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Federal Register · Notice · Jun 29, 2000
Animals held for this period may still be sent for slaughter, however. … Animals held for this period may still be sent for slaughter, however.
65 FR 40104Health and Human Services DepartmentFood and Drug AdministrationGeneral Principles of Software Validation; Draft Guidance; Extension of the Comment Period
Federal Register · Notice · Sep 29, 1997
FDA received a request from the Health Industry Manufacturers Association to extend the comment period for 90 days. … FDA is extending the comment period for 90 days to assure adequate time for preparation of comments.
62 FR 50953Health and Human Services DepartmentFood and Drug AdministrationMicrobiology Devices; Reclassification of Herpes Simplex Virus Types 1 and 2 Serological Assays
Federal Register · Proposed Rule · Aug 25, 2009
If we receive any significant adverse comment regarding the direct final rule, we will withdraw the direct final rule within 30 days after the comment period ends and proceed to respond to all of the comments … The comment period for this companion proposed rule runs concurrently with the direct final rule's comment period.
74 FR 42810Health and Human Services DepartmentFood and Drug AdministrationAdministrative Actions for Noncompliance; Lesser Administrative Actions
Federal Register · Rule · Apr 4, 2016
The comment period for this direct final rule runs concurrently with the comment period of the companion proposed rule. … after the comment period ends.
81 FR 19033Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 26, 2000
ACTION: Request for written comments; reopening of comment period. … Dotzel, Acting Associate Commissioner for Policy.
65 FR 4252Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 26, 2024
Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. … The previously approved collections of information are subject to review by Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).
89 FR 32440Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Aug 3, 1998
]] October 15, 1998, the comment period on a proposal rule that was published in the Federal Register of May 22, 1998 (63 FR 28301). … Public Health Service Act.
63 FR 41219Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Medical Device Reporting; Baseline Reports; Confirmation of Effective Date
Federal Register · Rule · Sep 17, 2008
FDA stated that the effective date of the direct final rule would be on October 27, 2008, 60 days after the end of the comment period, unless any significant adverse comment was submitted to FDA during … the comment period.
73 FR 53686Health and Human Services DepartmentFood and Drug AdministrationRichard M. Fleming; Denial of Hearing on Application for Termination of Debarment
Federal Register · Notice · Feb 28, 2023
Fleming, in any capacity during his period of debarment, will be subject to civil money penalties (section 307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))). If Dr. … Fleming during his period of debarment (section 306(c)(1)(B) of the FD&C Act). Dated: February 22, 2023. Namandjé N. Bumpus, Chief Scientist.
88 FR 12686Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 3, 2001
In addition, section 505 of the act provides several periods of marketing exclusivity ranging from 3 to 10 years (depending primarily on the nature of the innovation). … To promote product innovation, the act also gives NDA applicants several periods of “market exclusivity” ranging from 3 to 10 years (depending primarily on the nature of the innovation).
66 FR 372Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 6, 2001
ACTION: Notice; extension of comment period. … Because a public meeting has been scheduled close to the end of the comment period, FDA is extending the comment period until May 21, 2001, in order to allow additional time for public comment.
66 FR 13546Health and Human Services DepartmentFood and Drug AdministrationGeneric Drug User Fee Amendments; Public Meeting; Request for Comments
Federal Register · Notice · Oct 29, 2021
GDUFA was originally enacted in 2012 as part of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) and was authorized for a period of 5 years. … For members of the public who would like to make verbal comments on the proposed enhancements (see instructions below), there will be a public comment period at the end of the meeting.
86 FR 60049Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 18, 2025
DATES: Electronic or written comments on the applications may be submitted beginning June 18, 2025. FDA will establish a closing date for the comment period as described in section I. … FDA believes that this comment period is appropriate given the volume and complexity of the applications being posted.
90 FR 26053Health and Human Services DepartmentFood and Drug AdministrationRegulations Regarding “Intended Uses”
Federal Register · Rule · Aug 2, 2021
Introduction We received approximately 15 comment submissions on the proposed rule by the close of the comment period, each containing one or more comments on one or more issues. … An automobile is not subject to regulation by the Federal Aviation Administration, unless it is `intended to be used for flight in the air.' ”) (citations omitted).
86 FR 41383Health and Human Services DepartmentFood and Drug AdministrationQuality Standards and Certification Requirements for Mammography Facilities; Personnel Requirements
Federal Register · Proposed Rule · Apr 3, 1996
There were numerous comments on this requirement in the interim regulations, most of which focused on the lack of a specified average period. … Some comments suggested that it should be 15 hours over a 3-year period.
61 FR 14898Health and Human Services DepartmentHealth and Human Services DepartmentFederal Register · Notice · May 20, 2019
One comment was received that was PRA related. … The number of documents received each year since the original collection period has fallen to less than 5 percent of what was received in the original collection period.
84 FR 22860Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 16, 2018
With Food and Drug Administration Review Staff Under the Sixth Authorization of the Prescription Drug User Fee Act AGENCY: Food and Drug Administration, HHS. … ERG will interview 1 to 3 sponsor representatives at a time for up to 150 INDs during the annual assessment period.
83 FR 40771Health and Human Services DepartmentFood and Drug AdministrationGeneric Drug User Fee; Notice of Public Meeting; Reopening of the Comment Period
Federal Register · Notice · Nov 4, 2010
ACTION: Notice; reopening of the comment period. … In light of this request, and the arrival of late submitted comments, FDA is reopening the comment period for an additional 30 days. III.
75 FR 67984Health and Human Services DepartmentFood and Drug AdministrationGeneric Drug User Fee; Notice of Public Meeting; Reopening of the Comment Period
Federal Register · Notice · Jan 24, 2011
ACTION: Notice; reopening of the comment period. … In light of these requests, FDA is reopening the comment period for an additional 30 days. III.
76 FR 4119Health and Human Services DepartmentFood and Drug AdministrationExports: Notification and Recordkeeping Requirements
Federal Register · Rule · Dec 19, 2001
Several comments protested that the 5-year period was excessive. … Several comments objected to the 5-year period. Two comments advocated a 2-year period in order to be consistent with the QS regulation requirements.
66 FR 65429Health and Human Services DepartmentFood and Drug Administration
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