Skip to Content

Rule

Administrative Actions for Noncompliance; Lesser Administrative Actions; Confirmation of Effective Date

A Rule by the Food and Drug Administration on 07/21/2016

  • PDF
  • Document Details
  • Document Dates
  • Table of Contents
  • Related Documents
  • Public Comments
  • Regulations.gov Data
  • Sharing
  • Print
  • Document Statistics
  • Other Formats
  • Public Inspection
Published Document: 2016-17186 (81 FR 47288)

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Document Headings

Document headings vary by document type but may contain the following:

  1. the agency or agencies that issued and signed a document
  2. the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to
  3. the agency docket number / agency internal file number
  4. the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions

See the Document Drafting Handbook for more details.

Department of Health and Human Services
Food and Drug Administration
  1. 21 CFR Part 56
  2. [Docket No. FDA-2015-N-5052]

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Direct final rule; confirmation of effective date.

SUMMARY:

The Food and Drug Administration (FDA) is confirming the effective date of August 17, 2016, for the direct final rule that appeared in the Federal Register of April 4, 2016. The direct final rule amends the regulations describing lesser administrative actions that may be imposed on an Institutional Review Board (IRB) that has failed to comply with applicable regulations. We are taking this action to ensure clarity and improve the accuracy of the regulations. This document confirms the effective date of the direct final rule.

DATES:

Effective date of final rule published in the Federal Register of April 4, 2016 (81 FR 19033), confirmed: August 17, 2016.

FOR FURTHER INFORMATION CONTACT:

Sheila Brown, Office of Good Clinical Practice, Office of Special Medical Programs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002, 301-796-6563.

SUPPLEMENTARY INFORMATION:

In the Federal Register of April 4, 2016 (81 FR 19033), FDA solicited comments concerning the direct final rule for a 75-day period ending June 20, 2016. FDA stated that the effective date of the direct final rule would be on August 17, 2016, no later than 60 days after the end of the comment period, unless any significant adverse comment was submitted to FDA during the comment period. FDA did not receive any significant adverse comments.

Authority: 21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 351, 352, 353, 355, 360, 360c-360f, 360h, 360i, 360j, 360hh-360ss, 371, 379e, 381; 42 U.S.C. 216, 241, 262. Accordingly, the amendment issued thereby is effective.

Dated: July 15, 2016.

Leslie Kux,

Associate Commissioner for Policy.

[FR Doc. 2016-17186 Filed 7-20-16; 8:45 am]

BILLING CODE 4164-01-P

Published Document: 2016-17186 (81 FR 47288)