Federal Register / Vol. 73, No. 174 / Monday, September 8, 2008 / Notices 52059 

2004) and associated foreign rights from 

PCT/US04/05881 (filed February 27, 

2004) (HHS references E–093–2003/ 

0,1,2) 

to MedImmune, LLC, having a place of 

business in Gaithersburg, Maryland, 

USA. The patent rights in these 

inventions have been assigned to the 

United States of America. 

DATES: Only written comments and/or 

application for a license which are 

received by the NIH Office of 

Technology Transfer on or before 

November 7, 2008 will be considered. 

ADDRESSES: Requests for a copy of the 

patents and patent applications, 

inquiries, comments and other materials 

relating to the contemplated license 

should be directed to: Michael 

Shmilovich, Office of Technology 

Transfer, National Institutes of Health, 

6011 Executive Boulevard, Suite 325, 

Rockville, MD 20852–3804; e-mail: 

shmilovm@mail.nih.gov; Telephone: 

(301) 435–5019; Facsimile: (301) 402–

0220. 

SUPPLEMENTARY INFORMATION: The 

prospective exclusive license will be 

royalty bearing and will comply with 

the terms and conditions of 35 U.S.C. 

209 and 37 CFR 404.7. The prospective 

exclusive license may be granted unless, 

within sixty (60) days from the date of 

this published Notice, NIH receives 

written evidence and argument that 

establishes that the grant of the license 

would not be consistent with the 

requirements of 35 U.S.C. 209 and 37 

CFR 404.7. 

The above referenced technologies 

describe development of live, attenuated 

virus vaccines for respiratory syncytial 

virus (RSV), subgroups A and B, human 

parainfluenza, types 1, 2,3 (HPIV1, 

HPIV2, and HPIV3), and human 

metapneumovirus (hMPV). 

The field of use in which NIH 

contemplates granting an exclusive 

license may be limited to the following 

and excludes fields employing any 

vectored vaccines and any humanbovine chimeras for RSV A, RSV B, 

HPIV3, HPIV2, HPIVI, and hMPV: 

Live attenuated virus vaccines for 

intranasal administration to humans 

against RSV subgroups A and B, HPIV1, 

HPIV2, HPIV3, and hMPV based on the 

following viruses (in bold) and their 

corresponding attenuating mutations (in 

bulleted italics): 

Human RSV subgroups A or B or A/ 

B chimeras: 

• rcp248/404/1030∆SH, including the 

stabilized version of this virus; 

• ∆NS1; 

• ∆M2–2. 

HPIV3 

• rcp45 

HPIV2 

• Mutations in C and L imported from 

other viruses, e.g., HRSV, BPIV3, and 

HPIV3, with or without stabilization by 

codon substitution or deletion; 

• L(∆1724); 

• Viruses with P and V genes 

separated 

HPIV1 

• Mutations in C and L imported from 

other viruses, e.g., HRSV, BPIV3, and 

HPIV3, with or without stabilization by 

codon substitution or deletion; 

• C(170); 

• C(R84G) mutation; 

• L(942stablized); 

• Viruses with P and C genes 

separated. 

hMPV 

• ∆G, alone or in combination with 

∆SH; 

• ∆M2–2; 

• Avian-human chimera with avian P 

ORF placed in hMPV backbone. 

Properly filed competing applications 

for a license filed in response to this 

notice will be treated as objections to 

the contemplated license. Comments 

and objections submitted in response to 

this notice will not be made available 

for public inspection, and, to the extent 

permitted by law, will not be released 

under the Freedom of Information Act, 

5 U.S.C. 552. 

Dated: August 26, 2008. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E8–20650 Filed 9–5–08; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Toxicology Program (NTP); 

Report on Carcinogens (RoC); Request 

for Public Comments on the RoC 

Expert Panel’s Recommendation on 

Listing Status for Styrene in the 12th 

RoC and the Scientific Justification for 

the Recommendation 

AGENCY: National Institute of 

Environmental Health Sciences 

(NIEHS); National Institutes of Health 

(NIH). 

ACTION: Request for comments. 

SUMMARY: The RoC Office invites public 

comment on the recommendation from 

an expert panel on the listing status for 

styrene in the 12th RoC and the 

scientific justification for the 

recommendation. The recommendation 

and scientific justification for styrene is 

available electronically in Part B of the 

Expert Panel Report (http:// 

ntp.niehs.nih.gov/go/29682, see Expert 

Panel Report Part B) or in printed text 

from the RoC Office (see FOR FURTHER

INFORMATION CONTACT below). The RoC 

Office convened an eleven-member 

expert panel of scientists from the 

public and private sectors on July 21–

22, 2008. The panel was asked (1) to 

apply the RoC listing criteria to the 

relevant scientific evidence and make a 

recommendation regarding listing status 

(i.e., known to be a human carcinogen, 

reasonably anticipated to be a human 

carcinogen, or not to list) for styrene in 

the 12th RoC and (2) to provide the 

scientific justification for the 

recommendation. 

DATES: The Expert Panel Report (Part B) 

for styrene will be available for public 

comment by September 3, 2008. Written 

comments should be submitted by 

October 23, 2008. 

ADDRESSES: Comments should be sent to 

Dr. Ruth Lunn, Director, RoC Office 

[NIEHS, P.O. Box 12233, MD EC–14, 

Research Triangle Park, NC 27709, Fax: 

919–541–0144, or lunn@niehs.nih.gov. 

Courier address: Report on Carcinogens, 

79 T.W. Alexander Drive, Building 

4401, Room 3118, Research Triangle 

Park, NC 27709]. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Ruth Lunn, RoC Office, 919–316–4637 

lunn@niehs.nih.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

Styrene is a flammable liquid used 

worldwide in the manufacture of 

polystyrene, which is used extensively 

in the manufacture of plastic packaging, 

thermal insulation in building 

construction and refrigeration 

equipment, and disposable cups and 

containers. Styrene also is used in other 

polymers and resins that are used to 

manufacture boats, shower stalls, tires, 

automotive parts, and many other 

products. The general population is 

exposed to styrene from inhalation of 

indoor air; and outdoor air, tobacco 

smoke, and ingestion of food. 

Occupational exposure occurs mainly in 

the reinforced plastics, styrenebutadiene rubber, and styrene monomer 

and polymer industries. 

As part of the RoC review process 

(available at http://ntp.niehs.nih.gov/go/ 

15208), the NTP announced the 

availability of the draft background 

document for styrene (Federal Register: 

May 20, 2008: Vol. 73, No. 98, pages 

29139–29140), invited public comments 

mstockstill on PROD1PC66 with NOTICES

52060 Federal Register / Vol. 73, No. 174 / Monday, September 8, 2008 / Notices 

on the draft background document, and 

announced the styrene expert panel 

meeting. The RoC Office convened an 

eleven-member expert panel of 

scientists from the public and private 

sectors to evaluate styrene. The expert 

panel met on July 21–22, 2008, in a 

public forum at the Radisson Governors 

Inn, Research Triangle Park, North 

Carolina. The panel was charged to peer 

review the draft background document 

for styrene and then to make a 

recommendation on its listing status in 

the 12th RoC and to provide a scientific 

justification for that recommendation. 

Details about the meeting, including 

public comments received and the 

expert panel reports, are available on 

the RoC Web site (http:// 

ntp.niehs.nih.gov/go/29682). The expert 

panel report for styrene contains two 

parts: Part A contains the peer-review 

comments on the draft background 

document and Part B is the 

recommendation on listing status and 

its scientific justification. The expert 

panel recommended that (1) styrene be 

listed in the 12th RoC as reasonably 

anticipated to be a human carcinogen. 

The panel’s recommendation on listing 

status and its scientific justification are 

now being released for public comment. 

Request for Comments 

The RoC Office invites written public 

comments on the expert panel’s 

recommendation on listing status for 

styrene and the scientific justification 

for the recommendation. All comments 

received will be posted on the RoC Web 

site. Persons submitting written 

comments are asked to include their 

name and contact information 

(affiliation, mailing address, telephone 

and facsimile numbers, e-mail, and 

sponsoring organization, if any) and 

send them to Dr. Lunn (see ADDRESSES

above). The deadline for submission of 

written comments is October 23, 2008. 

Next Steps 

The RoC Office is in the process of 

finalizing the background document for 

styrene based upon the expert panel’s 

peer review comments and the public 

comments received (73 FR 29139). 

Persons can register free-of-charge with 

the NTP listserve (http:// 

ntp.niehs.nih.gov/go/231) to receive 

notification when the final background 

document is posted on the RoC Web site 

(http://ntp.niehs.nih.gov/go/10091). As 

part of the RoC review process, two 

government groups will also conduct 

reviews of styrene; these meetings are 

not open to the public. Upon 

completion of these reviews, the NTP 

will (1) draft a substance profile for 

styrene, which contains its listing 

recommendation for the 12th RoC and 

the scientific information supporting 

that recommendation; (2) solicit public 

comment on the draft substance profile; 

and (3) convene a meeting of the Board 

of Scientific Counselors to peer review 

the draft substance profile. 

Background Information on the RoC 

The RoC is a Congressionally 

mandated document that identifies and 

discusses agents, substances, mixtures, 

or exposure circumstances (collectively 

referred to as ‘‘substances’’) that may 

pose a hazard to human health by virtue 

of their carcinogenicity. The RoC 

follows a formal, multi-step process for 

review and evaluation of selected 

chemicals. Substances are listed in the 

report as either known or reasonably 

anticipated human carcinogens. The 

NTP prepares the RoC on behalf of the 

Secretary of Health and Human 

Services. Information about the RoC and 

the review process is available on its 

Web site (http://ntp.niehs.nih.gov/go/ 

roc) or by contacting Dr. Lunn (see FOR

FURTHER INFORMATION CONTACT above). 

Dated: August 29, 2008. 

Samuel H. Wilson, 

Acting Director, National Institute of 

Environmental Health Sciences and National 

Toxicology Program. 

[FR Doc. E8–20777 Filed 9–5–08; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

Agency Information Collection 

Activities: Entry and Manifest of 

Merchandise Free of Duty 

AGENCY: U.S. Customs and Border 

Protection, Department of Homeland 

Security. 

ACTION: 30-Day notice and request for 

comments; extension of an existing 

information collection: 1651–0013. 

ACTION: Proposed collection; comments 

requested. 

SUMMARY: U.S. 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: Entry and Manifest of 

Merchandise Free of Duty. This is a 

proposed extension of an information 

collection that was previously 

approved. CBP is proposing that this 

information collection be extended with 

no change to the burden hours. This 

document is published to obtain 

comments from the public and affected 

agencies. This proposed information 

collection was previously published in 

the Federal Register (73 FR 36544) on 

June 27, 2008, 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 October 8, 2008. 

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 the OMB Desk Officer for Customs 

and Border Protection, Department of 

Homeland Security, and sent via 

electronic mail to 

oira_submission@omb.eop.gov or faxed 

to (202) 395–6974. 

SUPPLEMENTARY INFORMATION: U.S. 

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 (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: Entry and Manifest of 

Merchandise Free of Duty. 

OMB Number: 1651–0013. 

Form Number: CBP Form–7523. 

Abstract: CBP Form–7523 is used by 

carriers and importers as a manifest for 

the entry of merchandise free of duty 

under certain condition and by CBP to 

authorize the entry of such 

merchandise. It is also used by carriers 

to show that the articles being imported 

mstockstill on PROD1PC66 with NOTICES