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Federal Register · Notice · Mar 14, 2007
the provisions of the act. … If this were not possible, they requested that the comment period remain open until commenters have the ability to look at the questionnaire materials.
72 FR 11889Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Exemptions From Premarket Notification; Class II Devices
Federal Register · Rule · Nov 15, 2001
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. … FDA received no comments.
66 FR 57368Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 22, 2005
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 … FDA estimates a 2-year time period during which these requests will be made following the issuance of this guidance.
70 FR 70621Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Sep 20, 2024
Legal Authority FDA is taking this action under the general administrative provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act). … of Benefits, Costs and Distributional Effects of Proposed Rule Category Primary estimate Low estimate High estimate Units Year dollars Discount rate (%) Period
89 FR 77062Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 27, 2014
The comment stated that the Food Safety Modernization Act (FSMA) gave FDA authority “to require producers to implement prevention based food safety standards.” … The comment also noted the periodic scheduling of audits and inspections of hospitals by the regulator.
79 FR 4350Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Exemptions From Premarket Notification; Class II Devices
Federal Register · Rule · Jan 8, 1999
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. … FDA received no comments.
64 FR 1123Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 23, 2022
The comment period for the July 2020 notice was reopened for 30 days on January 8, 2021 (86 FR 1515), to allow interested parties an additional opportunity to comment. … The comment period for the July 2020 notice was reopened for 30 days on January 8, 2021 (86 FR 1515), to provide interested parties an additional opportunity to comment before FDA began to develop its
87 FR 71642Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Feb 19, 2019
Comments on the Proposed Rule and FDA Response A. Introduction We received 12 total comments posted to the docket for the proposed rule by the close of the comment period. … The comment also noted that the FD&C Act recognizes the HPUS as “official” in 21 U.S.C. 358(b), and in the definitions at 21 U.S.C. 321, the FD&C Act defines “drug” to include articles recognized in the
84 FR 4696Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Nov 28, 2012
FDA seeks comment on the following issues related to section 918(a)(2) of the FD&C Act: 2.1. … FDA seeks comment on the following issues related to section 918(a)(3) of the FD&C Act: 3.1.
77 FR 70955Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 24, 2014
The Agency is making this information available consistent with the PHS Act. … The sodium nitroprusside docket remained opened for public comment from October 3, 2012, through November 2, 2012.
79 FR 4167Health and Human Services DepartmentFood and Drug AdministrationSubstances Prohibited From Use in Animal Food or Feed; Confirmation of Effective Date of Final Rule
Federal Register · Rule · Apr 24, 2009
April 9, 2009 (74 FR 16160) (referred to herein as the April 9, 2009, proposal), FDA published a proposal that would delay the effective date of the April 25, 2008, final rule for 60 days and provided a period … FDA has consulted with the Environmental Protection Agency (EPA) on this issue and EPA has recently published a statement on its Web site stating that, under the Resource Conservation and Recovery Act
74 FR 18626Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Radiology Devices; Reclassification of Full-Field Digital Mammography System
Federal Register · Rule · Nov 5, 2010
Comments and FDA's Response During the public comment period, 23 respondents submitted comments. … (Response) FDA agrees with the comment and has revised the identification to be similar to the language suggested by the comment. V.
75 FR 68200Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 21, 2020
Section 130(a) of the Food and Drug Administration Modernization Act of 1997 amended the FD&C Act by adding section 506B of the FD&C Act (21 U.S.C. 356b). … • Period covered by the report. • PMR/PMC update for each “Open” PMR/PMC.
85 FR 66995Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 7, 2007
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 … This notice contained an incorrect deadline for comments on the proposed collection of information in the DATES section. FDA is republishing the notice and providing a full 30-day comment period.
72 FR 10220Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 17, 2005
(the act) (21 U.S.C. 393(d)(2)). … The Nutrition Labeling and Education Act of 1990 (Public Law 101-535) amended the act. Section 403(r)(1)(A) of the act (21 U.S.C. 343(r)(1)(A)) was added under these amendments.
70 FR 48423Health and Human Services DepartmentFood and Drug AdministrationInvestigational New Drug Applications and New Drug Applications
Federal Register · Proposed Rule · Sep 8, 1995
DATES: Written comments by December 7, 1995. … The General Accounting Office (GAO) conducted a larger study of drugs approved during the period 1988 through 1991, and found similar proportions.
60 FR 46794Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Aug 25, 2000
Under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Animal Drug Availability Act of 1996 (ADAA), any person intending to file a new animal drug application (NADA) or supplemental … DATES: Submit written comments on the proposed rule by November 8, 2000. Submit written comments on the information collection provisions by September 25, 2000.
65 FR 51782Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 3, 2016
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 … deactivate the Plan and make decisions during the emergency, (2) prioritizing the manufacturer's drug products based on medical necessity, (3) identifying actions that should be taken prior to an anticipated period
81 FR 76618Health and Human Services DepartmentFood and Drug AdministrationEvaporated Milk; Amendment of the Standard of Identity
Federal Register · Uncategorized Document · Apr 14, 1994
These data show that the yearly average milkfat content for all producers' milk, before standardization for beverage purposes, during the period 1970 to 1991 (Ref. 1) ranged between 3.64 percent and 3.68 … The Regulatory Flexibility Act requires that the agency analyze options for regulatory relief for small businesses.
Food and Drug AdministrationFood Labeling: Health Claims; Omega-3 Fatty Acids and the Risk in Adults of Cardiovascular Disease
Federal 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 34107Health and Human Services DepartmentFood and Drug Administration
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