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Briefs, oral arguments, agency decisions and the Federal Register.
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Federal Register · Notice · Mar 19, 2020
ACTION: Notice of availability; reopening of the comment period. … FDA is reopening the comment period until May 18, 2020.
85 FR 15788Health and Human Services DepartmentFood and Drug AdministrationUnapproved Animal Drugs; Extension of Comment Period
Federal Register · Notice · Feb 18, 2011
FDA-2010-N-0528] Unapproved Animal Drugs; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Request for comments; extension of comment period. … The Agency has received requests for a 60-day extension of the comment period.
76 FR 9584Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 13, 2014
This guidance describes when and how extrapolation can be considered when proposing a retest period for a drug substance or a shelf life for a veterinary medicinal product that extends beyond the period … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations.
79 FR 27312Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 4, 2012
period covered by available data from the stability study under the long-term storage condition. … Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations.
77 FR 20406Health and Human Services DepartmentFood and Drug AdministrationExports: Notification and Recordkeeping Requirements; Extension of Comment Period
Federal Register · Proposed Rule · Jun 17, 1999
, the comment period for the proposed rule that appeared in the Federal Register of April 2, 1999 (64 FR 15944). … Therefore, FDA is extending the comment period until July 16, 1999.
64 FR 32442Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 5, 2003
Drug Availability Act of 1996. … With regard to the comment that there is an increased reporting burden due to the Animal Drug Availability Act of 1996, increased reporting is due to the increased number of approved applications.
68 FR 23726Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jan 27, 2012
ACTION: Proposed rule; reopening of comment period on specific data. … The proposed rule provided a 90-day period for public comment. The comment period closed June 28, 2010.
77 FR 4273Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Oct 14, 1998
, 1998, the comment period on a proposed rule that was published in the Federal Register of May 22, 1998 (63 FR 28301). … Public Health Service Act.
63 FR 55067Health and Human Services DepartmentFood and Drug AdministrationRevision of the Requirements for Live Vaccine Processing
Federal Register · Rule · Oct 18, 2007
The comment period for the direct final rule runs concurrently with the companion proposed rule. … We are providing a comment period on the direct final rule of 75 days after the date of publication in the Federal Register .
72 FR 59000Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · May 8, 1997
The comment period is being reopened for the sole purpose of inviting interested persons to submit comments that will give FDA guidance in developing proposed regulations defining ``good study practices … The purpose of these revisions is to: (1) Implement the Animal Drug Availability Act of 1996 (ADAA) (Pub.
62 FR 25152Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Sep 9, 1996
Cosmetic Act (21 U.S.C. 351). … At the close of the 60-day comment period, FDA will review the comments received, make revisions as necessary to the information collection requirements, and submit the requirements to OMB for review and
61 FR 47413Health and Human Services DepartmentFood and Drug AdministrationPostmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements
Federal Register · Proposed Rule · Feb 14, 2018
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by March 16, 2018. ADDRESSES: You may submit comments as follows. … Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (PRA) to the Office of Management and Budget (OMB) in the following ways: • Fax to the Office of Information
83 FR 6480Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 14, 2008
ACTION: Notice; reopening of comment period. … The Controlled Substances Act (21 U.S.C. 811 et seq. ) (Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970) provides that when WHO notifies the United States under Article
73 FR 60705Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Dec 19, 2011
Submit comments on the information collection requirements under the Paperwork Reduction Act of 1995 by January 3, 2012 (see the “Paperwork Reduction Act of 1995” section of this document). … Act of 1995 (Pub.
76 FR 78530Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 12, 2010
Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010-8231 Filed 4-9-10; 8:45 am] BILLING CODE 4160-01-S
75 FR 18504Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 3, 1995
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act became effective: October 10, 1986.
60 FR 39752Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; MERREMRegister I.V.
Federal Register · Notice · Feb 11, 1997
SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
62 FR 6261Health and Human Services DepartmentFood and Drug AdministrationElectronic Records; Electronic Signatures
Federal Register · Rule · Mar 20, 1997
Although the August 31, 1994, proposed rule (59 FR 45160) provided a 90-day comment period under the Paperwork Reduction Act of 1980, FDA is providing an additional opportunity for public comment under … the Paperwork Reduction Act of 1995, which was enacted after the expiration of the comment period and applies to this final rule.
62 FR 13430Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Apr 26, 2024
ACTION: Proposed rule; reopening of the comment period. … We are reopening the comment period for 30 days specifically to invite public comments on the new information being added to the administrative record.
89 FR 32384Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 23, 1999
Period AGENCY: Food and Drug Administration, HHS. … In response to this request, FDA has decided to extend the comment period on the draft standard MOU to June 1, 1999.
64 FR 13997Health and Human Services DepartmentFood and Drug Administration
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