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Federal Register · Notice · Apr 28, 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. … ), (2)(i) and (ii), (3) , and (4)(iv)(A) and (C) 1932 85 1,249 98,639 1 98,639 Voluntary reporting FDA Form 1932a for the public 1932a 106 1 106 1 106 514.80(b)(4) Periodic
88 FR 26318Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 23, 2009
Under section 701(a) of the act, FDA is authorized to issue regulations for the act's efficient enforcement. … Existing records may be used if they contain all of the required information and are retained for the required time period.
74 FR 54827Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 8, 2005
(the act) (21 U.S.C. 393(d)(2)). … The Nutrition Labeling and Education Act of 1990 (Public Law 101-535) amended the act. Section 403(r)(1)(A) of the act (21 U.S.C. 343(r)(1)(A)) was added under these amendments.
70 FR 18032Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 19, 2019
Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed … Changes to PS plan for a device that is no longer marketed (822.28) 6 1 6 8 48 Waiver (822.29) 1 1 1 40 40 Exemption request (822.30) 16 1 16 40 640 Periodic
84 FR 28554Health and Human Services DepartmentFood and Drug AdministrationAdequate and Well-Controlled Studies for Investigational Use and Approval of New Animal Drugs
Federal Register · Proposed Rule · May 8, 1997
DATES: Written comments by July 22, 1997. … (See definition of substantial evidence, section 512(d)(3) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b(d)(3))).
62 FR 25153Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 16, 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. … Although FDA receives fewer than one application submission annually under section 571 of the FD&C Act when averaged over a 3-year period, we use a place holder of one response and 1 hour annually to account
90 FR 25335Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Health Claims; Soluble Dietary Fiber From Certain Foods and Coronary Heart Disease
Federal Register · Rule · Oct 2, 2002
The Nutrition Labeling and Education Act of 1990 The Nutrition Labeling and Education Act of 1990 (the 1990 amendments) (Public Law 101-535) amended the Federal Food, Drug, and Cosmetic Act (the act) … Section 403(r)(7) of the act authorizes us to make proposed regulations issued under section 403(r) of the act effective upon publication pending consideration of public comment and publication of
67 FR 61773Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 14, 2018
Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to conduct research relating to drugs and other FDA regulated products in carrying … out the provisions of the FD&C Act.
83 FR 56845Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jul 20, 2010
The comment period closed on June 15, 2010. FDA is withdrawing the direct final rule because the agency received significant adverse comment. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010-17617 Filed 7-19-10; 8:45 am] BILLING CODE 4160-01-S
75 FR 41986Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 23, 2020
FDA believes that dispensers can use the 3-year period to ensure the systems and processes that are put into place to meet the enhanced system requirements by November 27, 2023, will also fulfill all dispenser … verification requirements under section 582(d)(4) of the FD&C Act.
85 FR 67550Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 25, 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 … records of compensation agreements with any compensation paid to nonemployee clinical investigators, including information showing any financial interests held by the clinical investigator, for a time period
66 FR 38712Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 2, 2013
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 … testing of the donor indicating T. cruzi infection, we recommend that the establishment notify consignees of all previously distributed blood and blood components collected during the “lookback” period
78 FR 46954Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 25, 2005
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 … records of compensation agreements with any compensation paid to nonemployee clinical investigators, including information showing any financial interests held by the clinical investigator, for a time period
70 FR 49928Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Technical Amendments
Federal Register · Rule · Mar 15, 2024
(FD&C Act). … Notice and Public Comment Publication of this document constitutes final action under the Administrative Procedure Act (APA) (5 U.S.C. 553).
89 FR 18792Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 12, 2018
Act; this requirement is subject to certain exceptions during a 10-year transition period ending on March 23, 2020 (see section 7002(e)(1)-(3) and (e)(5) of the BPCI Act). … FDA received several comments on the draft guidance, and those comments were considered as the guidance was finalized.
83 FR 63896Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 5, 2001
Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report—21 CFR Part 510 (OMB Control No. 0910-0012)—Extension Section 512(l) of the Federal Food, Drug, and Cosmetic Act (the act … FDA Form 2301 is available for the required transmittal of periodic reports and promotional material for new animal drugs.
66 FR 55942Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 25, 2006
DATES: Fax written comments on the collection of information by June 26, 2006. … During the period since the publication of the January 2000 final rule, FDA has received approximately 100 supplements and analytical method validation from approximately four respondents.
71 FR 30143Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 7, 2000
Submit electronic comments on the collection of information on the Internet at: http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm. … In such a case the applicant may begin distribution of the drug 30 days after FDA receives a supplemental application unless the agency notifies the applicant within the 30-day period that prior approval
65 FR 54279Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Aug 15, 1997
FDA notes that the Federal Food, Drug, and Cosmetic Act (the act) authorizes FDA, under certain circumstances, to grant periods of exclusive marketing to manufacturers who obtain approval of labeling supplements … Over this 5-year period, only two were for products sponsored by small businesses as defined by the Small Business Administration.
62 FR 43900RuleHealth and Human Services DepartmentFederal Register · Notice · Jan 26, 2010
Under section 701(a) of the act, FDA is authorized to issue regulations for the act's efficient enforcement. … Existing records may be used if they contain all of the required information and are retained for the required time period.
75 FR 4077Health and Human Services DepartmentFood and Drug Administration
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