Funding Opportunity for the Community Opioid Intervention Prevention Program, 87435-87444 [2023-27765]
Download as PDF
Federal Register / Vol. 88, No. 241 / Monday, December 18, 2023 / Notices
Dated: December 11, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–27655 Filed 12–15–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–5344]
Pharmacyclics LLC.; Withdrawal of
Approval of Indications for Mantle Cell
Lymphoma and Marginal Zone
Lymphoma for IMBRUVICA (ibrutinib)
Capsules and Tablets
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing that it is withdrawing
approval of the indications for mantle
cell lymphoma (MCL) and marginal
zone lymphoma (MZL) for IMBRUVICA
(ibrutinib) Capsules and Tablets
approved, respectively, under new drug
applications (NDAs) 205552 and
210563. These NDAs are held by
Pharmacyclics LLC, 1000 Gateway
Blvd., South San Francisco, CA 94080
(Pharmacyclics). Pharmacyclics
voluntarily requested that the Agency
withdraw approval of these indications
and waived its opportunity for a
hearing.
DATES: Approval is withdrawn as of
December 18, 2023.
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137, Kimberly.Lehrfeld@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On
November 13, 2013, FDA approved
NDA 205552 for IMBRUVICA (ibrutinib)
Capsules for the treatment of adult
patients with MCL who have received at
least one prior therapy (the MCL
indication). On January 18, 2017, FDA
approved a prior approval supplement
for NDA 205552 for IMBRUVICA
(ibrutinib) Capsules for the treatment of
adult patients with MZL who require
systemic therapy and have received at
least one prior anti-CD20-based therapy
(the MZL indication). On February 16,
2018, FDA approved NDA 210563 for
IMBRUVICA (ibrutinib) Tablets, a new
dosage form of IMBRUVICA (ibrutinib),
for the MCL and MZL indications. FDA
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SUMMARY:
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approved the MCL and MZL indications
for both products under the Agency’s
accelerated approval regulations, 21
CFR part 314, subpart H. As a condition
of accelerated approval of IMBRUVICA
(ibrutinib) Capsules and Tablets for the
MCL and MZL indications, the
applicant was required to conduct
postmarketing trials to verify the
clinical benefit of ibrutinib for the MCL
and MZL indications.
On February 8, 2023, FDA met with
Pharmacyclics to inform the applicant
of the plans to convene the Oncologic
Drugs Advisory Committee regarding
the accelerated approvals for the MCL
and MZL indications because the
required postmarketing trials did not
verify the clinical benefit of ibrutinib for
these indications. On March 21, 2023,
FDA met with Pharmacyclics to discuss
the applicant’s request to voluntarily
withdraw approval of the MCL and MZL
indications for IMBRUVICA (ibrutinib)
Capsules and Tablets. On April 6, 2023,
Pharmacyclics submitted a letter
requesting withdrawal of the MCL and
MZL indications for IMBRUVICA
(ibrutinib) Capsules and Tablets
pursuant to § 314.150(d) (21 CFR
314.150(d)) and waiving its opportunity
for a hearing.
Therefore, under § 314.150(d),
approvals of the MCL and MZL
indications for IMBRUVICA (ibrutinib)
Capsules and Tablets are withdrawn as
of December 18, 2023. Withdrawal of
approval of these indications does not
affect any other approved indication for
IMBRUVICA (ibrutinib) Capsules and
Tablets.
Dated: December 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–27662 Filed 12–15–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Funding Opportunity for the
Community Opioid Intervention
Prevention Program
Announcement Type: New.
Funding Announcement Number:
HHS–2024–IHS–COIPP–0001.
Assistance Listing (Catalog of Federal
Domestic Assistance or CFDA) Number:
93.654.
Key Dates
Application Deadline Date: February
7, 2024.
Earliest Anticipated Start Date: April
1, 2024.
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I. Funding Opportunity Description
Statutory Authority
The Indian Health Service (IHS),
Office of Clinical and Preventive
Services, Division of Behavioral Health
(DBH) is accepting applications for
grants for the Community Opioid
Intervention Prevention Program
(COIPP). This program is authorized
under the Snyder Act, 25 U.S.C. 13, and
the Transfer Act, 42 U.S.C. 2001(a).
Funding for this program is provided in
the Consolidated Appropriations Act,
2023, Public Law 117–328, 136 Stat.
4459, 4808 (2022). The Assistance
Listings section of SAM.gov (https://
sam.gov/content/home) describes this
program under 93.654.
Background
The initial opioid prevention
program, called the Community Opioid
Intervention Pilot Project, was first
established in Fiscal Year (FY) 2019,
pursuant to Congressional instruction to
better combat the opioid epidemic. The
goal was to create a pilot program to
address the opioid epidemic in Indian
Country and award grants that
supported the development,
documentation, and sharing of locally
designed and culturally appropriate
prevention, treatment, recovery, and
aftercare services for opioid use
disorders in the American Indian and
Alaska Native (AI/AN) communities.
Evidence-based activities are available
for reference at https://www.ihs.gov/
asap/coipp/. A total of 35 grants were
awarded to Tribal and Urban Indian
communities in the pilot phase. Based
on evaluation results from the pilot
project, this funding opportunity will
continue to provide grant support to
Tribal and Urban Indian communities to
continue efforts to combat the opioid
epidemic and develop strategies that
align with the Department of Health and
Human Services Overdose Prevention
Strategy.
The Centers for Disease Control and
Prevention (CDC) reported that the AI/
AN population had the highest drug
overdose death rates in both 2020 and
2021, at rates of 42.5 and 56.6 deaths
per 100,000 persons, respectively. The
AI/AN population also experienced a 33
percent increase in drug overdose
deaths from 2020 through 2021.
Overdose deaths among AI/AN have
continued to increase over the last 20
years. The CDC reported from 2019 to
2020, overdose death rates increased 39
percent for the non-Hispanic AI/AN
population and drug overdose death
rates were highest for AI/AN people
compared to other racial and ethnic
groups.
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While the overall AI/AN population is
at risk for overdoses, special
populations to consider are youth,
pregnant persons, young parents, and
those experiencing housing insecurity.
Over the last two decades, opioidrelated overdose mortality among
adolescent and young adults has
increased dramatically. Low-income
women and women of color are at
higher risk for barriers to seek
appropriate care for substance use
disorders during pregnancy. AI/AN
women with opioid use disorder (OUD)
encounter barriers to accessing services
for treatment. Maternal substance
misuse can result in neonatal abstinence
syndrome, a drug withdrawal process in
newborns exposed in utero to drugs.
Correct racial classification is an
important factor in improving data
quality for AI/AN populations and
establishing accurate surveillance to
help address the disproportionate
burden of neonatal abstinence syndrome
among AI/AN.
Housing insecurity takes on many
forms, including homelessness, housing
cost burden, overcrowding, poor quality
housing, and living with persons who
use substances. The rate of AI/AN that
experience housing insecurity is 45 out
of 10,000. Young AI/AN adults are three
times more likely to experience
homelessness than their non-Native
peers and one third of AI/AN adults
experienced homelessness.
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Purpose
The purpose of this grant program is
to address the opioid crisis in AI/AN
communities by doing the following:
first, developing and expanding
community education and awareness of
prevention, treatment, and recovery
activities for opioid misuse and opioid
use disorder; second, increasing
knowledge and use of culturally
appropriate interventions and to
encourage an increased use of
medication-assisted treatment/
medications for opioid use disorder
(MAT/MOUD); third, supporting Tribal
and Urban Indian communities in their
effort to provide prevention, treatment,
and recovery services to address the
impact of the opioid crisis; and fourth,
increase harm reduction within their
communities.
Recipients for this funding
opportunity are required to address the
following four objectives:
1. Increase public awareness and
education about culturally appropriate
and family-centered opioid and
overdose prevention, treatment, and
recovery practices and programs in AI/
AN communities.
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2. Create comprehensive support
teams to strengthen and empower AI/
AN families in addressing the opioid
and overdose crisis in Tribal or Urban
Indian communities.
3. Increase access to MAT/MOUD
treatment for persons who experience
opioid misuse, opioid use disorder, and
opioid related overdoses.
4. Increase harm reduction activities
in Tribal and Urban Indian
communities.
In alignment with the agency goals to
ensure that comprehensive, culturally
appropriate personal and public health
services are available and accessible to
AI/AN people, the COIPP is designed to
provide recipients with the ability to
develop unique and innovative
community interventions that will
address the opioid crisis at a local level.
The IHS supports Tribal and Urban
Indian efforts that include addressing
substance use prevention, treatment,
and aftercare from a community-driven
context. The IHS encourages applicants
to develop and submit a plan that
emphasizes cross-system collaboration,
the inclusion of family, youth,
community resources, and culturally
appropriate approaches.
Recipients are also encouraged to
incorporate foundational elements,
priorities, and strategies from the
National Tribal Behavioral Health
Agenda (TBHA) as appropriate. The
TBHA was developed by Substance
Abuse and Mental Health Services
Administration (SAMHSA) in
collaboration with Tribes, the Indian
Health Service, and the National Indian
Health Board. A component of the
TBHA is the AI/AN Cultural Wisdom
Declaration (CWD), which elevates the
importance of Tribal identities, culture,
spiritual beliefs, and practices for
improving well-being. This grant
announcement supports the CWD and
inclusion of ancestral cultural
knowledge, wisdom, ceremony, and
practices of AI/AN Tribes into the grant
application. The TBHA can be found at
https://store.samhsa.gov/product/TheNational-Tribal-BehavioralHealthAgenda/PEP16-NTBH-AGENDA.
Required Activities
The focus of this program is to
support AI/ANs in their efforts to
provide prevention, treatment, aftercare,
and recovery services to address the
impact of the opioid crisis in Native
communities. All COIPP activities
should be culturally-based, and familyoriented.
The IHS is seeking applications that
include the following required
activities:
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1. Community Awareness and
Education:
a. Recipients shall promote family,
youth and community engagement in
the planning and implementation of
opioid use prevention and harm
reduction activities.
b. Recipients shall design community
awareness campaigns and education
programs that inform and train
community members on how to
recognize the signs of opioid misuse and
overdose. Educational tool(s) shall be
culturally-appropriate and intended to
engage families.
c. Recipients will develop educational
resources, such as factsheets using
culturally relevant messaging;
disseminate materials through
community stakeholders and
community partners, and identify
culturally appropriate ways to
implement educational programs in
their local communities.
d. Awareness Campaign should
include instructions on the following,
among others:
• How to access local opioid-specific
services.
• How to safeguard controlled
prescription medications from children
and adolescents.
• How to dispose properly of unused
controlled prescription medications.
2. Expand access to MAT/MOUD
services that include Tribal values,
culture and treatments:
a. Promote family, youth and
community engagement in the planning
and implementation of opioid use
treatment.
b. Increase number of providers
receiving training in MAT/MOUD
services that include Tribal values,
culture, and treatments.
c. Increase access to continuing
education on MAT/MOUD.
d. Expand access to integrated MAT/
MOUD services for Tribal communities,
including TeleMAT.
e. Increase the availability and
utilization of buprenorphine to Tribal
communities in both rural and urban
settings including increased
collaboration with local Emergency
Departments to establish buprenorphine
bridge programs.
3. Build a support system for
strengthening Native families by
implementing culturally-appropriate
approaches.
a. Promote family, youth and
community engagement in the planning
and implementation of opioid use
recovery activities.
b. Develop a family-focused and
culturally-based assessment that
captures biopsychosocial needs of AI/
ANs.
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c. Link assessment needs to support
and recovery services.
d. Collaborate with relevant partners
to build a support system for recovery.
4. Increase harm reduction activities.
a. Increase awareness and distribution
of naloxone as an overdose intervention
and teach skills in how to use it.
b. Increase awareness and distribution
of medication lock boxes and teach
skills in how to use.
c. Collaborate with relevant partners
to implement harm reduction activities.
II. Award Information
Funding Instrument—Grant
Estimated Funds Available
The total annual funding identified is
approximately $9.5 million. Individual
award amounts for the first budget year
are anticipated to be between $350,000
and $500,000. The funding available for
subsequent budget years 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 to applicants selected for
funding under this announcement.
The actual amount available will not
be determined until enactment of the FY
24 Fiscal Year federal budget. This
program announcement is subject to the
appropriation of funds, and is a
contingency action taken to ensure that,
should funds become available for this
purpose, applications can be processed,
and funds can be awarded in a timely
manner.
Anticipated Number of Awards
The IHS anticipates issuing up to 27
awards under this program
announcement.
Period of Performance
2. Additional Information on Eligibility
The period of performance is for 5
years.
III. Eligibility Information
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1. Eligibility
To be eligible for this funding
opportunity an applicant must be one of
the following, as defined by 25 U.S.C.
1603:
• A federally recognized Indian Tribe
as defined by 25 U.S.C. 1603(14). The
term ‘‘Indian Tribe’’ means any Indian
Tribe, band, nation, or other organized
group or community, including any
Alaska Native village or group, or
regional or village corporation, as
defined in or established pursuant to the
Alaska Native Claims Settlement Act (85
Stat. 688) [43 U.S.C. 1601 et seq.], which
is recognized as eligible for the special
programs and services provided by the
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United States to Indians because of their
status as Indians.
• A Tribal organization as defined by
25 U.S.C. 1603(26). The term ‘‘Tribal
organization’’ has the meaning given the
term in section 4 of the Indian SelfDetermination and Education
Assistance Act (25 U.S.C. 5304(l)):
‘‘Tribal organization’’ means the
recognized governing body of any
Indian Tribe; any legally established
organization of Indians which is
controlled, sanctioned, or chartered by
such governing body or which is
democratically elected by the adult
members of the Indian community to be
served by such organization and which
includes the maximum participation of
Indians in all phases of its activities:
provided that, in any case where a
contract is let or grant made to an
organization to perform services
benefiting more than one Indian Tribe,
the approval of each such Indian Tribe
shall be a prerequisite to the letting or
making of such contract or grant.
Applicant shall submit letters of support
and/or Tribal Resolutions from the
Tribes to be served.
• An Urban Indian Organization
(UIO), as defined by 25 U.S.C. 1603(29).
The term ‘‘Urban Indian Organization’’
means a nonprofit corporate body
situated in an urban center, governed by
an Urban Indian controlled board of
directors, and providing for the
maximum participation of all interested
Indian groups and individuals, which
body is capable of legally cooperating
with other public and private entities
for the purpose of performing the
activities described in 25 U.S.C. 1653(a).
Applicants must provide proof of nonprofit status with the application, e.g.,
501(c)(3).
The IHS does not fund concurrent
projects. If an applicant is successful
under this announcement, any
subsequent applications in response to
other COIPP announcements from the
same applicant will not be funded.
Applications on behalf of individuals
(including sole proprietorships) and
foreign organizations are not eligible.
Applications deemed ineligible will be
disqualified from competitive review
and funding under this funding
opportunity.
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.
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87437
3. Cost Sharing or Matching
The IHS does not require matching
funds or cost sharing for grants or
cooperative agreements.
4. 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 DGM will notify the
applicant.
Additional Required Documentation
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.
Applicants organized with a
governing structure other than a Tribal
council may submit an equivalent
document commensurate with their
governing organization. Please include
documentation explaining and
substantiating this.
Proof of Non-Profit Status
Organizations claiming non-profit
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
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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 merit
review and in processing awards.
Upload all requested and optional
documents individually, rather than
combining them into a single file.
Creating a single file 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 merit 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
applications are listed below. An
application is incomplete if any of the
listed mandatory documents are
missing. Incomplete applications will
not be reviewed.
• 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 10
pages). See Section IV.2.A, Project
Narrative for instructions.
• Budget Narrative (not to exceed 4
pages). See Section IV.2.B, Budget
Narrative for instructions.
• One-page Timeframe Chart.
• Biographical sketches for all Key
Personnel.
• Contractor/Consultant resumes or
qualifications and scope of work.
• Certification Regarding Lobbying
(GG-Lobbying Form).
• Organizational Chart (optional).
The documents listed here may be
required. Please read this list carefully.
• Tribal Resolution(s) as described in
Section III, Eligibility.
• Letters of Support from
organization’s Board of Directors.
• Disclosure of Lobbying Activities
(SF–LLL), if applicant conducts
reportable lobbying.
• 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:
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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/
.
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.
• Organizational chart.
• Map of area identifying project
location(s).
• Additional documents to support
narrative (i.e., data tables, key news
articles, etc.).
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 10 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
reviewers will be directed to ignore any
content beyond the page limit. The 10page 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.
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There are four parts to the project
narrative:
Part 1—Statement of Need;
Part 2—Program Plan—Objectives and
Activities;
Part 3—Organizational Capacity; and
Part 4—Program Evaluation (Data
Collection and Reporting).
See below for additional details about
what must be included in the narrative.
Part 1: Statement of Need (Limit—1
Page)
Describe the extent of the problem
related to opioid misuse, opioid use
disorder, and opioid related overdoses
in the applicant’s community
(‘‘community’’ means the applicant’s
Tribe, village, Tribal organization,
consortium of Tribes or Tribal
organizations, or urban center). Provide
the facts and evidence that support the
need for the project and establish that
the Tribe, Tribal organization, or UIO
understand the problems and can
reasonably address them. This section
must also succinctly but completely
answer the questions listed under the
evaluation criteria in Section V.1.A.
Statement of Need.
Part 2: Program Plan—Objectives and
Activities (Limit—6 Pages)
Describe the scope of work the Tribe,
Tribal organization, or UIO by clearly
and concisely outlining the following
required components:
1. Goals and Objectives. Reference all
required objectives.
2. Project Activities. Link your project
activities to your outlined goals and
objectives.
This section must also succinctly but
completely answer the questions listed
under the evaluation criteria in Section
V.1.B. Program Plan (Objectives and
Activities).
Part 3: Organizational Capacity (Limit—
2 Pages)
Describe the Tribe, Tribal
organization, or UIO’s organizational
capacity to implement the proposed
activities, in the following areas: Ability
to provide direct care, treatment, and
services, including MAT/MOUD;
current or ongoing projects related to
opioid prevention, treatment, recovery
support, and aftercare; a detailed
description of partnerships and
networks with opioid misuse and harm
reduction providers. Provide detail on
significant program activities and
achievements/accomplishments over
the past 5 years associated with opioid
prevention, treatment, recovery support,
and aftercare activities. Provide success
stories, data, or other examples of how
other funded projects/programs made an
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impact in your community to address
opioid use. If applicable, provide
justification for lack of progress of
previous efforts. This section must also
succinctly but completely answer the
questions listed under the evaluation
criteria in Section V.1.C. Organizational
Capacity.
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Part 4: Program Evaluation (Limit 1
Page)
Based on the required activities in
Section V, describe how the Tribe,
Tribal organization, or UIO plans to
collect data for the proposed project and
activities. Identify any type(s) of
evaluation(s) that will be used and how
you will collaborate with partners to
complete any evaluation efforts or data
collection. Progress reports will include
compilation of quantitative data (e.g.,
number served; screenings completed,
etc.) and qualitative or narrative (text)
data. Reporting elements should be
specific to activities/programs,
processes and outcomes such as
performance measures and other data
relevant to evaluation outcomes
including intended results (i.e., impact
and outcomes). Logic Models are highly
recommended to include in the
application. The IHS will partner with
Technical Assistance Providers to assist
recipients develop data collection and
evaluation plans and tools. Recipients
will be required to collect and submit
semi-annual and annual progress
reports. Additional information
regarding Data Collection refer to
Section V.1.D. Program Evaluation (Data
Collection & Reporting).
B. Budget Narrative (Limit—4 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 entire
project, by year. 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
would support the achievement of
proposed objectives. Be very careful
about showing how each item in the
‘‘Other’’ category is justified. Do 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
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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, Deputy Director, DGM, by email
at DGM@ihs.gov. 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
• The available funds are inclusive of
direct and indirect costs.
• Only one grant may be awarded per
applicant.
• Food is an allowable expense under
this program. Recipient may not exceed
$10,000.00.
• While construction is not an
allowable cost, alteration and
renovation (A&R) is allowable. A&R
must be consistent with the following
criteria and documentation
requirements:
a. The building has a useful life
consistent with program purposes and is
architecturally and structurally suitable
for conversion to the type of space
required.
b. The A&R is essential to the purpose
of the grant-supported project or
program.
c. The space involved will be
occupied by the project or program.
d. The space is suitable for human
occupancy before A&R work is started
except where the purpose of the A&R is
to make the space suitable for some
purpose other than human occupancy,
such as storage.
e. For minor A&R, if the space is
rented, evidence is provided that the
terms of the lease are compatible with
the A&R proposed and cover the
duration of the period of performance.
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
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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.
You must submit your waiver request by
email to DGM@ihs.gov. Your waiver
request must include clear justification
for the need to deviate from the required
application submission process. The
IHS will not accept any applications
submitted through any means outside of
Grants.gov without an approved waiver.
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 waiver approval from 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 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
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acknowledgment from Grants.gov that
contains a Grants.gov tracking number.
The IHS will not notify you that the
application has been received.
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System for Award Management
Organizations that are not registered
with the System for Award Management
(SAM) must access the SAM online
registration through the SAM home page
at https://sam.gov. Organizations based
in the United States (U.S.) 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 recipients to report
information on sub-awards.
Accordingly, all IHS recipients must
notify potential first-tier sub-recipients
that no entity may receive a first-tier
sub-award unless the entity has
provided its UEI number to the prime
recipient 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/.
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V. Application Review Information
Possible points assigned to each
section are noted in parentheses. The
project narrative and budget narrative
should include the proposed activities
for the entire period of performance.
The project narrative should be written
in a 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
Applications will be reviewed and
scored according to the quality of
responses to the required application
components in Sections A—E. The
number of points after each heading is
the maximum number of points a
review committee may assign to that
section. Although scoring weights are
not assigned to individual numbers,
responses to each number are assessed
in deriving the overall section score.
A. Statement of Need (20 Points)
(1) Describe the extent of the problem
related to opioid misuse, opioid use
disorder and opioid related overdoses in
the applicant’s community
(‘‘community’’ means the applicant’s
Tribe, village, Tribal organization,
consortium of Tribes or Tribal
organizations, or urban center). Provide
the facts and evidence that support the
need for the project and establishes that
the Tribe, Tribal organization, or UIO
understands the problems, and can
reasonably address them.
(2) Include a description of social
determinants of health that may
contribute to the opioid misuse, opioid
use disorder, and opioid related
overdoses in the community. Include
details on economic stability (such as
housing and food insecurity); education
(such as early childhood education and
development, high school graduation,
and language and literacy); social and
community context (such as
discrimination, incarceration, and social
cohesion); health and health care (such
as access to health care and health
literacy); and neighborhood and built
environment (such as access to foods
that support healthy eating patterns,
crime and violence, environmental
conditions, and quality of housing).
(3) Provides background information
on the Tribe, Tribal organization, or
UIO.
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(4) Based on the information and/or
data currently available, document the
prevalence of opioid misuse and
overdose rates.
(5) Based on the information and/or
data currently available, document the
need to increase the capacity to
implement, sustain, and improve
effective opioid misuse and overdose
prevention, treatment, aftercare,
recovery, and harm reduction services
in the proposed catchment area that is
consistent with the purpose of this
funding opportunity announcement.
(6) Describe the service gaps and other
problems related to the need for funds
targeting opioid misuse. Identify the
source of the data.
(7) Describe potential Tribal and
community partners and resources in
the catchment area that can participate
in the broad community awareness
campaign.
(8) Affirm the goals of the project are
consistent with priorities of the Tribal
government or board of directors and
that the governing body is in support of
this application.
B. Program Plan—Objectives and
Activities (35 Points)
(1) Identify the population of focus for
your project. Describe the purpose of the
proposed project, including goals and
objectives and how they are linked.
Describe how the achievement of goals
will increase Tribe, Tribal organization,
or UIO’s capacity to support the goals
and required activities identified in
Section I of this announcement.
(2) Describe how the proposed project
activities relate to the proposed project’s
goals and objectives. Describe how the
project activities will increase the
capacity of the community to prevent
and treat opioid misuse, opioid use
disorder, and overdose in the
communities and implement harm
reduction activities.
(3) Describe organizational capacity to
implement the proposed activities,
including increased public awareness
and education on opioids and overdose;
developing a comprehensive support
team to strengthen and empower AI/AN
families in addressing the opioid and
overdose crisis in Tribal or Urban
Indian communities; integrating the use
of MAT/MOUD, and harm reduction
into the community.
(4) Describe how community partners
(prevention and recovery support
providers, substance use disorder
treatment programs, peer recovery
specialists, social workers, behavioral
health clinics, community health
centers, youth serving organizations,
family and youth homeless providers,
child welfare agencies, primary care
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providers, pharmacists, schools, clergy,
and law enforcement, among others)
will be involved in the planning and
implementation of the project.
(5) Describe if/how the efforts of the
proposed project will be coordinated
with any other related Federal grants or
programs funded through the IHS,
SAMHSA, BIA, or other Federal
agencies.
(6) Provide a timeline chart depicting
a realistic timeline for the project period
showing key activities, milestones, and
responsible staff. These key activities
should include the required activities
identified in Section V of this
announcement.
C. Organizational Capacity (15 Points)
Organizational capacity including
increased public awareness and
education on opioids; developing a
comprehensive support team to
strengthen and empower AI/AN families
in addressing the opioid crisis in Tribal
or Urban Indian communities;
integrating the use of MAT/MOUD, and
implementing harm reduction activities
into the Tribal and Urban Indian
community.
(1) Describe significant harm
reduction activities, achievements, and/
or accomplishments over the past five
years for opioid misuse, opioid use
disorder, and opioid related overdoses.
(2) Describe the applicant Tribe,
Tribal organization, or UIO experience
and capacity to provide culturally
appropriate/competent opioid misuse
and harm reduction services to the
community and specific populations of
focus.
(3) Describe the resources available
for the proposed project (e.g., facilities,
equipment, information technology
systems, and financial management
systems).
(4) Describe how project continuity
will be maintained if/when there is a
change in the operational environment
(e.g., staff turnover, change in project
leadership, change in elected officials)
to ensure project stability over the life
of the grant.
(5) Provide a complete list of staff
positions anticipated for the project,
including the Project Director, Project
Coordinator, and other key personnel,
showing the role of each and their level
of effort and qualifications. Key staff
have the following:
a. Relevant health or behavioral
health experience.
b. Experience with award program
management, including skills in
program coordination, budgeting,
reporting, and staff supervision.
(6) For key staff currently on board,
include a biographical sketch for the
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Project Director, Project Coordinator, or
other key positions as attachments to
the project proposal/application. Do not
include any of the following in the
biographical sketch:
a. Personal Identifiable Information
(i.e., SSN, home address, etc.);
b. Resumes; or
c. Curriculum Vitae.
D. Program Evaluation (Data Collection
and Reporting) (20 Points)
Recipients will be required to collect
and submit semi-annual and annual
progress reports. Logic Models are
highly recommended to provide
guidance on collecting data for
evaluation purposes (see Attachment A).
Applicants are required to collect data
within their communities on the
prevalence and incidence rates for
opioid misuse, opioid use disorders,
opioid related overdoses, and other data
metrics such as mortality and morbidity
rates from opioid related events.
(1) Progress reports will include the
compilation of quantitative data (e.g.
number served; screenings completed,
etc.) and qualitative or narrative (text)
data.
(2) Reporting elements should include
data from local community-based, and
evidence-based programs which pertain
to proposed activities, processes and
outcomes such as performance measures
and other data relevant to evaluation
outcomes including intended results
(i.e., impact and outcomes).
(3) Describe how the applicant will
measure variables, what method will be
used and how the data will be used for
quality improvement and sustainability
of program and meeting required
reporting deadlines.
(4) Based on the required objectives,
did the applicant describe any type(s) of
evaluation(s) that will be used and how
they will collaborate with partners such
as Tribal Epidemiology Centers to
complete any evaluation efforts or data
collection?
(5) Did the applicant affirm their
organization will participate in
completing the annual progress report
and did they describe their capability
and experience with similar
evaluations?
(6) Did applicant describe necessary
data-sharing agreements established, or
will be established in support of these
activities?
E. Budget and Budget Justification (10
Points)
(1) The applicant is required to
include a line item budget for all
expenditures identifying reasonable and
allowable costs necessary to accomplish
the goals and objectives as outlined in
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87441
the project narrative for the entire
period of performance. The budget
expenditures should correlate with the
scope of work described in the project
narrative.
(2) The applicant must provide a
narrative justification of the budget line
items, as well as a description of
existing resources and other support the
applicant expects to receive for the
proposed project. Other support is
defined as funds or resources, whether
Federal, non-federal or institutional, in
direct support of activities through
fellowships, gifts, prizes, in-kind
contributions, or non-federal means.
(This should correspond to Item #18 on
the applicant’s SF–424, Estimated
Funding, and SF–424A Budget
Information, Section C Non-federal
resources.)
(3) Provide a narrative justification
supporting the development or
continued collaboration with other
partners regarding the proposed
activities to be implemented.
(4) Depending on the availability of
funds, the IHS may host annual
meetings to provide in-depth training
and technical assistance to awardees. In
order to help establish critical mass of
community and staff members who are
informed and committed to implement
the project, awardees should plan to
send a minimum of two people
(including the Project Director/Project
Coordinator) to one meeting of all
awardees in each year of the grant. At
these meetings, awardees will receive
training related to grant objectives,
discuss success and challenges in
implementation of the program, present
the results of their projects, and receive
other technical assistance from IHS staff
and/or contractors. Each meeting may
be up to 3 days. The locations will be
determined at a later date, but
applicants should estimate costs for
Denver, CO as a potential site that is
accessible to most of ‘‘Indian Country’’
and attendance is strongly encouraged.
2. Review and Selection
Each application will be prescreened
for eligibility and completeness as
outlined in this funding announcement.
The Review Committee (RC) will review
applications that meet the eligibility
criteria. The RC will review the
applications for merit based on the
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 RC and will not be funded. The
DGM will notify the applicant of this
determination.
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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 DBH within 30 days of the
conclusion of the review 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 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
• If you receive an award, HHS may
terminate it if any of the conditions in
2 CFR 200.340(a)(1)–(4) are met. Please
review all HHS regulatory provisions for
Termination at 2 CFR 200.340, at the
time of this publication located at
https://www.govinfo.gov/content/pkg/
CFR-2023-title2-vol1/pdf/CFR-2023title2-vol1-sec200-340.pdf. No other
termination conditions apply.
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, at the time of this publication located
at https://www.govinfo.gov/content/pkg/
CFR-2022-title45-vol1/pdf/CFR-2022title45-vol1-part75-subpartE.pdf.
E. Audit Requirements:
• Uniform Administrative
Requirements for HHS Awards, ‘‘Audit
Requirements,’’ at 45 CFR part 75
subpart F, at the time of this publication
located at https://www.govinfo.gov/
content/pkg/CFR-2022-title45-vol1/pdf/
CFR-2022-title45-vol1-part75subpartF.pdf.
F. As of August 13, 2020, 2 CFR part
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, at the time of this publication
located at https://www.govinfo.gov/
content/pkg/CFR-2023-title2-vol1/pdf/
CFR-2023-title2-vol1-sec200-216.pdf.
This will also be described in the terms
and conditions of every IHS grant and
cooperative agreement awarded on or
after August 13, 2020.
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1. Administrative Requirements
2. Indirect Costs
This section applies to all recipients
Awards issued under this
that request reimbursement of IDC in
announcement are subject to, and are
their application budget. In accordance
administered in accordance with, the
with HHS Grants Policy Statement, Part
following regulations and policies:
II–27, the IHS requires applicants to
A. The criteria as outlined in this
obtain a current IDC rate agreement and
program announcement.
submit it to the DGM prior to the DGM
B. Administrative Regulations for
issuing an award. The rate agreement
Awards:
must be prepared in accordance with
• Uniform Administrative
the applicable cost principles and
Requirements, Cost Principles, and
guidance as provided by the cognizant
Audit Requirements for HHS Awards
agency or office. A current rate covers
currently in effect or implemented
the applicable award activities under
during the period of award, other
the current award’s budget period. If the
Department regulations and policies in
current rate agreement is not on file
effect at the time of award, and
with the DGM at the time of award, the
applicable statutory provisions. At the
IDC portion of the budget will be
time of publication, this includes 45
CFR part 75, at https://www.govinfo.gov/ restricted. The restrictions remain in
content/pkg/CFR-2022-title45-vol1/pdf/ place until the current rate agreement is
provided to the DGM.
CFR-2022-title45-vol1-part75.pdf.
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Please refer to 2 CFR 200.414(f)
Indirect (F&A) costs, found at https://
www.govinfo.gov/content/pkg/CFR2023-title2-vol1/pdf/CFR-2023-title2vol1-sec200-414.pdf.
Electing to charge a de minimis rate
of 10 percent can be used by applicants
that have 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
award.
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 recipients
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 write to
DGM@ihs.gov.
3. Reporting Requirements
The recipient 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 award, 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 recipient 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.
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A. Progress Reports
Program progress reports are required
semi-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.
Recipient must submit a final report
within 120 days of the period of
performance end date.
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/.
B. Financial Reports
Federal Financial Reports are due 30
days after the end of each budget period,
and a final report is due 120 days after
the end of the period of performance.
Recipients are responsible and
accountable for reporting accurate
information on all required reports: the
Progress Reports and the Federal
Financial Report.
Failure to submit timely reports may
result in adverse award actions blocking
access to funds.
E. Non-Discrimination Legal
Requirements for Recipients of Federal
Financial Assistance (FFA)
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C. Data Collection and Reporting
All recipients will be required to
collect and report data pertaining to
activities, processes, and outcomes.
Logic Models are highly recommended
to provide guidance on collecting data
for evaluation purposes (see Attachment
A). The IHS DBH will provide guidance
on data collection and reporting for
evaluation purposes within 6 months of
award. All reporting items will be
submitted via the GrantSolutions.
Technical assistance for web-based data
entry will be timely and readily
available to recipients by assigned IHS
DBH staff. Recipients are responsible
and accountable for accurate
information being submitted by required
due dates for Data Collection and
Reporting.
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 recipients of Federal
awards to report information about firsttier sub-awards and executive
compensation under Federal assistance
awards.
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17:41 Dec 15, 2023
Jkt 262001
If you receive an award, you must
follow all applicable nondiscrimination
laws. You agree to this when you
register in SAM.gov. You must also
submit an Assurance of Compliance
(HHS–690). To learn more, see https://
www.hhs.gov/civil-rights/for-providers/
laws-regulations-guidance/laws/
index.html. 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.
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://sam.gov/content/fapiis 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
million for any period of time during
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87443
the period of performance of an award/
project.
Mandatory Disclosure Requirements
As required by 2 CFR part 200 of the
Uniform Guidance, and 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 recipients 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) 443–5204,
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 program matters
may be directed to: Cassandra Allen,
Public Health Advisor, Indian Health
Service, Division of Behavioral Health,
5600 Fishers Lane, Mail Stop: 0834NB,
Rockville, MD 20857, Phone: (240) 485–
7524, Email: Cassandra.Allen@ihs.gov.
2. Questions on awards management
and fiscal matters may be directed to:
Indian Health Service, Division of
Grants Management, 5600 Fishers Lane,
Mail Stop: 09E70, Rockville, MD 20857,
Email: DGM@ihs.gov.
E:\FR\FM\18DEN1.SGM
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Federal Register / Vol. 88, No. 241 / Monday, December 18, 2023 / Notices
3. For technical assistance with
Grants.gov, please contact the
Grants.gov help desk at (800) 518–4726,
or by email at support@grants.gov.
4. For technical assistance with
GrantSolutions, please contact the
GrantSolutions help desk at (866) 577–
0771, or by email at help@
grantsolutions.gov.
VIII. Other Information
The Public Health Service strongly
encourages all grant, cooperative
agreement, and contract recipients 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
Roselyn Tso,
Director, Indian Health Service.
Attachment A: Community Opioid
Intervention Prevention Program Logic
Model (Example)
Input
Activities
Outputs
D Implementing agency leadership
and support.
D Participants (families, community
leaders, Tribal leaders, professional staff).
D Community support and partnerships.
D Program management, evaluation and continuous improvement.
D Training.
D Technical Assistance to grantees.
D Annual convening of grantees.
1. Community awareness/education:
—Cultural integration.
—Promote family and community
engagement.
2. Build support system to
strengthen AI/AN families:
—Cultural integration.
—Maternal & Child Health.
—Promote family and community
engagement.
• # of trainings offered.
• # of educational awareness
campaigns across service population.
• Increasing community awareness.
D # of partnerships/collaboration
(MOU, MOA, etc).
D # of providers supporting activities.
D # of facilities providing MAT/
MOUD.
D # of referrals to treatment.
D # of systems involved (social
services, child advocacy, etc).
D # of providers trained in MAT/
MOUD.
D # of Buprenorphine/Suboxone
administered.
D # of active MAT/MOUD prescribers.
D Promote family engagement in
treatment.
D # of Naloxone provided.
D # of Naloxone administered.
D # Medication lock boxes.
D # Syringe exchange.
D # of FTS administered.
• Develop a response team.
3. Expand access to MAT/MOUD:
—Cultural integration.
—Buprenorphine/Suboxone.
—Promote family and community
engagement.
4. Implement harm reduction activities:
—Naloxone.
—Medication lock boxes.
—Syringe Service Program.
—Fentanyl Test Strips (FTS).
would constitute a clearly unwarranted
invasion of personal privacy.
[FR Doc. 2023–27765 Filed 12–15–23; 8:45 am]
BILLING CODE 4166–14 –P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
khammond on DSKJM1Z7X2PROD with NOTICES
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.
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
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Name of Committee: National Institute on
Aging Initial Review Group Career
Development for Established Investigators
and Conference Grants Study Section
Date: February 8–9, 2024.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Suite: 2W200, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Rajasri Roy, Ph.D., M.P.H.,
Scientific Review Officer, Scientific Review
Branch, National Institute on Aging, 7201
Wisconsin Avenue, Gateway Bldg. Suite
2W200, Bethesda, MD 20892, 301–496–6477,
rajasri.roy@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
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Outcomes
• Increase access to treatment.
• Increase access to harm reduction services.
Dated: December 8, 2023.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–27685 Filed 12–15–23; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Dental and
Craniofacial Research; Notice of
Closed Meetings
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings 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
E:\FR\FM\18DEN1.SGM
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Agencies
[Federal Register Volume 88, Number 241 (Monday, December 18, 2023)]
[Notices]
[Pages 87435-87444]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27765]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service
Funding Opportunity for the Community Opioid Intervention
Prevention Program
Announcement Type: New.
Funding Announcement Number: HHS-2024-IHS-COIPP-0001.
Assistance Listing (Catalog of Federal Domestic Assistance or CFDA)
Number: 93.654.
Key Dates
Application Deadline Date: February 7, 2024.
Earliest Anticipated Start Date: April 1, 2024.
I. Funding Opportunity Description
Statutory Authority
The Indian Health Service (IHS), Office of Clinical and Preventive
Services, Division of Behavioral Health (DBH) is accepting applications
for grants for the Community Opioid Intervention Prevention Program
(COIPP). This program is authorized under the Snyder Act, 25 U.S.C. 13,
and the Transfer Act, 42 U.S.C. 2001(a). Funding for this program is
provided in the Consolidated Appropriations Act, 2023, Public Law 117-
328, 136 Stat. 4459, 4808 (2022). The Assistance Listings section of
SAM.gov (https://sam.gov/content/home) describes this program under
93.654.
Background
The initial opioid prevention program, called the Community Opioid
Intervention Pilot Project, was first established in Fiscal Year (FY)
2019, pursuant to Congressional instruction to better combat the opioid
epidemic. The goal was to create a pilot program to address the opioid
epidemic in Indian Country and award grants that supported the
development, documentation, and sharing of locally designed and
culturally appropriate prevention, treatment, recovery, and aftercare
services for opioid use disorders in the American Indian and Alaska
Native (AI/AN) communities. Evidence-based activities are available for
reference at https://www.ihs.gov/asap/coipp/. A total of 35 grants were
awarded to Tribal and Urban Indian communities in the pilot phase.
Based on evaluation results from the pilot project, this funding
opportunity will continue to provide grant support to Tribal and Urban
Indian communities to continue efforts to combat the opioid epidemic
and develop strategies that align with the Department of Health and
Human Services Overdose Prevention Strategy.
The Centers for Disease Control and Prevention (CDC) reported that
the AI/AN population had the highest drug overdose death rates in both
2020 and 2021, at rates of 42.5 and 56.6 deaths per 100,000 persons,
respectively. The AI/AN population also experienced a 33 percent
increase in drug overdose deaths from 2020 through 2021. Overdose
deaths among AI/AN have continued to increase over the last 20 years.
The CDC reported from 2019 to 2020, overdose death rates increased 39
percent for the non-Hispanic AI/AN population and drug overdose death
rates were highest for AI/AN people compared to other racial and ethnic
groups.
[[Page 87436]]
While the overall AI/AN population is at risk for overdoses,
special populations to consider are youth, pregnant persons, young
parents, and those experiencing housing insecurity. Over the last two
decades, opioid-related overdose mortality among adolescent and young
adults has increased dramatically. Low-income women and women of color
are at higher risk for barriers to seek appropriate care for substance
use disorders during pregnancy. AI/AN women with opioid use disorder
(OUD) encounter barriers to accessing services for treatment. Maternal
substance misuse can result in neonatal abstinence syndrome, a drug
withdrawal process in newborns exposed in utero to drugs. Correct
racial classification is an important factor in improving data quality
for AI/AN populations and establishing accurate surveillance to help
address the disproportionate burden of neonatal abstinence syndrome
among AI/AN.
Housing insecurity takes on many forms, including homelessness,
housing cost burden, overcrowding, poor quality housing, and living
with persons who use substances. The rate of AI/AN that experience
housing insecurity is 45 out of 10,000. Young AI/AN adults are three
times more likely to experience homelessness than their non-Native
peers and one third of AI/AN adults experienced homelessness.
Purpose
The purpose of this grant program is to address the opioid crisis
in AI/AN communities by doing the following: first, developing and
expanding community education and awareness of prevention, treatment,
and recovery activities for opioid misuse and opioid use disorder;
second, increasing knowledge and use of culturally appropriate
interventions and to encourage an increased use of medication-assisted
treatment/medications for opioid use disorder (MAT/MOUD); third,
supporting Tribal and Urban Indian communities in their effort to
provide prevention, treatment, and recovery services to address the
impact of the opioid crisis; and fourth, increase harm reduction within
their communities.
Recipients for this funding opportunity are required to address the
following four objectives:
1. Increase public awareness and education about culturally
appropriate and family-centered opioid and overdose prevention,
treatment, and recovery practices and programs in AI/AN communities.
2. Create comprehensive support teams to strengthen and empower AI/
AN families in addressing the opioid and overdose crisis in Tribal or
Urban Indian communities.
3. Increase access to MAT/MOUD treatment for persons who experience
opioid misuse, opioid use disorder, and opioid related overdoses.
4. Increase harm reduction activities in Tribal and Urban Indian
communities.
In alignment with the agency goals to ensure that comprehensive,
culturally appropriate personal and public health services are
available and accessible to AI/AN people, the COIPP is designed to
provide recipients with the ability to develop unique and innovative
community interventions that will address the opioid crisis at a local
level. The IHS supports Tribal and Urban Indian efforts that include
addressing substance use prevention, treatment, and aftercare from a
community-driven context. The IHS encourages applicants to develop and
submit a plan that emphasizes cross-system collaboration, the inclusion
of family, youth, community resources, and culturally appropriate
approaches.
Recipients are also encouraged to incorporate foundational
elements, priorities, and strategies from the National Tribal
Behavioral Health Agenda (TBHA) as appropriate. The TBHA was developed
by Substance Abuse and Mental Health Services Administration (SAMHSA)
in collaboration with Tribes, the Indian Health Service, and the
National Indian Health Board. A component of the TBHA is the AI/AN
Cultural Wisdom Declaration (CWD), which elevates the importance of
Tribal identities, culture, spiritual beliefs, and practices for
improving well-being. This grant announcement supports the CWD and
inclusion of ancestral cultural knowledge, wisdom, ceremony, and
practices of AI/AN Tribes into the grant application. The TBHA can be
found at https://store.samhsa.gov/product/The-National-Tribal-Behavioral-HealthAgenda/PEP16-NTBH-AGENDA.
Required Activities
The focus of this program is to support AI/ANs in their efforts to
provide prevention, treatment, aftercare, and recovery services to
address the impact of the opioid crisis in Native communities. All
COIPP activities should be culturally-based, and family-oriented.
The IHS is seeking applications that include the following required
activities:
1. Community Awareness and Education:
a. Recipients shall promote family, youth and community engagement
in the planning and implementation of opioid use prevention and harm
reduction activities.
b. Recipients shall design community awareness campaigns and
education programs that inform and train community members on how to
recognize the signs of opioid misuse and overdose. Educational tool(s)
shall be culturally-appropriate and intended to engage families.
c. Recipients will develop educational resources, such as
factsheets using culturally relevant messaging; disseminate materials
through community stakeholders and community partners, and identify
culturally appropriate ways to implement educational programs in their
local communities.
d. Awareness Campaign should include instructions on the following,
among others:
How to access local opioid-specific services.
How to safeguard controlled prescription medications from
children and adolescents.
How to dispose properly of unused controlled prescription
medications.
2. Expand access to MAT/MOUD services that include Tribal values,
culture and treatments:
a. Promote family, youth and community engagement in the planning
and implementation of opioid use treatment.
b. Increase number of providers receiving training in MAT/MOUD
services that include Tribal values, culture, and treatments.
c. Increase access to continuing education on MAT/MOUD.
d. Expand access to integrated MAT/MOUD services for Tribal
communities, including TeleMAT.
e. Increase the availability and utilization of buprenorphine to
Tribal communities in both rural and urban settings including increased
collaboration with local Emergency Departments to establish
buprenorphine bridge programs.
3. Build a support system for strengthening Native families by
implementing culturally-appropriate approaches.
a. Promote family, youth and community engagement in the planning
and implementation of opioid use recovery activities.
b. Develop a family-focused and culturally-based assessment that
captures biopsychosocial needs of AI/ANs.
[[Page 87437]]
c. Link assessment needs to support and recovery services.
d. Collaborate with relevant partners to build a support system for
recovery.
4. Increase harm reduction activities.
a. Increase awareness and distribution of naloxone as an overdose
intervention and teach skills in how to use it.
b. Increase awareness and distribution of medication lock boxes and
teach skills in how to use.
c. Collaborate with relevant partners to implement harm reduction
activities.
II. Award Information
Funding Instrument--Grant
Estimated Funds Available
The total annual funding identified is approximately $9.5 million.
Individual award amounts for the first budget year are anticipated to
be between $350,000 and $500,000. The funding available for subsequent
budget years 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 to applicants selected
for funding under this announcement.
The actual amount available will not be determined until enactment
of the FY 24 Fiscal Year federal budget. This program announcement is
subject to the appropriation of funds, and is a contingency action
taken to ensure that, should funds become available for this purpose,
applications can be processed, and funds can be awarded in a timely
manner.
Anticipated Number of Awards
The IHS anticipates issuing up to 27 awards under this program
announcement.
Period of Performance
The period of performance is for 5 years.
III. Eligibility Information
1. Eligibility
To be eligible for this funding opportunity an applicant must be
one of the following, as defined by 25 U.S.C. 1603:
A federally recognized Indian Tribe as defined by 25
U.S.C. 1603(14). The term ``Indian Tribe'' means any Indian Tribe,
band, nation, or other organized group or community, including any
Alaska Native village or group, or regional or village corporation, as
defined in or established pursuant to the Alaska Native Claims
Settlement Act (85 Stat. 688) [43 U.S.C. 1601 et seq.], which is
recognized as eligible for the special programs and services provided
by the United States to Indians because of their status as Indians.
A Tribal organization as defined by 25 U.S.C. 1603(26).
The term ``Tribal organization'' has the meaning given the term in
section 4 of the Indian Self-Determination and Education Assistance Act
(25 U.S.C. 5304(l)): ``Tribal organization'' means the recognized
governing body of any Indian Tribe; any legally established
organization of Indians which is controlled, sanctioned, or chartered
by such governing body or which is democratically elected by the adult
members of the Indian community to be served by such organization and
which includes the maximum participation of Indians in all phases of
its activities: provided that, in any case where a contract is let or
grant made to an organization to perform services benefiting more than
one Indian Tribe, the approval of each such Indian Tribe shall be a
prerequisite to the letting or making of such contract or grant.
Applicant shall submit letters of support and/or Tribal Resolutions
from the Tribes to be served.
An Urban Indian Organization (UIO), as defined by 25
U.S.C. 1603(29). The term ``Urban Indian Organization'' means a
nonprofit corporate body situated in an urban center, governed by an
Urban Indian controlled board of directors, and providing for the
maximum participation of all interested Indian groups and individuals,
which body is capable of legally cooperating with other public and
private entities for the purpose of performing the activities described
in 25 U.S.C. 1653(a). Applicants must provide proof of non-profit
status with the application, e.g., 501(c)(3).
2. Additional Information on Eligibility
The IHS does not fund concurrent projects. If an applicant is
successful under this announcement, any subsequent applications in
response to other COIPP announcements from the same applicant will not
be funded. Applications on behalf of individuals (including sole
proprietorships) and foreign organizations are not eligible.
Applications deemed ineligible will be disqualified from competitive
review and funding under this funding opportunity.
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.
3. Cost Sharing or Matching
The IHS does not require matching funds or cost sharing for grants
or cooperative agreements.
4. 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 DGM will notify the applicant.
Additional Required Documentation
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.
Applicants organized with a governing structure other than a Tribal
council may submit an equivalent document commensurate with their
governing organization. Please include documentation explaining and
substantiating this.
Proof of Non-Profit Status
Organizations claiming non-profit 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
[[Page 87438]]
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 merit review and in
processing awards. Upload all requested and optional documents
individually, rather than combining them into a single file. Creating a
single file 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 merit 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 applications are listed below. An
application is incomplete if any of the listed mandatory documents are
missing. Incomplete applications will not be reviewed.
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 10 pages). See Section
IV.2.A, Project Narrative for instructions.
Budget Narrative (not to exceed 4 pages). See Section
IV.2.B, Budget Narrative for instructions.
One-page Timeframe Chart.
Biographical sketches for all Key Personnel.
Contractor/Consultant resumes or qualifications and scope
of work.
Certification Regarding Lobbying (GG-Lobbying Form).
Organizational Chart (optional).
The documents listed here may be required. Please read this list
carefully.
Tribal Resolution(s) as described in Section III,
Eligibility.
Letters of Support from organization's Board of Directors.
Disclosure of Lobbying Activities (SF-LLL), if applicant
conducts reportable lobbying.
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/.
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.
Organizational chart.
Map of area identifying project location(s).
Additional documents to support narrative (i.e., data
tables, key news articles, etc.).
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
10 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 reviewers will be directed to
ignore any content beyond the page limit. The 10-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 four parts to the project narrative:
Part 1--Statement of Need;
Part 2--Program Plan--Objectives and Activities;
Part 3--Organizational Capacity; and
Part 4--Program Evaluation (Data Collection and Reporting).
See below for additional details about what must be included in the
narrative.
Part 1: Statement of Need (Limit--1 Page)
Describe the extent of the problem related to opioid misuse, opioid
use disorder, and opioid related overdoses in the applicant's community
(``community'' means the applicant's Tribe, village, Tribal
organization, consortium of Tribes or Tribal organizations, or urban
center). Provide the facts and evidence that support the need for the
project and establish that the Tribe, Tribal organization, or UIO
understand the problems and can reasonably address them. This section
must also succinctly but completely answer the questions listed under
the evaluation criteria in Section V.1.A. Statement of Need.
Part 2: Program Plan--Objectives and Activities (Limit--6 Pages)
Describe the scope of work the Tribe, Tribal organization, or UIO
by clearly and concisely outlining the following required components:
1. Goals and Objectives. Reference all required objectives.
2. Project Activities. Link your project activities to your
outlined goals and objectives.
This section must also succinctly but completely answer the
questions listed under the evaluation criteria in Section V.1.B.
Program Plan (Objectives and Activities).
Part 3: Organizational Capacity (Limit--2 Pages)
Describe the Tribe, Tribal organization, or UIO's organizational
capacity to implement the proposed activities, in the following areas:
Ability to provide direct care, treatment, and services, including MAT/
MOUD; current or ongoing projects related to opioid prevention,
treatment, recovery support, and aftercare; a detailed description of
partnerships and networks with opioid misuse and harm reduction
providers. Provide detail on significant program activities and
achievements/accomplishments over the past 5 years associated with
opioid prevention, treatment, recovery support, and aftercare
activities. Provide success stories, data, or other examples of how
other funded projects/programs made an
[[Page 87439]]
impact in your community to address opioid use. If applicable, provide
justification for lack of progress of previous efforts. This section
must also succinctly but completely answer the questions listed under
the evaluation criteria in Section V.1.C. Organizational Capacity.
Part 4: Program Evaluation (Limit 1 Page)
Based on the required activities in Section V, describe how the
Tribe, Tribal organization, or UIO plans to collect data for the
proposed project and activities. Identify any type(s) of evaluation(s)
that will be used and how you will collaborate with partners to
complete any evaluation efforts or data collection. Progress reports
will include compilation of quantitative data (e.g., number served;
screenings completed, etc.) and qualitative or narrative (text) data.
Reporting elements should be specific to activities/programs, processes
and outcomes such as performance measures and other data relevant to
evaluation outcomes including intended results (i.e., impact and
outcomes). Logic Models are highly recommended to include in the
application. The IHS will partner with Technical Assistance Providers
to assist recipients develop data collection and evaluation plans and
tools. Recipients will be required to collect and submit semi-annual
and annual progress reports. Additional information regarding Data
Collection refer to Section V.1.D. Program Evaluation (Data Collection
& Reporting).
B. Budget Narrative (Limit--4 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 entire project, by year. 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 would support the
achievement of proposed objectives. Be very careful about showing how
each item in the ``Other'' category is justified. Do 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, Deputy Director, DGM, by email at [email protected]. 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
The available funds are inclusive of direct and indirect
costs.
Only one grant may be awarded per applicant.
Food is an allowable expense under this program. Recipient
may not exceed $10,000.00.
While construction is not an allowable cost, alteration
and renovation (A&R) is allowable. A&R must be consistent with the
following criteria and documentation requirements:
a. The building has a useful life consistent with program purposes
and is architecturally and structurally suitable for conversion to the
type of space required.
b. The A&R is essential to the purpose of the grant-supported
project or program.
c. The space involved will be occupied by the project or program.
d. The space is suitable for human occupancy before A&R work is
started except where the purpose of the A&R is to make the space
suitable for some purpose other than human occupancy, such as storage.
e. For minor A&R, if the space is rented, evidence is provided that
the terms of the lease are compatible with the A&R proposed and cover
the duration of the period of performance.
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. You must submit
your waiver request by email to [email protected]. Your waiver request must
include clear justification for the need to deviate from the required
application submission process. The IHS will not accept any
applications submitted through any means outside of Grants.gov without
an approved waiver.
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
waiver approval from 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 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
[[Page 87440]]
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
Organizations that are not registered with the System for Award
Management (SAM) must access the SAM online registration through the
SAM home page at https://sam.gov. Organizations based in the United
States (U.S.) 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 recipients to report
information on sub-awards. Accordingly, all IHS recipients must notify
potential first-tier sub-recipients that no entity may receive a first-
tier sub-award unless the entity has provided its UEI number to the
prime recipient 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 the proposed
activities for the entire period of performance. The project narrative
should be written in a 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
Applications will be reviewed and scored according to the quality
of responses to the required application components in Sections A--E.
The number of points after each heading is the maximum number of points
a review committee may assign to that section. Although scoring weights
are not assigned to individual numbers, responses to each number are
assessed in deriving the overall section score.
A. Statement of Need (20 Points)
(1) Describe the extent of the problem related to opioid misuse,
opioid use disorder and opioid related overdoses in the applicant's
community (``community'' means the applicant's Tribe, village, Tribal
organization, consortium of Tribes or Tribal organizations, or urban
center). Provide the facts and evidence that support the need for the
project and establishes that the Tribe, Tribal organization, or UIO
understands the problems, and can reasonably address them.
(2) Include a description of social determinants of health that may
contribute to the opioid misuse, opioid use disorder, and opioid
related overdoses in the community. Include details on economic
stability (such as housing and food insecurity); education (such as
early childhood education and development, high school graduation, and
language and literacy); social and community context (such as
discrimination, incarceration, and social cohesion); health and health
care (such as access to health care and health literacy); and
neighborhood and built environment (such as access to foods that
support healthy eating patterns, crime and violence, environmental
conditions, and quality of housing).
(3) Provides background information on the Tribe, Tribal
organization, or UIO.
(4) Based on the information and/or data currently available,
document the prevalence of opioid misuse and overdose rates.
(5) Based on the information and/or data currently available,
document the need to increase the capacity to implement, sustain, and
improve effective opioid misuse and overdose prevention, treatment,
aftercare, recovery, and harm reduction services in the proposed
catchment area that is consistent with the purpose of this funding
opportunity announcement.
(6) Describe the service gaps and other problems related to the
need for funds targeting opioid misuse. Identify the source of the
data.
(7) Describe potential Tribal and community partners and resources
in the catchment area that can participate in the broad community
awareness campaign.
(8) Affirm the goals of the project are consistent with priorities
of the Tribal government or board of directors and that the governing
body is in support of this application.
B. Program Plan--Objectives and Activities (35 Points)
(1) Identify the population of focus for your project. Describe the
purpose of the proposed project, including goals and objectives and how
they are linked. Describe how the achievement of goals will increase
Tribe, Tribal organization, or UIO's capacity to support the goals and
required activities identified in Section I of this announcement.
(2) Describe how the proposed project activities relate to the
proposed project's goals and objectives. Describe how the project
activities will increase the capacity of the community to prevent and
treat opioid misuse, opioid use disorder, and overdose in the
communities and implement harm reduction activities.
(3) Describe organizational capacity to implement the proposed
activities, including increased public awareness and education on
opioids and overdose; developing a comprehensive support team to
strengthen and empower AI/AN families in addressing the opioid and
overdose crisis in Tribal or Urban Indian communities; integrating the
use of MAT/MOUD, and harm reduction into the community.
(4) Describe how community partners (prevention and recovery
support providers, substance use disorder treatment programs, peer
recovery specialists, social workers, behavioral health clinics,
community health centers, youth serving organizations, family and youth
homeless providers, child welfare agencies, primary care
[[Page 87441]]
providers, pharmacists, schools, clergy, and law enforcement, among
others) will be involved in the planning and implementation of the
project.
(5) Describe if/how the efforts of the proposed project will be
coordinated with any other related Federal grants or programs funded
through the IHS, SAMHSA, BIA, or other Federal agencies.
(6) Provide a timeline chart depicting a realistic timeline for the
project period showing key activities, milestones, and responsible
staff. These key activities should include the required activities
identified in Section V of this announcement.
C. Organizational Capacity (15 Points)
Organizational capacity including increased public awareness and
education on opioids; developing a comprehensive support team to
strengthen and empower AI/AN families in addressing the opioid crisis
in Tribal or Urban Indian communities; integrating the use of MAT/MOUD,
and implementing harm reduction activities into the Tribal and Urban
Indian community.
(1) Describe significant harm reduction activities, achievements,
and/or accomplishments over the past five years for opioid misuse,
opioid use disorder, and opioid related overdoses.
(2) Describe the applicant Tribe, Tribal organization, or UIO
experience and capacity to provide culturally appropriate/competent
opioid misuse and harm reduction services to the community and specific
populations of focus.
(3) Describe the resources available for the proposed project
(e.g., facilities, equipment, information technology systems, and
financial management systems).
(4) Describe how project continuity will be maintained if/when
there is a change in the operational environment (e.g., staff turnover,
change in project leadership, change in elected officials) to ensure
project stability over the life of the grant.
(5) Provide a complete list of staff positions anticipated for the
project, including the Project Director, Project Coordinator, and other
key personnel, showing the role of each and their level of effort and
qualifications. Key staff have the following:
a. Relevant health or behavioral health experience.
b. Experience with award program management, including skills in
program coordination, budgeting, reporting, and staff supervision.
(6) For key staff currently on board, include a biographical sketch
for the Project Director, Project Coordinator, or other key positions
as attachments to the project proposal/application. Do not include any
of the following in the biographical sketch:
a. Personal Identifiable Information (i.e., SSN, home address,
etc.);
b. Resumes; or
c. Curriculum Vitae.
D. Program Evaluation (Data Collection and Reporting) (20 Points)
Recipients will be required to collect and submit semi-annual and
annual progress reports. Logic Models are highly recommended to provide
guidance on collecting data for evaluation purposes (see Attachment A).
Applicants are required to collect data within their communities on the
prevalence and incidence rates for opioid misuse, opioid use disorders,
opioid related overdoses, and other data metrics such as mortality and
morbidity rates from opioid related events.
(1) Progress reports will include the compilation of quantitative
data (e.g. number served; screenings completed, etc.) and qualitative
or narrative (text) data.
(2) Reporting elements should include data from local community-
based, and evidence-based programs which pertain to proposed
activities, processes and outcomes such as performance measures and
other data relevant to evaluation outcomes including intended results
(i.e., impact and outcomes).
(3) Describe how the applicant will measure variables, what method
will be used and how the data will be used for quality improvement and
sustainability of program and meeting required reporting deadlines.
(4) Based on the required objectives, did the applicant describe
any type(s) of evaluation(s) that will be used and how they will
collaborate with partners such as Tribal Epidemiology Centers to
complete any evaluation efforts or data collection?
(5) Did the applicant affirm their organization will participate in
completing the annual progress report and did they describe their
capability and experience with similar evaluations?
(6) Did applicant describe necessary data-sharing agreements
established, or will be established in support of these activities?
E. Budget and Budget Justification (10 Points)
(1) The applicant is required to include a line item budget for all
expenditures identifying reasonable and allowable costs necessary to
accomplish the goals and objectives as outlined in the project
narrative for the entire period of performance. The budget expenditures
should correlate with the scope of work described in the project
narrative.
(2) The applicant must provide a narrative justification of the
budget line items, as well as a description of existing resources and
other support the applicant expects to receive for the proposed
project. Other support is defined as funds or resources, whether
Federal, non-federal or institutional, in direct support of activities
through fellowships, gifts, prizes, in-kind contributions, or non-
federal means. (This should correspond to Item #18 on the applicant's
SF-424, Estimated Funding, and SF-424A Budget Information, Section C
Non-federal resources.)
(3) Provide a narrative justification supporting the development or
continued collaboration with other partners regarding the proposed
activities to be implemented.
(4) Depending on the availability of funds, the IHS may host annual
meetings to provide in-depth training and technical assistance to
awardees. In order to help establish critical mass of community and
staff members who are informed and committed to implement the project,
awardees should plan to send a minimum of two people (including the
Project Director/Project Coordinator) to one meeting of all awardees in
each year of the grant. At these meetings, awardees will receive
training related to grant objectives, discuss success and challenges in
implementation of the program, present the results of their projects,
and receive other technical assistance from IHS staff and/or
contractors. Each meeting may be up to 3 days. The locations will be
determined at a later date, but applicants should estimate costs for
Denver, CO as a potential site that is accessible to most of ``Indian
Country'' and attendance is strongly encouraged.
2. Review and Selection
Each application will be prescreened for eligibility and
completeness as outlined in this funding announcement. The Review
Committee (RC) will review applications that meet the eligibility
criteria. The RC will review the applications for merit based on the
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 RC and will not be
funded. The DGM will notify the applicant of this determination.
[[Page 87442]]
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 DBH within 30 days of the conclusion of the review 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 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 Awards:
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-2022-title45-vol1/pdf/CFR-2022-title45-vol1-part75.pdf.
If you receive an award, HHS may terminate it if any of
the conditions in 2 CFR 200.340(a)(1)-(4) are met. Please review all
HHS regulatory provisions for Termination at 2 CFR 200.340, at the time
of this publication located at https://www.govinfo.gov/content/pkg/CFR-2023-title2-vol1/pdf/CFR-2023-title2-vol1-sec200-340.pdf. No other
termination conditions apply.
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, at the time of this
publication located at https://www.govinfo.gov/content/pkg/CFR-2022-title45-vol1/pdf/CFR-2022-title45-vol1-part75-subpartE.pdf.
E. Audit Requirements:
Uniform Administrative Requirements for HHS Awards,
``Audit Requirements,'' at 45 CFR part 75 subpart F, at the time of
this publication located at https://www.govinfo.gov/content/pkg/CFR-2022-title45-vol1/pdf/CFR-2022-title45-vol1-part75-subpartF.pdf.
F. As of August 13, 2020, 2 CFR part 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,
at the time of this publication located at https://www.govinfo.gov/content/pkg/CFR-2023-title2-vol1/pdf/CFR-2023-title2-vol1-sec200-216.pdf. 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 recipients 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 award
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.
Please refer to 2 CFR 200.414(f) Indirect (F&A) costs, found at
https://www.govinfo.gov/content/pkg/CFR-2023-title2-vol1/pdf/CFR-2023-title2-vol1-sec200-414.pdf.
Electing to charge a de minimis rate of 10 percent can be used by
applicants that have 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
award.
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 recipients 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 write
to [email protected].
3. Reporting Requirements
The recipient 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
award, 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 recipient
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.
[[Page 87443]]
A. Progress Reports
Program progress reports are required semi-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. Recipient must submit a
final report within 120 days of the period of performance end date.
B. Financial Reports
Federal Financial Reports are due 30 days after the end of each
budget period, and a final report is due 120 days after the end of the
period of performance.
Recipients are responsible and accountable for reporting accurate
information on all required reports: the Progress Reports and the
Federal Financial Report.
Failure to submit timely reports may result in adverse award
actions blocking access to funds.
C. Data Collection and Reporting
All recipients will be required to collect and report data
pertaining to activities, processes, and outcomes. Logic Models are
highly recommended to provide guidance on collecting data for
evaluation purposes (see Attachment A). The IHS DBH will provide
guidance on data collection and reporting for evaluation purposes
within 6 months of award. All reporting items will be submitted via the
GrantSolutions. Technical assistance for web-based data entry will be
timely and readily available to recipients by assigned IHS DBH staff.
Recipients are responsible and accountable for accurate information
being submitted by required due dates for Data Collection and
Reporting.
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 recipients of Federal awards 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 Recipients of Federal
Financial Assistance (FFA)
If you receive an award, you must follow all applicable
nondiscrimination laws. You agree to this when you register in SAM.gov.
You must also submit an Assurance of Compliance (HHS-690). To learn
more, see https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/laws/. 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.
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://sam.gov/content/fapiis
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 million for any period of time
during the period of performance of an award/project.
Mandatory Disclosure Requirements
As required by 2 CFR part 200 of the Uniform Guidance, and 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 recipients 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-
5204, 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 program matters may be directed to: Cassandra
Allen, Public Health Advisor, Indian Health Service, Division of
Behavioral Health, 5600 Fishers Lane, Mail Stop: 0834NB, Rockville, MD
20857, Phone: (240) 485-7524, Email: [email protected].
2. Questions on awards management and fiscal matters may be
directed to: Indian Health Service, Division of Grants Management, 5600
Fishers Lane, Mail Stop: 09E70, Rockville, MD 20857, Email:
[email protected].
[[Page 87444]]
3. For technical assistance with Grants.gov, please contact the
Grants.gov help desk at (800) 518-4726, or by email at
[email protected].
4. For technical assistance with GrantSolutions, please contact the
GrantSolutions help desk at (866) 577-0771, or by email at
[email protected].
VIII. Other Information
The Public Health Service strongly encourages all grant,
cooperative agreement, and contract recipients 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.
Roselyn Tso,
Director, Indian Health Service.
Attachment A: Community Opioid Intervention Prevention Program Logic
Model (Example)
------------------------------------------------------------------------
Input Activities Outputs Outcomes
------------------------------------------------------------------------
[ssquf] 1. Community # of
Implementing awareness/ trainings Increasing
agency education: offered. community
leadership and --Cultural # of awareness.
support. integration. educational
[ssquf] --Promote family awareness
Participants and community campaigns
(families, engagement. across service
community population.
leaders, Tribal
leaders,
professional
staff).
[ssquf] Community 2. Build support [ssquf] # of Develop
support and system to partnerships/ a response
partnerships. strengthen AI/AN collaboration team.
[ssquf] Program families: (MOU, MOA,
management, --Cultural etc).
evaluation and integration. [ssquf] # of
continuous --Maternal & providers
improvement. Child Health. supporting
[ssquf] Training. --Promote family activities.
[ssquf] Technical and community [ssquf] # of
Assistance to engagement. facilities
grantees. providing MAT/
[ssquf] Annual MOUD.
convening of [ssquf] # of
grantees. referrals to
treatment.
[ssquf] # of
systems
involved
(social
services, child
advocacy, etc).
3. Expand access [ssquf] # of
to MAT/MOUD: providers Increase access
--Cultural trained in MAT/ to treatment.
integration. MOUD.
--Buprenorphine/ [ssquf] # of
Suboxone. Buprenorphine/
--Promote family Suboxone
and community administered.
engagement. [ssquf] # of
active MAT/MOUD
prescribers.
[ssquf] Promote
family
engagement in
treatment.
4. Implement harm [ssquf] # of
reduction Naloxone Increase access
activities: provided. to harm
--Naloxone. [ssquf] # of reduction
--Medication lock Naloxone services.
boxes. administered.
--Syringe Service [ssquf] #
Program. Medication lock
--Fentanyl Test boxes.
Strips (FTS). [ssquf] #
Syringe
exchange.
[ssquf] # of FTS
administered.
------------------------------------------------------------------------
[FR Doc. 2023-27765 Filed 12-15-23; 8:45 am]
BILLING CODE 4166-14 -P