60-Day FRN

50772

Federal Register / Vol. 75, No. 158 / Tuesday, August 17, 2010 / Notices

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to the European Union, Japan, and the
United States.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by October 18,
2010.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Communications Staff (HFV–12), Center
for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
Submit electronic comments on the
draft guidance to http://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Mai
Huynh, Center for Veterinary Medicine
(HFV–142), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8273,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In recent years, many important
initiatives have been undertaken by
regulatory authorities and industry
associations to promote the
international harmonization of
regulatory requirements. FDA has
participated in efforts to enhance
harmonization and has expressed its
commitment to seek scientifically based
harmonized technical procedures for the
development of pharmaceutical
products. One of the goals of
harmonization is to identify and then
reduce differences in technical
requirements for drug development
among regulatory agencies in different
countries.
FDA has actively participated in the
International Conference on
Harmonization of Technical
Requirements for Approval of
Pharmaceuticals for Human Use for
several years to develop harmonized
technical requirements for the approval
of human pharmaceutical and biological
products among the European Union,
Japan, and the United States. The VICH
is a parallel initiative for veterinary
medicinal products. The VICH is
concerned with developing harmonized

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technical requirements for the approval
of veterinary medicinal products in the
European Union, Japan, and the United
States, and includes input from both
regulatory and industry representatives.
The VICH Steering Committee is
composed of member representatives
from the European Commission,
European Medicines Evaluation Agency,
European Federation of Animal Health,
Committee on Veterinary Medicinal
Products, the U.S. Food and Drug
Administration, the U.S. Department of
Agriculture, the Animal Health
Institute, the Japanese Veterinary
Pharmaceutical Association, the
Japanese Association of Veterinary
Biologics, and the Japanese Ministry of
Agriculture, Forestry, and Fisheries.
Four observers are eligible to
participate in the VICH Steering
Committee: One representative from the
government of Australia/New Zealand,
one representative from the industry in
Australia/New Zealand, one
representative from the government of
Canada, and one representative from the
industry of Canada. The VICH
Secretariat, which coordinates the
preparation of documentation, is
provided by the International
Federation for Animal Health (IFAH).
An IFAH representative also
participates in the VICH Steering
Committee meetings.
II. Draft Revised Guidance on Residual
Solvents in New Veterinary Medicinal
Products, Active Substances and
Excipients
In April 2010, the VICH Steering
Committee agreed that a draft revised
guidance entitled ‘‘Residual Solvents in
New Veterinary Medicinal Products,
Active Substances and Excipients
(Revision) VICH GL18(R)’’ should be
made available for public comment. The
draft revised guidance is a revision of
the 2001 final guidance on the same
topic. The draft revised guidance revises
the lower PDE (permissible daily
exposure) for N–Methylpyrrolidone
being kept in Class 2 (Table 2 of the
draft revised guidance) and for
Tetrahydrofuran being placed into Class
2 from Class 3 (Table 3 of the draft
revised guidance). The draft revised
guidance is a product of the Quality
Expert Working Group of the VICH.
Comments about this draft will be
considered by FDA and the VICH
Quality Expert Working Group.
III. Paperwork Reduction Act of 1995
This draft revised guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of

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Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in sections II–VI of this
document have been approved under
OMB Control No. 0910–0032.
IV. Significance of Guidance
This draft guidance developed under
the VICH process, includes mandatory
language that does not describe a
statutory or regulatory requirement, as
permitted by good guidance practices
regulation (21 CFR 10.115(i)(3)).
Mandatory language that does not
describe a statutory or regulatory
requirement will be revised in the final
guidance document.
The draft revised VICH guidance (GFI
#100) is consistent with the agency’s
current thinking on this topic. This
guidance does not create or confer any
rights for or on any person and will not
operate to bind FDA or the public. An
alternative method may be used as long
as it satisfies the requirements of
applicable statutes and regulations.
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
VI. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
http://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm or
http://www.regulations.gov.
Dated: August 9, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–20235 Filed 8–16–10; 8:45 am]
BILLING CODE 4160–01–S

DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
Agency Information Collection
Activities: Importation Bond Structure
U.S. Customs and Border
Protection, Department of Homeland
Security.

AGENCY:

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Federal Register / Vol. 75, No. 158 / Tuesday, August 17, 2010 / Notices
60-Day Notice and request for
comments; Extension and revision of an
existing collection of information: 1651–
0050.

ACTION:

As part of its continuing effort
to reduce paperwork and respondent
burden, CBP invites the general public
and other Federal agencies to comment
on an information collection
requirement concerning the:
Importation Bond Structure. This
request for comment is being made
pursuant to the Paperwork Reduction
Act of 1995 (Pub. L. 104–13; 44 U.S.C.
3505(c)(2)).
DATES: Written comments should be
received on or before October 18, 2010,
to be assured of consideration.
ADDRESSES: Direct all written comments
to U.S. Customs and Border Protection,
Attn: Tracey Denning, Regulations and
Rulings, Office of International Trade,
799 9th Street, NW., 7th Floor,
Washington, DC. 20229–1177.
FOR FURTHER INFORMATION CONTACT:
Requests for additional information
should be directed to Tracey Denning,
U.S. Customs and Border Protection,
Regulations and Rulings, Office of
International Trade, 799 9th Street,
NW., 7th Floor, Washington, DC 20229–
1177, at 202–325–0265.
SUPPLEMENTARY INFORMATION: CBP
invites the general public and other
Federal agencies to comment on
proposed and/or continuing information
collections pursuant to the Paperwork
Reduction Act of 1995 (Pub. L. 104–13;
44 U.S.C. 3505(c)(2)). The comments
should address: (a) Whether the
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimates of the burden of the
collection of information; (c) ways to
enhance the quality, utility, and clarity
of the information to be collected; (d)
ways to minimize the burden including
the use of automated collection
techniques or the use of other forms of
information technology; and (e) the
annual costs burden to respondents or
record keepers from the collection of
information (a total capital/startup costs
and operations and maintenance costs).
The comments that are submitted will
be summarized and included in the CBP
request for Office of Management and
Budget (OMB) approval. All comments
will become a matter of public record.
In this document CBP is soliciting
comments concerning the following
information collection:
Title: Importation Bond Structure.
OMB Number: 1651–0050.

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SUMMARY:

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Form Numbers: 301 and 5297.
Abstract: Bonds are used to assure
that duties, taxes, charges, penalties,
and reimbursable expenses owed to the
Government are paid; to facilitate the
movement of cargo and conveyances
through CBP processing; and to provide
legal recourse for the Government for
noncompliance with laws and
regulations. Any person who is required
to post a bond to secure a customs
transaction usually submits the bond on
CBP Form 301, Customs Bond, to CBP.
CBP proposes to revise CBP Form 301
in order to accurately reflect the changes
that have occurred with regard to CBP
bonds. Specifically, the revised Form
301 will capture the new types of bonds
which have been authorized by law and
regulation, as well as better harmonize
this form with current and future
automation system requirements.
Section II of the CBP Form 301 will be
revised to specifically cover continuous
activity code bonds for Importer
Security Filing, Marine Terminal
Operator, and Intellectual Property
Rights Samples.
Bonds are usually executed by an
agent of the surety. The surety company
grants authority to the agent via CBP
Form 5297, Corporate Surety Power of
Attorney. Once this form is filed with
CBP, the validity of the authority of the
agent executing the bond and the name
of the surety can be verified to the
surety’s grant. The trade community
now has the ability to submit the
information on CBP Form 5297 via the
internet by using Automated
Commercial Environment (ACE) portal
technology. ACE surety portal account
access allows sureties to add, revoke,
and change their surety agent powers of
attorney electronically. This ACE portal
account access is available to any surety
who applies for the functionality at
http://www.cbp.gov.
Bonds are required pursuant to 19
U.S.C.1608, and 1623; 22 U.S.C. 463; 19
CFR Part 113.37 and 113.11. CBP Forms
301 and 5297 are accessible at http://
www.cbp.gov/xp/cgov/toolbox/forms/.
Current Actions: This submission is
being made to extend the expiration
date with a change to the burden hours
based on revised estimates by CBP.
Type of Review: Extension (with
change)
Affected Public: Businesses.
Form 301, Customs Bond
Estimated Number of Respondents:
800,000.
Total Number of Estimated Annual
Responses: 800,000.
Estimated Time per Response: 15
minutes.

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Estimated Total Annual Burden
Hours: 200,000.
Form 5297, Corporate Surety Power of
Attorney
Estimated Number of Respondents:
500.
Total Number of Estimated Annual
Responses: 500.
Estimated time per Response: 15
minutes.
Estimated Total Annual Burden
Hours: 125.
Dated: August 11, 2010.
Tracey Denning,
Agency Clearance Officer, U.S. Customs and
Border Protection.
[FR Doc. 2010–20314 Filed 8–16–10; 8:45 am]
BILLING CODE 9111–14–P

DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2010–0783]

Invocation of Sunken Military Craft Act
Coast Guard, DHS.
Notice.

AGENCY:
ACTION:

The Coast Guard is
announcing that a C–130 aircraft which
crashed off the coast of California is a
sunken military craft. It is therefore
prohibited for any person to engage or
attempt to engage the aircraft or its
contents in any way that disturbs,
removes, or injures the aircraft or its
contents.

SUMMARY:

If
you have questions on this notice,
contact LCDR Kevin Smith, Office of
Aviation Forces, telephone 202–372–
2211.
If you have questions on viewing the
docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone
202–366–9826.
SUPPLEMENTARY INFORMATION: On the
evening of October 29, 2009, the Coast
Guard Air Station Sacramento C–130
aircraft CG 1705 collided with a Marine
Corps AH–1W attack helicopter while
conducting a search and rescue
operation. All seven crewmembers
aboard CG 1705 and both crewmembers
of the Marine Corps helicopter were
killed in the collision. CG 1705 was
never recovered and currently rests in
approximately 2450 ft of water near
position: 32–58.0 N 118–10.10 W. This
location now serves as the gravesite and
final resting place for the U.S. Coast
Guard personnel killed in the crash.
Both the Coast Guard and the Marine
Corps undertook independent
FOR FURTHER INFORMATION CONTACT:

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