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Federal Register · Notice · Jan 7, 2020
Index of Legally Marketed Unapproved New Animal Drugs for Minor Species—21 CFR Part 516 OMB Control Number 0910-0620—Extension The Minor Use and Minor Species Animal Health Act of 2004 (the MUMS Act) … We based our estimates in tables 1 and 2 on our experience with the MUMS indexing program and the requests for eligibility for indexing and for addition to the index, as well as the periodic drug experience
85 FR 714Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Dec 23, 1997
DATES: Written comments by March 23, 1998. … Received comments may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday. FDA does not anticipate granting requests for extension to this 90-day comment period.
62 FR 67011Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities: Proposed Collection; Comment Request
Federal Register · Notice · Jun 9, 1998
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 … information, firm's recall [[Page 31503]] strategy and a contact official; notifying direct accounts of the recall and to provide recipients with a ready means of reporting to the recalling firm; provide periodic
63 FR 31502Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 24, 2022
Under section 705 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 375), the Secretary of the Department of Health and Human Services (the Secretary) may require dissemination of information … We have identified 24 DHCP letters that 18 distinct sponsors submitted to FDA during the 3-year period (2019 to 2021).
87 FR 37871Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Aug 27, 1998
, as amended by the FDA Modernization Act of 1997 (FDAMA). … The comment period closed July 27, 1998. FDA is withdrawing the direct final rule because the agency received significant adverse comment.
63 FR 45716Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 4, 2026
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. … These incentives include a 3-year period of exclusivity for drugs approved in certain NDAs or supplements to NDAs during which applications submitted pursuant to section 505(b)(2) of the FD&C Act (505(
91 FR 10617Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 1, 2014
DATES: Fax written comments on the collection of information by July 31, 2014. … In the Federal Register of April 16, 2014 (79 FR 21469) FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
79 FR 37330Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 17, 2012
ADDRESSES: Submit electronic comments on the collection of information to http://www.regulations.gov. … FDA based these estimates on the number of original HDE applications received in the period between October 1, 2008, and September 30, 2011.
77 FR 74667Health and Human Services DepartmentFood and Drug AdministrationEar, Nose, and Throat Devices; Reclassification of Endolymphatic Shunt Tube With Valve
Federal Register · Proposed Rule · Aug 15, 2001
The period for requesting a change in the classification of the device closed on May 21, 1990. The period for commenting on the proposed rule closed on July 3, 1990. … FDA did not receive any comments on the proposed rule.
66 FR 42809Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 7, 2014
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 and to allow 60 days … for public comment in response to the notice.
79 FR 26252Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 19, 2023
2019 (COVID-19) Public Health Emergency” guidance to exercise certain enforcement policies for certain devices beyond the expiration of the COVID-19 PHE (which expired on May 11, 2023) and the 180-day period … the FD&C Act (21 U.S.C. 371(h)(1)(C)) and § 10.115(g)(2) (21 CFR 10.115(g)(2)).
88 FR 72080Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 11, 2016
Drug Administration (FDA) 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 … There are 42 State programs enrolled, in which each State may receive up to $300,000 each year for a period of 5 years provided there is significant conformance with the 10 standards.
81 FR 53148Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 19, 2019
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 … Changes to PS plan for a device that is no longer marketed (822.28) 6 1 6 8 48 Waiver (822.29) 1 1 1 40 40 Exemption request (822.30) 16 1 16 40 640 Periodic
84 FR 28554Health and Human Services DepartmentFood and Drug AdministrationGina Acosta: Final Debarment Order
Federal Register · Notice · May 15, 2024
of the FD&C Act). … Acosta during her period of debarment, other than in connection with an audit under section 306 of the FD&C Act (section 306(c)(1)(B) of the FD&C Act).
89 FR 42474Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities; Submission for OMB Review; Comment Request
Federal Register · Notice · Jul 23, 1998
FDA's response to this comment is twofold. … This is because the numbers in the previous estimate were too low and represented a study period of only 6 months, which is not enough time to obtain interviews both before and after the final implementation
63 FR 39581Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 19, 2023
The final rule implements a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. … This subsection requires that the FDA-approved plan must be retained while in effect and for a period of not less than 4 years from the date it was last in effect.
88 FR 24191Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 21, 2002
The information is critical to the agency’s mission of regulating food labeling and is needed prior to the expiration of the normal time periods for OMB clearance under the PRA regulations (5 CFR part … Under section 903(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 393(d)(2)(C)), FDA is authorized to conduct research related to food labeling.
67 FR 8030Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities; Submission for OMB Review; Comment Request
Federal Register · Notice · Sep 1, 1998
DATES: Submit written comments on the collection of information by October 1, 1998. … The manufacturer may distribute the device 30 days after FDA receives the notice, unless FDA notifies the applicant, within that 30- day period, that the notice is inadequate.
63 FR 46464Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities: Proposed Collection; Comment Request
Federal Register · Notice · Dec 23, 1997
This notice solicits comments on the recordkeeping requirements for manufacturers of medicated animal feeds. DATES: Submit written comments on the collection of information by February 23, 1998. … A license is required when the manufacturer of a medicated feed involves the use of a drug or drugs which FDA has determined requires more control because of the need for a withdrawal period before slaughter
62 FR 67076Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Health Claims; Soluble Fiber From Certain Foods and Risk of Coronary Heart Disease
Federal Register · Rule · Feb 25, 2008
Section 403(r)(7) of the act authorizes us to make proposed regulations issued under section 403(r) of the act effective upon publication pending consideration of public comment and publication of a final … FDA invites public comment on this interim final rule. The agency will consider modifications to this interim final rule based on comments made during the comment period.
73 FR 9938Health and Human Services DepartmentFood and Drug Administration
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