Administrative Actions for Noncompliance; Lesser Administrative Actions; Confirmation of Effective Date
Federal Register, Volume 81 Issue 140 (Thursday, July 21, 2016)
Federal Register Volume 81, Number 140 (Thursday, July 21, 2016)
Rules and Regulations
Page 47288
From the Federal Register Online via the Government Publishing Office www.gpo.gov
FR Doc No: 2016-17186
Page 47288
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 56
Docket No. FDA-2015-N-5052
Administrative Actions for Noncompliance; Lesser Administrative Actions; Confirmation of Effective Date
AGENCY: Food and Drug Administration, HHS.
ACTION: Direct final rule; confirmation of effective date.
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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
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