Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products; Confirmation of Effective Date, 52329 [2016-18584]
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Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Rules and Regulations
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0E521. Technology.
No. 1 ‘‘Technology’’ required for the ‘‘development’’ or ‘‘production’’ of 0A521 No. 1 items.
August 8, 2016 (ID) ...
Dated: July 25, 2016.
Matthew S. Borman,
Deputy Assistant Secretary for Export
Administration.
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 75day 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.
[FR Doc. 2016–18070 Filed 8–5–16; 8:45 am]
BILLING CODE 3510–33–P
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.
Direct final rule; confirmation of
effective date.
ACTION:
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is taking this action to update outdated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,
rmajette on DSK2TPTVN1PROD with RULES
SUMMARY:
VerDate Sep<11>2014
13:12 Aug 05, 2016
Jkt 238001
August 8, 2017 ..........
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1105
[Docket No. FDA–2016–N–1555]
Refuse To Accept Procedures for
Premarket Tobacco Product
Submissions
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Direct final rule.
The Food and Drug
Administration (FDA) is issuing a rule
describing when FDA will refuse to
accept a tobacco product submission (or
application) because the application has
SUMMARY:
PO 00000
Frm 00005
Fmt 4700
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License
Exception
§ 740.11(b)(2)(ii) only.
GOV
under
not met a minimum threshold for
acceptability for FDA review. Under the
rule, FDA will refuse to accept a tobacco
product submission, for example, that is
not in English, does not pertain to a
tobacco product, or does not identify the
type of submission. By refusing to
accept submissions that have the
deficiencies identified in the rule, FDA
will be able to focus our review
resources on submissions that meet a
threshold of acceptability and encourage
quality submissions. FDA is issuing this
action directly as a final rule because we
believe there is little likelihood that we
will receive any significant adverse
comments opposing the rule given the
specific deficiencies identified that will
result in FDA’s refusal to accept the
submission.
DATES: This rule is effective December
21, 2016. Submit either electronic or
written comments on this direct final
rule by October 24, 2016. If we receive
no significant adverse comments during
the specified comment period, we
intend to publish a confirmation
document on or before the effective date
by publication of a document in the
Federal Register.
ADDRESSES: You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
E:\FR\FM\08AUR1.SGM
08AUR1
]]>Agencies
[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.
-----------------------------------------------------------------------
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
