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Briefs, oral arguments, agency decisions and the Federal Register.
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Federal Register · Notice · Mar 16, 2004
DATES: Fax written comments on the collection of information by April 15, 2004. … The comment recommended the incorporation of risk-based analysis.
69 FR 12331Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 29, 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. … In the Federal Register of May 1, 2025 (90 FR 18682), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
90 FR 35695Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Oct 5, 1999
This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA … During the comment period, FDA received following comments. 1. Two comments requested that an additional classification category be added for the nonsterile hydrogel wound and burn dressing.
64 FR 53927Health and Human Services DepartmentFood and Drug AdministrationRemoval of Regulations Regarding Certification of Antibiotic Drugs
Federal Register · Rule · May 12, 1998
The comment period for the direct final rule runs concurrently with that of the companion proposed rule. … adverse comment.
63 FR 26066Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 27, 2024
part 320 (21 CFR part 320), by adding a requirement to retain reserve samples of certain drug products (that is, samples of the drug products that were used to conduct BA or BE studies) for a specified period … Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information.
89 FR 21255Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 17, 2015
Submit comments on the information collection issues under the Paperwork Reduction Act of 1995 by February 16, 2016. … Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each
80 FR 78743Health and Human Services DepartmentFood and Drug AdministrationRevocation of the Test for Mycoplasma
Federal Register · Rule · Aug 21, 2020
, Drug, and Cosmetic Act (FD&C Act). … Mandates Reform Act of 1995 (Pub.
85 FR 51635Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 11, 2018
FDA-2016-N-0407] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Pilot Project Program Under the Drug Supply Chain Security Act AGENCY … All comments should be identified with the OMB control number 0910-NEW and title “Pilot Project Program Under the Drug Supply Chain Security Act.”
83 FR 22085Health and Human Services DepartmentFood and Drug AdministrationProduct-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Federal Register · Notice · Feb 25, 2019
Under that process, draft guidances are posted on FDA's website and announced periodically in the Federal Register . … Schiller, Acting Associate Commissioner for Policy. [FR Doc. 2019-03129 Filed 2-22-19; 8:45 am] BILLING CODE 4164-01-P
84 FR 6005Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 3, 2017
extended-release oral tablets, submitted by Intellipharmaceutics Corp., with the proposed indication of management of moderate-to-severe pain when a continuous around-the-clock analgesic is needed for an extended period … Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: June 27, 2017. Anna K.
82 FR 30874Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Mar 5, 1996
The comment asserted that a 2-year period would allow adequate time to incorporate changes on labels of slower moving products as well as products with higher retail turn rates. … Furthermore, the agency points out that a 2-year period is consistent with the amount of time given for implementation of the Nutrition Labeling and Education Act (NLEA) requirements.
61 FR 8781Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 17, 2020
Therefore, designated countries may respond to our periodic requests by submitting information to confirm their designations remain appropriate. … Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020-27746 Filed 12-16-20; 8:45 am] BILLING CODE 4164-01-P
85 FR 81930Health and Human Services DepartmentFood and Drug AdministrationPostmarketing Studies for Approved Human Drug and Licensed Biological Products; Status Reports
Federal Register · Rule · Oct 30, 2000
(Comment 4) One comment claimed that the proposed rule is contrary to FOIA and the Trade Secrets Act. … the act.
65 FR 64607Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities: Proposed Collection; Comment Request
Federal Register · Notice · Apr 8, 1998
Statutory authority for this collection of information is found in section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262). … In the interim period, the old Form FDA 356h and the new Form FDA 356h were to be acceptable alternatives for NDA's, ANDA's, AADA's, and BLA's.
63 FR 17183Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 13, 2002
Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each … During that 4-year period, an average of five antimicrobial NADAs (including original and major supplements) were approved in food-producing animals per year.
67 FR 58058Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 2, 2014
The draft guidance was made available on April 1, 2014, and the period to provide comments lasted 60 days, closing on June 2, 2014. … 503A and 503B of the FD&C Act.
79 FR 52012Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 19, 2023
In preparing the draft guidance, FDA considered comments received on the 2020 Notifying FDA Guidance. 2 The CARES Act (Pub. L. 116-136) was enacted on March 27, 2020. … The CARES Act amendments to section 506C of the FD&C Act took effect on September 23, 2020. See section 3112(g) of the CARES Act.
88 FR 72084Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 12, 2023
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. … The records of processing information are periodically reviewed during factory inspections by FDA to verify fulfillment of the requirements in parts 113 or 114.
88 FR 70663Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 19, 2025
The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco … The original figure of 60 represented the total number of respondents across a three-year period rather than an annual average.
90 FR 45227Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 18, 2015
for public comment in response to the notice. … The total hours column reflects the total number of hours averaged over the 4-year period. III.
80 FR 14134Health and Human Services DepartmentFood and Drug Administration
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