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Briefs, oral arguments, agency decisions and the Federal Register.
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Animal Drug User Fee Act; Public Meeting; Request for Comments
Federal Register · Notice · Feb 21, 2008
FDA agreed to review and act on submissions within shorter periods of time each fiscal year. … In general, the meeting format will include presentations by FDA and an open comment period for the public.
73 FR 9571Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 16, 2021
ACTION: Notice; reopening comment period. … DATES: FDA is reopening the comment period for the notice published July 23, 2021 (86 FR 39038). Submit either electronic or written comments by August 24, 2021.
86 FR 45738Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 4, 2016
Background In accordance with section 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e(d)(4) and (e)(2)), notification of an order approving, denying, or … Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period.
81 FR 51453Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 26, 2006
Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each … Description : Devices subject to premarket approval under section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e) are also subject to periodic reports imposed by the premarket approval
71 FR 62595Health and Human Services DepartmentFood and Drug AdministrationBiological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review
Federal Register · Rule · Dec 19, 2005
Periodic Review of Product Labeling C. Improvement in the Reporting of Adverse Reactions D. Periodic Review of Product Licenses E. … Periodic review of labeling on a set schedule is unnecessary.
70 FR 75018Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 5, 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 18094Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 25, 2022
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. … FDA expects this is because documents created within the specified period should have already been submitted.
87 FR 10800Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 23, 2018
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. … FDA expects this is because documents created within the specified period should have already been submitted.
83 FR 42664Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Sep 17, 2012
ACTION: Notification; extension of comment period. … SUMMARY: The Food and Drug Administration (FDA) is extending the comment period pertaining to information collection issues under the Paperwork Reduction Act of 1995 (the PRA) associated with the proposed
77 FR 57055Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 18, 2021
The statutory basis for FDA conducting this study is derived from the Public Health Service Act (PHS Act) (42 U.S.C. 243, section 311(a)). … The sample for each data collection period is evenly distributed among Specialists.
86 FR 10087Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Sep 23, 1996
1996, the comment period on the proposed rule that published in the Federal Register of July 9, 1996 (61 FR 36154). … The agency is taking this action in response to a request for an extension of the comment period.
61 FR 49714Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 18, 2000
the provisions of the Federal Food, Drug, and Cosmetic Act that apply to drugs (21 U.S.C. 301 et seq .). … (Comment 2) The other comment stated that, in view of rapidly changing technology that would require conversion of data whenever newer computer systems are acquired, the retention period would constitute
65 FR 62359Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Feb 3, 2015
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 … One comment suggested that the 15-month period should be extended to 30 months, which the commenter claimed would be consistent with section 501(f)(2)(B) of the FD&C Act.
80 FR 5674Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 17, 2025
under section 760(c)(2) of the FD&C Act. … Section 760(e) of the FD&C Act also requires that responsible persons maintain records of nonprescription drug adverse event reports, whether the event is serious or not, for a period of 6 years.
90 FR 5895Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 4, 1998
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … period.
63 FR 24557Health and Human Services DepartmentFood and Drug AdministrationPresiding Officers at Regulatory Hearings
Federal Register · Proposed Rule · Aug 15, 2002
If FDA receives any significant adverse comments, the agency will publish a document withdrawing the direct final rule within 30 days after the comment period ends. … The comment period for this companion proposed rule runs concurrently with the comment period of the direct final rule.
67 FR 53324Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jun 16, 1998
FDA is providing a 75-day period for comment on this companion proposed rule, to run concurrently with the comment period for the direct final rule. … This comment period begins on June 16, 1998, and ends on August 31, 1998.
63 FR 32772Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jan 14, 2015
FSMA amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish the foundation of a modernized, prevention-based food safety system. … The NOI asked for public comment by November 15, 2013, and FDA later extended the deadline for the comment period to April 18, 2014 (79 FR 13593; March 11, 2014).
80 FR 1852Health and Human Services DepartmentFood and Drug AdministrationReauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments
Federal Register · Notice · Sep 22, 2021
This notice, the 30-day comment period, and the public meeting will satisfy some of these requirements. … BsUFA was originally enacted in 2012 as the Biosimilar User Fee Act under the Food and Drug Administration Safety and Innovation Act (FDASIA, Pub. L. 112-144) for a period of 5 years.
86 FR 52685Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 12, 2018
ACTION: Notice of availability; reopening of the comment period. … The Agency has received a request for a 30-day extension of the comment period for the draft guidance.
83 FR 1618Health and Human Services DepartmentFood and Drug Administration
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