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Irradiation in the Production, Processing, and Handling of Animal Feed and Pet Food; Electron Beam and X-Ray Sources for Irradiation of Poultry Feed and Poultry Feed Ingredients
Federal Register · Rule · May 10, 2013
Follow the instructions for submitting comments. … The notice of filing provided for a 30-day comment period on the petitioner's environmental assessment. One comment was received that was not substantive. II.
78 FR 27303Health and Human Services DepartmentFood and Drug Administration
Over-The-Counter Human Drugs; Labeling Requirements; Final Rule; Technical Amendment
Federal Register · Rule · Jan 3, 2000
Submit written comments by March 18, 2000. … Therefore, under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 201, 341, and 369 are amended
65 FR 7Health and Human Services DepartmentFood and Drug Administration
Exocrine Pancreatic Insufficiency Drug Products for Over-The- Counter Human Use
Federal Register · Rule · Apr 24, 1995
Interested persons were invited to submit comments by April 21, 1980. Reply comments in response to comments filed in the initial comment period could be submitted by May 21, 1980. … (the act) (21 U.S.C. 321(p)).
60 FR 20162Health and Human Services DepartmentFood and Drug Administration
Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material From Cattle
Federal 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 Administration
FDA 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 Administration
Toll-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 Administration
Medical Devices; Exemption From Premarket Notification; Class II Devices; Optical Impression Systems for Computer Assisted Design and Manufacturing
Federal Register · Rule · Apr 22, 2003
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 did not receive any comments.
68 FR 19736Health and Human Services DepartmentFood and Drug Administration
Agency Information Collection Activities: Proposed Collections; Comment Request; Reinstatements
Federal Register · Notice · Jan 22, 1997
Drug, and Cosmetic Act (the act); and reporting and recordkeeping requirements imposed on entities that have had products detained during an establishment inspection that are believed to be adulterated … DATES: Submit written comments on the collections of information by March 24, 1997.
62 FR 3293Health and Human Services DepartmentFood and Drug Administration
Current Good Manufacturing Practice Requirements for Combination Products
Federal Register · Rule · Jan 22, 2013
(the PHS Act) (42 U.S.C. 262). … 201 of the FD&C Act.
78 FR 4307Health and Human Services DepartmentFood and Drug Administration
Institutional Review Boards; Cooperative Research
Federal Register · Proposed Rule · Sep 28, 2022
(Cures Act). … Submit written comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 (PRA) by October 28, 2022.
87 FR 58752Health and Human Services DepartmentFood and Drug Administration
Food 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 Administration
Reclassification of Category IIIA Biological Products, Bacterial Vaccines and Related Biological Products; Implementation of Efficacy Review; Final Order; and Delmont Laboratories, Inc.: Denial of Request for a Hearing, and Revocation of License
Federal 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 Administration
Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2017
Federal Register · Notice · Aug 1, 2016
As a first step in developing these guidelines, FDA invited public comment on the potential impact of the fees authorized by section 743 of the FD&C Act on small businesses (76 FR 45818, August 1, 2011 … The comment period for this request ended November 30, 2011.
81 FR 50525Health and Human Services DepartmentFood and Drug Administration
Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2022
Federal Register · Notice · Jul 28, 2021
As a first step in developing these guidelines, FDA invited public comment on the potential impact of the fees authorized by section 743 of the FD&C Act on small businesses (76 FR 45818, August 1, 2011 … The comment period for this request ended November 30, 2011.
86 FR 40571Health and Human Services DepartmentFood and Drug Administration
Topical Drug Products for Over-the-Counter Human Use; Products for the Prevention of Swimmer's Ear and for the Drying of Water-Clogged Ears; Final Rule
Federal Register · Rule · Feb 15, 1995
Interested persons were invited to submit comments by March 16, 1978. Reply comments in response to comments filed in the initial comment period could be submitted by April 14, 1978. … One comment contended that products for the treatment of ``water-clogged ears'' are not drugs within the meaning of section 201(g) of the act (21 U.S.C. 321(g)) and, thus, are not the proper subject of
60 FR 8916Final RuleHealth and Human Services Department
Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2023
Federal Register · Notice · Jul 28, 2022
As a first step in developing these guidelines, FDA invited public comment on the potential impact of the fees authorized by section 743 of the FD&C Act on small businesses (76 FR 45818, August 1, 2011 … The comment period for this request ended November 30, 2011.
87 FR 45331Health and Human Services DepartmentFood and Drug Administration
Medical Devices; Retention in Class III and Effective Date of Requirement for Premarket Approval for Three Preamendment Class III Devices
Federal Register · Rule · Apr 14, 1999
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. … Regulatory Fairness Act of 1996 (Pub.
64 FR 18327Health and Human Services DepartmentFood and Drug Administration
Plascon, 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 Administration
Medical 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 Administration
Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2016
Federal Register · Notice · Aug 3, 2015
As a first step in developing these guidelines, FDA invited public comment on the potential impact of the fees authorized by section 743 of the FD&C Act on small businesses (76 FR 45818, August 1, 2011 … The comment period for this request ended November 30, 2011.
80 FR 46020Health and Human Services DepartmentFood and Drug Administration

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