Documents
Briefs, oral arguments, agency decisions and the Federal Register.
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Federal Register · Proposed Rule · Mar 11, 2014
ACTION: Notification of public scoping meeting; extension of comment period for the Environmental Impact Statement. … 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.
79 FR 13593Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 8, 2018
Under § 314.80(c)(2), applicants must provide periodic reports of adverse drug experiences. … Section 760(e) of the FD&C Act (21 U.S.C. 379aa(e)) also requires that responsible persons maintain records of nonprescription adverse event reports, whether or not the event is serious, for a period of
83 FR 55900Health 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 … FDA received an e-mail request, dated January 4, 2001, requesting that the agency extend the comment period on the draft guidance by 60 days, allowing 90 days for comments.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 · May 11, 1998
The comment period for the direct final rule runs concurrently with that of the companion proposed rule. … Extend compliance period. FDA considered an extended compliance period.
63 FR 25764Health 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 · Oct 4, 2018
3 years of the close of the comment period and for the remaining 20 percent, within 5 years. … Looking forward, in FY 2019, CDRH will strive to finalize, withdraw, or reopen the comment period for 50 percent of existing draft guidances issued prior to October 1, 2013. B.
83 FR 50107Health 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 · Oct 27, 2020
FDA received 38 comments during the comment period on the 2018 revised draft standard MOU. … Most comments on the 2013 draft 503A guidance that raised this issue said this period was too short but did not recommend a specific alternative.
85 FR 68074Health 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 AdministrationFederal Register · Rule · Mar 30, 2023
FD&C Act Federal Food, Drug, and Cosmetic Act. PMA Premarket Approval Application. III. Background A. … Comments on the Proposed Rule and FDA Response A. Introduction We received a few comment letters on the proposed rule by the close of the comment period.
88 FR 18987Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 9, 2021
ACTION: Notice; reopening of the comment period. … FDA is reopening the comment period to allow interested persons additional time to submit comments.
86 FR 50539Health 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 AdministrationDraft Guidance for Industry on Developing Medical Imaging Drugs and Biologics; Availability
Federal Register · Proposed Rule · Oct 14, 1998
In a separate document published elsewhere in this issue of the Federal Register, FDA is further extending the comment period to November 16, 1998. … Persons will have additional time to submit comments on the draft guidance after the comment period on the proposed rule closes.
63 FR 55067Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 27, 2018
follows: • Sponsors with a Request For Designation (RFD) or pre-RFD submitted during the data collection period … • Sponsors with a combination product Investigational New Drug (IND) or pre-IND submitted during the data collection period.
83 FR 48822Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Patient Examination and Surgeons' Gloves; Test Procedures and Acceptance Criteria
Federal Register · Rule · Dec 19, 2006
We provided a period of 90 days for comments from interested parties. … Introduction FDA has examined the final rule under Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-602), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).
71 FR 75865Health and Human Services DepartmentFood and Drug AdministrationAdministrative Practices and Procedures; Good Guidance Practices
Federal Register · Proposed Rule · Feb 14, 2000
After reviewing and considering all of the comments received during the meeting and the public comment period, the agency finalized its procedures. … All comments received during that period will be reviewed and considered immediately.
65 FR 7321Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 7, 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. … In addition, section 223 of FDAAA amends section 510(j)(2) of the FD&C Act to require establishments to list their devices annually with FDA during the period beginning on October 1 and ending on December
73 FR 25750Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · May 21, 1998
The agency is providing a period of 90 days from the date of publication of this proposed rulemaking in the Federal Register for development and submission of comments on this subject. … ``Do not take more than 20 mL (4 teaspoonfuls) in a 24-hour period.''
63 FR 27886Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 19, 2010
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 … After the transition period, Form FDA 2301 will continue to be counted as part of OMB Control No. 0910-0284.
75 FR 2865Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Feb 23, 2016
ACTION: Notification; extension of comment period. … We have received a request for a 60-day extension of the comment period for the petition.
81 FR 8867Health and Human Services DepartmentFood and Drug Administration
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