Federal Register Vol 73, No 174 Monday, September 8, 2008…
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@https://www.wendangku.net/doc/356500275.html,; 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 human-bovine 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://
https://www.wendangku.net/doc/356500275.html,/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@https://www.wendangku.net/doc/356500275.html,.
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@https://www.wendangku.net/doc/356500275.html,.
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, styrene-
butadiene rubber, and styrene monomer
and polymer industries.
As part of the RoC review process
(available at https://www.wendangku.net/doc/356500275.html,/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
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://
https://www.wendangku.net/doc/356500275.html,/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://
https://www.wendangku.net/doc/356500275.html,/go/231) to receive notification when the final background document is posted on the RoC Web site (https://www.wendangku.net/doc/356500275.html,/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 (https://www.wendangku.net/doc/356500275.html,/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@https://www.wendangku.net/doc/356500275.html, 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