Office of Public Health Support; Division of Planning, Evaluation & Research Native American Research Centers for Health (NARCH) V Evidence-Based Interventions for Tribal Communities Against AIDS and STDs, 32792-32797 [2010-13852]
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Protect Children and Adolescents,’’ at 21
CFR part 1140. The final regulations
apply to manufacturers, distributors,
and retailers who make, distribute, or
sell cigarettes or smokeless tobacco
products.
Beginning on June 22, 2010, these
Federal regulations will prohibit
retailers from selling cigarettes, cigarette
tobacco, or smokeless tobacco to
persons under the age of 18, and will
require retailers to verify the age of all
customers under the age of 27 by
checking a photographic identification
that includes the bearer’s date of birth.
FDA is announcing the availability of
a draft guidance document, which is
intended to help small businesses
comply with the requirements of the
new regulations. FDA is soliciting
comments on the draft guidance
document and may amend the guidance
document periodically as a result of
comments received.
II. Significance of Guidance
FDA is issuing this draft guidance
document consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent the agency’s
current thinking on ‘‘Compliance with
Regulations Restricting the Sale and
Distribution of Cigarettes and Smokeless
Tobacco To Protect Children and
Adolescents.’’ It does not create or
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and does not operate to bind FDA or the
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III. Comments
The draft guidance is being
distributed for comment purposes only
and is not intended for implementation
at this time. Interested persons may
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electronic or written comments
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necessary to send one set of comments.
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seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
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IV. Electronic Access
An electronic version of the guidance
document is available on the Internet at
https://www.regulations.gov and https://
www.fda.gov/TobaccoProducts/
GuidanceComplianceRegulatory
Information/default.htm.
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Dated: June 7, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–13922 Filed 6–7–10; 11:15 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Office of Public Health Support;
Division of Planning, Evaluation &
Research Native American Research
Centers for Health (NARCH) V
Evidence-Based Interventions for
Tribal Communities Against AIDS and
STDs
Announcement Type: Competitive
Supplements.
Funding Announcement Number:
HHS–2010–IHS–NARCH–0001.
Catalog of Federal Domestic
Assistance Number: 93.933.
Key Dates
Application Deadline Date: June 30,
2010.
Review Date: July 15, 2010.
Earliest Anticipated Start Date:
September 1, 2010.
I. Funding Opportunity Description
Statutory Authority
The Indian Health Service (IHS) is
accepting competitive supplemental
grant applications from existing Native
American Research Centers for Health
(NARCH) V grantees to establish and
test Evidence-Based Interventions for
Tribal Communities Against Acquired
Immune Deficiency Syndrome (AIDS)
and sexually transmitted diseases
(STDs). This program is authorized
under: the Snyder Act, 25 U.S.C. 13, the
Public Health Service Act, 42 U.S.C. 241
as amended, and the Indian Health Care
Improvement Act, 25 U.S.C.
1602(a)(b)(16). This program is
described in the Catalog of Federal
Domestic Assistance under 93.933.
Background
The NARCH V program supports
partnerships between Federally
recognized American Indian and Alaska
Native (AI/AN) Tribes or Tribal
organizations (including national and
area Indian health boards, and Tribal
colleges meeting the definition of a
Tribal organization as defined by 25
U.S.C. 1603(d) or (e)) and institutions
that conduct intensive academic-level
biomedical, behavioral and health
services research. These partnerships
are called Native American Research
Centers for Health (NARCH). Due to the
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complexity of factors contributing to the
health and disease of AI/ANs, and to
their health disparities compared with
other Americans, the collaborative
efforts of the agencies of the Department
of Health and Human Services (HHS)
and the collaboration of academic
researchers and AI/AN communities are
needed to achieve significant
improvements in the health status of AI/
AN people. To accomplish this goal, in
addition to objectives set by the Tribes,
Tribal organizations or Indian health
boards, the IHS NARCH program
pursues the following program
objectives:
To develop a cadre of AI/AN
scientists and health professionals—
Opportunities are needed to develop
more AI/AN scientists and health
professionals engaged in research, and
to conduct biomedical, clinical,
behavioral and health services research
that is responsive to the needs of the AI/
AN community and the goals of this
initiative. Faculty/researchers and
students at each proposed NARCH
develop investigator-initiated,
scientifically meritorious research
projects, including pilot research
projects, and will be supported through
science education projects designed to
increase the numbers of, and to improve
the research skills of, AI/AN
investigators and investigators involved
with AI/ANs.
To enhance partnerships and reduce
distrust of research by AI/AN
communities—Recent community-based
participatory research suggests that AI/
AN communities can work
collaboratively in partnership with
health researchers to further the
research needs of AI/ANs. Fully
utilizing all cultural and scientific
knowledge, strengths, and
competencies, such partnerships can
lead to better understanding of the
biological, genetic, behavioral,
psychological, cultural, social, and
economic factors either promoting or
hindering improved health status of AI/
ANs, and generate the development and
evaluation of interventions to improve
their health status. Community distrust
of research and researchers will be
reduced by offering the Tribe greater
control over the research process.
Purpose
The purpose of this opportunity for
supplementing the existing NARCH V
program is to determine the feasibility
of adapting and implementing HIV
evidence based interventions (EBI)(s)
supported by the CDC for effective use
within AI/AN communities, and to
contribute to, and document, a
successful adaption and implementation
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in this new population and setting.
Baseline and ongoing data will be
collected and analyzed to help
determine future effectiveness of the
adapted EBI(s).
While new treatments continue to
offer hope for individuals infected with
HIV, behavioral interventions shown to
reduce HIV risk behaviors remain one of
the most powerful tools in curbing the
AIDS epidemic. Health departments
(HDs) and community-based
organizations (CBOs) increasingly are
required to implement EBI(s) or public
health strategies (PHSs) that have been
shown to be efficacious for HIV
prevention in rigorous controlled trials.
Unfortunately, the development of new
EBI(s) is a resource-intensive process
that has not progressed as quickly as the
epidemiology of the disease. One
method to accelerate this process is by
adapting existing EBI(s) supported by
CDC’s previous Prevention Research
Synthesis (PRS), Replicating Effective
Programs (REP), and Diffusion of
Effective Behavioral Interventions
(DEBI) projects for new populations or
settings. This announcement responds
to concerns from the field and many AI/
AN communities that existing EBI(s) do
not address the focused HIV prevention
needs of AI/ANs due, at least in part, to
lack of cultural relevance and to the
absence of effectiveness data for these
interventions with respect to Tribal
communities.
These supplements will facilitate the
creation and testing of culturally
adapted and evidence based
interventions against AIDS and STDs.
The methodology of Tribal or
community based participatory research
(T/CBPR) is expected to be the most
effective approach to selecting, adapting
and testing an existing EBI for
deployment and maximal effectiveness
in a given Tribal community. Effective
T/CBPR partnerships can take years to
develop, but the need for culturally
relevant EBI(s) is urgent. Fortunately, a
number of such partnerships have
already been created under the NARCH
program. These partnerships are an
already existing T/CBPR infrastructure
whose core purposes include the ability
to help the Tribes respond to urgent
research needs and opportunities, such
as the object of this announcement.
Grantees will test the use of a T/CBPR
adaptation model to assist agencies with
the process of tailoring an existing
prevention intervention, previously
shown to be effective and catalogued by
CDC, for use in different small or hardto-access AI/AN population at risk for
HIV infection. When adapting the EBI,
the core elements that contributed to the
efficacy of the original intervention will
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be maintained, which will increase
efficiency of adaptation. Each grantee’s
ability to successfully adapt, tailor, and
implement their chosen intervention
will be monitored and evaluated, and all
operational processes will be
documented.
The nature of these projects will
require collaboration to: (1) Coordinate
activities with the IHS Research
Program and IHS National HIV Program
and (2) acquire technical assistance
from the IHS Research Program and the
Capacity Building Branch (CBB) of the
Division of HIV/AIDS Prevention
(DHAP) at CDC.
Proposed activities that cover large
populations and/or geographical areas
that do not necessarily correspond with
current IHS administrative areas are
allowed. In conducting activities to
achieve the purpose of this program, the
recipient will be responsible for the
activities under: 1. Recipient Activities,
and HHS will be responsible for
conducting activities under 2. HHS
Activities.
1. Recipient Activities
• Conduct targeted research and
literature review on the question of
whether any of the existing EBI
supported by CDC can be successfully
adapted to an AI/AN population at risk.
• Identify the unique risk behaviors
and contextual factors that lead to an
increased risk of HIV acquisition or
transmission.
• Conduct pre-implementation
phases of assessment, adaptation,
tailoring of intervention, and IRB
submission.
• Assess EBI(s) to determine their
compatibility with the needs of the
community and IHS capacity and
resources. No EBI(s) are capable of
addressing all of the identified risk
behaviors and contextual factors in the
selected population. NARCH partners
will select those most suitable for
adaptation and implementation (i.e., the
EBI that can be adapted to be most
responsive to identified risk behaviors,
contextual factors, and circumstances).
• Review adaptations to determine
cultural proficiency.
• Conduct process evaluation to
document an evidence base for the
adaptations.
• Adapt and tailor selected
interventions to meet the needs of the
AI/AN population identified.
• Implement the adapted and tailored
interventions.
• Evaluate the utility and
effectiveness of the adaptation and
tailoring of the intervention.
• Evaluate the effectiveness of the
adapted and tailored intervention.
Compare the magnitude of behavioral/
biologic change in the original and
adapted interventions using measures
from the original intervention with as
little modification as possible (i.e.
unprotected sex, condom negotiation,
numbers of sex partners, etc).
• Collaborate with IHS national
programs (IHS Research Program and
IHS National HIV Program) per
quarterly meetings (including use of
telecommunications) and by providing
data on a bi-annual basis, identifying
and documenting best practices for
developing and implementing
interventions.
• Document the operational processes
used during adaptation, tailoring,
implementation and evaluation.
• Report to IHS Research Program. A
three page mid-year progress report and
no more than a ten-page summary
annual assessment and evaluation at the
end of each project year. The report
should establish the impact and
outcomes of various methods of
adapting, tailoring and implementing
the intervention.
2. HHS Activities (IHS Research and
HIV Programs and CDC)
• Provide funded NARCH with
ongoing consultation and technical
assistance to plan, implement, and
evaluate each component of the
comprehensive program as described
under Recipient Activities above.
Consultation and technical assistance
will include, but not be limited to, the
following areas:
(a) CDC will train grantee(s) to deliver
the original intervention. Grantees
trained in the original intervention will
develop an adapted and tailored
intervention training curriculum based
on the original intervention training
included in the REP intervention
package. Grantees will train local staff.
(b) Provide oversight and technical
assistance throughout adaptation,
tailoring, implementation and
evaluation. Awardees will implement
the adapted intervention tailored to
address the AI/AN population and
locale.
(c) Analyze Data: Participate in
analysis of data gathered from project
activities; assist in reporting and
disseminating results.
(d) Provide overall operational
planning and program management.
• Conduct site visits to assess
program progress and mutually resolve
problems, as needed.
• Coordinate these activities with all
IHS HIV activities on a national basis.
• Coordinate with the CBB of DHAP
at CDC to provide technical assistance
related to the selection of the
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appropriate EBI or PHS, cultural and
linguistic adaptation of the intervention
and supporting materials, and training
of facilitators.
the IHS Research Program. No current
grantees other than existing NARCH V
grantees are expected to meet this
remaining project period requirement.
II. Award Information
2. Cost Sharing or Matching
The NARCH Program does not require
matching funds or cost sharing.
Type of Awards
Competitive supplemental revisions
to existing NARCH V awards.
Estimated Funds Available
The total amount of funding
identified for the current fiscal year (FY)
2010 is approximately $1,800,000.
Competing and continuation awards
issued under this announcement are
subject to the availability of funds. In
the absence of funding, the agency is
under no obligation to make awards
funded under this announcement.
Anticipated Number of Awards
Three supplements of $600,000 per
grantee are anticipated in FY 2010
under the existing NARCH V awards.
Additional NARCH awards may be
supplemented, if additional funds
become available.
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Project Period
Projects will be funded for one annual
budget period. There will be yearly
continuation applications required. The
continuation years will be pending
funding and based on the following:
• Satisfactory progress.
• Availability of funds and agency
capacity to sustain program(s).
• Continuing need for IHS to support
the program (program priorities).
Awardees will be required to submit
semi-annual cumulative progress
reports, as described within this
announcement and existing NARCH V
Notices of Grant Award (NoA), as well
as the Standard Form (SF) 2590 and a
Progress Report, annually and financial
statements as required in the PHS
Grants Policy Statement, revised 0107.
Forms are available at the following
Web site https://grants.nih.gov/grants/
funding/2590/2590.htm. The progress
report should provide information about
changes in the program and a summary
report of any evaluations. These biannual reports will be closely monitored
by the IHS staff to ensure that the grant
is achieving the goals of the Office of
HIV/AIDS Policy (OHAP) and the
NARCH program.
III. Eligibility Information
1. Eligibility
Eligible applicants are limited to
current NARCH grantees with at least
two years remaining of their current
NARCH project period. Proof of
eligibility status will be confirmed by
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3. Other Requirements
Letters of intent are not required
under this announcement.
IV. Application and Submission
Information
1. Obtaining Application Materials
1. The application package and
instructions can be requested from the
NARCH Program Official, Reyes
Building, 801 Thompson Avenue,
Rockville, MD 20852 or by e-mail to
narch@ihs.gov. The National Institutes
of Health (NIH) PHS 398 application
instructions are available in an
interactive format at: https://grants.nih.
gov/grants/funding/phs398/phs398.
html. Applicants must use the currently
approved version of the PHS 398. For
further assistance contact Mr. Paul
Gettys Telephone (301) 443–2114, Email: Paul.Gettys@ihs.gov. In any
instance where the PHS 398 instructions
are contradicted by this announcement,
the instructions in this announcement
must be followed. PHS 398 page limits
should be followed as for NIH activity
Code R21.
2. Content and Form Application
Submission
Mandatory documents for all
applicants include:
• Application forms:
• PHS–398 Package https://grants.nih.
gov/grants/funding/phs398/phs398.
html;
• Documentation of current OMB A–
133 required Financial Audit, if
applicable. Acceptable forms of
documentation include:
Æ E-mail confirmation from Federal
Audit Clearinghouse (FAC) that audits
were submitted; or
Æ Face sheets from audit reports.
These can be found on the FAC Web
site: https://harvester.census.gov/fac/
dissem/accessoptions.html?submit=
Retrieve+Records.
• Disclosure of Lobbying Activities
(SF–LLL) (if applicable).
Public Policy Requirements
All Federal-wide public policies
apply to IHS grants with exception of
the Discrimination policy.
3. Submission Dates and Times
Submit a typed and signed original
application, including the Checklist,
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and five (5) single-sided photocopies of
the entire application (including
Appendices and supporting documents)
in one package to: Division of Grants
Operations, Indian Health Service,
Reyes Building, 801 Thompson Avenue,
TMP 360, Rockville, MD 20852–1627
Attn: Mr. Roscoe Brunson, (zip code is
unchanged for express/courier services),
Telephone: (301) 443–5204 by no later
than 5pm EDT on June 30, 2010.
Letters of Intent: Letters of Intent will
not be required under this funding
opportunity announcement.
4. Intergovernmental Review
Executive Order 12372 requiring
intergovernmental review is not
applicable to this program.
5. Funding Restrictions
• Pre-award costs are not allowable
under this announcement.
• The available funds are inclusive of
direct and appropriate indirect costs.
• Only one grant/cooperative
agreement will be awarded per
applicant.
• IHS will not acknowledge receipt of
applications.
6. Dun and Bradstreet (D&B) Data
Universal Numbering System (DUNS)
Applicants are required to have a
DUNS number to apply for a grant or
cooperative agreement from the Federal
Government. The DUNS number is a
unique nine-digit identification number
provided by D&B, which uniquely
identifies business entities. The DUNS
number is site specific; therefore each
distinct performance site may be
assigned a DUNS number. Obtaining a
DUNS number is easy and there is no
charge. To obtain a DUNS number,
access https://fedgov.dnb.com/webform
or by phone (866) 705–5711.
V. Application Review Information
Points will be assigned to each
evaluation criteria adding up to a total
of 100 points. A minimum score of 65
points is required for funding. Points are
assigned as follows:
1. Evaluation Criteria
The instructions for preparing the
application narrative also constitute the
evaluation criteria for reviewing and
scoring the application. Weights
assigned to each section are noted in
parentheses. The narrative should
include all prior years of activity;
information for multi-year projects
should be included as an appendix (see
E. ‘‘Categorical Budget and Budget
Justification’’) at the end of this section
for more information. It should be well
organized, succinct, and contain all
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information necessary for reviewers to
understand the project fully. You are
required to provide measures of
effectiveness that will demonstrate the
accomplishment of the various
identified research objectives of the
grant. Measures of effectiveness must
relate to the purpose and goal stated in
the ‘‘Funding Description’’ section of
this announcement. Measures should
include process and outcome
information and contain both
quantitative and qualitative data that
measure the intended outcome. These
measures of effectiveness must be
submitted with the application and will
be an element of evaluation. The goals
of this IHS-supported research are to
advance the understanding of HIV/
AIDS-related behavior and biological
systems, improve the control and
prevention of HIV/AIDS, and enhance
community health and wellness. In the
written comments, reviewers will be
asked to evaluate the application and
the likelihood that the proposed
research will have a substantial impact
on the pursuit of these goals.
A. Significance (10 Points)
a. Is the proposed selection process of
the specific EBI to be implemented
justified in terms of AI/AN risk, AI/AN
behavior, and HIV or STD
epidemiology? Are the proposed
interventions and populations
realistically matched in terms of
behavioral determinants and risk
behaviors? Is the applicant’s selected
AI/AN population either small with
high HIV incidence or harder to gain
access to (e.g. male-to-female
transgender, men who have sex with
other men, rural communities with high
stigma, etc.)? Is the selected population
HIV positive? If HIV has not yet been
detected in the population, are there
existing STD or blood-borne disease
problems that suggest a fertile field for
HIV dissemination if the virus were to
enter the community?
b. If the aims of the application are
achieved, how will scientific knowledge
in AI/AN be advanced? What will be the
effect of these studies on AI/AN
communities and what will be the
benefits to service providers and/or
communities?
c. Define the project target population,
identify their unique characteristics,
and describe the impact of HIV and/or
other STDs or blood-borne diseases on
the population.
B. Research Objectives and Approach
(40 Points)
Applicants should address the
following research objectives in their
application:
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a. Process of selection, adaptation,
tailoring and implementation of the EBI.
One potential EBI may be selected to
use as a tentative example in the
application, to illustrate the approach
that is planned by the applicant.
However, if used, the example EBI
should be justified for the anticipated
population, either in terms of relevant
theory or based on preliminary,
preparatory T/CBPR activity such as
meetings with Tribal officials, groups,
Community Advisory Boards of the
existing NARCH, or focus groups. Use of
a specific EBI as an example as
described above is not required in the
application and is only one of various
different ways the applicant may choose
to describe their approach. If an
example EBI is chosen for use in the
application, it will not necessarily be
the EBI finally chosen by the grantee’s
full eventual process if the grant is
funded.
b. Refinement of adaptation and
tailoring guidance.
c. Research plan should address
activities to be conducted over the
entire project period. Are the conceptual
framework, design, methods, and
analyses adequately developed, wellintegrated, and appropriate to the aims
of the project? Does the applicant
acknowledge potential problem areas
and consider alternative tactics?
d. How will grantee gain access to and
rapidly assess the specific population(s)
(i.e., via community planning groups,
community advisory boards, focus
groups)? Has the applicant used local
data to inform the current RFA? Are
there existing relationships between the
applicant and local/Tribal public health
authorities and/or Tribal or IHS medical
providers? Is the plan to obtain
appropriate Tribal and/or Board
approval(s) to test the intervention
adequately described?
e. Has the applicant demonstrated
how they will establish and maintain
collaboration with universities, research
partners, IHS national programs, etc.?
f. Has the applicant chosen an
adequate sample size and demonstrated
access to at least that many members of
the target population who are not
currently receiving intervention,
particularly if the population is small or
hard-to-reach?
g. Has the applicant included a
relative timeline or action plan for each
phase of activities (selection,
assessment, adaptation, tailoring,
implementation, and evaluation
including milestones; costs;
development of materials (i.e., adapted
and tailored training curriculum,
evaluation tools, checklists) and
required reports? Absolute timelines
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and dates will not be required.
However, each necessary step should be
described, in logical order, to complete
the project within the total budget
amount allowed ($600,000).
h. Has the applicant demonstrated
sufficient understanding of EBI(s) as set
forth by the CDC?
i. Describe how the program will
ensure that the intervention services
and analyses will be culturally sensitive
and relevant.
C. Innovation (10 Points)
a. Does the project employ concepts,
approaches or methods novel to
standard biomedical science?
b. Does the project challenge existing
paradigms or develop new
methodologies or technologies?
c. Is the target sub-population one that
is not typically targeted for behavioral
intervention research (e.g. AI/AN
transgender, AI/AN men who have sex
with other men, AI/AN communities,
etc)?
D. Project Evaluation and Reporting (20
Points)
a. Does the grantee provide a clear
and organized plan for monitoring and
evaluating each phase of the project
through implementation, and to identify
best practices?
b. Has the applicant provided a
quality assurance plan that addresses all
phases of adaptation, tailoring,
implementation and evaluation and
included personnel responsible for
ensuring quality? Has the applicant
provided a plan for documenting
process measures including who is
responsible, processes to be measured,
and sample tools that might be used?
c. Do the outcomes and performance
measures described in the evaluation
include both quantitative and
qualitative approaches?
d. Reporting Requirements. Does
application provide a clear and
organized plan to strictly adhere to
reporting requirements set forth in
section VI.4.?
e. Based on the plans for monitoring,
evaluation through each phase, and
reporting, does the grantee demonstrate
obvious understanding of the evaluation
and reporting processes and
requirements?
E. Organizational Capacity (10 Points)
This section outlines the broader
capacity of the organization to complete
the project outlined in the work plan. It
includes the identification of principal
investigator and personnel responsible
for completing tasks for successful
completion of the project.
a. Describe the ability of the
organization to manage the proposed
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research project and the quality of the
established NARCH partnership(s).
b. Include information regarding any
similarly sized projects in scope and
financial assistance as well as any other
similar projects successfully completed
and/or under way.
c. Note who will be writing the
required reports.
F. Categorical Budget and Budget
Justification (10 Points)
Is the proposed budget reasonable in
relation to the proposed work and
research? Applicants must provide an
itemized budget to complete the project
in one year and budget justification for
direct and indirect costs.
a. Narrative justification for all costs,
explaining why each line item is
necessary or relevant to the proposed
project.
b. Budget justification should include
a brief program narrative for the second
and third years, in the event that the
project is not completed in the first year.
2. Review and Selection
Each application will be prescreened
by the DGO staff for eligibility and
completeness as outlined in the funding
announcement. Incomplete applications
and applications that are nonresponsive to the eligibility criteria will
not be referred to the Objective Review
Committee. Applicants will be notified
by DGO, via letter, to outline the
missing components of the application.
To obtain a minimum score for
funding, applicants must address all
program requirements and provide all
required documentation. Applicants
that receive less than a minimum score
will be informed via e-mail of their
application’s deficiencies. A summary
statement outlining the strengths and
weaknesses of the application will be
provided to these applicants. The
summary statement will be sent to the
Authorized Organizational
Representative that is identified on the
face page of the application.
VI. Award Administration Information
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1. Award Notices
The Notice of Award (NoA) will be
initiated by the DGO and will be mailed
via postal mail to each entity that is
approved for funding under this
announcement. The NoA will be signed
by the Grants Management Officer and
this is the authorizing document for
which funds are dispersed to the
approved entities. The NoA will serve
as the official notification of the grant
award and will reflect the amount of
Federal funds awarded, the purpose of
the grant, the terms and conditions of
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the award, the effective date of the
award, and the budget/project period.
The NoA is the legally binding
document and is signed by an
authorized grants official within the
IHS.
4. Reporting Requirements
2. Administrative Requirements
Grants are administered in accordance
with the following regulations, policies,
and OMB cost principles:
A. The criteria as outlined in this
Program Announcement.
B. Administrative Regulations for
Grants:
• 45 CFR, Part 92, Uniform
Administrative Requirements for Grants
and Cooperative Agreements to State,
Local and Tribal Governments.
• 45 CFR, Part 74, Uniform
Administrative Requirements for Grants
and Agreements with Institutions of
Higher Education, Hospitals, and other
Non-profit Organizations.
C. Grants Policy:
• HHS Grants Policy Statement,
Revised 01/07.
D. Cost Principles:
• Title 2: Grant and Agreements, Part
225—Cost Principles for State, Local,
and Indian Tribal Governments (OMB
A–87).
• Title 2: Grant and Agreements, Part
230—Cost Principles for Non-Profit
Organizations (OMB Circular A–122).
E. Audit Requirements:
• OMB Circular A–133, Audits of
States, Local Governments, and Nonprofit Organizations.
Program progress reports are required
semi-annually. These reports will
include a brief comparison of actual
accomplishments to the goals
established for the period, or, if
applicable, provide sound justification
for the lack of progress, and other
pertinent information as required. A
final report must be submitted within 90
days of expiration of the budget/project
period.
3. Indirect Costs
This section applies to all grant
recipients that request reimbursement of
indirect costs in their grant application.
In accordance with HHS Grants Policy
Statement, Part II–27, IHS requires
applicants to obtain a current indirect
cost rate agreement prior to award. The
rate agreement must be prepared in
accordance with the applicable cost
principles and guidance as provided by
the cognizant agency or office. A current
rate covers the applicable grant
activities under the current award’s
budget period. If the current rate is not
on file with the DGO at the time of
award, the indirect cost portion of the
budget will be restricted. The
restrictions remain in place until the
current rate is provided to the DGO.
Generally, indirect costs rates for IHS
grantees are negotiated with the
Division of Cost Allocation (DCA)
https://rates.psc.gov/and the Department
of Interior (National Business Center)
https://www.aqd.nbc.gov/indirect/
indirect.asp. If your organization has
questions regarding the indirect cost
policy, please call (301) 443–5204 to
request assistance.
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The reporting requirements for this
program are noted below.
A. Progress Reports
B. Financial Reports
Semi-annual Financial Status Reports
(FSR) reports must be submitted within
30 days after the budget period ends.
Final FSRs are due within 90 days of
expiration of the project period.
Standard Form 269 (long form for those
reporting on program income; short
form for all others) will be used for
financial reporting.
Federal Cash Transaction Reports are
due every calendar quarter to the
Division of Payment Management,
Payment Management Branch at:
www.dpm.gov. Failure to submit timely
reports may cause a disruption in timely
payments to your organization.
Grantees are responsible and
accountable for accurate reporting of the
Progress Reports and Financial Status
Reports which are generally due semiannually. Financial Status Reports (SF–
269) are due 90 days after each budget
period and the final SF–269 must be
verified from the grantee records on
how the value was derived.
Failure to submit required reports
within the time allowed may result in
suspension or termination of an active
grant, withholding of additional awards
for the project, or other enforcement
actions such as withholding of
payments or converting to the
reimbursement method of payment.
Continued failure to submit required
reports may result in one or both of the
following: (1) The imposition of special
award provisions; and (2) the nonfunding or non-award of other eligible
projects or activities. This requirement
applies whether the delinquency is
attributable to the failure of the grantee
organization or the individual
responsible for preparation of the
reports.
Telecommunication for the hearing
impaired is available at: TTY (301) 443–
6394.
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Federal Register / Vol. 75, No. 110 / Wednesday, June 9, 2010 / Notices
VII. Agency Contacts
Grants (Business): For specific grantrelated and business management
information:
Roscoe Brunson, Grants Management
Specialist, 801 Thompson Avenue,
TMP, Suite 360, Rockville, MD 20852,
(301) 443–5204 or
roscoe.brunson@ihs.gov.
Program (Programmatic/Technical):
For program-related and general
information regarding this
announcement:
Alan Trachtenberg, MD, MPH, IHS
Research Program, 801 Thompson
Ave, TMP Suite 450, Rockville, MD
20852, (301) 443–0578 or
narch@ihs.gov.
Dated: June 2, 2010.
Yvette Roubideaux,
Director, Indian Health Service.
[FR Doc. 2010–13852 Filed 6–8–10; 8:45 am]
BILLING CODE 4165–16–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Health Center Program
erowe on DSK5CLS3C1PROD with NOTICES
AGENCY: Health Resources and Services
Administration, HHS.
ACTION: Notice of Noncompetitive
Replacement Awards to Albany Area
Primary Health Care, Inc.
SUMMARY: The Health Resources and
Services Administration (HRSA) will be
transferring Health Center Program
(section 330 of the Public Health Service
Act) Community Health Center (CHC),
Increased Demand for Services (IDS),
and Capital Improvement Program (CIP)
funds originally awarded to Unadilla
Health Care Center, Inc., to Albany Area
Primary Health Care, Inc., to ensure the
provision of critical primary health care
services to underserved populations in
Dooly County, Georgia.
SUPPLEMENTARY INFORMATION:
Former Grantee of Record: Unadilla
Health Care Center, Inc.
Original Period of Grant Support:
December 1, 2008, to November 30,
2010 (CHC); March 27, 2009, to March
26, 2011 (IDS); and June 29, 2009, to
June 28, 2011 (CIP).
Replacement Awardee: Albany Area
Primary Health Care, Inc.
Amount of Replacement Awards: The
current awards for Unadilla Health Care
Center, Inc., were issued at $678,041
(CHC); $126,411 (IDS); and $316,325
(CIP). The amounts transferred will be
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the remaining funds from those most
recent awards.
Period of Replacement Awards: The
period of support for the replacement
awards is the remaining time in the
Health Center project period ending on
November 30, 2010 (CHC); March 26,
2011 (IDS); and June 28, 2011 (CIP).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Authority: Section 330 of the Public
Health Service Act, 42 U.S.C. 254b.
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
CFDA Numbers: 93.224 and 93.703
Justification for the Exception to
Competition
The former grantee, Unadilla Health
Care Center, Inc. (UnaHealth), notified
HRSA that it was unable to carry out the
administrative and programmatic
requirements to appropriately manage
the grant funds and indicated that it
would be relinquishing the grant funds.
UnaHealth is unable to provide the
necessary primary health care services
in Dooly County, Georgia, to the more
than 3,000 low income, underserved
and uninsured individuals in the
service area.
Albany Area Primary Health Care, Inc.
(AAPHC) is an experienced provider of
care and has a demonstrated record of
compliance with the Health Center
Program statutory and regulatory
requirements and is located in the same
geographical area. AAPHC will provide
services to the residents of Dooly
County at a site proximate to
UnaHealth’s current location.
Community support for this transfer is
demonstrated by letters of support from
three other existing section 330 grantees
in the service area, as well as a letter of
support from the local Primary Care
Association.
This underserved target population
has an immediate need for vital primary
health care services and would be
negatively impacted by any delay or
disruption of services caused by a
competition. As a result, in order to
ensure that critical primary health care
services remain available to the original
target population without disruption,
this replacement award will not be
competed.
FOR FURTHER INFORMATION CONTACT:
Lynn Spector via e-mail at
lspector@hrsa.gov or 301–594–4300.
Dated: June 3, 2010.
Mary K. Wakefield,
Administrator.
National Institutes of Health
National Institute of Environmental
Health Sciences; Notice of Closed
Meeting
Name of Committee: National Institute of
Environmental Health Sciences Special
Emphasis Panel; Conferences and Scientific
Meetings Support.
Date: June 30, 2010.
Time: 1 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: NIEHS/National Institutes of Health,
Building 4401, East Campus, 79 T.W.
Alexander Drive, Research Triangle Park, NC
27709, (Telephone Conference Call)
Contact Person: Leroy Worth, PhD,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Research and
Training, Nat. Institute of Environmental
Health Sciences, P.O. Box 12233, MD EC–30/
Room 3171, Research Triangle Park, NC
27709, (919) 541–0670, worth@niehs.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.115, Biometry and Risk
Estimation—Health Risks from
Environmental Exposures; 93.142, NIEHS
Hazardous Waste Worker Health and Safety
Training; 93.143, NIEHS Superfund
Hazardous Substances—Basic Research and
Education; 93.894, Resources and Manpower
Development in the Environmental Health
Sciences; 93.113, Biological Response to
Environmental Health Hazards; 93.114,
Applied Toxicological Research and Testing,
National Institutes of Health, HHS)
Dated: June 2, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–13842 Filed 6–8–10; 8:45 am]
BILLING CODE 4140–01–P
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Agencies
[Federal Register Volume 75, Number 110 (Wednesday, June 9, 2010)]
[Notices]
[Pages 32792-32797]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-13852]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service
Office of Public Health Support; Division of Planning, Evaluation
& Research Native American Research Centers for Health (NARCH) V
Evidence-Based Interventions for Tribal Communities Against AIDS and
STDs
Announcement Type: Competitive Supplements.
Funding Announcement Number: HHS-2010-IHS-NARCH-0001.
Catalog of Federal Domestic Assistance Number: 93.933.
Key Dates
Application Deadline Date: June 30, 2010.
Review Date: July 15, 2010.
Earliest Anticipated Start Date: September 1, 2010.
I. Funding Opportunity Description
Statutory Authority
The Indian Health Service (IHS) is accepting competitive
supplemental grant applications from existing Native American Research
Centers for Health (NARCH) V grantees to establish and test Evidence-
Based Interventions for Tribal Communities Against Acquired Immune
Deficiency Syndrome (AIDS) and sexually transmitted diseases (STDs).
This program is authorized under: the Snyder Act, 25 U.S.C. 13, the
Public Health Service Act, 42 U.S.C. 241 as amended, and the Indian
Health Care Improvement Act, 25 U.S.C. 1602(a)(b)(16). This program is
described in the Catalog of Federal Domestic Assistance under 93.933.
Background
The NARCH V program supports partnerships between Federally
recognized American Indian and Alaska Native (AI/AN) Tribes or Tribal
organizations (including national and area Indian health boards, and
Tribal colleges meeting the definition of a Tribal organization as
defined by 25 U.S.C. 1603(d) or (e)) and institutions that conduct
intensive academic-level biomedical, behavioral and health services
research. These partnerships are called Native American Research
Centers for Health (NARCH). Due to the complexity of factors
contributing to the health and disease of AI/ANs, and to their health
disparities compared with other Americans, the collaborative efforts of
the agencies of the Department of Health and Human Services (HHS) and
the collaboration of academic researchers and AI/AN communities are
needed to achieve significant improvements in the health status of AI/
AN people. To accomplish this goal, in addition to objectives set by
the Tribes, Tribal organizations or Indian health boards, the IHS NARCH
program pursues the following program objectives:
To develop a cadre of AI/AN scientists and health professionals--
Opportunities are needed to develop more AI/AN scientists and health
professionals engaged in research, and to conduct biomedical, clinical,
behavioral and health services research that is responsive to the needs
of the AI/AN community and the goals of this initiative. Faculty/
researchers and students at each proposed NARCH develop investigator-
initiated, scientifically meritorious research projects, including
pilot research projects, and will be supported through science
education projects designed to increase the numbers of, and to improve
the research skills of, AI/AN investigators and investigators involved
with AI/ANs.
To enhance partnerships and reduce distrust of research by AI/AN
communities--Recent community-based participatory research suggests
that AI/AN communities can work collaboratively in partnership with
health researchers to further the research needs of AI/ANs. Fully
utilizing all cultural and scientific knowledge, strengths, and
competencies, such partnerships can lead to better understanding of the
biological, genetic, behavioral, psychological, cultural, social, and
economic factors either promoting or hindering improved health status
of AI/ANs, and generate the development and evaluation of interventions
to improve their health status. Community distrust of research and
researchers will be reduced by offering the Tribe greater control over
the research process.
Purpose
The purpose of this opportunity for supplementing the existing
NARCH V program is to determine the feasibility of adapting and
implementing HIV evidence based interventions (EBI)(s) supported by the
CDC for effective use within AI/AN communities, and to contribute to,
and document, a successful adaption and implementation
[[Page 32793]]
in this new population and setting. Baseline and ongoing data will be
collected and analyzed to help determine future effectiveness of the
adapted EBI(s).
While new treatments continue to offer hope for individuals
infected with HIV, behavioral interventions shown to reduce HIV risk
behaviors remain one of the most powerful tools in curbing the AIDS
epidemic. Health departments (HDs) and community-based organizations
(CBOs) increasingly are required to implement EBI(s) or public health
strategies (PHSs) that have been shown to be efficacious for HIV
prevention in rigorous controlled trials. Unfortunately, the
development of new EBI(s) is a resource-intensive process that has not
progressed as quickly as the epidemiology of the disease. One method to
accelerate this process is by adapting existing EBI(s) supported by
CDC's previous Prevention Research Synthesis (PRS), Replicating
Effective Programs (REP), and Diffusion of Effective Behavioral
Interventions (DEBI) projects for new populations or settings. This
announcement responds to concerns from the field and many AI/AN
communities that existing EBI(s) do not address the focused HIV
prevention needs of AI/ANs due, at least in part, to lack of cultural
relevance and to the absence of effectiveness data for these
interventions with respect to Tribal communities.
These supplements will facilitate the creation and testing of
culturally adapted and evidence based interventions against AIDS and
STDs. The methodology of Tribal or community based participatory
research (T/CBPR) is expected to be the most effective approach to
selecting, adapting and testing an existing EBI for deployment and
maximal effectiveness in a given Tribal community. Effective T/CBPR
partnerships can take years to develop, but the need for culturally
relevant EBI(s) is urgent. Fortunately, a number of such partnerships
have already been created under the NARCH program. These partnerships
are an already existing T/CBPR infrastructure whose core purposes
include the ability to help the Tribes respond to urgent research needs
and opportunities, such as the object of this announcement.
Grantees will test the use of a T/CBPR adaptation model to assist
agencies with the process of tailoring an existing prevention
intervention, previously shown to be effective and catalogued by CDC,
for use in different small or hard-to-access AI/AN population at risk
for HIV infection. When adapting the EBI, the core elements that
contributed to the efficacy of the original intervention will be
maintained, which will increase efficiency of adaptation. Each
grantee's ability to successfully adapt, tailor, and implement their
chosen intervention will be monitored and evaluated, and all
operational processes will be documented.
The nature of these projects will require collaboration to: (1)
Coordinate activities with the IHS Research Program and IHS National
HIV Program and (2) acquire technical assistance from the IHS Research
Program and the Capacity Building Branch (CBB) of the Division of HIV/
AIDS Prevention (DHAP) at CDC.
Proposed activities that cover large populations and/or
geographical areas that do not necessarily correspond with current IHS
administrative areas are allowed. In conducting activities to achieve
the purpose of this program, the recipient will be responsible for the
activities under: 1. Recipient Activities, and HHS will be responsible
for conducting activities under 2. HHS Activities.
1. Recipient Activities
Conduct targeted research and literature review on the
question of whether any of the existing EBI supported by CDC can be
successfully adapted to an AI/AN population at risk.
Identify the unique risk behaviors and contextual factors
that lead to an increased risk of HIV acquisition or transmission.
Conduct pre-implementation phases of assessment,
adaptation, tailoring of intervention, and IRB submission.
Assess EBI(s) to determine their compatibility with the
needs of the community and IHS capacity and resources. No EBI(s) are
capable of addressing all of the identified risk behaviors and
contextual factors in the selected population. NARCH partners will
select those most suitable for adaptation and implementation (i.e., the
EBI that can be adapted to be most responsive to identified risk
behaviors, contextual factors, and circumstances).
Review adaptations to determine cultural proficiency.
Conduct process evaluation to document an evidence base
for the adaptations.
Adapt and tailor selected interventions to meet the needs
of the AI/AN population identified.
Implement the adapted and tailored interventions.
Evaluate the utility and effectiveness of the adaptation
and tailoring of the intervention.
Evaluate the effectiveness of the adapted and tailored
intervention. Compare the magnitude of behavioral/biologic change in
the original and adapted interventions using measures from the original
intervention with as little modification as possible (i.e. unprotected
sex, condom negotiation, numbers of sex partners, etc).
Collaborate with IHS national programs (IHS Research
Program and IHS National HIV Program) per quarterly meetings (including
use of telecommunications) and by providing data on a bi-annual basis,
identifying and documenting best practices for developing and
implementing interventions.
Document the operational processes used during adaptation,
tailoring, implementation and evaluation.
Report to IHS Research Program. A three page mid-year
progress report and no more than a ten-page summary annual assessment
and evaluation at the end of each project year. The report should
establish the impact and outcomes of various methods of adapting,
tailoring and implementing the intervention.
2. HHS Activities (IHS Research and HIV Programs and CDC)
Provide funded NARCH with ongoing consultation and
technical assistance to plan, implement, and evaluate each component of
the comprehensive program as described under Recipient Activities
above. Consultation and technical assistance will include, but not be
limited to, the following areas:
(a) CDC will train grantee(s) to deliver the original intervention.
Grantees trained in the original intervention will develop an adapted
and tailored intervention training curriculum based on the original
intervention training included in the REP intervention package.
Grantees will train local staff.
(b) Provide oversight and technical assistance throughout
adaptation, tailoring, implementation and evaluation. Awardees will
implement the adapted intervention tailored to address the AI/AN
population and locale.
(c) Analyze Data: Participate in analysis of data gathered from
project activities; assist in reporting and disseminating results.
(d) Provide overall operational planning and program management.
Conduct site visits to assess program progress and
mutually resolve problems, as needed.
Coordinate these activities with all IHS HIV activities on
a national basis.
Coordinate with the CBB of DHAP at CDC to provide
technical assistance related to the selection of the
[[Page 32794]]
appropriate EBI or PHS, cultural and linguistic adaptation of the
intervention and supporting materials, and training of facilitators.
II. Award Information
Type of Awards
Competitive supplemental revisions to existing NARCH V awards.
Estimated Funds Available
The total amount of funding identified for the current fiscal year
(FY) 2010 is approximately $1,800,000. Competing and continuation
awards issued under this announcement are subject to the availability
of funds. In the absence of funding, the agency is under no obligation
to make awards funded under this announcement.
Anticipated Number of Awards
Three supplements of $600,000 per grantee are anticipated in FY
2010 under the existing NARCH V awards. Additional NARCH awards may be
supplemented, if additional funds become available.
Project Period
Projects will be funded for one annual budget period. There will be
yearly continuation applications required. The continuation years will
be pending funding and based on the following:
Satisfactory progress.
Availability of funds and agency capacity to sustain
program(s).
Continuing need for IHS to support the program (program
priorities).
Awardees will be required to submit semi-annual cumulative progress
reports, as described within this announcement and existing NARCH V
Notices of Grant Award (NoA), as well as the Standard Form (SF) 2590
and a Progress Report, annually and financial statements as required in
the PHS Grants Policy Statement, revised 0107. Forms are available at
the following Web site https://grants.nih.gov/grants/funding/2590/2590.htm. The progress report should provide information about changes
in the program and a summary report of any evaluations. These bi-annual
reports will be closely monitored by the IHS staff to ensure that the
grant is achieving the goals of the Office of HIV/AIDS Policy (OHAP)
and the NARCH program.
III. Eligibility Information
1. Eligibility
Eligible applicants are limited to current NARCH grantees with at
least two years remaining of their current NARCH project period. Proof
of eligibility status will be confirmed by the IHS Research Program. No
current grantees other than existing NARCH V grantees are expected to
meet this remaining project period requirement.
2. Cost Sharing or Matching
The NARCH Program does not require matching funds or cost sharing.
3. Other Requirements
Letters of intent are not required under this announcement.
IV. Application and Submission Information
1. Obtaining Application Materials
1. The application package and instructions can be requested from
the NARCH Program Official, Reyes Building, 801 Thompson Avenue,
Rockville, MD 20852 or by e-mail to narch@ihs.gov. The National
Institutes of Health (NIH) PHS 398 application instructions are
available in an interactive format at: https://grants.nih.gov/grants/funding/phs398/phs398.html. Applicants must use the currently approved
version of the PHS 398. For further assistance contact Mr. Paul Gettys
Telephone (301) 443-2114, E-mail: Paul.Gettys@ihs.gov. In any instance
where the PHS 398 instructions are contradicted by this announcement,
the instructions in this announcement must be followed. PHS 398 page
limits should be followed as for NIH activity Code R21.
2. Content and Form Application Submission
Mandatory documents for all applicants include:
Application forms:
PHS-398 Package https://grants.nih.gov/grants/funding/phs398/phs398.html;
Documentation of current OMB A-133 required Financial
Audit, if applicable. Acceptable forms of documentation include:
[cir] E-mail confirmation from Federal Audit Clearinghouse (FAC)
that audits were submitted; or
[cir] Face sheets from audit reports. These can be found on the FAC
Web site: https://harvester.census.gov/fac/dissem/
accessoptions.html?submit=Retrieve+Records.
Disclosure of Lobbying Activities (SF-LLL) (if
applicable).
Public Policy Requirements
All Federal-wide public policies apply to IHS grants with exception
of the Discrimination policy.
3. Submission Dates and Times
Submit a typed and signed original application, including the
Checklist, and five (5) single-sided photocopies of the entire
application (including Appendices and supporting documents) in one
package to: Division of Grants Operations, Indian Health Service, Reyes
Building, 801 Thompson Avenue, TMP 360, Rockville, MD 20852-1627 Attn:
Mr. Roscoe Brunson, (zip code is unchanged for express/courier
services), Telephone: (301) 443-5204 by no later than 5pm EDT on June
30, 2010.
Letters of Intent: Letters of Intent will not be required under
this funding opportunity announcement.
4. Intergovernmental Review
Executive Order 12372 requiring intergovernmental review is not
applicable to this program.
5. Funding Restrictions
Pre-award costs are not allowable under this announcement.
The available funds are inclusive of direct and
appropriate indirect costs.
Only one grant/cooperative agreement will be awarded per
applicant.
IHS will not acknowledge receipt of applications.
6. Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS)
Applicants are required to have a DUNS number to apply for a grant
or cooperative agreement from the Federal Government. The DUNS number
is a unique nine-digit identification number provided by D&B, which
uniquely identifies business entities. The DUNS number is site
specific; therefore each distinct performance site may be assigned a
DUNS number. Obtaining a DUNS number is easy and there is no charge. To
obtain a DUNS number, access https://fedgov.dnb.com/webform or by phone
(866) 705-5711.
V. Application Review Information
Points will be assigned to each evaluation criteria adding up to a
total of 100 points. A minimum score of 65 points is required for
funding. Points are assigned as follows:
1. Evaluation Criteria
The instructions for preparing the application narrative also
constitute the evaluation criteria for reviewing and scoring the
application. Weights assigned to each section are noted in parentheses.
The narrative should include all prior years of activity; information
for multi-year projects should be included as an appendix (see E.
``Categorical Budget and Budget Justification'') at the end of this
section for more information. It should be well organized, succinct,
and contain all
[[Page 32795]]
information necessary for reviewers to understand the project fully.
You are required to provide measures of effectiveness that will
demonstrate the accomplishment of the various identified research
objectives of the grant. Measures of effectiveness must relate to the
purpose and goal stated in the ``Funding Description'' section of this
announcement. Measures should include process and outcome information
and contain both quantitative and qualitative data that measure the
intended outcome. These measures of effectiveness must be submitted
with the application and will be an element of evaluation. The goals of
this IHS-supported research are to advance the understanding of HIV/
AIDS-related behavior and biological systems, improve the control and
prevention of HIV/AIDS, and enhance community health and wellness. In
the written comments, reviewers will be asked to evaluate the
application and the likelihood that the proposed research will have a
substantial impact on the pursuit of these goals.
A. Significance (10 Points)
a. Is the proposed selection process of the specific EBI to be
implemented justified in terms of AI/AN risk, AI/AN behavior, and HIV
or STD epidemiology? Are the proposed interventions and populations
realistically matched in terms of behavioral determinants and risk
behaviors? Is the applicant's selected AI/AN population either small
with high HIV incidence or harder to gain access to (e.g. male-to-
female transgender, men who have sex with other men, rural communities
with high stigma, etc.)? Is the selected population HIV positive? If
HIV has not yet been detected in the population, are there existing STD
or blood-borne disease problems that suggest a fertile field for HIV
dissemination if the virus were to enter the community?
b. If the aims of the application are achieved, how will scientific
knowledge in AI/AN be advanced? What will be the effect of these
studies on AI/AN communities and what will be the benefits to service
providers and/or communities?
c. Define the project target population, identify their unique
characteristics, and describe the impact of HIV and/or other STDs or
blood-borne diseases on the population.
B. Research Objectives and Approach (40 Points)
Applicants should address the following research objectives in
their application:
a. Process of selection, adaptation, tailoring and implementation
of the EBI. One potential EBI may be selected to use as a tentative
example in the application, to illustrate the approach that is planned
by the applicant. However, if used, the example EBI should be justified
for the anticipated population, either in terms of relevant theory or
based on preliminary, preparatory T/CBPR activity such as meetings with
Tribal officials, groups, Community Advisory Boards of the existing
NARCH, or focus groups. Use of a specific EBI as an example as
described above is not required in the application and is only one of
various different ways the applicant may choose to describe their
approach. If an example EBI is chosen for use in the application, it
will not necessarily be the EBI finally chosen by the grantee's full
eventual process if the grant is funded.
b. Refinement of adaptation and tailoring guidance.
c. Research plan should address activities to be conducted over the
entire project period. Are the conceptual framework, design, methods,
and analyses adequately developed, well-integrated, and appropriate to
the aims of the project? Does the applicant acknowledge potential
problem areas and consider alternative tactics?
d. How will grantee gain access to and rapidly assess the specific
population(s) (i.e., via community planning groups, community advisory
boards, focus groups)? Has the applicant used local data to inform the
current RFA? Are there existing relationships between the applicant and
local/Tribal public health authorities and/or Tribal or IHS medical
providers? Is the plan to obtain appropriate Tribal and/or Board
approval(s) to test the intervention adequately described?
e. Has the applicant demonstrated how they will establish and
maintain collaboration with universities, research partners, IHS
national programs, etc.?
f. Has the applicant chosen an adequate sample size and
demonstrated access to at least that many members of the target
population who are not currently receiving intervention, particularly
if the population is small or hard-to-reach?
g. Has the applicant included a relative timeline or action plan
for each phase of activities (selection, assessment, adaptation,
tailoring, implementation, and evaluation including milestones; costs;
development of materials (i.e., adapted and tailored training
curriculum, evaluation tools, checklists) and required reports?
Absolute timelines and dates will not be required. However, each
necessary step should be described, in logical order, to complete the
project within the total budget amount allowed ($600,000).
h. Has the applicant demonstrated sufficient understanding of
EBI(s) as set forth by the CDC?
i. Describe how the program will ensure that the intervention
services and analyses will be culturally sensitive and relevant.
C. Innovation (10 Points)
a. Does the project employ concepts, approaches or methods novel to
standard biomedical science?
b. Does the project challenge existing paradigms or develop new
methodologies or technologies?
c. Is the target sub-population one that is not typically targeted
for behavioral intervention research (e.g. AI/AN transgender, AI/AN men
who have sex with other men, AI/AN communities, etc)?
D. Project Evaluation and Reporting (20 Points)
a. Does the grantee provide a clear and organized plan for
monitoring and evaluating each phase of the project through
implementation, and to identify best practices?
b. Has the applicant provided a quality assurance plan that
addresses all phases of adaptation, tailoring, implementation and
evaluation and included personnel responsible for ensuring quality? Has
the applicant provided a plan for documenting process measures
including who is responsible, processes to be measured, and sample
tools that might be used?
c. Do the outcomes and performance measures described in the
evaluation include both quantitative and qualitative approaches?
d. Reporting Requirements. Does application provide a clear and
organized plan to strictly adhere to reporting requirements set forth
in section VI.4.?
e. Based on the plans for monitoring, evaluation through each
phase, and reporting, does the grantee demonstrate obvious
understanding of the evaluation and reporting processes and
requirements?
E. Organizational Capacity (10 Points)
This section outlines the broader capacity of the organization to
complete the project outlined in the work plan. It includes the
identification of principal investigator and personnel responsible for
completing tasks for successful completion of the project.
a. Describe the ability of the organization to manage the proposed
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research project and the quality of the established NARCH
partnership(s).
b. Include information regarding any similarly sized projects in
scope and financial assistance as well as any other similar projects
successfully completed and/or under way.
c. Note who will be writing the required reports.
F. Categorical Budget and Budget Justification (10 Points)
Is the proposed budget reasonable in relation to the proposed work
and research? Applicants must provide an itemized budget to complete
the project in one year and budget justification for direct and
indirect costs.
a. Narrative justification for all costs, explaining why each line
item is necessary or relevant to the proposed project.
b. Budget justification should include a brief program narrative
for the second and third years, in the event that the project is not
completed in the first year.
2. Review and Selection
Each application will be prescreened by the DGO staff for
eligibility and completeness as outlined in the funding announcement.
Incomplete applications and applications that are non-responsive to the
eligibility criteria will not be referred to the Objective Review
Committee. Applicants will be notified by DGO, via letter, to outline
the missing components of the application.
To obtain a minimum score for funding, applicants must address all
program requirements and provide all required documentation. Applicants
that receive less than a minimum score will be informed via e-mail of
their application's deficiencies. A summary statement outlining the
strengths and weaknesses of the application will be provided to these
applicants. The summary statement will be sent to the Authorized
Organizational Representative that is identified on the face page of
the application.
VI. Award Administration Information
1. Award Notices
The Notice of Award (NoA) will be initiated by the DGO and will be
mailed via postal mail to each entity that is approved for funding
under this announcement. The NoA will be signed by the Grants
Management Officer and this is the authorizing document for which funds
are dispersed to the approved entities. The NoA will serve as the
official notification of the grant award and will reflect the amount of
Federal funds awarded, the purpose of the grant, the terms and
conditions of the award, the effective date of the award, and the
budget/project period. The NoA is the legally binding document and is
signed by an authorized grants official within the IHS.
2. Administrative Requirements
Grants are administered in accordance with the following
regulations, policies, and OMB cost principles:
A. The criteria as outlined in this Program Announcement.
B. Administrative Regulations for Grants:
45 CFR, Part 92, Uniform Administrative Requirements for
Grants and Cooperative Agreements to State, Local and Tribal
Governments.
45 CFR, Part 74, Uniform Administrative Requirements for
Grants and Agreements with Institutions of Higher Education, Hospitals,
and other Non-profit Organizations.
C. Grants Policy:
HHS Grants Policy Statement, Revised 01/07.
D. Cost Principles:
Title 2: Grant and Agreements, Part 225--Cost Principles
for State, Local, and Indian Tribal Governments (OMB A-87).
Title 2: Grant and Agreements, Part 230--Cost Principles
for Non-Profit Organizations (OMB Circular A-122).
E. Audit Requirements:
OMB Circular A-133, Audits of States, Local Governments,
and Non-profit Organizations.
3. Indirect Costs
This section applies to all grant recipients that request
reimbursement of indirect costs in their grant application. In
accordance with HHS Grants Policy Statement, Part II-27, IHS requires
applicants to obtain a current indirect cost rate agreement prior to
award. The rate agreement must be prepared in accordance with the
applicable cost principles and guidance as provided by the cognizant
agency or office. A current rate covers the applicable grant activities
under the current award's budget period. If the current rate is not on
file with the DGO at the time of award, the indirect cost portion of
the budget will be restricted. The restrictions remain in place until
the current rate is provided to the DGO.
Generally, indirect costs rates for IHS grantees are negotiated
with the Division of Cost Allocation (DCA) https://rates.psc.gov/and the
Department of Interior (National Business Center) https://www.aqd.nbc.gov/indirect/indirect.asp. If your organization has
questions regarding the indirect cost policy, please call (301) 443-
5204 to request assistance.
4. Reporting Requirements
The reporting requirements for this program are noted below.
A. Progress Reports
Program progress reports are required semi-annually. These reports
will include a brief comparison of actual accomplishments to the goals
established for the period, or, if applicable, provide sound
justification for the lack of progress, and other pertinent information
as required. A final report must be submitted within 90 days of
expiration of the budget/project period.
B. Financial Reports
Semi-annual Financial Status Reports (FSR) reports must be
submitted within 30 days after the budget period ends. Final FSRs are
due within 90 days of expiration of the project period. Standard Form
269 (long form for those reporting on program income; short form for
all others) will be used for financial reporting.
Federal Cash Transaction Reports are due every calendar quarter to
the Division of Payment Management, Payment Management Branch at:
www.dpm.gov. Failure to submit timely reports may cause a disruption in
timely payments to your organization.
Grantees are responsible and accountable for accurate reporting of
the Progress Reports and Financial Status Reports which are generally
due semi-annually. Financial Status Reports (SF-269) are due 90 days
after each budget period and the final SF-269 must be verified from the
grantee records on how the value was derived.
Failure to submit required reports within the time allowed may
result in suspension or termination of an active grant, withholding of
additional awards for the project, or other enforcement actions such as
withholding of payments or converting to the reimbursement method of
payment. Continued failure to submit required reports may result in one
or both of the following: (1) The imposition of special award
provisions; and (2) the non-funding or non-award of other eligible
projects or activities. This requirement applies whether the
delinquency is attributable to the failure of the grantee organization
or the individual responsible for preparation of the reports.
Telecommunication for the hearing impaired is available at: TTY
(301) 443-6394.
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VII. Agency Contacts
Grants (Business): For specific grant-related and business
management information:
Roscoe Brunson, Grants Management Specialist, 801 Thompson Avenue, TMP,
Suite 360, Rockville, MD 20852, (301) 443-5204 or
roscoe.brunson@ihs.gov.
Program (Programmatic/Technical): For program-related and general
information regarding this announcement:
Alan Trachtenberg, MD, MPH, IHS Research Program, 801 Thompson Ave, TMP
Suite 450, Rockville, MD 20852, (301) 443-0578 or narch@ihs.gov.
Dated: June 2, 2010.
Yvette Roubideaux,
Director, Indian Health Service.
[FR Doc. 2010-13852 Filed 6-8-10; 8:45 am]
BILLING CODE 4165-16-P