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Federal Register · Notice · Dec 21, 2020
New Animal Drugs for Investigational Use—21 CFR Part 511 OMB Control Number 0910-0117—Extension FDA has the authority under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to approve new animal drugs … Section 512(j) of the FD&C Act authorizes us to issue regulations relating to the investigational use of new animal drugs.
85 FR 83092Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Hearing Aids; Technical Data Amendments; Confirmation of Effective Date
Federal Register · Rule · Feb 25, 2000
FDA stated that the effective date of the direct final rule would be on March 17, 2000, 60 days after the end of the comment period, unless any significant adverse comment was submitted to FDA during the … comment period.
65 FR 10012Health and Human Services DepartmentFood and Drug AdministrationAnimal Cloning Risk Assessment; Risk Management Plan; Guidance for Industry; Availability
Federal Register · Notice · Jan 16, 2008
Background In the Federal Register of January 3, 2007 (72 FR 136), FDA published a notice of availability with a 90-day comment period to request comments on a draft risk assessment on animal cloning … In response to requests to extend the comment period on these documents, FDA subsequently published a notice in the Federal Register (72 FR 15887, April 3, 2007) extending the comment period for an
73 FR 2923Health and Human Services DepartmentFood and Drug AdministrationEffective Date of Requirement for Premarket Approval for Automated External Defibrillator System.
Federal Register · Proposed Rule · Mar 25, 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 … We request comment on whether it is appropriate to exercise enforcement discretion and, if so, whether the 15-month period proposed is reasonable.
78 FR 17890Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Apr 1, 2010
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.
75 FR 16365Health and Human Services DepartmentFood and Drug AdministrationOver-the-Counter Vaginal Contraceptive Drug Products Containing Nonoxynol 9; Required Labeling
Federal Register · Proposed Rule · Jan 16, 2003
The agency is providing a period of 90 days from the date of publication of this proposed rule in the Federal Register for comments on this subject to be developed and submitted. … Three copies of all written comments are to be submitted. Individuals submitting written comments or anyone submitting electronic comments may submit one copy.
68 FR 2254Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 8, 2017
ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk … No comments were received.
82 FR 37098Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities: Proposed Collection; Comment Request
Federal Register · Notice · Jan 6, 2000
The period for public comment on the proposed regulations closed on September 13, 1999, and FDA is currently reviewing the comments and preparing a final rule. … The comment period for the draft guidance closed on August 27, 1999, and FDA has considered these comments when preparing the guidance that is the subject of this request.
65 FR 779Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Apr 11, 1996
FDA, on the basis of these comments on the information collection, is extending that comment period to July 31, 1996, without further notice and comment procedures. … The Administrative Procedure Act and FDA regulations provide that the agency may issue a regulation without notice and comment procedures when the agency for good cause finds (and incorporates the finding
61 FR 16043Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Nov 18, 2003
Section 515(b)(3) of the act provides that FDA shall, after the close of the comment period on the proposed rule and consideration of any comments received, issue a final rule to require premarket approval … The act does not permit an extension of the 90-day period after issuance of a final rule within which an application or a notice is required to be filed.
68 FR 65014Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jan 5, 1999
The comment period for this companion proposed rule runs concurrently with the comment period of the direct final rule. … This comment period runs concurrently with the comment period for the direct final rule; any comments received will be considered as comments regarding the direct final rule.
64 FR 448Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jan 24, 1997
The proposed rule provided a 90-day period for public comment. The agency extended the comment period for an additional 120 days on March 22, 1996. The comment period closed on July 18, 1996. … Interested parties may submit comments on these studies during the reopened comment period. I. The FDA Study A.
62 FR 3635Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 20, 2009
We encourage sponsors to send in applications as soon as possible to allow sufficient time for review, comment, and re-submission as needed to complete all actions by the end of this 2-year period. … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations.
74 FR 53753Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 16, 2013
However, in response to a request, the comment period was extended to August 26, 2003 (68 FR 38247, June 27, 2003). … FDA again reopened the comment period on August 1, 2006 (71 FR 43392) (the 2006 reopening) for 45 days to accept comment on a limited set of issues.
78 FR 28854Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 7, 2018
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.
83 FR 5441Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 5, 2020
Background Section 505-1(g)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355-1) specifies that a REMS assessment shall include, with respect to each goal included in the strategy … Key findings: No shipments of Drug X were sent to non-certified healthcare settings during the reporting period.
85 FR 70639Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jul 17, 2003
Within 60 days after this 12-month period ends, comments on the new data and information may be submitted (see § 330.10(a)(7)(iv)). … Request for Comments FDA is reopening the administrative record for a period of 90 days for comments, new data, and information to be submitted.
68 FR 42324Health and Human Services DepartmentFood and Drug AdministrationAnimal Generic Drug User Fee Act; Public Meeting; Request for Comments
Federal Register · Notice · Apr 17, 2026
; (3) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes; and (4) publish the comments on FDA's website. … This notice, the public meeting, the comment period after the meeting, and the posting of the comments on the FDA website will satisfy these requirements.
91 FR 20691Health and Human Services DepartmentFood and Drug AdministrationAnimal Drug User Fee Act; Public Meeting; Request for Comments
Federal Register · Notice · Apr 17, 2026
; (3) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes; and (4) publish the comments on FDA's website. … This notice, the public meeting, the comment period after the meeting, and the posting of the comments on the FDA website will satisfy these requirements.
91 FR 20695Health and Human Services DepartmentFood and Drug AdministrationForeign Supplier Verification Programs for Importers of Food for Humans and Animals
Federal Register · Proposed Rule · Sep 29, 2014
We extended the comment period for the proposed rule and its information collection provisions (which are subject to review by OMB under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520 … The comment period for the proposed rule closed on January 27, 2014.
79 FR 58574Health and Human Services DepartmentFood and Drug Administration
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