82_FR_14054 82 FR 14004 - Healthy Lifestyles in Youth Project; Proposed Single Source Competing Continuation Cooperative Agreement with National Congress of American Indians

82 FR 14004 - Healthy Lifestyles in Youth Project; Proposed Single Source Competing Continuation Cooperative Agreement with National Congress of American Indians

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service

Federal Register Volume 82, Issue 50 (March 16, 2017)

Page Range14004-14012
FR Document2017-05243

Federal Register, Volume 82 Issue 50 (Thursday, March 16, 2017)
[Federal Register Volume 82, Number 50 (Thursday, March 16, 2017)]
[Notices]
[Pages 14004-14012]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-05243]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Indian Health Service

[Funding Announcement Number: HHS-2017-IHS-HLY-0001; Catalog of Federal 
Domestic Assistance Number: 93.933]


Healthy Lifestyles in Youth Project; Proposed Single Source 
Competing Continuation Cooperative Agreement with National Congress of 
American Indians

Key Dates

Application Deadline Date: May 15, 2017
Review Date: May 22-26, 2017
Earliest Anticipated Start Date: September 1, 2017
Proof of Non-Profit Status Due Date: May 15, 2017

I. Funding Opportunity Description

Statutory Authority

    The Indian Health Service (IHS) Office of Clinical and Preventive 
Services, Division of Diabetes Treatment and Prevention, is accepting 
applications for a single source competing continuation cooperative 
agreement with the National Congress of American Indians (NCAI) for the 
purpose of continued implementation of the Healthy Lifestyles in Youth 
Project in selected Native American Boys and Girls Clubs of America. 
This program is authorized under the authority of the Snyder Act, 25 
U.S.C. 13; the Transfer Act, 42 U.S.C. 2001; and the Public Health 
Service Act, as amended, 42 U.S.C. 241(a). This program is described in 
the Catalog of Federal Domestic Assistance (CFDA) under 93.933.

Background

    This program promotes healthy lifestyles among American Indian and 
Alaska Native (AI/AN) youth using the curriculum ``Together Raising 
Awareness for Indian Life'' (TRAIL) among selected Boys and Girls Club 
sites. Under this cooperative agreement, IHS proposes to enter into a 
collaborative effort/initiative with NCAI, because of their unique 
experience partnering with the IHS and Boys and Girls Clubs of America 
(BGCA) in successfully establishing this program, as well as, their 
overall expertise and experience in addressing and evaluating healthy 
lifestyle techniques in AI/AN youth.

Purpose

    This work will continue to support the IHS mission to improve the 
health of AI/AN youth through health

[[Page 14005]]

promotion and health education programs. The purpose of this IHS 
cooperative agreement is to focus on addressing healthy lifestyle 
development, emphasizing nutrition and physical activity for AI/AN 
children and youth 7 through 11 years of age. The long term goal is to 
prevent or delay the onset of obesity and related diseases such as type 
2 diabetes. NCAI will continue partnering work with selected Native 
American Boys and Girls Club sites to: (a) Provide health and physical 
education programs; (b) help youth achieve and maintain healthy 
lifestyles through participation in fitness programs; (c) help youth to 
acquire a range of physical skills; and (d) help youth develop a sense 
of teamwork and cooperation.
    These early intervention strategies provide evidence based 
opportunities to reduce and/or halt the increasing trend of obesity and 
diabetes among youth and young adults. Clubs that develop a health 
promotion program that includes the TRAIL curriculum may help curtail 
the effects of unhealthy eating behaviors and lack of physical activity 
that can lead to obesity, diabetes, and other chronic diseases later in 
life. The TRAIL curriculum was developed to provide information on good 
nutrition and to promote physical activity among youth participating in 
Native American Boys and Girls Clubs. TRAIL is a three month (12 
lessons) program that provides youth with a comprehensive understanding 
of healthy lifestyles in order to prevent diabetes. Woven throughout 
the program are self-esteem and prevention activities. Participants 
draw from Tribal traditions and history to learn about nutrition, 
healthy food choices, media influences, and the impact of diabetes. 
Clubs also implement the Nike Let Me Play and SPARK physical activity 
programs to foster Club-wide participation in fun activities and games 
for 60 minutes every day. TRAIL emphasizes the importance of teamwork 
and community service. Members engage in service projects to improve 
healthy lifestyles in their communities, including starting community 
gardens to connect youth to their food source and organizing community-
wide physical fitness events.
    Since the inception of the program in 2003, TRAIL has been 
implemented at over 79 Native American Boys and Girls Club of America 
sites located in 17 states. There are currently over 50 sites in more 
than 15 states participating in the program.
    The overall results show improvement in participant knowledge of 
diabetes, health, and healthy food choices, as well as, improved 
fitness and level of physical activity. To support this project, NCAI 
will select and assist at least 50 Native American Boys and Girls Club 
sites to establish and implement this curriculum project. Boys and Girl 
Club sites that are located outside of Tribal communities will not be 
considered by the grantee. The Boys and Girls Club sites selected by 
the grantee may use IHS grant funds to provide services to eligible IHS 
beneficiaries only. The grantee will be expected to: Provide technical 
consultation; train; monitor; evaluate; as well as provide funds to 
support these activities.

Single Source Justification

    NCAI is identified as the single source for the award, based on 
their successful record of performance with this project, their unique 
relationship and work in developing and maintaining: (1) Relationships 
with the Boys and Girls Clubs organization and staff, (2) being able to 
successfully implement the TRAIL program curriculum, (3) the project 
Web site information, and (4) the project data and evaluation systems. 
The award is for a continuation of activities identified. These 
activities, the collaboration with the network of Native American Boys 
and Girls Clubs, and the evaluation process have been effectively 
undertaken by NCAI for the past 13 years. The process, as well as the 
outcomes, have been deemed very successful and clearly supportive of 
Agency initiatives for youth.
    The grantee has documented success in (1) recruiting and working 
with sites, (2) developing and implementing the TRAIL curriculum at the 
sites, (3) implementing a method for collecting data from the sites, 
(4) fostering collaboration between sites and their communities, and 
(5) collecting and reporting data that demonstrates participant 
increases in health and food choice knowledge and increases in 
participant physical activity and level of fitness. Some of the data 
for the most recent years of the current 5 year cooperative agreement 
(2013-2016) are as follows:

------------------------------------------------------------------------
 
------------------------------------------------------------------------
                             2013-2014 Data
------------------------------------------------------------------------
Number of AI/AN Children Participating   1,403 (610 males/716 females--
 in the Curriculum, Training, and         77 gender not identified).
 Strength and Endurance Challenges.
Age Range of Children Participating....  ages 4-14 (representing grades
                                          2-6, with 96% of children in
                                          grades 2-5).
Achieving Goal of 60 Minutes/Day of      Average of 2,970 Children at 54
 Physical Activity--Club Wide (Children   Sites Performed an Average of
 in TRAIL plus Other Boys and Girls       74.15 Minutes/Day of Physical
 Club Children).                          Activity = 3,683 hours of
                                          Physical Activity/Day
                                          Nationwide (128 Days in the
                                          Reporting Period).
------------------------------------------------------------------------
  Program test scores indicate: (a) Increased knowledge about diabetes,
 (b) increased physical activity, and (c) increased ability to identify
    healthier food options (increase in post test scores vs. pre test
  scores--82% of Clubs had post test scores of >70% compared to 3% with
                         pre-test scores >70%).
------------------------------------------------------------------------
                             2014-2015 Data
------------------------------------------------------------------------
Number of AI/AN Children Participating   1332 (590 males/669 females--63
 in the Curriculum, Training, and         gender not identified).
 Strength and Endurance Challenges.
Age Range of Children Participating....  ages 6-11 (representing grades
                                          K-6, with 89% of children in
                                          grades 2-5).
Achieving Goal of 60 Minutes/Day of      Average of 2,450 Children at 50
 Physical Activity--Club Wide (Children   sites Performed an Average of
 in TRAIL plus Other Boys and Girls       74.15 Minutes/Day of Physical
 Club Children).                          Activity = 3,038 hours of
                                          Physical Activity/Day
                                          Nationwide (128 Days in the
                                          Reporting Period).
------------------------------------------------------------------------
  Program test scores indicate: (a) Increased knowledge about diabetes,
 (b) increased physical activity, and (c) increased ability to identify
    healthier food options (increase in post test scores vs. pre test
  scores--85% of Clubs had post test scores of >70% compared to 9% with
                         pre-test scores >70%).
------------------------------------------------------------------------
                             2015-2016 Data
------------------------------------------------------------------------
Number of AI/AN Children Participating   1,256 Children (606 boys, 627
 in the Curriculum, Training, and         girls, 23 gender not
 Strength and Endurance Challenges.       identified).

[[Page 14006]]

 
Age Range of Children Participating....  6-12 years (representing grades
                                          K-6 with 87% of children in
                                          grades 2-5).
Achieving Goal of 60 Minutes/Day of      Average of 2,907 Children
 Physical Activity--Club Wide (Children   Performed an Average of 63.9
 in TRAIL plus Other Boys and Girls       Minutes/Day of Physical
 Club Children).                          Activity = 3,038 hours of
                                          Physical Activity/Day
                                          Nationwide (128 Days in the
                                          Reporting Period).
------------------------------------------------------------------------
  Program test scores indicate: (a) Increased knowledge about diabetes,
 (b) increased physical activity, and (c) increased ability to identify
    healthier food options (increase in post test scores vs. pre test
 scores--82% of Clubs had post test scores of >70% compared to 18% with
                         pre-test scores >70%).
------------------------------------------------------------------------

    The TRAIL curriculum and subsequent revision were developed by the 
grantee as a part of earlier agreements. If there is a need to update 
the curriculum and subsequently implement the revised curriculum, it 
will be more efficiently and cost effectively performed as the grantee 
is very familiar with the existing curriculum and the implementation.
    The grantee uses a sub-contractor (First Pic) to develop and 
implement the evaluation and reporting process for individual sites and 
for analysis and reporting of aggregated data. This unique and program 
specific evaluation system has been beneficial to sites and to IHS. All 
of the tools for using this system have been made available via the 
Native American Boys and Girls Clubs Web site--http://www.naclubs.org/index.php/club-programs/trail-diabetes-prevention.
    The grantee (NCAI) has been effective, timely, and cooperative, and 
has consistently achieved or exceeded requirements of the previous 
agreement. NCAI and First Pic are uniquely qualified to continue to 
receive the award and provide the identified program activities based 
on their history with this project and project sites, their evaluation 
system, their knowledge of the curriculum, and their documented 
performance achievements with the sites under the previous agreement.
    All Department of Health and Human Services (HHS) and IHS policies, 
regulations, grants management and programmatic reporting requirements 
from the prior funding segment remain in effect under this renewal 
announcement unless otherwise stated or modified in the terms and 
conditions of the new Notice of Award.

II. Award Information

Type of Award

    Cooperative Agreement.

Estimated Funds Available

    The total amount of funding identified for the current fiscal year 
(FY) 2017 is $1,250,000. The average award amount will be $1,250,000 
annually. The amount of funding available for competing and 
continuation awards issued under this announcement are subject to the 
availability of appropriations and budgetary priorities of the Agency. 
The IHS is under no obligation to make awards that are selected for 
funding under this announcement.

Anticipated Number of Awards

    One award will be issued under this program announcement.

Project Period

    The project period is for five years and will run consecutively 
from September 1, 2017 to August 31, 2022.

Cooperative Agreement

    Cooperative agreements awarded by the HHS are administered under 
the same policies as a grant. However, the funding agency (IHS) is 
required to have substantial programmatic involvement in the project 
during the entire award segment. Below is a detailed description of the 
level of involvement required for both IHS and the grantee. IHS will be 
responsible for activities listed under section A and the grantee will 
be responsible for activities listed under section B as stated:

Substantial Involvement Description for Cooperative Agreement

A. IHS Programmatic Involvement
    (1) Identify a core group of IHS staff to work with the grantee in 
providing technical assistance and guidance.
    (2) Meet with the grantee to review grantee work plan and provide 
guidance on implementation and data collection tools.
    (3) Participate in quarterly conference calls. Work with the 
grantee to showcase the results of this project by publishing on shared 
Web sites as well as in jointly authored publications.
B. Grantee Cooperative Agreement Award Activities
    (1) Develop a written plan for the planning, implementation, and 
evaluation of this project to include selecting at least 50 sites as 
agreed upon with the IHS. This task will be completed within 30 days 
from award and approved by the IHS.
    (2) Develop selection criteria for new sites, announce, evaluate, 
and select sites. Sites must submit documentation verifying they serve 
only AI/AN youth from eligible IHS beneficiaries as a requirement for 
selection by the grantee. A start-up planning meeting with new sites 
will be conducted within two months of each site's initial selection 
and award.
    (3) Plan and facilitate an orientation and training meeting for new 
sites within two months of selection. Submit agenda, training goals and 
objectives, and participant list to IHS within one month of completion 
of each orientation session.
    (4) Update TRAIL curriculum as needed/directed and implement use.
    (5) Develop, in consultation with the IHS, the implementation and 
technical assistance plan for the coordination of the selected Boys and 
Girls Club sites. Submit criteria to the IHS for approval. Grantee will 
continue work with sites to develop and report measurements for 
assessment of physical activity and nutrition behaviors among club 
participants.
    (6) Each site will implement the TRAIL program, emphasizing healthy 
behaviors such as physical activity and nutrition. Each program plan 
will also include a parent component describing approaches for 
involving the families of participants.
    (7) Each site will implement Physical Activity Strength and 
Endurance Challenges three times, six to eight weeks apart. Physical 
activity data will be collected and summarized.
    (8) Grantee will promote and facilitate local, state, and national 
partnerships for the purpose of establishing or enhancing program 
support that involves increasing physical activity and good nutrition 
for the Tribally-managed Boys and Girls Club sites. This includes but 
is not limited to establishing other partners such as American Indian-
Alaska Native Program Branch (AI-ANPB) of Head Start Programs, Wings of 
America, United National Indian Tribal Youth, Inc. (UNITY), Tribal 
colleges, BGCA, Tribal organizations, local community health providers 
and other private organizations as appropriate.
    (9) Grantee will continue to implement current evaluation processes 
in consultation for the TRAIL project. At a minimum, the evaluation 
will include:

[[Page 14007]]

    (a) Training attendance (gender, age, grade level);
    (b) pre- and post- tests to assess participant knowledge;
    (c) monthly activity logs from each site on the physical activity 
portion of their program. Daily data to be collected includes the date, 
number of minutes of physical activity, and number of children 
participating; and
    (d) information/log on parent and family participation in education 
and activity programs, community involvement and partnerships.
    (10) Submit collated and summarized data to the IHS. Work with the 
IHS in drafting an evaluation summary at the end of the project period 
for publication. Submit collated and summarized data and project 
evaluation summaries to all sites. Provide a minimum of annual reports 
(feedback) to each site on how their data compare to data (mean, 
median, and range) from other selected sites.
    (11) Provide ongoing technical support to the sites for the 
duration of the initiative. Provide training and technical assistance 
in all forms, i.e., on-site, on-line, by phone, and mail. The planning, 
design and delivery of training and technical assistance will support 
the local organization's long-term planning and outreach efforts. The 
training will be customized based on sites' capability and experience. 
Technical assistance will also be provided on program planning and 
implementation. Collaborate with IHS to provide services to club sites. 
Maintain records and reports.
    (12) Provide technical consultation to the sites in developing a 
written work plan, with measurable goals, objectives and activities.
    (13) Establish a formal agreement with Native American Boys and 
Girls Club sites which involves minimal fiscal assistance but 
substantial technical support to make sure clubs successfully implement 
the TRAIL program.
    (14) Submit to the IHS a written work plan and report describing 
each site's demographics, information on the number of youth in the 
eligible age range in the catchment area, the number that attend the 
Boys and Girls Clubs regularly, and the number served by this project, 
goals, objectives, activities, partnerships, and proposed outcomes.
    (15) Provide IHS written quarterly reports on the evaluation 
outcomes, activity reports at each site, any parent involvement 
activities and other participation, description of the community 
partnerships, and other activities as appropriate
    (16) Conduct quarterly conference calls with IHS to review project 
status.

III. Eligibility Information

1. Eligibility

    The award is offered as a single source competing continuation 
cooperative agreement with the NCAI. NCAI is identified as the single 
source for the award, based on their successful record of performance 
with this project, their unique relationship and work in developing and 
maintaining: (1) Relationships with the Boys and Girls Clubs 
organization and staff, (2) being able to successfully implement the 
TRAIL program curriculum, (3) the project Web site information, and (4) 
the project data and evaluation systems. The award is for a 
continuation of activities identified. NCAI is the sole organization 
eligible to apply for competing continuation funding under this 
announcement and must demonstrate that they have complied with previous 
terms and conditions of the Healthy Lifestyles in Youth grant in order 
to receive funding under this announcement.

2. Cost Sharing or Matching

    The IHS does not require matching funds or cost sharing for grants 
or cooperative agreements.

3. Other Requirements

    If application budgets exceed the highest dollar amount outlined 
under the ``Estimated Funds Available'' section within this funding 
announcement, the application will be considered ineligible and will 
not be reviewed for further consideration. If deemed ineligible, IHS 
will not return the application. The applicant will be notified by 
email by the Division of Grants Management (DGM) of this decision.
Proof of Non-Profit Status
    Organizations claiming non-profit status must submit proof. A copy 
of the 501(c)(3) Certificate must be received with the application 
submission by the Application Deadline Date listed under the Key Dates 
section on page one of this announcement.
    An applicant submitting any of the above additional documentation 
after the initial application submission due date is required to ensure 
the information was received by the IHS by obtaining documentation 
confirming delivery (i.e., FedEx tracking, postal return receipt, 
etc.).

IV. Application and Submission Information

1. Obtaining Application Materials

    The application package and detailed instructions for this 
announcement can be found at http://www.Grants.gov or http://www.ihs.gov/dgm/funding/.
    Questions regarding the electronic application process may be 
directed to Mr. Paul Gettys at (301) 443-2114 or (301) 443-5204.

2. Content and Form Application Submission

    The applicant must include the project narrative as an attachment 
to the application package. Mandatory documents for all applicants 
include:
     Table of contents.
     Abstract (one page) summarizing the project.
     Application forms:
    [cir] SF-424, Application for Federal Assistance.
    [cir] SF-424A, Budget Information--Non-Construction Programs.
    [cir] SF-424B, Assurances--Non-Construction Programs.
     Budget Justification and Narrative (must be single-spaced 
and not exceed 30 pages).
     Project Narrative (must be single-spaced and not exceed 30 
pages).
    [cir] Background information on the organization.
    [cir] Proposed scope of work, objectives, and activities that 
provide a description of what will be accomplished, including a one-
page Timeframe Chart.
     501(c)(3) Certificate (if applicable).
     Biographical sketches for all Key Personnel.
     Contractor/Consultant resumes or qualifications and scope 
of work.
     Disclosure of Lobbying Activities (SF-LLL).
     Certification Regarding Lobbying (GG-Lobbying Form).
     Copy of current Negotiated Indirect Cost rate (IDC) 
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:
    [cir] Email confirmation from Federal Audit Clearinghouse (FAC) 
that audits were submitted; or
    [cir] Face sheets from audit reports. These can be found on the FAC 
Web site: https://harvester.census.gov/facdissem/Main.aspx.
Public Policy Requirements
    All Federal-wide public policies apply to IHS grants and 
cooperative agreements with exception of the discrimination policy.
Requirements for Project and Budget Narratives
    A. Project Narrative: This narrative should be a separate Word 
document

[[Page 14008]]

that is no longer than 30 pages and must: Be single-spaced, type 
written, have consecutively numbered pages, use black type not smaller 
than 12 characters per one inch, and be printed on one side only of 
standard size 8\1/2\'' x 11'' paper.
    Be sure to succinctly answer all questions listed under the 
evaluation criteria (refer to Section V.1, Evaluation criteria in this 
announcement) and place all responses and required information in the 
correct section (noted below), or they will not be considered or 
scored. These narratives will assist the Objective Review Committee 
(ORC) in becoming familiar with the applicant's activities and 
accomplishments prior to this possible cooperative agreement award. If 
the narrative exceeds the page limit, only the first 30 pages will be 
reviewed. The 30 page limit for the narrative does not include the work 
plan, standard forms, Tribal resolutions, table of contents, budget, 
budget justifications, narratives, and/or other appendix items.
    There are three parts to the narrative: Part A--Introduction and 
Need for Assistance; Part B--Work Plan; and Part C--Organizational 
Capabilities. See below for additional details about what must be 
included in the narrative.
Part A: Introduction and Need for Assistance 10 Page Limitation
    Please provide description of the need for assistance with offering 
this program. Applicant should demonstrate knowledge of: Health 
concerns for AI/AN youth; health promotion activities in Tribal 
communities such as BGCA; and working with Tribes and Tribal 
organizations.
Part B: Work Plan 10 Page Limitation
Section 1: Program Plans
    This section should demonstrate the soundness and effectiveness of 
the proposal. The work plan should be designed to describe how and when 
the sites will be selected; describe how the sites will be trained on 
the curriculum and provided technical assistance; and describe how 
sites will be supported for a physical activity program with the 
equipment and participant incentives.
Section 2: Program Evaluation
    Describe the plan for collecting data, monitoring, and assuring 
quality and quantity of data and the plan for evaluating and reporting 
program results.
Part C: Organizational Capabilities 10 Page Limitation
    Describe the broader capacity of the organization to complete the 
project outlined in the work plan, including (1) identification and 
bios for key personnel responsible for completing tasks; (2) 
description of the structure of the organization and chain of 
responsibility for successful completion of the project outline in the 
work plan; (3) description of financial and project management 
capacity, including information regarding similarly sized projects in 
scope and financial assistance as well as other grants and projects 
successfully completed; (4) description of national experience in 
providing administrative and support services to Tribal youth 
organizations, education agencies and other Tribal programs for the 
benefit of AI/AN children and youth and Tribal communities. Indicate 
experience in national partnerships or national support efforts on 
behalf of AI/AN communities especially as it pertains to health 
concerns; (5) description of equipment and space available for use 
during the proposed project; and (6) description of specialized 
experience working with Tribal Boys and Girls Club sites and the TRAIL 
curriculum program.
B. Budget Narrative: 30 Page Limit
    This narrative must include a line item budget with a narrative 
justification for all expenditures identifying reasonable allowable, 
allocable costs necessary to accomplish the goals and objectives as 
outlined in the project narrative. Budget should match the scope of 
work described in the project narrative. This section should provide a 
clear estimate of the project program costs and justification for 
expenses for the entire cooperative agreement period. The budget and 
budget justification should be consistent with the tasks identified in 
the work plan.

3. Submission Dates and Times

    Applications must be submitted electronically through Grants.gov by 
11:59 p.m. Daylight Saving Time (DST), on the Application Deadline Date 
listed in the Key Dates section on page one of this announcement. Any 
application received after the application deadline will not be 
accepted for processing, nor will it be given further consideration for 
funding. Grants.gov will notify the applicant via email if the 
application is rejected.
    If technical challenges arise and assistance is required with the 
electronic application process, contact Grants.gov Customer Support via 
email to [email protected] or at (800) 518-4726. Customer Support is 
available to address questions 24 hours a day, 7 days a week (except on 
Federal holidays). If problems persist, contact Mr. Gettys 
([email protected]), DGM Grant Systems Coordinator, by telephone at 
(301) 443-2114 or (301) 443-5204. Please be sure to contact Mr. Gettys 
at least ten 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.

4. Intergovernmental Review

    Executive Order 12372 requiring intergovernmental review is not 
applicable to this program.

5. Funding Restrictions

     Pre-award costs are not allowable.
     The available funds are inclusive of direct and 
appropriate indirect costs.
     Only one grant/cooperative agreement will be awarded per 
applicant.
     IHS will not acknowledge receipt of applications.

6. Electronic Submission Requirements

    All applications must be submitted electronically. Please use the 
http://www.Grants.gov Web site to submit an application electronically 
and select the ``Find Grant Opportunities'' link on the homepage. 
Download a copy of the application package, complete it offline, and 
then upload and submit the completed application via the http://www.Grants.gov Web site. Electronic copies of the application may not 
be submitted as attachments to email messages addressed to IHS 
employees or offices.
    If the applicant needs to submit a paper application instead of 
submitting electronically through Grants.gov, a waiver must be 
requested. Prior approval must be requested and obtained from Mr. 
Robert Tarwater, Director, DGM, (see Section IV.6 below for additional 
information). A written waiver request must be sent to 
[email protected] with a copy to [email protected]. The waiver 
must (1) be documented in writing (emails are acceptable) before 
submitting a paper application, and (2) include clear justification for 
the need to deviate from the required electronic grants submission 
process.
    Once the waiver request has been approved, the applicant will 
receive a confirmation of approval email containing submission 
instructions and the mailing address to submit the application. A copy 
of the written approval must be submitted along with the hardcopy of 
the application that is mailed to DGM. Paper applications that are 
submitted without a copy of the

[[Page 14009]]

signed waiver from the Mr. Tarwater of the DGM will not be reviewed or 
considered for funding. The applicant will be notified via email of 
this decision by the Grants Management Officer of the DGM. Paper 
applications must be received by the DGM no later than 5:00 p.m., DST 
on the Application Deadline Date listed in the Key Dates section on 
page one of this announcement. Late applications will not be accepted 
for processing or considered for funding. Applicants that do not adhere 
to the timelines for System for Award Management (SAM) and/or http://www.Grants.gov registration or that fail to request timely assistance 
with technical issues will not be considered for a waiver to submit a 
paper application.
    Please be aware of the following:
     Please search for the application package in http://www.Grants.gov by entering the CFDA number or the Funding Opportunity 
Number. Both numbers are located in the header of this announcement.
     If you experience technical challenges while submitting 
your application electronically, please contact Grants.gov Support 
directly at: [email protected] or (800) 518-4726. Customer Support is 
available to address questions 24 hours a day, 7 days a week (except on 
Federal holidays).
     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 
fifteen working days.
     Please use the optional attachment feature in Grants.gov 
to attach additional documentation that may be requested by the DGM.
     All applicants must comply with any page limitation 
requirements described in this funding announcement.
     After electronically submitting the application, the 
applicant will receive an automatic acknowledgment from Grants.gov that 
contains a Grants.gov tracking number. The DGM will download the 
application from Grants.gov and provide necessary copies to the 
appropriate agency officials. Neither the DGM nor IHS Office of 
Clinical and Preventive Services, Division of Diabetes Treatment and 
Prevention will notify the applicant that the application has been 
received.
     Email applications will not be accepted under this 
announcement.
Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS)
    All IHS applicants and grantee organizations are required to obtain 
a DUNS number and maintain an active registration in the SAM database. 
The DUNS number is a unique 9-digit identification number provided by 
D&B which uniquely identifies each entity. The DUNS number is site 
specific; therefore, each distinct performance site may be assigned a 
DUNS number. Obtaining a DUNS number is easy, and there is no charge. 
To obtain a DUNS number, you may access it through http://fedgov.dnb.com/webform, or to expedite the process, call (866) 705-
5711.
    All HHS recipients are required by the Federal Funding 
Accountability and Transparency Act of 2006, as amended (``Transparency 
Act''), to report information on sub-awards. Accordingly, all IHS 
grantees must notify potential first-tier sub-recipients that no entity 
may receive a first-tier sub-award unless the entity has provided its 
DUNS number to the prime grantee 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.
System for Award Management (SAM)
    Organizations that were not registered with Central Contractor 
Registration and have not registered with SAM will need to obtain a 
DUNS number first and then access the SAM online registration through 
the SAM home page at https://www.sam.gov (U.S. organizations will also 
need to provide an Employer Identification Number from the Internal 
Revenue Service that may take an additional 2-5 weeks to become 
active). Completing and submitting the registration takes approximately 
one hour to complete and SAM registration will take 3-5 business days 
to process. Registration with the SAM is free of charge. Applicants may 
register online at https://www.sam.gov.
    Additional information on implementing the Transparency Act, 
including the specific requirements for DUNS and SAM, can be found on 
the IHS Grants Management, Grants Policy Web site: http://www.ihs.gov/dgm/policytopics/.

V. Application Review Information

    The instructions for preparing the application narrative also 
constitute the evaluation criteria for reviewing and scoring the 
application. Weights assigned to each section are noted in parentheses. 
The 30 page narrative should include only the first year of activities; 
information for multi-year projects should be included as an appendix. 
See ``Multi-year Project Requirements'' at the end of this section for 
more information. The narrative section 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 understand the 
project fully. Points will be assigned to each evaluation criteria 
adding up to a total of 100 points. A minimum score of 60 points is 
required for funding. Points are assigned as follows:

1. Criteria

A. Introduction and Need for Assistance 20 points
    This section should demonstrate knowledges of health concerns and 
issues regarding AI/AN youth, health promotion activities in Tribal 
communities, and working with Tribes and Tribal organizations.
B. Work Plan 30 points
    This section should demonstrate a sound and effective annual work 
plan that will support accomplishment of deliverables and milestones of 
the TRAIL project. The work plan should be designed to:
     Describe how and when the sites will be selected;
     Describe how the sites will be trained on the curriculum 
and provided technical assistance;
     Describe the plan for collecting data, monitoring, and 
assuring quality and quantity of data;
     Describe the plan for evaluating and reporting;
     Describe how sites will be supported for a physical 
activity program.
C. Organizational Capabilities 40 points
    This section should outline the broader capacity of the 
organization to complete the project outlined in the work plan. It 
includes the identification of personnel responsible for completing 
tasks and the chain of responsibility for successful completion of the 
project outline in the work plan. The section should:
     Describe the structure of the organization.
     Describe the ability of the organization to manage the 
proposed project and include information

[[Page 14010]]

regarding similarly sized projects in scope and financial assistance as 
well as other grants and projects successfully completed.
     Describe what equipment (i.e., phone, Web sites, etc.) and 
facility space (i.e., office space) will be available for use during 
the proposed project. Include information about any equipment not 
currently available that will be purchased throughout the agreement.
     List and provide bios for key personnel who will work on 
the project. The section should demonstrate knowledge in:
    [cir] Financial and project management.
    [cir] Nationwide experience in providing administrative and support 
services to Tribal youth organizations, education agencies and other 
Tribal programs for the benefit of children and youth.
    [cir] AI/AN youth and Tribal communities and indicate experience in 
national partnerships or national support efforts on behalf of AI/AN 
communities especially as it pertains to health concerns.
    [cir] Experience working with Tribal Boys and Girls Club sites and 
the TRAIL curriculum program.
D. Categorical Budget and Budget Justification 10 points
    This section should provide a clear estimate of the project program 
costs and justification for expenses for the entire cooperative 
agreement period. The budget and budget justification should be 
consistent with the tasks identified in the work plan.
     Categorical budget (Form SF 424A, Budget Information Non 
Construction Programs) completing each of the budget periods requested.
     Narrative justification for all costs, explaining why each 
line item is necessary or relevant to the proposed project. Include 
sufficient details to facilitate the determination of cost allow 
ability.
     Indication of any special start-up costs.
     Budget justification should include a brief program 
narrative for the third and fourth years.
     If indirect costs are claimed, indicate and apply the 
current negotiated rate to the budget. Include a copy of the rate 
agreement in the appendix.
Multi-Year Project Requirements (if applicable)
    Projects requiring a second, third, fourth, and/or fifth year must 
include a brief project narrative and budget (one additional page per 
year) addressing the developmental plans for each additional year of 
the project.
Additional documents can be uploaded as Appendix Items in Grants.gov
     Work plan, logic model and/or time line 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 Agreement.
     Map of area identifying project location(s).
     Additional documents to support narrative (i.e., data 
tables, key news articles, etc.).

2. Review and Selection

    Each application will be prescreened by the DGM staff for 
eligibility and completeness as outlined in the funding announcement. 
Applications that meet the eligibility criteria shall be reviewed for 
merit by the ORC based on evaluation criteria in this funding 
announcement. The ORC could be composed of both Tribal and Federal 
reviewers appointed by the IHS program to review and make 
recommendations on these applications. The technical review process 
ensures selection of quality projects in a national competition for 
limited funding. Incomplete applications and applications that are non-
responsive to the eligibility criteria will not be referred to the ORC. 
The applicant will be notified via email of this decision by the Grants 
Management Officer of the DGM. Applicants will be notified by DGM, via 
email, to outline minor missing components (i.e., budget narratives, 
audit documentation, key contact form) needed for an otherwise complete 
application. All missing documents must be sent to DGM on or before the 
due date listed in the email of notification of missing documents 
required.
    To obtain a minimum score for funding by the ORC, applicants must 
address all program requirements and provide all required 
documentation.

VI. Award Administration Information

1. Award Notices

    The Notice of Award (NoA) is a legally binding document signed by 
the Grants Management Officer and serves as the official notification 
of the grant award. The NoA will be initiated by the DGM in our grant 
system, GrantSolutions (https://www.grantsolutions.gov). Each entity 
that is approved for funding under this announcement will need to 
request or have a user account in GrantSolutions in order to retrieve 
their NoA. 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 grant, the terms and conditions of 
the award, the effective date of the award, and the budget/project 
period.
Disapproved Applicants
    Applicants who received a score less than the recommended funding 
level for approval (60), and were deemed to be disapproved by the ORC, 
will receive an Executive Summary Statement from the IHS program office 
within 30 days of the conclusion of the ORC outlining the strengths and 
weaknesses of their application submitted. The summary statement will 
be sent to the Authorized Organizational Representative that is 
identified on the face page (SF-424) of the application. The IHS 
program office will also provide additional contact information as 
needed to address questions and concerns as well as provide technical 
assistance if desired.
Approved but Unfunded Applicants
    Approved but unfunded applicants that met the minimum scoring range 
and were deemed by the ORC to be ``Approved'', but were not funded due 
to lack of funding, will have their applications held by DGM for a 
period of one year. If additional funding becomes available during the 
course of FY 2017 the approved but unfunded application may be re-
considered by the awarding program office for possible funding. The 
applicant will also receive an Executive Summary Statement from the IHS 
program office within 30 days of the conclusion of the ORC.

    Note: Any correspondence other than the official NoA signed 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 IHS.

2. Administrative Requirements

    Cooperative agreements are administered in accordance with the 
following regulations and policies:
    A. The criteria as outlined in this program announcement.
    B. Administrative Regulations for Grants:
     Uniform Administrative Requirements for HHS Awards, 
located at 45 CFR part 75.
    C. Grants Policy:
     HHS Grants Policy Statement, Revised 01/07.
    D. Cost Principles:
     Uniform Administrative Requirements for HHS Awards, ``Cost 
Principles,'' located at 45 CFR part 75, subpart E.

[[Page 14011]]

    E. Audit Requirements:
     Uniform Administrative Requirements for HHS Awards, 
``Audit Requirements,'' located at 45 CFR part 75, subpart F.

3. Indirect Costs

    This section applies to all grant recipients that request 
reimbursement of indirect costs (IDC) in their grant application. In 
accordance with HHS Grants Policy Statement, Part II-27, IHS requires 
applicants to obtain a current IDC rate agreement prior to award. The 
rate agreement must be prepared in accordance with the applicable cost 
principles and guidance as provided by the cognizant agency or office. 
A current rate covers the applicable grant activities under the current 
award's budget period. If the current rate is not on file with the DGM 
at the time of award, the IDC portion of the budget will be restricted. 
The restrictions remain in place until the current rate is provided to 
the DGM.
    Generally, IDC rates for IHS grantees are negotiated with the 
Division of Cost Allocation (DCA) https://rates.psc.gov/ and the 
Department of Interior (Interior Business Center) https://www.doi.gov/ibc/services/finance/indirect-Cost-Services/indian-tribes. For 
questions regarding the indirect cost policy, please call the Grants 
Management Specialist listed under ``Agency Contacts'' or the main DGM 
office at (301) 443-5204.

4. Reporting Requirements

    The grantee must submit required reports consistent with the 
applicable deadlines. Failure to submit required reports within the 
time allowed may result in suspension or termination of an active 
grant, withholding of additional awards for the project, or other 
enforcement actions such as withholding of payments or converting to 
the reimbursement method of payment. Continued failure to submit 
required reports may result in one or both of the following: (1) The 
imposition of special award provisions; and (2) the non-funding or non-
award of other eligible projects or activities. This requirement 
applies whether the delinquency is attributable to the failure of the 
grantee organization or the individual responsible for preparation of 
the reports. Per DGM policy, all reports are required to 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 see the Agency Contacts 
list in section VII for the systems contact information.
    The reporting requirements for this program are noted below.
A. Progress Reports
    Program progress reports are required annually, within 30 days 
after the budget period ends. These reports must include a brief 
comparison of actual accomplishments to the goals established for the 
period, a summary of progress to date or, if applicable, provide sound 
justification for the lack of progress, and other pertinent information 
as required. A final report must be submitted within 90 days of 
expiration of the budget/project period.
B. Financial Reports
    Federal Financial Report FFR (SF-425), Cash Transaction Reports are 
due 30 days after the close of every calendar quarter to the Payment 
Management Services, HHS at http://www.dpm.psc.gov. It is recommended 
that the applicant also send a copy of the FFR (SF-425) report to the 
Grants Management Specialist. Failure to submit timely reports may 
cause a disruption in timely payments to the organization.
    Grantees are responsible and accountable for accurate information 
being reported on all required reports: The Progress Reports and 
Federal Financial Report.
C. 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 grants to 
report information about first-tier sub-awards and executive 
compensation under Federal assistance awards.
    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 dollar threshold met for any specific 
reporting period. Additionally, all new (discretionary) IHS awards 
(where the project period is made up of more than one budget period) 
and where: (1) The project period start date was October 1, 2010 or 
after and (2) the primary awardee will have a $25,000 sub-award 
obligation dollar threshold during any specific reporting period will 
be required to address the FSRS reporting.
    For the full IHS award term implementing this requirement and 
additional award applicability information, visit the DGM Grants Policy 
Web site at: http://www.ihs.gov/dgm/policytopics/.
D. Compliance With Executive Order 13166 Implementation of Services 
Accessibility Provisions for All Grant Application Packages and Funding 
Opportunity Announcements
    Recipients of Federal financial assistance (FFA) from HHS must 
administer their programs in compliance with Federal civil rights law. 
This means that recipients of HHS funds must ensure equal access to 
their programs without regard to a person's race, color, national 
origin, disability, age and, in some circumstances, sex and religion. 
This includes ensuring your programs are accessible to persons with 
limited English proficiency. HHS provides guidance to recipients of FFA 
on meeting their legal obligation to take reasonable steps to provide 
meaningful access to their programs by persons with limited English 
proficiency. Please see http://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/guidance-federal-financial-assistance-recipients-title-VI/.
    The HHS Office for Civil Rights (OCR) also provides guidance on 
complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and 
http://www.hhs.gov/civil-rights/index.html. Recipients of FFA also have 
specific legal obligations for serving qualified individuals with 
disabilities. Please see http://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS OCR for more 
information about obligations and prohibitions under Federal civil 
rights laws at http://www.hhs.gov/ocr/about-us/contact-us/headquarters-and-regional-addresses/index.html or call 1-800-368-1019 or TDD 1-800-
537-7697. Also note it is an HHS Departmental goal to ensure access to 
quality, culturally competent care, including long-term services and 
supports, for vulnerable populations. For further guidance on providing 
culturally and linguistically appropriate services, recipients should 
review the National Standards for Culturally and Linguistically 
Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

[[Page 14012]]

    Pursuant to 45 CFR 80.3(d), an individual shall not be deemed 
subjected to discrimination by reason of his/her exclusion from 
benefits limited by Federal law to individuals eligible for benefits 
and services from the IHS.
    Recipients will be required to sign the HHS-690 Assurance of 
Compliance form which can be obtained from the following Web site: 
http://www.hhs.gov/sites/default/files/forms/hhs-690.pdf, and send it 
directly to the: U.S. Department of Health and Human Services, Office 
of Civil Rights, 200 Independence Ave. SW., Washington, DC 20201.
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 Federal Awardee Performance and Integrity 
Information System (FAPIIS) before making any award in excess of the 
simplified acquisition threshold (currently $150,000) over the period 
of performance. An applicant may review and comment on any information 
about itself that a Federal awarding agency previously entered. 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, 
non-federal entities (NFEs) are required to disclose in FAPIIS any 
information about criminal, civil, and administrative proceedings, and/
or affirm that there is no new information to provide. This applies to 
NFEs that receive Federal awards (currently active grants, cooperative 
agreements, and procurement contracts) greater than $10,000,000 for any 
period of time during the period of performance of an award/project.
Mandatory Disclosure Requirements
    As required by 2 CFR part 200 of the Uniform Guidance, and the HHS 
implementing regulations at 45 CFR part 75, effective January 1, 2016, 
the IHS must require a non-federal entity 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.
    Submission is required for all applicants and recipients, in 
writing, 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: Robert Tarwater, Director, 5600 
Fishers Lane, Mail Stop: 09E70, Rockville, Maryland 20857 (Include 
``Mandatory Grant Disclosures'' in subject line) Ofc: (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: http://oig.hhs.gov/fraud/report-fraud/index.asp (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 parts 180 & 376 and 31 
U.S.C. 3321).

VII. Agency Contacts

    1. Questions on the programmatic issues may be directed to: Ms. 
Carmen Licavoli Hardin, Deputy Director, Division of Diabetes Treatment 
and Prevention, Indian Health Service (HQ), 5600 Fishers Lane, Mail 
Stop: 08N34 A&B, Rockville, MD 20857, Telephone: 1-844-IHS-DDTP (1-844-
447-3387), Fax: 301-594-6213, Email address: [email protected].
    2. Questions on grants management and fiscal matters may be 
directed to: Donald Gooding, Senior Grants Management Specialist, 5600 
Fishers Lane, Mail Stop: 09E70, Rockville, MD 20857, Telephone: 301-
443-2298, Fax: 301-594-0899, Email address: [email protected].
    3. Questions on systems matters may be directed to: Paul Gettys, 
Grant Systems Coordinator, 5600 Fishers Lane, Mail Stop: 09E70, 
Rockville, MD 20857, Phone: 301-443-2114; or the DGM main line 301-443-
5204, Fax: 301-594-0899, Email: [email protected].

VIII. Other Information

    The Public Health Service strongly encourages all 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.

    Dated: March 6, 2017.
RADM Chris Buchanan,
Assistant Surgeon General, USPHS, Acting Director, Indian Health 
Service.
[FR Doc. 2017-05243 Filed 3-15-17; 8:45 am]
 BILLING CODE 4165-16-P



                                                  14004                        Federal Register / Vol. 82, No. 50 / Thursday, March 16, 2017 / Notices

                                                  information about FDA’s posting of                      industry on generic 200 mg rifaximin                  DEPARTMENT OF HEALTH AND
                                                  comments to public dockets, see 80 FR                   oral tablets; in February 2012, FDA                   HUMAN SERVICES
                                                  56469, September 18, 2015, or access                    issued a draft guidance for industry on
                                                  the information at: https://www.gpo.gov/                generic 550 mg rifaximin oral tablets.                Indian Health Service
                                                  fdsys/pkg/FR-2015-09-18/pdf/2015-                       We are now consolidating these two                    [Funding Announcement Number: HHS–
                                                  23389.pdf.                                              guidances and issuing a single revised                2017–IHS–HLY–0001; Catalog of Federal
                                                     Docket: For access to the docket to                  draft guidance for industry on generic                Domestic Assistance Number: 93.933]
                                                  read background documents or the                        rifaximin oral tablets (‘‘Draft Guidance
                                                  electronic and written/paper comments                   on Rifaximin’’).                                      Healthy Lifestyles in Youth Project;
                                                  received, go to https://                                                                                      Proposed Single Source Competing
                                                  www.regulations.gov and insert the                         In May 2008, Salix Pharmaceuticals,                Continuation Cooperative Agreement
                                                  docket number, found in brackets in the                 Inc. (Salix), manufacturer of the                     with National Congress of American
                                                  heading of this document, into the                      reference listed drugs XIFAXAN 200 mg                 Indians
                                                  ‘‘Search’’ box and follow the prompts                   and XIFAXAN 550 mg, submitted a
                                                  and/or go to the Division of Dockets                    citizen petition requesting that FDA                  Key Dates
                                                  Management, 5630 Fishers Lane, Rm.                      refrain from approving any ANDA                       Application Deadline Date: May 15,
                                                  1061, Rockville, MD 20852.                              referencing XIFAXAN 200 mg unless                       2017
                                                     Submit written requests for single                   certain conditions were satisfied,                    Review Date: May 22–26, 2017
                                                  copies of the draft guidance to the                     including conditions related to                       Earliest Anticipated Start Date:
                                                  Division of Drug Information, Center for                demonstrating BE. In October 2016,                      September 1, 2017
                                                  Drug Evaluation and Research, Food                      Baker & Hostetler LLP submitted a                     Proof of Non-Profit Status Due Date:
                                                  and Drug Administration, 10001 New                      citizen petition on behalf of Salix                     May 15, 2017
                                                  Hampshire Ave., Hillandale Building,                    requesting that FDA refrain from                      I. Funding Opportunity Description
                                                  4th Floor, Silver Spring, MD 20993–                     approving any ANDA referencing
                                                  0002. Send one self-addressed adhesive                  XIFAXAN 200 mg or XIFAXAN 550 mg                      Statutory Authority
                                                  label to assist that office in processing               unless certain conditions were satisfied,               The Indian Health Service (IHS)
                                                  your requests. See the SUPPLEMENTARY                    including conditions related to                       Office of Clinical and Preventive
                                                  INFORMATION section for electronic                      demonstrating BE. FDA has reviewed                    Services, Division of Diabetes Treatment
                                                  access to the draft guidance.                           the issues raised in these citizen                    and Prevention, is accepting
                                                  FOR FURTHER INFORMATION CONTACT:                        petitions and is responding to the                    applications for a single source
                                                  Xiaoqiu Tang, Center for Drug                           citizen petitions separately in the                   competing continuation cooperative
                                                  Evaluation and Research (HFD–600),                      dockets for those citizen petitions                   agreement with the National Congress of
                                                  Food and Drug Administration, 10903                     (Docket Nos. FDA–2008–P–0300 and                      American Indians (NCAI) for the
                                                  New Hampshire Ave., Bldg. 75, Rm.                       FDA–2016–P–3418, available at https://                purpose of continued implementation of
                                                  4730, Silver Spring, MD 20993–0002,                     www.regulations.gov).                                 the Healthy Lifestyles in Youth Project
                                                  301–796–5850.                                                                                                 in selected Native American Boys and
                                                  SUPPLEMENTARY INFORMATION:
                                                                                                             The revised draft guidance is being
                                                                                                                                                                Girls Clubs of America. This program is
                                                                                                          issued consistent with FDA’s good                     authorized under the authority of the
                                                  I. Background                                           guidance practices regulation (21 CFR                 Snyder Act, 25 U.S.C. 13; the Transfer
                                                     In the Federal Register of June 11,                  10.115). The revised draft guidance,                  Act, 42 U.S.C. 2001; and the Public
                                                  2010 (75 FR 33311), FDA announced the                   when finalized, will represent the                    Health Service Act, as amended, 42
                                                  availability of a guidance for industry                 current thinking of FDA on ‘‘Draft                    U.S.C. 241(a). This program is described
                                                  entitled ‘‘Bioequivalence                               Guidance on Rifaximin.’’ It does not                  in the Catalog of Federal Domestic
                                                  Recommendations for Specific                            establish any rights for any person and               Assistance (CFDA) under 93.933.
                                                  Products,’’ which explained the process                 is not binding on FDA or the public.
                                                  that would be used to make product-                     You can use an alternative approach if                Background
                                                  specific guidances available to the                     it satisfies the requirements of the                     This program promotes healthy
                                                  public on FDA’s Web site at http://                     applicable statutes and regulations.                  lifestyles among American Indian and
                                                  www.fda.gov/Drugs/                                                                                            Alaska Native (AI/AN) youth using the
                                                  GuidanceCompliance                                      II. Electronic Access                                 curriculum ‘‘Together Raising
                                                  RegulatoryInformation/Guidances/                          Persons with access to the Internet                 Awareness for Indian Life’’ (TRAIL)
                                                  default.htm.                                                                                                  among selected Boys and Girls Club
                                                                                                          may obtain the draft guidances at either
                                                     As described in that guidance, FDA                                                                         sites. Under this cooperative agreement,
                                                                                                          https://www.fda.gov/Drugs/
                                                  adopted this process to develop and                                                                           IHS proposes to enter into a
                                                  disseminate product-specific guidances                  GuidanceCompliance
                                                                                                                                                                collaborative effort/initiative with
                                                  and to provide a meaningful                             RegulatoryInformation/Guidances/
                                                                                                                                                                NCAI, because of their unique
                                                  opportunity for the public to consider                  default.htm or https://                               experience partnering with the IHS and
                                                  and comment on the guidances. This                      www.regulations.gov.                                  Boys and Girls Clubs of America
                                                  notice announces the availability of a                    Dated: March 13, 2017.                              (BGCA) in successfully establishing this
                                                  revised draft guidance for generic                      Leslie Kux,                                           program, as well as, their overall
                                                  rifaximin oral tablets.
mstockstill on DSK3G9T082PROD with NOTICES




                                                                                                          Associate Commissioner for Policy.                    expertise and experience in addressing
                                                     FDA initially approved new drug                                                                            and evaluating healthy lifestyle
                                                                                                          [FR Doc. 2017–05245 Filed 3–15–17; 8:45 am]
                                                  application (NDA) 021361 for XIFAXAN                                                                          techniques in AI/AN youth.
                                                  (rifaximin oral tablets) 200 milligram                  BILLING CODE 4164–01–P

                                                  (mg) in May 2004 and NDA 022554 for                                                                           Purpose
                                                  XIFAXAN (rixaximin oral tablets) 550                                                                            This work will continue to support
                                                  mg in March 2010. In November 2011,                                                                           the IHS mission to improve the health
                                                  FDA issued a draft guidance for                                                                               of AI/AN youth through health


                                             VerDate Sep<11>2014   17:12 Mar 15, 2017   Jkt 241001   PO 00000   Frm 00032   Fmt 4703   Sfmt 4703   E:\FR\FM\16MRN1.SGM   16MRN1


                                                                                    Federal Register / Vol. 82, No. 50 / Thursday, March 16, 2017 / Notices                                                        14005

                                                  promotion and health education                                 draw from Tribal traditions and history                  well as provide funds to support these
                                                  programs. The purpose of this IHS                              to learn about nutrition, healthy food                   activities.
                                                  cooperative agreement is to focus on                           choices, media influences, and the
                                                  addressing healthy lifestyle                                   impact of diabetes. Clubs also                           Single Source Justification
                                                  development, emphasizing nutrition                             implement the Nike Let Me Play and                          NCAI is identified as the single source
                                                  and physical activity for AI/AN children                       SPARK physical activity programs to                      for the award, based on their successful
                                                  and youth 7 through 11 years of age.                           foster Club-wide participation in fun                    record of performance with this project,
                                                  The long term goal is to prevent or delay                      activities and games for 60 minutes                      their unique relationship and work in
                                                  the onset of obesity and related diseases                      every day. TRAIL emphasizes the                          developing and maintaining: (1)
                                                  such as type 2 diabetes. NCAI will                             importance of teamwork and                               Relationships with the Boys and Girls
                                                  continue partnering work with selected                         community service. Members engage in                     Clubs organization and staff, (2) being
                                                  Native American Boys and Girls Club                            service projects to improve healthy                      able to successfully implement the
                                                  sites to: (a) Provide health and physical                      lifestyles in their communities,
                                                                                                                                                                          TRAIL program curriculum, (3) the
                                                  education programs; (b) help youth                             including starting community gardens
                                                                                                                                                                          project Web site information, and (4) the
                                                  achieve and maintain healthy lifestyles                        to connect youth to their food source
                                                                                                                                                                          project data and evaluation systems.
                                                  through participation in fitness                               and organizing community-wide
                                                                                                                                                                          The award is for a continuation of
                                                  programs; (c) help youth to acquire a                          physical fitness events.
                                                                                                                    Since the inception of the program in                 activities identified. These activities, the
                                                  range of physical skills; and (d) help
                                                                                                                 2003, TRAIL has been implemented at                      collaboration with the network of Native
                                                  youth develop a sense of teamwork and
                                                                                                                 over 79 Native American Boys and Girls                   American Boys and Girls Clubs, and the
                                                  cooperation.
                                                     These early intervention strategies                         Club of America sites located in 17                      evaluation process have been effectively
                                                  provide evidence based opportunities to                        states. There are currently over 50 sites                undertaken by NCAI for the past 13
                                                  reduce and/or halt the increasing trend                        in more than 15 states participating in                  years. The process, as well as the
                                                  of obesity and diabetes among youth                            the program.                                             outcomes, have been deemed very
                                                  and young adults. Clubs that develop a                            The overall results show                              successful and clearly supportive of
                                                  health promotion program that includes                         improvement in participant knowledge                     Agency initiatives for youth.
                                                  the TRAIL curriculum may help curtail                          of diabetes, health, and healthy food                       The grantee has documented success
                                                  the effects of unhealthy eating behaviors                      choices, as well as, improved fitness                    in (1) recruiting and working with sites,
                                                  and lack of physical activity that can                         and level of physical activity. To                       (2) developing and implementing the
                                                  lead to obesity, diabetes, and other                           support this project, NCAI will select                   TRAIL curriculum at the sites, (3)
                                                  chronic diseases later in life. The TRAIL                      and assist at least 50 Native American                   implementing a method for collecting
                                                  curriculum was developed to provide                            Boys and Girls Club sites to establish                   data from the sites, (4) fostering
                                                  information on good nutrition and to                           and implement this curriculum project.                   collaboration between sites and their
                                                  promote physical activity among youth                          Boys and Girl Club sites that are located                communities, and (5) collecting and
                                                  participating in Native American Boys                          outside of Tribal communities will not                   reporting data that demonstrates
                                                  and Girls Clubs. TRAIL is a three month                        be considered by the grantee. The Boys                   participant increases in health and food
                                                  (12 lessons) program that provides                             and Girls Club sites selected by the                     choice knowledge and increases in
                                                  youth with a comprehensive                                     grantee may use IHS grant funds to                       participant physical activity and level of
                                                  understanding of healthy lifestyles in                         provide services to eligible IHS                         fitness. Some of the data for the most
                                                  order to prevent diabetes. Woven                               beneficiaries only. The grantee will be                  recent years of the current 5 year
                                                  throughout the program are self-esteem                         expected to: Provide technical                           cooperative agreement (2013–2016) are
                                                  and prevention activities. Participants                        consultation; train; monitor; evaluate; as               as follows:

                                                                                                                                    2013–2014 Data
                                                  Number of AI/AN Children Participating in the Curriculum, Training, and                        1,403 (610 males/716 females—77 gender not identified).
                                                    Strength and Endurance Challenges.
                                                  Age Range of Children Participating ........................................................   ages 4–14 (representing grades 2–6, with 96% of children in grades 2–
                                                                                                                                                   5).
                                                  Achieving Goal of 60 Minutes/Day of Physical Activity—Club Wide                                Average of 2,970 Children at 54 Sites Performed an Average of 74.15
                                                    (Children in TRAIL plus Other Boys and Girls Club Children).                                   Minutes/Day of Physical Activity = 3,683 hours of Physical Activity/
                                                                                                                                                   Day Nationwide (128 Days in the Reporting Period).
                                                  Program test scores indicate: (a) Increased knowledge about diabetes, (b) increased physical activity, and (c) increased ability to identify
                                                      healthier food options (increase in post test scores vs. pre test scores—82% of Clubs had post test scores of >70% compared to 3% with
                                                      pre-test scores >70%).
                                                                                                                                    2014–2015 Data
                                                  Number of AI/AN Children Participating in the Curriculum, Training, and                        1332 (590 males/669 females—63 gender not identified).
                                                    Strength and Endurance Challenges.
                                                  Age Range of Children Participating ........................................................   ages 6–11 (representing grades K–6, with 89% of children in grades
                                                                                                                                                   2–5).
                                                  Achieving Goal of 60 Minutes/Day of Physical Activity—Club Wide                                Average of 2,450 Children at 50 sites Performed an Average of 74.15
                                                    (Children in TRAIL plus Other Boys and Girls Club Children).                                   Minutes/Day of Physical Activity = 3,038 hours of Physical Activity/
                                                                                                                                                   Day Nationwide (128 Days in the Reporting Period).
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                                                  Program test scores indicate: (a) Increased knowledge about diabetes, (b) increased physical activity, and (c) increased ability to identify
                                                      healthier food options (increase in post test scores vs. pre test scores—85% of Clubs had post test scores of >70% compared to 9% with
                                                      pre-test scores >70%).
                                                                                                                                    2015–2016 Data
                                                  Number of AI/AN Children Participating in the Curriculum, Training, and                        1,256 Children (606 boys, 627 girls, 23 gender not identified).
                                                    Strength and Endurance Challenges.



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                                                  14006                             Federal Register / Vol. 82, No. 50 / Thursday, March 16, 2017 / Notices

                                                  Age Range of Children Participating ........................................................   6–12 years (representing grades K–6 with 87% of children in grades
                                                                                                                                                   2–5).
                                                  Achieving Goal of 60 Minutes/Day of Physical Activity—Club Wide                                Average of 2,907 Children Performed an Average of 63.9 Minutes/Day
                                                    (Children in TRAIL plus Other Boys and Girls Club Children).                                   of Physical Activity = 3,038 hours of Physical Activity/Day Nationwide
                                                                                                                                                   (128 Days in the Reporting Period).
                                                  Program test scores indicate: (a) Increased knowledge about diabetes, (b) increased physical activity, and (c) increased ability to identify
                                                      healthier food options (increase in post test scores vs. pre test scores—82% of Clubs had post test scores of >70% compared to 18% with
                                                      pre-test scores >70%).



                                                     The TRAIL curriculum and                                    appropriations and budgetary priorities                  from eligible IHS beneficiaries as a
                                                  subsequent revision were developed by                          of the Agency. The IHS is under no                       requirement for selection by the grantee.
                                                  the grantee as a part of earlier                               obligation to make awards that are                       A start-up planning meeting with new
                                                  agreements. If there is a need to update                       selected for funding under this                          sites will be conducted within two
                                                  the curriculum and subsequently                                announcement.                                            months of each site’s initial selection
                                                  implement the revised curriculum, it                                                                                    and award.
                                                  will be more efficiently and cost                              Anticipated Number of Awards
                                                                                                                                                                             (3) Plan and facilitate an orientation
                                                  effectively performed as the grantee is                          One award will be issued under this                    and training meeting for new sites
                                                  very familiar with the existing                                program announcement.                                    within two months of selection. Submit
                                                  curriculum and the implementation.                             Project Period                                           agenda, training goals and objectives,
                                                     The grantee uses a sub-contractor                                                                                    and participant list to IHS within one
                                                  (First Pic) to develop and implement the                         The project period is for five years                   month of completion of each orientation
                                                  evaluation and reporting process for                           and will run consecutively from                          session.
                                                  individual sites and for analysis and                          September 1, 2017 to August 31, 2022.
                                                                                                                                                                             (4) Update TRAIL curriculum as
                                                  reporting of aggregated data. This                             Cooperative Agreement                                    needed/directed and implement use.
                                                  unique and program specific evaluation
                                                                                                                   Cooperative agreements awarded by                         (5) Develop, in consultation with the
                                                  system has been beneficial to sites and
                                                                                                                 the HHS are administered under the                       IHS, the implementation and technical
                                                  to IHS. All of the tools for using this
                                                                                                                 same policies as a grant. However, the                   assistance plan for the coordination of
                                                  system have been made available via the
                                                                                                                 funding agency (IHS) is required to have                 the selected Boys and Girls Club sites.
                                                  Native American Boys and Girls Clubs
                                                                                                                 substantial programmatic involvement                     Submit criteria to the IHS for approval.
                                                  Web site—http://www.naclubs.org/
                                                                                                                 in the project during the entire award                   Grantee will continue work with sites to
                                                  index.php/club-programs/trail-diabetes-
                                                                                                                 segment. Below is a detailed description                 develop and report measurements for
                                                  prevention.
                                                     The grantee (NCAI) has been effective,                      of the level of involvement required for                 assessment of physical activity and
                                                  timely, and cooperative, and has                               both IHS and the grantee. IHS will be                    nutrition behaviors among club
                                                  consistently achieved or exceeded                              responsible for activities listed under                  participants.
                                                  requirements of the previous agreement.                        section A and the grantee will be                           (6) Each site will implement the
                                                  NCAI and First Pic are uniquely                                responsible for activities listed under                  TRAIL program, emphasizing healthy
                                                  qualified to continue to receive the                           section B as stated:                                     behaviors such as physical activity and
                                                  award and provide the identified                                                                                        nutrition. Each program plan will also
                                                                                                                 Substantial Involvement Description for                  include a parent component describing
                                                  program activities based on their history                      Cooperative Agreement
                                                  with this project and project sites, their                                                                              approaches for involving the families of
                                                  evaluation system, their knowledge of                          A. IHS Programmatic Involvement                          participants.
                                                  the curriculum, and their documented                             (1) Identify a core group of IHS staff                    (7) Each site will implement Physical
                                                  performance achievements with the                              to work with the grantee in providing                    Activity Strength and Endurance
                                                  sites under the previous agreement.                            technical assistance and guidance.                       Challenges three times, six to eight
                                                     All Department of Health and Human                            (2) Meet with the grantee to review                    weeks apart. Physical activity data will
                                                  Services (HHS) and IHS policies,                               grantee work plan and provide guidance                   be collected and summarized.
                                                  regulations, grants management and                             on implementation and data collection                       (8) Grantee will promote and facilitate
                                                  programmatic reporting requirements                            tools.                                                   local, state, and national partnerships
                                                  from the prior funding segment remain                            (3) Participate in quarterly conference                for the purpose of establishing or
                                                  in effect under this renewal                                   calls. Work with the grantee to                          enhancing program support that
                                                  announcement unless otherwise stated                           showcase the results of this project by                  involves increasing physical activity
                                                  or modified in the terms and conditions                        publishing on shared Web sites as well                   and good nutrition for the Tribally-
                                                  of the new Notice of Award.                                    as in jointly authored publications.                     managed Boys and Girls Club sites. This
                                                                                                                                                                          includes but is not limited to
                                                  II. Award Information                                          B. Grantee Cooperative Agreement                         establishing other partners such as
                                                  Type of Award                                                  Award Activities                                         American Indian-Alaska Native Program
                                                    Cooperative Agreement.                                          (1) Develop a written plan for the                    Branch (AI–ANPB) of Head Start
                                                                                                                 planning, implementation, and                            Programs, Wings of America, United
                                                  Estimated Funds Available                                      evaluation of this project to include                    National Indian Tribal Youth, Inc.
                                                     The total amount of funding                                 selecting at least 50 sites as agreed upon               (UNITY), Tribal colleges, BGCA, Tribal
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                                                  identified for the current fiscal year (FY)                    with the IHS. This task will be                          organizations, local community health
                                                  2017 is $1,250,000. The average award                          completed within 30 days from award                      providers and other private
                                                  amount will be $1,250,000 annually.                            and approved by the IHS.                                 organizations as appropriate.
                                                  The amount of funding available for                               (2) Develop selection criteria for new                   (9) Grantee will continue to
                                                  competing and continuation awards                              sites, announce, evaluate, and select                    implement current evaluation processes
                                                  issued under this announcement are                             sites. Sites must submit documentation                   in consultation for the TRAIL project. At
                                                  subject to the availability of                                 verifying they serve only AI/AN youth                    a minimum, the evaluation will include:


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                                                                               Federal Register / Vol. 82, No. 50 / Thursday, March 16, 2017 / Notices                                             14007

                                                     (a) Training attendance (gender, age,                III. Eligibility Information                          be found at http://www.Grants.gov or
                                                  grade level);                                                                                                 http://www.ihs.gov/dgm/funding/.
                                                     (b) pre- and post- tests to assess                   1. Eligibility
                                                                                                                                                                  Questions regarding the electronic
                                                  participant knowledge;                                     The award is offered as a single                   application process may be directed to
                                                     (c) monthly activity logs from each                  source competing continuation                         Mr. Paul Gettys at (301) 443–2114 or
                                                  site on the physical activity portion of                cooperative agreement with the NCAI.                  (301) 443–5204.
                                                  their program. Daily data to be collected               NCAI is identified as the single source
                                                  includes the date, number of minutes of                 for the award, based on their successful              2. Content and Form Application
                                                  physical activity, and number of                        record of performance with this project,              Submission
                                                  children participating; and                             their unique relationship and work in                    The applicant must include the
                                                     (d) information/log on parent and                    developing and maintaining: (1)                       project narrative as an attachment to the
                                                  family participation in education and                   Relationships with the Boys and Girls                 application package. Mandatory
                                                  activity programs, community                            Clubs organization and staff, (2) being               documents for all applicants include:
                                                  involvement and partnerships.                           able to successfully implement the                       • Table of contents.
                                                     (10) Submit collated and summarized                  TRAIL program curriculum, (3) the                        • Abstract (one page) summarizing
                                                  data to the IHS. Work with the IHS in                   project Web site information, and (4) the             the project.
                                                  drafting an evaluation summary at the                   project data and evaluation systems.                     • Application forms:
                                                  end of the project period for                           The award is for a continuation of                       Æ SF–424, Application for Federal
                                                  publication. Submit collated and                        activities identified. NCAI is the sole               Assistance.
                                                  summarized data and project evaluation                  organization eligible to apply for                       Æ SF–424A, Budget Information—
                                                  summaries to all sites. Provide a                       competing continuation funding under                  Non-Construction Programs.
                                                  minimum of annual reports (feedback)                    this announcement and must                               Æ SF–424B, Assurances—Non-
                                                  to each site on how their data compare                  demonstrate that they have complied                   Construction Programs.
                                                  to data (mean, median, and range) from                  with previous terms and conditions of                    • Budget Justification and Narrative
                                                  other selected sites.                                   the Healthy Lifestyles in Youth grant in              (must be single-spaced and not exceed
                                                     (11) Provide ongoing technical                       order to receive funding under this                   30 pages).
                                                  support to the sites for the duration of                announcement.                                            • Project Narrative (must be single-
                                                  the initiative. Provide training and                                                                          spaced and not exceed 30 pages).
                                                                                                          2. Cost Sharing or Matching
                                                  technical assistance in all forms, i.e., on-                                                                     Æ Background information on the
                                                  site, on-line, by phone, and mail. The                     The IHS does not require matching                  organization.
                                                  planning, design and delivery of                        funds or cost sharing for grants or                      Æ Proposed scope of work, objectives,
                                                  training and technical assistance will                  cooperative agreements.                               and activities that provide a description
                                                  support the local organization’s long-                  3. Other Requirements                                 of what will be accomplished, including
                                                  term planning and outreach efforts. The                                                                       a one-page Timeframe Chart.
                                                  training will be customized based on                       If application budgets exceed the                     • 501(c)(3) Certificate (if applicable).
                                                  sites’ capability and experience.                       highest dollar amount outlined under                     • Biographical sketches for all Key
                                                  Technical assistance will also be                       the ‘‘Estimated Funds Available’’                     Personnel.
                                                  provided on program planning and                        section within this funding                              • Contractor/Consultant resumes or
                                                  implementation. Collaborate with IHS to                 announcement, the application will be                 qualifications and scope of work.
                                                  provide services to club sites. Maintain                considered ineligible and will not be                    • Disclosure of Lobbying Activities
                                                  records and reports.                                    reviewed for further consideration. If                (SF–LLL).
                                                     (12) Provide technical consultation to               deemed ineligible, IHS will not return                   • Certification Regarding Lobbying
                                                  the sites in developing a written work                  the application. The applicant will be                (GG-Lobbying Form).
                                                  plan, with measurable goals, objectives                 notified by email by the Division of                     • Copy of current Negotiated Indirect
                                                  and activities.                                         Grants Management (DGM) of this                       Cost rate (IDC) agreement (required in
                                                     (13) Establish a formal agreement with               decision.                                             order to receive IDC).
                                                  Native American Boys and Girls Club                     Proof of Non-Profit Status                               • Documentation of current Office of
                                                  sites which involves minimal fiscal                                                                           Management and Budget (OMB)
                                                  assistance but substantial technical                      Organizations claiming non-profit
                                                                                                                                                                Financial Audit (if applicable).
                                                  support to make sure clubs successfully                 status must submit proof. A copy of the
                                                                                                                                                                   Acceptable forms of documentation
                                                  implement the TRAIL program.                            501(c)(3) Certificate must be received
                                                                                                                                                                include:
                                                     (14) Submit to the IHS a written work                with the application submission by the
                                                                                                                                                                   Æ Email confirmation from Federal
                                                  plan and report describing each site’s                  Application Deadline Date listed under
                                                                                                                                                                Audit Clearinghouse (FAC) that audits
                                                  demographics, information on the                        the Key Dates section on page one of
                                                                                                                                                                were submitted; or
                                                  number of youth in the eligible age                     this announcement.                                       Æ Face sheets from audit reports.
                                                  range in the catchment area, the number                   An applicant submitting any of the
                                                                                                                                                                These can be found on the FAC Web
                                                  that attend the Boys and Girls Clubs                    above additional documentation after
                                                                                                                                                                site: https://harvester.census.gov/
                                                  regularly, and the number served by this                the initial application submission due
                                                                                                                                                                facdissem/Main.aspx.
                                                  project, goals, objectives, activities,                 date is required to ensure the
                                                  partnerships, and proposed outcomes.                    information was received by the IHS by                Public Policy Requirements
                                                     (15) Provide IHS written quarterly                   obtaining documentation confirming                      All Federal-wide public policies
                                                  reports on the evaluation outcomes,                     delivery (i.e., FedEx tracking, postal
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                                                                                                                                                                apply to IHS grants and cooperative
                                                  activity reports at each site, any parent               return receipt, etc.).                                agreements with exception of the
                                                  involvement activities and other                        IV. Application and Submission                        discrimination policy.
                                                  participation, description of the                       Information                                           Requirements for Project and Budget
                                                  community partnerships, and other
                                                                                                          1. Obtaining Application Materials                    Narratives
                                                  activities as appropriate
                                                     (16) Conduct quarterly conference                       The application package and detailed                 A. Project Narrative: This narrative
                                                  calls with IHS to review project status.                instructions for this announcement can                should be a separate Word document


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                                                  14008                        Federal Register / Vol. 82, No. 50 / Thursday, March 16, 2017 / Notices

                                                  that is no longer than 30 pages and                     outlined in the work plan, including (1)              problems persist, contact Mr. Gettys
                                                  must: Be single-spaced, type written,                   identification and bios for key personnel             (Paul.Gettys@ihs.gov), DGM Grant
                                                  have consecutively numbered pages, use                  responsible for completing tasks; (2)                 Systems Coordinator, by telephone at
                                                  black type not smaller than 12                          description of the structure of the                   (301) 443–2114 or (301) 443–5204.
                                                  characters per one inch, and be printed                 organization and chain of responsibility              Please be sure to contact Mr. Gettys at
                                                  on one side only of standard size 81⁄2″                 for successful completion of the project              least ten days prior to the application
                                                  x 11″ paper.                                            outline in the work plan; (3) description             deadline. Please do not contact the DGM
                                                     Be sure to succinctly answer all                     of financial and project management                   until you have received a Grants.gov
                                                  questions listed under the evaluation                   capacity, including information                       tracking number. In the event you are
                                                  criteria (refer to Section V.1, Evaluation              regarding similarly sized projects in                 not able to obtain a tracking number,
                                                  criteria in this announcement) and place                scope and financial assistance as well as             call the DGM as soon as possible.
                                                  all responses and required information                  other grants and projects successfully
                                                  in the correct section (noted below), or                completed; (4) description of national                4. Intergovernmental Review
                                                  they will not be considered or scored.                  experience in providing administrative                   Executive Order 12372 requiring
                                                  These narratives will assist the                        and support services to Tribal youth                  intergovernmental review is not
                                                  Objective Review Committee (ORC) in                     organizations, education agencies and                 applicable to this program.
                                                  becoming familiar with the applicant’s                  other Tribal programs for the benefit of
                                                  activities and accomplishments prior to                                                                       5. Funding Restrictions
                                                                                                          AI/AN children and youth and Tribal
                                                  this possible cooperative agreement                     communities. Indicate experience in                      • Pre-award costs are not allowable.
                                                  award. If the narrative exceeds the page                national partnerships or national                        • The available funds are inclusive of
                                                  limit, only the first 30 pages will be                  support efforts on behalf of AI/AN                    direct and appropriate indirect costs.
                                                  reviewed. The 30 page limit for the                     communities especially as it pertains to                 • Only one grant/cooperative
                                                  narrative does not include the work                     health concerns; (5) description of                   agreement will be awarded per
                                                  plan, standard forms, Tribal resolutions,               equipment and space available for use                 applicant.
                                                  table of contents, budget, budget                       during the proposed project; and (6)                     • IHS will not acknowledge receipt of
                                                  justifications, narratives, and/or other                description of specialized experience                 applications.
                                                  appendix items.                                         working with Tribal Boys and Girls Club               6. Electronic Submission Requirements
                                                     There are three parts to the narrative:              sites and the TRAIL curriculum
                                                  Part A—Introduction and Need for                        program.                                                 All applications must be submitted
                                                  Assistance; Part B—Work Plan; and Part                                                                        electronically. Please use the http://
                                                  C—Organizational Capabilities. See                      B. Budget Narrative: 30 Page Limit                    www.Grants.gov Web site to submit an
                                                  below for additional details about what                    This narrative must include a line                 application electronically and select the
                                                  must be included in the narrative.                      item budget with a narrative                          ‘‘Find Grant Opportunities’’ link on the
                                                                                                          justification for all expenditures                    homepage. Download a copy of the
                                                  Part A: Introduction and Need for                       identifying reasonable allowable,                     application package, complete it offline,
                                                  Assistance 10 Page Limitation                           allocable costs necessary to accomplish               and then upload and submit the
                                                    Please provide description of the need                the goals and objectives as outlined in               completed application via the http://
                                                  for assistance with offering this                       the project narrative. Budget should                  www.Grants.gov Web site. Electronic
                                                  program. Applicant should demonstrate                   match the scope of work described in                  copies of the application may not be
                                                  knowledge of: Health concerns for AI/                   the project narrative. This section                   submitted as attachments to email
                                                  AN youth; health promotion activities                   should provide a clear estimate of the                messages addressed to IHS employees or
                                                  in Tribal communities such as BGCA;                     project program costs and justification               offices.
                                                  and working with Tribes and Tribal                      for expenses for the entire cooperative                  If the applicant needs to submit a
                                                  organizations.                                          agreement period. The budget and                      paper application instead of submitting
                                                                                                          budget justification should be consistent             electronically through Grants.gov, a
                                                  Part B: Work Plan        10 Page Limitation                                                                   waiver must be requested. Prior
                                                                                                          with the tasks identified in the work
                                                  Section 1: Program Plans                                plan.                                                 approval must be requested and
                                                     This section should demonstrate the                                                                        obtained from Mr. Robert Tarwater,
                                                                                                          3. Submission Dates and Times                         Director, DGM, (see Section IV.6 below
                                                  soundness and effectiveness of the
                                                  proposal. The work plan should be                          Applications must be submitted                     for additional information). A written
                                                  designed to describe how and when the                   electronically through Grants.gov by                  waiver request must be sent to
                                                  sites will be selected; describe how the                11:59 p.m. Daylight Saving Time (DST),                GrantsPolicy@ihs.gov with a copy to
                                                  sites will be trained on the curriculum                 on the Application Deadline Date listed               Robert.Tarwater@ihs.gov. The waiver
                                                  and provided technical assistance; and                  in the Key Dates section on page one of               must (1) be documented in writing
                                                  describe how sites will be supported for                this announcement. Any application                    (emails are acceptable) before
                                                  a physical activity program with the                    received after the application deadline               submitting a paper application, and (2)
                                                  equipment and participant incentives.                   will not be accepted for processing, nor              include clear justification for the need
                                                                                                          will it be given further consideration for            to deviate from the required electronic
                                                  Section 2: Program Evaluation                           funding. Grants.gov will notify the                   grants submission process.
                                                    Describe the plan for collecting data,                applicant via email if the application is                Once the waiver request has been
                                                  monitoring, and assuring quality and                    rejected.                                             approved, the applicant will receive a
                                                                                                             If technical challenges arise and                  confirmation of approval email
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                                                  quantity of data and the plan for
                                                  evaluating and reporting program                        assistance is required with the                       containing submission instructions and
                                                  results.                                                electronic application process, contact               the mailing address to submit the
                                                                                                          Grants.gov Customer Support via email                 application. A copy of the written
                                                  Part C: Organizational Capabilities 10                  to support@grants.gov or at (800) 518–                approval must be submitted along with
                                                  Page Limitation                                         4726. Customer Support is available to                the hardcopy of the application that is
                                                    Describe the broader capacity of the                  address questions 24 hours a day, 7 days              mailed to DGM. Paper applications that
                                                  organization to complete the project                    a week (except on Federal holidays). If               are submitted without a copy of the


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                                                                               Federal Register / Vol. 82, No. 50 / Thursday, March 16, 2017 / Notices                                            14009

                                                  signed waiver from the Mr. Tarwater of                    • Email applications will not be                    assigned to each section are noted in
                                                  the DGM will not be reviewed or                         accepted under this announcement.                     parentheses. The 30 page narrative
                                                  considered for funding. The applicant                                                                         should include only the first year of
                                                                                                          Dun and Bradstreet (D&B) Data
                                                  will be notified via email of this                                                                            activities; information for multi-year
                                                                                                          Universal Numbering System (DUNS)
                                                  decision by the Grants Management                                                                             projects should be included as an
                                                  Officer of the DGM. Paper applications                     All IHS applicants and grantee                     appendix. See ‘‘Multi-year Project
                                                  must be received by the DGM no later                    organizations are required to obtain a                Requirements’’ at the end of this section
                                                  than 5:00 p.m., DST on the Application                  DUNS number and maintain an active                    for more information. The narrative
                                                  Deadline Date listed in the Key Dates                   registration in the SAM database. The                 section should be written in a manner
                                                  section on page one of this                             DUNS number is a unique 9-digit                       that is clear to outside reviewers
                                                  announcement. Late applications will                    identification number provided by D&B                 unfamiliar with prior related activities
                                                  not be accepted for processing or                       which uniquely identifies each entity.                of the applicant. It should be well
                                                  considered for funding. Applicants that                 The DUNS number is site specific;                     organized, succinct, and contain all
                                                  do not adhere to the timelines for                      therefore, each distinct performance site             information necessary for reviewers to
                                                  System for Award Management (SAM)                       may be assigned a DUNS number.                        understand the project fully. Points will
                                                  and/or http://www.Grants.gov                            Obtaining a DUNS number is easy, and                  be assigned to each evaluation criteria
                                                  registration or that fail to request timely             there is no charge. To obtain a DUNS                  adding up to a total of 100 points. A
                                                  assistance with technical issues will not               number, you may access it through                     minimum score of 60 points is required
                                                  be considered for a waiver to submit a                  http://fedgov.dnb.com/webform, or to                  for funding. Points are assigned as
                                                  paper application.                                      expedite the process, call (866) 705–                 follows:
                                                     Please be aware of the following:                    5711.
                                                                                                             All HHS recipients are required by the             1. Criteria
                                                     • Please search for the application
                                                  package in http://www.Grants.gov by                     Federal Funding Accountability and                    A. Introduction and Need for Assistance
                                                  entering the CFDA number or the                         Transparency Act of 2006, as amended                  20 points
                                                  Funding Opportunity Number. Both                        (‘‘Transparency Act’’), to report
                                                                                                          information on sub-awards.                               This section should demonstrate
                                                  numbers are located in the header of                                                                          knowledges of health concerns and
                                                  this announcement.                                      Accordingly, all IHS grantees must
                                                                                                          notify potential first-tier sub-recipients            issues regarding AI/AN youth, health
                                                     • If you experience technical                                                                              promotion activities in Tribal
                                                  challenges while submitting your                        that no entity may receive a first-tier
                                                                                                          sub-award unless the entity has                       communities, and working with Tribes
                                                  application electronically, please                                                                            and Tribal organizations.
                                                  contact Grants.gov Support directly at:                 provided its DUNS number to the prime
                                                  support@grants.gov or (800) 518–4726.                   grantee organization. This requirement                B. Work Plan      30 points
                                                  Customer Support is available to                        ensures the use of a universal identifier
                                                                                                          to enhance the quality of information                    This section should demonstrate a
                                                  address questions 24 hours a day, 7 days                                                                      sound and effective annual work plan
                                                  a week (except on Federal holidays).                    available to the public pursuant to the
                                                                                                          Transparency Act.                                     that will support accomplishment of
                                                     • Upon contacting Grants.gov, obtain                                                                       deliverables and milestones of the
                                                  a tracking number as proof of contact.                  System for Award Management (SAM)                     TRAIL project. The work plan should be
                                                  The tracking number is helpful if there                    Organizations that were not registered             designed to:
                                                  are technical issues that cannot be                     with Central Contractor Registration and                 • Describe how and when the sites
                                                  resolved and a waiver from the agency                   have not registered with SAM will need                will be selected;
                                                  must be obtained.                                       to obtain a DUNS number first and then                   • Describe how the sites will be
                                                     • Applicants are strongly encouraged                 access the SAM online registration                    trained on the curriculum and provided
                                                  not to wait until the deadline date to                  through the SAM home page at https://                 technical assistance;
                                                  begin the application process through                   www.sam.gov (U.S. organizations will                     • Describe the plan for collecting
                                                  Grants.gov as the registration process for              also need to provide an Employer                      data, monitoring, and assuring quality
                                                  SAM and Grants.gov could take up to                     Identification Number from the Internal               and quantity of data;
                                                  fifteen working days.                                   Revenue Service that may take an                         • Describe the plan for evaluating and
                                                     • Please use the optional attachment                 additional 2–5 weeks to become active).               reporting;
                                                  feature in Grants.gov to attach                         Completing and submitting the                            • Describe how sites will be
                                                  additional documentation that may be                    registration takes approximately one                  supported for a physical activity
                                                  requested by the DGM.                                   hour to complete and SAM registration                 program.
                                                     • All applicants must comply with                    will take 3–5 business days to process.
                                                  any page limitation requirements                                                                              C. Organizational Capabilities   40
                                                                                                          Registration with the SAM is free of                  points
                                                  described in this funding                               charge. Applicants may register online
                                                  announcement.                                           at https://www.sam.gov.                                 This section should outline the
                                                     • After electronically submitting the                   Additional information on                          broader capacity of the organization to
                                                  application, the applicant will receive                 implementing the Transparency Act,                    complete the project outlined in the
                                                  an automatic acknowledgment from                        including the specific requirements for               work plan. It includes the identification
                                                  Grants.gov that contains a Grants.gov                   DUNS and SAM, can be found on the                     of personnel responsible for completing
                                                  tracking number. The DGM will                           IHS Grants Management, Grants Policy                  tasks and the chain of responsibility for
                                                  download the application from                                                                                 successful completion of the project
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                                                                                                          Web site: http://www.ihs.gov/dgm/
                                                  Grants.gov and provide necessary copies                 policytopics/.                                        outline in the work plan. The section
                                                  to the appropriate agency officials.                                                                          should:
                                                  Neither the DGM nor IHS Office of                       V. Application Review Information                       • Describe the structure of the
                                                  Clinical and Preventive Services,                         The instructions for preparing the                  organization.
                                                  Division of Diabetes Treatment and                      application narrative also constitute the               • Describe the ability of the
                                                  Prevention will notify the applicant that               evaluation criteria for reviewing and                 organization to manage the proposed
                                                  the application has been received.                      scoring the application. Weights                      project and include information


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                                                  14010                        Federal Register / Vol. 82, No. 50 / Thursday, March 16, 2017 / Notices

                                                  regarding similarly sized projects in                   Additional documents can be uploaded                  is the authorizing document for which
                                                  scope and financial assistance as well as               as Appendix Items in Grants.gov                       funds are dispersed to the approved
                                                  other grants and projects successfully                     • Work plan, logic model and/or time               entities and reflects the amount of
                                                  completed.                                              line for proposed objectives.                         Federal funds awarded, the purpose of
                                                     • Describe what equipment (i.e.,                        • Position descriptions for key staff.             the grant, the terms and conditions of
                                                  phone, Web sites, etc.) and facility space                 • Resumes of key staff that reflect                the award, the effective date of the
                                                  (i.e., office space) will be available for              current duties.                                       award, and the budget/project period.
                                                  use during the proposed project. Include                   • Consultant or contractor proposed
                                                  information about any equipment not                                                                           Disapproved Applicants
                                                                                                          scope of work and letter of commitment
                                                  currently available that will be                        (if applicable).                                         Applicants who received a score less
                                                  purchased throughout the agreement.                        • Current Indirect Cost Agreement.                 than the recommended funding level for
                                                     • List and provide bios for key                         • Map of area identifying project                  approval (60), and were deemed to be
                                                  personnel who will work on the project.                 location(s).                                          disapproved by the ORC, will receive an
                                                  The section should demonstrate                             • Additional documents to support                  Executive Summary Statement from the
                                                  knowledge in:                                           narrative (i.e., data tables, key news                IHS program office within 30 days of the
                                                     Æ Financial and project management.                  articles, etc.).                                      conclusion of the ORC outlining the
                                                     Æ Nationwide experience in                                                                                 strengths and weaknesses of their
                                                  providing administrative and support                    2. Review and Selection                               application submitted. The summary
                                                  services to Tribal youth organizations,                    Each application will be prescreened               statement will be sent to the Authorized
                                                  education agencies and other Tribal                     by the DGM staff for eligibility and                  Organizational Representative that is
                                                  programs for the benefit of children and                completeness as outlined in the funding               identified on the face page (SF–424) of
                                                  youth.                                                  announcement. Applications that meet                  the application. The IHS program office
                                                     Æ AI/AN youth and Tribal                                                                                   will also provide additional contact
                                                                                                          the eligibility criteria shall be reviewed
                                                  communities and indicate experience in                                                                        information as needed to address
                                                                                                          for merit by the ORC based on
                                                  national partnerships or national                                                                             questions and concerns as well as
                                                                                                          evaluation criteria in this funding
                                                  support efforts on behalf of AI/AN                                                                            provide technical assistance if desired.
                                                                                                          announcement. The ORC could be
                                                  communities especially as it pertains to
                                                                                                          composed of both Tribal and Federal                   Approved but Unfunded Applicants
                                                  health concerns.
                                                     Æ Experience working with Tribal                     reviewers appointed by the IHS program
                                                                                                          to review and make recommendations                       Approved but unfunded applicants
                                                  Boys and Girls Club sites and the TRAIL                                                                       that met the minimum scoring range
                                                  curriculum program.                                     on these applications. The technical
                                                                                                          review process ensures selection of                   and were deemed by the ORC to be
                                                  D. Categorical Budget and Budget                        quality projects in a national                        ‘‘Approved’’, but were not funded due
                                                  Justification 10 points                                 competition for limited funding.                      to lack of funding, will have their
                                                    This section should provide a clear                   Incomplete applications and                           applications held by DGM for a period
                                                  estimate of the project program costs                   applications that are non-responsive to               of one year. If additional funding
                                                  and justification for expenses for the                  the eligibility criteria will not be                  becomes available during the course of
                                                  entire cooperative agreement period.                    referred to the ORC. The applicant will               FY 2017 the approved but unfunded
                                                  The budget and budget justification                     be notified via email of this decision by             application may be re-considered by the
                                                  should be consistent with the tasks                     the Grants Management Officer of the                  awarding program office for possible
                                                  identified in the work plan.                            DGM. Applicants will be notified by                   funding. The applicant will also receive
                                                    • Categorical budget (Form SF 424A,                   DGM, via email, to outline minor                      an Executive Summary Statement from
                                                  Budget Information Non Construction                     missing components (i.e., budget                      the IHS program office within 30 days
                                                  Programs) completing each of the                        narratives, audit documentation, key                  of the conclusion of the ORC.
                                                  budget periods requested.                               contact form) needed for an otherwise                   Note: Any correspondence other than the
                                                    • Narrative justification for all costs,              complete application. All missing                     official NoA signed by an IHS grants
                                                  explaining why each line item is                        documents must be sent to DGM on or                   management official announcing to the
                                                  necessary or relevant to the proposed                   before the due date listed in the email               project director that an award has been made
                                                  project. Include sufficient details to                  of notification of missing documents                  to their organization is not an authorization
                                                  facilitate the determination of cost allow                                                                    to implement their program on behalf of IHS.
                                                                                                          required.
                                                  ability.                                                   To obtain a minimum score for
                                                    • Indication of any special start-up                                                                        2. Administrative Requirements
                                                                                                          funding by the ORC, applicants must
                                                  costs.                                                  address all program requirements and                     Cooperative agreements are
                                                    • Budget justification should include                 provide all required documentation.                   administered in accordance with the
                                                  a brief program narrative for the third                                                                       following regulations and policies:
                                                  and fourth years.                                       VI. Award Administration Information                     A. The criteria as outlined in this
                                                    • If indirect costs are claimed,                      1. Award Notices                                      program announcement.
                                                  indicate and apply the current                                                                                   B. Administrative Regulations for
                                                  negotiated rate to the budget. Include a                   The Notice of Award (NoA) is a                     Grants:
                                                  copy of the rate agreement in the                       legally binding document signed by the                   • Uniform Administrative
                                                  appendix.                                               Grants Management Officer and serves                  Requirements for HHS Awards, located
                                                                                                          as the official notification of the grant             at 45 CFR part 75.
                                                  Multi-Year Project Requirements (if                     award. The NoA will be initiated by the
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                                                                                                                                                                   C. Grants Policy:
                                                  applicable)                                             DGM in our grant system,                                 • HHS Grants Policy Statement,
                                                    Projects requiring a second, third,                   GrantSolutions (https://                              Revised 01/07.
                                                  fourth, and/or fifth year must include a                www.grantsolutions.gov). Each entity                     D. Cost Principles:
                                                  brief project narrative and budget (one                 that is approved for funding under this                  • Uniform Administrative
                                                  additional page per year) addressing the                announcement will need to request or                  Requirements for HHS Awards, ‘‘Cost
                                                  developmental plans for each additional                 have a user account in GrantSolutions                 Principles,’’ located at 45 CFR part 75,
                                                  year of the project.                                    in order to retrieve their NoA. The NoA               subpart E.


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                                                                               Federal Register / Vol. 82, No. 50 / Thursday, March 16, 2017 / Notices                                            14011

                                                    E. Audit Requirements:                                  The reporting requirements for this                 have a $25,000 sub-award obligation
                                                    • Uniform Administrative                              program are noted below.                              dollar threshold during any specific
                                                  Requirements for HHS Awards, ‘‘Audit                                                                          reporting period will be required to
                                                                                                          A. Progress Reports
                                                  Requirements,’’ located at 45 CFR part                                                                        address the FSRS reporting.
                                                  75, subpart F.                                            Program progress reports are required                 For the full IHS award term
                                                                                                          annually, within 30 days after the                    implementing this requirement and
                                                  3. Indirect Costs                                       budget period ends. These reports must                additional award applicability
                                                     This section applies to all grant                    include a brief comparison of actual                  information, visit the DGM Grants
                                                  recipients that request reimbursement of                accomplishments to the goals                          Policy Web site at: http://www.ihs.gov/
                                                  indirect costs (IDC) in their grant                     established for the period, a summary of              dgm/policytopics/.
                                                  application. In accordance with HHS                     progress to date or, if applicable,
                                                                                                                                                                D. Compliance With Executive Order
                                                  Grants Policy Statement, Part II–27, IHS                provide sound justification for the lack
                                                                                                                                                                13166 Implementation of Services
                                                  requires applicants to obtain a current                 of progress, and other pertinent
                                                                                                                                                                Accessibility Provisions for All Grant
                                                  IDC rate agreement prior to award. The                  information as required. A final report
                                                                                                                                                                Application Packages and Funding
                                                  rate agreement must be prepared in                      must be submitted within 90 days of
                                                                                                                                                                Opportunity Announcements
                                                  accordance with the applicable cost                     expiration of the budget/project period.
                                                                                                                                                                   Recipients of Federal financial
                                                  principles and guidance as provided by                  B. Financial Reports                                  assistance (FFA) from HHS must
                                                  the cognizant agency or office. A current
                                                                                                            Federal Financial Report FFR (SF–                   administer their programs in
                                                  rate covers the applicable grant
                                                                                                          425), Cash Transaction Reports are due                compliance with Federal civil rights
                                                  activities under the current award’s
                                                                                                          30 days after the close of every calendar             law. This means that recipients of HHS
                                                  budget period. If the current rate is not                                                                     funds must ensure equal access to their
                                                                                                          quarter to the Payment Management
                                                  on file with the DGM at the time of                                                                           programs without regard to a person’s
                                                                                                          Services, HHS at http://
                                                  award, the IDC portion of the budget                                                                          race, color, national origin, disability,
                                                                                                          www.dpm.psc.gov. It is recommended
                                                  will be restricted. The restrictions                                                                          age and, in some circumstances, sex and
                                                                                                          that the applicant also send a copy of
                                                  remain in place until the current rate is                                                                     religion. This includes ensuring your
                                                                                                          the FFR (SF–425) report to the Grants
                                                  provided to the DGM.                                                                                          programs are accessible to persons with
                                                                                                          Management Specialist. Failure to
                                                     Generally, IDC rates for IHS grantees                submit timely reports may cause a                     limited English proficiency. HHS
                                                  are negotiated with the Division of Cost                disruption in timely payments to the                  provides guidance to recipients of FFA
                                                  Allocation (DCA) https://rates.psc.gov/                 organization.                                         on meeting their legal obligation to take
                                                  and the Department of Interior (Interior                  Grantees are responsible and                        reasonable steps to provide meaningful
                                                  Business Center) https://www.doi.gov/                   accountable for accurate information                  access to their programs by persons with
                                                  ibc/services/finance/indirect-Cost-                     being reported on all required reports:               limited English proficiency. Please see
                                                  Services/indian-tribes. For questions                   The Progress Reports and Federal                      http://www.hhs.gov/civil-rights/for-
                                                  regarding the indirect cost policy, please              Financial Report.                                     individuals/special-topics/limited-
                                                  call the Grants Management Specialist                                                                         english-proficiency/guidance-federal-
                                                  listed under ‘‘Agency Contacts’’ or the                 C. Federal Sub-Award Reporting System                 financial-assistance-recipients-title-VI/.
                                                  main DGM office at (301) 443–5204.                      (FSRS)                                                   The HHS Office for Civil Rights (OCR)
                                                  4. Reporting Requirements                                  This award may be subject to the                   also provides guidance on complying
                                                                                                          Transparency Act sub-award and                        with civil rights laws enforced by HHS.
                                                     The grantee must submit required                     executive compensation reporting                      Please see http://www.hhs.gov/civil-
                                                  reports consistent with the applicable                  requirements of 2 CFR part 170.                       rights/for-individuals/section-1557/
                                                  deadlines. Failure to submit required                      The Transparency Act requires the                  index.html; and http://www.hhs.gov/
                                                  reports within the time allowed may                     OMB to establish a single searchable                  civil-rights/index.html. Recipients of
                                                  result in suspension or termination of                  database, accessible to the public, with              FFA also have specific legal obligations
                                                  an active grant, withholding of                         information on financial assistance                   for serving qualified individuals with
                                                  additional awards for the project, or                   awards made by Federal agencies. The                  disabilities. Please see http://
                                                  other enforcement actions such as                       Transparency Act also includes a                      www.hhs.gov/civil-rights/for-
                                                  withholding of payments or converting                   requirement for recipients of Federal                 individuals/disability/index.html.
                                                  to the reimbursement method of                          grants to report information about first-             Please contact the HHS OCR for more
                                                  payment. Continued failure to submit                    tier sub-awards and executive                         information about obligations and
                                                  required reports may result in one or                   compensation under Federal assistance                 prohibitions under Federal civil rights
                                                  both of the following: (1) The                          awards.                                               laws at http://www.hhs.gov/ocr/about-
                                                  imposition of special award provisions;                    IHS has implemented a Term of                      us/contact-us/headquarters-and-
                                                  and (2) the non-funding or non-award of                 Award into all IHS Standard Terms and                 regional-addresses/index.html or call 1–
                                                  other eligible projects or activities. This             Conditions, NoAs and funding                          800–368–1019 or TDD 1–800–537–7697.
                                                  requirement applies whether the                         announcements regarding the FSRS                      Also note it is an HHS Departmental
                                                  delinquency is attributable to the failure              reporting requirement. This IHS Term of               goal to ensure access to quality,
                                                  of the grantee organization or the                      Award is applicable to all IHS grant and              culturally competent care, including
                                                  individual responsible for preparation                  cooperative agreements issued on or                   long-term services and supports, for
                                                  of the reports. Per DGM policy, all                     after October 1, 2010, with a $25,000                 vulnerable populations. For further
                                                  reports are required to be submitted                    sub-award obligation dollar threshold                 guidance on providing culturally and
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                                                  electronically by attaching them as a                   met for any specific reporting period.                linguistically appropriate services,
                                                  ‘‘Grant Note’’ in GrantSolutions.                       Additionally, all new (discretionary)                 recipients should review the National
                                                  Personnel responsible for submitting                    IHS awards (where the project period is               Standards for Culturally and
                                                  reports will be required to obtain a login              made up of more than one budget                       Linguistically Appropriate Services in
                                                  and password for GrantSolutions. Please                 period) and where: (1) The project                    Health and Health Care at http://
                                                  see the Agency Contacts list in section                 period start date was October 1, 2010 or              minorityhealth.hhs.gov/omh/
                                                  VII for the systems contact information.                after and (2) the primary awardee will                browse.aspx?lvl=2&lvlid=53.


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                                                  14012                        Federal Register / Vol. 82, No. 50 / Thursday, March 16, 2017 / Notices

                                                     Pursuant to 45 CFR 80.3(d), an                       the IHS and to the HHS Office of                      VIII. Other Information
                                                  individual shall not be deemed                          Inspector General all information                       The Public Health Service strongly
                                                  subjected to discrimination by reason of                related to violations of Federal criminal             encourages all cooperative agreement
                                                  his/her exclusion from benefits limited                 law involving fraud, bribery, or gratuity             and contract recipients to provide a
                                                  by Federal law to individuals eligible                  violations potentially affecting the                  smoke-free workplace and promote the
                                                  for benefits and services from the IHS.                 Federal award. 45 CFR 75.113.                         non-use of all tobacco products. In
                                                     Recipients will be required to sign the                Disclosures must be sent in writing to:             addition, Public Law 103–227, the Pro-
                                                  HHS–690 Assurance of Compliance
                                                                                                          U.S. Department of Health and Human                   Children Act of 1994, prohibits smoking
                                                  form which can be obtained from the
                                                                                                            Services, Indian Health Service,                    in certain facilities (or in some cases,
                                                  following Web site: http://www.hhs.gov/
                                                  sites/default/files/forms/hhs-690.pdf,                    Division of Grants Management,                      any portion of the facility) in which
                                                  and send it directly to the: U.S.                         ATTN: Robert Tarwater, Director,                    regular or routine education, library,
                                                  Department of Health and Human                            5600 Fishers Lane, Mail Stop: 09E70,                day care, health care, or early childhood
                                                  Services, Office of Civil Rights, 200                     Rockville, Maryland 20857 (Include                  development services are provided to
                                                  Independence Ave. SW., Washington,                        ‘‘Mandatory Grant Disclosures’’ in                  children. This is consistent with the
                                                  DC 20201.                                                 subject line) Ofc: (301) 443–5204, Fax:             HHS mission to protect and advance the
                                                                                                            (301) 594–0899, Email:                              physical and mental health of the
                                                  F. Federal Awardee Performance and                        Robert.Tarwater@ihs.gov.                            American people.
                                                  Integrity Information System (FAPIIS)                                                                           Dated: March 6, 2017.
                                                                                                          AND
                                                     The IHS is required to review and                                                                          RADM Chris Buchanan,
                                                  consider any information about the                      U.S. Department of Health and Human
                                                                                                                                                                Assistant Surgeon General, USPHS, Acting
                                                  applicant that is in the Federal Awardee                  Services, Office of Inspector General,              Director, Indian Health Service.
                                                  Performance and Integrity Information                     ATTN: Mandatory Grant Disclosures,
                                                                                                                                                                [FR Doc. 2017–05243 Filed 3–15–17; 8:45 am]
                                                  System (FAPIIS) before making any                         Intake Coordinator, 330 Independence
                                                                                                                                                                BILLING CODE 4165–16–P
                                                  award in excess of the simplified                         Avenue SW., Cohen Building, Room
                                                  acquisition threshold (currently                          5527, Washington, DC 20201, URL:
                                                  $150,000) over the period of                              http://oig.hhs.gov/fraud/report-fraud/
                                                                                                                                                                DEPARTMENT OF HEALTH AND
                                                  performance. An applicant may review                      index.asp (Include ‘‘Mandatory Grant
                                                                                                                                                                HUMAN SERVICES
                                                  and comment on any information about                      Disclosures’’ in subject line) Fax:
                                                  itself that a Federal awarding agency                     (202) 205–0604 (Include ‘‘Mandatory                 Indian Health Service
                                                  previously entered. IHS will consider                     Grant Disclosures’’ in subject line) or
                                                  any comments by the applicant, in                         Email:                                              [Funding Announcement Number: HHS–
                                                  addition to other information in FAPIIS                   MandatoryGranteeDisclosures@                        2017–IHS–PHN–0001: Catalog of Federal
                                                  in making a judgment about the                            oig.hhs.gov.                                        Domestic Assistance Number: 93.933]
                                                  applicant’s integrity, business ethics,                   Failure to make required disclosures
                                                  and record of performance under                         can result in any of the remedies                     Community Based Model of PHN Case
                                                  Federal awards when completing the                      described in 45 CFR 75.371 Remedies                   Management Services (Behavioral
                                                  review of risk posed by applicants as                   for noncompliance, including                          Health)
                                                  described in 45 CFR 75.205.                             suspension or debarment (See 2 CFR                    AGENCY: Division of Nursing, Public
                                                     As required by 45 CFR part 75                        parts 180 & 376 and 31 U.S.C. 3321).                  Health Nursing, Indian Health Service,
                                                  Appendix XII of the Uniform Guidance,                                                                         HHS.
                                                  non-federal entities (NFEs) are required                VII. Agency Contacts
                                                  to disclose in FAPIIS any information                      1. Questions on the programmatic                   Key Dates
                                                  about criminal, civil, and administrative               issues may be directed to: Ms. Carmen                 Application Deadline Date: May 15,
                                                  proceedings, and/or affirm that there is                Licavoli Hardin, Deputy Director,                       2017
                                                  no new information to provide. This                     Division of Diabetes Treatment and                    Review Date: May 26–June 5, 2017
                                                  applies to NFEs that receive Federal                    Prevention, Indian Health Service (HQ),               Earliest Anticipated Start Date: June 15,
                                                  awards (currently active grants,                        5600 Fishers Lane, Mail Stop: 08N34                     2017
                                                  cooperative agreements, and                             A&B, Rockville, MD 20857, Telephone:                  Proof of Non-Profit Due Date: May 15,
                                                  procurement contracts) greater than                     1–844–IHS–DDTP (1–844–447–3387),                        2017
                                                  $10,000,000 for any period of time                      Fax: 301–594–6213, Email address:
                                                  during the period of performance of an                                                                        I. Funding Opportunity Description
                                                                                                          diabetesprogram@ihs.gov.
                                                  award/project.                                                                                                Statutory Authority
                                                                                                             2. Questions on grants management
                                                  Mandatory Disclosure Requirements                       and fiscal matters may be directed to:                   The Indian Health Service (IHS)
                                                    As required by 2 CFR part 200 of the                  Donald Gooding, Senior Grants                         Office of Clinical and Preventive
                                                  Uniform Guidance, and the HHS                           Management Specialist, 5600 Fishers                   Services (OCPS), Division of Nursing
                                                  implementing regulations at 45 CFR part                 Lane, Mail Stop: 09E70, Rockville, MD                 Services/Public Health Nursing (PHN),
                                                  75, effective January 1, 2016, the IHS                  20857, Telephone: 301–443–2298, Fax:                  is accepting applications for grant
                                                  must require a non-federal entity or an                 301–594–0899, Email address:                          awards for the Community Based Model
                                                  applicant for a Federal award to                        Donald.Gooding@ihs.gov.                               of PHN Case Management Services
                                                  disclose, in a timely manner, in writing                   3. Questions on systems matters may                (Behavioral Health). This program is
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                                                  to the IHS or pass-through entity all                   be directed to: Paul Gettys, Grant                    authorized under the Snyder Act, 25
                                                  violations of Federal criminal law                      Systems Coordinator, 5600 Fishers                     U.S.C. 13; the Transfer Act, 42 U.S.C.
                                                  involving fraud, bribery, or gratuity                   Lane, Mail Stop: 09E70, Rockville, MD                 2011; the Public Health Service Act, as
                                                  violations potentially affecting the                    20857, Phone: 301–443–2114; or the                    amended, 42 U.S.C. 241; and the Indian
                                                  Federal award.                                          DGM main line 301–443–5204, Fax:                      Health Care Improvement Act, as
                                                    Submission is required for all                        301–594–0899, Email: Paul.Gettys@                     amended, (IHCIA), 25 U.S.C. 1653(c).
                                                  applicants and recipients, in writing, to               ihs.gov.                                              This program is described in the Catalog


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Document Created: 2017-03-16 02:18:45
Document Modified: 2017-03-16 02:18:45
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
DatesMay 15, 2017 Review Date: May 22-26, 2017 Earliest Anticipated Start Date: September 1, 2017 Proof of Non-Profit Status Due Date: May 15, 2017
FR Citation82 FR 14004 

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