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Federal Register · Notice · Nov 19, 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) ( … 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 65039Health 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 AdministrationFederal Register · Notice · Sep 14, 2012
In this notice, FDA seeks comments on the extension of OMB approval for the existing three rational questionnaires, as well as comments on a proposed fourth rational questionnaire that will be used for … 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
77 FR 56847Health 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 AdministrationVaginal Contraceptive Drug Products for Over-the-Counter Human Use
Federal Register · Proposed Rule · Feb 3, 1995
Interested persons were invited to submit comments by March 12, 1981. Reply comments in response to comments filed in the initial comment period could be submitted by April 13, 1981. … Because the agency has not previously invited specific comment on the economic impact of the OTC drug review on vaginal contraceptive drug products, a period of 120 days from the date of publication of
60 FR 6892Proposed RuleHealth and Human Services DepartmentFederal 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 AdministrationFederal 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 · Notice · Mar 6, 2002
Infant Formula Recall Regulations—21 CFR 107.230, 107.240, 107.250, 107.260, and 107.280 (OMB Control No. 0910-0188)—Extension Section 412(e) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 … Manufacturers keep infant formula distribution records for the prescribed period as a matter of routine business practice.
67 FR 10219Health 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 AdministrationFederal Register · Notice · Dec 29, 1999
Advisory Opinions--21 CFR 10.85 (OMB Control Number 0910-0193)-- Extension Section 10.85 (21 CFR 10.85), issued under section 701(a) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C … In the Federal Register of September 28, 1999 (64 FR 52329), the agency requested comments on the proposed collection of information. No significant comments were received.
64 FR 73056Health 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 AdministrationFederal Register · Rule · Oct 19, 2011
In the Federal Register of April 1, 2010 (75 FR 16363), FDA announced that it was reopening the comment period for the 1993 proposed rule to seek further comment on finalizing the allowable level for … Summary of and Response to Comments The agency received 10 responses, each containing one or more comments, to the April 1, 2010, Federal Register document reopening the comment period for the 1993
76 FR 64810Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 13, 1998
The agency believes that this guidance will enable food producers to meet the criteria for notifications that are established in section 403(r)(2)(G) and (r)(3)(C) of the act during the interim period … while the agency is initiating notice-and-comment rulemaking in this matter.
63 FR 43400Health and Human Services DepartmentFood and Drug AdministrationRoquette America, Inc.; Filing of Food Additive Petition
Federal Register · Uncategorized Document · Dec 13, 1994
During this period of continuing evaluation, mannitol continues to be listed, on an interim basis, for food use. … Rulis, Acting Director, Office of Premarket Approval, Center for Food Safety and Applied Nutrition. [FR Doc. 94-30585 Filed 12-12-94; 8:45 am] BILLING CODE 4160-01-F
Health 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 · May 16, 2016
This guidance is intended to assist manufacturers of devices subject to section 522 postmarket surveillance orders by providing an overview of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), information … The comment period ended on November 14, 2011.
81 FR 30311Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities; Proposed Collection; Comment Request; Recall Regulations
Federal Register · Notice · May 1, 2001
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 … 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); submitting periodic
66 FR 21767Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 7, 2002
One letter of comment was received in response to the 60-day notice on the information collection in which we received one comment on the proposed information collection. … Consequently, we decline to adopt the comment's recommendations.
67 FR 39406Health and Human Services DepartmentFood and Drug Administration
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