(n) of the act (21 U.S.C. 321(n)), a drug's
69 FR 3921Health and Human Services DepartmentFood and Drug AdministrationGuidance for Tobacco Retailers on Tobacco Retailer Training Programs; Availability
Federal Register · Notice · Sep 5, 2013
Under each schedule, violators are subject to increasing penalties for multiple violations within prescribed time periods. … Comments Interested persons may submit either written comments regarding this document to the Division of Dockets Management (see ADDRESSES ) or electronic comments to http://www.regulations.gov
78 FR 54657Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 23, 2018
Submissions under 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), newly deemed product manufacturers should have … This includes any statutorily regulated product that would receive a marketing authorization and any new deemed product not subject to the deeming compliance period.
83 FR 53478Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 16, 2005
In brief, section 401 of FDAMA amended the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360aaa through 360aaa-6) to permit drug, biologic, and device manufacturers to disseminate certain written … at the end of each 6-month period), and if the volume of disseminated materials is small.
70 FR 35099Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 25, 2023
Subsequent to the close of the 60-day notice public comment period, additional comments were received from internal and external stakeholders through our solicitation of feedback external to the PRA public … comment opportunity.
88 FR 73347Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 10, 2021
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. … 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
86 FR 30953Health and Human Services DepartmentFood and Drug AdministrationRevocation of Food Standards for 11 Products Not Currently Sold
Federal Register · Rule · Jul 17, 2025
The comment period for the direct final rule runs concurrently with the companion proposed rule. … Review Act/Small Business Regulatory Enforcement Fairness Act (5 U.S.C. 801, Pub.
90 FR 33268Health and Human Services DepartmentFood and Drug Administration
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