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Food Labeling: Nutrient Content Claims, Expansion of the Nutrient Content Claim “Lean”
Federal Register · Proposed Rule · Nov 25, 2005
(Nestlé) under the Federal Food, Drug, and Cosmetic Act (the act). … Paperwork Reduction Act of 1995 X. Comments XI. References I. Background On November 8, 1990, President George H.W.
70 FR 71041Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 28, 2012
Background Section 409 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 348) establishes a premarket approval requirement for “food additives;” section 201(s) of the FD&C Act (21 … In the Federal Register of December 28, 2010 (75 FR 81536) (the GRAS reopener), FDA announced the reopening of the comment period for the 1997 proposed rule.
77 FR 38638Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jan 16, 2018
Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. … These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
83 FR 2057Health and Human Services DepartmentFood and Drug AdministrationKnickerbocker Biologicals, Inc.; Revocation of U.S. License No. 458-001
Federal Register · Notice · Jun 19, 1998
The notice provided other interested persons with 60 days to submit written comments on the proposed revocation. … No comments were received from any other parties within the 60-day time period.
63 FR 33680Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 23, 2018
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 … Panel members will be asked to participate in up to eight experimental and observational studies over the 3-year panel commitment period.
83 FR 53485Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 21, 2000
DATES: Submit written comments by June 5, 2000. … Dotzel, Acting Associate Commissioner for Policy. [FR Doc. 00-9942 Filed 4-20-00; 8:45 am] BILLING CODE 4160-01-F
65 FR 21446Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 25, 2011
FDA now intends to complete the notice and comment rulemaking process for the Patient Protection and Affordable Care Act of 2010 (hereinafter “section 4205”) before initiating enforcement activities based … , in part, on extensive comments on the draft guidance submitted to the Agency.
76 FR 4360Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 19, 2015
Most commenters on the 2013 draft 503A guidance said this period was too short, but did not recommend a specific alternative. … The Agency is providing a 120-day comment period.
80 FR 8874Health and Human Services DepartmentFood and Drug AdministrationGuidance for Industry on Preparation of Food Contact Notifications: Administrative; Availability
Federal Register · Notice · May 21, 2002
Background FDAMA (Public Law 105-115) amended section 409 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 348) to establish an FCN process as the primary method for authorizing new uses … The comment period for the guidance document closed on September 26, 2000. FDA received no comments on the guidance document.
67 FR 35826Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 3, 2000
DATES: Submit written comments on the collection of information by September 5, 2000. … One comment was received which questioned the necessity for the information and criticized the funding mechanism for obtaining the information. FDA disagrees with the commentator on both points.
65 FR 47736Health and Human Services DepartmentFood and Drug AdministrationFood 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 AdministrationSherri Insprucker: Final Debarment Order
Federal Register · Notice · Feb 19, 2026
SUMMARY: The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Sherri Insprucker for a period of 5 years from importing … In proposing a debarment period, FDA weighed the considerations set forth in section 306(c)(3) of the FD&C Act that the Agency considered applicable to Ms.
91 FR 8001Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; 30-Day Notices and 135-Day PMA Supplement Review
Federal Register · Rule · Oct 8, 1998
FDA received a single comment, which the agency deemed to be significant. … Summary of Comments The agency received one comment, which stated that the list of examples of changes affecting the safety or effectiveness of a device which would require the submission of a PMA
63 FR 54042Health and Human Services DepartmentFood and Drug AdministrationOphthalmic Drug Products for Over-The-Counter Human Use; Proposed Amendment of Final Monograph
Federal Register · Proposed Rule · Feb 23, 1998
DATES: Submit written comments by May 26, 1998; written comments on the agency's economic impact determination by May 26, 1998. … The agency considered but rejected several labeling alternatives, such as: (1) A shorter implementation period, and (2) an exemption from coverage for small entities.
63 FR 8888Health 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 · Proposed Rule · Jan 5, 2007
The agency has extended or reopened the comment period for the 1995 proposal four times in response to requests by stakeholders and other FDA initiatives and developments. … The most recent reopening of the comment period was announced in the Federal Register of May 4, 2004 (69 FR 24541), and the comment period was open until July 6, 2004.
72 FR 519Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 3, 2015
Paperwork Reduction Act of 1995 The draft guidance refers to previously approved collections of information found in FDA regulations. … These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
80 FR 75681Health and Human Services DepartmentFood and Drug AdministrationLuis Anarbol Moran: Final Debarment Order
Federal Register · Notice · Jun 12, 2023
SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Luis Anarbol Moran for a period of 5 years from importing … In proposing a debarment period, FDA weighed the considerations set forth in section 306(c)(3) of the FD&C Act that it considered applicable to Mr.
88 FR 38059Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 16, 2011
The Food and Drug Administration Amendments Act of 2007 amended section 522 of the FD&C Act to expand the situations in which FDA may order postmarket surveillance and allow longer surveillance periods … It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments.
76 FR 50740Health and Human Services DepartmentFood and Drug AdministrationPediatric Ethics Subcommittee of the Pediatric Advisory Committee; Notice of Meeting
Federal Register · Notice · May 25, 2005
Also elsewhere in this issue of the Federal Register is a notice announcing a public comment period concerning whether the proposed clinical investigation should proceed. … Information regarding submitting comments during that period is contained in that notice.
70 FR 30126Health and Human Services DepartmentFood and Drug Administration
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