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Revocation of the Regulations for Human Tissue Intended for Transplantation and Human Dura Mater
Federal Register · Rule · Jan 13, 2022
(FD&C Act). … We did not receive any comments on the proposed rule. Therefore, we are finalizing the proposed rule without change. III.
87 FR 2045Health and Human Services DepartmentFood and Drug AdministrationAgency Emergency Processing Request Under OMB Review
Federal Register · Notice · Oct 21, 1998
The statutory authority to collect this information is provided under sections 351 and 361 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262 and 264) and the provisions of the Federal Food, … Drug, and Cosmetic Act that apply to drugs (21 U.S.C. 201 et seq.).
63 FR 56192Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Feb 19, 2013
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by March 21, 2013, (see the “Paperwork Reduction Act of 1995” section of this document). … On April 1, 2010, FDA had published a proposed rule, along with a companion direct final rule (75 FR 16347), with a 75-day comment period to request input from interested parties (75 FR 16365) as a step
78 FR 11612Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 30, 2026
As required by section 743(b)(2)(B)(iii) of the FD&C Act, FDA published guidelines in consideration of the burden of the VQIP fee on small businesses and provided for a period of public comment on the … Consistent with section 743(b)(2)(B)(iii) of the FD&C Act, if we determine to provide for a small business fee reduction, we will adjust the fee schedule for small businesses only through notice and comment
91 FR 48125Health and Human Services DepartmentFood and Drug AdministrationFee Rates Under the Over-the-Counter Monograph Drug User Fee Program for Fiscal Year 2021
Federal Register · Notice · Mar 26, 2021
Under section 744M(a)(1)(A) of the FD&C Act, a facility fee for FY 2021 shall be assessed with respect to each facility that is identified as an OTC monograph drug facility during the period from January … These fees are for the period from October 1, 2020, through September 30, 2021. 4 This document is issued pursuant to sections 744M(a)(4) and (c)(4)(A) 5 of the FD&C Act and describes the calculations
86 FR 16223Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 21, 2019
L. 111-31) (Tobacco Control Act), enacted on June 22, 2009, amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and provided FDA with the authority to regulate the manufacture, marketing, and … The revised draft guidance recommends that records be maintained and available for inspection upon request for a period of at least 4 years after the date on which the investigation is terminated or
84 FR 5448Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 2, 2014
Follow the instructions for submitting comments. … Individuals and organizations will be able to comment on nominated substances after the nomination period has closed or petition FDA to make additional list amendments after the list is published, in accordance
79 FR 37750Health and Human Services DepartmentFood and Drug AdministrationGRAS Status of Propylene Glycol; Exclusion of Use in Cat Food
Federal Register · Proposed Rule · May 10, 1995
In the first study, adult cats were fed diets containing 0, 6, or 12 percent PG on a dry matter basis over a 16-week period. … Comments Interested persons may, on or before July 24, 1995, submit to the Dockets Management Branch (address above) written comments regarding this proposal.
60 FR 24808Health and Human Services DepartmentFood and Drug AdministrationAdvisory Committees; Notice of Meetings
Federal Register · Uncategorized Document · Jun 27, 1994
emphasized, however, that the 1 hour time limit for an open public hearing represents a minimum rather than a maximum time for public participation, and an open public hearing may last for whatever longer period … The Federal Advisory Committee Act (FACA) (5 U.S.C. app. 2, 10(d)), permits such closed advisory committee meetings in certain circumstances.
Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Nov 29, 1996
DATES: Written comments by February 27, 1997. … FDA will review and consider all comments received.
61 FR 60661Health and Human Services DepartmentFood and Drug AdministrationAdvisory Committee; Notice of Meeting
Federal Register · Uncategorized Document · Mar 15, 1994
If necessary, comments may be limited to 5 minutes per participant. Open committee discussion. … This notice is issued under section 10(a)(1) and (2) of the Federal Advisory Committee Act (5 U.S.C. app. 2), and FDA's regulations (21 CFR part 14) on advisory committees. Dated: March 9, 1994.
Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 15, 2017
Infant Formula Requirements—21 CFR parts 106 and 107 OMB Control Number 0910-0256—Extension Statutory requirements for infant formula under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) are … We estimate that there will be 10 rats in the control and test groups (20 rats total) and that food consumption and body weight will be measured at day 0 and at 7-day intervals during the 28-day study period
82 FR 52927Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 9, 2022
(FD&C Act). … ADDRESSES: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets
87 FR 13294Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 8, 2000
act) (21 U.S.C. 321(p)), and not misbranded under section 502 of the act (21 U.S.C. 352). … However, in accordance with 21 CFR 10.40(e)(1), the agency will accept comment on this extension for a period of 90 days. VI.
65 FR 36319Health and Human Services DepartmentFood and Drug AdministrationSanyasi Raju Kalidindi; Grant of Special Termination
Federal Register · Notice · Nov 16, 2021
ADDRESSES: Comments should reference Docket No. … Pursuant to section 306(d)(4)(C)-(D), FDA may grant a request for special termination and limit the period of debarment to less than permanent but no less than 1 year if the Agency finds: (1) That the
86 FR 63401Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 24, 2024
Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d). … Such standards are those that FDA has recognized by notice published in the Federal Register or that FDA has decided to recognize but for which recognition is pending (because a periodic notice has
89 FR 52473Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 15, 2013
Often this will involve studies that expose a large number of patients to the drug, normally for an extended period of time. … Comments Interested persons may submit either electronic comments to http://www.regulations.gov or written comments regarding this document to the Division of Dockets Management (see ADDRESSES
78 FR 3005Health and Human Services DepartmentFood and Drug AdministrationListing of Color Additives Exempt From Certification; Synthetic Iron Oxide
Federal Register · Rule · Nov 1, 2018
From the NHANES data, Colorcon determined that 2 dietary supplements are consumed in a 24-hour period at the mean, and 4 at the 90th percentile. … We have not received any new information or comments that would affect our previous determination. VIII. Paperwork Reduction Act of 1995 This final rule contains no collection of information.
83 FR 54869Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jul 13, 2026
Submit comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 by September 11, 2026. ADDRESSES: You may submit comments as follows. … Subsequent reviews and updates must occur annually, during the period beginning on October 1 and ending December 31 of each calendar year.
91 FR 42888Health and Human Services DepartmentFood and Drug AdministrationInternational Conference on Harmonisation; Choice of Control Group in Clinical Trials
Federal Register · Notice · Sep 24, 1999
DATES: Written comments by December 23, 1999. … Dotzel, Acting Associate Commissioner for Policy [FR Doc. 99-24855 Filed 9-23-99; 8:45 am] BILLING CODE 4160-01-F
64 FR 51767Health and Human Services DepartmentFood and Drug Administration
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