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Federal Register · Notice · Jun 11, 2021
Table 1 provides examples of the types of studies that may be administered and estimated burden levels during the 3-year period. … FDA received two comments; however, only one was PRA-related. (Comment) The comment expressed support for FDA's collection of qualitative research on tobacco products.
86 FR 31328Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 7, 2005
) amends section 704 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 374) by adding paragraph (g). … FDA received one comment concerning the potential burden associated with the third party inspectional program application process if related cumulative partial inspections over a 2-year period were not
70 FR 33179Health and Human Services DepartmentFood and Drug AdministrationFood Labeling; Nutrient Content Claims, Definition of Sodium Levels for the Term “Healthy”
Federal Register · Proposed Rule · Feb 20, 2003
(the act) (21 U.S.C. 343(r)). … In response to requests for an extension to coincide with the end of the comment period for the U.S.
68 FR 8163Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 30, 2019
FDA is establishing the electronic format requirements described in this guidance under the Federal Food, Drug, and Cosmetic Act (FD&C Act). … The collection of information for submitting periodic adverse drug experience reports has been approved under OMB control number 0910-0230.
84 FR 58158Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Exemption From Premarket Notification: Over-the-Counter Denture Repair Kits
Federal Register · Notice · Nov 20, 2017
FDA is publishing this notice to obtain comments in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA). … L. 114-255), requires FDA to publish in the Federal Register a notice of intent to exempt a device, or of the petition, and to provide a 60-day comment period.
82 FR 55105Health and Human Services DepartmentFood and Drug AdministrationPrescription Drug User Fee Rates for Fiscal Year 2014
Federal Register · Notice · Aug 2, 2013
After review of the reports and receipt of public comments, FDA may adopt appropriate changes to the workload adjustment methodology. … that human drug review became less complex over this period.
78 FR 46980Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 15, 2003
FDA will consider the comments received and make every effort to issue the draft guidance for implementation in a reasonable time after the comment period has closed. … Paperwork Reduction Act of 1995 This draft guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act
68 FR 26308Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 15, 2020
(FD&C Act). … period to September 16, 2019 (84 FR 40071).
85 FR 42879Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 27, 2001
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360m), directing FDA to accredit persons in the private sector to review certain premarket applications and notifications. … Third-party reviews should maintain records of their 510(k) reviews and a copy of the 510(k) for a reasonable period of time.
66 FR 45047Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Preemption of State Product Liability Claims
Federal Register · Proposed Rule · Jul 24, 1998
The comment period on this proposed rule was open until February 10, 1998. … The agency received 41 comments from a variety of associations, law firms, and individuals representing industry and consumer interests.
63 FR 39789Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 18, 2001
The regulations further provide that fish and fishery products are adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 342(a)(4)) if their processor fails … The provision in question, § 123.9(b)(3), allows a processor to store records offsite under two circumstances: (1) The facility is closed for prolonged periods between seasonal packs, or (2) the facility
66 FR 37482Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 28, 1999
This notice solicits comments on reporting requirements for filing a notice of participation with FDA. DATES: Submit written comments on the collection of information by November 29, 1999. … The agency bases this estimate on an average for the period 1996 through 1998 in which each notice of participation filed took an estimated 3 hours to complete. Dated: September 22, 1999.
64 FR 52330Health and Human Services DepartmentFood and Drug AdministrationAdvisory Committees; Notice of Meetings
Federal Register · Uncategorized Document · Feb 25, 1994
In addition, the period for public comment on the November 1993 guidance has been extended until February 15, 1994. Closed committee deliberations. … 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 · Notice · Nov 18, 2015
The Biologics Price Competition and Innovation Act of 2009 amended the Public Health Service Act (PHS Act) and other statutes to create an abbreviated licensure pathway in section 351(k) of the PHS Act … All comments received during the comment period for the draft guidance have been reviewed and, where appropriate, incorporated into this guidance.
80 FR 72069Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 1, 2020
Records are maintained on file at each testing facility and examined there periodically by FDA inspectors. … Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020-26502 Filed 11-30-20; 8:45 am] BILLING CODE 4164-01-P
85 FR 77219Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 18, 2010
(Comment) Some of the comments related to the placement of information in the draft guidance. … FDA based these estimates on the number of original HDE applications that the Center for Devices and Radiological Health (CDRH) received for the period October 1, 2004, through September 30, 2007.
75 FR 7270Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 12, 2010
FDA transitioned to the Federal Dockets Management System (FDMS) in January 2008, and this comment was not posted to the docket until after the closing of the comment period. … With regard to item 3, the comment said that implementing the unique device identification provision (UDI) of the Food and Drug Administration Modernization Act (FDAMA) would go a long way in enhancing
75 FR 69447Health and Human Services DepartmentFood and Drug AdministrationStatus of Certain Additional Over-the-Counter Drug Category II and III Active Ingredients
Federal Register · Rule · Aug 24, 1998
The periods for submission of comments and new data following the publication of a notice of proposed rulemaking (NPRM) had closed and no significant comments or new data had been submitted to upgrade … (the act) (21 U.S.C. 352) and a new drug under section 201(p) of the act (21 U.S.C. 321(p)) for which an approved application under section 505 of the act (21 U.S.C. 355) and part 314 of the regulations
63 FR 44996Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 4, 2016
FDA is publishing this notice to obtain comments in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA). … This section requires FDA to publish in the Federal Register a notice of intent to exempt a device, or of the petition, and to provide a 30-day comment period.
81 FR 26802Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 7, 2025
under section 319 of the Public Health Service Act (PHS Act) (42 U.S.C. 247d). … FDA expects that the list will evolve over time and FDA intends to periodically reevaluate the list.
90 FR 1152Health and Human Services DepartmentFood and Drug Administration
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