[Federal Register Volume 77, Number 101 (Thursday, May 24, 2012)]
[Rules and Regulations]
[Pages 30887-30888]
[FR Doc No: 2012-12594]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 600, 610, and 680

[Docket No. FDA-2011-N-0080]
RIN 0910-AG16

Amendments to Sterility Test Requirements for Biological
Products; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule, correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a

final rule that appeared in the Federal Register of May 3, 2012. (77 FR
26162). The final rule provides manufacturers of biological products
greater flexibility, as appropriate, and encourages use of the most
appropriate and state-of-the-art test methods for assuring the safety
of biological products. The rule was published with an inaccurate
citation in the codified section of the rule. This notice corrects that
error.

DATES: Effective June 4, 2012.

FOR FURTHER INFORMATION CONTACT: Paul E. Levine, Jr., Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-
1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In FR Doc. 2012-10649, appearing on page
26162 in the Federal Register of Thursday, May 3, 2012, the following
correction is made:

Sec.  680.3  [Corrected]

    1. On page 26175, in the second column, in Part 680 Additional
Standards for Miscellaneous Products, in Sec.  680.3 Tests, paragraph
(c), in line 4, ``Sec.  601.12'' is corrected to read ``Sec.  610.12''.

    Dated: May 18, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-12594 Filed 5-23-12; 8:45 a.m.]
BILLING CODE 4160-01-P


[Federal Register Volume 88, Number 164 (Friday, August 25, 2023)]
[Rules and Regulations]
[Page 58102]
[FR Doc No: 2023-18327]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2023-0682]

Special Local Regulation; Olympia Harbor Days Tug Boat Races,
Budd Inlet, WA

AGENCY: Coast Guard, Department of Homeland Security (DHS).

ACTION: Notification of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce special local regulations for the
Olympia Harbor Days Tug Boat Races, Budd Inlet, WA, from 11 a.m. until
4 p.m. on September 2, 2023. This action is necessary to prevent injury
and to protect life and property of the maritime public from the
hazards associated with the tug boat races. During the enforcement
periods, the operator of any vessel in the regulated area must comply
with directions from the Patrol Commander or any Official Patrol
displaying a Coast Guard ensign.

DATES: The regulations in 33 CFR 100.1309 will be enforced from 11 a.m.
until 4 p.m. on September 2, 2023.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notification of enforcement, call or email Lieutenant Peter McAndrew,
Sector Puget Sound Waterways Management Division, U.S. Coast Guard;
telephone<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION: The Coast Guard will enforce special local
regulations in 33 CFR 100.1309 for the Olympia Harbor Days Tug Boat
Races, Budd Inlet, WA, regulated area from 11 a.m. until 4 p.m. on
September 2, 2023. This action is being taken to provide for the safety
of life on navigable waterways during this event. District Thirteen
regulation 33 CFR 100.1309(a) specifies the location of the regulated
area which encompasses approximately 2 nautical miles of the navigable
waters in Budd Inlet. During the enforcement periods, if you are the
operator of a vessel in the regulated area you must comply with
directions from the Patrol Commander or any Official Patrol displaying
a Coast Guard ensign. All persons or vessels who desire to enter the
race area while it is enforced must obtain permission from the on-scene
patrol craft on VHF-FM channel 16.
    In addition to this notification of enforcement in the Federal
Register, the Coast Guard will provide notification of this enforcement
period via the Local Notice to Mariners. If the Captain of the Port
determines that the regulated area need not be enforced for the full
duration stated in this notification, he may use a Broadcast Notice to
Mariners to grant general permission to enter the regulated area.

    Dated: August 21, 2023.
Y Moon,
Captain, U.S. Coast Guard, Acting Captain of the Port, Sector Puget
Sound.
[FR Doc. 2023-18327 Filed 8-24-23; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: December 23, 2009 (Volume 74, Number 245)]
[Rules and Regulations]
[Page 68147-68149]
[DOCID:fr23de09-7]

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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Part 748

[Docket No.<PHONE_NUMBER>-91397-01]
RIN 0694-AE77

Authorization Validated End-User: Amendment to Existing Validated
End-User Authorizations in the People's Republic of China (PRC) and
India

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Final rule.

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SUMMARY: In this final rule, the Bureau of Industry and Security (BIS)
amends the Export Administration Regulations (EAR) to suspend the
availability of Authorization Validated End-User

(VEU) status for any export, reexport, or transfer (in-country) of
items subject to the EAR to Aviza Technology China, a VEU in the
People's Republic of China (PRC/China) and to GE India's GE Fanuc
Systems PVT Ltd facility in India. VEU status was provided to the PRC
company in an April 2009 final rule published in the Federal Register,
and to the eligible facility of the Indian company in a July 2009 final
rule published in the Federal Register.
    BIS is suspending the availability of Authorization VEU for
exports, reexports, and transfers (in-country) due to material changes
at the companies, consistent with the authorization's eligible end-user
provisions. Suspension of the availability of Authorization VEU in this
amendment is not the result of prohibited activities by the two
companies. This amendment does not otherwise create a new license
requirement or adversely affect the licensing policy for exports,
reexports or transfers of items to the company and facility identified
in this rule.

DATES: This rule is effective December 23, 2009.

ADDRESSES: Although there is no formal comment period, public comments
on this regulation are welcome on a continuing basis. You may submit
comments, identified by RIN 0694-AE77 (VEUAVIZAGE), by any of the
following methods:
    E-mail<EMAIL_ADDRESS>Include ``RIN 0694-AE77
(VEUAVIZAGE)'' in the subject line of the message.
    Fax:<PHONE_NUMBER>. Please alert the Regulatory Policy Division,
by calling<PHONE_NUMBER>, if you are faxing comments.
    Mail or Hand Delivery/Courier: Sheila Quarterman, U.S. Department
of Commerce, Bureau of Industry and Security, Regulatory Policy
Division, 14th St. & Pennsylvania Avenue, NW., Room 2705, Washington,
DC 20230, Attn: RIN 0694-AE77 (VEUAVIZAGE).
    Send comments regarding the collection of information associated
with this rule, including suggestions for reducing the burden, to
Jasmeet Seehra, Office of Management and Budget (OMB), by e-mail to
<EMAIL_ADDRESS>or by fax to<PHONE_NUMBER>. Comments
on this collection of information should be submitted separately from
comments on the final rule (i.e., RIN 0694-AE77 (VEUAVIZAGE))--all
comments on the matter should be submitted by one of the three methods
outlined above.

FOR FURTHER INFORMATION CONTACT: Elizabeth Scott Sangine, Acting Chair,
End-User Review Committee, Bureau of Industry and Security, U.S.
Department of Commerce, 14th St. & Pennsylvania Avenue, NW., Room 2705,
Washington, DC 20230; by telephone<PHONE_NUMBER>, or by e-mail to
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    BIS amended the EAR in a final rule published in the Federal
Register on June 19, 2007 (72 FR 33646) to create a new Authorization
Validated End-User (VEU). Authorization VEU allows the export, reexport
or transfer (in-country) of certain specified items (including
commodities, software and technology, except for those controlled for
missile technology or crime control reasons) to approved civil end-
users located in eligible destinations under a general authorization
instead of under multiple individual licenses. Authorization VEU is
described in Sec.  748.15 of the EAR. The June 19 rule also identified
China as the initial eligible destination for shipments under the
authorization; BIS identified India as an eligible destination in an
October 1, 2007 final rule (72 FR 56010).
    In a rule published in the Federal Register on April 29, 2009 (74
FR 19382), BIS designated Aviza Technology China (Aviza) as a VEU, thus
authorizing certain specific exports, reexports and transfers (in-
country) to the listed facilities of the company under Authorization
VEU. On July 2, 2009, BIS designated GE India as a VEU (74 FR 31620);
GE India's listing included its GE Fanuc Systems PVT Ltd. (GE Fanuc)
facility as an ``Eligible Destination,'' and listed specific items that
could be exported, reexported or transferred (in-country) to the GE
Fanuc facility under Authorization VEU. Prior to publication of this
rule, Aviza and GE India's GE Fanuc facility were listed in Supplement
No. 7 to Part 748 of the EAR (Supplement No. 7 to Part 748--
Authorization Validated End-User (VEU): List of Validated End-Users,
Respective Eligible Items and Eligible Destinations).
    In this final rule, BIS amends the EAR to suspend, until further
notice, the authority of any person to export, reexport, or transfer
(in-country) any items subject to the EAR under Authorization VEU to
Aviza and to the GE Fanuc facility in India. BIS is suspending the
availability of Authorization VEU for Aviza and the GE Fanuc facility
due to material changes at the companies, consistent with Sec.  748.15
of the EAR.
    Suspension of the availability of Authorization VEU in this
amendment is not the result of prohibited activities by the two
companies. This amendment does not otherwise create a new license
requirement or adversely affect the licensing policy for exports,
reexports or transfers of items to the company and facility identified
in this rule.
    This amendment applies only to transactions under Authorization VEU
involving Aviza and the GE Fanuc facility in India, which were
previously identified in Supplement No. 7 to Part 748 of the EAR. This
amendment does not apply to other companies or facilities in China or
India that may be designated as eligible under Authorization VEU.
License requirements and other provisions of the EAR continue to apply
to exports, reexports, or transfers (in-country) to Aviza in China and
the GE Fanuc facility in India. Additionally, all conditions and
restrictions that applied to transactions involving Aviza or the GE
Fanuc facility pursuant to Authorization VEU prior to the effective
date of this amendment continue to apply. These restrictions and
conditions include any that were imposed on either company in
connection with its eligibility for Authorization VEU, as communicated
by BIS in the initial letter that granted each company VEU status.
    Since August 21, 2001, the Export Administration Act has been in
lapse and the President, through Executive Order 13222 of August 17,
2001 (3 CFR, 2001 Comp., p. 783 (2002)), as extended most recently by
the Notice of August 13, 2009 (74 FR 41325 (August 14, 2009), has
continued the EAR in effect under the International Emergency Economic
Powers Act. BIS continues to carry out the provisions of the Act, as
appropriate and to the extent permitted by law, pursuant to Executive
Order 13222.

Saving Clause

    Shipments of items removed from eligibility for export, reexport or
transfer under Authorization VEU as a result of this regulatory action
that were on dock for loading, on lighter, laden aboard an exporting
carrier, or en route aboard a carrier to a port of export, on December
23, 2009, pursuant to actual orders for export or reexport to a foreign
destination, may proceed to that destination under the previously
applicable authorization so long as they are exported, reexported or
transferred before January 6, 2010. Any such items not actually
exported or reexported before midnight, on January 6, 2010, require a
license in accordance with this regulation.

Rulemaking Requirements

    1. This final rule has been determined to be not significant for
purposes of Executive Order 12866.
    2. Notwithstanding any other provision of law, no person is
required to respond to, nor shall any person be subject to a penalty
for failure to comply with, a collection of information, subject to the
requirements of the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C.
3501 et seq., unless that collection of information displays a
currently valid OMB Control Number. This regulation involves
information collections previously approved by the OMB under control
number 0694-0088, ``Multi-Purpose Application'', which carries a burden
hour estimate of 58 minutes to prepare and submit form BIS-748, and
which involves requirements in connection with Authorization Validated
End-User. This rule is expected to result in an increase in license
applications submitted to BIS. Total burden hours associated with the
PRA and OMB control number 0694-0088 are not expected to increase
significantly as a result of this rule.
    3. This rule does not contain policies with Federalism implications
as that term is defined under Executive Order 13132.
    4. The provisions of the Administrative Procedure Act requiring
notice of proposed rulemaking, the opportunity for public
participation, and a delay in effective date, are inapplicable to this
rule because this regulation involves a military and foreign affairs
function of the United States (5 U.S.C. 553(a)(1)). Further, no other
law requires that a notice of proposed rulemaking and an opportunity
for public comment be given for this final rule. Because a notice of
proposed rulemaking and an opportunity for public comment are not
required to be given for this rule under the Administrative Procedure
Act or by any other law, the analytical requirements of the Regulatory
Flexibility Act, 5 U.S.C. 601 et seq., are not applicable. Therefore,
this regulation is issued in final form. Although there is no formal
comment period, public comments on this regulation are welcome on a
continuing basis. Comments may be submitted to Sheila Quarterman,
Regulatory Policy Division, Bureau of Industry and Security, Department
of Commerce, 14th St. & Pennsylvania Avenue, NW., Room 2705,
Washington, DC 20230.

List of Subjects in 15 CFR Part 748

    Administrative practice and procedure, Exports, Reporting and
recordkeeping requirements.

0
Accordingly, part 748 of the Export Administration Regulations (15 CFR
parts 730-774) is amended as follows:

PART 748--[AMENDED]

0
1. The authority citation for 15 CFR part 748 continues to read as
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66
FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 13, 2009, 74
FR 41325 (August 14, 2009).

Supplement No. 7 to Part 748 [Amended]

0
2. Supplement No. 7 to part 748 (Authorization Validated End-User
(VEU): List of Validated End-Users, Respective Eligible Items and
Eligible Destinations) is amended by:
0
a. Removing the entry for Aviza Technology China from the ``Validated
End-User,'' ``Eligible Items (By ECCN),'' and ``Eligible Destination''
columns; and
0
b. Removing the entry for GE Fanuc Systems PVT Ltd. from the ``Eligible
Items (by ECCN)'' and ``Eligible Destination'' columns associated with
the VEU GE India.

    Dated: December 18, 2009.
Matthew S. Borman,
Deputy Assistant Secretary for Export Administration.
[FR Doc. E9-30487 Filed 12-22-09; 8:45 am]

BILLING CODE 3150-33-P