3150 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. 

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 

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) 

AGENCY: Bureau of Customs and Border 

Protection, Department of Homeland 

Security. 

ACTION: Proposed collection; comments 

requested. 

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. 

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 

oira_submission@omb.eop.gov 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. 


pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 72, No. 15 / Wednesday, January 24, 2007 / Notices 3151 

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 

DEPARTMENT OF THE INTERIOR 

Bureau of Land Management 

[OR–130–1020–PH; GP7–0053] 

Notice of Public Meeting, Eastern 

Washington Resource Advisory 

Council Meeting 

AGENCY: Bureau of Land Management, 

U.S. Department of the Interior. 

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. 

DATES: 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. 

SUPPLEMENTARY INFORMATION: 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. 

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. 

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 

AGENCY: U.S. International Trade 

Commission. 

ACTION: Notice. 

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 

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 


pwalker on PROD1PC71 with NOTICES