Documents
Briefs, oral arguments, agency decisions and the Federal Register.
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Federal Register · Notice · Sep 9, 2011
ACTION: Notice; extension of comment period. … The Agency has received a request for a 45-day extension of the comment period for this notice.
76 FR 55927Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 16, 2001
This final guidance implements provisions of the Government Paperwork Elimination Act (GPEA). DATES: Submit written comments on the final guidance at any time. … FDA will periodically review the comments in the docket and, where appropriate, will amend the guidance.
66 FR 10700Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Sep 13, 2017
DATES: Submit either electronic or written comments on this proposed rule by November 13, 2017. ADDRESSES: You may submit comments on the extension of the compliance period as follows. … Reform Act of 1995 (Pub.
82 FR 42963Health and Human Services DepartmentFood and Drug AdministrationIrradiation in the Production, Processing and Handling of Food
Federal Register · Proposed Rule · Apr 4, 2007
period if relabeling is permitted voluntarily. … The agency requests comments on the likely effect on small firms as a result of this proposed rule, and on the effects of longer compliance periods for these firms. E.
72 FR 16291Health and Human Services DepartmentFood and Drug AdministrationCourt Decisions, ANDA Approvals, and 180-Day Exclusivity
Federal Register · Rule · Jul 13, 2000
Submit written comments by October 11, 2000. … Therefore a public comment period before the establishment of this interim rule may be dispensed with under 5 U.S.C. 553(b)(3)(B) and § 10.40(e)(1) (21 CFR 10.40(e)(1)).
65 FR 43233Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 16, 2011
ACTION: Notice; extension of comment period. … FDA has considered the comments from the APAC meeting and is extending the comment period for the notice until April 25, 2012.
76 FR 71045Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 5, 2021
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. … 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.
86 FR 61277Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 11, 2020
ACTION: Notice of availability; extension of comment period. … The Agency has received a request for a 30-day extension of the comment period.
85 FR 80117Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 23, 1998
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).
63 FR 13864Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 23, 2017
Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed … This notice solicits comments on the collection of information associated with the Guidance “Providing Post-market Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report
82 FR 23578Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Feb 24, 2009
” direct final rule and solicited comments concerning the direct final rule for a 75-day period ending March 27, 2009. … comment period.
74 FR 8200Health and Human Services DepartmentFood and Drug AdministrationRefuse To Accept Procedures for Premarket Tobacco Product Submissions
Federal Register · Rule · Dec 29, 2016
(Comment 2) One commenter suggested that FDA apply this “commonsense regulation” to premarket submissions for newly deemed tobacco products submitted during the compliance period announced in the Deeming … (Comment 7) One commenter argued that implementing the rule would allow FDA to deprive manufacturers of the valuable substantive right to market their products during the compliance period for deemed products
81 FR 95863Health and Human Services DepartmentFood and Drug AdministrationRevocation of Food Standards for 11 Products Not Currently Sold
Federal Register · Proposed Rule · Jul 17, 2025
after the comment period ends, and we will then proceed to respond to comments under this proposed rule using the usual notice and comment procedures. … The comment period for this companion proposed rule runs concurrently with the comment period for the direct final rule.
90 FR 33346Health and Human Services DepartmentFood and Drug AdministrationRevocation of Uses of Partially Hydrogenated Oils in Foods
Federal Register · Rule · Aug 9, 2023
30 days after the comment period on this direct final rule ends. … If FDA receives no significant adverse comments during the specified comment period, we intend to publish a document confirming the effective date within 30 days after the comment period ends. III.
88 FR 53764Health 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 · 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 AdministrationMaximum 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 AdministrationMedical Device User Fee and Modernization Act; Public Meeting
Federal Register · Notice · Apr 18, 2007
After the public meeting and the close of the 30-day comment period, we will undertake a careful review of all the public comments we receive on these proposed recommendations. II. … We propose to publish draft guidance by the end of FY 2008 and allow for a 90-day public comment period. We propose to issue a final guidance within one year of the close of the comment period. 5.
72 FR 19528Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 23, 2021
ACTION: Notice; request for comments; extension of comment period. … period.
86 FR 10979Health and Human Services DepartmentFood and Drug AdministrationDefining Small Numbers of Animals for Minor Use Designation; Periodic Reassessment
Federal Register · Notice · May 19, 2014
In the preamble for the final rule FDA responded to comments with the following: “FDA agrees that there is a need to periodically reevaluate the definition of “small number of animals.” … Significance of Determinations While the small numbers will not be revised at this time, FDA concludes periodic reassessment is useful for implementing the provisions of the MUMS Act.
79 FR 28736Health and Human Services DepartmentFood and Drug Administration
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