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Briefs, oral arguments, agency decisions and the Federal Register.
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Federal Register · Notice · Jul 2, 2014
Follow the instructions for submitting “comments.” … Individuals and organizations will be able to comment on nominated substances after the nomination period has closed or petition FDA to make additional list amendments after the list is published, in accordance
79 FR 37747Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 28, 2015
(the FD&C Act). … How frequently should metrics be reported and/or segmented within the reporting period ( e.g., annually, semiannually, or quarterly)? C.
80 FR 44973Health and Human Services DepartmentFood and Drug AdministrationFood Additives Permitted in Feed and Drinking Water of Animals; Selenium Yeast
Federal Register · Rule · Jul 19, 2007
Follow the instructions for submitting comments. • Agency Web site: http://www.fda.gov/dockets/ecomments . Follow the instructions for submitting comments on the agency Web site. … The notice of filing provided for a 60-day comment period on the petitioner's environmental assessment. No substantive comments have been received. II.
72 FR 39560Health and Human Services DepartmentFood and Drug AdministrationFDA Regulation of Combination Products; Public Hearing
Federal Register · Notice · Oct 28, 2002
If you wish to make an oral presentation during the open public comment period of the hearing, you must state your intention on your registration form or with the registration contact person listed ( … In accordance with section 503(g)(1) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 353(g)(l)), the agency is required to assign premarket review responsibility for combination products
67 FR 65801Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Exemption From Premarket Notification for Certain Classified Devices
Federal Register · Rule · Jul 28, 1995
During the comment period, FDA received comments that questioned the appropriateness of the proposed exemptions for a small number of the devices. … FDA disagrees with this comment.
60 FR 38896Health and Human Services DepartmentFood and Drug AdministrationAdvisory Committees; Notice of Meetings
Federal Register · Notice · May 16, 1995
If necessary, comments may be limited to 5 minutes. Open working group discussion. … If necessary, comments may be limited to 5 minutes. Open committee discussion.
60 FR 26036Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jul 14, 2004
We seek comments on this interpretation. … FDA invites public comment on this proposed rule. The agency will consider modifications to this proposed rule based on comments made during the comment period.
69 FR 42275Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Apr 30, 1997
Before marketing could begin, the comment period for the proposal must have ended [[Page 23351]] and another Federal Register notice must have been published setting forth the agency's determination … The comment requested that the agency do the following for an initial period of at least 2 years: (1) Restrict the general use of avobenzone- containing OTC sunscreen drug products to use by adults with
62 FR 23350Health and Human Services DepartmentFood and Drug AdministrationPlascon, Inc.; Opportunity for Hearing on a Proposal to Revoke U.S. License No. 572-003
Federal Register · Notice · Nov 17, 1995
Plascon, Inc., did not respond to FDA's letter within the specified response period. … This notice is issued under the Public Health Service Act (sec. 351 (42 U.S.C. 262)) and the Federal Food, Drug, and Cosmetic Act (secs. 201, 501, 502, 505, 701 (21 U.S.C. 321, 351, 352, 355, 371)) and
60 FR 57719Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 4, 2019
). 5 Section 503B(b)(4) and (5) of the FD&C Act. 6 Section 503B(d)(4)(C) of the FD&C Act. … establish the 503B Bulks List by (1) publishing a notice in the Federal Register proposing bulk drug substances to be included on the list, including the rationale for such proposal; (2) providing a period
84 FR 7383Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Exemptions From Premarket Notification; Class II Devices; Vascular Tunnelers
Federal Register · Rule · Mar 3, 2000
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. … In the Federal Register of November 17, 1999 (64 FR 62678), FDA published a notice announcing that this petition had been received and providing an opportunity for interested persons to submit comments
65 FR 11466Health and Human Services DepartmentFood and Drug AdministrationAdvisory Committees; Notice of Meetings
Federal Register · Uncategorized Document · Oct 18, 1994
If necessary, comments may be limited to 5 minutes. Open committee discussion. … This notice is issued under section 10(a)(1) and (2) of the Federal Advisory Committee Act (5 U.S.C. app. 2), and FDA's regulations (21 CFR part 14) on advisory committees.
Health and Human Services DepartmentFood and Drug AdministrationRegulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring
Federal Register · Rule · May 17, 1999
In the Federal Register of January 5, 1999 (64 FR 457), FDA reopened until February 12, 1999, the comment period on the medical imaging draft guidance. … In the Federal Register of February 16, 1999 (64 FR 7561), the agency further extended the comment period to April 14, 1999.
64 FR 26657Health and Human Services DepartmentFood and Drug AdministrationToll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products
Federal Register · Proposed Rule · Apr 22, 2004
(the act) (21 U.S.C. 355). … FDA requests comment on this assumption.
69 FR 21778Health and Human Services DepartmentFood and Drug AdministrationWithdrawal of Certain Proposed Rules and Other Proposed Actions
Federal Register · Proposed Rule · Dec 12, 2008
Background In 1990, the Food and Drug Administration (FDA) began the process of conducting periodic, comprehensive reviews of its regulations process that included reviewing the backlog of ANPRMs, notices … Should we decide to undertake such rulemakings in the future, we will re-propose the actions and provide new opportunities for comment.
73 FR 75625Health and Human Services DepartmentFood and Drug AdministrationFood Additives Permitted in Feed and Drinking Water of Animals; Sodium Stearate
Federal Register · Rule · Feb 20, 1998
The notice of filing provided for a 60-day comment period. No comments have been received. FDA has evaluated data in the petition and other relevant material. … Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Director, Center for Veterinary Medicine, 21 CFR part
63 FR 8572Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Apr 14, 1999
Background The Safe Medical Devices Act of 1990 added new section 515(i) to the act (21 U.S.C. 360e(i)). … The comment period closed October 28, 1998. The agency did not receive any comments or petitions requesting a change in the classification of these devices. II.
64 FR 18329Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 27, 2021
This notice also ends the period for submission of responses to Part II of the November 25, 2020, notice and request for information. … The HHS Notice also includes other misstatements, including erroneously describing the UDI and FDA's CPG 440.100 guidance as a new policy that should have been adopted through notice-and-comment rulemaking
86 FR 28605Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 6, 2010
The agency further stated that, after the end of the comment period on the proposed order, if it decided to proceed with the license revocation proceeding, it would publish a NOOH on the revocation of … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010-30441 Filed 12-3-10; 8:45 am] BILLING CODE 4160-01-P
75 FR 75682Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Apr 7, 2000
One comment objected that OTC drugs of abuse test kits are not medical devices under section 201(h) of the act (21 U.S.C. 321(h)). … Fairness Act of 1996 (Public Law 104-121), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).
65 FR 18230Health and Human Services DepartmentFood and Drug Administration
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