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Food Labeling: Nutrient Content Claims, Definition of Term: Healthy
Federal Register · Proposed Rule · Dec 30, 1997
(the act) (21 U.S.C. 343(r)). … In addition, the agency established a transition period to allow time for industry to reformulate products to meet the new qualifying sodium levels.
62 FR 67771Health and Human Services DepartmentFood and Drug AdministrationFederal 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 34112Health and Human Services DepartmentFood and Drug AdministrationMethodological Challenges Related to Patient Experience Data; Summary of Received Comments
Federal Register · Notice · Dec 13, 2023
period was open until July 3, 2023. … Food, Drug, and Cosmetic Act, as amended by the 21st Century Cures Act (Pub.
88 FR 86343Health and Human Services DepartmentFood and Drug AdministrationRisk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting
Federal Register · Notice · Apr 20, 2009
an extended period of time. … Long acting products allow these patients to have their pain controlled for long periods of time without the need for another dose and to significantly reduce the number of tablets the patient must take
74 FR 17967Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 8, 2025
The VMSR Program was established under section 519(a)(1)(B)(ii) of the FD&C Act. … (See section 519(b) of the FD&C Act; 21 CFR 803.30(a).)
90 FR 19490Health and Human Services DepartmentFood and Drug AdministrationAnimal Drug Availability Act; Medicated Feed Mill Licenses
Federal Register · Proposed Rule · Jul 30, 1997
DATES: Submit written comments on the proposed rule by October 28, 1997. Submit written comments on the information collection provisions by August 29, 1997. … The March 31, 1997, Federal Register notice solicited public comment on the collection of information and provided 60 days for such comments. FDA received no comments in response to this notice.
62 FR 40765Health and Human Services DepartmentFood and Drug AdministrationMedical Device De Novo Classification Process
Federal Register · Rule · Oct 5, 2021
Introduction We received several sets of comments on the proposed rule by the close of the comment period, each containing one or more comments on one or more issues. … Section 513(f)(2) of the FD&C Act provides that any device classified through the De Novo pathway “shall be a predicate device for determining substantial equivalence” and does not impose a waiting period
86 FR 54826Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 31, 2007
Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. … FDA periodically will review the comments in the docket and, where appropriate, will amend the guidance.
72 FR 30386Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Mar 8, 1999
Two comments questioned FDA's shortening the comment period from 75 to 45 days. … As FDA stated in the preamble to the proposed rule (63 FR 54082 at 54087 to 54088), the agency believes that a shorter comment period was warranted to expedite this rulemaking proceeding because the compounding
64 FR 10944Health and Human Services DepartmentFood and Drug AdministrationBernardo Garmendia; Denial of Hearing; Final Debarment Order
Federal Register · Notice · Mar 14, 2025
(a)(7) of the FD&C Act). … In addition, FDA will not accept or review any abbreviated new drug applications submitted by or with the assistance of Garmendia during his period of debarment (section 306(c)(1)(B) of the FD&C Act).
90 FR 12164Health and Human Services DepartmentFood and Drug AdministrationInvestigational New Drug Applications and New Drug Applications
Federal Register · Rule · Feb 11, 1998
Although the proposed rule of September 8, 1995 (60 FR 46794), provided a 90-day comment period under the PRA of 1980, FDA is providing an additional opportunity for public comment under the PRA of 1995 … At the close of the 60-day comment period, FDA will review the comments received, revise the information collection provisions as necessary, and submit these provisions to OMB for review and approval.
63 FR 6854Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Exemption From Premarket Notification: Wheelchair Elevator
Federal Register · Notice · Jun 1, 2012
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.
77 FR 32644Health and Human Services DepartmentFood and Drug AdministrationGuidance for Industry on Blue Bird Medicated Feed Labels; Availability
Federal Register · Notice · Apr 10, 2008
amended by the Paperwork Reduction Act of 1995, Pub. … Reduction Act of 1995.
73 FR 19516Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 22, 2001
This guidance implements provisions of the Government Paperwork Elimination Act (GPEA). DATES: Submit written comments at any time. … FDA will periodically review the comments in the docket and, where appropriate, will amend the guidance.
66 FR 11172Health and Human Services DepartmentFood and Drug AdministrationRevision of the Requirements for Constituent Materials
Federal Register · Proposed Rule · Mar 30, 2010
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by April 29, 2010, (see the “Paperwork Reduction Act of 1995” section of this document). … FDA-2010-N-0099 and/or RIN number 0910-AG15, by any of the following methods, except that comments on information collection issues under the Paperwork Reduction Act of 1995 must be submitted to the Office
75 FR 15639Health and Human Services DepartmentFood and Drug AdministrationBenzocaine; Weight Control Drug Products for Over-the-Counter Human Use
Federal Register · Proposed Rule · Mar 9, 2011
Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), all “new drugs” are required to obtain approval under section 505 of the FD&C Act (21 U.S.C. 355) prior to marketing. … We believe the only alternative to this approach is a longer implementation period. 2 We could allow a longer implementation period so manufacturers would have time to submit additional effectiveness
76 FR 12916Health and Human Services DepartmentFood and Drug AdministrationFood Additives Permitted for Direct Addition to Food for Human Consumption; Acesulfame Potassium
Federal Register · Rule · Jul 6, 1998
Summary of FDA's Response to Comments V. Conclusion of Safety VI. Environmental Impact VII. Paperwork Reduction Act VIII. Objections IX. References I. … Summary of Comments 1.
63 FR 36344Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 29, 2019
(See section 417(a)(2) of the FD&C Act.) … Periodic drug experience reports and special drug experience reports must be accompanied by a completed Form FDA 2301, “Transmittal of Periodic Reports and Promotional Material for New Animal Drugs” (see
84 FR 24798Health and Human Services DepartmentFood and Drug AdministrationPrescription Drug User Fee Act IV Information Technology Plan
Federal Register · Notice · Sep 19, 2011
Under section XIV of the PDUFA Performance Goals, FDA agreed to develop, periodically update, and publish for comment an IT plan for achieving the objectives defined in section XIV, Information Technology … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011-23923 Filed 9-16-11; 8:45 am] BILLING CODE 4160-01-P
76 FR 58020Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jul 29, 1997
FDA received 14 comments during the extended comment period. … In light of comments received during the extended comment period, FDA held a number of meetings with representatives of the labeling industry and others to examine control options available through current
62 FR 40489Health and Human Services DepartmentFood and Drug Administration
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