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Federal Register · Notice · Jun 12, 2024
Electronic Product Reporting to FDA Outsourcing facilities submit their initial and biannual product reports identifying drug products repackaged during the previous 6-month period to FDA via the Agency's … We invite comment on this assumption.
89 FR 49880Health and Human Services DepartmentFood and Drug AdministrationNonclinical Testing Terminology
Federal Register · Proposed Rule · Sep 22, 2026
The comment period for this companion proposed rule runs concurrently with the comment period for the direct final rule. … The comment period for this companion proposed rule runs concurrently with the comment period for the direct final rule.
91 FR 60036Health and Human Services DepartmentFood and Drug AdministrationFederal 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 AdministrationLaboratory Accreditation for Analyses of Foods
Federal Register · Proposed Rule · Nov 4, 2019
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by March 3, 2020 (see the “Paperwork Reduction Act of 1995” section of this document). … period.
84 FR 59452Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 6, 2015
The comment period on the revised draft guidance ended on September 23, 2014. We reviewed all comments received on the draft guidance and revised several sections of the guidance. … These requirements will be phased in over 2- and 3-year periods after the issuance of this guidance.
80 FR 26057Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 23, 2015
Other comments supported a time-based deferral policy shorter than 1year, or no deferral period at all, because of advances in blood donor testing technologies that permit earlier detection of new HIV … Paperwork Reduction Act of 1995 The guidance refers to previously approved collections of information found in FDA regulations.
80 FR 79913Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jan 16, 2018
(FD&C Act). … (FD&C Act).
83 FR 2092Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jul 23, 1996
Comments also objected to requiring that the reporter certify all reportable events have been filed on the basis that such a requirement was not specifically required in the act, and that potential liability … The Administrative Procedure Act (Pub.
61 FR 38346Health and Human Services DepartmentFood and Drug AdministrationRevising the Announcement Procedures for Approvals and Denials of Premarket Approval Applications
Federal Register · Proposed Rule · Jun 27, 1997
Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period. … Comments Interested persons may, on or before September 25, 1997, submit to the Dockets Management Branch (address above) written comments regarding this proposal.
62 FR 34680Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Aug 2, 2004
DATES: Submit written or electronic comments on the document and comments on the agency's economic impact determination by November 1, 2004. … Analysis of Impacts FDA has examined the impacts of this proposed rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (
69 FR 46119Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Oct 18, 2024
If FDA receives no significant adverse comments within the specified comment period, the Agency intends to publish a document confirming the effective date of the final rule in the Federal Register … within 30 days after the comment period on this direct final rule ends.
89 FR 83781Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Medical Device Reporting; Confirmation of Effective Date
Federal Register · Rule · Jun 15, 2005
FDA stated that the effective date of the direct final rule would be on July 13, 2005, 60 days after the end of the comment period, unless any significant adverse comment was submitted to FDA during the … comment period.
70 FR 34652Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 26, 2004
and members of the European Free Trade Association (EFTA) would be issued by the National Oceanic and Atmospheric Administration Seafood Inspection Program (NOAA SIP) under the Agricultural Marketing Act … FDA intends to cease to issue EU Export Certificates for live and perishable fish and fishery products during this period.
69 FR 68948Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 17, 2016
Because the cohort aged over the study period, data have been collected from youth aged 11 to 18. … Media Tracking Survey The media tracking survey consists of assessments of youth aged 13 to 18 conducted periodically during the campaign period.
81 FR 39675Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Oct 26, 2011
We will not consider comments received during the reply comment period that do not identify the specific issue(s) raised during the initial comment period on which the reply comment is based. … It is the Agency's intent to comply with Executive Order 13563 as quickly as possible, so we will not look favorably on requests for extensions of the comment period.
76 FR 66235Health and Human Services DepartmentFood and Drug AdministrationDraft Prescription Drug User Fee Act IV Drug Safety Five-Year Plan; Availability for Comment
Federal Register · Notice · May 5, 2008
FDA-2008-N-0257] Draft Prescription Drug User Fee Act IV Drug Safety Five-Year Plan; Availability for Comment AGENCY: Food and Drug Administration, HHS. ACTION: Notice. … At the end of the comment period, FDA will review the comments, update the “PDUFA IV Drug Safety Five-Year Plan,” and publish the final version. II.
73 FR 24599Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 20, 2025
Under section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360) and part 807, subparts A through D (21 CFR part 807, subparts A through D), medical device establishment owners … We attribute this adjustment to a decrease in the number of submissions we received over the last approval period. Dated: June 13, 2025. Grace R.
90 FR 26304Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 14, 2013
The draft guidance document and comment period were announced in the Federal Register on January 3, 2007 (72 FR 137). The comment period closed on April 2, 2007. … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations.
78 FR 49529Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 22, 2018
Background In accordance with section 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360e(d)(4) and (e)(2)), notification of an order approving, denying, or withdrawing … Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period.
83 FR 23686Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 26, 2018
DATES: Fax written comments on the collection of information by March 28, 2018. … 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
83 FR 8284Health and Human Services DepartmentFood and Drug Administration
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