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Maximum Civil Money Penalty Amounts; Civil Money Penalty Complaints; Confirmation of Effective Date
Federal Register · Rule · Jun 6, 2014
FDA stated that the effective date of the direct final rule would be June 18, 2014, 60 days after the end of the comment period, unless any significant adverse comment was submitted to FDA during the comment … period.
79 FR 32643Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 8, 2020
The Federal Food, Drug, and Cosmetic Act (FD&C Act) directs that FDA begin MDUFA reauthorization by publishing a notice in the Federal Register requesting public input and holding a public meeting … This notice, the public meeting, the 30-day comment period after the meeting, and the posting of the comments on FDA's website will satisfy these requirements.
85 FR 55462Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 1, 2019
The Food and Drug Administration Amendments Act of 2007 created section 505-1 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355-1), which authorizes FDA to require a REMS for certain … When appropriate, the data should be reported for the reporting period and cumulatively, and trends in performance compared to previous periods should be reported and discussed; (9) a discussion including
84 FR 1153Health and Human Services DepartmentFood and Drug AdministrationReauthorization of the Generic Drug User Fee Amendments; Public Meeting; Request for Comments
Federal Register · Notice · Aug 11, 2026
The FD&C Act directs FDA, following negotiations with the regulated industry and periodic consultations with other stakeholders, to present recommendations for reauthorization of the GDUFA program to the … This notice, the 30-day comment period, and the public meeting described in this notice will satisfy certain of these statutory requirements.
91 FR 51718Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 19, 2020
3 years of the close of the comment period and for the remaining 20 percent, within 5 years. … Looking forward, in FY 2021, CDRH will strive to finalize, withdraw, or reopen the comment period for 50 percent of existing draft guidances issued prior to October 1, 2015. C.
85 FR 66333Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Aug 17, 2026
This notification is a periodic proposal pursuant to section 513(f)(6)(D)(i) of the FD&C Act, and FDA is seeking feedback on this proposal through public comment. … Once the comment period ends, FDA will consider the comments and publish in the Federal Register a final action distinctly classifying suitable accessories into class I, if any. III.
91 FR 53205Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 28, 2010
Third-party reviewers should maintain records of their 510(k) reviews and a copy of the 510(k) for a reasonable period of time, usually a period of 3 years. … FDA received one comment; however, it was not PRA related.
75 FR 81616Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Feb 19, 2026
The public was invited to submit electronic or written comments during the comment period, which closed on November 19, 2024. B. … Introduction We received eight comment submissions on the proposed rule by the close of comment period, with each containing one or more comments on one or more issues.
91 FR 7825Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Dec 2, 2005
The comment period for this companion proposed rule runs concurrently with the comment period for the direct final rule. … response in a notice-and-comment process in accordance with section 553 of the Administrative Procedure Act (5 U.S.C. 553).
70 FR 72257Health and Human Services DepartmentFood and Drug AdministrationGeneric Drug User Fees; Public Meeting; Request for Comments
Federal Register · Notice · Apr 21, 2015
Program Performance Goals and Procedures ( i.e., the Commitment Letter), provide a period of 30 days after the public meeting to obtain written comments from the public, and publish the comments on … This notice, the public meeting, the 30-day comment period after the meeting, and the posting of the comments on the FDA Web site will satisfy these requirements.
80 FR 22204Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 10, 2018
Some comments requested up to 7 days to provide the notification, but several others suggested that FDA revise the notification period to 3 business days. … Most comments on the 2013 draft 503A guidance said this period was too short, but did not recommend a specific alternative.
83 FR 45631Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 4, 2018
3 years of the close of the comment period and for the remaining 20 percent, within 5 years. … Looking forward, in FY 2019, CDRH will strive to finalize, withdraw, or reopen the comment period for 50 percent of existing draft guidances issued prior to October 1, 2013. B.
83 FR 50107Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 27, 2020
Paperwork Reduction Act of 1995 This guidance contains no collection of information. … Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020-26183 Filed 11-25-20; 8:45 am] BILLING CODE 4164-01-P
85 FR 76085Health and Human Services DepartmentFood and Drug AdministrationProminence of Name of Distributor of Biological Products
Federal Register · Rule · Nov 6, 1996
In the Federal Register of August 17, 1994 (59 FR 42193), FDA extended the comment periods to November 15, 1994, in response to requests to allow for additional time for public comment. … The notice of public meeting indicated that the public comment period was to close on February 13, 1995.
61 FR 57328Health and Human Services DepartmentFood and Drug AdministrationFood Additives: Food Contact Substance Notification That Is No Longer Effective
Federal Register · Proposed Rule · Jan 26, 2022
Submit written comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 by March 28, 2022. … Act of 1995 (Pub.
87 FR 3949Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 14, 2004
This notice solicits comments on information collection requirements for medical devices; third-party review under the Food and Drug Administration Modernization Act (FDAMA), third-party premarket submission … Third-party reviews should maintain records of their 510(k) reviews and a copy of the 510(k) for a reasonable period of time, usually a period of 3 years.
69 FR 61021Health and Human Services DepartmentFood and Drug AdministrationDavid Winne: Grant of Special Termination; Final Order Terminating Debarment
Federal Register · Notice · Nov 1, 2023
ADDRESSES: Submit comments electronically at https://www.regulations.gov. … Under section 306(d)(4)(D) of the FD&C Act, the period of debarment of an individual who qualifies for special termination may be limited to less than permanent but to no less than 1 year. Mr.
88 FR 74999Health 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 · Rule · Mar 30, 2023
FD&C Act Federal Food, Drug, and Cosmetic Act. PMA Premarket Approval Application. III. Background A. … Comments on the Proposed Rule and FDA Response A. Introduction We received a few comment letters on the proposed rule by the close of the comment period.
88 FR 18987Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 22, 2018
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.
83 FR 7735Health and Human Services DepartmentFood and Drug Administration
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