Documents
Briefs, oral arguments, agency decisions and the Federal Register.
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Draft Guidances for Industry on Medical Imaging Drug and Biological Products; Availability
Federal Register · Proposed Rule · May 19, 2003
In a document published in the Federal Register of January 5, 1999 (64 FR 457), FDA reopened the comment period on the medical imaging draft guidance until February 12, 1999. … In a document published in the Federal Register of February 16, 1999 (64 FR 7561), FDA extended the comment period until April 14, 1999.
68 FR 27008Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jan 12, 2017
Transition Period (Comment 3) While one commenter expressed agreement that the proposed 1 year timeframe should be sufficient for manufacturers to bring devices already on the market into compliance with … The commenter did not identify why 1 year would be an insufficient period of transition time.
82 FR 3609Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 29, 2023
of the FD&C Act. … No comments were received.
88 FR 42080Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 9, 2017
Manufacturers keep infant formula distribution records for the prescribed period as a matter of routine business practice. … Manufacturers keep infant formula distribution records for the prescribed period as a matter of routine business practice.
82 FR 52055Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 20, 2011
FD&C Act. … Therefore, designated countries may respond to periodic requests by FDA by submitting information to confirm that their designation remains appropriate.
76 FR 35897Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 8, 2013
DATES: Fax written comments on the collection of information by May 8, 2013. … The regulations that are codified at 21 CFR part 1140 (previously codified at 21 CFR part 897) are authorized by section 102 of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act
78 FR 20923Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 7, 2010
ACTION: Notice of public meeting; and reopening of comment period. … The comment period for the Draft Guidance has been reopened until January 5, 2011.
75 FR 54349Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Uncategorized Document · Aug 29, 1994
(the act). … (the act).
Health and Human Services DepartmentFood and Drug AdministrationPresiding Officers at Regulatory Hearings; Confirmation of Effective Date
Federal Register · Rule · Dec 2, 2002
SUPPLEMENTARY INFORMATION: In the Federal Register of August 15, 2002 (67 FR 53305), FDA solicited comments concerning the direct final rule for a 75-day period ending October 29, 2002. … submitted to FDA during the comment period.
67 FR 71461Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Apr 24, 2019
Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)(1)(C)(i)) and § 10.115(g)(2)). … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations.
84 FR 17081Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 23, 2011
It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011-21447 Filed 8-22-11; 8:45 am] BILLING CODE 4160-01-P
76 FR 52667Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 1, 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 report must cover the period of the preceding calendar year and include separate information for each month of the calendar year.
90 FR 18662Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 15, 2008
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 … There were an estimated 23,835 15-day Alert reports, 21,872 periodic reports, and 179 lot distribution reports submitted to FDA.
73 FR 8881Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 3, 1999
Medical Devices; Recall Authority--21 CFR Part 810 Section 518(e) (21 U.S.C. 360h) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321 et seq.) provides that if FDA finds that there … The 60-day comment period closed January 21, 1997. The agency received two comments.
64 FR 59775Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 13, 2001
Specifically in the European Union, certain member countries have legal requirements for a minimum manure storage period. … FDA will periodically review the comments in the docket and, where appropriate, will amend the guidance.
66 FR 14589Health and Human Services DepartmentFood and Drug AdministrationBenefit-Risk Assessment for New Drug and Biological Products; Guidance for Industry; Availability
Federal Register · Notice · Oct 20, 2023
2017 and requirements under the 21st Century Cures Act. … The collections of information in the guidance for industry entitled “Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format (Periodic Benefit-Risk
88 FR 72491Health and Human Services DepartmentFood and Drug AdministrationPublic Information Regulations; Companion Document to Direct Final Rule
Federal Register · Proposed Rule · Sep 2, 2004
The comment period for the companion proposed rule runs concurrently with the comment period of the direct final rule. … Therefore, under the Regulatory Flexibility Act, no further analysis is required.
69 FR 53662Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Dec 30, 2013
Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed order, consideration of any comments received, and a meeting of a device classification … For ECP devices, the preamendments class III devices that are the subject of this final order, the later of these two time periods is the 90-day period.
78 FR 79304Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 29, 2014
drug experiences and product/manufacturing defects as applicable under section 512(l) of the FD&C Act. … Periodic drug experience reports and special drug experience reports must be accompanied by a completed Form FDA 2301, “Transmittal of Periodic Reports and Promotional Material for New Animal Drugs,” (
79 FR 58355Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 19, 2012
(the FD&C Act). … FDA received comments and suggestions to pilot this program for a period of time; an evaluation will follow to allow both FDA and industry to work out potential issues, obstacles, and resource allocations
77 FR 16036Health and Human Services DepartmentFood and Drug Administration
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