Documents
Briefs, oral arguments, agency decisions and the Federal Register.
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Federal Register · Rule · May 17, 1999
SUPPLEMENTARY INFORMATION: FDA solicited comments concerning the direct final rule for a 75-day period ending March 22, 1999. … comment period.
64 FR 26657Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 9, 2001
ACTION: Notice; extension of comment period. … FDA received an e-mail request, dated January 4, 2001, requesting that the agency extend the comment period on the draft guidance by 60 days, allowing 90 days for comments.
66 FR 9711Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 27, 2016
ACTION: Final rule; extension of the comment period. … The extended comment period will close on July 19, 2016. Dated: June 20, 2016. Tracey Forfa, Acting Director, Center for Veterinary Medicine.
81 FR 41441Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 5, 2021
Medical Device Recall Authority—21 CFR part 810 OMB Control Number 0910-0432—Extension This collection of information implements section 518(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) … FDA issued part 810 to implement the provisions of section 518 of the FD&C Act.
86 FR 17610Health 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 · Notice · Jan 26, 2000
The agency believes it is appropriate to require distributors to retain records for the same time period. … Prior to FDAMA, distributor reporting and manufacturer and distributor certification were required under the Federal Food, Drug, and Cosmetic Act (the act).
65 FR 4249Health and Human Services DepartmentFood and Drug AdministrationPediatric Medical Devices; Public Workshop; Reopening of Comment Period
Federal Register · Notice · Jan 25, 2012
FDA-2011-N-0754] Pediatric Medical Devices; Public Workshop; Reopening of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; reopening of comment period. … Background In 2007, Congress passed the Pediatric Medical Device Safety and Improvement Act (the Act).
77 FR 3781Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Medical Device Reporting; Baseline Reports; Companion to Direct Final Rule
Federal Register · Proposed Rule · Jun 13, 2008
If we receive any significant adverse comment regarding the direct final rule, we will withdraw the direct final rule within 30 days after the comment period ends and proceed to respond to all of the comments … The comment period for this companion proposed rule runs concurrently with the direct final rule's comment period.
73 FR 33749Health 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 AdministrationFederal Register · Proposed Rule · May 14, 1999
30 days after the comment period on the direct final rule ends. … The comment period for this companion proposed rule runs concurrently with the comment period for the direct final rule.
64 FR 26344Health and Human Services DepartmentFood and Drug AdministrationDraft Prescription Drug User Fee Act IV Information Technology Plan; Availability for Comment
Federal Register · Notice · Dec 28, 2007
As part of this process, FDA will develop and periodically update a 5-year IT plan and will solicit and consider comments from the public on the draft IT plan. … At the end of the comment period, FDA will review the comments, update the IT plan, and publish the final version no later than May 30, 2008. II.
72 FR 73851Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 18, 2026
ACTION: Petition for rulemaking; request for information; extension of comment period. … The notice requested comments by March 23, 2026. We have received a request to extend the comment period for this notice.
91 FR 13037Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 12, 2017
3 years of the close of the comment period and for the remaining 20 percent, within 5 years. … Looking forward, in FY 2018, CDRH will strive to finalize, withdraw, or re-open the comment period for 50 percent of existing draft guidances issued prior to October 1, 2012. B.
82 FR 58429Health 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 · Dec 17, 2018
One of the comments requested that the comment period be extended for an additional 90 days due to the complexity and importance of the issues raised in the proposed rule. … In the Federal Register of June 12, 2014 (79 FR 33711), FDA reopened the comment period for an additional 90 days.
83 FR 64443Health and Human Services DepartmentFood and Drug AdministrationBar Code Label Requirement For Human Drug Products and Blood
Federal Register · Proposed Rule · Mar 14, 2003
We also acknowledge the various comments from the public meeting suggested different implementation periods for this rule. … period.
68 FR 12500Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 12, 2008
Section 222 of FDAAA amends section 510(b) of the FD&C Act to require domestic establishments to register annually during the period beginning October 1 and ending December 31 of each year. … Further, section 223 of FDAAA amends section 510(j)(2) of the FD&C Act to require establishments list their devices with FDA annually, during the time period beginning October 1 and ending December 31
73 FR 75723Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 9, 2015
Paperwork Reduction Act of 1995 This revised guidance refers to previously approved collections of information found in FDA regulations. … Comments Interested persons may submit either electronic comments regarding this document to www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES ).
80 FR 12501Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 1, 2008
Section 222 of FDAAA amends sections 510(b) of the FD&C Act to require domestic establishments to register annually during the period beginning October 1 and ending December 31 of each year. … Further, section 223 of FDAAA amends section 510(j)(2) of the FD&C Act to require establishments to list their devices with FDA annually, during the time period beginning October 1 and ending December
73 FR 57106Health and Human Services DepartmentFood and Drug Administration
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