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Federal Register · Notice · Feb 25, 2022
The number of documents received each year since the original collection period has fallen to less than 5 percent of what was received in the original collection period. … FDA expects this is because documents created within the specified period should have already been submitted.
87 FR 10800Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 17, 2025
under section 760(c)(2) of the FD&C Act. … Section 760(e) of the FD&C Act also requires that responsible persons maintain records of nonprescription drug adverse event reports, whether the event is serious or not, for a period of 6 years.
90 FR 5895Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Aug 29, 2000
How Can I Comment on This Proposed Rule? A. Electronic Access and Filing Address B. Written Comments VIII. How Does This Regulation Comply With the Paperwork Reduction Act of 1995? I. … FDA may not consider or include in the administrative record for the final rule comments that we receive after the close of the comment period (see the DATES section) or comments delivered to an address
65 FR 52376Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Aug 18, 1998
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, issue a final rule to require premarket approval … Interested persons were given until September 16, 1997, to comment on the proposed rule. During the comment period, the agency received no comments on the proposed rule.
63 FR 44177Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jan 5, 2016
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 … The commenter requested clarification regarding what actions will be taken should the PMA not be approved within the 180-day review period.
81 FR 364Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 23, 2018
The number of documents received each year since the original collection period has fallen to less than 5 percent of what was received in the original collection period. … FDA expects this is because documents created within the specified period should have already been submitted.
83 FR 42664Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 18, 2000
the provisions of the Federal Food, Drug, and Cosmetic Act that apply to drugs (21 U.S.C. 301 et seq .). … (Comment 2) The other comment stated that, in view of rapidly changing technology that would require conversion of data whenever newer computer systems are acquired, the retention period would constitute
65 FR 62359Health and Human Services DepartmentFood and Drug AdministrationMedical Devices: Quality Mammography Standards; Delay of Effective Date
Federal Register · Rule · Oct 1, 1999
SUPPLEMENTARY INFORMATION: FDA solicited comments concerning the direct final rule for a 75-day period ending August 31, 1999. … the comment period.
64 FR 53195Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 12, 2018
ACTION: Notice of availability; reopening of the comment period. … The Agency has received a request for a 30-day extension of the comment period for the draft guidance.
83 FR 1618Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 29, 2017
FDA-2017-N-3199] Program for Enhanced Review Transparency and Communication for Original 351(k) Biologics License Applications in Biosimilar User Fee Act II AGENCY: Food and Drug Administration, … DATES: FDA is providing a period of 30 days for public comment on the statement of work before beginning the assessment.
82 FR 29569Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 22, 2021
FDA is authorized to collect this information under sections 351 and 361 of the PHS Act (42 U.S.C. 262 and 264) and provisions of the Federal Food, Drug, and Cosmetic Act that apply to drugs (21 U.S.C. … These characteristics include long latency periods and the ability to establish persistent infections.
86 FR 58666Health and Human Services DepartmentFood and Drug AdministrationNew Animal Drug Applications; Confirmation of Effective Date
Federal Register · Rule · Mar 8, 2010
FDA stated that the effective date of the direct final rule would be on March 8, 2010, 60 days after the end of the comment period, unless any significant adverse comment was submitted to FDA during the … comment period.
75 FR 10413Health and Human Services DepartmentFood and Drug AdministrationMedical Devices: Reports of Corrections and Removals; Delay of Effective Date
Federal Register · Rule · Nov 18, 1998
SUPPLEMENTARY INFORMATION: FDA solicited comments concerning the direct final rule for a 75-day period ending October 21, 1998. … the comment period.
63 FR 63983Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 20, 2019
One comment was received that was PRA related. … The number of documents received each year since the original collection period has fallen to less than 5 percent of what was received in the original collection period.
84 FR 22860Health and Human Services DepartmentFood and Drug AdministrationHuman Tissue Intended for Transplantation
Federal Register · Rule · Jul 29, 1997
Paperwork Reduction Act of 1995 Although the December 14, 1993, interim rule (58 FR 65514) provided a 90-day comment period under the Paperwork Reduction Act of 1980, and this final rule responds … to the comments received, 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
62 FR 40429Health and Human Services DepartmentFood and Drug AdministrationPresiding Officers at Regulatory Hearings
Federal Register · Proposed Rule · Aug 15, 2002
If FDA receives any significant adverse comments, the agency will publish a document withdrawing the direct final rule within 30 days after the comment period ends. … The comment period for this companion proposed rule runs concurrently with the comment period of the direct final rule.
67 FR 53324Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jan 14, 2015
FSMA amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish the foundation of a modernized, prevention-based food safety system. … The NOI asked for public comment by November 15, 2013, and FDA later extended the deadline for the comment period to April 18, 2014 (79 FR 13593; March 11, 2014).
80 FR 1852Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 25, 1997
Comments on the Proposed Rule The agency received five comments from industry and the public. … Act of 1995 (Pub.
62 FR 34166Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 27, 2020
ACTION: Notice of public meeting and request for comments; extension of comment period. … DATES: FDA is extending the comment period announced in the notice of public meeting and request for comments published October 13, 2020 (85 FR 64481).
85 FR 76081Health and Human Services DepartmentFood and Drug AdministrationDesignation of New Animal Drugs for Minor Uses or Minor Species
Federal Register · Rule · Jul 26, 2007
In response to this, in the Federal Register of December 28, 2005 (70 FR 76732), FDA reopened the comment period allowing an additional 30 days of public comment. II. … Also in a Federal Register of December 28, 2005, FDA published a notice reopening the comment period for the proposed rule to allow interested persons additional time to comment.
72 FR 41010Health and Human Services DepartmentFood and Drug Administration
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