Healthy Lifestyles in Youth Project, 49865-49873 [2022-17403]
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Federal Register / Vol. 87, No. 155 / Friday, August 12, 2022 / Notices
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the guidance to the Policy and
Regulations Staff (HFV–6), Center for
Veterinary Medicine, Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Aime´e Phillippi-Taylor, Center for
Veterinary Medicine (HFV–114), Food
and Drug Administration, 7500 Standish
Pl, Rockville, MD 20855, 240–402–0601,
aimee.phillippi-taylor@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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I. Background
FDA is announcing the availability of
a draft guidance for industry GFI #97
(VICH GL14(R1)) entitled ‘‘Effectiveness
of Anthelmintics: Specific
Recommendations for Caprines
(Revision 1).’’ It should be read in
conjunction with GFI #90 (VICH GL7),
‘‘Effectiveness of Anthelmintics:
General Recommendations,’’ which
should be referred to for discussion of
broad aspects for providing pivotal data
to demonstrate product anthelmintic
effectiveness. The purpose of this
guidance is: (1) to be more specific for
certain specific caprine issues not
discussed in GFI #90 (VICH GL7); (2) to
highlight differences with the GFI #90
(VICH GL7) on effectiveness data
recommendations; and (3) to give
explanations for disparities with the GFI
#90 (VICH GL7). This revision clarifies
the definition of adequate infection in
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individual animals, updates
considerations for field studies, and
makes additional clarifying changes.
FDA has participated in efforts to
enhance international harmonization
and is committed to seeking
scientifically based harmonized
technical procedures for pharmaceutical
development. One of the goals of
harmonization is to identify, and then
reduce, differences in technical
requirements for drug development
among regulatory agencies in different
countries.
FDA has actively participated in the
International Council for Harmonisation
of Technical Requirements for
Pharmaceuticals for Human Use to
develop harmonized technical
requirements for the approval of human
pharmaceutical and biological products
among the European Union, Japan, and
the United States. The VICH is a parallel
initiative for veterinary medicinal
products. The VICH is concerned with
developing harmonized technical
requirements for the approval of
veterinary medicinal products in the
European Union, Japan, and the United
States, and includes input from both
regulatory and industry representatives.
The VICH Steering Committee is
composed of member representatives
from the European Commission and
European Medicines Agency;
AnimalhealthEurope; FDA—Center for
Veterinary Medicine and U.S.
Department of Agriculture—Center for
Veterinary Biologics; the U.S. Animal
Health Institute; the Japanese Ministry
of Agriculture, Forestry and Fisheries;
and the Japanese Veterinary Products
Association.
There are 10 observers to the VICH
Steering Committee: one representative
from government and one representative
from industry of Australia, New
Zealand, Canada, South Africa, and the
United Kingdom. The World
Organisation for Animal Health is an
associate member of the VICH. The
VICH Secretariat, which coordinates the
preparation of documentation, is
provided by HealthforAnimals.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Effectiveness of Anthelmintics:
Specific Recommendations for Caprines
(Revision 1).’’ It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
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II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 514 have
been approved under OMB Control
Number 0910–0032.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/animal-veterinary/
guidance-regulations/guidanceindustry, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: August 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–17318 Filed 8–11–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Healthy Lifestyles in Youth Project
Announcement Type: New.
Funding Announcement Number:
HHS–2022–IHS–HLY–0001.
Assistance Listing (Catalog of Federal
Domestic Assistance or CFDA) Number:
93.933.
Key Dates
Application Deadline Date:
September 15, 2022.
Earliest Anticipated Start Date:
September 30, 2022.
I. Funding Opportunity Description
Statutory Authority
The Indian Health Service (IHS) is
accepting applications for a cooperative
agreement for the Healthy Lifestyles in
Youth (HLY) Program. This program is
authorized under the Snyder Act, 25
U.S.C. 13; and the Transfer Act, 42
U.S.C. 2001(a). This program is
described in the Assistance Listings
located at https://sam.gov/content/home
(formerly known as the CFDA) under
93.933.
Background
This program promotes healthy
lifestyles for American Indian and
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Alaska Native (AI/AN) youth using the
curriculum ‘‘Together Raising
Awareness for Indian Life’’ (TRAIL)
among selected Native Boys and Girls
Club sites. Under this cooperative
agreement, IHS proposes to enter into a
collaborative effort/initiative with an
entity that has experience working with
Boys and Girls Clubs of America
(BGCA), experience working with and
implementing the TRAIL curriculum,
and overall expertise and experience in
addressing and evaluating healthy
lifestyle techniques in AI/AN youth.
The IHS issued the original funding
opportunity announcement for the HLY
cooperative agreement in 2003 and the
program has been ongoing since that
time.
Purpose
The purpose of this program is to
support the IHS mission to improve the
health of AI/AN youth through health
promotion and health education
programs. The goal of this IHS
cooperative agreement is to address
healthy lifestyle development and
emphasize nutrition and physical
activity for AI/AN children and youth 7
through 11 years of age. To do this, the
awardee must meet the following
objectives:
• Collaborate with selected Native
American Boys and Girls Club sites, via
a grant application process;
• Provide health and physical
education programs;
• Help youth achieve and maintain
healthy lifestyles through participation
in fitness programs;
• Help youth acquire a range of
physical skills; and
• Help youth develop a sense of
teamwork and cooperation.
These early intervention strategies
provide evidence based opportunities to
reduce and/or halt the increasing trend
of obesity and diabetes among youth
and young adults. Native Boys and Girls
Clubs that develop a health promotion
program that includes the TRAIL
curriculum may help curtail the effects
of unhealthy eating behaviors and lack
of physical activity that can lead to
obesity, diabetes, and other chronic
diseases later in life. The TRAIL
curriculum was developed to provide
information on good nutrition and to
promote physical activity among youth
participating in Native American Boys
and Girls Clubs. The TRAIL curriculum
is a 3-month (12 lessons) program that
provides youth with a comprehensive
understanding of healthy lifestyles in
order to prevent diabetes. Woven
throughout the program are self-esteem
and prevention activities. Participants
draw from Tribal traditions and history
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to learn about nutrition, healthy food
choices, media influences, and the
impact of diabetes. The TRAIL
curriculum emphasizes the importance
of teamwork and community service.
Members engage in service projects to
improve healthy lifestyles in their
communities, including starting
community gardens to connect youth to
their food source and organizing
community-wide physical fitness
events.
The overall results show
improvement in participant knowledge
of diabetes, health, and healthy food
choices, as well as improved levels of
fitness and physical activity. To date,
this cooperative agreement has funded
over 95 Native American Boys and Girls
Club sites that have established and
implemented this curriculum project
and have served over 22,144 AI/AN
youth. Program test scores each year
consistently indicate: (a) increased
knowledge about diabetes; (b) increased
physical activity; and, (c) increased
ability to identify healthier food options
(post-intervention scores vs. preintervention test scores). Program
physical activity logs show participating
AI/AN youth collectively perform
approximately 20,000 hours of physical
activity each year. Boys and Girls Clubs
also report annually on the service
projects that are carried out by TRAIL
participants in their local communities.
Boys and Girl Club sites that are
located outside of Tribal communities
are not eligible.
The Boys and Girls Club sites selected
by the awardee may use IHS grant funds
to provide services to eligible IHS
beneficiaries only. The awardee will:
provide technical consultation; train;
monitor; evaluate; and provide funds to
support these activities.
Required, Optional, and Allowable
Activities
1. Develop a written plan for the
planning, implementation, and
evaluation of this project to include
overseeing at least 98 sites, as agreed
upon with the IHS. The local evaluation
effort should include local evidencebased practice (EBP) fidelity data and
how data will integrate with the
National Evaluation Frame. Complete
this task within 30 days of the award
date and obtain approval by the IHS.
2. Develop selection criteria for
additional sites as well as announce,
evaluate, and select new sites. Sites
must submit documentation verifying
that they serve only AI/AN youth from
eligible IHS beneficiaries, as a
requirement for selection by the
awardee. Conduct a start-up planning
meeting with new sites within 2 months
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of each site’s initial selection and
award.
3. Plan and conduct an orientation
and training meeting for new sites
within 2 months of selection. Submit
agenda, training goals and objectives,
and participant list to IHS within 1
month of completion of each orientation
session.
4. Update TRAIL curriculum as
needed/directed and implement use.
Document any specific changes to the
curriculum and note expected impacts
on implementation, data collection and
outcomes.
5. Develop, in consultation with the
IHS, the implementation and technical
assistance plan for the coordination of
the selected Boys and Girls Club sites.
Submit criteria to the IHS for approval.
6. Each site will implement the TRAIL
program, emphasizing healthy
behaviors, such as physical activity and
nutrition. Each program plan will also
include a parent component describing
approaches for involving the families of
participants.
7. Each site will implement Physical
Activity Strength and Endurance
Challenges 3 times, 6 to 8 weeks apart.
Physical activity data will be collected
and summarized.
8. Awardee will promote and
facilitate local, state, and national
partnerships for the purpose of
establishing or enhancing program
support that involves increasing
physical activity and good nutrition for
the tribally-managed Boys and Girls
Club sites. This includes, but is not
limited to, establishing other partners
such as American Indian-Alaska Native
Program Branch (AI–ANPB) of Head
Start Programs, Wings of America,
United National Indian Tribal Youth,
Inc. (UNITY), Tribal colleges, BGCA,
Tribal organizations, local community
health providers, and other private
organizations as appropriate.
9. Awardee will continue to
implement current evaluation processes
in consultation for the TRAIL project. At
a minimum, the evaluation will include:
a. training attendance (gender, age,
grade level);
b. pre- and post- tests to assess
participant knowledge;
c. monthly activity logs from each site
on the physical activity portion of their
program. Daily data to be collected
includes the date, number of minutes of
physical activity, and number of
children participating; and
d. information/log on parent and
family participation in education and
activity programs, community
involvement and partnerships.
10. Submit collated and summarized
data to the IHS. Work with the IHS in
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drafting an evaluation summary at the
end of the project period. Submit
collated and summarized data and
project evaluation summaries to all
sites. Provide a minimum of annual
reports (feedback) to each site on how
their data compare to data (mean,
median, and range) from other selected
sites.
11. Provide ongoing technical support
to the sites for the duration of the
initiative. Provide training and technical
assistance in all forms, i.e., on-site, online, by phone, and mail. The planning,
design, and delivery of training and
technical assistance will support the
local organization’s long-term planning
and outreach efforts. The training will
be customized based on sites’ capability
and experience. Technical assistance
will also be provided on program
planning, implementation, evaluation,
and data collection. Collaborate with the
IHS to provide services to club sites.
Maintain records and reports.
12. Provide technical assistance to the
sites in developing a written work plan,
with measurable goals, objectives and
activities that adheres to the terms and
conditions of the cooperative agreement.
13. Establish a formal agreement with
Native American Boys and Girls Club
sites, involving funding assistance and
technical support to ensure clubs
successfully implement the TRAIL
program.
14. Submit to the IHS a written work
plan and report describing each site’s
demographics, information on the
number of youth in the eligible age
range in the catchment area, the number
that attend the Boys and Girls Clubs
regularly, and the number served by this
project, goals, objectives, activities,
partnerships, and proposed outcomes.
15. Provide the IHS written quarterly
reports on the evaluation outcomes,
activity reports at each site, any parent
involvement activities and other
participation, description of the
community partnerships, and other
activities as appropriate. Conduct
quarterly conference calls with IHS to
review project status.
II. Award Information
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Funding Instrument—Cooperative
Agreement
Estimated Funds Available
The total funding identified for the
first budget year, starting in fiscal year
(FY) 2022, is approximately $1,250,000.
The funding available for competing
and subsequent continuation awards
issued under this announcement is
subject to the availability of
appropriations and budgetary priorities
of the Agency. The IHS is under no
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obligation to make awards that are
selected for funding under this
announcement.
Anticipated Number of Awards
One award will be issued under this
program announcement.
Period of Performance
The project period is for 5 years.
Cooperative Agreement
Cooperative agreements awarded by
the Department of Health and Human
Services (HHS) are administered under
the same policies as grants. However,
the funding agency, IHS, is anticipated
to have substantial programmatic
involvement in the project during the
entire period of performance. Below is
a detailed description of the level of
involvement required of the IHS.
Substantial Agency Involvement
Description for Cooperative Agreement
(1) Identify a core group of IHS staff
to work with the awardee in providing
technical assistance and guidance.
(2) Meet with the awardee to review
awardee work plan and provide
guidance on implementation, program
evaluation, and data collection strategy
and tools.
(3) Participate in quarterly conference
calls. Work with the awardee to display
the results of this project by publishing
on shared websites as well as in jointly
authored publications.
(4) Use the evidence-based
program(s), framework(s), and data
collection requirement(s) to develop a
National Logic Model and Evaluation
Plan to collect national program
aggregate and local EBP fidelity data.
III. Eligibility Information
1. Eligibility
To be eligible for this funding
opportunity an applicant must be an
organization with extensive experience
developing and managing youth
programs, health advocacy and
education, and outreach related to AI/
AN health care on a national scale.
The program office will notify any
applicants deemed ineligible.
Note: Please refer to Section IV.2
(Application and Submission Information/
Subsection 2, Content and Form of
Application Submission) for additional proof
of applicant status documents required, such
as Tribal Resolutions, proof of nonprofit
status, etc.
2. Cost Sharing or Matching
The IHS does not require matching
funds or cost sharing for grants or
cooperative agreements.
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3. Other Requirements
Applications with budget requests
that exceed the highest dollar amount
outlined under Section II Award
Information, Estimated Funds Available,
or exceed the period of performance
outlined under Section II Award
Information, Period of Performance, are
considered not responsive and will not
be reviewed. The Division of Grants
Management (DGM) will notify the
applicant.
The following documentation is
required (if applicable):
Tribal Resolution
The DGM must receive an official,
signed Tribal Resolution prior to issuing
a Notice of Award (NoA) to any Tribe
or Tribal organization selected for
funding. An applicant that is proposing
a project affecting another Indian Tribe
must include resolutions from all
affected Tribes to be served. However, if
an official signed Tribal Resolution
cannot be submitted with the
application prior to the application
deadline date, a draft Tribal Resolution
must be submitted with the application
by the deadline date in order for the
application to be considered complete
and eligible for review. The draft Tribal
Resolution is not in lieu of the required
signed resolution but is acceptable until
a signed resolution is received. If an
application without a signed Tribal
Resolution is selected for funding, the
applicant will be contacted by the
Grants Management Specialist (GMS)
listed in this funding announcement
and given 90 days to submit an official
signed Tribal Resolution to the GMS. If
the signed Tribal Resolution is not
received within 90 days, the award will
be forfeited.
Tribes organized with a governing
structure other than a Tribal council
may submit an equivalent document
commensurate with their governing
organization.
Proof of Nonprofit Status
Organizations claiming nonprofit
status must submit a current copy of the
501(c)(3) Certificate with the
application.
IV. Application and Submission
Information
Grants.gov uses a Workspace model
for accepting applications. The
Workspace consists of several online
forms and three forms in which to
upload documents—Project Narrative,
Budget Narrative, and Other Documents.
Give your files brief descriptive names.
The filenames are key in finding
specific documents during the objective
review and in processing awards.
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Upload all requested and optional
documents individually, rather than
combining them into a package.
Creating a package creates confusion
when trying to find specific documents.
Such confusion can contribute to delays
in processing awards, and could lead to
lower scores during the objective
review.
1. Obtaining Application Materials
The application package and detailed
instructions for this announcement are
available at https://www.Grants.gov.
Please direct questions regarding the
application process to DGM@ihs.gov.
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2. Content and Form Application
Submission
Mandatory documents for all
applicants include:
• Application forms:
1. SF–424, Application for Federal
Assistance.
2. SF–424A, Budget Information—
Non-Construction Programs.
3. SF–424B, Assurances—NonConstruction Programs.
4. Project Abstract Summary form.
• Project Narrative (not to exceed 25
pages). See Section IV.2.A, Project
Narrative for instructions.
• Budget Justification/Narrative (not
to exceed 5 pages). See Section IV.2.B,
Budget Narrative for instructions.
• Tribal Resolution(s) as described in
Section III, Eligibility.
• 501(c)(3) Certificate, if applicable.
• Biographical sketches for all Key
Personnel.
• Contractor/Consultant resumes or
qualifications and scope of work.
• Disclosure of Lobbying Activities
(SF–LLL), if applicant conducts
reportable lobbying.
• Certification Regarding Lobbying
(GG-Lobbying Form).
• Copy of current Negotiated Indirect
Cost (IDC) rate agreement (required in
order to receive IDC).
• Documentation of current Office of
Management and Budget (OMB)
Financial Audit (if applicable).
Acceptable forms of documentation
include:
1. Email confirmation from Federal
Audit Clearinghouse (FAC) that audits
were submitted; or
2. Face sheets from audit reports.
Applicants can find these on the FAC
website at https://facdissem.census
.gov/.
Public Policy Requirements
All Federal public policies apply to
IHS grants and cooperative agreements.
Pursuant to 45 CFR 80.3(d), an
individual shall not be deemed
subjected to discrimination by reason of
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their exclusion from benefits limited by
Federal law to individuals eligible for
benefits and services from the IHS. See
https://www.hhs.gov/grants/grants/
grants-policies-regulations/.
Requirements for Project and Budget
Narratives
A. Project Narrative
This narrative should be a separate
document that is no more than 25 pages
and must: (1) have consecutively
numbered pages; (2) use black font 12
points or larger (applicants may use 10
point font for tables); (3) be singlespaced; and (4) be formatted to fit
standard letter paper (81⁄2 x 11 inches).
Do not combine this document with any
others.
Be sure to succinctly answer all
questions listed under the evaluation
criteria (refer to Section V.1, Evaluation
Criteria) and place all responses and
required information in the correct
section noted below or they will not be
considered or scored. If the narrative
exceeds the overall page limit, the
application will be considered not
responsive and will not be reviewed.
The 25-page limit for the project
narrative does not include the work
plan, standard forms, Tribal
Resolutions, budget, budget narratives,
and/or other items. Page limits for each
section within the project narrative are
guidelines, not hard limits.
There are three parts to the narrative:
Part 1—Introduction and Need for
Assistance; Part 2—Work Plan; and Part
3—Organizational Capabilities. See
below for additional details about what
must be included in the narrative. The
page limits below are for each narrative
and budget submitted.
Part 1: Program Information (Limit—5
Pages)
Section 1: Needs
Please provide a description of the
need for assistance with offering this
program. Applicant should demonstrate
knowledge of: health concerns for AI/
AN youth; health promotion activities
in Tribal communities such as BGCA;
and working with Tribes and Tribal
organizations.
Part 2: Program Planning and Evaluation
(Limit—10 Pages)
Section 1: Program Plans
This section should demonstrate the
soundness and effectiveness of the
proposal. The work plan should be
designed to describe how and when the
sites will be selected; describe how the
sites will be trained on the curriculum
and provided technical assistance; and
describe how sites will be supported for
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a physical activity program with the
equipment and participant incentives.
Section 2: Program Evaluation
Describe the plan for collecting data,
monitoring, and assuring quality and
quantity of data and the plan for
evaluating and reporting program
results.
Part 3: Organizational Capabilities
(Limit—10 Pages)
Describe the broader capacity of the
organization to complete the project
outlined in the work plan, including: (1)
identification and bios for key personnel
responsible for completing tasks; (2)
description of the structure of the
organization and chain of responsibility
for successful completion of the project
outline in the work plan; (3) description
of financial and project management
capacity, including information
regarding similarly sized projects in
scope and financial assistance as well as
other grants and projects successfully
completed; (4) description of national
experience in providing administrative
and support services to Tribal youth
organizations, education agencies and
other Tribal programs for the benefit of
AI/AN children and youth and Tribal
communities (indicate experience in
national partnerships or national
support efforts on behalf of AI/AN
communities especially as it pertains to
health concerns); (5) description of
equipment and space available for use
during the proposed project; and (6)
description of specialized experience
working with Native Boys and Girls
Club sites and the TRAIL curriculum
program.
B. Budget Narrative (Limit—5 Pages)
Provide a budget narrative that
explains the amounts requested for each
line item of the budget from the SF–
424A (Budget Information for NonConstruction Programs) for the first year
of the project. The applicant can submit
with the budget narrative a more
detailed spreadsheet than is provided by
the SF–424A (the spreadsheet will not
be considered part of the budget
narrative). The budget narrative should
specifically describe how each item will
support the achievement of proposed
objectives. Be very careful about
showing how each item in the ‘‘Other’’
category is justified. For subsequent
budget years (see Multi-Year Project
Requirements in Section V.1,
Application Review Information,
Evaluation Criteria), the additional
pages should highlight the changes from
the first year or clearly indicate that
there are no substantive budget changes
during the period of performance. Do
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NOT use the budget narrative to expand
the project narrative.
3. Submission Dates and Times
Applications must be submitted
through Grants.gov by 11:59 p.m.
Eastern Time on the Application
Deadline Date. Any application received
after the application deadline will not
be accepted for review. Grants.gov will
notify the applicant via email if the
application is rejected.
If technical challenges arise and
assistance is required with the
application process, contact Grants.gov
Customer Support (see contact
information at https://www.Grants.gov).
If problems persist, contact Mr. Paul
Gettys (Paul.Gettys@ihs.gov), Deputy
Director, DGM, by telephone at (301)
443–2114. Please be sure to contact Mr.
Gettys at least 10 days prior to the
application deadline. Please do not
contact the DGM until you have
received a Grants.gov tracking number.
In the event you are not able to obtain
a tracking number, call the DGM as soon
as possible.
The IHS will not acknowledge receipt
of applications.
4. Intergovernmental Review
Executive Order 12372 requiring
intergovernmental review is not
applicable to this program.
5. Funding Restrictions
• Pre-award costs are not allowable.
• The available funds are inclusive of
direct and indirect costs.
• Only one cooperative agreement
may be awarded per applicant.
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6. Electronic Submission Requirements
All applications must be submitted
via Grants.gov. Please use the https://
www.Grants.gov website to submit an
application. Find the application by
selecting the ‘‘Search Grants’’ link on
the homepage. Follow the instructions
for submitting an application under the
Package tab. No other method of
application submission is acceptable.
If you cannot submit an application
through Grants.gov, you must request a
waiver prior to the application due date.
This contact must be initiated prior to
the application due date or your waiver
request will be denied. Prior approval
must be requested and obtained from
Mr. Paul Gettys, Deputy Director, DGM.
You must send a written waiver request
to GrantsPolicy@ihs.gov with a copy to
Paul.Gettys@ihs.gov. The waiver request
must be documented in writing (emails
are acceptable) before submitting an
application by some other method, and
must include clear justification for the
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need to deviate from the required
application submission process.
If the DGM approves your waiver
request, you will receive a confirmation
of approval email containing
submission instructions. You must
include a copy of the written approval
with the application submitted to the
DGM. Applications that do not include
a copy of the signed waiver from the
Deputy Director of the DGM will not be
reviewed. The Grants Management
Officer of the DGM will notify the
applicant via email of this decision.
Applications submitted under waiver
must be received by the DGM no later
than 5:00 p.m. Eastern Time on the
Application Deadline Date. Late
applications will not be accepted for
processing. Applicants that do not
register for both the System for Award
Management (SAM) and Grants.gov
and/or fail to request timely assistance
with technical issues will not be
considered for a waiver to submit an
application via alternative method.
Please be aware of the following:
• Please search for the application
package in https://www.Grants.gov by
entering the Assistance Listing (CFDA)
number or the Funding Opportunity
Number. Both numbers are located in
the header of this announcement.
• If you experience technical
challenges while submitting your
application, please contact Grants.gov
Customer Support (see contact
information at https://www.Grants.gov).
• Upon contacting Grants.gov, obtain
a tracking number as proof of contact.
The tracking number is helpful if there
are technical issues that cannot be
resolved and a waiver from the agency
must be obtained.
• Applicants are strongly encouraged
not to wait until the deadline date to
begin the application process through
Grants.gov as the registration process for
SAM and Grants.gov could take up to 20
working days.
• Please follow the instructions on
Grants.gov to include additional
documentation that may be requested by
this funding announcement.
• Applicants must comply with any
page limits described in this funding
announcement.
• After submitting the application,
you will receive an automatic
acknowledgment from Grants.gov that
contains a Grants.gov tracking number.
The IHS will not notify you that the
application has been received.
System for Award Management (SAM)
Organizations that are not registered
with SAM must access the SAM online
registration through the SAM home page
at https://sam.gov. United States (U.S.)
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organizations will also need to provide
an Employer Identification Number
from the Internal Revenue Service that
may take an additional 2–5 weeks to
become active. Please see SAM.gov for
details on the registration process and
timeline. Registration with the SAM is
free of charge but can take several weeks
to process. Applicants may register
online at https://sam.gov.
Unique Entity Identifier
Your SAM.gov registration now
includes a Unique Entity Identifier
(UEI), generated by SAM.gov, which
replaces the DUNS number obtained
from Dun and Bradstreet. SAM.gov
registration no longer requires a DUNS
number.
Check your organization’s SAM.gov
registration as soon as you decide to
apply for this program. If your SAM.gov
registration is expired, you will not be
able to submit an application. It can take
several weeks to renew it or resolve any
issues with your registration, so do not
wait.
Check your Grants.gov registration.
Registration and role assignments in
Grants.gov are self-serve functions. One
user for your organization will have the
authority to approve role assignments,
and these must be approved for active
users in order to ensure someone in
your organization has the necessary
access to submit an application.
The Federal Funding Accountability
and Transparency Act of 2006, as
amended (‘‘Transparency Act’’),
requires all HHS awardees to report
information on sub-awards.
Accordingly, all IHS awardees must
notify potential first-tier sub-awardees
that no entity may receive a first-tier
sub-award unless the entity has
provided its UEI number to the prime
awardee organization. This requirement
ensures the use of a universal identifier
to enhance the quality of information
available to the public pursuant to the
Transparency Act.
Additional information on
implementing the Transparency Act,
including the specific requirements for
SAM, are available on the DGM Grants
Management, Policy Topics web page at
https://www.ihs.gov/dgm/policytopics/.
V. Application Review Information
Possible points assigned to each
section are noted in parentheses. The
project narrative and budget narrative
should include only the first year of
activities; information for multi-year
projects should be included as a
separate document. See ‘‘Multi-year
Project Requirements’’ at the end of this
section for more information. The
project narrative should be written in a
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manner that is clear to outside reviewers
unfamiliar with prior related activities
of the applicant. It should be well
organized, succinct, and contain all
information necessary for reviewers to
fully understand the project.
Attachments requested in the criteria do
not count toward the page limit for the
narratives. Points will be assigned to
each evaluation criteria adding up to a
total of 100 possible points. Points are
assigned as follows:
1. Evaluation Criteria
A. Introduction and Need for Assistance
(20 Points)
This section should demonstrate
knowledge of health concerns and
issues regarding AI/AN youth, health
promotion activities in Tribal
communities, and working with Tribes
and Tribal organizations.
B. Work Plan (30 Points)
This section should demonstrate a
sound and effective annual work plan
that will support accomplishment of
deliverables and milestones of the
TRAIL project. The work plan should be
designed to:
a. Describe how and when the sites
will be selected.
b. Describe how the sites will be
trained on the curriculum and provided
technical assistance.
c. Describe the plan for collecting
data, monitoring, and assuring quality
and quantity of data.
d. Describe the plan for evaluating
and reporting.
e. Describe how sites will be
supported for a physical activity
program.
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C. Organizational Capabilities (40
Points)
This section should outline the
broader capacity of the organization to
complete the project outlined in the
work plan. It includes the identification
of personnel responsible for completing
tasks and the chain of responsibility for
successful completion of the project
outline in the work plan. The section
should:
a. Describe the structure of the
organization.
b. Describe the ability of the
organization to manage the proposed
project and include information
regarding similarly sized projects in
scope and financial assistance as well as
other grants and projects successfully
completed.
c. Describe what equipment (i.e.,
phone, websites, etc.) and facility space
(i.e., office space) will be available for
use during the proposed project. Include
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information about any equipment not
currently available that will be
purchased throughout the agreement.
d. List and provide bios for key
personnel who will work on the project.
The section should demonstrate
knowledge in:
i. Financial and project management.
ii. Nationwide experience in
providing administrative and support
services to Tribal youth organizations,
education agencies and other Tribal
programs for the benefit of children and
youth.
iii. AI/AN youth and Tribal
communities and indicate experience in
national partnerships or national
support efforts on behalf of AI/AN
communities especially as it pertains to
health concerns.
iv. Experience working with Tribal
Boys and Girls Club sites and the TRAIL
curriculum program.
v. Local and national evaluation,
including data collection and analysis
D. Categorical Budget and Budget
Justification (10 Points)
This section should provide a clear
estimate of the project program costs
and justification for expenses for the
entire cooperative agreement period.
The budget and budget justification
should be consistent with the tasks
identified in the work plan.
a. Categorical budget (Form SF–424A,
Budget Information Non Construction
Programs) completed for the first budget
period.
b. Narrative justification for all costs,
explaining why each line item is
necessary or relevant to the proposed
project. Include sufficient details to
facilitate the determination of cost allow
ability.
c. Indication of any special start-up
costs.
d. Budget justification should include
a description of the planned costs and
how they relate to or support the
proposed project activities.
Multi-Year Project Requirements
Applications must include a brief
project narrative and budget (one
additional page per year) addressing the
developmental plans for each additional
year of the project. This attachment will
not count as part of the project narrative
or the budget narrative. This narrative
should include discussion regarding the
meaningful use of program
implementation, process, and fidelity
data.
Additional documents can be
uploaded as Other Attachments in
Grants.gov. These can include:
• Work plan, logic model, and/or
timeline for proposed objectives.
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• Position descriptions for key staff.
• Resumes of key staff that reflect
current duties.
• Consultant or contractor proposed
scope of work and letter of commitment
(if applicable).
• Current Indirect Cost Rate
Agreement.
• Map of area identifying project
location(s).
• Additional documents to support
narrative (i.e., data tables, key news
articles, etc.).
2. Review and Selection
Each application will be prescreened
for eligibility and completeness as
outlined in the funding announcement.
Applications that meet the eligibility
criteria shall be reviewed for merit by
the Objective Review Committee (ORC)
based on evaluation criteria. Incomplete
applications and applications that are
not responsive to the administrative
thresholds (budget limit, period of
performance limit) will not be referred
to the ORC and will not be funded. The
program office will notify the applicant
of this determination.
Applicants must address all program
requirements and provide all required
documentation.
3. Notifications of Disposition
All applicants will receive an
Executive Summary Statement from the
IHS Division of Diabetes Treatment and
Prevention within 30 days of the
conclusion of the ORC outlining the
strengths and weaknesses of their
application. The summary statement
will be sent to the Authorizing Official
identified on the face page (SF–424) of
the application.
A. Award Notices for Funded
Applications
The NoA is the authorizing document
for which funds are dispersed to the
approved entities and reflects the
amount of Federal funds awarded, the
purpose of the award, the terms and
conditions of the award, the effective
date of the award, the budget period,
and period of performance. Each entity
approved for funding must have a user
account in GrantSolutions in order to
retrieve the NoA. Please see the Agency
Contacts list in Section VII for the
systems contact information.
B. Approved but Unfunded
Applications
Approved applications not funded
due to lack of available funds will be
held for 1 year. If funding becomes
available during the course of the year,
the application may be reconsidered.
Note: Any correspondence, other than
the official NoA executed by an IHS
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II–27, the IHS requires applicants to
obtain a current IDC rate agreement and
submit it to the DGM prior to the DGM
issuing an award. The rate agreement
must be prepared in accordance with
the applicable cost principles and
VI. Award Administration Information guidance as provided by the cognizant
agency or office. A current rate covers
1. Administrative Requirements
the applicable grant activities under the
Awards issued under this
current award’s budget period. If the
announcement are subject to, and are
current rate agreement is not on file
administered in accordance with, the
with the DGM at the time of award, the
following regulations and policies:
IDC portion of the budget will be
A. The criteria as outlined in this
restricted. The restrictions remain in
program announcement.
place until the current rate agreement is
B. Administrative Regulations for
provided to the DGM.
Grants:
Per 45 CFR 75.414(f) Indirect (F&A)
• Uniform Administrative
costs, ‘‘any non-Federal entity (NFE)
Requirements, Cost Principles, and
[i.e., applicant] that has never received
Audit Requirements for HHS Awards
a negotiated indirect cost rate, . . . may
currently in effect or implemented
elect to charge a de minimis rate of 10
during the period of award, other
percent of modified total direct costs
Department regulations and policies in
which may be used indefinitely. As
effect at the time of award, and
described in Section 75.403, costs must
applicable statutory provisions. At the
be consistently charged as either
time of publication, this includes 45
indirect or direct costs, but may not be
CFR part 75, at https://www.govinfo.gov/ double charged or inconsistently
content/pkg/CFR-2020-title45-vol1/pdf/ charged as both. If chosen, this
CFR-2020-title45-vol1-part75.pdf.
methodology once elected must be used
• Please review all HHS regulatory
consistently for all Federal awards until
provisions for Termination at 45 CFR
such time as the NFE chooses to
75.372, at https://www.ecfr.gov/cgi-bin/
negotiate for a rate, which the NFE may
retrieveECFR?gp&SID=
apply to do at any time.’’
2970eec67399fab1413
Electing to charge a de minimis rate
ede53d7895d99&mc=true&n= of 10 percent only applies to applicants
pt45.1.75&r=PART&ty=
that have never received an approved
HTML&se45.1.75_1372#se45.1.75_ negotiated indirect cost rate from HHS
1372.
or another cognizant Federal agency.
C. Grants Policy:
Applicants awaiting approval of their
• HHS Grants Policy Statement,
indirect cost proposal may request the
Revised January 2007, at https://
10 percent de minimis rate. When the
www.hhs.gov/sites/default/files/grants/
applicant chooses this method, costs
grants/policies-regulations/
included in the indirect cost pool must
hhsgps107.pdf.
not be charged as direct costs to the
D. Cost Principles:
grant.
• Uniform Administrative
Available funds are inclusive of direct
Requirements for HHS Awards, ‘‘Cost
and appropriate indirect costs.
Principles,’’ at 45 CFR part 75 subpart
Approved indirect funds are awarded as
E.
part of the award amount, and no
E. Audit Requirements:
additional funds will be provided.
• Uniform Administrative
Generally, IDC rates for IHS awardees
Requirements for HHS Awards, ‘‘Audit
are negotiated with the Division of Cost
Requirements,’’ at 45 CFR part 75
Allocation at https://rates.psc.gov/ or
subpart F.
the Department of the Interior (Interior
F. As of August 13, 2020, 2 CFR 200
Business Center) at https://ibc.doi.gov/
was updated to include a prohibition on ICS/tribal. For questions regarding the
certain telecommunications and video
indirect cost policy, please call the
surveillance services or equipment. This Grants Management Specialist listed
prohibition is described in 2 CFR
under ‘‘Agency Contacts’’ or write to
200.216. This will also be described in
DGM@ihs.gov.
the terms and conditions of every IHS
3. Reporting Requirements
grant and cooperative agreement
The awardee must submit required
awarded on or after August 13, 2020.
reports consistent with the applicable
2. Indirect Costs
deadlines. Failure to submit required
reports within the time allowed may
This section applies to all awardees
result in suspension or termination of
that request reimbursement of IDC in
an active grant, withholding of
their application budget. In accordance
with HHS Grants Policy Statement, Part additional awards for the project, or
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grants management official announcing
to the project director that an award has
been made to their organization, is not
an authorization to implement their
program on behalf of the IHS.
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49871
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 the
imposition of special award provisions
and/or 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 awardee organization or the
individual responsible for preparation
of the reports. Per DGM policy, all
reports must be submitted electronically
by attaching them as a ‘‘Grant Note’’ in
GrantSolutions. Personnel responsible
for submitting reports will be required
to obtain a login and password for
GrantSolutions. Please use the form
under the Recipient User section of
https://www.grantsolutions.gov/home/
getting-started-request-a-user-account/.
Download the Recipient User Account
Request Form, fill it out completely, and
submit it as described on the web page
and in the form.
The reporting requirements for this
program are noted below.
A. Progress Reports
Program progress reports are required
annually. The progress reports are due
within 30 days after the reporting period
ends (specific dates will be listed in the
NoA Terms and Conditions). These
reports must include a brief comparison
of actual accomplishments to the goals
established for the period, a summary of
progress to date 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 period of performance.
B. Financial Reports
Federal Financial Reports are due 30
days after the end of each budget period,
and a final report is due 90 days after
the end of the period of performance.
Awardees are responsible and
accountable for reporting accurate
information on all required reports: the
Progress Reports and the Federal
Financial Report.
C. Data Collection and Reporting
The BGCA defines impact as the
contribution a Club makes to the
attitudes, skills, values, and behaviors of
Club members that enables them to
succeed in adulthood. BGCA has
designed a model called Formula for
Impact—a roadmap for Clubs to help
ensure that members achieve BGCA’s
priority outcomes of Academic Success,
Good Character and Citizenship, and
Healthy Lifestyles. These priority
outcomes are achieved through the
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implementation of BGCA’s national
programs; education and careers,
character and leadership, health and life
skills, the arts, sports, fitness and
recreation, and specialized programs.
Through Formula for Impact, BGCA and
Clubs are able to use indicators to track
and assess their impact, as well as
demonstrate it in a consistent and
meaningful way. Each Boys & Girls Club
is required to complete the Formula for
Impact Assessment annually.
The National Youth Outcomes
Initiative (NYOI) is an online data
management tool that is designed to
collect data from Clubs, compile that
information, and provides reports on
impact back to Clubs and BGCA. The
NYOI was developed via the National
Commission on Impact’s National
Outcomes Database and Reporting Tool.
One of the priority outcomes tracked
through NYOI is Healthy Lifestyles. The
indicators measured under this outcome
go hand-in-hand with the indicators
measured throughout the TRAIL
program. In addition, the Good
Character and Citizenship indicators
support the TRAIL program requirement
of participants engaging with their
community and community health
partners.
Healthy Lifestyles Indicators:
• Regular physical activity (monitored
daily)
• Good nutrition (examples provided)
• Avoidance of risky behaviors
Good Character and Citizenship
Indicators:
• Contributions to Club and local
community
• Positive opportunities
• Building conflict resolution skills
NYOI also measures Club members’
engagement in the following physical
activities:
• Number of days per week they
participate in physical activity during
their free time;
• Number of days per week they
participate in physical activity during
school physical education class;
• Number of days per week they
participate in physical activity at the
Club;
• Daily fruit and vegetable intake;
• Number of sugar sweetened drinks
consumed per day;
• Alcohol, drug, and tobacco use and
abuse;
• Sexual activity and condom use;
• Demographic information including
gender, age, and grade level of AI/AN
youth participants;
• Pre- and Post-tests to assess
participant knowledge; and
• Quarterly progress reports to
capture program implementation tasks
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and feedback received from youth
participants, family members, and
community members.
D. Federal Sub-award Reporting System
(FSRS)
This award may be subject to the
Transparency Act sub-award and
executive compensation reporting
requirements of 2 CFR part 170.
The Transparency Act requires the
OMB to establish a single searchable
database, accessible to the public, with
information on financial assistance
awards made by Federal agencies. The
Transparency Act also includes a
requirement for awardees of Federal
grants to report information about firsttier sub-awards and executive
compensation under Federal assistance
awards.
The IHS has implemented a Term of
Award into all IHS Standard Terms and
Conditions, NoAs, and funding
announcements regarding the FSRS
reporting requirement. This IHS Term of
Award is applicable to all IHS grant and
cooperative agreements issued on or
after October 1, 2010, with a $25,000
sub-award obligation threshold met for
any specific reporting period.
For the full IHS award term
implementing this requirement and
additional award applicability
information, visit the DGM Grants
Management website at https://
www.ihs.gov/dgm/policytopics/.
E. Non-Discrimination Legal
Requirements for Awardees of Federal
Financial Assistance
Should you successfully compete for
an award, recipients of Federal financial
assistance (FFA) from HHS must
administer their programs in
compliance with Federal civil rights
laws that prohibit discrimination on the
basis of race, color, national origin,
disability, age and, in some
circumstances, religion, conscience, and
sex (including gender identity, sexual
orientation, and pregnancy). This
includes ensuring programs are
accessible to persons with limited
English proficiency and persons with
disabilities. The HHS Office for Civil
Rights provides guidance on complying
with civil rights laws enforced by HHS.
Please see https://www.hhs.gov/civilrights/for-providers/providerobligations/ and https://
www.hhs.gov/civil-rights/forindividuals/nondiscrimination/
index.html.
• Recipients of FFA must ensure that
their programs are accessible to persons
with limited English proficiency. For
guidance on meeting your legal
obligation to take reasonable steps to
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ensure meaningful access to your
programs or activities by limited English
proficiency individuals, see https://
www.hhs.gov/civil-rights/forindividuals/special-topics/limitedenglish-proficiency/fact-sheet-guidance/
index.html and https://www.lep.gov.
• For information on your specific
legal obligations for serving qualified
individuals with disabilities, including
reasonable modifications and making
services accessible to them, see https://
www.hhs.gov/civil-rights/forindividuals/disability/.
• HHS funded health and education
programs must be administered in an
environment free of sexual harassment.
See https://www.hhs.gov/civil-rights/forindividuals/sex-discrimination/
index.html.
• For guidance on administering your
program in compliance with applicable
Federal religious nondiscrimination
laws and applicable Federal conscience
protection and associated antidiscrimination laws, see https://
www.hhs.gov/conscience/conscienceprotections/ and https://
www.hhs.gov/conscience/religiousfreedom/.
F. Federal Awardee Performance and
Integrity Information System (FAPIIS)
The IHS is required to review and
consider any information about the
applicant that is in the FAPIIS at
https://www.fapiis.gov/fapiis/#/home
before making any award in excess of
the simplified acquisition threshold
(currently $250,000) over the period of
performance. An applicant may review
and comment on any information about
itself that a Federal awarding agency
previously entered. The IHS will
consider any comments by the
applicant, in addition to other
information in FAPIIS, in making a
judgment about the applicant’s integrity,
business ethics, and record of
performance under Federal awards
when completing the review of risk
posed by applicants, as described in 45
CFR 75.205.
As required by 45 CFR part 75
Appendix XII of the Uniform Guidance,
NFEs are required to disclose in FAPIIS
any information about criminal, civil,
and administrative proceedings, and/or
affirm that there is no new information
to provide. This applies to NFEs that
receive Federal awards (currently active
grants, cooperative agreements, and
procurement contracts) greater than
$10,000,000 for any period of time
during the period of performance of an
award/project.
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Mandatory Disclosure Requirements
As required by 2 CFR part 200 of the
Uniform Guidance, and the HHS
implementing regulations at 45 CFR part
75, the IHS must require an NFE or an
applicant for a Federal award to
disclose, in a timely manner, in writing
to the IHS or pass-through entity all
violations of Federal criminal law
involving fraud, bribery, or gratuity
violations potentially affecting the
Federal award. All applicants and
awardees must disclose in writing, in a
timely manner, to the IHS and to the
HHS Office of Inspector General all
information related to violations of
Federal criminal law involving fraud,
bribery, or gratuity violations
potentially affecting the Federal award.
45 CFR 75.113.
Disclosures must be sent in writing to:
U.S. Department of Health and Human
Services, Indian Health Service,
Division of Grants Management,
ATTN: Marsha Brookins, Director,
5600 Fishers Lane, Mail Stop: 09E70,
Rockville, MD 20857, (Include
‘‘Mandatory Grant Disclosures’’ in
subject line), Office: (301) 443–4750,
Fax: (301) 594–0899, Email: DGM@
ihs.gov
AND
U.S. Department of Health and Human
Services, Office of Inspector General,
ATTN: Mandatory Grant Disclosures,
Intake Coordinator, 330 Independence
Avenue SW, Cohen Building, Room
5527, Washington, DC 20201, URL:
https://oig.hhs.gov/fraud/reportfraud/, (Include ‘‘Mandatory Grant
Disclosures’’ in subject line), Fax:
(202) 205–0604 (Include ‘‘Mandatory
Grant Disclosures’’ in subject line) or
Email:
MandatoryGranteeDisclosures@
oig.hhs.gov
Failure to make required disclosures
can result in any of the remedies
described in 45 CFR 75.371 Remedies
for noncompliance, including
suspension or debarment (see 2 CFR
part 180 and 2 CFR part 376).
VII. Agency Contacts
1. Questions on the programmatic
issues may be directed to: Ms. Carmen
Licavoli Hardin, Acting Director, Indian
Health Service, Division of Diabetes
Treatment and Prevention, 5600 Fishers
Lane, Mail Stop: 08N34A&B, Rockville,
MD 20897, Phone: 1–844–IHS–DDTP
(1–844–447–3387), Fax: 301–594–6213,
Email: diabetesprogram@ihs.gov.
2. Questions on grants management
and fiscal matters may be directed to:
Donald Gooding, Senior Grants
Management Specialist, Indian Health
Service, Division of Grants
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Management, 5600 Fishers Lane, Mail
Stop: 09E70, Rockville, MD 20857,
Phone: 301–443–2298, Email:
Donald.Gooding@ihs.gov.
3. Questions on systems matters may
be directed to: Paul Gettys, Deputy
Director, Indian Health Service,
Division of Grants Management, 5600
Fishers Lane, Mail Stop: 09E70,
Rockville, MD 20857, Phone: (301) 443–
2114; or the DGM main line (301) 443–
5204, E-Mail: Paul.Gettys@ihs.gov.
VIII. Other Information
The Public Health Service strongly
encourages all grant, cooperative
agreement, and contract awardees to
provide a smoke-free workplace and
promote the non-use of all tobacco
products. In addition, Public Law 103–
227, the Pro-Children Act of 1994,
prohibits smoking in certain facilities
(or in some cases, any portion of the
facility) in which regular or routine
education, library, day care, health care,
or early childhood development
services are provided to children. This
is consistent with the HHS mission to
protect and advance the physical and
mental health of the American people.
Elizabeth A. Fowler,
Acting Director, Indian Health Service.
[FR Doc. 2022–17403 Filed 8–11–22; 8:45 am]
BILLING CODE 4165–16–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Human Genome Research
Institute; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Advisory
Council for Human Genome Research.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend as well
as those who need special assistance,
such as sign language interpretation or
other reasonable accommodations,
should notify the Contact Person listed
below in advance of the meeting. The
meeting will be videocast and can be
accessed from https://www.genome.gov/
about-nhgri/Institute-Advisors/
National-Advisory-Council-for-HumanGenome-Research.
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
PO 00000
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Fmt 4703
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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.
Name of Committee: National Advisory
Council for Human Genome Research.
Date: September 19–20, 2022.
Closed: September 19, 2022, 9:00 a.m. to
9:30 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Human Genome Research
Institute, National Institutes of Health, 6700B
Rockledge Drive, Suite 1100, Bethesda, MD
20892.
Open: September 19, 2022, 10:00 a.m. to
6:30 p.m.
Agenda: Report of Institute Director and
Institute Staff.
Place: National Human Genome Research
Institute, National Institutes of Health, 6700B
Rockledge Drive, Suite 1100, Bethesda, MD
20892.
Closed: September 20, 2022, 10:00 a.m. to
4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Human Genome Research
Institute, National Institutes of Health, 6700B
Rockledge Drive, Suite 1100, Bethesda, MD
20892.
Contact Person: Rudy O. Pozzatti, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, National Human Genome Research
Institute, National Institutes of Health, 6700B
Rockledge Drive, Suite 1100, Bethesda, MD
20892, (301) 402–0838, pozzattr@
mail.nih.gov.
Any interested person may file written
comments with the committee within 15
days after the meeting by forwarding the
statement to the Contact Person listed on this
notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
procedures at https://www.nih.gov/aboutnih/visitor-information/campus-accesssecurity for entrance into on-campus and offcampus facilities. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors attending a meeting on
campus or at an off-campus federal facility
will be asked to show one form of
identification (for example, a governmentissued photo ID, driver’s license, or passport)
and to state the purpose of their visit.
Additional Health and Safety Guidance:
Before attending a meeting at an NIH facility,
it is important that visitors review the NIH
COVID–19 Safety Plan at https://
ors.od.nih.gov/sr/dohs/safety/NIH-covid-19safety-plan/Pages/default.aspx and the NIH
testing and assessment web page at https://
ors.od.nih.gov/sr/dohs/safety/NIH-covid-19safety-plan/COVID-assessment-testing/Pages/
visitor-testing-requirement.aspx for
information about requirements and
procedures for entering NIH facilities,
especially when COVID–19 community
E:\FR\FM\12AUN1.SGM
12AUN1
Agencies
[Federal Register Volume 87, Number 155 (Friday, August 12, 2022)]
[Notices]
[Pages 49865-49873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17403]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service
Healthy Lifestyles in Youth Project
Announcement Type: New.
Funding Announcement Number: HHS-2022-IHS-HLY-0001.
Assistance Listing (Catalog of Federal Domestic Assistance or CFDA)
Number: 93.933.
Key Dates
Application Deadline Date: September 15, 2022.
Earliest Anticipated Start Date: September 30, 2022.
I. Funding Opportunity Description
Statutory Authority
The Indian Health Service (IHS) is accepting applications for a
cooperative agreement for the Healthy Lifestyles in Youth (HLY)
Program. This program is authorized under the Snyder Act, 25 U.S.C. 13;
and the Transfer Act, 42 U.S.C. 2001(a). This program is described in
the Assistance Listings located at https://sam.gov/content/home
(formerly known as the CFDA) under 93.933.
Background
This program promotes healthy lifestyles for American Indian and
[[Page 49866]]
Alaska Native (AI/AN) youth using the curriculum ``Together Raising
Awareness for Indian Life'' (TRAIL) among selected Native Boys and
Girls Club sites. Under this cooperative agreement, IHS proposes to
enter into a collaborative effort/initiative with an entity that has
experience working with Boys and Girls Clubs of America (BGCA),
experience working with and implementing the TRAIL curriculum, and
overall expertise and experience in addressing and evaluating healthy
lifestyle techniques in AI/AN youth. The IHS issued the original
funding opportunity announcement for the HLY cooperative agreement in
2003 and the program has been ongoing since that time.
Purpose
The purpose of this program is to support the IHS mission to
improve the health of AI/AN youth through health promotion and health
education programs. The goal of this IHS cooperative agreement is to
address healthy lifestyle development and emphasize nutrition and
physical activity for AI/AN children and youth 7 through 11 years of
age. To do this, the awardee must meet the following objectives:
Collaborate with selected Native American Boys and Girls
Club sites, via a grant application process;
Provide health and physical education programs;
Help youth achieve and maintain healthy lifestyles through
participation in fitness programs;
Help youth acquire a range of physical skills; and
Help youth develop a sense of teamwork and cooperation.
These early intervention strategies provide evidence based
opportunities to reduce and/or halt the increasing trend of obesity and
diabetes among youth and young adults. Native Boys and Girls Clubs that
develop a health promotion program that includes the TRAIL curriculum
may help curtail the effects of unhealthy eating behaviors and lack of
physical activity that can lead to obesity, diabetes, and other chronic
diseases later in life. The TRAIL curriculum was developed to provide
information on good nutrition and to promote physical activity among
youth participating in Native American Boys and Girls Clubs. The TRAIL
curriculum is a 3-month (12 lessons) program that provides youth with a
comprehensive understanding of healthy lifestyles in order to prevent
diabetes. Woven throughout the program are self-esteem and prevention
activities. Participants draw from Tribal traditions and history to
learn about nutrition, healthy food choices, media influences, and the
impact of diabetes. The TRAIL curriculum emphasizes the importance of
teamwork and community service. Members engage in service projects to
improve healthy lifestyles in their communities, including starting
community gardens to connect youth to their food source and organizing
community-wide physical fitness events.
The overall results show improvement in participant knowledge of
diabetes, health, and healthy food choices, as well as improved levels
of fitness and physical activity. To date, this cooperative agreement
has funded over 95 Native American Boys and Girls Club sites that have
established and implemented this curriculum project and have served
over 22,144 AI/AN youth. Program test scores each year consistently
indicate: (a) increased knowledge about diabetes; (b) increased
physical activity; and, (c) increased ability to identify healthier
food options (post-intervention scores vs. pre-intervention test
scores). Program physical activity logs show participating AI/AN youth
collectively perform approximately 20,000 hours of physical activity
each year. Boys and Girls Clubs also report annually on the service
projects that are carried out by TRAIL participants in their local
communities.
Boys and Girl Club sites that are located outside of Tribal
communities are not eligible.
The Boys and Girls Club sites selected by the awardee may use IHS
grant funds to provide services to eligible IHS beneficiaries only. The
awardee will: provide technical consultation; train; monitor; evaluate;
and provide funds to support these activities.
Required, Optional, and Allowable Activities
1. Develop a written plan for the planning, implementation, and
evaluation of this project to include overseeing at least 98 sites, as
agreed upon with the IHS. The local evaluation effort should include
local evidence-based practice (EBP) fidelity data and how data will
integrate with the National Evaluation Frame. Complete this task within
30 days of the award date and obtain approval by the IHS.
2. Develop selection criteria for additional sites as well as
announce, evaluate, and select new sites. Sites must submit
documentation verifying that they serve only AI/AN youth from eligible
IHS beneficiaries, as a requirement for selection by the awardee.
Conduct a start-up planning meeting with new sites within 2 months of
each site's initial selection and award.
3. Plan and conduct an orientation and training meeting for new
sites within 2 months of selection. Submit agenda, training goals and
objectives, and participant list to IHS within 1 month of completion of
each orientation session.
4. Update TRAIL curriculum as needed/directed and implement use.
Document any specific changes to the curriculum and note expected
impacts on implementation, data collection and outcomes.
5. Develop, in consultation with the IHS, the implementation and
technical assistance plan for the coordination of the selected Boys and
Girls Club sites. Submit criteria to the IHS for approval.
6. Each site will implement the TRAIL program, emphasizing healthy
behaviors, such as physical activity and nutrition. Each program plan
will also include a parent component describing approaches for
involving the families of participants.
7. Each site will implement Physical Activity Strength and
Endurance Challenges 3 times, 6 to 8 weeks apart. Physical activity
data will be collected and summarized.
8. Awardee will promote and facilitate local, state, and national
partnerships for the purpose of establishing or enhancing program
support that involves increasing physical activity and good nutrition
for the tribally-managed Boys and Girls Club sites. This includes, but
is not limited to, establishing other partners such as American Indian-
Alaska Native Program Branch (AI-ANPB) of Head Start Programs, Wings of
America, United National Indian Tribal Youth, Inc. (UNITY), Tribal
colleges, BGCA, Tribal organizations, local community health providers,
and other private organizations as appropriate.
9. Awardee will continue to implement current evaluation processes
in consultation for the TRAIL project. At a minimum, the evaluation
will include:
a. training attendance (gender, age, grade level);
b. pre- and post- tests to assess participant knowledge;
c. monthly activity logs from each site on the physical activity
portion of their program. Daily data to be collected includes the date,
number of minutes of physical activity, and number of children
participating; and
d. information/log on parent and family participation in education
and activity programs, community involvement and partnerships.
10. Submit collated and summarized data to the IHS. Work with the
IHS in
[[Page 49867]]
drafting an evaluation summary at the end of the project period. Submit
collated and summarized data and project evaluation summaries to all
sites. Provide a minimum of annual reports (feedback) to each site on
how their data compare to data (mean, median, and range) from other
selected sites.
11. Provide ongoing technical support to the sites for the duration
of the initiative. Provide training and technical assistance in all
forms, i.e., on-site, on-line, by phone, and mail. The planning,
design, and delivery of training and technical assistance will support
the local organization's long-term planning and outreach efforts. The
training will be customized based on sites' capability and experience.
Technical assistance will also be provided on program planning,
implementation, evaluation, and data collection. Collaborate with the
IHS to provide services to club sites. Maintain records and reports.
12. Provide technical assistance to the sites in developing a
written work plan, with measurable goals, objectives and activities
that adheres to the terms and conditions of the cooperative agreement.
13. Establish a formal agreement with Native American Boys and
Girls Club sites, involving funding assistance and technical support to
ensure clubs successfully implement the TRAIL program.
14. Submit to the IHS a written work plan and report describing
each site's demographics, information on the number of youth in the
eligible age range in the catchment area, the number that attend the
Boys and Girls Clubs regularly, and the number served by this project,
goals, objectives, activities, partnerships, and proposed outcomes.
15. Provide the IHS written quarterly reports on the evaluation
outcomes, activity reports at each site, any parent involvement
activities and other participation, description of the community
partnerships, and other activities as appropriate. Conduct quarterly
conference calls with IHS to review project status.
II. Award Information
Funding Instrument--Cooperative Agreement
Estimated Funds Available
The total funding identified for the first budget year, starting in
fiscal year (FY) 2022, is approximately $1,250,000. The funding
available for competing and subsequent continuation awards issued under
this announcement is subject to the availability of appropriations and
budgetary priorities of the Agency. The IHS is under no obligation to
make awards that are selected for funding under this announcement.
Anticipated Number of Awards
One award will be issued under this program announcement.
Period of Performance
The project period is for 5 years.
Cooperative Agreement
Cooperative agreements awarded by the Department of Health and
Human Services (HHS) are administered under the same policies as
grants. However, the funding agency, IHS, is anticipated to have
substantial programmatic involvement in the project during the entire
period of performance. Below is a detailed description of the level of
involvement required of the IHS.
Substantial Agency Involvement Description for Cooperative Agreement
(1) Identify a core group of IHS staff to work with the awardee in
providing technical assistance and guidance.
(2) Meet with the awardee to review awardee work plan and provide
guidance on implementation, program evaluation, and data collection
strategy and tools.
(3) Participate in quarterly conference calls. Work with the
awardee to display the results of this project by publishing on shared
websites as well as in jointly authored publications.
(4) Use the evidence-based program(s), framework(s), and data
collection requirement(s) to develop a National Logic Model and
Evaluation Plan to collect national program aggregate and local EBP
fidelity data.
III. Eligibility Information
1. Eligibility
To be eligible for this funding opportunity an applicant must be an
organization with extensive experience developing and managing youth
programs, health advocacy and education, and outreach related to AI/AN
health care on a national scale.
The program office will notify any applicants deemed ineligible.
Note: Please refer to Section IV.2 (Application and Submission
Information/Subsection 2, Content and Form of Application
Submission) for additional proof of applicant status documents
required, such as Tribal Resolutions, proof of nonprofit status,
etc.
2. Cost Sharing or Matching
The IHS does not require matching funds or cost sharing for grants
or cooperative agreements.
3. Other Requirements
Applications with budget requests that exceed the highest dollar
amount outlined under Section II Award Information, Estimated Funds
Available, or exceed the period of performance outlined under Section
II Award Information, Period of Performance, are considered not
responsive and will not be reviewed. The Division of Grants Management
(DGM) will notify the applicant.
The following documentation is required (if applicable):
Tribal Resolution
The DGM must receive an official, signed Tribal Resolution prior to
issuing a Notice of Award (NoA) to any Tribe or Tribal organization
selected for funding. An applicant that is proposing a project
affecting another Indian Tribe must include resolutions from all
affected Tribes to be served. However, if an official signed Tribal
Resolution cannot be submitted with the application prior to the
application deadline date, a draft Tribal Resolution must be submitted
with the application by the deadline date in order for the application
to be considered complete and eligible for review. The draft Tribal
Resolution is not in lieu of the required signed resolution but is
acceptable until a signed resolution is received. If an application
without a signed Tribal Resolution is selected for funding, the
applicant will be contacted by the Grants Management Specialist (GMS)
listed in this funding announcement and given 90 days to submit an
official signed Tribal Resolution to the GMS. If the signed Tribal
Resolution is not received within 90 days, the award will be forfeited.
Tribes organized with a governing structure other than a Tribal
council may submit an equivalent document commensurate with their
governing organization.
Proof of Nonprofit Status
Organizations claiming nonprofit status must submit a current copy
of the 501(c)(3) Certificate with the application.
IV. Application and Submission Information
Grants.gov uses a Workspace model for accepting applications. The
Workspace consists of several online forms and three forms in which to
upload documents--Project Narrative, Budget Narrative, and Other
Documents. Give your files brief descriptive names. The filenames are
key in finding specific documents during the objective review and in
processing awards.
[[Page 49868]]
Upload all requested and optional documents individually, rather than
combining them into a package. Creating a package creates confusion
when trying to find specific documents. Such confusion can contribute
to delays in processing awards, and could lead to lower scores during
the objective review.
1. Obtaining Application Materials
The application package and detailed instructions for this
announcement are available at https://www.Grants.gov.
Please direct questions regarding the application process to
[email protected].
2. Content and Form Application Submission
Mandatory documents for all applicants include:
Application forms:
1. SF-424, Application for Federal Assistance.
2. SF-424A, Budget Information--Non-Construction Programs.
3. SF-424B, Assurances--Non-Construction Programs.
4. Project Abstract Summary form.
Project Narrative (not to exceed 25 pages). See Section
IV.2.A, Project Narrative for instructions.
Budget Justification/Narrative (not to exceed 5 pages).
See Section IV.2.B, Budget Narrative for instructions.
Tribal Resolution(s) as described in Section III,
Eligibility.
501(c)(3) Certificate, if applicable.
Biographical sketches for all Key Personnel.
Contractor/Consultant resumes or qualifications and scope
of work.
Disclosure of Lobbying Activities (SF-LLL), if applicant
conducts reportable lobbying.
Certification Regarding Lobbying (GG-Lobbying Form).
Copy of current Negotiated Indirect Cost (IDC) rate
agreement (required in order to receive IDC).
Documentation of current Office of Management and Budget
(OMB) Financial Audit (if applicable).
Acceptable forms of documentation include:
1. Email confirmation from Federal Audit Clearinghouse (FAC) that
audits were submitted; or
2. Face sheets from audit reports. Applicants can find these on the
FAC website at https://facdissem.census .gov/.
Public Policy Requirements
All Federal public policies apply to IHS grants and cooperative
agreements. Pursuant to 45 CFR 80.3(d), an individual shall not be
deemed subjected to discrimination by reason of their exclusion from
benefits limited by Federal law to individuals eligible for benefits
and services from the IHS. See https://www.hhs.gov/grants/grants/grants-policies-regulations/.
Requirements for Project and Budget Narratives
A. Project Narrative
This narrative should be a separate document that is no more than
25 pages and must: (1) have consecutively numbered pages; (2) use black
font 12 points or larger (applicants may use 10 point font for tables);
(3) be single-spaced; and (4) be formatted to fit standard letter paper
(8\1/2\ x 11 inches). Do not combine this document with any others.
Be sure to succinctly answer all questions listed under the
evaluation criteria (refer to Section V.1, Evaluation Criteria) and
place all responses and required information in the correct section
noted below or they will not be considered or scored. If the narrative
exceeds the overall page limit, the application will be considered not
responsive and will not be reviewed. The 25-page limit for the project
narrative does not include the work plan, standard forms, Tribal
Resolutions, budget, budget narratives, and/or other items. Page limits
for each section within the project narrative are guidelines, not hard
limits.
There are three parts to the narrative: Part 1--Introduction and
Need for Assistance; Part 2--Work Plan; and Part 3--Organizational
Capabilities. See below for additional details about what must be
included in the narrative. The page limits below are for each narrative
and budget submitted.
Part 1: Program Information (Limit--5 Pages)
Section 1: Needs
Please provide a description of the need for assistance with
offering this program. Applicant should demonstrate knowledge of:
health concerns for AI/AN youth; health promotion activities in Tribal
communities such as BGCA; and working with Tribes and Tribal
organizations.
Part 2: Program Planning and Evaluation (Limit--10 Pages)
Section 1: Program Plans
This section should demonstrate the soundness and effectiveness of
the proposal. The work plan should be designed to describe how and when
the sites will be selected; describe how the sites will be trained on
the curriculum and provided technical assistance; and describe how
sites will be supported for a physical activity program with the
equipment and participant incentives.
Section 2: Program Evaluation
Describe the plan for collecting data, monitoring, and assuring
quality and quantity of data and the plan for evaluating and reporting
program results.
Part 3: Organizational Capabilities (Limit--10 Pages)
Describe the broader capacity of the organization to complete the
project outlined in the work plan, including: (1) identification and
bios for key personnel responsible for completing tasks; (2)
description of the structure of the organization and chain of
responsibility for successful completion of the project outline in the
work plan; (3) description of financial and project management
capacity, including information regarding similarly sized projects in
scope and financial assistance as well as other grants and projects
successfully completed; (4) description of national experience in
providing administrative and support services to Tribal youth
organizations, education agencies and other Tribal programs for the
benefit of AI/AN children and youth and Tribal communities (indicate
experience in national partnerships or national support efforts on
behalf of AI/AN communities especially as it pertains to health
concerns); (5) description of equipment and space available for use
during the proposed project; and (6) description of specialized
experience working with Native Boys and Girls Club sites and the TRAIL
curriculum program.
B. Budget Narrative (Limit--5 Pages)
Provide a budget narrative that explains the amounts requested for
each line item of the budget from the SF-424A (Budget Information for
Non-Construction Programs) for the first year of the project. The
applicant can submit with the budget narrative a more detailed
spreadsheet than is provided by the SF-424A (the spreadsheet will not
be considered part of the budget narrative). The budget narrative
should specifically describe how each item will support the achievement
of proposed objectives. Be very careful about showing how each item in
the ``Other'' category is justified. For subsequent budget years (see
Multi-Year Project Requirements in Section V.1, Application Review
Information, Evaluation Criteria), the additional pages should
highlight the changes from the first year or clearly indicate that
there are no substantive budget changes during the period of
performance. Do
[[Page 49869]]
NOT use the budget narrative to expand the project narrative.
3. Submission Dates and Times
Applications must be submitted through Grants.gov by 11:59 p.m.
Eastern Time on the Application Deadline Date. Any application received
after the application deadline will not be accepted for review.
Grants.gov will notify the applicant via email if the application is
rejected.
If technical challenges arise and assistance is required with the
application process, contact Grants.gov Customer Support (see contact
information at https://www.Grants.gov). If problems persist, contact
Mr. Paul Gettys ([email protected]), Deputy Director, DGM, by
telephone at (301) 443-2114. Please be sure to contact Mr. Gettys at
least 10 days prior to the application deadline. Please do not contact
the DGM until you have received a Grants.gov tracking number. In the
event you are not able to obtain a tracking number, call the DGM as
soon as possible.
The IHS will not acknowledge receipt of applications.
4. Intergovernmental Review
Executive Order 12372 requiring intergovernmental review is not
applicable to this program.
5. Funding Restrictions
Pre-award costs are not allowable.
The available funds are inclusive of direct and indirect
costs.
Only one cooperative agreement may be awarded per
applicant.
6. Electronic Submission Requirements
All applications must be submitted via Grants.gov. Please use the
https://www.Grants.gov website to submit an application. Find the
application by selecting the ``Search Grants'' link on the homepage.
Follow the instructions for submitting an application under the Package
tab. No other method of application submission is acceptable.
If you cannot submit an application through Grants.gov, you must
request a waiver prior to the application due date. This contact must
be initiated prior to the application due date or your waiver request
will be denied. Prior approval must be requested and obtained from Mr.
Paul Gettys, Deputy Director, DGM. You must send a written waiver
request to [email protected] with a copy to [email protected]. The
waiver request must be documented in writing (emails are acceptable)
before submitting an application by some other method, and must include
clear justification for the need to deviate from the required
application submission process.
If the DGM approves your waiver request, you will receive a
confirmation of approval email containing submission instructions. You
must include a copy of the written approval with the application
submitted to the DGM. Applications that do not include a copy of the
signed waiver from the Deputy Director of the DGM will not be reviewed.
The Grants Management Officer of the DGM will notify the applicant via
email of this decision. Applications submitted under waiver must be
received by the DGM no later than 5:00 p.m. Eastern Time on the
Application Deadline Date. Late applications will not be accepted for
processing. Applicants that do not register for both the System for
Award Management (SAM) and Grants.gov and/or fail to request timely
assistance with technical issues will not be considered for a waiver to
submit an application via alternative method.
Please be aware of the following:
Please search for the application package in https://www.Grants.gov by entering the Assistance Listing (CFDA) number or the
Funding Opportunity Number. Both numbers are located in the header of
this announcement.
If you experience technical challenges while submitting
your application, please contact Grants.gov Customer Support (see
contact information at https://www.Grants.gov).
Upon contacting Grants.gov, obtain a tracking number as
proof of contact. The tracking number is helpful if there are technical
issues that cannot be resolved and a waiver from the agency must be
obtained.
Applicants are strongly encouraged not to wait until the
deadline date to begin the application process through Grants.gov as
the registration process for SAM and Grants.gov could take up to 20
working days.
Please follow the instructions on Grants.gov to include
additional documentation that may be requested by this funding
announcement.
Applicants must comply with any page limits described in
this funding announcement.
After submitting the application, you will receive an
automatic acknowledgment from Grants.gov that contains a Grants.gov
tracking number. The IHS will not notify you that the application has
been received.
System for Award Management (SAM)
Organizations that are not registered with SAM must access the SAM
online registration through the SAM home page at https://sam.gov.
United States (U.S.) organizations will also need to provide an
Employer Identification Number from the Internal Revenue Service that
may take an additional 2-5 weeks to become active. Please see SAM.gov
for details on the registration process and timeline. Registration with
the SAM is free of charge but can take several weeks to process.
Applicants may register online at https://sam.gov.
Unique Entity Identifier
Your SAM.gov registration now includes a Unique Entity Identifier
(UEI), generated by SAM.gov, which replaces the DUNS number obtained
from Dun and Bradstreet. SAM.gov registration no longer requires a DUNS
number.
Check your organization's SAM.gov registration as soon as you
decide to apply for this program. If your SAM.gov registration is
expired, you will not be able to submit an application. It can take
several weeks to renew it or resolve any issues with your registration,
so do not wait.
Check your Grants.gov registration. Registration and role
assignments in Grants.gov are self-serve functions. One user for your
organization will have the authority to approve role assignments, and
these must be approved for active users in order to ensure someone in
your organization has the necessary access to submit an application.
The Federal Funding Accountability and Transparency Act of 2006, as
amended (``Transparency Act''), requires all HHS awardees to report
information on sub-awards. Accordingly, all IHS awardees must notify
potential first-tier sub-awardees that no entity may receive a first-
tier sub-award unless the entity has provided its UEI number to the
prime awardee organization. This requirement ensures the use of a
universal identifier to enhance the quality of information available to
the public pursuant to the Transparency Act.
Additional information on implementing the Transparency Act,
including the specific requirements for SAM, are available on the DGM
Grants Management, Policy Topics web page at https://www.ihs.gov/dgm/policytopics/.
V. Application Review Information
Possible points assigned to each section are noted in parentheses.
The project narrative and budget narrative should include only the
first year of activities; information for multi-year projects should be
included as a separate document. See ``Multi-year Project
Requirements'' at the end of this section for more information. The
project narrative should be written in a
[[Page 49870]]
manner that is clear to outside reviewers unfamiliar with prior related
activities of the applicant. It should be well organized, succinct, and
contain all information necessary for reviewers to fully understand the
project. Attachments requested in the criteria do not count toward the
page limit for the narratives. Points will be assigned to each
evaluation criteria adding up to a total of 100 possible points. Points
are assigned as follows:
1. Evaluation Criteria
A. Introduction and Need for Assistance (20 Points)
This section should demonstrate knowledge of health concerns and
issues regarding AI/AN youth, health promotion activities in Tribal
communities, and working with Tribes and Tribal organizations.
B. Work Plan (30 Points)
This section should demonstrate a sound and effective annual work
plan that will support accomplishment of deliverables and milestones of
the TRAIL project. The work plan should be designed to:
a. Describe how and when the sites will be selected.
b. Describe how the sites will be trained on the curriculum and
provided technical assistance.
c. Describe the plan for collecting data, monitoring, and assuring
quality and quantity of data.
d. Describe the plan for evaluating and reporting.
e. Describe how sites will be supported for a physical activity
program.
C. Organizational Capabilities (40 Points)
This section should outline the broader capacity of the
organization to complete the project outlined in the work plan. It
includes the identification of personnel responsible for completing
tasks and the chain of responsibility for successful completion of the
project outline in the work plan. The section should:
a. Describe the structure of the organization.
b. Describe the ability of the organization to manage the proposed
project and include information regarding similarly sized projects in
scope and financial assistance as well as other grants and projects
successfully completed.
c. Describe what equipment (i.e., phone, websites, etc.) and
facility space (i.e., office space) will be available for use during
the proposed project. Include information about any equipment not
currently available that will be purchased throughout the agreement.
d. List and provide bios for key personnel who will work on the
project. The section should demonstrate knowledge in:
i. Financial and project management.
ii. Nationwide experience in providing administrative and support
services to Tribal youth organizations, education agencies and other
Tribal programs for the benefit of children and youth.
iii. AI/AN youth and Tribal communities and indicate experience in
national partnerships or national support efforts on behalf of AI/AN
communities especially as it pertains to health concerns.
iv. Experience working with Tribal Boys and Girls Club sites and
the TRAIL curriculum program.
v. Local and national evaluation, including data collection and
analysis
D. Categorical Budget and Budget Justification (10 Points)
This section should provide a clear estimate of the project program
costs and justification for expenses for the entire cooperative
agreement period. The budget and budget justification should be
consistent with the tasks identified in the work plan.
a. Categorical budget (Form SF-424A, Budget Information Non
Construction Programs) completed for the first budget period.
b. Narrative justification for all costs, explaining why each line
item is necessary or relevant to the proposed project. Include
sufficient details to facilitate the determination of cost allow
ability.
c. Indication of any special start-up costs.
d. Budget justification should include a description of the planned
costs and how they relate to or support the proposed project
activities.
Multi-Year Project Requirements
Applications must include a brief project narrative and budget (one
additional page per year) addressing the developmental plans for each
additional year of the project. This attachment will not count as part
of the project narrative or the budget narrative. This narrative should
include discussion regarding the meaningful use of program
implementation, process, and fidelity data.
Additional documents can be uploaded as Other Attachments in
Grants.gov. These can include:
Work plan, logic model, and/or timeline for proposed
objectives.
Position descriptions for key staff.
Resumes of key staff that reflect current duties.
Consultant or contractor proposed scope of work and letter
of commitment (if applicable).
Current Indirect Cost Rate Agreement.
Map of area identifying project location(s).
Additional documents to support narrative (i.e., data
tables, key news articles, etc.).
2. Review and Selection
Each application will be prescreened for eligibility and
completeness as outlined in the funding announcement. Applications that
meet the eligibility criteria shall be reviewed for merit by the
Objective Review Committee (ORC) based on evaluation criteria.
Incomplete applications and applications that are not responsive to the
administrative thresholds (budget limit, period of performance limit)
will not be referred to the ORC and will not be funded. The program
office will notify the applicant of this determination.
Applicants must address all program requirements and provide all
required documentation.
3. Notifications of Disposition
All applicants will receive an Executive Summary Statement from the
IHS Division of Diabetes Treatment and Prevention within 30 days of the
conclusion of the ORC outlining the strengths and weaknesses of their
application. The summary statement will be sent to the Authorizing
Official identified on the face page (SF-424) of the application.
A. Award Notices for Funded Applications
The NoA is the authorizing document for which funds are dispersed
to the approved entities and reflects the amount of Federal funds
awarded, the purpose of the award, the terms and conditions of the
award, the effective date of the award, the budget period, and period
of performance. Each entity approved for funding must have a user
account in GrantSolutions in order to retrieve the NoA. Please see the
Agency Contacts list in Section VII for the systems contact
information.
B. Approved but Unfunded Applications
Approved applications not funded due to lack of available funds
will be held for 1 year. If funding becomes available during the course
of the year, the application may be reconsidered.
Note: Any correspondence, other than the official NoA executed by
an IHS
[[Page 49871]]
grants management official announcing to the project director that an
award has been made to their organization, is not an authorization to
implement their program on behalf of the IHS.
VI. Award Administration Information
1. Administrative Requirements
Awards issued under this announcement are subject to, and are
administered in accordance with, the following regulations and
policies:
A. The criteria as outlined in this program announcement.
B. Administrative Regulations for Grants:
Uniform Administrative Requirements, Cost Principles, and
Audit Requirements for HHS Awards currently in effect or implemented
during the period of award, other Department regulations and policies
in effect at the time of award, and applicable statutory provisions. At
the time of publication, this includes 45 CFR part 75, at https://www.govinfo.gov/content/pkg/CFR-2020-title45-vol1/pdf/CFR-2020-title45-vol1-part75.pdf.
Please review all HHS regulatory provisions for
Termination at 45 CFR 75.372, at https://www.ecfr.gov/cgi-bin/retrieveECFR?gp&SID=2970eec67399fab1413ede53d7895d99&mc=true&
;n=pt45.1.75&r=PART&ty=HTML&se45.1.75_1372#se45.1.75_1372.
C. Grants Policy:
HHS Grants Policy Statement, Revised January 2007, at
https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf.
D. Cost Principles:
Uniform Administrative Requirements for HHS Awards, ``Cost
Principles,'' at 45 CFR part 75 subpart E.
E. Audit Requirements:
Uniform Administrative Requirements for HHS Awards,
``Audit Requirements,'' at 45 CFR part 75 subpart F.
F. As of August 13, 2020, 2 CFR 200 was updated to include a
prohibition on certain telecommunications and video surveillance
services or equipment. This prohibition is described in 2 CFR 200.216.
This will also be described in the terms and conditions of every IHS
grant and cooperative agreement awarded on or after August 13, 2020.
2. Indirect Costs
This section applies to all awardees that request reimbursement of
IDC in their application budget. In accordance with HHS Grants Policy
Statement, Part II-27, the IHS requires applicants to obtain a current
IDC rate agreement and submit it to the DGM prior to the DGM issuing an
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 agreement
is not on file with the DGM at the time of award, the IDC portion of
the budget will be restricted. The restrictions remain in place until
the current rate agreement is provided to the DGM.
Per 45 CFR 75.414(f) Indirect (F&A) costs, ``any non-Federal entity
(NFE) [i.e., applicant] that has never received a negotiated indirect
cost rate, . . . may elect to charge a de minimis rate of 10 percent of
modified total direct costs which may be used indefinitely. As
described in Section 75.403, costs must be consistently charged as
either indirect or direct costs, but may not be double charged or
inconsistently charged as both. If chosen, this methodology once
elected must be used consistently for all Federal awards until such
time as the NFE chooses to negotiate for a rate, which the NFE may
apply to do at any time.''
Electing to charge a de minimis rate of 10 percent only applies to
applicants that have never received an approved negotiated indirect
cost rate from HHS or another cognizant Federal agency. Applicants
awaiting approval of their indirect cost proposal may request the 10
percent de minimis rate. When the applicant chooses this method, costs
included in the indirect cost pool must not be charged as direct costs
to the grant.
Available funds are inclusive of direct and appropriate indirect
costs. Approved indirect funds are awarded as part of the award amount,
and no additional funds will be provided.
Generally, IDC rates for IHS awardees are negotiated with the
Division of Cost Allocation at https://rates.psc.gov/ or the Department
of the Interior (Interior Business Center) at https://ibc.doi.gov/ICS/tribal. For questions regarding the indirect cost policy, please call
the Grants Management Specialist listed under ``Agency Contacts'' or
write to [email protected].
3. Reporting Requirements
The awardee must submit required reports consistent with the
applicable deadlines. 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 the imposition of special award
provisions and/or 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 awardee organization
or the individual responsible for preparation of the reports. Per DGM
policy, all reports must be submitted electronically by attaching them
as a ``Grant Note'' in GrantSolutions. Personnel responsible for
submitting reports will be required to obtain a login and password for
GrantSolutions. Please use the form under the Recipient User section of
https://www.grantsolutions.gov/home/getting-started-request-a-user-account/.
Download the Recipient User Account Request Form, fill it out
completely, and submit it as described on the web page and in the form.
The reporting requirements for this program are noted below.
A. Progress Reports
Program progress reports are required annually. The progress
reports are due within 30 days after the reporting period ends
(specific dates will be listed in the NoA Terms and Conditions). These
reports must include a brief comparison of actual accomplishments to
the goals established for the period, a summary of progress to date 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 period of performance.
B. Financial Reports
Federal Financial Reports are due 30 days after the end of each
budget period, and a final report is due 90 days after the end of the
period of performance. Awardees are responsible and accountable for
reporting accurate information on all required reports: the Progress
Reports and the Federal Financial Report.
C. Data Collection and Reporting
The BGCA defines impact as the contribution a Club makes to the
attitudes, skills, values, and behaviors of Club members that enables
them to succeed in adulthood. BGCA has designed a model called Formula
for Impact--a roadmap for Clubs to help ensure that members achieve
BGCA's priority outcomes of Academic Success, Good Character and
Citizenship, and Healthy Lifestyles. These priority outcomes are
achieved through the
[[Page 49872]]
implementation of BGCA's national programs; education and careers,
character and leadership, health and life skills, the arts, sports,
fitness and recreation, and specialized programs. Through Formula for
Impact, BGCA and Clubs are able to use indicators to track and assess
their impact, as well as demonstrate it in a consistent and meaningful
way. Each Boys & Girls Club is required to complete the Formula for
Impact Assessment annually.
The National Youth Outcomes Initiative (NYOI) is an online data
management tool that is designed to collect data from Clubs, compile
that information, and provides reports on impact back to Clubs and
BGCA. The NYOI was developed via the National Commission on Impact's
National Outcomes Database and Reporting Tool. One of the priority
outcomes tracked through NYOI is Healthy Lifestyles. The indicators
measured under this outcome go hand-in-hand with the indicators
measured throughout the TRAIL program. In addition, the Good Character
and Citizenship indicators support the TRAIL program requirement of
participants engaging with their community and community health
partners.
Healthy Lifestyles Indicators:
Regular physical activity (monitored daily)
Good nutrition (examples provided)
Avoidance of risky behaviors
Good Character and Citizenship Indicators:
Contributions to Club and local community
Positive opportunities
Building conflict resolution skills
NYOI also measures Club members' engagement in the following
physical activities:
Number of days per week they participate in physical
activity during their free time;
Number of days per week they participate in physical
activity during school physical education class;
Number of days per week they participate in physical
activity at the Club;
Daily fruit and vegetable intake;
Number of sugar sweetened drinks consumed per day;
Alcohol, drug, and tobacco use and abuse;
Sexual activity and condom use;
Demographic information including gender, age, and grade
level of AI/AN youth participants;
Pre- and Post-tests to assess participant knowledge; and
Quarterly progress reports to capture program
implementation tasks and feedback received from youth participants,
family members, and community members.
D. Federal Sub-award Reporting System (FSRS)
This award may be subject to the Transparency Act sub-award and
executive compensation reporting requirements of 2 CFR part 170.
The Transparency Act requires the OMB to establish a single
searchable database, accessible to the public, with information on
financial assistance awards made by Federal agencies. The Transparency
Act also includes a requirement for awardees of Federal grants to
report information about first-tier sub-awards and executive
compensation under Federal assistance awards.
The IHS has implemented a Term of Award into all IHS Standard Terms
and Conditions, NoAs, and funding announcements regarding the FSRS
reporting requirement. This IHS Term of Award is applicable to all IHS
grant and cooperative agreements issued on or after October 1, 2010,
with a $25,000 sub-award obligation threshold met for any specific
reporting period.
For the full IHS award term implementing this requirement and
additional award applicability information, visit the DGM Grants
Management website at https://www.ihs.gov/dgm/policytopics/.
E. Non-Discrimination Legal Requirements for Awardees of Federal
Financial Assistance
Should you successfully compete for an award, recipients of Federal
financial assistance (FFA) from HHS must administer their programs in
compliance with Federal civil rights laws that prohibit discrimination
on the basis of race, color, national origin, disability, age and, in
some circumstances, religion, conscience, and sex (including gender
identity, sexual orientation, and pregnancy). This includes ensuring
programs are accessible to persons with limited English proficiency and
persons with disabilities. The HHS Office for Civil Rights provides
guidance on complying with civil rights laws enforced by HHS. Please
see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/ and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/.
Recipients of FFA must ensure that their programs are
accessible to persons with limited English proficiency. For guidance on
meeting your legal obligation to take reasonable steps to ensure
meaningful access to your programs or activities by limited English
proficiency individuals, see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/ and https://www.lep.gov.
For information on your specific legal obligations for
serving qualified individuals with disabilities, including reasonable
modifications and making services accessible to them, see https://www.hhs.gov/civil-rights/for-individuals/disability/.
HHS funded health and education programs must be
administered in an environment free of sexual harassment. See https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/.
For guidance on administering your program in compliance
with applicable Federal religious nondiscrimination laws and applicable
Federal conscience protection and associated anti-discrimination laws,
see https://www.hhs.gov/conscience/conscience-protections/
and https://www.hhs.gov/conscience/religious-freedom/.
F. Federal Awardee Performance and Integrity Information System
(FAPIIS)
The IHS is required to review and consider any information about
the applicant that is in the FAPIIS at https://www.fapiis.gov/fapiis/#/home before making any award in excess of the simplified acquisition
threshold (currently $250,000) over the period of performance. An
applicant may review and comment on any information about itself that a
Federal awarding agency previously entered. The IHS will consider any
comments by the applicant, in addition to other information in FAPIIS,
in making a judgment about the applicant's integrity, business ethics,
and record of performance under Federal awards when completing the
review of risk posed by applicants, as described in 45 CFR 75.205.
As required by 45 CFR part 75 Appendix XII of the Uniform Guidance,
NFEs are required to disclose in FAPIIS any information about criminal,
civil, and administrative proceedings, and/or affirm that there is no
new information to provide. This applies to NFEs that receive Federal
awards (currently active grants, cooperative agreements, and
procurement contracts) greater than $10,000,000 for any period of time
during the period of performance of an award/project.
[[Page 49873]]
Mandatory Disclosure Requirements
As required by 2 CFR part 200 of the Uniform Guidance, and the HHS
implementing regulations at 45 CFR part 75, the IHS must require an NFE
or an applicant for a Federal award to disclose, in a timely manner, in
writing to the IHS or pass-through entity all violations of Federal
criminal law involving fraud, bribery, or gratuity violations
potentially affecting the Federal award. All applicants and awardees
must disclose in writing, in a timely manner, to the IHS and to the HHS
Office of Inspector General all information related to violations of
Federal criminal law involving fraud, bribery, or gratuity violations
potentially affecting the Federal award. 45 CFR 75.113.
Disclosures must be sent in writing to:
U.S. Department of Health and Human Services, Indian Health Service,
Division of Grants Management, ATTN: Marsha Brookins, Director, 5600
Fishers Lane, Mail Stop: 09E70, Rockville, MD 20857, (Include
``Mandatory Grant Disclosures'' in subject line), Office: (301) 443-
4750, Fax: (301) 594-0899, Email: [email protected]
AND
U.S. Department of Health and Human Services, Office of Inspector
General, ATTN: Mandatory Grant Disclosures, Intake Coordinator, 330
Independence Avenue SW, Cohen Building, Room 5527, Washington, DC
20201, URL: https://oig.hhs.gov/fraud/report-fraud/, (Include
``Mandatory Grant Disclosures'' in subject line), Fax: (202) 205-0604
(Include ``Mandatory Grant Disclosures'' in subject line) or Email:
[email protected]
Failure to make required disclosures can result in any of the
remedies described in 45 CFR 75.371 Remedies for noncompliance,
including suspension or debarment (see 2 CFR part 180 and 2 CFR part
376).
VII. Agency Contacts
1. Questions on the programmatic issues may be directed to: Ms.
Carmen Licavoli Hardin, Acting Director, Indian Health Service,
Division of Diabetes Treatment and Prevention, 5600 Fishers Lane, Mail
Stop: 08N34A&B, Rockville, MD 20897, Phone: 1-844-IHS-DDTP (1-844-447-
3387), Fax: 301-594-6213, Email: [email protected].
2. Questions on grants management and fiscal matters may be
directed to: Donald Gooding, Senior Grants Management Specialist,
Indian Health Service, Division of Grants Management, 5600 Fishers
Lane, Mail Stop: 09E70, Rockville, MD 20857, Phone: 301-443-2298,
Email: [email protected].
3. Questions on systems matters may be directed to: Paul Gettys,
Deputy Director, Indian Health Service, Division of Grants Management,
5600 Fishers Lane, Mail Stop: 09E70, Rockville, MD 20857, Phone: (301)
443-2114; or the DGM main line (301) 443-5204, E-Mail:
[email protected].
VIII. Other Information
The Public Health Service strongly encourages all grant,
cooperative agreement, and contract awardees to provide a smoke-free
workplace and promote the non-use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of the facility) in
which regular or routine education, library, day care, health care, or
early childhood development services are provided to children. This is
consistent with the HHS mission to protect and advance the physical and
mental health of the American people.
Elizabeth A. Fowler,
Acting Director, Indian Health Service.
[FR Doc. 2022-17403 Filed 8-11-22; 8:45 am]
BILLING CODE 4165-16-P