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Federal Register · Rule · May 16, 2022
The comment period on the proposed order closed on April 21, 2020. II. … of the comment period, each containing one or more comments on one or more issues.
87 FR 29661Health and Human Services DepartmentFood and Drug AdministrationSherrie R. McCain: Final Debarment Order
Federal Register · Notice · Feb 19, 2026
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. … FDA finds that the offense should be accorded a debarment period of 5 years as provided by section 306(c)(2)(A)(iii) of the FD&C Act. As a result of the foregoing finding, Ms.
91 FR 8003Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 12, 2015
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 … Under § 314.80(c)(2), applicants must provide periodic reports of adverse drug experiences.
80 FR 13009Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 19, 2011
We are requesting that OMB extend approval for the information in this collection, as described below, which will continue to be submitted to FDA during this multi-year period. … David Dorsey, Acting Associate Commissioner for Policy and Planning. [FR Doc. 2011-32397 Filed 12-16-11; 8:45 am] BILLING CODE 4160-01-P
76 FR 78668Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities; Proposed Collection; Comment Request; Recall Regulations
Federal Register · Notice · Jun 3, 2008
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 … Recall Status Reports Request that recalling firms provide periodic status reports so the FDA can ascertain the progress of the recall.
73 FR 31696Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 16, 2025
The previously approved collections of information are subject to review by OMB under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). … The collections of information in 21 CFR 314.80 for submitting periodic adverse drug experience reports have been approved under OMB control number 0910-0230.
90 FR 58250Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 18, 2024
Treatment with medical products during the neonatal period coincides with a time of critical growth and physiologic development. … Eric Flamm, Acting Associate Commissioner for Policy. [FR Doc. 2024-24108 Filed 10-17-24; 8:45 am] BILLING CODE 4164-01-P
89 FR 83892Health and Human Services DepartmentFood and Drug AdministrationNew Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food
Federal Register · Proposed Rule · Dec 5, 2012
Act of 1995 (Pub. … Comments Interested persons may submit either written comments regarding this document to the Division of Dockets Management (see ADDRESSES ) or electronic comments to http://www.regulations.gov
77 FR 72254Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 9, 2008
In the Federal Register of June 3, 2008 (73 FR 31696), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. … Recall Status Reports Request that recalling firms provide periodic status reports so FDA can ascertain the progress of the recall.
73 FR 59633Health and Human Services DepartmentFood and Drug AdministrationAnimal Drug Availability Act; Medicated Feed Mill Licenses
Federal Register · Rule · Nov 19, 1999
Ninety-Day Approval Period 6. One comment noted that proposed Sec. 515.20 provides the agency 90 days to act upon a medicated feed mill license application. … The comment stated that this burden applies to sponsors under section 512(a)(1)(B) of the act and to licensed feed mills under proposed Sec. 510.305.
64 FR 63195Health and Human Services DepartmentFood and Drug AdministrationFood Additives Permitted for Direct Addition to Food for Human Consumption; Advantame
Federal Register · Rule · May 21, 2014
Comments IV. Conclusion V. Public Disclosure VI. Environmental Impact VII. Paperwork Reduction Act of 1995 VIII. Section 301( ll ) of the FD&C Act IX. Objections X. References I. … Comments We received two comments in response to the advantame food additive petition.
79 FR 29078Health and Human Services DepartmentFood and Drug AdministrationRevision of the Requirements for Live Vaccine Processing; Companion to Direct Final Rule
Federal Register · Proposed Rule · Oct 18, 2007
The comment period for this companion proposed rule runs concurrently with the comment period for the direct final rule. … response in a notice-and-comment process in accordance with section 553 of the Administrative Procedure Act (5 U.S.C. 553).
72 FR 59041Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 29, 2019
DATES: Fax written comments on the collection of information by April 29, 2019. … Schiller, Acting Associate Commissioner for Policy. [FR Doc. 2019-06069 Filed 3-28-19; 8:45 am] BILLING CODE 4164-01-P
84 FR 11984Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 16, 2001
All comments received during the comment period have been carefully reviewed and incorporated in this revised guidance where appropriate. … Witt, Acting Associate Commissioner for Policy. [FR Doc. 01-3956 Filed 2-15-01; 8:45 am] BILLING CODE 4160-01-F
66 FR 10699Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 24, 2003
To ensure that comments on the information collection are received, OMB recommends that comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer for … In the Federal Register of July 28, 2003 (68 FR 44341), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received.
68 FR 65937Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 17, 2022
Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act … ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain.
87 FR 9057Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 25, 2021
ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. … After the initial outreach, we will request updates to the information periodically to keep the data current and accurate.
86 FR 28116Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 23, 2003
DATES: Submit written comments on the collection of information by February 24, 2003. … In the Federal Register of October 4, 2002 (67 FR 62249), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received.
68 FR 3262Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jul 17, 1997
If FDA does not initiate such a proceeding, section 515(b)(3) of the act provides that FDA shall, after the close of the comment period on the proposed rule and consideration of any comments received, … The act does not permit an extension of the 90-day period after issuance of a final rule within which an application or a notice is required to be filed.
62 FR 38231Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jul 22, 1999
DATES: Submit written comments by October 20, 1999; written comments on the agency's economic impact determination by October 20, 1999. … The agency considered but rejected several labeling alternatives: (1) A shorter implementation period, and (2) an exemption from coverage for small entities.
64 FR 39452Health and Human Services DepartmentFood and Drug Administration
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