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60380 Federal Register / Vol. 72, No.

205 / Wednesday, October 24, 2007 / Notices

Grantees must provide evidence that HIV/AIDS Program, are available to all PHS Act in the service area within 30
all of the core medical services listed in individuals with HIV/AIDS identified days.
the statute, regardless of whether such and eligible under Title XXVI of the The estimated annual burden is as
services are funded by the Ryan White follows:

Number of Responses per Total Hours per Total


Application respondents respondent responses response burden hours

Waiver Request ............................................... 20 1 20 6.5 130

Total .......................................................... 20 ............................ 20 ............................ 130

Send comments to Susan G. Queen, Type of Information Collection Request: partners with NICHD programs or
Ph.D., HRSA Reports Clearance Officer, Extension without change. Need and initiatives, including both
Room 10–33, Parklawn Building, 5600 Use of Information Collection: Executive responsiveness to scientific aims and
Fishers Lane, Rockville, MD 20857. Order 12862 directs agencies that convenience of operations to support
Written comments should be received provide significant services directly to research and its effective use; and (2) to
within 60 days of this notice. the public to survey customers to learn from research partners the ways in
Dated: October 18, 2007. determine the kind and quality of which the NICHD can improve the
Alexandra Huttinger, services they want and their level of overall planning and management of it
Acting Director, Division of Policy Review satisfaction with existing services. With programs and initiatives. Findings will
and Coordination. this submission, the NICHD seeks to be used to improve NICHD’s research
[FR Doc. E7–20945 Filed 10–23–07; 8:45 am] obtain OMB’s generic approval to programs and initiatives in the
conduct customer satisfaction surveys following ways: (1) To assess the
BILLING CODE 4165–15–P
surrounding its research programs and effectiveness and efficiency of
activities. operations; (2) to identify opportunities
DEPARTMENT OF HEALTH AND The NICHD was founded in 1963. Its for improving program performance; (3)
HUMAN SERVICES mission is to ensure, through research, to develop plans to incorporate
the birth of healthy infants and the innovations in program management; (4)
National Institutes of Health opportunity for each to reach full to measure partner satisfaction and
potential in adulthood, unimpaired by document program outcomes for
Proposed Collection; Comment physical or mental disabilities. The
Request; NICHD Research Partner governmental accountability reporting;
NICHD conducts and supports research and (5) to identify the need for creating
Satisfaction Surveys on the many factors that protect and new programs or initiatives or
SUMMARY: Under the provisions of enhance the process of human growth restructuring existing ones to respond to
Section 3507(a)(1)(D) of the Paperwork and development. The developmental emerging scientific opportunities.
Reduction Act of 1995, the National focus of the NICHD means that its
research portfolio is unusually broad. Frequency of Response: Annual [As
Institute of Child Health and Human
NICHD programs include research on needed on an ongoing and concurrent
Development (NICHD), the National
infant mortality, birth defects, learning basis]. Affected Public: Members of the
Institutes of Health (NIH), has submitted
to the Office of Management and Budget disorders, developmental disabilities, public, researchers, practitioners, and
(OMB) a request to review and approve vaccine development, and demographic other health professionals. Type of
the information collection listed below. and behavioral sciences, among others. Respondents: Members of the public;
The proposed information collection In addition to supporting basic research, eligible grant applicants and actual
was previously published in the Federal clinical trials, and epidemiological applicants (both successful and
Register on July 25, 2007, in Volume 72, studies that explore health processes, unsuccessful); clinicians and other
No. 142, pages 40887–40888, and the NICHD forms partnerships with health professionals; and actual or
allowed 60 days for public comment. No organizations or institutions to ensure potential clinical trials participants. The
public comments were received. The effective use of scientific findings and annual reporting burden is as follows:
purpose of this notice is to allow an research products. Estimated Number of Respondents:
additional 30 days for public comment. The NICHD utilizes strategic 28,000; Estimated Number of Responses
The NIH may not conduct or sponsor, assessments to support Institute per Respondent: 1; Average Burden
and the respondent is not required to planning and policy development, and Hours per Response: Varies with survey
respond to, an information collection to help determine programmatic and type, see below; and Estimated Total
that has been extended, revised, or scientific objectives and priorities. Annual Burden Hours Requested: 5,883.
implemented after October 1, 1995, Research partner surveys will augment The annualized cost to respondents is
unless it displays a currently valid OMB NICHD’s ongoing efforts to assess estimated at: $109,541.46. There are no
control number. research-related activities. The two Capital Costs to report. There are no
Proposed Collection: Title: NICHD principal objectives are: (1) To measure Operating or Maintenance Costs to
Research Partner Satisfaction Surveys. the personal satisfaction of research report.

Estimated Estimated total


Estimated Average burden
Type of number of re- annual burden
yshivers on PROD1PC62 with NOTICES

number of hours per


respondents sponses per hours
respondents response
respondent requested

Web-based ..................................................................................................... 24,000 1 0.167 4,008.00


Telephone ...................................................................................................... 2,000 1 0.50 1,000.00

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Federal Register / Vol. 72, No. 205 / Wednesday, October 24, 2007 / Notices 60381

Estimated Estimated total


Estimated Average burden
Type of number of re- annual burden
number of hours per
respondents sponses per hours
respondents response
respondent requested

Paper ............................................................................................................. 1,500 1 0.25 375.00


In-person ........................................................................................................ 500 1 1.00 500.00

Total ........................................................................................................ 28,000 5,883.00

Request for Comments: Written SUMMARY: The inventions listed below mouse model, miR-181a increased the
comments and/or suggestions from the are owned by an agency of the U.S. function of self/tumor-specific CD8+ T
public and affected agencies are invited Government and are available for cells enabling effective tumor
on one or more of the following points: licensing in the U.S. in accordance with destruction in the absence of
(1) Whether the proposed collection of 35 U.S.C. 207 to achieve expeditious vaccination or exogenous cytokines that
information is necessary for the proper commercialization of results of were otherwise essential requirements.
performance of the function of the federally-funded research and This technology is the first reported use
agency, including whether the development. Foreign patent of a miRNA gene as tool in the treatment
information will have practical utility; applications are filed on selected of disease.
(2) The accuracy of the agency’s inventions to extend market coverage Applications: The microRNA
estimate of the burden of the proposed for companies and may also be available sequence (‘‘miR-181a’’) can be used to
collection of information, including the for licensing. enhance the tumor recognizing capacity
validity of the methodology and ADDRESSES: Licensing information and of T-lymphocytes against several
assumptions used; (3) Ways to enhance copies of the U.S. patent applications tumors.
the quality, utility, and clarity of the listed below may be obtained by writing This technology can be used for
information to be collected; and (4) to the indicated licensing contact at the selective treatment of several cancers
Ways to minimize the burden of the Office of Technology Transfer, National more effectively.
collection of information on those who Advantages: Proof-of concept pre-
Institutes of Health, 6011 Executive
are to respond, including the use of clinical data are available and clinical
Boulevard, Suite 325, Rockville,
appropriate automated, electronic, trials are currently being planned.
Maryland 20852–3804; telephone: 301/ This technology is based on adoptive
mechanical, or other technological 496–7057; fax: 301/402–0220. A signed
collection techniques or other forms of immunotherapy, which is now an
Confidential Disclosure Agreement will accepted and effective form of cancer
information technology. be required to receive copies of the treatment.
FOR FURTHER INFORMATION: To request patent applications. Benefits: The microRNA identified
more information on the proposed Novel Micro-RNA Sequence has the potential to broaden and
project, contact Paul L. Johnson, NIH Transforms Non-Functional T- enhance the scope of adoptive
NICHD Office of Science Policy, Lymphocytes to Highly Functional: Key immunotherapy.
Analysis and Communication (OSPAC), to Improved Immunotherapy for the Development Status: Pre-clinical work
9000 Rockville Pike, Bldg. 31, Rm. 2A– Treatment of Cancers has been completed and clinical studies
18, Bethesda, Maryland 20892–2425, or are forthcoming.
call non-toll-free at 301–402–3213. You Description of Technology: This Inventors: Dr. Nicholas P. Restifo et al.
may also e-mail your request to technology is directed to the therapeutic (NCI).
pjohnson@mail.nih.gov. use of microRNA-181a in the adoptive Relevant Publication: Q Li et al. miR-
Comments Due Date: Comments immunotherapy of cancer. 181a is an intrinsic modulator of T cell
regarding this information collection are The adoptive transfer of anti-tumor T sensitivity and selection. Cell. 2007 Apr
best assured of having their full effect if cells after a lymphodepleting regimen 6;129(1):147–161.
received within 30 days of the date of can result in the regression of metastatic Patent Status: U.S. Provisional
this publication. cancer both in mouse and human, but Application filed 25 May 2007 (HHS
the production of highly-reactive, Reference No. E–224–2007/0–US–01).
Dated: October 17, 2007. tumor-specific T cells still represents a Licensing Status: This technology is
Paul L. Johnson, barrier to broad implementation of T available for licensing under an
Project Clearance Liaison, NICHD National cell-based immunotherapies. This exclusive or non-exclusive patent
Institutes of Health. technology enables the use of microRNA license.
[FR Doc. E7–20910 Filed 10–23–07; 8:45 am] (miR)-181a, a recently identified Licensing Contact: Michelle A.
BILLING CODE 4140–01–P intrinsic modulator of T-cell receptor Booden, PhD; 301/451–7337;
(TCR) signaling, to improve anti-tumor boodenm@mail.nih.gov.
T cell responsiveness. Micro-RNAs are Collaborative Research Opportunity:
DEPARTMENT OF HEALTH AND short RNA molecules that regulate the The Surgery Branch of the National
HUMAN SERVICES activity of genes and appear to control Cancer Institute is seeking statements of
biological processes. capability or interest from parties
National Institutes of Health We found that genetic engineering of interested in collaborative research to
T lymphocytes with miR-181a further develop, evaluate, or
Government-Owned Inventions;
dramatically augmented the function of commercialize the therapeutic use of
yshivers on PROD1PC62 with NOTICES

Availability for Licensing


poorly responsive human tumor- microRNA-181a in the adoptive
AGENCY: National Institutes of Health, infiltrating lymphocytes and TCR- immunotherapy of cancer. Please
Public Health Service, HHS. engineered peripheral blood contact John D. Hewes, PhD at 301–435–
lymphocytes, resulting in potent anti- 3121 or hewesj@mail.nih.gov for more
ACTION: Notice.
tumor reactivity. Furthermore, in a information.

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