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HHS/FDA | RIN: 0910-AI48 | Publication ID: Spring 2020 |
Title: ●Amendments to Good Guidance Practices Regulation | |
Abstract:
The Food and Drug Administration seeks to develop a proposed rule that would amend its current Good Guidance Practices (GGP) regulation (21 CFR. 10.115). This action is intended to implement Executive Order 13891, "Promoting the Rule of Law Through Improved Agency Guidance Documents." The Executive Order requires that agency regulations address certain issues related to guidance documents by 8/27/2020. The amendments to the GGP regulation would address the issues in the EO that are not currently addressed by 21 CFR 10.115. |
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Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
RIN Status: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: No | Unfunded Mandates: No |
EO 13771 Designation: Fully or Partially Exempt | |
CFR Citation: 21 CFR 10.115 | |
Legal Authority: 21 U.S.C. 371(h) 21 U.S.C. 371(a) |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Small Entities Affected: No | Federalism: No |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Brian L. Pendleton Senior Policy Advisor Department of Health and Human Services Food and Drug Administration Suite 3037 (HFD-7), Office of Policy, WO 32, Room 4250, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002 Phone:301 796-4614 Fax:301 847-3541 Email: brian.pendleton@fda.hhs.gov |