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Briefs, oral arguments, agency decisions and the Federal Register.
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Federal Register · Notice · Aug 30, 2013
Following the close of the comment period on this guidance, FDA intends to consider the comments received, revise this draft guidance as appropriate, and publish it in final. … Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations.
78 FR 53773Health and Human Services DepartmentFood and Drug AdministrationSecure Supply Chain Pilot Program
Federal Register · Notice · Aug 20, 2013
A subsequent request for comments on the collection of information was issued June 20, 2012 (77 FR 37055). … (the FD&C Act) relating to drug products that FDA otherwise deems to have violated any requirements of the FD&C Act relating to drug products or (2) fails to comply with the SSCPP.
78 FR 51192Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 16, 2014
GRAS affirmation petition process still exists, FDA has not received a GRAS affirmation petition since the establishment of the voluntary GRAS notification program and is not expecting any during the period … and other specific labeling acts administered by FDA.
79 FR 21469Health and Human Services DepartmentFood and Drug AdministrationDiana Daffin: Final Debarment Order
Federal Register · Notice · Jul 27, 2023
Follow the instructions for submitting comments. An application submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. … Daffin during her period of debarment, other than in connection with an audit under section 306 of the FD&C Act (section 306(c)(1)(B) of the FD&C Act (21 U.S.C. 335a(c)(1)(B))).
88 FR 48473Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 22, 2019
(PHS Act). … period for the withdrawn guidance, “Statistical Approaches to Evaluate Analytical Similarity.”
84 FR 23569Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 5, 2014
The public comment period closed on September 23, 2010. … Paperwork Reduction Act of 1995 This guidance contains collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44
79 FR 12511Health and Human Services DepartmentFood and Drug AdministrationGuidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability
Federal Register · Notice · Apr 26, 2013
The public comment period closed on March 1, 2012. … The Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations.
78 FR 24754Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 7, 2025
(FD&C Act). … We considered all comments received during the comment period before developing the final guidance.
90 FR 1163Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 27, 2011
Oral presentations from the public during the open public comment period will be scheduled between approximately 2 and 3 p.m. on July 20, 2011. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011-15982 Filed 6-24-11; 8:45 am] BILLING CODE 4160-01-P
76 FR 37356Health and Human Services DepartmentFood and Drug AdministrationRepeal of Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation
Federal Register · Proposed Rule · Sep 12, 2018
Act of 1995 (Pub. … Reduction Act of 1995 (44 U.S.C. 3501-3520).
83 FR 46121Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Uncategorized Document · Sep 14, 1994
(the act) (21 U.S.C. 321(n) and 343(a)). … Section 701(e) of the act, unlike the informal rulemaking procedures of section 701(a) of the act, requires that the agency provide an opportunity for objections to the final rule.
Health and Human Services DepartmentFood and Drug AdministrationMatthew Teltser: Final Debarment Order
Federal Register · Notice · Feb 6, 2026
of the FD&C Act). … Teltser during his period of debarment, other than in connection with an audit under section 306 of the FD&C Act (section 306(c)(1)(B) of the FD&C Act).
91 FR 5495Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 24, 2022
Section 506(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 356(a)) provides for the granting of BTD “if the drug is intended, alone or in combination with 1 or more other drugs, to … Accordingly, in keeping with the Agency's authority to grant BTD only to drugs that meet the legal criteria, FDA periodically assesses whether the criteria for BTD continue to be met for designated products
87 FR 37865Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 3, 2013
DATES: Fax written comments on the collection of information by May 3, 2013. … FDA based these estimates on the number of original HDE applications received in the period between October 1, 2008, and September 30, 2011.
78 FR 20115Health and Human Services DepartmentFood and Drug AdministrationAntiparasitic Drug Use and Resistance in Ruminants and Equines; Public Meeting; Request for Comments
Federal Register · Notice · Feb 13, 2012
Oral presentations from the public during the open public comment period will be scheduled between approximately 2 p.m. and 3 p.m. on March 5, 2012, and 10:30 a.m. and 12 noon on March 6, 2012. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2012-3221 Filed 2-10-12; 8:45 am] BILLING CODE 4160-01-P
77 FR 7588Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jul 26, 2011
Question 19: Regarding the Excused category, should there be a brief waiting period ( e.g. … Implementation Guidance for Title V of the E-Government Act, Confidential Information Protection and Statistical Efficiency Act of 2002.
76 FR 44512Health and Human Services DepartmentOffice of the SecretaryRicardo Andres Acuna: Final Debarment Order
Federal Register · Notice · Aug 3, 2026
the FD&C Act. … Acuna during his period of debarment, other than in connection with an audit under section 306 of the FD&C Act (section 306(c)(1)(B) of the FD&C Act.
91 FR 48877Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 29, 2024
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.
89 FR 94734Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 12, 2016
Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed … There are 42 State programs enrolled, which may receive up to $300,000 each year for a period of 5 years provided there is significant conformance with the 10 standards.
81 FR 7544Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 23, 2012
Drug Consumer Protection Act (the DSNDCPA). … Under the statute, the records must be retained for a period of 6 years.
77 FR 17076Health and Human Services DepartmentFood and Drug Administration
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