Documents
Briefs, oral arguments, agency decisions and the Federal Register.
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Antacid Drug Products for Over-the-Counter Human Use; Proposed Amendment of Antacid Final Monograph
Federal Register · Uncategorized Document · Feb 2, 1994
During this period, no medications were given (including sodium bicarbonate). … section 505(a) of the act
Health and Human Services DepartmentFood and Drug AdministrationMayya Tatsene: Final Debarment Order
Federal Register · Notice · Sep 12, 2023
) of the FD&C Act). … Tatsene during her period of debarment, other than in connection with an audit under section 306 of the FD&C Act.
88 FR 62575Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 12, 2013
Section 130(a) of the Food and Drug Administration Modernization Act of 1997 (Pub. … L. 105-115) amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by adding a new provision (section 506B of the FD&C Act (21 U.S.C. 356b)) requiring reports of postmarketing studies for approved
78 FR 35273Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Sep 13, 2018
Act of 1995 (Pub. … Act of 1995.
83 FR 46444Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 23, 2020
On August 15, 2018, we published a notice reopening the comment period to October 15, 2018 (83 FR 40524). … Paperwork Reduction Act of 1995 This guidance contains no collection of information.
85 FR 74736Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 26, 2008
Infant Formula Recall Regulations—21 CFR 107.230, 107.240, 107.250, 107.260, and 107.280 (OMB Control Number 0910-0188)—Extension Section 412(e) of the Federal Food, Drug, and Cosmetic Act (the act) ( … Manufacturers keep infant formula distribution records for the prescribed period as a matter of routine business practice.
73 FR 16018Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 20, 2004
Paperwork Reduction Act of 1995 According to the Paperwork Reduction Act of 1995, a collection of information should display a valid OMB control number. … FDA periodically will review the comments in the docket and, where appropriate, will amend the guidance.
69 FR 29140Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 8, 2010
It also amends section 520(m) of the act to exempt some HUDs from the prohibition on profit (new section 520(m)(6) of the act). … In the Federal Register of August 5, 2008 (73 FR 45460), FDA published a 60-day notice requesting public comment. The comment period closed on November 3, 2008.
75 FR 39263Health and Human Services DepartmentFood and Drug AdministrationProposal To Revoke 23 Standards of Identity for Foods
Federal Register · Proposed Rule · Jul 17, 2025
DATES: Submit either electronic or written comments on the proposed rule by September 15, 2025. FDA does not intend to extend the comment period. … , and the Unfunded Mandates Reform Act of 1995 (Pub.
90 FR 33339Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 14, 2004
Current Good Manufacturing Practice Regulations for Medicated Feeds—21 CFR Part 225 (OMB Control Number 0910-0152)—Extension Under section 501 of the Federal Food, Drug, and Cosmetic Act (the act) (21 … A license is required when the manufacturer of a medicated feed involves the use of a drug or drugs that FDA has determined requires more control because of the need for a withdrawal period before slaughter
69 FR 33040Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 16, 2007
Current Good Manufacturing Practice Regulations for Medicated Feeds—21 CFR Part 225 (OMB Control Number 0910-0152)—Extension Under section 501 of the Federal Food, Drug, and Cosmetic Act (the act) (21 … A license is required when the manufacturer of a medicated feed involves the use of a drug or drugs that FDA has determined requires more control because of the need for a withdrawal period before slaughter
72 FR 46089Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Safe Handling Statements: Labeling of Shell Eggs
Federal Register · Rule · Aug 20, 2007
Analysis of Economic Impacts FDA has examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 … The range of cost savings from option two is estimated to be between $5 and $19 million, with a mean of $11 million, assuming a 12-month compliance period. 3.
72 FR 46375Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 22, 2020
during implanted embryo's major organogenesis period; • material toxicity endpoints (minimum CL, BW, FW, DS); • caesarean section endpoints in PY, IC, FM, FX (pregnancy, Corpora Lutea, implantations … Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020-23393 Filed 10-21-20; 8:45 am] BILLING CODE 4164-01-P
85 FR 67355Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 19, 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. … FDA has adjusted its burden estimate by removing estimates of burden associated with tobacco health document submissions for NTN products because the compliance period for initial submission from NTN manufacturers
90 FR 45218Health and Human Services DepartmentFood and Drug AdministrationPrescription Drug User Fee Rates for Fiscal Year 2014
Federal Register · Notice · Aug 2, 2013
After review of the reports and receipt of public comments, FDA may adopt appropriate changes to the workload adjustment methodology. … that human drug review became less complex over this period.
78 FR 46980Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 23, 1999
This notice solicits comments on requirements related to the recall of infant formula. DATES: Submit written comments on the collection of information by April 26, 1999. … Manufacturers keep infant formula distribution records for the prescribed period as a matter of routine business practice.
64 FR 8832Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 28, 2011
of 2002 (the Bioterrorism Act) added section 414 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 350c), which requires that persons who manufacture, process, pack, hold, receive, … Existing records may be used if they contain all of the required information and are retained for the required time period.
76 FR 17131Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 13, 1998
The agency requested comments on this guidance. DATES: Written comments may be submitted at any time. … The guidance advises that, for a limited period of time, FDA does not intend to object if manufacturers, packers, or distributors of already approved products implement section 126 of FDAMA at the time
63 FR 12473Health and Human Services DepartmentFood and Drug AdministrationNew Animal Drug Applications; Sheep as a Minor Species
Federal Register · Proposed Rule · Jul 26, 1999
A tissue residue depletion study would be conducted in sheep to establish the withdrawal period. … Reform Act (Pub.
64 FR 40321Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 4, 2019
This guidance describes policies that FDA intends to use in evaluating bulk drug substances nominated for use in compounding under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for … The comment period ended on May 25, 2018. FDA received approximately 60 comments on the draft guidance.
84 FR 7390Health and Human Services DepartmentFood and Drug Administration
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