Documents
Briefs, oral arguments, agency decisions and the Federal Register.
5,436 results
0.67s
Federal Register · Rule · Mar 20, 1998
No comments were received in response to the agency's request for specific comment on the economic impact of this rulemaking. … The agency considered but rejected several alternatives: (1) To allow continued marketing of OTC quinine drug products for the treatment of malaria, and (2) to allow a longer implementation period.
63 FR 13526Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 15, 2006
This notice is issued under the Controlled Substances Act. DATES: Submit written or electronic comments by January 16, 2007. … The abbreviated period for the submission of comments is necessary to allow sufficient time for the Secretary of HHS to carry out the required action and respond to the United Nations.
71 FR 75560Health and Human Services DepartmentFood and Drug AdministrationProgestational Drug Products for Human Use; Requirements for Labeling Directed to the Patient
Federal Register · Proposed Rule · Apr 13, 1999
Using a pharmaceutical labeling cost model developed for the agency, the average cost for this labeling change is $1,317 per insert, assuming a compliance period of 1 year. … Request for Comments Interested persons may, on or before July 12, 1999, submit to the Dockets Management Branch (address above) written comments on this proposal.
64 FR 17985Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jan 26, 2001
However, in accordance with 21 CFR 10.40(e)(1), the agency will accept comment on this extension for a period of 90 days. Dated: January 18, 2001. Ann M. … Witt, Acting Associate Commissioner for Policy. [FR Doc. 01-2125 Filed 1-25-01; 8:45 am] BILLING CODE 4160-01-F
66 FR 7864Health and Human Services DepartmentFood and Drug AdministrationNew Animal Drugs; Approval of New Animal Drug Applications
Federal Register · Rule · Apr 1, 2021
This rule is issued under section 512(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(i)), which requires Federal Register publication of the conditions of use of an approved … A notice published pursuant to section 512(i) is not subject to the notice-and-comment rulemaking requirements of the Administrative Procedure Act, 5 U.S.C. 551 et seq.
86 FR 17061Health and Human Services DepartmentFood and Drug AdministrationPhysical Medicine Devices; Reclassification of Iontophoresis Device Intended for Any Other Purposes
Federal Register · Rule · Jul 26, 2016
The comments and FDA's responses to the comments are summarized as follows. … the time of the 2014 Panel meeting, 40 adverse event reports for a 5-year period that implicated device malfunction, 12 of which include burns, in a search of the Manufacturer and User Facility Device
81 FR 48703Health and Human Services DepartmentFood and Drug AdministrationIrradiation in the Production, Processing, and Handling of Animal Feed and Pet Food; Irradiation
Federal Register · Rule · Apr 10, 2001
The notice of filing provided for a 60-day comment period. The agency received no comments. … Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 579 is amended
66 FR 18539Health and Human Services DepartmentFood and Drug AdministrationBavarian Red Cross; Opportunity for Hearing on a Proposal to Revoke U.S. License No. 1002
Federal Register · Notice · May 9, 2002
Other interested persons may submit written or electronic comments on the proposed revocation by July 8, 2002. … This notice is issued under section 351 of the Public Health Service Act (42 U.S.C. 262) and sections 201, 501, 502, 505, and 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 355
67 FR 31348Health and Human Services DepartmentFood and Drug AdministrationSupplements and Other Changes to an Approved Application
Federal Register · Proposed Rule · Jun 28, 1999
DATES: Written comments by September 13, 1999. Comments on the collection of information by July 28, 1999. … Request for Comments Interested persons may, on or before September 13, 1999, submit to the Dockets Management Branch (address above) written comments regarding this proposal.
64 FR 34608Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 2, 2000
by the Food Quality Protection Act (FQPA) of 1996. … Comments Interested persons may submit to the Dockets Management Branch (address above) written comments on the proposed guidance by August 1, 2000.
65 FR 35376Health and Human Services DepartmentFood and Drug AdministrationRevocation of the Regulations for Human Tissue Intended for Transplantation and Human Dura Mater
Federal Register · Proposed Rule · Dec 21, 2020
(the FD&C Act). … Summary of Benefits, Costs and Distributional Effects of Proposed Rule Category Primary estimate Low estimate High estimate Units Year ollars Discount rate Period
85 FR 82990Health and Human Services DepartmentFood and Drug AdministrationFood Additive Permitted in Feed and Drinking Water of Animals; Feed-Grade Biuret
Federal Register · Rule · May 22, 2003
The notice of filing provided for a 75-day comment period on the petitioner's environmental information. No substantive comments have been received. II. … Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 573 is amended
68 FR 27904Health and Human Services DepartmentFood and Drug AdministrationPrescription Drug User Fee Act (PDUFA); Public Meeting
Federal Register · Notice · Nov 19, 2001
The Federal Food, Drug, and Cosmetic Act (the act) encourages FDA to consult with stakeholders, as appropriate, in carrying out agency responsibilities. … If you wish to make an oral presentation during the open public comment period of the meeting, you must specify on your registration you wish to make a presentation.
66 FR 57967Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 13, 2022
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. … Our annualized estimate of burden addresses new products and products for which the DFL and/or net quantity of contents otherwise change in a 12-month period. C.
87 FR 76200Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 28, 2023
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.
88 FR 48861Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Exemption From Premarket Notification for Certain Classified Devices
Federal Register · Rule · Jul 28, 1995
During the comment period, FDA received comments that questioned the appropriateness of the proposed exemptions for a small number of the devices. … FDA disagrees with this comment.
60 FR 38896Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 10, 2006
Administration (FDA) 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 … In the Federal Register of November 24, 2004 (69 FR 68381), FDA published a notice of availability with a 60-day comment period requesting public comment on the collection of information in FDA's draft
71 FR 7048Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 8, 2016
ACTION: Notice; request for comments. … CDRH has periodically taken such actions consistent with the medical device statutory framework but has typically done so on an ad hoc basis.
81 FR 52445Health and Human Services DepartmentFood and Drug AdministrationAdvisory Committee; Science Board to the Food and Drug Administration; Formation of a Subcommittee
Federal Register · Notice · May 23, 1996
During this period there will be opportunities for public comment; these opportunities will be announced in the Federal Register at least 15 days prior to each scheduled public meeting. … This notice is issued under the Federal Advisory Committee Act of October 6, 1972 (Pub. L. 92-463 (5 U.S.C. app. 2)). Dated: May 16, 1996. Michael A.
61 FR 25882Health and Human Services DepartmentFood and Drug AdministrationMarketing Exclusivity and Patent Provisions for Certain Antibiotic Drugs
Federal Register · Proposed Rule · Jan 24, 2000
DATES: Written comments by April 24, 2000. … Request for Comments Interested persons may, on or before April 24, 2000, submit to the Dockets Management Branch (address above) written comments regarding this proposal.
65 FR 3623Health 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.