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Federal Register · Notice · Jul 21, 2014
Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 393(d)(2)(C) authorizes FDA to conduct research relating to drugs and other FDA regulated products in carrying … out the provisions of the FD&C Act.
79 FR 42333Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 14, 2025
FDA's Center for Tobacco Products (CTP) was created to carry out the authorities granted under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. … We will replenish the sample up to 4 times during the study period.
90 FR 31229Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 5, 2000
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 … For breath mint products, the average administrative, redesign, and inventory disposal costs for a labeling change of this type, with a 1-year compliance period, would result in a one-time operating cost
65 FR 75940Health and Human Services DepartmentFood and Drug AdministrationMark Moffett; Denial of Hearing; Final Debarment Order
Federal Register · Notice · Jan 25, 2023
Moffett, in any capacity during his period of debarment, will be subject to civil money penalties (section 307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))). If Mr. … 7) of the FD&C Act).
88 FR 4826Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Aug 4, 1999
ACTION: Notice of public meeting; reopening of comment period; correction. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is correcting … Dotzel, Acting Associate Commissioner for Policy. [FR Doc. 99-19790 Filed 8-3-99; 8:45 am] BILLING CODE 4160-01-F
64 FR 42277Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 10, 2016
(the FD&C Act). … The comment period on the draft guidance ended on December 28, 2015. FDA received 11 comments on the draft guidance.
81 FR 37500Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis
Federal Register · Rule · Sep 29, 2008
Summary of Comments and the Agency's Response FDA solicited comments on the calcium and vitamin D proposed rule. The comment period closed on March 21, 2007. … per product if the compliance period is 24 months.
73 FR 56477Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 14, 2012
In this notice, FDA seeks comments on the extension of OMB approval for the existing three rational questionnaires, as well as comments on a proposed fourth rational questionnaire that will be used for … Periodic drug experience reports and special drug experience reports must be accompanied by a completed Form FDA 2301, “Transmittal of Periodic Reports and Promotional Material for New Animal Drugs” (see
77 FR 56847Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 30, 2002
Emergency Medical Device Shortage Program Survey (OMB Control Number 0910-0491)—Reinstatement Under section 903(d)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 393(d)(2)), the Commissioner … Therefore, FDA estimates that approximately 150 manufacturers would be contacted in a 1-year period.
67 FR 79637Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 6, 2014
(the FD&C Act) to require that certain submissions under the FD&C Act and Public Health Service Act (PHS Act) be submitted in electronic format, beginning no earlier than 24 months after issuance of final … These requirements will be phased in over 2- and 3-year periods after the issuance of the final guidance.
79 FR 7201Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Apr 29, 2009
(the act) (21 U.S.C. 379r(a)). … Comment No. EC2. 9. Comment No. EREG1. 10. Comment No. C5. 11. Comment No. EC4. 12. Comment No. C8. 13. Bower, W.
74 FR 19385Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Dec 18, 2014
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by January 20, 2015 (see the “Paperwork Reduction Act of 1995” section of this document). … ADDRESSES: You may submit comments, by any of the following methods, except that written comments on information collection issues under the Paperwork Reduction Act of 1995 must be faxed to the Office
79 FR 75506Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 28, 2025
period was open until July 3, 2023. … Century Cures Act (Pub.
90 FR 42017Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 23, 2005
22, 2004, Blood Products Advisory Committee Meeting indicating that self-reported fever with headache in the past week did not appear to be predictive of WNV infection and did not correlate with peak periods … Paperwork Reduction Act of 1995 This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995
70 FR 29529Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 13, 2020
On July 20, 2018, FDA published a notice of availability announcing the extension of the comment period to October 18, 2018 (83 FR 34595). … Paperwork Reduction Act of 1995 This guidance contains no collection of information.
85 FR 72671Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 4, 1999
Paperwork Reduction Act of 1995 VI. References VII. Objections I. … Paperwork Reduction Act of 1995 This final rule contains no collection of information.
64 FR 29949Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 9, 2021
product provisions of the FD&C Act (chapter IX of the FD&C Act). … On July 26, 2021, the comment period closed with no comments having been received. We are now finalizing the guidance with no substantive changes.
86 FR 70129Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 15, 2019
We are now adjusting our estimate to 193 respondents per year to better reflect the data for the time period January 1 to December 31, 2018. … We attribute this adjustment to the reauthorizations of both the Animal Drug User Fee Act and the Animal Generic Drug User Fee Act, which require sponsors to submit information electronically to the CVM's
84 FR 55160Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Mar 22, 2006
Section 530.25 provides for a public comment period of not less than 60 days. … It also provides that the order of prohibition will become effective 90 days after the date of publication, unless we revoke the order, modify it, or extend the period of public comment.
71 FR 14374Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 25, 2024
Medical Device Recall Authority OMB Control Number 0910-0432—Extension This collection of information helps to implement section 518(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C … FDA issued part 810 to implement the provisions of section 518 of the FD&C Act.
89 FR 78313Health and Human Services DepartmentFood and Drug Administration
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