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68588 Federal Register / Vol. 72, No.

233 / Wednesday, December 5, 2007 / Notices

Estimated Estimated
Estimated Average
number of total annual
Type of respondents number of burden hours
responses per burden hours
respondents per response
respondent * requested

Participants .............................................................................................. 346 1.2 0.5 208


Participant proxies ................................................................................... 121 1.2 0.5 73

Total .................................................................................................. 467 1.2 0.5 281

Request for Comments: Written Dated: November 1, 2007. mammal; especially neutralizing
comments and/or suggestions from the Mike Lauer, antibodies, against human and avian
public and affected agencies should Director, Division of Prevention and influenza strains H1N1, H3N2, H5N1
address one or more of the following Population Sciences, NHLBI, National and H7N7. Materials in the form of
points: (1) Evaluate whether the Institutes of Health. immunogenic compositions including
proposed collection of information is Dated: November 20, 2007. these peptides and polypeptides can
necessary for the proper performance of Suzanne Freeman, also be in-licensed along with the patent
the function of the agency, including OMB Clearance Officer, NHLBI, National rights. Pharmaceutical compositions
whether the information will have Institutes of Health. including these peptides and
practical utility; (2) Evaluate the [FR Doc. E7–23515 Filed 12–4–07; 8:45 am] polypeptides with or without adjuvants
are within the scope of the invention.
accuracy of the agency’s estimate of the BILLING CODE 4140–01–P
Nucleic acids and expression cassettes
burden of the proposed collection of encoding these peptides and
information, including the validity of polypeptides are also within the scope
the methodology and assumptions used; DEPARTMENT OF HEALTH AND
HUMAN SERVICES of the invention. Methods of inhibiting
(3) Enhance the quality, utility, and infection by influenza, with or without
clarity of the information to be National Institutes of Health cell entry, are also within the scope of
collected; and (4) Minimize the burden the invention using the aforementioned
of the collection of information on those Government-Owned Inventions; peptides and polypeptides.
who are to respond, including the use Availability for Licensing Applications: Vaccines; Therapeutics;
of appropriate automated, electronic, Diagnostics; Influenza.
AGENCY: National Institutes of Health, Inventors: Hana Golding and Surender
mechanical, or other technological Public Health Service, HHS.
collection techniques or other forms of Khurana (FDA).
ACTION: Notice. Patent Status: U.S. Provisional
information technology.
Application No. 60/929,119 filed 13
Direct Comments to OMB: Written SUMMARY: The inventions listed below
June 2007 (HHS Reference No. E–236–
comments and/or suggestions regarding are owned by an agency of the U.S.
2007/0–US–01).
the item(s) contained in this notice, Government and are available for Licensing Status: Available for
especially regarding the estimated licensing in the U.S. in accordance with licensing.
public burden and associated response 35 U.S.C. 207 to achieve expeditious Licensing Contact: Michael A.
time, should be directed to the Office of commercialization of results of Shmilovich, Esq.; 301/435–5019;
Management and Budget, Office of federally-funded research and shmilovm@mail.nih.gov.
development. Foreign patent Collaborative Research Opportunity:
Regulatory Affairs, New Executive
applications are filed on selected The FDA/CBER Laboratory of Retrovirus
Office Building, Room 10235,
inventions to extend market coverage Research is seeking statements of
Washington, DC 20503, Attention: Desk for companies and may also be available
Officer for NIH. To request more capability or interest from parties
for licensing. interested in collaborative research to
information on the proposed project or
ADDRESSES: Licensing information and further develop, evaluate, or
to obtain a copy of the data collection copies of the U.S. patent applications commercialize this technology. Please
plans and instruments, contact: Dr. Jean listed below may be obtained by writing contact Beatrice A. Droke at 301/827–
Olson, Epidemiology Branch, Division to the indicated licensing contact at the 7008 or bdroke@oc.fda.gov for more
of Prevention and Population Sciences, Office of Technology Transfer, National information.
NHLBI, NIH, II Rockledge Centre, 6701 Institutes of Health, 6011 Executive
Rockledge Drive, Suite 10018, MSC # Trifunctional Imaging Agent for
Boulevard, Suite 325, Rockville,
7936, Bethesda, MD 20892–7936, or call Monoclonal Antibody Tumor-Targeted
Maryland 20852–3804; telephone: 301/
301–435–0397 (non-toll-free number), or Imaging
496–7057; fax: 301/402–0220. A signed
e-mail your request, including your Confidential Disclosure Agreement will Description of Technology: Available
address to: OlsonJ@nhlbi.nih.gov. be required to receive copies of the for licensing and commercial
Comments Due Date: Comments patent applications. development is a novel lysine-based
trifunctional chelate which bears both a
regarding this information collection are New Epitopes Recognized by chelating moiety (CHX–A″) for
best assured of having their full effect if Antibodies Against Human and Avian sequestering radiometals (86Y or 111In)
received within 30 days of the date of Influenza for Vaccines and Diagnostic and a near-infrared dye, e.g., Cy5.5, for
this publication.
mstockstill on PROD1PC66 with NOTICES

Assays dual modality PET (or SPECT) and


Description of Technology: Available fluorescence imaging. Successful
for licensing and commercial conjugation of monoclonal antibody
development are intellectual properties trastuzumab (Herceptin) or cetuximab
drawn to peptides and polypeptides that (Erbitux) has also been achieved by
elicit immunogenic responses in a efficient thiol-maleimide chemistry,

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Federal Register / Vol. 72, No. 233 / Wednesday, December 5, 2007 / Notices 68589

thereby yielding an immunoconjugate Patent Status: U.S. Provisional development are patent rights covering
(Signaling agent (Cy5.5–Lys(SMCC)– Application No. 60/929,913 filed 17 Jul tri-imageable nanoparticles which have
CHX–A″) conjugated to trastuzumab) or 2007 (HHS Reference No. E–194–2007/ great potential for application in the
(Signaling agent (Cy7–Lys(SMCC)– 0–US–01). laboratory and clinic for labeling at the
CHX–A″) conjugated to cetuximab). Licensing Status: Available for cellular level, diagnostics, and drug
Both specifically target antigen licensing. delivery. The particle includes a silica
expressing cells and internalization of Licensing Contact: Michael A. encased ultrasmall superparamagnetic
the agent has been imaged over time. Shmilovich, Esq.; 301/435–5019;
iron oxide (SPIONs) that can be detected
Trastuzumab can be radiolabeled with shmilovm@mail.nih.gov.
Collaborative Research Opportunity: using MRI. A fluorescent probe (e.g.,
isothiocyanate derivatives of the
The National Cancer Institute Radiation Cy5.5) for optical imaging is embedded
bifunctional chelating agents 1B4M (2–
Oncology Branch is seeking statements in the silica. The resulting particles are
(4–aminobenzyl)–6–
methyldiethylenetriaminepentaacetic of capability or interest from parties about 20–25nm in diameter. Target
acid); and CHX–A″ (N–[(R)–2–amino–3– interested in collaborative research to specific antibodies are attached to the
(p-aminophenyl)propyl]-trans-(S,S)– further develop, Trifunctional Imaging surface of the particles. Chelated to the
cyclohexane–1,2–diamine– Agent for Monoclonal Antibody Tumor- antibodies is a radioisotope (e.g.,
N,N,N′,N″,N″–pentaacetic acid). Targeted Imaging. Please contact John D. Indium–111) useful for particle
Applications: Imaging; Diagnostics. Hewes, PhD at 301–435–3121 or quantification and can be imaged
Inventors: Martin W. Brechbiel, Heng hewesj@mail.nih.gov for more through techniques such as single
Xu, Kwamena E. Baidoo (NCI). information. photon emission computed tomography
Publication: H Xu et al. Design, (SPECT) or positron emission
synthesis, and characterization of a dual Nanoparticles for Imaging: Targeted
Nanoparticles That Can Be Imaged tomography (PET). A graphical
modality positron emission tomography representation of an exemplary
and fluorescence imaging agent for Through Magnetic Resonance, Optical,
and Radioisotope Imaging nanoparticle according to the invention
monoclonal antibody tumor-targeted is shown in the accompanying
imaging. J Med Chem. 2007 Sep Description of Technology: Available illustration.
20;50(19):4759–4765. for licensing and commercial
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Applications: Imaging; Cancer; 2007 (HHS Reference No. E–157–2007/ Licensing Contact: Michael A.
Multiple Sclerosis. 0–US–01 and HHS Reference No. E– Shmilovich, Esq.; 301–435–5019;
Inventors: Martin W. Brechbiel (NCI), 157–2007/1–US–01). shmilovm@mail.nih.gov.
Peter L. Choyke (NCI), et al. Licensing Status: Available for Collaborative Research Opportunity:
Patent Status: U.S. Provisional licensing. The National Cancer Institute Radiation
Application No. 60/907,085 filed 19 Mar Oncology Branch is seeking statements
en05de07.013</GPH>

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68590 Federal Register / Vol. 72, No. 233 / Wednesday, December 5, 2007 / Notices

of capability or interest from parties conducted by the National Eye Institute, Special Emphasis Panel; Health and
interested in collaborative research to including consideration of personnel Healthcare Trajectories.
further develop, evaluate, or qualifications and performance, and the Date: December 11, 2007.
commercialize these tri-imageable competence of individual investigators, Time: 2 p.m. to 5 p.m.
Agenda: To review and evaluate grant
nanoparticles. Please contact John the disclosure of which would applications.
Hewes, PhD, at 301–435–3121 or constitute a clearly unwarranted Place: National Institutes of Health, 6100
hewesj@mail.nih.gov for more invasion of personal privacy. Executive Boulevard, 5B01, Rockville, MD
information. Name of Committee: Board of Scientific 20852 (Telephone Conference Call).
Dated: November 27, 2007. Counselors, National Eye Institute. Contact Person: Marita R. Hopmann, PhD,
Date: December 9–11, 2007. Scientific Review Administrator, Division of
Steven M. Ferguson, Scientific Review, National Institute of Child
Time: 7 p.m. to 1 p.m.
Director, Division of Technology Development Health, and Human Development, 6100
Agenda: To review and evaluate personal
and Transfer, Office of Technology Transfer, Building, Room 5B01, Bethesda, MD 20892,
qualifications and performance, and
National Institutes of Health. (301) 435–6911, hopmannm@mail.nih.gov.
competence of individual investigators.
[FR Doc. E7–23514 Filed 12–4–07; 8:45 am] Place: National Institutes of Health, This notice is being published less than 15
BILLING CODE 4140–01–P Building 31, 31 Center Drive, Bethesda, MD days prior to the meeting due to the timing
20892. limitations imposed by the review and
Contact Person: Sheldon S. Miller, PhD, funding cycle.
DEPARTMENT OF HEALTH AND Scientific Director, National Institutes of (Catalogue of Federal Domestic Assistance
HUMAN SERVICES Health, National Eye Institute, Bethesda, MD Program Nos. 93.864, Population Research;
20892, (301) 451–6763. 93.865, Research for Mothers and Children;
National Institutes of Health This notice is being published less than 15 93.929, Center for Medical Rehabilitation
days prior to the meeting due to the timing Research; 93.209, Contraception and
National Center for Complementary & limitations imposed by the review and Infertility Loan Repayment Program, National
Alternative Medicine; Amended Notice funding cycle. Institutes of Health, HHS)
Information is also available on the
of Meeting Dated: November 27, 2007.
Institute’s/Center’s home page:
www.nei.nih.gov, where an agenda and any Jennifer Spaeth,
Notice is hereby given of a change in
additional information for the meeting will Director, Office of Federal Advisory
the meeting of the National Center for
be posted when available. Committee Policy.
Complementary and Alternative
(Catalogue of Federal Domestic Assistance [FR Doc. 07–5930 Filed 12–4–07; 8:45 am]
Medicine Special Emphasis Panel,
Program Nos. 93.867, Vision Research, BILLING CODE 4140–01–M
December 7, 2007, 8 a.m. to December
National Institutes of Health, HHS)
7, 2007, 5 p.m., Bethesda Marriott, 5151
Pooks Hill Road, Bethesda, MD, 20814 Dated: November 28, 2007.
Jennifer Spaeth, DEPARTMENT OF HEALTH AND
which was published in the Federal
HUMAN SERVICES
Register on November 13, 2007, Director, Office of Federal Advisory
72FR63915. Committee Policy.
National Institutes of Health
This meeting is being amended to [FR Doc. 07–5927 Filed 12–4–07; 8:45 am]
change the format to a telephone BILLING CODE 4140–01–M National Library of Medicine; Notice of
conference and to change the date from Meeting
December 7, 2007 to December 18, 2007.
The meeting is closed to the public. DEPARTMENT OF HEALTH AND Pursuant to section 10(d) of the
HUMAN SERVICES Federal Advisory Committee Act, as
Dated: November 27, 2007. amended (5 U.S.C. Appendix 2), notice
Jennifer Spaeth, National Institutes of Health is hereby given of the following
Director, Office of Federal Advisory meeting.
Committee Policy. National Institute of Child Health and The meeting will be open to the
[FR Doc. 07–5928 Filed 12–04–07; 8:45 am] Human Development; Notice of Closed public as indicated below, with
BILLING CODE 4140–01–M Meeting attendance limited to space available.
Individuals who plan to attend and
Pursuant to section 10(d) of the need special assistance, such as sign
DEPARTMENT OF HEALTH AND Federal Advisory Committee Act, as language interpretation or other
HUMAN SERVICES amended (5 U.S.C. Appendix 2), notice reasonable accommodations, should
is hereby given of the following notify the Contact Person listed below
National Institutes of Health meeting. in advance of the meeting.
The meeting will be closed to the The portions of the meeting devoted
National Eye Institute; Notice of Closed public in accordance with the
Meeting to the review and evaluation of journals
provisions set forth in sections for potential indexing by the National
Pursuant to section 10(d) of the 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Library of Medicine will be closed to the
Federal Advisory Committee Act, as as amended. The grant applications and public in accordance with the
amended (5 U.S.C. Appendix 2), notice the discussions could disclose provisions set forth in section
is hereby given of a meeting of the confidential trade secrets or commercial 552b(c)(9)(B), Title 5 U.S.C., as
Board of Scientific Counselors, National property such as patentable material, amended. Premature disclosure of the
Eye Institute. The meeting will be and personal information concerning titles of the journals as potential titles to
mstockstill on PROD1PC66 with NOTICES

closed to the public as indicated below individuals associated with the grant be indexed by the National Library of
in accordance with the provisions set applications, the disclosure of which Medicine, the discussions, and the
forth in section 552b(c)(6), Title 5 would constitute a clearly unwarranted presence of individuals associated with
U.S.C., as amended for the review, invasion of personal privacy. these publications could significantly
discussion, and evaluation of individual Name of Committee: National Institute of frustrate the review and evaluation of
intramural programs and projects Child Health and Human Development individual journals.

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