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Federal Register · Notice · Nov 30, 2004
The comment period for the proposed information collection provisions closed on December 29, 2003. FDA received seven comments from manufacturers on the draft guidance. … 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
69 FR 69606Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 12, 2021
Following the public consultation period, clarifications were made to the guidance based on the comments received. … Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021-09962 Filed 5-11-21; 8:45 am] BILLING CODE 4164-01-P
86 FR 26054Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 24, 2011
Prescription Drug Advertisements—(OMB Control Number 0910)—New Section 502(n) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 352(n)) requires that manufacturers, packers, and distributors … Section 202.1 applies to advertisements published in journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television, and telephone communication
76 FR 4117Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Nov 1, 2018
The rule is part of the Agency's ongoing efforts to implement the FDA Food Safety Modernization Act (FSMA; Pub. L. 111-353). … These meetings will be held during the formal comment period on the draft guidance. 1 All four public meetings will cover the same agenda items and are intended to facilitate and support the public's
83 FR 54888Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 22, 1998
comment and publication of a final regulation'' if the agency ``determines that such action is necessary * * * to enable [FDA] to act promptly to ban or modify a claim'' under section 403(r) of the act … 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.
63 FR 34110Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 30, 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 … In the Federal Register of June 14, 2010 (75 FR 33624), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
75 FR 52954Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 3, 2020
Section 301(a) of the FD&C Act (21 U.S.C. 331(a)) prohibits the introduction or delivery for introduction into interstate commerce of adulterated food. … The records of processing information are periodically reviewed during factory inspections by FDA to verify fulfillment of the requirements in parts 113 or 114.
85 FR 18995Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 5, 2020
Act; this requirement is subject to certain exceptions during a 10-year transition period ending on March 23, 2020 (see section 7002(e)(1) to (3) and (e)(5) of the BPCI Act). … In the Federal Register of December 12, 2018 (83 FR 63894), FDA invited comment on the preliminary list of approved applications for biological products under the FD&C Act that will be affected by
85 FR 12930Health and Human Services DepartmentFood and Drug AdministrationOlga L. Torres: Final Debarment Order
Federal Register · Notice · Apr 12, 2023
of the FD&C Act). … Torres 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).
88 FR 22043Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs
Federal Register · Notice · Apr 16, 2026
(FD&C Act) (21 U.S.C. 360aa, 360bb, 360cc, and 360dd), as well as related guidance and Agency forms. … FDA marketing approval for that drug for the orphan indication for a period of 7 years; and, finally, section 528 is intended to encourage sponsors to make investigational orphan drugs available for treatment
91 FR 20460Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 19, 2025
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.
90 FR 59533Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 20, 1999
One comment correctly stated that the ``estimate may be about right for the physical act of filling out the form itself.'' … As both the Forms FDA 3500 (instructions) and 3500A (guidance) can be updated periodically based on questions/comments from stakeholders and statutory/regulatory changes, changing the forms themselves
64 FR 50820Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 16, 2016
A draft of this guidance was made available in the Federal Register on April 23, 2013, and the comment period closed on July 22, 2013. … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations.
81 FR 39269Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 17, 2010
for public comment in response to the notice. … Prescription Drug Advertisements—21 CFR 202.1 (OMB Control Number 0910)—New Section 502(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) (the act) requires that manufacturers, packers
75 FR 12756Health and Human Services DepartmentFood and Drug AdministrationAdam Paul Runsdorf: Final Debarment Order
Federal Register · Notice · May 7, 2024
) of the FD&C Act). … Runsdorf during his 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 38159Health and Human Services DepartmentFood and Drug AdministrationJonathan R. Shaver: Final Debarment Order
Federal Register · Notice · Jun 13, 2024
of the FD&C Act). … Shaver during his period of debarment, other than in connection with an audit under section 306(c)(1)(B) of the FD&C Act.
89 FR 50343Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 9, 2001
for public comment in response to the notice. … Jurisdictions that request listing in the FDA National Registry of participating regulatory agencies will be expected to perform certain management tasks and periodically report the results to FDA.
66 FR 23715Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Apr 25, 2016
the FD&C Act (21 U.S.C. 360j(g)). … The comments submitted by JRC question the effectiveness of positive behavioral interventions, citing three case review studies of “positive-only” approaches covering successive time periods.
81 FR 24386Health and Human Services DepartmentFood and Drug AdministrationPilot Project Program Under the Drug Supply Chain Security Act; Program Announcement
Federal Register · Notice · Feb 8, 2019
Each pilot project is expected to be completed within the proposed duration time period. This time period does not include an additional 30 days for completion of a final report (see Section II.G. … Reports Each pilot project is expected to be completed within the proposed duration time period, and FDA asks that all participants submit periodic progress reports to FDA while the pilot project is being
84 FR 2879Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 11, 2012
for public comment in response to the notice. … Section 102(a) of FSMA amended section 415 of the FD&C Act to create section 415(a)(3) (21 U.S.C. 350d(a)(3)), which requires that during the period beginning on October 1 and ending on December 31 of
77 FR 27779Health and Human Services DepartmentFood and Drug Administration
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