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Federal Register · Rule · Jan 10, 2014
On April 1, 2010, FDA published a proposed rule, along with a companion direct final rule, with a 75-day comment period to request input from interested parties (75 FR 16365, April 1, 2010) as a step towards … How has FDA addressed comments received on the proposed rule?
79 FR 1735Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 8, 2013
In accordance with this process, we will normally allow a period of 60 days during which any interested person may file comments, and we will evaluate all comments received (§ 170.38(b)). … We welcome comments on what would be an adequate time period for compliance. 5.
78 FR 67169Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 21, 2013
for public comment in response to the notice. … As the cohort will be aging over this time period, the data collected throughout the study will reflect information from youth aged 11 to 18.
78 FR 37546Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 21, 2000
DATES: Submit written or electronic comments on the collection of information by February 20, 2001. … In the same time period, 134 sponsors submitted 4,243 postmarketing reports via Forms FDA 2253 and 2567 to CBER.
65 FR 80437Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jun 10, 2004
351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262). … The 56 small firms submitted a total of 76 NDAs during that period, which is about 1.5 applications each over a 3-year period (or 0.5 annually per small entity).
69 FR 32467Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 29, 2012
DATES: Fax written comments on the collection of information by June 28, 2012. … Under the statute, the records must be retained for a period of 6 years.
77 FR 31622Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 29, 1997
The interim rule was issued under the authority of sections 215, 311, 361, and 368 of the Public Health Service Act (42 U.S.C. 216, 243, 264, 271) because of an immediate need to protect the public health … FDA periodically will review written comments on the guidance document to [[Page 40537]] determine whether future revisions to the guidance document are warranted. Dated: January 21, 1997.
62 FR 40536Health 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 AdministrationProduct-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Federal Register · Notice · Oct 2, 2025
Under that process, draft guidances are posted on FDA's website and announced periodically in the Federal Register . … The previously approved collections of information are subject to review by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).
90 FR 47778Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 19, 2016
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. 3501-3520).
81 FR 8504Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 8, 1997
(the [[Page 36559]] PHS Act) and the Federal Food, Drug, and Cosmetic Act (the act). … In the interim period the old Form FDA 356h, interim Form FDA 3439, and the new Form FDA 356h are all acceptable alternatives for NDA's, ANDA's, and AADA's.
62 FR 36558Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 27, 2010
Comments received during the comment period have been carefully reviewed, and changes were made to the draft guidance in an effort to make the document clearer. … David Dorsey, Acting Deputy Commissioner for Policy, Planning and Budget. [FR Doc. 2010-1517 Filed 1-26-10; 8:45 am] BILLING CODE 4160-01-S
75 FR 4401Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 1, 2023
ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. … the previous 6-month period.
88 FR 83949Health and Human Services DepartmentFood and Drug AdministrationInvestigational New Drug Applications; Clinical Holds
Federal Register · Rule · Dec 14, 1998
The comment period for the direct final rule runs concurrently with that of the companion proposed rule. … adverse comment.
63 FR 68676Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Sep 13, 2022
The rule implements section 801(m) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 381(m)), which was added by section 307 of the Public Health Security and Bioterrorism Preparedness … and Response Act of 2002 (the Bioterrorism Act) (Pub.
87 FR 55932Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 29, 2021
Section 301 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 331) prohibits the misbranding of FDA-regulated products, including prescription drugs. … 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
86 FR 22686Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 8, 2010
Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each … David Dorsey, Acting Deputy Commissioner for Policy, Planning and Budget. [FR Doc. 2010-87 Filed 1-7-10; 8:45 am] BILLING CODE 4160-01-S
75 FR 1060Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · May 29, 2014
L. 101-535), which added section 403(q) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 343(q), we issued various regulations related to nutrition information on food labels, including … Comments, Transcripts, and Recorded Video Information and data, including any personal information, submitted to FDA during the public meeting and the comment period for the proposed rules will become
79 FR 30763Health and Human Services DepartmentFood and Drug AdministrationPublic Information; Communications With State and Foreign Government Officials
Federal Register · Rule · Dec 8, 1995
The final rule also promotes efficiency during any public review period. … submitted during a comment period.
60 FR 63372Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Health Claims; Soluble Fiber From Certain Foods and Risk of Coronary Heart Disease
Federal Register · Rule · Aug 15, 2008
Summary of Comments and the Agency's Response FDA solicited comments on the IFR. The comment period closed on May 12, 2008. … One consumer comment and the comment from academia supported the IFR.
73 FR 47828Health and Human Services DepartmentFood and Drug Administration
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