Document ID: FDA-2016-N-1170-0004
Agency: fda
Document Type: Rule
Title: Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products; Confirmation of Effective Date
Posted Date: 2016-08-08T04:00Z

[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)]
[Rules and Regulations]
[Page 52329]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18584]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 610

[Docket No. FDA-2016-N-1170]

Standard Preparations, Limits of Potency, and Dating Period 
Limitations for Biological Products; 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 September 16, 2016, for the final rule that appeared 
in the Federal Register of May 4, 2016. The direct final rule amends 
the general biological products standards relating to dating periods 
and removes certain standards relating to standard preparations and 
limits of potency. FDA is taking this action to update outdated 
requirements, and accommodate new and evolving technology and testing 
capabilities without diminishing public health concerns. This action is 
part of FDA's retrospective review of its regulations in response to an 
Executive order. This document confirms the effective date of the 
direct final rule.

DATES: Effective date of final rule published in the Federal Register 
of May 4, 2016 (81 FR 26687), confirmed: September 16, 2016.

FOR FURTHER INFORMATION CONTACT: Tami Belouin, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION: In the Federal Register of May 4, 2016 (81 
FR 26687), FDA solicited comments concerning the direct final rule for 
a 75-day period ending July 18, 2016. FDA stated that the effective 
date of the direct final rule would be on September 16, 2016, 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: Therefore, under the biological products provisions 
of the Public Health Service Act (42 U.S.C. 216, 262, 263, 263a, and 
264) and the drugs and general administrative provisions of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 
353, 355, 360, 360c, 360d, 360h, 360i, 371, 372, 374, and 381), and 
under authority delegated to the Commissioner of Food and Drugs, 21 
CFR part 610 is amended. Accordingly, the amendments issued thereby 
are effective.

    Dated: August 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18584 Filed 8-5-16; 8:45 am]
 BILLING CODE 4164-01-P