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Federal Register · Notice · Sep 30, 2015
FDA-2015-N-0007] Biosimilar User Fee Act; Stakeholder Meetings on Biosimilar User Fee Act of 2012 Reauthorization; Request for Notification of Regulated Industry Organization Intention To Participate … The FD&C Act further requires that after negotiations with the regulated industry are concluded, FDA shall present those recommendations for public review and comment, and finally transmit recommendations
80 FR 58738Health and Human Services DepartmentFood and Drug AdministrationProduct-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Federal Register · Notice · Nov 19, 2020
Under that process, draft guidances are posted on FDA's website and announced periodically in the Federal Register . … Paperwork Reduction Act of 1995 FDA tentatively concludes that this draft guidance contains no collection of information.
85 FR 73725Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Aug 6, 1998
Because of the significant adverse comment received, FDA is unable to promulgate monitoring requirements within the statutory time period, i.e., by August 6, 1998, set forth in section 410(b)(1) of the … Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 349(b)(1)).
63 FR 42198Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities; Submission for OMB Review; Comment Request
Federal Register · Notice · Feb 21, 1997
DATES: Submit written comments on the collection of information by March 24, 1997. … There are 39 national and international organizations with one report each reporting period. Dated: February 12, 1997. William K. Hubbard, Associate Commissioner for Policy Coordination.
62 FR 8024Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 22, 2017
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. Section 101 of the FDA Food Safety Modernization Act (FSMA) (Pub.
82 FR 44427Health and Human Services DepartmentFood and Drug AdministrationOver-the-Counter Sunscreen Drug Products-Regulatory Status of Ecamsule
Federal Register · Proposed Rule · Feb 25, 2015
Publication of a proposed sunscreen order triggers several timelines under the SIA, including a 45-day public comment period, and a 30-day period in which a sponsor may request a meeting with FDA to discuss … Comments Similarly, section 586C(b)(6) of the FD&C Act, as amended by the SIA, establishes that a proposed sunscreen order shall provide 45 days for public comment.
80 FR 10035Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 13, 2026
In response to a request for an extension, the comment period was extended to January 5, 2024 (88 FR 82384, November 24, 2023). … Paperwork Reduction Act of 1995 While this guidance contains no new collection of information, it does refer to previously approved FDA collections of information.
91 FR 6855Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 7, 2025
In the Federal Register of April 6, 2023 (88 FR 20525), we announced that we were reopening the comment period until May 8, 2023, to allow interested parties additional time to submit comments. … Paperwork Reduction Act of 1995 This guidance contains no collection of information.
90 FR 1135Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 7, 2014
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 FD&C 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
79 FR 19091Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 9, 2001
Current Good Manufacturing Practice Regulations for Medicated Feeds—21 CFR Part 225 (OMB Control No. 0910-0152)—Extension Under section 501 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C … A license is required when the manufacturer of a medicated feed involves the use of a drug or drugs, which FDA has determined requires more control because of the need for a withdrawal period before slaughter
66 FR 9707Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 1, 2014
for public comment in response to the notice. … Table 1 provides examples of the types of studies that may be administered and estimated burden levels during the 3-year period.
79 FR 44779Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 28, 2012
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 … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2012-7405 Filed 3-27-12; 8:45 am] BILLING CODE 4160-01-P
77 FR 18826Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 29, 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 … FDA form 2301 is available for the required transmittal of periodic reports and promotional material for new animal drugs.
66 FR 29141Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 3, 2017
) of the FD&C Act. … partners can determine that product was initially introduced by manufacturers in a transaction into commerce during that time period.
82 FR 30868Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 21, 2015
DATES: Submit either electronic or written comments on the collection of information by June 22, 2015. … the past 3 years in the regulation of tobacco products and is based on the actual number of establishment registration and product listings and product ingredient submissions received during this time period
80 FR 22202Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 24, 2022
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. … 80 9,280 Notification of withdrawal of an HDE—814.116(e)(3) 2 1 2 1 2 Notification of withdrawal of institutional review board approval—814.124(b) 1 1 1 2 2 Periodic
87 FR 51993Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Apr 4, 2008
The comment period closed February 19, 2008. FDA is withdrawing the direct final rule because the agency received significant adverse comments. … FDA will consider the comments received under our usual procedures for notice and comment in connection with the notice of proposed rulemaking that was published in the Federal Register of December
73 FR 18440Health and Human Services DepartmentFood and Drug AdministrationAntimicrobial Animal Drug Sales and Distribution Reporting
Federal Register · Proposed Rule · Jul 27, 2012
Background Section 512( l ) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b( l )) requires sponsors of approved or conditionally approved new animal drug applications … FDA is soliciting public comment on whether, consistent with its authority under section 512( l ) of the FD&C Act to collect information relating to approved new animal drugs, it should amend its regulations
77 FR 44177Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 22, 1999
The Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act (the PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each … Dotzel, Acting Associate Commissioner for Policy Coordination. [FR Doc. 99-15754 Filed 6-21-99; 8:45 am] BILLING CODE 4160-01-F
64 FR 33309Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; 30-Day Notices and 135-Day PMA Supplement Review
Federal Register · Rule · Aug 11, 1998
, as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). … The comment period closed on July 13, 1998. FDA is withdrawing the direct final rule because the agency received significant adverse comment.
63 FR 42699Health and Human Services DepartmentFood and Drug Administration
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