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Federal Register · Notice · Jun 16, 2025
FDA has the statutory authority under section 304(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 334(g)) to detain during established inspections devices that are believed to be adulterated … These recordkeeping requirements for administrative detentions permit FDA to trace devices for which the detention period expired before a seizure is accomplished or injunctive relief is obtained.
90 FR 25323Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 23, 2025
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 . … Changes to PS plan for a device that is no longer marketed 1 1 1 8 8 § 822.29; Waiver 1 1 1 40 40 § 822.30; Exemption request 1 1 1 40 40 § 822.38; Periodic
90 FR 60106Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Oct 23, 2007
In particular, under section 201(s)(4) of the act, any substance used in accordance with a sanction or approval granted prior to September 6, 1958, under the act, the Poultry Products Inspection Act (21 … If you wish to request an opportunity to make an oral presentation during the open public comment period of the hearing, your notice of participation also must include the title of your presentation, the
72 FR 59973Health and Human Services DepartmentFood and Drug AdministrationMicrobiology Devices; Reclassification of Human Immunodeficiency Virus Viral Load Monitoring Tests
Federal Register · Rule · Nov 4, 2022
The comment period on the proposed order closed on January 24, 2022. II. … ) by the close of the comment period, each containing one or more comments on one or more issues.
87 FR 66545Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 12, 2015
In the Federal Register of December 10, 2013 (78 FR 74154), FDA published a notice reopening the comment period for the draft guidance giving interested persons until January 9, 2014, to comment on … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations.
80 FR 33528Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Feb 10, 2009
The comment period closed December 15, 2008. FDA is withdrawing the direct final rule because the agency received significant adverse comment. … Comments received by the agency regarding the withdrawn rule will be considered in developing a final rule using the usual Administrative Procedure Act notice-and-comment procedures.
74 FR 6541Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 23, 2001
DATES: Submit written comments at any time. … Background The draft guidance document was issued for public comment in the Federal Register of September 13, 2000 (65 FR 55265). The comment period ended on December 13, 2000.
66 FR 28527Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 18, 2020
FDA is reopening the 30-day comment period in order to satisfy PRA requirements. No changes have been made to the information collection. Dated: December 14, 2020. Lauren K. … Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020-27963 Filed 12-17-20; 8:45 am] BILLING CODE 4164-01-P
85 FR 82488Health and Human Services DepartmentFood and Drug AdministrationCompounding Animal Drugs From Bulk Drug Substances; Guidance for Industry; Availability
Federal Register · Notice · Apr 14, 2022
period. … In response to requests from interested parties, we extended the comment period to July 17, 2020, and then to October 15, 2020.
87 FR 22212Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 25, 2013
(the FD&C Act) (21 U.S.C. 393(d)(2)(D)), and to develop stronger health warnings on tobacco packaging as authorized by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), it is … The third commenter indicated that the authorizing statute was incorrectly identified. The correct authorizing statute is section 1003(d)(2)(D) of the FD&C Act.
78 FR 5462Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 11, 2018
Section 503B (21 U.S.C. 353b), added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by the Drug Quality and Security Act in 2013, created a new category of compounders called outsourcing facilities … The comment period on the draft guidance ended on July 18, 2016. FDA received 19 comments on the draft guidance. In response to received comments, FDA made certain changes.
83 FR 22083Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 30, 2018
(See section 417(a)(2) of the FD&C Act.) … Periodic drug experience reports and special drug experience reports must be accompanied by a completed Form FDA 2301, “Transmittal of Periodic Reports and Promotional Material for New Animal Drugs” (see
83 FR 61653Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jul 21, 1995
DATES: Written comments by October 4, 1995. … Also, most manufacturers of food products typically redesign labels within a 2- year period.
60 FR 37611Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 24, 2014
Background In 1976, Congress enacted the Medical Device Amendments (MDA), which amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to create a comprehensive system for the regulation of medical … With the publication of the draft guidances, FDA announced a public comment period soliciting feedback on all aspects of the guidance documents as well as on the following specific issues: (1) Factors
79 FR 69860Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 7, 2011
The BPCI Act requires that FDA must publish the recommendations for a biosimilars user fee program in the Federal Register and provide a period of 30 days for the public to provide written comments … This notice, the 30-day comment period, and the public meeting will satisfy certain of these requirements.
76 FR 76424Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 1, 2009
for an additional 1-year period (i.e., for OTC drug products marketed without an approved application that are labeled on or after January 1, 2010), because the agency was still in the process of … Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy.
74 FR 45222Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 17, 2015
DATES: Fax written comments on the collection of information by July 17, 2015. … (the FD&C Act) (21 U.S.C. 360) clearance.
80 FR 34682Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 29, 2026
In addition, this guidance describes how to meet the BE requirements set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations. … This guidance will also be useful to applicants planning BE studies intended to be conducted during the postapproval period for changes to a drug product approved under an ANDA.
91 FR 32057Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 24, 2026
Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d). … Such standards are those that FDA has recognized by notice published in the Federal Register or that FDA has decided to recognize but for which recognition is pending (because a periodic notice has
91 FR 54715Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Sep 12, 2005
The guidance responds to various questions raised about the recordkeeping provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and the … Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy.
70 FR 53728Health and Human Services DepartmentFood and Drug Administration
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