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Federal Register · Notice · Oct 16, 2017
Under section 520(m) of the FD&C Act, FDA is authorized to exempt an HUD from the effectiveness requirements of sections 514 and 515 of the FD&C Act (21 U.S.C. 360d and 360e) provided that the device … 80 8,800 Notification of withdrawal of an HDE—814.116(e)(3) 1 1 1 1 1 Notification of withdrawal of Institutional Review Board approval—814.124(b) 1 1 1 2 2 Periodic
82 FR 48096Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities: Proposed Collection; Comment Request
Federal Register · Notice · Oct 24, 1997
public comment in response to the notice. … In the same period of time, CBER received 1,034 submissions from 57 manufacturers that could have made use of revised Form FDA 2253.
62 FR 55408Health and Human Services DepartmentFood and Drug AdministrationGuidance for Industry on Electronic Source Data in Clinical Investigations; Availability
Federal Register · Notice · Sep 18, 2013
The comment period on the draft guidance ended on March 26, 2013 (see the correction notice of December 26, 2012 (77 FR 76049)). … Paperwork Reduction Act of 1995 This guidance refers to collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (
78 FR 57395Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 29, 2026
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 FDA uses this information to allow for determining eligibility for designation and the associated incentives and benefits described in section 573 of the act, including a 7-year period of exclusive
91 FR 39104Health and Human Services DepartmentFood and Drug AdministrationStudy Data Technical Conformance Guide and Data Standards Catalog; Availability
Federal Register · Notice · Jan 12, 2015
Safety and Innovation Act (Pub. … The comment period on the Guide ended on May 7, 2014. We reviewed all comments received and revised it accordingly.
80 FR 1508Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Nov 15, 2006
Section 503(e)(1)(A) of the Federal Food, Drug, and Cosmetic Act (act) establishes the so-called “pedigree” requirement for prescription drugs. … As part of its June 14, 2006, announcement, FDA also issued and requested comment on draft Compliance Policy Guide 160.900 entitled “Prescription Drug Marketing Act Pedigree Requirements under 21 CFR Part
71 FR 66448Health and Human Services DepartmentFood and Drug AdministrationSEF, P.A.; Revocation of U.S. License No. 1166
Federal Register · Notice · Oct 10, 1997
The notice provided other interested persons with 60 days to submit comments on the proposed revocation. The firm did not respond within the 30-day time period with a written request for a hearing. … The 30-day time period, prescribed in the notice of opportunity for a hearing and in the regulation, may not be extended. No comments were received from any other parties.
62 FR 53011Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 1, 2015
(the FD&C Act) (21 U.S.C. 360(l))) from premarket notification requirements. … The comment period closed on September 30, 2014.
80 FR 37633Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 8, 2008
New Animal Drugs for Investigational Use—21 CFR Part 511 (OMB Control Number 0910-0117)—Extension FDA has authority under the Federal Food, Drug, and Cosmetic Act (the act) to approve new animal drugs … maintain records showing: (1) The name and post office address of the expert or expert organization to whom the drug is shipped; and (2) the date, quantity, batch or code mark for each shipment for a period
73 FR 19073Health and Human Services DepartmentFood and Drug AdministrationFederal 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 · 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 Administration
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