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Federal Register / Vol. 72, No.

106 / Monday, June 4, 2007 / Notices 30805

decision making that is transparent and 5. The relationship of a NHDSE and Purchasers, including employers and
involves the broad stakeholder its work to other initiatives which set healthcare consumers
communities. national standards for health Consumer and patient interest groups
8. Timely—Have the ability to carry information, such as the ANSI Health IT Community health delivery systems
out activities and achieve goals in a Standards Panel (HITSP) State and local health agencies
timely manner. 6. Key challenges to creation and Interested Federal agencies
9. Collaborative—Have the ability to maintenance of a NHDSE University-based health systems
engage and work with other 7. The risks of creating a NHDSE Advocacy groups and public interest
organizations to ensure effective 8. The appropriate role(s) of a NHDSE organizations
implementation of rules and standards. in advancing quality measurement Trade industry organizations
10. Sustainable—Have adequate 9. The appropriate role(s) of a NHDSE
Health information technology industry
resources to meet long and short term in characterization and evaluation of the
vendors
goals. comprehensiveness, accuracy and
Regional health information
The concept of a national entity reliability of shared and aggregated
organizations
responsible for setting rules and health care quality measurement data
standards for sharing and using 10. The appropriate role(s) of a Interested individuals
healthcare quality measurement data NHDSE regarding the transmission of We look forward to receiving
has also been supported by the Institute shared and aggregated data constructive comments representing
of Medicine in their 2005 report 11. The appropriate scope of activities diverse perspectives.
Performance Measurement. IOM for a NHDSE beyond quality Dated: May 25, 2007.
additionally proposed that this entity measurement (in such domains as Carolyn M. Clancy,
would be responsible for several other research and population health) AHRQ, Director.
roles in performance measurement, 12. The key stakeholders that would
[FR Doc. 07–2733 Filed 6–1–07; 8:45 am]
including articulation of national goals, be impacted by a NHDSE and how to
BILLING CODE 4160–90–M
selection of measures, aggregation of structure interactions with a NHDSE
data, reporting of results and 13. Appropriate governance model(s)
performance measurement research. It is for a NHDSE DEPARTMENT OF HEALTH AND
recognized that the role of a NHDSE 14. Means to assure NHDSE HUMAN SERVICES
might extend to domains beyond health objectivity and independence
care performance measurement. 15. Means to achieve trustworthiness Administration for Children and
Respondents are encouraged to describe or trust in a NHDSE, and how that Families
such domains and provide information would best be achieved
relating to NHDSE roles and 16. Recommendations for achieving Proposed Information Collection
characteristics, with the understanding timeliness in NHDSE decision making Activity; Comment Request
that any such information will be 17. Recommendations for achieving
considered and will be presented by compliance with NHDSE Proposed Projects:
AHRQ to AQA but may not be acted on recommendations, rules or standards Title: Communities Empowering
in the immediate future. 18. The essential external inputs to a Youth (CEY) Program Evaluation.
NHDSE OMB No.: New collection.
Information Requested 19. Recommendations for achieving Description: This proposed
For the purpose of achieving a organizational flexibility for a NHDSE information collection activity is to
broader understanding of the need for a 20. The potential organizational obtain information from Communities
nationwide health data stewardship infrastructure needs of a NHDSE Empowering Youth (CEY) grantee
entity, and what form it might take, 21. Potential funding requirements agencies and the faith-based and
input is requested from interested and sources of funding for a NHDSE community organizations working in
parties. It is not necessary to answer all 22. The organizational skill set partnership with them. The CEY
questions. In your response, please required of a NDHSE evaluation is an important opportunity
indicate which question you are 23. Priority activities for NHDSE to to examine the outcomes achieved
addressing in your comments. Specific support data sharing and aggregation through this component of the
areas for comment include: 24. Issues concerning the above- Compassion Capital Fund in meeting its
1. Whether or not there is a need for excerpted AQA characterizations of a objective of improving the capacity of
a national health data stewardship NHDSE faith-based and community
entity with reasons, including value 25. The suitability of one or more organizations and the partnerships they
such an entity might bring and issues it existing organizations to fulfill the role form to increase positive youth
might solve of a NHDSE development and address youth
2. Desirable governmental and private violence, gang involvement, and child
Potential Responders
sector roles in such an organization or abuse/neglect. The evaluation will be
in health data stewardship more Responses are both requested and designed to assess changes and
generally anticipated from a broad range of improvements in the structure and
3. The roles and responsibilities individual organizations that have functioning of the partnership and the
currently assumed by other existing interests in healthcare data. Examples of organizational capacity of each
entities that might be addressed by a commenters from whom we would hope participating organization.
NHDSE, as well as roles that should not to hear include, but are not limited to: Respondents: CEY grantees and the
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be fulfilled by a NHDSE Health care professional societies faith-based and community


4. The relationship of a NHDSE and Payers, including public and private organizations that are a part of the
its work to other quality improvement insurers partnership approved under the CEY
organizations and activities Health maintenance organizations grant.

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30806 Federal Register / Vol. 72, No. 106 / Monday, June 4, 2007 / Notices

ANNUAL BURDEN ESTIMATES


Number of re- Average
Number of Total burden
Instrument sponses per burden hours
respondents hours
respondent per response

Initial/Baseline Survey ..................................................................................... 800 1 .75 600


Follow-up Survey ............................................................................................. 640 1 .75 480

Estimated Total Annual Burden Government and are available for Applications: Serological assays for
Hours: 1,080. licensing in the U.S. in accordance with surveillance of pandemic influenza
In compliance with the requirements 35 U.S.C. 207 to achieve expeditious outbreaks; Serological assays for
of Section 3506(c)(2)(A) of the commercialization of results of distinguishing between exposure to
Paperwork Reduction Act of 1995, the Federally-funded research and human and bird influenza strains;
Administration for Children and development. Foreign patent Serological assays for diagnosing true
Families is soliciting public comment applications are filed on selected infections in previously vaccinated
on the specific aspects of the inventions to extend market coverage individuals; Rapid analyses of immune
information collection described above. for companies and may also be available sera from pre-clinical and clinical trials
Copies of the proposed collection of for licensing. of novel influenza vaccines; Mapping of
information can be obtained and ADDRESSES: Licensing information and monoclonal and polyclonal antibodies
comments may be forwarded by writing copies of the U.S. patent applications against different influenza gene
to the Administration for Children and listed below may be obtained by writing products; Identification of highly
Families, Office of Administration, to the indicated licensing contact at the conserved ‘‘protective’’ epitopes for
Office of Information Services, 370 Office of Technology Transfer, National inclusion in future broadly-reactive
L’Enfant Promenade, SW., Washington, Institutes of Health, 6011 Executive influenza vaccines (against either inter-
DC 20447. Attn: ACF Reports Clearance Boulevard, Suite 325, Rockville, pandemic or pandemic influenza
Officer. Email address: Maryland 20852–3804; telephone: 301/ strains); Studies of viral protein-protein,
infocollection@acf.hhs.gov. All requests 496–7057; fax: 301/402–0220. A signed viral RNA-protein and viral-host protein
should be identified by the title of the Confidential Disclosure Agreement will interactions (viral pathogenesis studies).
information collection. be required to receive copies of the Market: Influenza diagnostics and
The Department specifically requests patent applications. vaccines.
comments on: (a) Whether the proposed Development Status: Materials
Human and Avian Influenza Whole
collection of information is necessary available as research tools.
Genome Phage Display Libraries
for the proper performance of the Inventors: Hana Golding, Ph.D. (FDA),
functions of the agency, including Description of Technology: Available Surender Khurana, Ph.D. (FDA).
whether the information shall have for use in developing research reagents, Patent Status: HHS Reference No. E–
practical utility; (b) the accuracy of the therapeutics or diagnostics are 031–2007/0—Research Tool.
agency’s estimate of the burden of the recombinant bacteriophage display Licensing Status: Available for
proposed collection of information; (c) libraries for identifying influenza viral licensing as a biological material.
the quality, utility, and clarity of the gene products in preparation for Scientific Contact: Hana Golding,
information to be collected; and (d) pandemic threats the cross-reactivity Ph.D.; FDA/CBER/OVRR/DVP/LR; 9000
ways to minimize the burden of the and long-term protection of Rockville Pike, Building 29B, Room
collection of information on interpandemic influenza vaccines. 4N04, Bethesda, MD 20892; E-mail:
respondents. Consideration will be Influenza vaccines predominantly goldingh@cber.fda.gov; Phone: 301/827–
given to comments and suggestions include haemagglutinin (HA) and 0784.
submitted within 60 days of this Neuraminidase (NA) antigens that Licensing Contact: Michael A.
publication. characterize annual circulating Shmilovich, Esq.; National Institutes of
influenza types A and type B. Analyses Health, Office of Technology Transfer;
Dated: May 29, 2007.
of the immune responses against new 6011 Executive Blvd., Suite 325,
Brendan C. Kelly, candidate vaccines is required in order Rockville, MD 20852; E-mail:
Reports Clearance Officer. to identify the best correlate of shmilovm@mail.nih.gov; Phone: 301/
[FR Doc. 07–2724 Filed 6–1–07; 8:45 am] protection against seasonal human 435–5019; Fax: 301/402–0220.
BILLING CODE 4184–01–M influenza strains and potential
Diagnostic and Therapeutic Use of
pandemic strains.
These ‘‘Whole Viral Genome Phage Brother of the Regulator of Imprinted
DEPARTMENT OF HEALTH AND Display Libraries’’ express complete sets Sites (BORIS) Alternative Splice Forms
HUMAN SERVICES of protein fragments encoded by several Description of Technology: This
Human and Avian Influenza strains technology identifies twenty five (25)
National Institutes of Health including HlN1, H3N2, H5N1 and H7N7 new alternatively spliced transcripts of
and can be used for in depth analyses the BORIS gene. The transcripts lead to
Government-Owned Inventions;
of plasma samples from: (a) Individuals the expression of seventeen different
Availability for Licensing
exposed to human influenza; (b) protein isoforms with variable N- and C-
AGENCY: National Institutes of Health, individuals exposed to avian influenza; termini encoded by BORIS gene locus.
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Public Health Service, HHS. (c) individuals vaccinated with Differential expression levels of BORIS
ACTION: Notice. traditional influenza vaccines; (d) isoforms were observed in different
individuals vaccinated with new cancers. While some BORIS alternative
SUMMARY: The inventions listed below generation vaccines against human and splice variants were expressed at
are owned by an agency of the U.S. bird influenza viruses. different levels in all types of cancers,

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