Development of Health Risk Assessment Guidance, 70009-70010 [2010-28788]
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Federal Register / Vol. 75, No. 220 / Tuesday, November 16, 2010 / Notices
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[FR Doc. 2010–28855 Filed 11–15–10; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Development of Health Risk
Assessment Guidance
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Request for Information.
AGENCY:
The Centers for Disease
Control and Prevention (CDC) located
within the Department of Health and
Human Services (HHS) is seeking public
comment on the development of
guidance concerning Health Risk
Assessment (HRAs). Section 4103 of the
Affordable Care Act (ACA) (Pub. L. 111–
148) requires that a health risk
assessment be included in the annual
wellness visit benefit authorized for
Medicare beneficiaries under the ACA.
CDC is collaborating with the Centers
for Medicare and Medicaid Services
(CMS), also located within HHS, in the
mstockstill on DSKH9S0YB1PROD with NOTICES
SUMMARY:
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19:33 Nov 15, 2010
Jkt 223001
development of guidance for this type of
assessment. This guidance is also
intended to be useful for HRAs
conducted in other patient populations
such as privately insured populations,
including those persons covered by
employer healthcare plans. Comments
received from this request for
information will be used to inform the
HRA guidance development process.
DATES: Written comments must be
received on or before January 3, 2011.
Comments received after January 3,
2011 will be considered to the extent
possible.
ADDRESSES: You may submit written
comments to the following address:
Office of Prevention through Healthcare,
Office of the Associate Director for
Policy, Centers for Disease Control and
Prevention, 1600 Clifton Road, NE.,
Mailstop D–28, Atlanta, Georgia, 30333,
ATTN: Health Risk Assessment
Guidance.
You may also submit written
comments via e-mail to: OPTH@cdc.gov.
Please use ‘‘Health Risk Assessment
Guidance’’ for the subject line.
Submitted comments will be available
for public review from Monday through
Friday, except for legal holidays, from 9
a.m. until 5 p.m. Eastern Standard Time,
at 1600 Clifton Road NE., Atlanta,
Georgia 30333. Please call ahead to 1–
404–639–0210 and ask for a
representative in the Office of
Prevention through Healthcare to
schedule your visit. Comments will also
be available for viewing at the following
Internet address: https://www.cdc.gov/
policy/opth/.
CDC will make all comments it
receives available to the public without
change, including personal information
you may provide, which includes the
name of the person submitting the
comment or signing the comment on
behalf of an organization, business, or
any such entity. If anyone does not wish
to have this information published, then
that information should not be included
when submitting the comment.
FOR FURTHER INFORMATION CONTACT:
Paula Staley, Office of Prevention
through Healthcare, Associate Director
for Policy, Centers for Disease Control
and Prevention, 1600 Clifton Road, NE.,
Mailstop D–28, Atlanta, Georgia, 30333,
telephone: (404) 639–0210.
SUPPLEMENTARY INFORMATION:
Section 4103 of the Affordable Care
Act (ACA) requires that a health risk
assessment be included in the annual
wellness visit benefit authorized for
Medicare beneficiaries under the ACA.
CDC is collaborating with CMS to
develop guidance for this type of
assessment. This guidance is also
PO 00000
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Fmt 4703
Sfmt 4703
70009
intended to be useful for HRAs
conducted in other patient populations
such as privately insured populations,
including those persons covered by
employer healthcare plans.
Currently there is considerable
variation in available HRAs, with the
majority of assessments created to
support employer-based health and
wellness programs. Several instruments
have been created for use in research
and are not available in the marketplace;
and the scientific rigor of HRA tools is
not always evident. Therefore, the
development of HRA guidance is
essential for effective implementation of
this part of the Medicare wellness visit
and to support broader HRA use within
primary care.
Although comments on any aspect of
the guidance development process will
be accepted, comments are especially
solicited about these areas of emphasis:
Content and Design
• Risk assessment domains—What
are generic elements of any HRA and
what elements must be tailored to
specific populations, particularly those
stratified by age?
• How should literacy and other
cultural appropriateness factors be
factored into the design?
• How should the HRA instrument
support shared decision-making by
provider and patient?
Mode of Administration
• How will individuals access the
HRA (e.g., via kiosk or some other
means in the physician’s office, Internet,
mail-in paper form, other nontraditional healthcare locations, such as,
kiosk in a pharmacy)?
• What are the cultural
appropriateness factors in patient HRA
access?
Primary Care Office Capacity
• What primary care office capacity
(personnel, Information Technology
(IT), etc) is required to utilize HRA data
effectively in support of personalized
prevention planning?
• Are training and technical
assistance necessary for effective
practice utilization of an HRA? What
entity should provide this technical
assistance?
• What are potential or demonstrated
community care transition linkages—
follow-up outside the office by other
providers—that help patients and
providers manage priority risks
identified by the HRA?
• What is the current practice of HRA
in medical practices of various sizes,
particularly those with five or fewer
physicians?
E:\FR\FM\16NON1.SGM
16NON1
70010
Federal Register / Vol. 75, No. 220 / Tuesday, November 16, 2010 / Notices
Consumer/Patient Perspective
• How could HRA data be shared
with the patients for their feedback and
follow up in the primary care practice?
• What role, if any, do incentives play
in motivating patients to take the HRA
and/or participate in follow-up
interventions?
Data
• With respect to Information
Technology (IT), how could HRA data
entered in any form populate electronic
health records, and what special
challenges and solutions occur if the
data are entered in a non-electronic
form?
• Are there standardized and certified
tools available to support this data
migration from multiple data entry
sources?
Certification
• What certification tools and
processes should complement the HRA
guidance and how should they be made
available to support primary care office
selection of an HRA instrument?
Evaluation and Quality Assurance
• How should the HRA guidance be
evaluated and updated with respect to
individual and population-level
(practice-based panel management)
health outcomes?
Public Forum: CDC plans to convene
a public forum in early February 2011
to highlight some of the key challenges,
barriers, opportunities and innovations
related to HRA standardization. The
public forum will consist of panel
presentations followed by public
comment. CDC will publish a separate
notice in the Federal Register
announcing additional information for
the Public Forum.
Dated: November 8, 2010.
Tanja Popovic,
Deputy Associate Director for Science,
Centers for Disease Control and Prevention.
[FR Doc. 2010–28788 Filed 11–15–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
mstockstill on DSKH9S0YB1PROD with NOTICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
SUMMARY:
VerDate Mar<15>2010
19:33 Nov 15, 2010
Jkt 223001
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301/
496–7057; fax: 301/402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
Novel Anti-HIV Acylthiol Drugs and
Thioether Prodrugs
Description of Invention: The
inventions provide the compositions,
pharmaceutical carrier, and usages of
the new Acylthiols (E–329–2000 family)
and Thioether pro-drug (E–177–2010
family) compounds in treatment of
retroviral infections such as HIV. More
specifically, these compounds target the
highly-conserved nucleocapsid protein
of HIV–1. Activity of these compounds
against the nucleocapsid protein leads
to inactivation of the virus via
disruption of the zinc fingers, integral
for infectivity, without significantly
affecting cellular proteins. Finally, these
inventions can be prepared from
inexpensive starting materials and two
‘‘one-pot’’ reactions. Thus, they open the
possibility for an effective drug
treatment for HIV that could reach
underdeveloped countries. These new
compounds have the potential to be
used both as a systemic drug for the
treatment of HIV–1 infection and as a
topically-applied barrier to prevent viral
transmission.
Applications: Treatment and
prevention of HIV infections.
Advantages:
• Potent anti-HIV activity.
• Could be used both systemically
and locally.
• Unlikely to develop any drug
resistance.
• Can be inexpensively manufactured
in a large scale.
Development Status: In vitro data
available.
Market: According to the 2008
UNAIDS report, there were 33 million
people living with AIDS in 2007, with
2.7 million new cases occurring in that
year. In the US alone, there are 1.2
million AIDS patients.
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The anti-HIV drug market is among
the fastest-growing pharmaceutical
markets in the world. Due to the large
target market, duration of therapy
(lifetime), and nature of the disease
(incurable), manufacturers will continue
to benefit from technological
advancements. In 2007, the seven Major
Markets (7MM; US, Japan, Italy,
Germany, UK, Spain and France)
generated $9.3B in sales of antiretroviral
drugs. These markets are expected to
grow to $15.1B by 2017.
The current product market segments
for anti-retrovirals are: protease
inhibitors (PI), nucleoside reverse
transcriptase inhibitors (NRTI), nonnucleoside reverse transcriptase
inhibitors (NNRTI), entry inhibitors (EI),
integrase inhibitors (II), and maturation
inhibitors (Other).
Inventors: Daniel Appella (NIDDK),
Ettore Appella (NCI), John K. Inman
(NIAID), Deyun Wang (NIDDK), Lisa M.
Miller Jenkins (NCI), Ryo Hayashi (NCI).
Publications:
1. Miller Jenkins LM, et al. Nature
Chemical Biology, in press.
2. Miller Jenkins LM, et al. Specificity
of acyl transfer from 2mercaptobenzamide thioesters to the
HIV–1 nucleocapsid protein. J Am
Chem Soc. 2007 Sep12;129(36):11067–
11078. [PubMed: 17705474]
3. Schito ML, et al. In vivo antiviral
activity of novel human
immunodeficiency virus type 1
nucleocapsid p7 zinc finger inhibitors
in a transgenic murine model. AIDS Res
Hum Retroviruses. 2003 Feb;19:91–101.
[PubMed: 12639244]
Patent Status:
• U.S. Provisional Application No.
61/353,274 filed 10 Jun 2010 (HHS
Reference No. E–177–2010/0–US–01).
• PCT/US02/23924 (HHS Reference
No. E–329–2000/0–PCT–02) and entered
national stage in the U.S. (Patent No.
7,528,274 and Patent Application No.
12/414,321), Canada (Patent Application
No. 2456083), Australia (Patent No.
2002322721), and Europe (Patent
Application No. 02756732.0).
Licensing Status: Available for
licensing.
Licensing Contact: Sally Hu, Ph.D.;
301–435–5606; HuS@mail.nih.gov.
Collaborative Research Opportunity:
The Laboratory of Cell Biology, Center
for Cancer Research is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize the above invention for
the treatment/prevention of HIV
infection. Please contact John Hewes,
Ph.D. at 301–435–3121 or
hewesj@mail.nih.gov for more
information.
E:\FR\FM\16NON1.SGM
16NON1
]]>Agencies
[Federal Register Volume 75, Number 220 (Tuesday, November 16, 2010)]
[Notices]
[Pages 70009-70010]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-28788]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Development of Health Risk Assessment Guidance
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Request for Information.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC) located
within the Department of Health and Human Services (HHS) is seeking
public comment on the development of guidance concerning Health Risk
Assessment (HRAs). Section 4103 of the Affordable Care Act (ACA) (Pub.
L. 111-148) requires that a health risk assessment be included in the
annual wellness visit benefit authorized for Medicare beneficiaries
under the ACA. CDC is collaborating with the Centers for Medicare and
Medicaid Services (CMS), also located within HHS, in the development of
guidance for this type of assessment. This guidance is also intended to
be useful for HRAs conducted in other patient populations such as
privately insured populations, including those persons covered by
employer healthcare plans. Comments received from this request for
information will be used to inform the HRA guidance development
process.
DATES: Written comments must be received on or before January 3, 2011.
Comments received after January 3, 2011 will be considered to the
extent possible.
ADDRESSES: You may submit written comments to the following address:
Office of Prevention through Healthcare, Office of the Associate
Director for Policy, Centers for Disease Control and Prevention, 1600
Clifton Road, NE., Mailstop D-28, Atlanta, Georgia, 30333, ATTN: Health
Risk Assessment Guidance.
You may also submit written comments via e-mail to: OPTH@cdc.gov.
Please use ``Health Risk Assessment Guidance'' for the subject line.
Submitted comments will be available for public review from Monday
through Friday, except for legal holidays, from 9 a.m. until 5 p.m.
Eastern Standard Time, at 1600 Clifton Road NE., Atlanta, Georgia
30333. Please call ahead to 1-404-639-0210 and ask for a representative
in the Office of Prevention through Healthcare to schedule your visit.
Comments will also be available for viewing at the following Internet
address: https://www.cdc.gov/policy/opth/.
CDC will make all comments it receives available to the public
without change, including personal information you may provide, which
includes the name of the person submitting the comment or signing the
comment on behalf of an organization, business, or any such entity. If
anyone does not wish to have this information published, then that
information should not be included when submitting the comment.
FOR FURTHER INFORMATION CONTACT: Paula Staley, Office of Prevention
through Healthcare, Associate Director for Policy, Centers for Disease
Control and Prevention, 1600 Clifton Road, NE., Mailstop D-28, Atlanta,
Georgia, 30333, telephone: (404) 639-0210.
SUPPLEMENTARY INFORMATION:
Section 4103 of the Affordable Care Act (ACA) requires that a
health risk assessment be included in the annual wellness visit benefit
authorized for Medicare beneficiaries under the ACA. CDC is
collaborating with CMS to develop guidance for this type of assessment.
This guidance is also intended to be useful for HRAs conducted in other
patient populations such as privately insured populations, including
those persons covered by employer healthcare plans.
Currently there is considerable variation in available HRAs, with
the majority of assessments created to support employer-based health
and wellness programs. Several instruments have been created for use in
research and are not available in the marketplace; and the scientific
rigor of HRA tools is not always evident. Therefore, the development of
HRA guidance is essential for effective implementation of this part of
the Medicare wellness visit and to support broader HRA use within
primary care.
Although comments on any aspect of the guidance development process
will be accepted, comments are especially solicited about these areas
of emphasis:
Content and Design
Risk assessment domains--What are generic elements of any
HRA and what elements must be tailored to specific populations,
particularly those stratified by age?
How should literacy and other cultural appropriateness
factors be factored into the design?
How should the HRA instrument support shared decision-
making by provider and patient?
Mode of Administration
How will individuals access the HRA (e.g., via kiosk or
some other means in the physician's office, Internet, mail-in paper
form, other non-traditional healthcare locations, such as, kiosk in a
pharmacy)?
What are the cultural appropriateness factors in patient
HRA access?
Primary Care Office Capacity
What primary care office capacity (personnel, Information
Technology (IT), etc) is required to utilize HRA data effectively in
support of personalized prevention planning?
Are training and technical assistance necessary for
effective practice utilization of an HRA? What entity should provide
this technical assistance?
What are potential or demonstrated community care
transition linkages--follow-up outside the office by other providers--
that help patients and providers manage priority risks identified by
the HRA?
What is the current practice of HRA in medical practices
of various sizes, particularly those with five or fewer physicians?
[[Page 70010]]
Consumer/Patient Perspective
How could HRA data be shared with the patients for their
feedback and follow up in the primary care practice?
What role, if any, do incentives play in motivating
patients to take the HRA and/or participate in follow-up interventions?
Data
With respect to Information Technology (IT), how could HRA
data entered in any form populate electronic health records, and what
special challenges and solutions occur if the data are entered in a
non-electronic form?
Are there standardized and certified tools available to
support this data migration from multiple data entry sources?
Certification
What certification tools and processes should complement
the HRA guidance and how should they be made available to support
primary care office selection of an HRA instrument?
Evaluation and Quality Assurance
How should the HRA guidance be evaluated and updated with
respect to individual and population-level (practice-based panel
management) health outcomes?
Public Forum: CDC plans to convene a public forum in early February
2011 to highlight some of the key challenges, barriers, opportunities
and innovations related to HRA standardization. The public forum will
consist of panel presentations followed by public comment. CDC will
publish a separate notice in the Federal Register announcing additional
information for the Public Forum.
Dated: November 8, 2010.
Tanja Popovic,
Deputy Associate Director for Science, Centers for Disease Control and
Prevention.
[FR Doc. 2010-28788 Filed 11-15-10; 8:45 am]
BILLING CODE 4163-18-P
