30- Day FR Notice

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Federal Register / Vol. 72, No. 15 / Wednesday, January 24, 2007 / Notices

Were Tested for Communicable Diseases
Using Pooled Specimens or Diagnostic
Tests’’ dated January 2007. The
guidance document provides
establishments that make HCT/P donor
eligibility determinations with
recommendations concerning the donor
eligibility requirements under part 1271
(21 CFR part 1271), subpart C, when
donors of certain HCT/Ps were tested for
communicable diseases using pooled
specimens or diagnostic tests. The
effective date of the regulations
contained in part 1271, subpart C, was
May 25, 2005 (69 FR 29785, May 25,
2004). The guidance is applicable to
certain HCT/Ps that were not regulated
as HCT/Ps before May 25, 2005, and that
were recovered from donors on or after
May 25, 2005, and within 30 days of the
date of publication of this document in
the Federal Register. FDA has
determined that donor retesting, in
certain cases, needs to be conducted in
a timely manner in order to be feasible,
and the availability of certain HCT/Ps
may be critical to their intended
recipients.
The guidance is being issued
consistent with FDA’s good guidance
practices regulation § 10.115 (21 CFR
10.115). The guidance represents FDA’s
current thinking on this topic. It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.

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II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
part 1271, subpart C, have been
approved under OMB control number
0910–0543; the collections of
information in part 1271, subpart D, and
Form FDA–3486 have been approved
under OMB control number 0910–0559.
III. Comments
FDA is soliciting public comment, but
is implementing this guidance
immediately in accordance with
§ 10.115(g)(2) and (3) without initially
seeking prior comment because the
agency has determined that prior public
participation is not feasible or
appropriate. In certain cases, donor
retesting needs to be initiated quickly,
and the availability of certain HCT/Ps
may be critical to their intended
recipients. Interested persons may, at

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17:44 Jan 23, 2007

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any time, submit to the Division of
Dockets Management (See ADDRESSES)
written or electronic comments
regarding the guidance. Submit a single
copy of electronic comments or two
paper copies of any mailed comments,
except that individuals may submit one
paper copy. Comments are to be
identified with the docket number
found in the brackets in the heading of
this document. A copy of the guidance
and received comments are available for
public examination in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons with access to the Internet
may obtain the guidance at either http://
www.fda.gov/cber/guidelines.htm or
http://www.fda.gov/ohrms/dockets/
default.htm.
Dated: January 17, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–978 Filed 1–23–07; 8:45 am]
BILLING CODE 4160–01–S

DEPARTMENT OF HOMELAND
SECURITY
Bureau of Customs and Border
Protection
Agency Information Collection
Activities: Visa Waiver Program Carrier
Agreement (Form I–775)
Bureau of Customs and Border
Protection, Department of Homeland
Security.
ACTION: Proposed collection; comments
requested.
AGENCY:

SUMMARY: The Bureau of Customs and
Border Protection (CBP) of the
Department of Homeland Security has
submitted the following information
collection request to the Office of
Management and Budget (OMB) for
review and approval in accordance with
the Paperwork Reduction Act of 1995:
Visa Waiver Program Carrier Agreement
(Form I–775). This is a proposed
extension of an information collection
that was previously approved. CBP is
proposing that this information
collection be extended without a change
to the burden hours. This document is
published to obtain comments form the
public and affected agencies. This
proposed information collection was
previously published in the Federal
Register (71 FR 67149) on November 20,
2006, allowing for a 60-day comment
period. This notice allows for an
additional 30 days for public comments.

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This process is conducted in accordance
with 5 CFR 1320.10.
DATES: Written comments should be
received on or before February 23, 2007.
ADDRESSES: Interested persons are
invited to submit written comments on
the proposed information collection to
the Office of Information and Regulatory
Affairs, Office of Management and
Budget. Comments should be addressed
to Nathan Lesser, Desk Officer,
Department of Homeland Security/
Customs and Border Protection, and
sent via electronic mail to
[email protected] or faxed
to (202) 395–6974.
SUPPLEMENTARY INFORMATION: The
Bureau of Customs and Border
Protection (CBP) encourages the general
public and affected Federal agencies to
submit written comments and
suggestions on proposed and/or
continuing information collection
requests pursuant to the Paperwork
Reduction Act of 1995 (Pub. L.104–13).
Your comments should address one of
the following four points:
(1) Evaluate whether the proposed
collection of information is necessary
for the Proper performance of the
functions of the agency/component,
including whether the information will
have practical utility;
(2) Evaluate the accuracy of the
agencies/components estimate of the
burden of The proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collections of information on those who
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology, e.g., permitting
electronic submission of responses.
Title: Visa Waiver Program Carrier
Agreement.
OMB Number: 1651–0110.
Form Number: Form I–775.
Abstract: The Form I–775 provides for
certain aliens to be exempt from the
non-immigrant visa requirements if
seeking entry as a visitor for no more
than 90 days, provided that no potential
threat exists to the security of the
United States.
Current Actions: There are no changes
to the information collection. This
submission is to extend the expiration
date.
Type of Review: Extension (without
change).
Affected Public: Individuals.
Estimated Number of Respondents:
400.

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Federal Register / Vol. 72, No. 15 / Wednesday, January 24, 2007 / Notices
Estimated Time Per Respondent: 2
hours.
Estimated Total Annual Burden
Hours: 800.
Estimated Total Annualized Cost on
the Public: N/A.
If additional information is required
contact: Tracey Denning, Bureau of
Customs and Border Protection, 1300
Pennsylvania Avenue, NW., Room
3.2.C, Washington, DC 20229, at 202–
344–1429.
Dated: January 16, 2007.
Tracey Denning,
Agency Clearance Officer, Information
Services Branch.
[FR Doc. E7–959 Filed 1–23–07; 8:45 am]
BILLING CODE 9111–14–P

Dated: January 18, 2007.
Richard Bailey,
Acting District Manager.
[FR Doc. E7–989 Filed 1–23–07; 8:45 am]
BILLING CODE 4310–33–P

INTERNATIONAL TRADE
COMMISSION
[Investigation No. 337–TA–550]

In the Matter of Certain Modified
Vaccinia Ankara (‘‘MVA’’) Viruses and
Vaccines and Pharmaceutical
Compositions Based Thereon; Notice
of Commission Decision To Request
Supplemental Briefing and To Extend
the Target Date for Completion of the
Investigation
U.S. International Trade
Commission.
ACTION: Notice.
AGENCY:

DEPARTMENT OF THE INTERIOR
Bureau of Land Management
[OR–130–1020–PH; GP7–0053]

Notice of Public Meeting, Eastern
Washington Resource Advisory
Council Meeting
Bureau of Land Management,
U.S. Department of the Interior.

AGENCY:
ACTION:

Notice of public meeting.

SUMMARY: In accordance with the
Federal Land Policy and Management
Act of 1976 and the Federal Advisory
Committee Act of 1972, the U.S.
Department of the Interior, Bureau of
Land Management Eastern Washington
Resource Advisory Council will meet as
indicated below.

The Eastern Washington
Resource Advisory Council will meet
Friday, February 23, 2007 at the
Spokane District Office, Bureau of Land
Management, 1103 North Fancher Road,
Spokane Valley, Washington 99212–
1275.

DATES:

The
meeting will start at 8 a.m., adjourn at
4 p.m., and will be open to the public.
The meeting will focus on establishing
the Council’s agenda for calendar year
2007. The meeting will also include
updates on the status of projects and
issues discussed at previous meetings.
There will be an opportunity for public
comment at 3 p.m.

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SUPPLEMENTARY INFORMATION:

FOR FURTHER INFORMATION CONTACT:

Scott Pavey or Sandie Gourdin, Bureau
of Land Management, Spokane District
Office, 1103 N. Fancher Road, Spokane
Valley, Washington 99212–1275, or call
(509) 536–1200.

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SUMMARY: Notice is hereby given that
the U.S. International Trade
Commission has requested
supplemental briefing in the abovecaptioned investigation and has
determined to extend the target date for
completion of the investigation.
FOR FURTHER INFORMATION CONTACT:
James A. Worth, Office of the General
Counsel, U.S. International Trade
Commission, 500 E Street, SW.,
Washington, DC 20436, telephone (202)
205–3065. Copies of non-confidential
documents filed in connection with this
investigation are or will be available for
inspection during official business
hours (8:45 a.m. to 5:15 p.m.) in the
Office of the Secretary, U.S.
International Trade Commission, 500 E
Street, SW., Washington, DC 20436,
telephone (202) 205–2000. General
information concerning the Commission
may also be obtained by accessing its
Internet server (http://www.usitc.gov).
The public record for this investigation
may be viewed on the Commission’s
electronic docket (EDIS) at http://
edis.usitc.gov. Hearing-impaired
persons are advised that information on
this matter can be obtained by
contacting the Commission’s TDD
terminal on (202) 205–1810.
SUPPLEMENTARY INFORMATION: This
investigation was instituted on
September 23, 2005, based on a
complaint filed by Bavarian Nordic
A/S of Denmark. The complaint alleged
violations of section 337 of the Tariff
Act of 1930, as amended, 19 U.S.C.
1337, in the importation into the United
States, the sale for importation, and the
sale within the United States after
importation of certain modified vaccinia
ankara (‘‘MVA’’) viruses and vaccines

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3151

and pharmaceutical compositions based
thereon by reason of infringement of
various claims of United States Patent
Nos. 6,761,893 and 6,913,752. The
complaint also alleged violations of
section 337 in the importation of certain
MVA viruses and vaccines and
pharmaceutical compositions based
thereon or in the sale of such articles by
reason of misappropriation of trade
secrets, the threat or effect of which is
to destroy or substantially injure an
industry in the United States. The
complaint named a single respondent,
Acambis PLC (‘‘Acambis’’) of the United
Kingdom. Only the patent allegations
remain in this investigation.
After a hearing and post-hearing
briefing, the ALJ issued a final initial
determination (‘‘final ID’’) on September
6, 2006, finding no violation of section
337. The ALJ held that the patents were
infringed but invalid.
Bavarian Nordic, Acambis, and the
Commission investigative attorney filed
petitions for review of the final ID. By
notice of November 22, 2006, the
Commission determined to review the
final ID in its entirety, as well as Order
No. 10, to extend the target date for
completion of the investigation to
January 31, 2007, and to ask the parties
for briefing on the issues on review and
on remedy, public interest and bonding.
The parties submitted their initial and
reply briefs on December 12 and
December 22, 2006, respectively.
In view of information set out in the
briefs on review, the Commission has
requested briefing on whether this
investigation has become or will shortly
become moot, and if so, whether the
investigation should be terminated. This
information includes a press release by
Acambis dated November 14, 2006
indicating that its ‘‘proposal is no longer
being considered for award as part of
the U.S. Government’s Modified
Vaccinia Ankara (‘‘MVA’’) smallpox
vaccine tender process.’’ To
accommodate briefing on this issue, the
Commission has determined to extend
the target date for completion of this
investigation to February 21, 2007.
This action is taken under the
authority of section 337 of the Tariff Act
of 1930, as amended (19 U.S.C. 1337),
and in section 210.51(a) of the
Commission’s Rules of Practice and
Procedure (19 CFR 210.51(a)).
Issued: January 19, 2007.
By order of the Commission.
Marilyn R. Abbott,
Secretary to the Commission.
[FR Doc. E7–985 Filed 1–23–07; 8:45 am]
BILLING CODE 7020–02–P

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