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Federal Register · Notice · Mar 6, 1995
The Director, GMP, will provide FDA with written comments on the individual's performance for the specified rating period. … Lipka Title: Acting Director Date: September 29, 1994 Approved and Accepted for the Food and Drug Administration By: Fred R.
60 FR 12240Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 6, 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 … During that period, microbial food safety for approximately 15 antimicrobial NADAs (including original and major supplements) was evaluated.
70 FR 1253Health and Human Services DepartmentFood and Drug AdministrationCalgene, Inc.; Availability of Letter Concluding Consultation
Federal Register · Uncategorized Document · May 23, 1994
the act) with respect to foods derived from new plant varieties. … The written summary includes a response to the comments received on the Calgene advisory opinion request, including comments contained in a citizen petition (Docket No. 92P- 0222/CP1) filed in accordance
Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 25, 2025
(the act) regarding safety, identity, strength, quality, and purity. … All records and documentation referenced in this part must be maintained for a period of at least 1 year from the date of final release, including conditional final release, of a PET drug product.
90 FR 46218Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 3, 2016
Background Section 226 of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) and Section 614 of the Food and Drug Administration Safety and Innovation Act (Pub. … FDA is particularly interested in receiving information relating to the following question: • Is a time period through September 24, 2018, an appropriate amount of additional time for stakeholders to
81 FR 5760Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 21, 2023
The March 13, 2023, notice also listed COVID-19-related guidance documents that FDA was revising to continue in effect for 180 days after the expiration of the PHE declaration to provide a period for stakeholder … Paperwork Reduction Act While this guidance contains no collection of information, it does refer to previously approved FDA collections of information.
88 FR 65177Health and Human Services DepartmentFood and Drug AdministrationProtection of Human Subjects; Informed Consent
Federal Register · Proposed Rule · Sep 21, 1995
Thus, FDA intends to issue a final rule, responding to comments received on this proposed rule, promptly following the 45-day comment period. B. … Because of these public health concerns, FDA does not intend to extend the comment period beyond that date.
60 FR 49086Health and Human Services DepartmentFood and Drug AdministrationAnimal Food Labeling; Declaration of Certifiable Color Additives
Federal Register · Rule · Nov 17, 2011
FDA is issuing a final regulation in response to the Nutrition Labeling and Education Act of 1990 (the 1990 amendments), which amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by requiring … Act of 1995 (Pub.
76 FR 71248Health and Human Services DepartmentFood and Drug AdministrationPrescription Drug Product Labeling; Medication Guide Requirements
Federal Register · Proposed Rule · Aug 24, 1995
Subsequent to this comment period, either the Medication Guide regulations proposed in this document would be finalized and implemented, or FDA would repropose a different approach to helping to ensure … FDA intends to evaluate this (and other possible) formats during the comment period for this proposal.
60 FR 44182Proposed RuleHealth and Human Services DepartmentFederal Register · Notice · Oct 11, 2012
the provisions of the FD&C Act. … (Response) As we have done in the screener and as suggested by these comments, we will use 1 week as the time period.
77 FR 61761Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Withdrawal of Proposed Exemptions
Federal Register · Proposed Rule · Jul 28, 1995
During the comment period, FDA received comments which questioned the appropriateness of the proposed exemptions for a small number of the devices. … Therefore, under the Federal Food, Drug, and Cosmetic Act (secs. 513 and 701(a) (21 U.S.C. 360c and 371(a)) and under 21 CFR 5.10, the proposed rule published in the Federal Register of July 21, 1994,
60 FR 38901Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 14, 2000
For hospital reprocessors, FDA intends to establish a 1-year phase in for active enforcement of the Federal Food, Drug, and Cosmetic Act's (the act's) nonpremarket requirements (e.g., registration, listing … The agency will use the 1-year period following issuance of this final guidance document to educate hospitals about their regulatory obligations.
65 FR 49583Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 19, 2017
In 2009, Congress enacted the Tobacco Control Act (TCA) (Pub. … period.
82 FR 43764Health and Human Services DepartmentFood and Drug AdministrationSanitary Transportation of Human and Animal Food; Public Meetings on Proposed Rule
Federal Register · Proposed Rule · Feb 14, 2014
(2005 SFTA) and the FDA Food Safety Modernization Act (FSMA). … period.
79 FR 8907Health and Human Services DepartmentFood and Drug AdministrationTobacco Product Standard for Characterizing Flavors in Cigars
Federal Register · Proposed Rule · May 4, 2022
Additional Considerations and Requests for Comments A. Section 907 of the FD&C Act B. Pathways to Market C. Considerations and Request for Comments on Scope of Products D. … Agency's own initiative or in response to a request for good cause made before the expiration of the comment period.
87 FR 26396Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 23, 2020
OMB Control Number 0910-0850—Extension Section 2011 of the 21st Century Cures Act of 2016 (Pub. … The guidance further outlines the process by which administrators 1 of genetic variant databases could voluntarily apply to FDA for recognition, and how FDA would review such applications and periodically
85 FR 59801Health and Human Services DepartmentFood and Drug AdministrationMaria Anzures-Camarena: Final Debarment Order
Federal Register · Notice · May 29, 2024
Follow the instructions for submitting comments. An application submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. … Anzures-Camarena during her period of debarment, other than in connection with an audit under section 306 of the FD&C Act (section 306(c)(1)(B) of the FD&C Act).
89 FR 46404Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 29, 2025
The public can submit comments on the roundtable topics during the open comment period; the request for comments is not limited to small tobacco product manufacturers. … (FD&C Act).
90 FR 60715Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 13, 2023
Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed … Similarly, during the same period, 6,385 recalls were terminated, for an average of 2,128 recall terminations annually, and we assume an average of 10 hours is needed for the corresponding information
88 FR 70995Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Exemptions From Premarket Notification; Surgical Lamps
Federal Register · Notice · Dec 4, 1998
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.
63 FR 67075Health and Human Services DepartmentFood and Drug Administration
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