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Federal Register · Notice · Mar 31, 2023
Section 502(n) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 352(n)) requires that manufacturers, packers, and distributors (firms) who advertise prescription human and animal drugs … Section 202.1 applies to advertisements published in journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television, and telephone communication
88 FR 19313Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 17, 2012
ADDRESSES: Submit electronic comments on the collection of information to http://www.regulations.gov. … FDA based these estimates on the number of original HDE applications received in the period between October 1, 2008, and September 30, 2011.
77 FR 74667Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 14, 2024
period was open until July 3, 2023. … , as amended by the 21st Century Cures Act (Pub.
89 FR 90018Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities; Submission for OMB Review; Comment Request
Federal Register · Notice · Aug 12, 1997
DATES: Submit written comments on the collection of information by September 11, 1997. … Most of the questions asked are identical to ones asked in a 1992-1993 survey so that changes over this time period can be assessed.
62 FR 43169Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 6, 2012
Medical Device User Fee Cover Sheet—Form FDA 3601 (OMB Control Number 0910-0511)—Extension The Federal Food, Drug, and Cosmetic Act, as amended by the Medical Device User Fee and Modernization Act of … , PDP, PMR, BLA), 1 3,561 premarket notifications, 12 panel track supplements, 180 real-time supplements, 127 180-day supplements, 749 30-day notices, 84 513(g) requests, and 463 annual fees for periodic
77 FR 33469Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 8, 2013
FDA-2013-N-0196] Food and Drug Administration Prescription Drug User Fee Act V Benefit-Risk Plan; Request for Comments AGENCY: Food and Drug Administration, HHS. … The comment period will remain open for 60 days following the publication of this notice. After consideration of public comments, FDA will finalize the plan.
78 FR 15019Health and Human Services DepartmentFood and Drug AdministrationRegulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation
Federal Register · Rule · Dec 16, 2019
Comments on the Proposed Rule V. Effective Date VI. Economic Analysis of Impacts VII. Analysis of Environmental Impact VIII. Paperwork Reduction Act of 1995 IX. Federalism X. … Comments on the Proposed Rule We received five comment letters on the proposed rule by the close of the comment period, all from individuals.
84 FR 68331Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 24, 2022
Under section 705 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 375), the Secretary of the Department of Health and Human Services (the Secretary) may require dissemination of information … We have identified 24 DHCP letters that 18 distinct sponsors submitted to FDA during the 3-year period (2019 to 2021).
87 FR 37871Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 12, 2006
DATES: Fax written comments on the collection of information by November 13, 2006. … ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer
71 FR 60157Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 22, 1998
comment and publication of a final regulation'' if the agency ``determines that such action is necessary * * * to enable [FDA] to act promptly to ban or modify a claim'' under section 403(r) of the act … FDA invites public comment on this interim final rule. The agency will consider modifications to this interim final rule based on comments made during the comment period.
63 FR 34092Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 11, 2026
period extended November 22, 2021 (86 FR 66318)). … FD&C Act.
91 FR 57892Health and Human Services DepartmentFood and Drug AdministrationBiological Products: Reporting of Biological Product Deviations in Manufacturing
Federal Register · Rule · Nov 7, 2000
The final rule also establishes a 45-day reporting period. … Although less than 10 persons usually do not represent the majority of the industry, the comment period for the proposed rule provides the opportunity for all interested persons to comment on the estimated
65 FR 66621Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 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. … (the act) regarding safety, identity, strength, quality, and purity.
90 FR 60726Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 30, 2020
OMB Control Number 0910-0560—Extension The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 added section 414 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C … Existing records may be used if they contain all the required information and are retained for the required time period. Section 101 of the FDA Food Safety Modernization Act (FSMA) (Pub.
85 FR 45888Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 28, 2023
Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act … 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.
88 FR 41964Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Dec 2, 1998
Two comments addressed the agency's reliance on section 701(a) of the act. … Another comment argued that 701(a) of the act does not authorize the agency to enforce requirements beyond those imposed by the act.
63 FR 66632Regulations Requiring Manufacturers to Assess the Safety andEffectiveness of New Drugs and Biological Products in PediatricFederal Register · Notice · Jun 27, 2014
Background Section 226 of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) and section 614 of the Food and Drug Administration Safety and Innovation Act (Pub. … During the 60-day comment period, which ended on November 25, 2013, more than 300 comments were received from 21 entities.
79 FR 36530Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 3, 2020
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 … includes an initial one-time submission burden, we expect reduced burden over a long term because filers can subsequently submit one entry covering multiple withdrawals from the FTZ in any given seven-day period
85 FR 318Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 18, 2014
The comment period on the draft guidance ended on May 6, 2014. We reviewed all comments received on the draft guidance and revised several sections of the guidance. … Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES
79 FR 75570Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 26, 2018
Because such radiopharmaceuticals are not eligible for exemptions from provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to the production of drugs, FDA is issuing this guidance … The comment period on the draft guidance ended on February 27, 2017. FDA received comments on the draft guidance.
83 FR 48633Health and Human Services DepartmentFood and Drug Administration
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