Documents
Briefs, oral arguments, agency decisions and the Federal Register.
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Federal Register · Notice · Jul 21, 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 … DATES: Submit written comments on the collection of information by September 19, 2000.
65 FR 45382Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · May 4, 2017
As of April 7, 2017, we have received five requests for an extension of the compliance period, which we will add to the docket. … 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub.
82 FR 20825Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 26, 2024
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. … After the initial outreach, we will request updates to the information periodically to keep the data current and accurate.
89 FR 32437Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 15, 2020
FDA will periodically review these requests, and, when appropriate, expand the list. … full consideration of the comment.”
85 FR 42860Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Nutrient Content Claims, Expansion of the Nutrient Content Claim “Lean”
Federal Register · Proposed Rule · Nov 25, 2005
(Nestlé) under the Federal Food, Drug, and Cosmetic Act (the act). … Paperwork Reduction Act of 1995 X. Comments XI. References I. Background On November 8, 1990, President George H.W.
70 FR 71041Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 28, 2012
Background Section 409 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 348) establishes a premarket approval requirement for “food additives;” section 201(s) of the FD&C Act (21 … In the Federal Register of December 28, 2010 (75 FR 81536) (the GRAS reopener), FDA announced the reopening of the comment period for the 1997 proposed rule.
77 FR 38638Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 15, 2022
The guidance provides recommendations on conducting relative BA studies during the investigational period for an NDA and bioequivalence (BE) studies during the postapproval period for certain changes to … Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information.
87 FR 22537Health and Human Services DepartmentFood and Drug AdministrationEligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products
Federal Register · Rule · May 25, 2004
The comment period for that proposed rule closed on December 29, 1999. On April 18, 2000, we reopened the comment period for an additional 90 days. … We received two requests for an extension of the comment period.
69 FR 29786Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 1, 2006
DATES: Fax written comments on the collection of information by January 2, 2007. … No comments were received before the comment period closed. Table 1.
71 FR 69569Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Patient Examination and Surgeons' Gloves; Test Procedures and Acceptance Criteria
Federal Register · Proposed Rule · Mar 31, 2003
the entire 10-year evaluation period. … Submit a single copy of electronic comments to http://www.fda.gov/dockets/ecomments or two copies of any mailed comments, except that individuals may submit one hard copy.
68 FR 15404Health and Human Services DepartmentFood and Drug AdministrationRequirements for Submission of In Vivo Bioequivalence Data; Proposed Rule
Federal Register · Proposed Rule · Oct 29, 2003
Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. … Regulatory Fairness Act of 1996 (Public Law 104-121))), and the Unfunded Mandates Reform Act (Public Law 104-4).
68 FR 61640Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 19, 2015
Most commenters on the 2013 draft 503A guidance said this period was too short, but did not recommend a specific alternative. … The Agency is providing a 120-day comment period.
80 FR 8874Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 5, 2014
disease specialists, public interest groups, and other members of the public were submitted to the docket via http://www.regulations.gov during the 60-day comment period. … Mandates Reform Act of 1995 (Pub.
79 FR 32464Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Nov 16, 2017
review by FDA under section 409 of the FD&C Act, as the “proponent” of that substance. … Act of 1995 (the PRA) (44 U.S.C. 3501-3520).
82 FR 53433Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 10, 2015
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 … (Comment) One commenter stated that FDA suggests that the approach includes a “3-year panel commitment period”. FDA should consider developing and sharing its plan for keeping or removing panelists.
80 FR 32963Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Nov 27, 2015
In response to several requests, we extended the proposed rule comment period until January 27, 2014. D. … Some comments contend that 10 days is insufficient time, and instead request a period of 3 months.
80 FR 74570Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Nov 17, 2017
Also in the Federal Register of October 30, 2015, FDA reopened the comment period on the Minimal Manipulation Draft Guidance (80 FR 66844), Adipose Draft Guidance (80 FR 66849), and a third HCT/P-related … period from April 29, 2016, until September 27, 2016, on the four HCT/P-related guidances.
82 FR 54290Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 9, 2010
Act (FFDCA) and providing FDA with the authority to regulate tobacco products. … FDA is soliciting comments on the draft guidance document and may amend the guidance document periodically as a result of comments received. II.
75 FR 32791Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 8, 2010
Several provisions of this act affect the PMA process, such as section 515(d)(6) of the act. … Thus, FDA estimates that the periodic reporting burden required by this section will take 6,480 hours.
75 FR 32476Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 20, 2012
DATES: Fax written comments on the collection of information by April 19, 2012. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2012-6693 Filed 3-19-12; 8:45 am] BILLING CODE 4160-01-P
77 FR 16234Health and Human Services DepartmentFood and Drug Administration
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