Documents
Briefs, oral arguments, agency decisions and the Federal Register.
5,436 results
0.16s
Federal Register · Notice · Jul 8, 2011
In the Federal Register of April 13, 2011 (76 FR 20677), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011-17141 Filed 7-7-11; 8:45 am] BILLING CODE 4160-01-P
76 FR 40374Health and Human Services DepartmentFood and Drug AdministrationInfusion Pumps; Public Meeting; Request for Comments
Federal Register · Notice · Apr 26, 2010
During the period from January 1, 2005, to December 31, 2009, FDA received over 56,000 medical device reports associated with the use of external infusion pumps. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010-9208 Filed 4-23-10; 8:45 am] BILLING CODE 4160-01-S
75 FR 21641Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · May 21, 2013
Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed order, consideration of any comments received, and a meeting of a device classification … For ECP devices, the preamendments class III devices that are the subject of this proposal, the later of these two time periods is the 90-day period.
78 FR 29672Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities: Proposed Collection; Comment Request
Federal Register · Notice · Jul 10, 1998
DATES: Submit written comments on the collections of information by September 8, 1998. … In FY 1996, there were 1,616 15-day alert reports, 5,903 periodic reports and 464 distribution reports submitted to FDA.
63 FR 37394Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Health Claims and Label Statements; Folate and Neural Tube Defects; Revocation
Federal Register · Proposed Rule · Mar 5, 1996
FDA provided 60 days for comment on this proposed action. The comment period closed on December 13, 1993. F. … FDA is also proposing to limit the comment period to 30 days, and to make any final rule that issues in this proceeding effective on the date of publication.
61 FR 8750Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 5, 2008
Medical Devices Act of 1990 (SMDA) (Public Law 101-629). … FDA issued tracking orders to 20 additional medical device manufacturers during the time period for FY2002 through FY2004.
73 FR 6729Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 20, 2005
This draft guidance proposes revised deferral periods for such donors, and updates information on product retrieval and quarantine. … Paperwork Reduction Act of 1995 This draft guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act
70 FR 20575Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Nov 20, 1996
The authority for Sec. 101.3 is section 403(c) of the act. … The cost of label inventory loss depends on average label inventory and the length of the compliance period.
61 FR 58991Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 12, 2011
Section 904(e) of the FD&C Act (21 U.S.C. 387d(e)), as added by the Tobacco Control Act, requires FDA to establish, and periodically revise as appropriate, “a list of harmful and potentially harmful constituents … FDA intends to do this both before and after it establishes its list of HPHCs for the purpose of section 904(e) of the FD&C Act, consistent with the directive in section 904(e) that the Agency periodically
76 FR 50226Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 4, 2002
This notice solicits comments on the information collection requirements relating to FDA? … There were an estimated 13,938 15-day alert reports, 10,102 periodic reports, and 339 distribution reports submitted to FDA.
67 FR 62249Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 16, 2008
Postmarketing Adverse Drug Experience Reporting—21 CFR 310.305 and 314.80 (OMB Control Number 0910-0230)—Extension Sections 201, 502, 505, and 701 of the Federal Food, Drug, and Cosmetic Act (the act) … Under § 314.80(c)(2), applicants must provide periodic reports of adverse drug experiences.
73 FR 76358Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 4, 1999
DATES: Submit written comments on the collection of information by May 3, 1999. … new list at the end of each 6-month period) and if the volume of disseminated materials is small.
64 FR 10470Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 18, 2000
During that same period, nearly 2,000 510(k) submissions from approximately 800 companies were eligible for third party review. … The pilot will begin after FDA reviews comments and finalizes the guidance entitled “Guidance for Staff, Industry and Third Parties: Implementation of Third Party Programs under the FDA Modernization Act
65 FR 44540Health and Human Services DepartmentFood and Drug AdministrationDietary Supplements Containing Ephedrine Alkaloids; Availability
Federal Register · Notice · Apr 3, 2000
DATES: Submit written comments by May 18, 2000. … basic elements expected in a Federal agency's cost-benefit analysis and that the ephedrine alkaloids proposal complied with regulatory flexibility analysis requirements under the Regulatory Flexibility Act
65 FR 17510Health and Human Services DepartmentFood and Drug AdministrationNicole Shelby Randall: Final Debarment Order
Federal Register · Notice · Nov 25, 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 Nicole Shelby Randall 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 the Agency considered applicable to Ms.
90 FR 53327Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 8, 2019
DATES: Fax written comments on the collection of information by June 7, 2019. … The report must cover the period of the preceding calendar year and include separate information for each month of the calendar year.
84 FR 20142Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 15, 2009
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 … —Estimated Annual Reporting Burden 1 21 CFR Section or Section of the Act FDA Form No.
74 FR 52967Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 20, 2006
The interim final rule established a 75-day comment period. … notice system, FDA reopened the comment period for 30 days on April 14, 2004 (69 FR 19763), and for an additional 60 days on May 18, 2004 (69 FR 28060), for a total of 165 days.
71 FR 76344Health and Human Services DepartmentFood and Drug AdministrationRecords and Reports Regulations for Radiation Emitting Electronic Products
Federal Register · Rule · Sep 19, 1995
Background The Regulatory Flexibility Act (5 U.S.C. 601) and Executive Order 12866 require FDA to periodically conduct a comprehensive review of existing regulations. … FDA invited interested parties to comment on the proposed rule by January 22, 1991. The comment period was later extended until March 25, 1991 (56 FR 7316). FDA received 11 comments.
60 FR 48374Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 23, 2011
Recall Status Reports Request that recalling firms provide periodic status reports so FDA can ascertain the progress of the recall. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011-30146 Filed 11-22-11; 8:45 am] BILLING CODE 4160-01-P
76 FR 72420Health and Human Services DepartmentFood and Drug Administration
Ask Donna what matters in the record.
She can read the source against your case and show you exactly where the answer came from.