81_FR_52481 81 FR 52329 - Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products; Confirmation of Effective Date

81 FR 52329 - Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products; Confirmation of Effective Date

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 152 (August 8, 2016)

Page Range52329-52329
FR Document2016-18584

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 FDA is taking this action to update outdated requirements, and accommodate new and evolving technology and testing capabilities without diminishing public health concerns.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.

Federal Register, Volume 81 Issue 152 (Monday, August 8, 2016) 
[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)]
[Rules and Regulations]
[Page 52329]
From the Federal Register Online  [www.thefederalregister.org]
[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 FDA is taking this action to update outdated 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

Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Rules and Regulations 52329 Date when the item Date of initial or will be designated Item descriptor subsequent BIS EAR99, unless reclas- Note: The description must match by model classification sified in another Item-specific license exception eligibility number or a broader descriptor that does not (ID = initial date; SD ECCN or the 0Y521 necessarily need to be company specific = subsequent date) classification is reissued * * * * * * * 0E521. Technology. No. 1 ‘‘Technology’’ required for the ‘‘develop- August 8, 2016 (ID) ... August 8, 2017 .......... License Exception GOV under ment’’ or ‘‘production’’ of 0A521 No. 1 items. § 740.11(b)(2)(ii) only. Dated: July 25, 2016. Silver Spring, MD 20993–0002, 240– not met a minimum threshold for Matthew S. Borman, 402–7911. acceptability for FDA review. Under the Deputy Assistant Secretary for Export SUPPLEMENTARY INFORMATION: In the rule, FDA will refuse to accept a tobacco Administration. Federal Register of May 4, 2016 (81 FR product submission, for example, that is [FR Doc. 2016–18070 Filed 8–5–16; 8:45 am] 26687), FDA solicited comments not in English, does not pertain to a BILLING CODE 3510–33–P concerning the direct final rule for a 75- tobacco product, or does not identify the day period ending July 18, 2016. FDA type of submission. By refusing to stated that the effective date of the accept submissions that have the DEPARTMENT OF HEALTH AND direct final rule would be on September deficiencies identified in the rule, FDA HUMAN SERVICES 16, 2016, 60 days after the end of the will be able to focus our review comment period, unless any significant resources on submissions that meet a Food and Drug Administration adverse comment was submitted to FDA threshold of acceptability and encourage during the comment period. FDA did quality submissions. FDA is issuing this 21 CFR Part 610 not receive any significant adverse action directly as a final rule because we comments. believe there is little likelihood that we [Docket No. FDA–2016–N–1170] will receive any significant adverse Authority: Therefore, under the biological Standard Preparations, Limits of products provisions of the Public Health comments opposing the rule given the Potency, and Dating Period Limitations Service Act (42 U.S.C. 216, 262, 263, 263a, specific deficiencies identified that will for Biological Products; Confirmation and 264) and the drugs and general result in FDA’s refusal to accept the of Effective Date administrative provisions of the Federal submission. Food, Drug, and Cosmetic Act (21 U.S.C. 321, DATES: This rule is effective December AGENCY: Food and Drug Administration, 331, 351, 352, 353, 355, 360, 360c, 360d, 360h, 360i, 371, 372, 374, and 381), and 21, 2016. Submit either electronic or HHS. written comments on this direct final under authority delegated to the ACTION: Direct final rule; confirmation of Commissioner of Food and Drugs, 21 CFR rule by October 24, 2016. If we receive effective date. part 610 is amended. Accordingly, the no significant adverse comments during SUMMARY: The Food and Drug amendments issued thereby are effective. the specified comment period, we Dated: August 1, 2016. intend to publish a confirmation Administration (FDA) is confirming the Leslie Kux, document on or before the effective date effective date of September 16, 2016, for by publication of a document in the the final rule that appeared in the Associate Commissioner for Policy. Federal Register. Federal Register of May 4, 2016. The [FR Doc. 2016–18584 Filed 8–5–16; 8:45 am] direct final rule amends the general ADDRESSES: You may submit comments BILLING CODE 4164–01–P biological products standards relating to as follows: dating periods and removes certain Electronic Submissions standards relating to standard DEPARTMENT OF HEALTH AND Submit electronic comments in the preparations and limits of potency. FDA HUMAN SERVICES following way: is taking this action to update outdated • Federal eRulemaking Portal: http:// requirements, and accommodate new Food and Drug Administration www.regulations.gov. Follow the and evolving technology and testing instructions for submitting comments. capabilities without diminishing public 21 CFR Part 1105 Comments submitted electronically, health concerns. This action is part of [Docket No. FDA–2016–N–1555] including attachments, to http:// FDA’s retrospective review of its www.regulations.gov will be posted to regulations in response to an Executive Refuse To Accept Procedures for the docket unchanged. Because your order. This document confirms the Premarket Tobacco Product comment will be made public, you are effective date of the direct final rule. Submissions solely responsible for ensuring that your DATES: Effective date of final rule AGENCY: Food and Drug Administration, comment does not include any published in the Federal Register of HHS. confidential information that you or a May 4, 2016 (81 FR 26687), confirmed: third party may not wish to be posted, rmajette on DSK2TPTVN1PROD with RULES ACTION: Direct final rule. September 16, 2016. such as medical information, your or FOR FURTHER INFORMATION CONTACT: SUMMARY: The Food and Drug anyone else’s Social Security number, or Tami Belouin, Center for Biologics Administration (FDA) is issuing a rule confidential business information, such Evaluation and Research, Food and describing when FDA will refuse to as a manufacturing process. Please note Drug Administration, 10903 New accept a tobacco product submission (or that if you include your name, contact Hampshire Ave., Bldg. 71, Rm. 7301, application) because the application has information, or other information that VerDate Sep<11>2014 13:12 Aug 05, 2016 Jkt 238001 PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 E:\FR\FM\08AUR1.SGM 08AUR1


Document Created: 2016-08-06 03:08:11
Document Modified: 2016-08-06 03:08:11
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionDirect final rule; confirmation of effective date.
DatesEffective date of final rule published in the Federal Register of May 4, 2016 (81 FR 26687), confirmed: September 16, 2016.
ContactTami 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.
FR Citation81 FR 52329 
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