[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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