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Federal Register · Notice · Jan 20, 1998
In response to requests to extend the comment period, a notice extending the comment period by 90 days was published in the Federal Register of May 28, 1996 (61 FR 26473). … and the Federal Food, Drug, and Cosmetic Act.
63 FR 2985Health and Human Services DepartmentFood and Drug AdministrationLabeling of Drugs for Use in Milk-Producing Animals
Federal Register · Proposed Rule · Apr 4, 1996
Withdrawal periods longer than 96 hours may be considered on a case-by-case basis depending on the use and safety of the drug. … In addition, a 12-hour milking schedule is used in Sec. 510.106 to calculate the number of milkings that occur during the withdrawal period.
61 FR 15003Health and Human Services DepartmentFood and Drug AdministrationBelen G. Ngo; Denial of Hearing; Final Debarment Order
Federal Register · Notice · Aug 2, 2021
In determining the appropriateness and period of Ms. Ngo's debarment, FDA considered the relevant factors listed in the FD&C Act. Ms. … Ngo during her period of debarment (section 306(c)(1)(B) of the FD&C Act). Dated: July 27, 2021. Denise Hinton, Chief Scientist.
86 FR 41486Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 14, 2011
If the participant wishes to request an opportunity to make an oral presentation during the open public comment period of the hearing, their notice of participation also must include the title of their … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011-5943 Filed 3-10-11; 4:15 pm] BILLING CODE 4160-01-P
76 FR 13638Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Oct 5, 1999
In addition to FDA's July 1997 request for comments, the issues have been examined in comments submitted to the agency in the 30-day comment period following the rule's publication in the Federal Register … Following the comment period, the agency intends promptly to publish a final rule. VI.
64 FR 54180Health and Human Services DepartmentFood and Drug AdministrationAlnashir Alibhai Punjani: Final Debarment Order
Federal Register · Notice · Mar 13, 2025
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 Alnashir Alibhai Punjani for a period of 5 years from … 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.
90 FR 11990Health and Human Services DepartmentFood and Drug AdministrationJonathan Corbett Cosie: Final Debarment Order
Federal Register · Notice · Mar 13, 2025
SUMMARY: The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Jonathan Corbett Cosie for a period of 10 years from importing or … 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.
90 FR 11984Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 17, 2014
Application for FDA Approval to Market a New Drug—(OMB Control Number 0910-0001)—Extension Under section 505(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(a)), a new drug … Other interested persons may also submit comments on the notice.
79 FR 55801Health and Human Services DepartmentFood and Drug AdministrationRadiological Health Regulations; Technical Amendments
Federal Register · Rule · Sep 18, 2025
Notice and Public Comment Publication of this document constitutes final action on these changes under the Administrative Procedure Act (APA) (5 U.S.C. 553). … (vi) The period of time it is desired that the variance be in effect, and, if appropriate, the number of units the applicant wishes to manufacture.
90 FR 44978Health and Human Services DepartmentFood and Drug AdministrationDraft Guidances for Industry on Medical Imaging Drug and Biological Products; Availability
Federal Register · Proposed Rule · May 19, 2003
In a document published in the Federal Register of January 5, 1999 (64 FR 457), FDA reopened the comment period on the medical imaging draft guidance until February 12, 1999. … In a document published in the Federal Register of February 16, 1999 (64 FR 7561), FDA extended the comment period until April 14, 1999.
68 FR 27008Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 20, 2011
FD&C Act. … Therefore, designated countries may respond to periodic requests by FDA by submitting information to confirm that their designation remains appropriate.
76 FR 35897Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 8, 2013
DATES: Fax written comments on the collection of information by May 8, 2013. … The regulations that are codified at 21 CFR part 1140 (previously codified at 21 CFR part 897) are authorized by section 102 of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act
78 FR 20923Health and Human Services DepartmentFood and Drug AdministrationRobert Lance Shuffert: Final Debarment Order
Federal Register · Notice · Apr 5, 2024
SUMMARY: The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Robert Lance Shuffert for a period of 5 years from importing or … 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.
89 FR 24013Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Apr 24, 2019
Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)(1)(C)(i)) and § 10.115(g)(2)). … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations.
84 FR 17081Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 6, 2015
The comment period on the revised draft guidance ended on September 23, 2014. We reviewed all comments received on the draft guidance and revised several sections of the guidance. … These requirements will be phased in over 2- and 3-year periods after the issuance of this guidance.
80 FR 26057Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 14, 2013
The draft guidance document and comment period were announced in the Federal Register on January 3, 2007 (72 FR 137). The comment period closed on April 2, 2007. … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations.
78 FR 49529Health and Human Services DepartmentFood and Drug AdministrationBrendon Gagne: Final Debarment Order
Federal Register · Notice · Feb 9, 2024
SUMMARY: The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Brendon Gagne for a period of 5 years from importing or offering … 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.
89 FR 9158Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Patient Examination and Surgeons' Gloves; Test Procedures and Acceptance Criteria
Federal Register · Proposed Rule · Mar 31, 2003
the entire 10-year evaluation period. … Submit a single copy of electronic comments to http://www.fda.gov/dockets/ecomments or two copies of any mailed comments, except that individuals may submit one hard copy.
68 FR 15404Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 1, 2014
Under section 701(a) of the FD&C Act, the FDA is authorized to issue regulations for the FD&C Act's efficient enforcement. … Existing records may be used if they contain all of the required information and are retained for the required time period.
79 FR 44785Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 1, 2020
Paperwork Reduction Act of 1995 The guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 … The period of this waiver will not exceed the period of time for the public health emergency related to COVID-19, including any immediate post-response review.
85 FR 18247Health and Human Services DepartmentFood and Drug Administration
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