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Guidance Documents Related to Coronavirus Disease 2019; Availability
Federal Register · Notice · Jan 21, 2022
Therefore, FDA will issue COVID-19-related guidances for immediate implementation without prior public comment (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)(1) … availability of certain COVID-19-related guidances that FDA issued during the relevant period, as included in table 1.
87 FR 3303Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Needle-Bearing Devices; Withdrawal of Advance Notice of Proposed Rulemaking
Federal Register · Proposed Rule · Sep 8, 2005
Several of these comments suggested that the criteria for banning a device under section 516 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360f) were not met. … The CDC reported that, for the period from June 1995 to July 1999, there were 4,951 sharp object injuries reported to its surveillance system.
70 FR 53326Health and Human Services DepartmentFood and Drug AdministrationEffective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator
Federal Register · Proposed Rule · Aug 8, 2011
Section 515(b)(3) of the FD&C 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 … The FD&C 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.
76 FR 48062Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities; Proposed Collection; Comment Request; Recall Regulations
Federal Register · Notice · Jun 3, 2008
Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed … Recall Status Reports Request that recalling firms provide periodic status reports so the FDA can ascertain the progress of the recall.
73 FR 31696Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Health Claims; Sugar Alcohols and Dental Caries
Federal Register · Proposed Rule · Jul 20, 1995
This new law amended the Federal Food, Drug, and Cosmetic Act (the act) in a number of important ways. … Section 403(r)(3)(B)(ii) and (r)(3)(B)(iii) of the act describes the information that must be included in any claim authorized under the act.
60 FR 37507Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 17, 2020
Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. … These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).
85 FR 36598Health and Human Services DepartmentFood and Drug AdministrationChanges to an Approved Application
Federal Register · Rule · Jul 24, 1997
To ensure that there was adequate time for the submission of written comments resulting from the public meeting, as announced in the notice of the public meeting, FDA extended the comment period an additional … As stated previously, FDA held an open public meeting during the comment period to facilitate public comment on this rule.
62 FR 39890Health and Human Services DepartmentFood and Drug AdministrationRoss Lucien: Final Debarment Order
Federal Register · Notice · Feb 14, 2024
SUMMARY: The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Ross Lucien for a period of 5 years from importing or offering for … In proposing a debarment period, FDA weighed the considerations set forth in section 306(c)(3) of the FD&C Act that it considered applicable to Mr.
89 FR 11298Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 26, 2010
DATES: Fax written comments on the collection of information by March 29, 2010. … 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
75 FR 8957Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 20, 2019
Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act … Panel members will be asked to participate in up to eight experimental and observational studies over the 3-year panel commitment period.
84 FR 22862Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 18, 2017
Form FDA 2301 is used by applicants to submit the required transmittal of periodic reports (§ 514.80(b)(4)); special drug experience reports (§ 514.80(b)(5)(i)); promotional material for new animal drugs … in accordance with a regulation or order issued under section 512(l) of the FD&C Act.
82 FR 32829Health and Human Services DepartmentFood and Drug AdministrationGood Laboratory Practice for Nonclinical Laboratory Studies
Federal Register · Proposed Rule · Dec 21, 2010
DATES: Submit either electronic or written comments by February 22, 2011. ADDRESSES: You may submit comments, identified by the Docket No. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010-31888 Filed 12-20-10; 8:45 am] BILLING CODE 4160-01-P
75 FR 80011Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jul 6, 2012
Section 515(b)(3) of the FD&C 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 … The comment period for the cardiovascular permanent pacemaker electrode closed November 7, 2011. FDA received no comments on the proposed rule.
77 FR 39924Health and Human Services DepartmentFood and Drug AdministrationRequirements for Submission of Bioequivalence Data; Final Rule
Federal Register · Rule · Jan 16, 2009
(Comment 31) Two comments asked whether FDA will apply the Freedom of Information Act (FOIA) to failed BE studies submitted to FDA under the rule. … Legal Authority Section 701(a) of the act (21 U.S.C. 371(a)) authorizes FDA to issue regulations for the efficient enforcement of the act.
74 FR 2849Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 29, 2019
DATES: Fax written comments on the collection of information by April 29, 2019. … Schiller, Acting Associate Commissioner for Policy. [FR Doc. 2019-06069 Filed 3-28-19; 8:45 am] BILLING CODE 4164-01-P
84 FR 11984Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 9, 2008
In the Federal Register of June 3, 2008 (73 FR 31696), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. … Recall Status Reports Request that recalling firms provide periodic status reports so FDA can ascertain the progress of the recall.
73 FR 59633Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Nov 1, 2023
Submit written comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 (PRA) by January 2, 2024. … Electronic Comments Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov . Follow the instructions for submitting comments.
88 FR 74939Health and Human Services DepartmentFood and Drug AdministrationDefinition of the Term “Biological Product”
Federal Register · Rule · Feb 21, 2020
Act, subject to certain exceptions during a 10-year transition period ending on March 23, 2020 (see section 7002(e)(1) through (3) and (e)(5) of the BPCI Act). … Introduction We received four comments on the proposed rule by the close of the comment period, two of which contained one or more substantive comments on one or more issues.
85 FR 10057Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 17, 2026
L. 115-52 ) amended section 514 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) ( 21 U.S.C. 360d(d) ) by adding a new subsection (d) entitled “Accreditation Scheme for Conformity Assessment … For example, a participating accreditation body or testing laboratory agrees to attend training, regularly communicate with FDA, and support periodic FDA audits.
91 FR 44854Health and Human Services DepartmentFood and Drug AdministrationReauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments
Federal Register · Notice · Nov 24, 2025
In addition, FDA will provide a period of 30 days after the public meeting for the public to submit written comments. … BsUFA was originally enacted in 2012 under the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) for a 5-year period.
90 FR 52967Health and Human Services DepartmentFood and Drug Administration
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