Healthy Lifestyles in Youth Project, 49865-49873 [2022-17403]

Download as PDF Federal Register / Vol. 87, No. 155 / Friday, August 12, 2022 / Notices in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https:// www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the guidance to the Policy and Regulations Staff (HFV–6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Aime´e Phillippi-Taylor, Center for Veterinary Medicine (HFV–114), Food and Drug Administration, 7500 Standish Pl, Rockville, MD 20855, 240–402–0601, aimee.phillippi-taylor@fda.hhs.gov. SUPPLEMENTARY INFORMATION: jspears on DSK121TN23PROD with NOTICES I. Background FDA is announcing the availability of a draft guidance for industry GFI #97 (VICH GL14(R1)) entitled ‘‘Effectiveness of Anthelmintics: Specific Recommendations for Caprines (Revision 1).’’ It should be read in conjunction with GFI #90 (VICH GL7), ‘‘Effectiveness of Anthelmintics: General Recommendations,’’ which should be referred to for discussion of broad aspects for providing pivotal data to demonstrate product anthelmintic effectiveness. The purpose of this guidance is: (1) to be more specific for certain specific caprine issues not discussed in GFI #90 (VICH GL7); (2) to highlight differences with the GFI #90 (VICH GL7) on effectiveness data recommendations; and (3) to give explanations for disparities with the GFI #90 (VICH GL7). This revision clarifies the definition of adequate infection in VerDate Sep<11>2014 17:38 Aug 11, 2022 Jkt 256001 individual animals, updates considerations for field studies, and makes additional clarifying changes. FDA has participated in efforts to enhance international harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify, and then reduce, differences in technical requirements for drug development among regulatory agencies in different countries. FDA has actively participated in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use to develop harmonized technical requirements for the approval of human pharmaceutical and biological products among the European Union, Japan, and the United States. The VICH is a parallel initiative for veterinary medicinal products. The VICH is concerned with developing harmonized technical requirements for the approval of veterinary medicinal products in the European Union, Japan, and the United States, and includes input from both regulatory and industry representatives. The VICH Steering Committee is composed of member representatives from the European Commission and European Medicines Agency; AnimalhealthEurope; FDA—Center for Veterinary Medicine and U.S. Department of Agriculture—Center for Veterinary Biologics; the U.S. Animal Health Institute; the Japanese Ministry of Agriculture, Forestry and Fisheries; and the Japanese Veterinary Products Association. There are 10 observers to the VICH Steering Committee: one representative from government and one representative from industry of Australia, New Zealand, Canada, South Africa, and the United Kingdom. The World Organisation for Animal Health is an associate member of the VICH. The VICH Secretariat, which coordinates the preparation of documentation, is provided by HealthforAnimals. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Effectiveness of Anthelmintics: Specific Recommendations for Caprines (Revision 1).’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 49865 II. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 514 have been approved under OMB Control Number 0910–0032. III. Electronic Access Persons with access to the internet may obtain the draft guidance at https:// www.fda.gov/animal-veterinary/ guidance-regulations/guidanceindustry, https://www.fda.gov/ regulatory-information/search-fdaguidance-documents, or https:// www.regulations.gov. Dated: August 8, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–17318 Filed 8–11–22; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service Healthy Lifestyles in Youth Project Announcement Type: New. Funding Announcement Number: HHS–2022–IHS–HLY–0001. Assistance Listing (Catalog of Federal Domestic Assistance or CFDA) Number: 93.933. Key Dates Application Deadline Date: September 15, 2022. Earliest Anticipated Start Date: September 30, 2022. I. Funding Opportunity Description Statutory Authority The Indian Health Service (IHS) is accepting applications for a cooperative agreement for the Healthy Lifestyles in Youth (HLY) Program. This program is authorized under the Snyder Act, 25 U.S.C. 13; and the Transfer Act, 42 U.S.C. 2001(a). This program is described in the Assistance Listings located at https://sam.gov/content/home (formerly known as the CFDA) under 93.933. Background This program promotes healthy lifestyles for American Indian and E:\FR\FM\12AUN1.SGM 12AUN1 49866 Federal Register / Vol. 87, No. 155 / Friday, August 12, 2022 / Notices jspears on DSK121TN23PROD with NOTICES Alaska Native (AI/AN) youth using the curriculum ‘‘Together Raising Awareness for Indian Life’’ (TRAIL) among selected Native Boys and Girls Club sites. Under this cooperative agreement, IHS proposes to enter into a collaborative effort/initiative with an entity that has experience working with Boys and Girls Clubs of America (BGCA), experience working with and implementing the TRAIL curriculum, and overall expertise and experience in addressing and evaluating healthy lifestyle techniques in AI/AN youth. The IHS issued the original funding opportunity announcement for the HLY cooperative agreement in 2003 and the program has been ongoing since that time. Purpose The purpose of this program is to support the IHS mission to improve the health of AI/AN youth through health promotion and health education programs. The goal of this IHS cooperative agreement is to address healthy lifestyle development and emphasize nutrition and physical activity for AI/AN children and youth 7 through 11 years of age. To do this, the awardee must meet the following objectives: • Collaborate with selected Native American Boys and Girls Club sites, via a grant application process; • Provide health and physical education programs; • Help youth achieve and maintain healthy lifestyles through participation in fitness programs; • Help youth acquire a range of physical skills; and • Help youth develop a sense of teamwork and cooperation. These early intervention strategies provide evidence based opportunities to reduce and/or halt the increasing trend of obesity and diabetes among youth and young adults. Native Boys and Girls Clubs that develop a health promotion program that includes the TRAIL curriculum may help curtail the effects of unhealthy eating behaviors and lack of physical activity that can lead to obesity, diabetes, and other chronic diseases later in life. The TRAIL curriculum was developed to provide information on good nutrition and to promote physical activity among youth participating in Native American Boys and Girls Clubs. The TRAIL curriculum is a 3-month (12 lessons) program that provides youth with a comprehensive understanding of healthy lifestyles in order to prevent diabetes. Woven throughout the program are self-esteem and prevention activities. Participants draw from Tribal traditions and history VerDate Sep<11>2014 17:38 Aug 11, 2022 Jkt 256001 to learn about nutrition, healthy food choices, media influences, and the impact of diabetes. The TRAIL curriculum emphasizes the importance of teamwork and community service. Members engage in service projects to improve healthy lifestyles in their communities, including starting community gardens to connect youth to their food source and organizing community-wide physical fitness events. The overall results show improvement in participant knowledge of diabetes, health, and healthy food choices, as well as improved levels of fitness and physical activity. To date, this cooperative agreement has funded over 95 Native American Boys and Girls Club sites that have established and implemented this curriculum project and have served over 22,144 AI/AN youth. Program test scores each year consistently indicate: (a) increased knowledge about diabetes; (b) increased physical activity; and, (c) increased ability to identify healthier food options (post-intervention scores vs. preintervention test scores). Program physical activity logs show participating AI/AN youth collectively perform approximately 20,000 hours of physical activity each year. Boys and Girls Clubs also report annually on the service projects that are carried out by TRAIL participants in their local communities. Boys and Girl Club sites that are located outside of Tribal communities are not eligible. The Boys and Girls Club sites selected by the awardee may use IHS grant funds to provide services to eligible IHS beneficiaries only. The awardee will: provide technical consultation; train; monitor; evaluate; and provide funds to support these activities. Required, Optional, and Allowable Activities 1. Develop a written plan for the planning, implementation, and evaluation of this project to include overseeing at least 98 sites, as agreed upon with the IHS. The local evaluation effort should include local evidencebased practice (EBP) fidelity data and how data will integrate with the National Evaluation Frame. Complete this task within 30 days of the award date and obtain approval by the IHS. 2. Develop selection criteria for additional sites as well as announce, evaluate, and select new sites. Sites must submit documentation verifying that they serve only AI/AN youth from eligible IHS beneficiaries, as a requirement for selection by the awardee. Conduct a start-up planning meeting with new sites within 2 months PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 of each site’s initial selection and award. 3. Plan and conduct an orientation and training meeting for new sites within 2 months of selection. Submit agenda, training goals and objectives, and participant list to IHS within 1 month of completion of each orientation session. 4. Update TRAIL curriculum as needed/directed and implement use. Document any specific changes to the curriculum and note expected impacts on implementation, data collection and outcomes. 5. Develop, in consultation with the IHS, the implementation and technical assistance plan for the coordination of the selected Boys and Girls Club sites. Submit criteria to the IHS for approval. 6. Each site will implement the TRAIL program, emphasizing healthy behaviors, such as physical activity and nutrition. Each program plan will also include a parent component describing approaches for involving the families of participants. 7. Each site will implement Physical Activity Strength and Endurance Challenges 3 times, 6 to 8 weeks apart. Physical activity data will be collected and summarized. 8. Awardee will promote and facilitate local, state, and national partnerships for the purpose of establishing or enhancing program support that involves increasing physical activity and good nutrition for the tribally-managed Boys and Girls Club sites. This includes, but is not limited to, establishing other partners such as American Indian-Alaska Native Program Branch (AI–ANPB) of Head Start Programs, Wings of America, United National Indian Tribal Youth, Inc. (UNITY), Tribal colleges, BGCA, Tribal organizations, local community health providers, and other private organizations as appropriate. 9. Awardee will continue to implement current evaluation processes in consultation for the TRAIL project. At a minimum, the evaluation will include: a. training attendance (gender, age, grade level); b. pre- and post- tests to assess participant knowledge; c. monthly activity logs from each site on the physical activity portion of their program. Daily data to be collected includes the date, number of minutes of physical activity, and number of children participating; and d. information/log on parent and family participation in education and activity programs, community involvement and partnerships. 10. Submit collated and summarized data to the IHS. Work with the IHS in E:\FR\FM\12AUN1.SGM 12AUN1 Federal Register / Vol. 87, No. 155 / Friday, August 12, 2022 / Notices drafting an evaluation summary at the end of the project period. Submit collated and summarized data and project evaluation summaries to all sites. Provide a minimum of annual reports (feedback) to each site on how their data compare to data (mean, median, and range) from other selected sites. 11. Provide ongoing technical support to the sites for the duration of the initiative. Provide training and technical assistance in all forms, i.e., on-site, online, by phone, and mail. The planning, design, and delivery of training and technical assistance will support the local organization’s long-term planning and outreach efforts. The training will be customized based on sites’ capability and experience. Technical assistance will also be provided on program planning, implementation, evaluation, and data collection. Collaborate with the IHS to provide services to club sites. Maintain records and reports. 12. Provide technical assistance to the sites in developing a written work plan, with measurable goals, objectives and activities that adheres to the terms and conditions of the cooperative agreement. 13. Establish a formal agreement with Native American Boys and Girls Club sites, involving funding assistance and technical support to ensure clubs successfully implement the TRAIL program. 14. Submit to the IHS a written work plan and report describing each site’s demographics, information on the number of youth in the eligible age range in the catchment area, the number that attend the Boys and Girls Clubs regularly, and the number served by this project, goals, objectives, activities, partnerships, and proposed outcomes. 15. Provide the IHS written quarterly reports on the evaluation outcomes, activity reports at each site, any parent involvement activities and other participation, description of the community partnerships, and other activities as appropriate. Conduct quarterly conference calls with IHS to review project status. II. Award Information jspears on DSK121TN23PROD with NOTICES Funding Instrument—Cooperative Agreement Estimated Funds Available The total funding identified for the first budget year, starting in fiscal year (FY) 2022, is approximately $1,250,000. The funding available for competing and subsequent continuation awards issued under this announcement is subject to the availability of appropriations and budgetary priorities of the Agency. The IHS is under no VerDate Sep<11>2014 17:38 Aug 11, 2022 Jkt 256001 obligation to make awards that are selected for funding under this announcement. Anticipated Number of Awards One award will be issued under this program announcement. Period of Performance The project period is for 5 years. Cooperative Agreement Cooperative agreements awarded by the Department of Health and Human Services (HHS) are administered under the same policies as grants. However, the funding agency, IHS, is anticipated to have substantial programmatic involvement in the project during the entire period of performance. Below is a detailed description of the level of involvement required of the IHS. Substantial Agency Involvement Description for Cooperative Agreement (1) Identify a core group of IHS staff to work with the awardee in providing technical assistance and guidance. (2) Meet with the awardee to review awardee work plan and provide guidance on implementation, program evaluation, and data collection strategy and tools. (3) Participate in quarterly conference calls. Work with the awardee to display the results of this project by publishing on shared websites as well as in jointly authored publications. (4) Use the evidence-based program(s), framework(s), and data collection requirement(s) to develop a National Logic Model and Evaluation Plan to collect national program aggregate and local EBP fidelity data. III. Eligibility Information 1. Eligibility To be eligible for this funding opportunity an applicant must be an organization with extensive experience developing and managing youth programs, health advocacy and education, and outreach related to AI/ AN health care on a national scale. The program office will notify any applicants deemed ineligible. Note: Please refer to Section IV.2 (Application and Submission Information/ Subsection 2, Content and Form of Application Submission) for additional proof of applicant status documents required, such as Tribal Resolutions, proof of nonprofit status, etc. 2. Cost Sharing or Matching The IHS does not require matching funds or cost sharing for grants or cooperative agreements. PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 49867 3. Other Requirements Applications with budget requests that exceed the highest dollar amount outlined under Section II Award Information, Estimated Funds Available, or exceed the period of performance outlined under Section II Award Information, Period of Performance, are considered not responsive and will not be reviewed. The Division of Grants Management (DGM) will notify the applicant. The following documentation is required (if applicable): Tribal Resolution The DGM must receive an official, signed Tribal Resolution prior to issuing a Notice of Award (NoA) to any Tribe or Tribal organization selected for funding. An applicant that is proposing a project affecting another Indian Tribe must include resolutions from all affected Tribes to be served. However, if an official signed Tribal Resolution cannot be submitted with the application prior to the application deadline date, a draft Tribal Resolution must be submitted with the application by the deadline date in order for the application to be considered complete and eligible for review. The draft Tribal Resolution is not in lieu of the required signed resolution but is acceptable until a signed resolution is received. If an application without a signed Tribal Resolution is selected for funding, the applicant will be contacted by the Grants Management Specialist (GMS) listed in this funding announcement and given 90 days to submit an official signed Tribal Resolution to the GMS. If the signed Tribal Resolution is not received within 90 days, the award will be forfeited. Tribes organized with a governing structure other than a Tribal council may submit an equivalent document commensurate with their governing organization. Proof of Nonprofit Status Organizations claiming nonprofit status must submit a current copy of the 501(c)(3) Certificate with the application. IV. Application and Submission Information Grants.gov uses a Workspace model for accepting applications. The Workspace consists of several online forms and three forms in which to upload documents—Project Narrative, Budget Narrative, and Other Documents. Give your files brief descriptive names. The filenames are key in finding specific documents during the objective review and in processing awards. E:\FR\FM\12AUN1.SGM 12AUN1 49868 Federal Register / Vol. 87, No. 155 / Friday, August 12, 2022 / Notices Upload all requested and optional documents individually, rather than combining them into a package. Creating a package creates confusion when trying to find specific documents. Such confusion can contribute to delays in processing awards, and could lead to lower scores during the objective review. 1. Obtaining Application Materials The application package and detailed instructions for this announcement are available at https://www.Grants.gov. Please direct questions regarding the application process to DGM@ihs.gov. jspears on DSK121TN23PROD with NOTICES 2. Content and Form Application Submission Mandatory documents for all applicants include: • Application forms: 1. SF–424, Application for Federal Assistance. 2. SF–424A, Budget Information— Non-Construction Programs. 3. SF–424B, Assurances—NonConstruction Programs. 4. Project Abstract Summary form. • Project Narrative (not to exceed 25 pages). See Section IV.2.A, Project Narrative for instructions. • Budget Justification/Narrative (not to exceed 5 pages). See Section IV.2.B, Budget Narrative for instructions. • Tribal Resolution(s) as described in Section III, Eligibility. • 501(c)(3) Certificate, if applicable. • Biographical sketches for all Key Personnel. • Contractor/Consultant resumes or qualifications and scope of work. • Disclosure of Lobbying Activities (SF–LLL), if applicant conducts reportable lobbying. • Certification Regarding Lobbying (GG-Lobbying Form). • Copy of current Negotiated Indirect Cost (IDC) rate agreement (required in order to receive IDC). • Documentation of current Office of Management and Budget (OMB) Financial Audit (if applicable). Acceptable forms of documentation include: 1. Email confirmation from Federal Audit Clearinghouse (FAC) that audits were submitted; or 2. Face sheets from audit reports. Applicants can find these on the FAC website at https://facdissem.census .gov/. Public Policy Requirements All Federal public policies apply to IHS grants and cooperative agreements. Pursuant to 45 CFR 80.3(d), an individual shall not be deemed subjected to discrimination by reason of VerDate Sep<11>2014 17:38 Aug 11, 2022 Jkt 256001 their exclusion from benefits limited by Federal law to individuals eligible for benefits and services from the IHS. See https://www.hhs.gov/grants/grants/ grants-policies-regulations/. Requirements for Project and Budget Narratives A. Project Narrative This narrative should be a separate document that is no more than 25 pages and must: (1) have consecutively numbered pages; (2) use black font 12 points or larger (applicants may use 10 point font for tables); (3) be singlespaced; and (4) be formatted to fit standard letter paper (81⁄2 x 11 inches). Do not combine this document with any others. Be sure to succinctly answer all questions listed under the evaluation criteria (refer to Section V.1, Evaluation Criteria) and place all responses and required information in the correct section noted below or they will not be considered or scored. If the narrative exceeds the overall page limit, the application will be considered not responsive and will not be reviewed. The 25-page limit for the project narrative does not include the work plan, standard forms, Tribal Resolutions, budget, budget narratives, and/or other items. Page limits for each section within the project narrative are guidelines, not hard limits. There are three parts to the narrative: Part 1—Introduction and Need for Assistance; Part 2—Work Plan; and Part 3—Organizational Capabilities. See below for additional details about what must be included in the narrative. The page limits below are for each narrative and budget submitted. Part 1: Program Information (Limit—5 Pages) Section 1: Needs Please provide a description of the need for assistance with offering this program. Applicant should demonstrate knowledge of: health concerns for AI/ AN youth; health promotion activities in Tribal communities such as BGCA; and working with Tribes and Tribal organizations. Part 2: Program Planning and Evaluation (Limit—10 Pages) Section 1: Program Plans This section should demonstrate the soundness and effectiveness of the proposal. The work plan should be designed to describe how and when the sites will be selected; describe how the sites will be trained on the curriculum and provided technical assistance; and describe how sites will be supported for PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 a physical activity program with the equipment and participant incentives. Section 2: Program Evaluation Describe the plan for collecting data, monitoring, and assuring quality and quantity of data and the plan for evaluating and reporting program results. Part 3: Organizational Capabilities (Limit—10 Pages) Describe the broader capacity of the organization to complete the project outlined in the work plan, including: (1) identification and bios for key personnel responsible for completing tasks; (2) description of the structure of the organization and chain of responsibility for successful completion of the project outline in the work plan; (3) description of financial and project management capacity, including information regarding similarly sized projects in scope and financial assistance as well as other grants and projects successfully completed; (4) description of national experience in providing administrative and support services to Tribal youth organizations, education agencies and other Tribal programs for the benefit of AI/AN children and youth and Tribal communities (indicate experience in national partnerships or national support efforts on behalf of AI/AN communities especially as it pertains to health concerns); (5) description of equipment and space available for use during the proposed project; and (6) description of specialized experience working with Native Boys and Girls Club sites and the TRAIL curriculum program. B. Budget Narrative (Limit—5 Pages) Provide a budget narrative that explains the amounts requested for each line item of the budget from the SF– 424A (Budget Information for NonConstruction Programs) for the first year of the project. The applicant can submit with the budget narrative a more detailed spreadsheet than is provided by the SF–424A (the spreadsheet will not be considered part of the budget narrative). The budget narrative should specifically describe how each item will support the achievement of proposed objectives. Be very careful about showing how each item in the ‘‘Other’’ category is justified. For subsequent budget years (see Multi-Year Project Requirements in Section V.1, Application Review Information, Evaluation Criteria), the additional pages should highlight the changes from the first year or clearly indicate that there are no substantive budget changes during the period of performance. Do E:\FR\FM\12AUN1.SGM 12AUN1 Federal Register / Vol. 87, No. 155 / Friday, August 12, 2022 / Notices NOT use the budget narrative to expand the project narrative. 3. Submission Dates and Times Applications must be submitted through Grants.gov by 11:59 p.m. Eastern Time on the Application Deadline Date. Any application received after the application deadline will not be accepted for review. Grants.gov will notify the applicant via email if the application is rejected. If technical challenges arise and assistance is required with the application process, contact Grants.gov Customer Support (see contact information at https://www.Grants.gov). If problems persist, contact Mr. Paul Gettys (Paul.Gettys@ihs.gov), Deputy Director, DGM, by telephone at (301) 443–2114. Please be sure to contact Mr. Gettys at least 10 days prior to the application deadline. Please do not contact the DGM until you have received a Grants.gov tracking number. In the event you are not able to obtain a tracking number, call the DGM as soon as possible. The IHS will not acknowledge receipt of applications. 4. Intergovernmental Review Executive Order 12372 requiring intergovernmental review is not applicable to this program. 5. Funding Restrictions • Pre-award costs are not allowable. • The available funds are inclusive of direct and indirect costs. • Only one cooperative agreement may be awarded per applicant. jspears on DSK121TN23PROD with NOTICES 6. Electronic Submission Requirements All applications must be submitted via Grants.gov. Please use the https:// www.Grants.gov website to submit an application. Find the application by selecting the ‘‘Search Grants’’ link on the homepage. Follow the instructions for submitting an application under the Package tab. No other method of application submission is acceptable. If you cannot submit an application through Grants.gov, you must request a waiver prior to the application due date. This contact must be initiated prior to the application due date or your waiver request will be denied. Prior approval must be requested and obtained from Mr. Paul Gettys, Deputy Director, DGM. You must send a written waiver request to GrantsPolicy@ihs.gov with a copy to Paul.Gettys@ihs.gov. The waiver request must be documented in writing (emails are acceptable) before submitting an application by some other method, and must include clear justification for the VerDate Sep<11>2014 17:38 Aug 11, 2022 Jkt 256001 need to deviate from the required application submission process. If the DGM approves your waiver request, you will receive a confirmation of approval email containing submission instructions. You must include a copy of the written approval with the application submitted to the DGM. Applications that do not include a copy of the signed waiver from the Deputy Director of the DGM will not be reviewed. The Grants Management Officer of the DGM will notify the applicant via email of this decision. Applications submitted under waiver must be received by the DGM no later than 5:00 p.m. Eastern Time on the Application Deadline Date. Late applications will not be accepted for processing. Applicants that do not register for both the System for Award Management (SAM) and Grants.gov and/or fail to request timely assistance with technical issues will not be considered for a waiver to submit an application via alternative method. Please be aware of the following: • Please search for the application package in https://www.Grants.gov by entering the Assistance Listing (CFDA) number or the Funding Opportunity Number. Both numbers are located in the header of this announcement. • If you experience technical challenges while submitting your application, please contact Grants.gov Customer Support (see contact information at https://www.Grants.gov). • Upon contacting Grants.gov, obtain a tracking number as proof of contact. The tracking number is helpful if there are technical issues that cannot be resolved and a waiver from the agency must be obtained. • Applicants are strongly encouraged not to wait until the deadline date to begin the application process through Grants.gov as the registration process for SAM and Grants.gov could take up to 20 working days. • Please follow the instructions on Grants.gov to include additional documentation that may be requested by this funding announcement. • Applicants must comply with any page limits described in this funding announcement. • After submitting the application, you will receive an automatic acknowledgment from Grants.gov that contains a Grants.gov tracking number. The IHS will not notify you that the application has been received. System for Award Management (SAM) Organizations that are not registered with SAM must access the SAM online registration through the SAM home page at https://sam.gov. United States (U.S.) PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 49869 organizations will also need to provide an Employer Identification Number from the Internal Revenue Service that may take an additional 2–5 weeks to become active. Please see SAM.gov for details on the registration process and timeline. Registration with the SAM is free of charge but can take several weeks to process. Applicants may register online at https://sam.gov. Unique Entity Identifier Your SAM.gov registration now includes a Unique Entity Identifier (UEI), generated by SAM.gov, which replaces the DUNS number obtained from Dun and Bradstreet. SAM.gov registration no longer requires a DUNS number. Check your organization’s SAM.gov registration as soon as you decide to apply for this program. If your SAM.gov registration is expired, you will not be able to submit an application. It can take several weeks to renew it or resolve any issues with your registration, so do not wait. Check your Grants.gov registration. Registration and role assignments in Grants.gov are self-serve functions. One user for your organization will have the authority to approve role assignments, and these must be approved for active users in order to ensure someone in your organization has the necessary access to submit an application. The Federal Funding Accountability and Transparency Act of 2006, as amended (‘‘Transparency Act’’), requires all HHS awardees to report information on sub-awards. Accordingly, all IHS awardees must notify potential first-tier sub-awardees that no entity may receive a first-tier sub-award unless the entity has provided its UEI number to the prime awardee organization. This requirement ensures the use of a universal identifier to enhance the quality of information available to the public pursuant to the Transparency Act. Additional information on implementing the Transparency Act, including the specific requirements for SAM, are available on the DGM Grants Management, Policy Topics web page at https://www.ihs.gov/dgm/policytopics/. V. Application Review Information Possible points assigned to each section are noted in parentheses. The project narrative and budget narrative should include only the first year of activities; information for multi-year projects should be included as a separate document. See ‘‘Multi-year Project Requirements’’ at the end of this section for more information. The project narrative should be written in a E:\FR\FM\12AUN1.SGM 12AUN1 49870 Federal Register / Vol. 87, No. 155 / Friday, August 12, 2022 / Notices manner that is clear to outside reviewers unfamiliar with prior related activities of the applicant. It should be well organized, succinct, and contain all information necessary for reviewers to fully understand the project. Attachments requested in the criteria do not count toward the page limit for the narratives. Points will be assigned to each evaluation criteria adding up to a total of 100 possible points. Points are assigned as follows: 1. Evaluation Criteria A. Introduction and Need for Assistance (20 Points) This section should demonstrate knowledge of health concerns and issues regarding AI/AN youth, health promotion activities in Tribal communities, and working with Tribes and Tribal organizations. B. Work Plan (30 Points) This section should demonstrate a sound and effective annual work plan that will support accomplishment of deliverables and milestones of the TRAIL project. The work plan should be designed to: a. Describe how and when the sites will be selected. b. Describe how the sites will be trained on the curriculum and provided technical assistance. c. Describe the plan for collecting data, monitoring, and assuring quality and quantity of data. d. Describe the plan for evaluating and reporting. e. Describe how sites will be supported for a physical activity program. jspears on DSK121TN23PROD with NOTICES C. Organizational Capabilities (40 Points) This section should outline the broader capacity of the organization to complete the project outlined in the work plan. It includes the identification of personnel responsible for completing tasks and the chain of responsibility for successful completion of the project outline in the work plan. The section should: a. Describe the structure of the organization. b. Describe the ability of the organization to manage the proposed project and include information regarding similarly sized projects in scope and financial assistance as well as other grants and projects successfully completed. c. Describe what equipment (i.e., phone, websites, etc.) and facility space (i.e., office space) will be available for use during the proposed project. Include VerDate Sep<11>2014 17:38 Aug 11, 2022 Jkt 256001 information about any equipment not currently available that will be purchased throughout the agreement. d. List and provide bios for key personnel who will work on the project. The section should demonstrate knowledge in: i. Financial and project management. ii. Nationwide experience in providing administrative and support services to Tribal youth organizations, education agencies and other Tribal programs for the benefit of children and youth. iii. AI/AN youth and Tribal communities and indicate experience in national partnerships or national support efforts on behalf of AI/AN communities especially as it pertains to health concerns. iv. Experience working with Tribal Boys and Girls Club sites and the TRAIL curriculum program. v. Local and national evaluation, including data collection and analysis D. Categorical Budget and Budget Justification (10 Points) This section should provide a clear estimate of the project program costs and justification for expenses for the entire cooperative agreement period. The budget and budget justification should be consistent with the tasks identified in the work plan. a. Categorical budget (Form SF–424A, Budget Information Non Construction Programs) completed for the first budget period. b. Narrative justification for all costs, explaining why each line item is necessary or relevant to the proposed project. Include sufficient details to facilitate the determination of cost allow ability. c. Indication of any special start-up costs. d. Budget justification should include a description of the planned costs and how they relate to or support the proposed project activities. Multi-Year Project Requirements Applications must include a brief project narrative and budget (one additional page per year) addressing the developmental plans for each additional year of the project. This attachment will not count as part of the project narrative or the budget narrative. This narrative should include discussion regarding the meaningful use of program implementation, process, and fidelity data. Additional documents can be uploaded as Other Attachments in Grants.gov. These can include: • Work plan, logic model, and/or timeline for proposed objectives. PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 • Position descriptions for key staff. • Resumes of key staff that reflect current duties. • Consultant or contractor proposed scope of work and letter of commitment (if applicable). • Current Indirect Cost Rate Agreement. • Map of area identifying project location(s). • Additional documents to support narrative (i.e., data tables, key news articles, etc.). 2. Review and Selection Each application will be prescreened for eligibility and completeness as outlined in the funding announcement. Applications that meet the eligibility criteria shall be reviewed for merit by the Objective Review Committee (ORC) based on evaluation criteria. Incomplete applications and applications that are not responsive to the administrative thresholds (budget limit, period of performance limit) will not be referred to the ORC and will not be funded. The program office will notify the applicant of this determination. Applicants must address all program requirements and provide all required documentation. 3. Notifications of Disposition All applicants will receive an Executive Summary Statement from the IHS Division of Diabetes Treatment and Prevention within 30 days of the conclusion of the ORC outlining the strengths and weaknesses of their application. The summary statement will be sent to the Authorizing Official identified on the face page (SF–424) of the application. A. Award Notices for Funded Applications The NoA is the authorizing document for which funds are dispersed to the approved entities and reflects the amount of Federal funds awarded, the purpose of the award, the terms and conditions of the award, the effective date of the award, the budget period, and period of performance. Each entity approved for funding must have a user account in GrantSolutions in order to retrieve the NoA. Please see the Agency Contacts list in Section VII for the systems contact information. B. Approved but Unfunded Applications Approved applications not funded due to lack of available funds will be held for 1 year. If funding becomes available during the course of the year, the application may be reconsidered. Note: Any correspondence, other than the official NoA executed by an IHS E:\FR\FM\12AUN1.SGM 12AUN1 Federal Register / Vol. 87, No. 155 / Friday, August 12, 2022 / Notices II–27, the IHS requires applicants to obtain a current IDC rate agreement and submit it to the DGM prior to the DGM issuing an award. The rate agreement must be prepared in accordance with the applicable cost principles and VI. Award Administration Information guidance as provided by the cognizant agency or office. A current rate covers 1. Administrative Requirements the applicable grant activities under the Awards issued under this current award’s budget period. If the announcement are subject to, and are current rate agreement is not on file administered in accordance with, the with the DGM at the time of award, the following regulations and policies: IDC portion of the budget will be A. The criteria as outlined in this restricted. The restrictions remain in program announcement. place until the current rate agreement is B. Administrative Regulations for provided to the DGM. Grants: Per 45 CFR 75.414(f) Indirect (F&A) • Uniform Administrative costs, ‘‘any non-Federal entity (NFE) Requirements, Cost Principles, and [i.e., applicant] that has never received Audit Requirements for HHS Awards a negotiated indirect cost rate, . . . may currently in effect or implemented elect to charge a de minimis rate of 10 during the period of award, other percent of modified total direct costs Department regulations and policies in which may be used indefinitely. As effect at the time of award, and described in Section 75.403, costs must applicable statutory provisions. At the be consistently charged as either time of publication, this includes 45 indirect or direct costs, but may not be CFR part 75, at https://www.govinfo.gov/ double charged or inconsistently content/pkg/CFR-2020-title45-vol1/pdf/ charged as both. If chosen, this CFR-2020-title45-vol1-part75.pdf. methodology once elected must be used • Please review all HHS regulatory consistently for all Federal awards until provisions for Termination at 45 CFR such time as the NFE chooses to 75.372, at https://www.ecfr.gov/cgi-bin/ negotiate for a rate, which the NFE may retrieveECFR?gp&amp;SID= apply to do at any time.’’ 2970eec67399fab1413 Electing to charge a de minimis rate ede53d7895d99&amp;mc=true&amp;n= of 10 percent only applies to applicants pt45.1.75&amp;r=PART&amp;ty= that have never received an approved HTML&amp;se45.1.75_1372#se45.1.75_ negotiated indirect cost rate from HHS 1372. or another cognizant Federal agency. C. Grants Policy: Applicants awaiting approval of their • HHS Grants Policy Statement, indirect cost proposal may request the Revised January 2007, at https:// 10 percent de minimis rate. When the www.hhs.gov/sites/default/files/grants/ applicant chooses this method, costs grants/policies-regulations/ included in the indirect cost pool must hhsgps107.pdf. not be charged as direct costs to the D. Cost Principles: grant. • Uniform Administrative Available funds are inclusive of direct Requirements for HHS Awards, ‘‘Cost and appropriate indirect costs. Principles,’’ at 45 CFR part 75 subpart Approved indirect funds are awarded as E. part of the award amount, and no E. Audit Requirements: additional funds will be provided. • Uniform Administrative Generally, IDC rates for IHS awardees Requirements for HHS Awards, ‘‘Audit are negotiated with the Division of Cost Requirements,’’ at 45 CFR part 75 Allocation at https://rates.psc.gov/ or subpart F. the Department of the Interior (Interior F. As of August 13, 2020, 2 CFR 200 Business Center) at https://ibc.doi.gov/ was updated to include a prohibition on ICS/tribal. For questions regarding the certain telecommunications and video indirect cost policy, please call the surveillance services or equipment. This Grants Management Specialist listed prohibition is described in 2 CFR under ‘‘Agency Contacts’’ or write to 200.216. This will also be described in DGM@ihs.gov. the terms and conditions of every IHS 3. Reporting Requirements grant and cooperative agreement The awardee must submit required awarded on or after August 13, 2020. reports consistent with the applicable 2. Indirect Costs deadlines. Failure to submit required reports within the time allowed may This section applies to all awardees result in suspension or termination of that request reimbursement of IDC in an active grant, withholding of their application budget. In accordance with HHS Grants Policy Statement, Part additional awards for the project, or jspears on DSK121TN23PROD with NOTICES grants management official announcing to the project director that an award has been made to their organization, is not an authorization to implement their program on behalf of the IHS. VerDate Sep<11>2014 17:38 Aug 11, 2022 Jkt 256001 PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 49871 other enforcement actions such as withholding of payments or converting to the reimbursement method of payment. Continued failure to submit required reports may result in the imposition of special award provisions and/or the non-funding or non-award of other eligible projects or activities. This requirement applies whether the delinquency is attributable to the failure of the awardee organization or the individual responsible for preparation of the reports. Per DGM policy, all reports must be submitted electronically by attaching them as a ‘‘Grant Note’’ in GrantSolutions. Personnel responsible for submitting reports will be required to obtain a login and password for GrantSolutions. Please use the form under the Recipient User section of https://www.grantsolutions.gov/home/ getting-started-request-a-user-account/. Download the Recipient User Account Request Form, fill it out completely, and submit it as described on the web page and in the form. The reporting requirements for this program are noted below. A. Progress Reports Program progress reports are required annually. The progress reports are due within 30 days after the reporting period ends (specific dates will be listed in the NoA Terms and Conditions). These reports must include a brief comparison of actual accomplishments to the goals established for the period, a summary of progress to date or, if applicable, provide sound justification for the lack of progress, and other pertinent information as required. A final report must be submitted within 90 days of expiration of the period of performance. B. Financial Reports Federal Financial Reports are due 30 days after the end of each budget period, and a final report is due 90 days after the end of the period of performance. Awardees are responsible and accountable for reporting accurate information on all required reports: the Progress Reports and the Federal Financial Report. C. Data Collection and Reporting The BGCA defines impact as the contribution a Club makes to the attitudes, skills, values, and behaviors of Club members that enables them to succeed in adulthood. BGCA has designed a model called Formula for Impact—a roadmap for Clubs to help ensure that members achieve BGCA’s priority outcomes of Academic Success, Good Character and Citizenship, and Healthy Lifestyles. These priority outcomes are achieved through the E:\FR\FM\12AUN1.SGM 12AUN1 jspears on DSK121TN23PROD with NOTICES 49872 Federal Register / Vol. 87, No. 155 / Friday, August 12, 2022 / Notices implementation of BGCA’s national programs; education and careers, character and leadership, health and life skills, the arts, sports, fitness and recreation, and specialized programs. Through Formula for Impact, BGCA and Clubs are able to use indicators to track and assess their impact, as well as demonstrate it in a consistent and meaningful way. Each Boys & Girls Club is required to complete the Formula for Impact Assessment annually. The National Youth Outcomes Initiative (NYOI) is an online data management tool that is designed to collect data from Clubs, compile that information, and provides reports on impact back to Clubs and BGCA. The NYOI was developed via the National Commission on Impact’s National Outcomes Database and Reporting Tool. One of the priority outcomes tracked through NYOI is Healthy Lifestyles. The indicators measured under this outcome go hand-in-hand with the indicators measured throughout the TRAIL program. In addition, the Good Character and Citizenship indicators support the TRAIL program requirement of participants engaging with their community and community health partners. Healthy Lifestyles Indicators: • Regular physical activity (monitored daily) • Good nutrition (examples provided) • Avoidance of risky behaviors Good Character and Citizenship Indicators: • Contributions to Club and local community • Positive opportunities • Building conflict resolution skills NYOI also measures Club members’ engagement in the following physical activities: • Number of days per week they participate in physical activity during their free time; • Number of days per week they participate in physical activity during school physical education class; • Number of days per week they participate in physical activity at the Club; • Daily fruit and vegetable intake; • Number of sugar sweetened drinks consumed per day; • Alcohol, drug, and tobacco use and abuse; • Sexual activity and condom use; • Demographic information including gender, age, and grade level of AI/AN youth participants; • Pre- and Post-tests to assess participant knowledge; and • Quarterly progress reports to capture program implementation tasks VerDate Sep<11>2014 17:38 Aug 11, 2022 Jkt 256001 and feedback received from youth participants, family members, and community members. D. Federal Sub-award Reporting System (FSRS) This award may be subject to the Transparency Act sub-award and executive compensation reporting requirements of 2 CFR part 170. The Transparency Act requires the OMB to establish a single searchable database, accessible to the public, with information on financial assistance awards made by Federal agencies. The Transparency Act also includes a requirement for awardees of Federal grants to report information about firsttier sub-awards and executive compensation under Federal assistance awards. The IHS has implemented a Term of Award into all IHS Standard Terms and Conditions, NoAs, and funding announcements regarding the FSRS reporting requirement. This IHS Term of Award is applicable to all IHS grant and cooperative agreements issued on or after October 1, 2010, with a $25,000 sub-award obligation threshold met for any specific reporting period. For the full IHS award term implementing this requirement and additional award applicability information, visit the DGM Grants Management website at https:// www.ihs.gov/dgm/policytopics/. E. Non-Discrimination Legal Requirements for Awardees of Federal Financial Assistance Should you successfully compete for an award, recipients of Federal financial assistance (FFA) from HHS must administer their programs in compliance with Federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civilrights/for-providers/providerobligations/ and https:// www.hhs.gov/civil-rights/forindividuals/nondiscrimination/ index.html. • Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting your legal obligation to take reasonable steps to PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 ensure meaningful access to your programs or activities by limited English proficiency individuals, see https:// www.hhs.gov/civil-rights/forindividuals/special-topics/limitedenglish-proficiency/fact-sheet-guidance/ index.html and https://www.lep.gov. • For information on your specific legal obligations for serving qualified individuals with disabilities, including reasonable modifications and making services accessible to them, see https:// www.hhs.gov/civil-rights/forindividuals/disability/. • HHS funded health and education programs must be administered in an environment free of sexual harassment. See https://www.hhs.gov/civil-rights/forindividuals/sex-discrimination/ index.html. • For guidance on administering your program in compliance with applicable Federal religious nondiscrimination laws and applicable Federal conscience protection and associated antidiscrimination laws, see https:// www.hhs.gov/conscience/conscienceprotections/ and https:// www.hhs.gov/conscience/religiousfreedom/. F. Federal Awardee Performance and Integrity Information System (FAPIIS) The IHS is required to review and consider any information about the applicant that is in the FAPIIS at https://www.fapiis.gov/fapiis/#/home before making any award in excess of the simplified acquisition threshold (currently $250,000) over the period of performance. An applicant may review and comment on any information about itself that a Federal awarding agency previously entered. The IHS will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgment about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants, as described in 45 CFR 75.205. As required by 45 CFR part 75 Appendix XII of the Uniform Guidance, NFEs are required to disclose in FAPIIS any information about criminal, civil, and administrative proceedings, and/or affirm that there is no new information to provide. This applies to NFEs that receive Federal awards (currently active grants, cooperative agreements, and procurement contracts) greater than $10,000,000 for any period of time during the period of performance of an award/project. E:\FR\FM\12AUN1.SGM 12AUN1 Federal Register / Vol. 87, No. 155 / Friday, August 12, 2022 / Notices jspears on DSK121TN23PROD with NOTICES Mandatory Disclosure Requirements As required by 2 CFR part 200 of the Uniform Guidance, and the HHS implementing regulations at 45 CFR part 75, the IHS must require an NFE or an applicant for a Federal award to disclose, in a timely manner, in writing to the IHS or pass-through entity all violations of Federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the Federal award. All applicants and awardees must disclose in writing, in a timely manner, to the IHS and to the HHS Office of Inspector General all information related to violations of Federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the Federal award. 45 CFR 75.113. Disclosures must be sent in writing to: U.S. Department of Health and Human Services, Indian Health Service, Division of Grants Management, ATTN: Marsha Brookins, Director, 5600 Fishers Lane, Mail Stop: 09E70, Rockville, MD 20857, (Include ‘‘Mandatory Grant Disclosures’’ in subject line), Office: (301) 443–4750, Fax: (301) 594–0899, Email: DGM@ ihs.gov AND U.S. Department of Health and Human Services, Office of Inspector General, ATTN: Mandatory Grant Disclosures, Intake Coordinator, 330 Independence Avenue SW, Cohen Building, Room 5527, Washington, DC 20201, URL: https://oig.hhs.gov/fraud/reportfraud/, (Include ‘‘Mandatory Grant Disclosures’’ in subject line), Fax: (202) 205–0604 (Include ‘‘Mandatory Grant Disclosures’’ in subject line) or Email: MandatoryGranteeDisclosures@ oig.hhs.gov Failure to make required disclosures can result in any of the remedies described in 45 CFR 75.371 Remedies for noncompliance, including suspension or debarment (see 2 CFR part 180 and 2 CFR part 376). VII. Agency Contacts 1. Questions on the programmatic issues may be directed to: Ms. Carmen Licavoli Hardin, Acting Director, Indian Health Service, Division of Diabetes Treatment and Prevention, 5600 Fishers Lane, Mail Stop: 08N34A&B, Rockville, MD 20897, Phone: 1–844–IHS–DDTP (1–844–447–3387), Fax: 301–594–6213, Email: diabetesprogram@ihs.gov. 2. Questions on grants management and fiscal matters may be directed to: Donald Gooding, Senior Grants Management Specialist, Indian Health Service, Division of Grants VerDate Sep<11>2014 17:38 Aug 11, 2022 Jkt 256001 Management, 5600 Fishers Lane, Mail Stop: 09E70, Rockville, MD 20857, Phone: 301–443–2298, Email: Donald.Gooding@ihs.gov. 3. Questions on systems matters may be directed to: Paul Gettys, Deputy Director, Indian Health Service, Division of Grants Management, 5600 Fishers Lane, Mail Stop: 09E70, Rockville, MD 20857, Phone: (301) 443– 2114; or the DGM main line (301) 443– 5204, E-Mail: Paul.Gettys@ihs.gov. VIII. Other Information The Public Health Service strongly encourages all grant, cooperative agreement, and contract awardees to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103– 227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of the facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the HHS mission to protect and advance the physical and mental health of the American people. Elizabeth A. Fowler, Acting Director, Indian Health Service. [FR Doc. 2022–17403 Filed 8–11–22; 8:45 am] BILLING CODE 4165–16–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome Research Institute; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Advisory Council for Human Genome Research. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend as well as those who need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The meeting will be videocast and can be accessed from https://www.genome.gov/ about-nhgri/Institute-Advisors/ National-Advisory-Council-for-HumanGenome-Research. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 49873 confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Advisory Council for Human Genome Research. Date: September 19–20, 2022. Closed: September 19, 2022, 9:00 a.m. to 9:30 a.m. Agenda: To review and evaluate grant applications. Place: National Human Genome Research Institute, National Institutes of Health, 6700B Rockledge Drive, Suite 1100, Bethesda, MD 20892. Open: September 19, 2022, 10:00 a.m. to 6:30 p.m. Agenda: Report of Institute Director and Institute Staff. Place: National Human Genome Research Institute, National Institutes of Health, 6700B Rockledge Drive, Suite 1100, Bethesda, MD 20892. Closed: September 20, 2022, 10:00 a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Human Genome Research Institute, National Institutes of Health, 6700B Rockledge Drive, Suite 1100, Bethesda, MD 20892. Contact Person: Rudy O. Pozzatti, Ph.D., Scientific Review Officer, Scientific Review Branch, National Human Genome Research Institute, National Institutes of Health, 6700B Rockledge Drive, Suite 1100, Bethesda, MD 20892, (301) 402–0838, pozzattr@ mail.nih.gov. Any interested person may file written comments with the committee within 15 days after the meeting by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. In the interest of security, NIH has procedures at https://www.nih.gov/aboutnih/visitor-information/campus-accesssecurity for entrance into on-campus and offcampus facilities. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors attending a meeting on campus or at an off-campus federal facility will be asked to show one form of identification (for example, a governmentissued photo ID, driver’s license, or passport) and to state the purpose of their visit. Additional Health and Safety Guidance: Before attending a meeting at an NIH facility, it is important that visitors review the NIH COVID–19 Safety Plan at https:// ors.od.nih.gov/sr/dohs/safety/NIH-covid-19safety-plan/Pages/default.aspx and the NIH testing and assessment web page at https:// ors.od.nih.gov/sr/dohs/safety/NIH-covid-19safety-plan/COVID-assessment-testing/Pages/ visitor-testing-requirement.aspx for information about requirements and procedures for entering NIH facilities, especially when COVID–19 community E:\FR\FM\12AUN1.SGM 12AUN1

Agencies

[Federal Register Volume 87, Number 155 (Friday, August 12, 2022)]
[Notices]
[Pages 49865-49873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17403]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Indian Health Service


Healthy Lifestyles in Youth Project

    Announcement Type: New.
    Funding Announcement Number: HHS-2022-IHS-HLY-0001.
    Assistance Listing (Catalog of Federal Domestic Assistance or CFDA) 
Number: 93.933.

Key Dates

    Application Deadline Date: September 15, 2022.
    Earliest Anticipated Start Date: September 30, 2022.

I. Funding Opportunity Description

Statutory Authority

    The Indian Health Service (IHS) is accepting applications for a 
cooperative agreement for the Healthy Lifestyles in Youth (HLY) 
Program. This program is authorized under the Snyder Act, 25 U.S.C. 13; 
and the Transfer Act, 42 U.S.C. 2001(a). This program is described in 
the Assistance Listings located at https://sam.gov/content/home 
(formerly known as the CFDA) under 93.933.

Background

    This program promotes healthy lifestyles for American Indian and

[[Page 49866]]

Alaska Native (AI/AN) youth using the curriculum ``Together Raising 
Awareness for Indian Life'' (TRAIL) among selected Native Boys and 
Girls Club sites. Under this cooperative agreement, IHS proposes to 
enter into a collaborative effort/initiative with an entity that has 
experience working with Boys and Girls Clubs of America (BGCA), 
experience working with and implementing the TRAIL curriculum, and 
overall expertise and experience in addressing and evaluating healthy 
lifestyle techniques in AI/AN youth. The IHS issued the original 
funding opportunity announcement for the HLY cooperative agreement in 
2003 and the program has been ongoing since that time.

Purpose

    The purpose of this program is to support the IHS mission to 
improve the health of AI/AN youth through health promotion and health 
education programs. The goal of this IHS cooperative agreement is to 
address healthy lifestyle development and emphasize nutrition and 
physical activity for AI/AN children and youth 7 through 11 years of 
age. To do this, the awardee must meet the following objectives:
     Collaborate with selected Native American Boys and Girls 
Club sites, via a grant application process;
     Provide health and physical education programs;
     Help youth achieve and maintain healthy lifestyles through 
participation in fitness programs;
     Help youth acquire a range of physical skills; and
     Help youth develop a sense of teamwork and cooperation.
    These early intervention strategies provide evidence based 
opportunities to reduce and/or halt the increasing trend of obesity and 
diabetes among youth and young adults. Native Boys and Girls Clubs that 
develop a health promotion program that includes the TRAIL curriculum 
may help curtail the effects of unhealthy eating behaviors and lack of 
physical activity that can lead to obesity, diabetes, and other chronic 
diseases later in life. The TRAIL curriculum was developed to provide 
information on good nutrition and to promote physical activity among 
youth participating in Native American Boys and Girls Clubs. The TRAIL 
curriculum is a 3-month (12 lessons) program that provides youth with a 
comprehensive understanding of healthy lifestyles in order to prevent 
diabetes. Woven throughout the program are self-esteem and prevention 
activities. Participants draw from Tribal traditions and history to 
learn about nutrition, healthy food choices, media influences, and the 
impact of diabetes. The TRAIL curriculum emphasizes the importance of 
teamwork and community service. Members engage in service projects to 
improve healthy lifestyles in their communities, including starting 
community gardens to connect youth to their food source and organizing 
community-wide physical fitness events.
    The overall results show improvement in participant knowledge of 
diabetes, health, and healthy food choices, as well as improved levels 
of fitness and physical activity. To date, this cooperative agreement 
has funded over 95 Native American Boys and Girls Club sites that have 
established and implemented this curriculum project and have served 
over 22,144 AI/AN youth. Program test scores each year consistently 
indicate: (a) increased knowledge about diabetes; (b) increased 
physical activity; and, (c) increased ability to identify healthier 
food options (post-intervention scores vs. pre-intervention test 
scores). Program physical activity logs show participating AI/AN youth 
collectively perform approximately 20,000 hours of physical activity 
each year. Boys and Girls Clubs also report annually on the service 
projects that are carried out by TRAIL participants in their local 
communities.
    Boys and Girl Club sites that are located outside of Tribal 
communities are not eligible.
    The Boys and Girls Club sites selected by the awardee may use IHS 
grant funds to provide services to eligible IHS beneficiaries only. The 
awardee will: provide technical consultation; train; monitor; evaluate; 
and provide funds to support these activities.

Required, Optional, and Allowable Activities

    1. Develop a written plan for the planning, implementation, and 
evaluation of this project to include overseeing at least 98 sites, as 
agreed upon with the IHS. The local evaluation effort should include 
local evidence-based practice (EBP) fidelity data and how data will 
integrate with the National Evaluation Frame. Complete this task within 
30 days of the award date and obtain approval by the IHS.
    2. Develop selection criteria for additional sites as well as 
announce, evaluate, and select new sites. Sites must submit 
documentation verifying that they serve only AI/AN youth from eligible 
IHS beneficiaries, as a requirement for selection by the awardee. 
Conduct a start-up planning meeting with new sites within 2 months of 
each site's initial selection and award.
    3. Plan and conduct an orientation and training meeting for new 
sites within 2 months of selection. Submit agenda, training goals and 
objectives, and participant list to IHS within 1 month of completion of 
each orientation session.
    4. Update TRAIL curriculum as needed/directed and implement use. 
Document any specific changes to the curriculum and note expected 
impacts on implementation, data collection and outcomes.
    5. Develop, in consultation with the IHS, the implementation and 
technical assistance plan for the coordination of the selected Boys and 
Girls Club sites. Submit criteria to the IHS for approval.
    6. Each site will implement the TRAIL program, emphasizing healthy 
behaviors, such as physical activity and nutrition. Each program plan 
will also include a parent component describing approaches for 
involving the families of participants.
    7. Each site will implement Physical Activity Strength and 
Endurance Challenges 3 times, 6 to 8 weeks apart. Physical activity 
data will be collected and summarized.
    8. Awardee will promote and facilitate local, state, and national 
partnerships for the purpose of establishing or enhancing program 
support that involves increasing physical activity and good nutrition 
for the tribally-managed Boys and Girls Club sites. This includes, but 
is not limited to, establishing other partners such as American Indian-
Alaska Native Program Branch (AI-ANPB) of Head Start Programs, Wings of 
America, United National Indian Tribal Youth, Inc. (UNITY), Tribal 
colleges, BGCA, Tribal organizations, local community health providers, 
and other private organizations as appropriate.
    9. Awardee will continue to implement current evaluation processes 
in consultation for the TRAIL project. At a minimum, the evaluation 
will include:
    a. training attendance (gender, age, grade level);
    b. pre- and post- tests to assess participant knowledge;
    c. monthly activity logs from each site on the physical activity 
portion of their program. Daily data to be collected includes the date, 
number of minutes of physical activity, and number of children 
participating; and
    d. information/log on parent and family participation in education 
and activity programs, community involvement and partnerships.
    10. Submit collated and summarized data to the IHS. Work with the 
IHS in

[[Page 49867]]

drafting an evaluation summary at the end of the project period. Submit 
collated and summarized data and project evaluation summaries to all 
sites. Provide a minimum of annual reports (feedback) to each site on 
how their data compare to data (mean, median, and range) from other 
selected sites.
    11. Provide ongoing technical support to the sites for the duration 
of the initiative. Provide training and technical assistance in all 
forms, i.e., on-site, on-line, by phone, and mail. The planning, 
design, and delivery of training and technical assistance will support 
the local organization's long-term planning and outreach efforts. The 
training will be customized based on sites' capability and experience. 
Technical assistance will also be provided on program planning, 
implementation, evaluation, and data collection. Collaborate with the 
IHS to provide services to club sites. Maintain records and reports.
    12. Provide technical assistance to the sites in developing a 
written work plan, with measurable goals, objectives and activities 
that adheres to the terms and conditions of the cooperative agreement.
    13. Establish a formal agreement with Native American Boys and 
Girls Club sites, involving funding assistance and technical support to 
ensure clubs successfully implement the TRAIL program.
    14. Submit to the IHS a written work plan and report describing 
each site's demographics, information on the number of youth in the 
eligible age range in the catchment area, the number that attend the 
Boys and Girls Clubs regularly, and the number served by this project, 
goals, objectives, activities, partnerships, and proposed outcomes.
    15. Provide the IHS written quarterly reports on the evaluation 
outcomes, activity reports at each site, any parent involvement 
activities and other participation, description of the community 
partnerships, and other activities as appropriate. Conduct quarterly 
conference calls with IHS to review project status.

II. Award Information

Funding Instrument--Cooperative Agreement

Estimated Funds Available
    The total funding identified for the first budget year, starting in 
fiscal year (FY) 2022, is approximately $1,250,000. The funding 
available for competing and subsequent continuation awards issued under 
this announcement is subject to the availability of appropriations and 
budgetary priorities of the Agency. The IHS is under no obligation to 
make awards that are selected for funding under this announcement.
Anticipated Number of Awards
    One award will be issued under this program announcement.
Period of Performance
    The project period is for 5 years.
Cooperative Agreement
    Cooperative agreements awarded by the Department of Health and 
Human Services (HHS) are administered under the same policies as 
grants. However, the funding agency, IHS, is anticipated to have 
substantial programmatic involvement in the project during the entire 
period of performance. Below is a detailed description of the level of 
involvement required of the IHS.
Substantial Agency Involvement Description for Cooperative Agreement
    (1) Identify a core group of IHS staff to work with the awardee in 
providing technical assistance and guidance.
    (2) Meet with the awardee to review awardee work plan and provide 
guidance on implementation, program evaluation, and data collection 
strategy and tools.
    (3) Participate in quarterly conference calls. Work with the 
awardee to display the results of this project by publishing on shared 
websites as well as in jointly authored publications.
    (4) Use the evidence-based program(s), framework(s), and data 
collection requirement(s) to develop a National Logic Model and 
Evaluation Plan to collect national program aggregate and local EBP 
fidelity data.

III. Eligibility Information

1. Eligibility

    To be eligible for this funding opportunity an applicant must be an 
organization with extensive experience developing and managing youth 
programs, health advocacy and education, and outreach related to AI/AN 
health care on a national scale.
    The program office will notify any applicants deemed ineligible.

    Note: Please refer to Section IV.2 (Application and Submission 
Information/Subsection 2, Content and Form of Application 
Submission) for additional proof of applicant status documents 
required, such as Tribal Resolutions, proof of nonprofit status, 
etc.

2. Cost Sharing or Matching

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

3. Other Requirements

    Applications with budget requests that exceed the highest dollar 
amount outlined under Section II Award Information, Estimated Funds 
Available, or exceed the period of performance outlined under Section 
II Award Information, Period of Performance, are considered not 
responsive and will not be reviewed. The Division of Grants Management 
(DGM) will notify the applicant.
    The following documentation is required (if applicable):
Tribal Resolution
    The DGM must receive an official, signed Tribal Resolution prior to 
issuing a Notice of Award (NoA) to any Tribe or Tribal organization 
selected for funding. An applicant that is proposing a project 
affecting another Indian Tribe must include resolutions from all 
affected Tribes to be served. However, if an official signed Tribal 
Resolution cannot be submitted with the application prior to the 
application deadline date, a draft Tribal Resolution must be submitted 
with the application by the deadline date in order for the application 
to be considered complete and eligible for review. The draft Tribal 
Resolution is not in lieu of the required signed resolution but is 
acceptable until a signed resolution is received. If an application 
without a signed Tribal Resolution is selected for funding, the 
applicant will be contacted by the Grants Management Specialist (GMS) 
listed in this funding announcement and given 90 days to submit an 
official signed Tribal Resolution to the GMS. If the signed Tribal 
Resolution is not received within 90 days, the award will be forfeited.
    Tribes organized with a governing structure other than a Tribal 
council may submit an equivalent document commensurate with their 
governing organization.
Proof of Nonprofit Status
    Organizations claiming nonprofit status must submit a current copy 
of the 501(c)(3) Certificate with the application.

IV. Application and Submission Information

    Grants.gov uses a Workspace model for accepting applications. The 
Workspace consists of several online forms and three forms in which to 
upload documents--Project Narrative, Budget Narrative, and Other 
Documents. Give your files brief descriptive names. The filenames are 
key in finding specific documents during the objective review and in 
processing awards.

[[Page 49868]]

Upload all requested and optional documents individually, rather than 
combining them into a package. Creating a package creates confusion 
when trying to find specific documents. Such confusion can contribute 
to delays in processing awards, and could lead to lower scores during 
the objective review.

1. Obtaining Application Materials

    The application package and detailed instructions for this 
announcement are available at https://www.Grants.gov.
    Please direct questions regarding the application process to 
[email protected].

2. Content and Form Application Submission

    Mandatory documents for all applicants include:
     Application forms:
    1. SF-424, Application for Federal Assistance.
    2. SF-424A, Budget Information--Non-Construction Programs.
    3. SF-424B, Assurances--Non-Construction Programs.
    4. Project Abstract Summary form.
     Project Narrative (not to exceed 25 pages). See Section 
IV.2.A, Project Narrative for instructions.
     Budget Justification/Narrative (not to exceed 5 pages). 
See Section IV.2.B, Budget Narrative for instructions.
     Tribal Resolution(s) as described in Section III, 
Eligibility.
     501(c)(3) Certificate, if applicable.
     Biographical sketches for all Key Personnel.
     Contractor/Consultant resumes or qualifications and scope 
of work.
     Disclosure of Lobbying Activities (SF-LLL), if applicant 
conducts reportable lobbying.
     Certification Regarding Lobbying (GG-Lobbying Form).
     Copy of current Negotiated Indirect Cost (IDC) rate 
agreement (required in order to receive IDC).
     Documentation of current Office of Management and Budget 
(OMB) Financial Audit (if applicable).
    Acceptable forms of documentation include:
    1. Email confirmation from Federal Audit Clearinghouse (FAC) that 
audits were submitted; or
    2. Face sheets from audit reports. Applicants can find these on the 
FAC website at https://facdissem.census .gov/.
Public Policy Requirements
    All Federal public policies apply to IHS grants and cooperative 
agreements. Pursuant to 45 CFR 80.3(d), an individual shall not be 
deemed subjected to discrimination by reason of their exclusion from 
benefits limited by Federal law to individuals eligible for benefits 
and services from the IHS. See https://www.hhs.gov/grants/grants/grants-policies-regulations/.
Requirements for Project and Budget Narratives
A. Project Narrative
    This narrative should be a separate document that is no more than 
25 pages and must: (1) have consecutively numbered pages; (2) use black 
font 12 points or larger (applicants may use 10 point font for tables); 
(3) be single-spaced; and (4) be formatted to fit standard letter paper 
(8\1/2\ x 11 inches). Do not combine this document with any others.
    Be sure to succinctly answer all questions listed under the 
evaluation criteria (refer to Section V.1, Evaluation Criteria) and 
place all responses and required information in the correct section 
noted below or they will not be considered or scored. If the narrative 
exceeds the overall page limit, the application will be considered not 
responsive and will not be reviewed. The 25-page limit for the project 
narrative does not include the work plan, standard forms, Tribal 
Resolutions, budget, budget narratives, and/or other items. Page limits 
for each section within the project narrative are guidelines, not hard 
limits.
    There are three parts to the narrative: Part 1--Introduction and 
Need for Assistance; Part 2--Work Plan; and Part 3--Organizational 
Capabilities. See below for additional details about what must be 
included in the narrative. The page limits below are for each narrative 
and budget submitted.
Part 1: Program Information (Limit--5 Pages)
Section 1: Needs
    Please provide a description of the need for assistance with 
offering this program. Applicant should demonstrate knowledge of: 
health concerns for AI/AN youth; health promotion activities in Tribal 
communities such as BGCA; and working with Tribes and Tribal 
organizations.
Part 2: Program Planning and Evaluation (Limit--10 Pages)
Section 1: Program Plans
    This section should demonstrate the soundness and effectiveness of 
the proposal. The work plan should be designed to describe how and when 
the sites will be selected; describe how the sites will be trained on 
the curriculum and provided technical assistance; and describe how 
sites will be supported for a physical activity program with the 
equipment and participant incentives.
Section 2: Program Evaluation
    Describe the plan for collecting data, monitoring, and assuring 
quality and quantity of data and the plan for evaluating and reporting 
program results.
Part 3: Organizational Capabilities (Limit--10 Pages)
    Describe the broader capacity of the organization to complete the 
project outlined in the work plan, including: (1) identification and 
bios for key personnel responsible for completing tasks; (2) 
description of the structure of the organization and chain of 
responsibility for successful completion of the project outline in the 
work plan; (3) description of financial and project management 
capacity, including information regarding similarly sized projects in 
scope and financial assistance as well as other grants and projects 
successfully completed; (4) description of national experience in 
providing administrative and support services to Tribal youth 
organizations, education agencies and other Tribal programs for the 
benefit of AI/AN children and youth and Tribal communities (indicate 
experience in national partnerships or national support efforts on 
behalf of AI/AN communities especially as it pertains to health 
concerns); (5) description of equipment and space available for use 
during the proposed project; and (6) description of specialized 
experience working with Native Boys and Girls Club sites and the TRAIL 
curriculum program.
B. Budget Narrative (Limit--5 Pages)
    Provide a budget narrative that explains the amounts requested for 
each line item of the budget from the SF-424A (Budget Information for 
Non-Construction Programs) for the first year of the project. The 
applicant can submit with the budget narrative a more detailed 
spreadsheet than is provided by the SF-424A (the spreadsheet will not 
be considered part of the budget narrative). The budget narrative 
should specifically describe how each item will support the achievement 
of proposed objectives. Be very careful about showing how each item in 
the ``Other'' category is justified. For subsequent budget years (see 
Multi-Year Project Requirements in Section V.1, Application Review 
Information, Evaluation Criteria), the additional pages should 
highlight the changes from the first year or clearly indicate that 
there are no substantive budget changes during the period of 
performance. Do

[[Page 49869]]

NOT use the budget narrative to expand the project narrative.

3. Submission Dates and Times

    Applications must be submitted through Grants.gov by 11:59 p.m. 
Eastern Time on the Application Deadline Date. Any application received 
after the application deadline will not be accepted for review. 
Grants.gov will notify the applicant via email if the application is 
rejected.
    If technical challenges arise and assistance is required with the 
application process, contact Grants.gov Customer Support (see contact 
information at https://www.Grants.gov). If problems persist, contact 
Mr. Paul Gettys ([email protected]), Deputy Director, DGM, by 
telephone at (301) 443-2114. Please be sure to contact Mr. Gettys at 
least 10 days prior to the application deadline. Please do not contact 
the DGM until you have received a Grants.gov tracking number. In the 
event you are not able to obtain a tracking number, call the DGM as 
soon as possible.
    The IHS will not acknowledge receipt of applications.

4. Intergovernmental Review

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

5. Funding Restrictions

     Pre-award costs are not allowable.
     The available funds are inclusive of direct and indirect 
costs.
     Only one cooperative agreement may be awarded per 
applicant.

6. Electronic Submission Requirements

    All applications must be submitted via Grants.gov. Please use the 
https://www.Grants.gov website to submit an application. Find the 
application by selecting the ``Search Grants'' link on the homepage. 
Follow the instructions for submitting an application under the Package 
tab. No other method of application submission is acceptable.
    If you cannot submit an application through Grants.gov, you must 
request a waiver prior to the application due date. This contact must 
be initiated prior to the application due date or your waiver request 
will be denied. Prior approval must be requested and obtained from Mr. 
Paul Gettys, Deputy Director, DGM. You must send a written waiver 
request to [email protected] with a copy to [email protected]. The 
waiver request must be documented in writing (emails are acceptable) 
before submitting an application by some other method, and must include 
clear justification for the need to deviate from the required 
application submission process.
    If the DGM approves your waiver request, you will receive a 
confirmation of approval email containing submission instructions. You 
must include a copy of the written approval with the application 
submitted to the DGM. Applications that do not include a copy of the 
signed waiver from the Deputy Director of the DGM will not be reviewed. 
The Grants Management Officer of the DGM will notify the applicant via 
email of this decision. Applications submitted under waiver must be 
received by the DGM no later than 5:00 p.m. Eastern Time on the 
Application Deadline Date. Late applications will not be accepted for 
processing. Applicants that do not register for both the System for 
Award Management (SAM) and Grants.gov and/or fail to request timely 
assistance with technical issues will not be considered for a waiver to 
submit an application via alternative method.
    Please be aware of the following:
     Please search for the application package in https://www.Grants.gov by entering the Assistance Listing (CFDA) number or the 
Funding Opportunity Number. Both numbers are located in the header of 
this announcement.
     If you experience technical challenges while submitting 
your application, please contact Grants.gov Customer Support (see 
contact information at https://www.Grants.gov).
     Upon contacting Grants.gov, obtain a tracking number as 
proof of contact. The tracking number is helpful if there are technical 
issues that cannot be resolved and a waiver from the agency must be 
obtained.
     Applicants are strongly encouraged not to wait until the 
deadline date to begin the application process through Grants.gov as 
the registration process for SAM and Grants.gov could take up to 20 
working days.
     Please follow the instructions on Grants.gov to include 
additional documentation that may be requested by this funding 
announcement.
     Applicants must comply with any page limits described in 
this funding announcement.
     After submitting the application, you will receive an 
automatic acknowledgment from Grants.gov that contains a Grants.gov 
tracking number. The IHS will not notify you that the application has 
been received.
System for Award Management (SAM)
    Organizations that are not registered with SAM must access the SAM 
online registration through the SAM home page at https://sam.gov. 
United States (U.S.) organizations will also need to provide an 
Employer Identification Number from the Internal Revenue Service that 
may take an additional 2-5 weeks to become active. Please see SAM.gov 
for details on the registration process and timeline. Registration with 
the SAM is free of charge but can take several weeks to process. 
Applicants may register online at https://sam.gov.
Unique Entity Identifier
    Your SAM.gov registration now includes a Unique Entity Identifier 
(UEI), generated by SAM.gov, which replaces the DUNS number obtained 
from Dun and Bradstreet. SAM.gov registration no longer requires a DUNS 
number.
    Check your organization's SAM.gov registration as soon as you 
decide to apply for this program. If your SAM.gov registration is 
expired, you will not be able to submit an application. It can take 
several weeks to renew it or resolve any issues with your registration, 
so do not wait.
    Check your Grants.gov registration. Registration and role 
assignments in Grants.gov are self-serve functions. One user for your 
organization will have the authority to approve role assignments, and 
these must be approved for active users in order to ensure someone in 
your organization has the necessary access to submit an application.
    The Federal Funding Accountability and Transparency Act of 2006, as 
amended (``Transparency Act''), requires all HHS awardees to report 
information on sub-awards. Accordingly, all IHS awardees must notify 
potential first-tier sub-awardees that no entity may receive a first-
tier sub-award unless the entity has provided its UEI number to the 
prime awardee organization. This requirement ensures the use of a 
universal identifier to enhance the quality of information available to 
the public pursuant to the Transparency Act.
    Additional information on implementing the Transparency Act, 
including the specific requirements for SAM, are available on the DGM 
Grants Management, Policy Topics web page at https://www.ihs.gov/dgm/policytopics/.

V. Application Review Information

    Possible points assigned to each section are noted in parentheses. 
The project narrative and budget narrative should include only the 
first year of activities; information for multi-year projects should be 
included as a separate document. See ``Multi-year Project 
Requirements'' at the end of this section for more information. The 
project narrative should be written in a

[[Page 49870]]

manner that is clear to outside reviewers unfamiliar with prior related 
activities of the applicant. It should be well organized, succinct, and 
contain all information necessary for reviewers to fully understand the 
project. Attachments requested in the criteria do not count toward the 
page limit for the narratives. Points will be assigned to each 
evaluation criteria adding up to a total of 100 possible points. Points 
are assigned as follows:

1. Evaluation Criteria

A. Introduction and Need for Assistance (20 Points)
    This section should demonstrate knowledge of health concerns and 
issues regarding AI/AN youth, health promotion activities in Tribal 
communities, and working with Tribes and Tribal organizations.
B. Work Plan (30 Points)
    This section should demonstrate a sound and effective annual work 
plan that will support accomplishment of deliverables and milestones of 
the TRAIL project. The work plan should be designed to:
    a. Describe how and when the sites will be selected.
    b. Describe how the sites will be trained on the curriculum and 
provided technical assistance.
    c. Describe the plan for collecting data, monitoring, and assuring 
quality and quantity of data.
    d. Describe the plan for evaluating and reporting.
    e. Describe how sites will be supported for a physical activity 
program.
C. Organizational Capabilities (40 Points)
    This section should outline the broader capacity of the 
organization to complete the project outlined in the work plan. It 
includes the identification of personnel responsible for completing 
tasks and the chain of responsibility for successful completion of the 
project outline in the work plan. The section should:
    a. Describe the structure of the organization.
    b. Describe the ability of the organization to manage the proposed 
project and include information regarding similarly sized projects in 
scope and financial assistance as well as other grants and projects 
successfully completed.
    c. Describe what equipment (i.e., phone, websites, etc.) and 
facility space (i.e., office space) will be available for use during 
the proposed project. Include information about any equipment not 
currently available that will be purchased throughout the agreement.
    d. List and provide bios for key personnel who will work on the 
project. The section should demonstrate knowledge in:
    i. Financial and project management.
    ii. Nationwide experience in providing administrative and support 
services to Tribal youth organizations, education agencies and other 
Tribal programs for the benefit of children and youth.
    iii. AI/AN youth and Tribal communities and indicate experience in 
national partnerships or national support efforts on behalf of AI/AN 
communities especially as it pertains to health concerns.
    iv. Experience working with Tribal Boys and Girls Club sites and 
the TRAIL curriculum program.
    v. Local and national evaluation, including data collection and 
analysis
D. Categorical Budget and Budget Justification (10 Points)
    This section should provide a clear estimate of the project program 
costs and justification for expenses for the entire cooperative 
agreement period. The budget and budget justification should be 
consistent with the tasks identified in the work plan.
    a. Categorical budget (Form SF-424A, Budget Information Non 
Construction Programs) completed for the first budget period.
    b. Narrative justification for all costs, explaining why each line 
item is necessary or relevant to the proposed project. Include 
sufficient details to facilitate the determination of cost allow 
ability.
    c. Indication of any special start-up costs.
    d. Budget justification should include a description of the planned 
costs and how they relate to or support the proposed project 
activities.
Multi-Year Project Requirements
    Applications must include a brief project narrative and budget (one 
additional page per year) addressing the developmental plans for each 
additional year of the project. This attachment will not count as part 
of the project narrative or the budget narrative. This narrative should 
include discussion regarding the meaningful use of program 
implementation, process, and fidelity data.
    Additional documents can be uploaded as Other Attachments in 
Grants.gov. These can include:
     Work plan, logic model, and/or timeline for proposed 
objectives.
     Position descriptions for key staff.
     Resumes of key staff that reflect current duties.
     Consultant or contractor proposed scope of work and letter 
of commitment (if applicable).
     Current Indirect Cost Rate Agreement.
     Map of area identifying project location(s).
     Additional documents to support narrative (i.e., data 
tables, key news articles, etc.).

2. Review and Selection

    Each application will be prescreened for eligibility and 
completeness as outlined in the funding announcement. Applications that 
meet the eligibility criteria shall be reviewed for merit by the 
Objective Review Committee (ORC) based on evaluation criteria. 
Incomplete applications and applications that are not responsive to the 
administrative thresholds (budget limit, period of performance limit) 
will not be referred to the ORC and will not be funded. The program 
office will notify the applicant of this determination.
    Applicants must address all program requirements and provide all 
required documentation.

3. Notifications of Disposition

    All applicants will receive an Executive Summary Statement from the 
IHS Division of Diabetes Treatment and Prevention within 30 days of the 
conclusion of the ORC outlining the strengths and weaknesses of their 
application. The summary statement will be sent to the Authorizing 
Official identified on the face page (SF-424) of the application.
A. Award Notices for Funded Applications
    The NoA is the authorizing document for which funds are dispersed 
to the approved entities and reflects the amount of Federal funds 
awarded, the purpose of the award, the terms and conditions of the 
award, the effective date of the award, the budget period, and period 
of performance. Each entity approved for funding must have a user 
account in GrantSolutions in order to retrieve the NoA. Please see the 
Agency Contacts list in Section VII for the systems contact 
information.
B. Approved but Unfunded Applications
    Approved applications not funded due to lack of available funds 
will be held for 1 year. If funding becomes available during the course 
of the year, the application may be reconsidered.
    Note: Any correspondence, other than the official NoA executed by 
an IHS

[[Page 49871]]

grants management official announcing to the project director that an 
award has been made to their organization, is not an authorization to 
implement their program on behalf of the IHS.

VI. Award Administration Information

1. Administrative Requirements

    Awards issued under this announcement are subject to, and are 
administered in accordance with, the following regulations and 
policies:
    A. The criteria as outlined in this program announcement.
    B. Administrative Regulations for Grants:
     Uniform Administrative Requirements, Cost Principles, and 
Audit Requirements for HHS Awards currently in effect or implemented 
during the period of award, other Department regulations and policies 
in effect at the time of award, and applicable statutory provisions. At 
the time of publication, this includes 45 CFR part 75, at https://www.govinfo.gov/content/pkg/CFR-2020-title45-vol1/pdf/CFR-2020-title45-vol1-part75.pdf.
     Please review all HHS regulatory provisions for 
Termination at 45 CFR 75.372, at https://www.ecfr.gov/cgi-bin/retrieveECFR?gp&;SID=2970eec67399fab1413ede53d7895d99&mc=true&
;n=pt45.1.75&r=PART&ty=HTML&se45.1.75_1372#se45.1.75_1372.
    C. Grants Policy:
     HHS Grants Policy Statement, Revised January 2007, at 
https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf.
    D. Cost Principles:
     Uniform Administrative Requirements for HHS Awards, ``Cost 
Principles,'' at 45 CFR part 75 subpart E.
    E. Audit Requirements:
     Uniform Administrative Requirements for HHS Awards, 
``Audit Requirements,'' at 45 CFR part 75 subpart F.
    F. As of August 13, 2020, 2 CFR 200 was updated to include a 
prohibition on certain telecommunications and video surveillance 
services or equipment. This prohibition is described in 2 CFR 200.216. 
This will also be described in the terms and conditions of every IHS 
grant and cooperative agreement awarded on or after August 13, 2020.

2. Indirect Costs

    This section applies to all awardees that request reimbursement of 
IDC in their application budget. In accordance with HHS Grants Policy 
Statement, Part II-27, the IHS requires applicants to obtain a current 
IDC rate agreement and submit it to the DGM prior to the DGM issuing an 
award. The rate agreement must be prepared in accordance with the 
applicable cost principles and guidance as provided by the cognizant 
agency or office. A current rate covers the applicable grant activities 
under the current award's budget period. If the current rate agreement 
is not on file with the DGM at the time of award, the IDC portion of 
the budget will be restricted. The restrictions remain in place until 
the current rate agreement is provided to the DGM.
    Per 45 CFR 75.414(f) Indirect (F&A) costs, ``any non-Federal entity 
(NFE) [i.e., applicant] that has never received a negotiated indirect 
cost rate, . . . may elect to charge a de minimis rate of 10 percent of 
modified total direct costs which may be used indefinitely. As 
described in Section 75.403, costs must be consistently charged as 
either indirect or direct costs, but may not be double charged or 
inconsistently charged as both. If chosen, this methodology once 
elected must be used consistently for all Federal awards until such 
time as the NFE chooses to negotiate for a rate, which the NFE may 
apply to do at any time.''
    Electing to charge a de minimis rate of 10 percent only applies to 
applicants that have never received an approved negotiated indirect 
cost rate from HHS or another cognizant Federal agency. Applicants 
awaiting approval of their indirect cost proposal may request the 10 
percent de minimis rate. When the applicant chooses this method, costs 
included in the indirect cost pool must not be charged as direct costs 
to the grant.
    Available funds are inclusive of direct and appropriate indirect 
costs. Approved indirect funds are awarded as part of the award amount, 
and no additional funds will be provided.
    Generally, IDC rates for IHS awardees are negotiated with the 
Division of Cost Allocation at https://rates.psc.gov/ or the Department 
of the Interior (Interior Business Center) at https://ibc.doi.gov/ICS/tribal. For questions regarding the indirect cost policy, please call 
the Grants Management Specialist listed under ``Agency Contacts'' or 
write to [email protected].

3. Reporting Requirements

    The awardee must submit required reports consistent with the 
applicable deadlines. Failure to submit required reports within the 
time allowed may result in suspension or termination of an active 
grant, withholding of additional awards for the project, or other 
enforcement actions such as withholding of payments or converting to 
the reimbursement method of payment. Continued failure to submit 
required reports may result in the imposition of special award 
provisions and/or the non-funding or non-award of other eligible 
projects or activities. This requirement applies whether the 
delinquency is attributable to the failure of the awardee organization 
or the individual responsible for preparation of the reports. Per DGM 
policy, all reports must be submitted electronically by attaching them 
as a ``Grant Note'' in GrantSolutions. Personnel responsible for 
submitting reports will be required to obtain a login and password for 
GrantSolutions. Please use the form under the Recipient User section of 
https://www.grantsolutions.gov/home/getting-started-request-a-user-account/.
    Download the Recipient User Account Request Form, fill it out 
completely, and submit it as described on the web page and in the form.
    The reporting requirements for this program are noted below.
A. Progress Reports
    Program progress reports are required annually. The progress 
reports are due within 30 days after the reporting period ends 
(specific dates will be listed in the NoA Terms and Conditions). These 
reports must include a brief comparison of actual accomplishments to 
the goals established for the period, a summary of progress to date or, 
if applicable, provide sound justification for the lack of progress, 
and other pertinent information as required. A final report must be 
submitted within 90 days of expiration of the period of performance.
B. Financial Reports
    Federal Financial Reports are due 30 days after the end of each 
budget period, and a final report is due 90 days after the end of the 
period of performance. Awardees are responsible and accountable for 
reporting accurate information on all required reports: the Progress 
Reports and the Federal Financial Report.
C. Data Collection and Reporting
    The BGCA defines impact as the contribution a Club makes to the 
attitudes, skills, values, and behaviors of Club members that enables 
them to succeed in adulthood. BGCA has designed a model called Formula 
for Impact--a roadmap for Clubs to help ensure that members achieve 
BGCA's priority outcomes of Academic Success, Good Character and 
Citizenship, and Healthy Lifestyles. These priority outcomes are 
achieved through the

[[Page 49872]]

implementation of BGCA's national programs; education and careers, 
character and leadership, health and life skills, the arts, sports, 
fitness and recreation, and specialized programs. Through Formula for 
Impact, BGCA and Clubs are able to use indicators to track and assess 
their impact, as well as demonstrate it in a consistent and meaningful 
way. Each Boys & Girls Club is required to complete the Formula for 
Impact Assessment annually.
    The National Youth Outcomes Initiative (NYOI) is an online data 
management tool that is designed to collect data from Clubs, compile 
that information, and provides reports on impact back to Clubs and 
BGCA. The NYOI was developed via the National Commission on Impact's 
National Outcomes Database and Reporting Tool. One of the priority 
outcomes tracked through NYOI is Healthy Lifestyles. The indicators 
measured under this outcome go hand-in-hand with the indicators 
measured throughout the TRAIL program. In addition, the Good Character 
and Citizenship indicators support the TRAIL program requirement of 
participants engaging with their community and community health 
partners.
    Healthy Lifestyles Indicators:

 Regular physical activity (monitored daily)
 Good nutrition (examples provided)
 Avoidance of risky behaviors

    Good Character and Citizenship Indicators:

 Contributions to Club and local community
 Positive opportunities
 Building conflict resolution skills

    NYOI also measures Club members' engagement in the following 
physical activities:
     Number of days per week they participate in physical 
activity during their free time;
     Number of days per week they participate in physical 
activity during school physical education class;
     Number of days per week they participate in physical 
activity at the Club;
     Daily fruit and vegetable intake;
     Number of sugar sweetened drinks consumed per day;
     Alcohol, drug, and tobacco use and abuse;
     Sexual activity and condom use;
     Demographic information including gender, age, and grade 
level of AI/AN youth participants;
     Pre- and Post-tests to assess participant knowledge; and
     Quarterly progress reports to capture program 
implementation tasks and feedback received from youth participants, 
family members, and community members.
D. Federal Sub-award Reporting System (FSRS)
    This award may be subject to the Transparency Act sub-award and 
executive compensation reporting requirements of 2 CFR part 170.
    The Transparency Act requires the OMB to establish a single 
searchable database, accessible to the public, with information on 
financial assistance awards made by Federal agencies. The Transparency 
Act also includes a requirement for awardees of Federal grants to 
report information about first-tier sub-awards and executive 
compensation under Federal assistance awards.
    The IHS has implemented a Term of Award into all IHS Standard Terms 
and Conditions, NoAs, and funding announcements regarding the FSRS 
reporting requirement. This IHS Term of Award is applicable to all IHS 
grant and cooperative agreements issued on or after October 1, 2010, 
with a $25,000 sub-award obligation threshold met for any specific 
reporting period.
    For the full IHS award term implementing this requirement and 
additional award applicability information, visit the DGM Grants 
Management website at https://www.ihs.gov/dgm/policytopics/.
E. Non-Discrimination Legal Requirements for Awardees of Federal 
Financial Assistance
    Should you successfully compete for an award, recipients of Federal 
financial assistance (FFA) from HHS must administer their programs in 
compliance with Federal civil rights laws that prohibit discrimination 
on the basis of race, color, national origin, disability, age and, in 
some circumstances, religion, conscience, and sex (including gender 
identity, sexual orientation, and pregnancy). This includes ensuring 
programs are accessible to persons with limited English proficiency and 
persons with disabilities. The HHS Office for Civil Rights provides 
guidance on complying with civil rights laws enforced by HHS. Please 
see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/ and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/.
     Recipients of FFA must ensure that their programs are 
accessible to persons with limited English proficiency. For guidance on 
meeting your legal obligation to take reasonable steps to ensure 
meaningful access to your programs or activities by limited English 
proficiency individuals, see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/ and https://www.lep.gov.
     For information on your specific legal obligations for 
serving qualified individuals with disabilities, including reasonable 
modifications and making services accessible to them, see https://www.hhs.gov/civil-rights/for-individuals/disability/.
     HHS funded health and education programs must be 
administered in an environment free of sexual harassment. See https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/.
     For guidance on administering your program in compliance 
with applicable Federal religious nondiscrimination laws and applicable 
Federal conscience protection and associated anti-discrimination laws, 
see https://www.hhs.gov/conscience/conscience-protections/ 
and https://www.hhs.gov/conscience/religious-freedom/.
F. Federal Awardee Performance and Integrity Information System 
(FAPIIS)
    The IHS is required to review and consider any information about 
the applicant that is in the FAPIIS at https://www.fapiis.gov/fapiis/#/home before making any award in excess of the simplified acquisition 
threshold (currently $250,000) over the period of performance. An 
applicant may review and comment on any information about itself that a 
Federal awarding agency previously entered. The IHS will consider any 
comments by the applicant, in addition to other information in FAPIIS, 
in making a judgment about the applicant's integrity, business ethics, 
and record of performance under Federal awards when completing the 
review of risk posed by applicants, as described in 45 CFR 75.205.
    As required by 45 CFR part 75 Appendix XII of the Uniform Guidance, 
NFEs are required to disclose in FAPIIS any information about criminal, 
civil, and administrative proceedings, and/or affirm that there is no 
new information to provide. This applies to NFEs that receive Federal 
awards (currently active grants, cooperative agreements, and 
procurement contracts) greater than $10,000,000 for any period of time 
during the period of performance of an award/project.

[[Page 49873]]

Mandatory Disclosure Requirements
    As required by 2 CFR part 200 of the Uniform Guidance, and the HHS 
implementing regulations at 45 CFR part 75, the IHS must require an NFE 
or an applicant for a Federal award to disclose, in a timely manner, in 
writing to the IHS or pass-through entity all violations of Federal 
criminal law involving fraud, bribery, or gratuity violations 
potentially affecting the Federal award. All applicants and awardees 
must disclose in writing, in a timely manner, to the IHS and to the HHS 
Office of Inspector General all information related to violations of 
Federal criminal law involving fraud, bribery, or gratuity violations 
potentially affecting the Federal award. 45 CFR 75.113.
    Disclosures must be sent in writing to:

U.S. Department of Health and Human Services, Indian Health Service, 
Division of Grants Management, ATTN: Marsha Brookins, Director, 5600 
Fishers Lane, Mail Stop: 09E70, Rockville, MD 20857, (Include 
``Mandatory Grant Disclosures'' in subject line), Office: (301) 443-
4750, Fax: (301) 594-0899, Email: [email protected]

AND

U.S. Department of Health and Human Services, Office of Inspector 
General, ATTN: Mandatory Grant Disclosures, Intake Coordinator, 330 
Independence Avenue SW, Cohen Building, Room 5527, Washington, DC 
20201, URL: https://oig.hhs.gov/fraud/report-fraud/, (Include 
``Mandatory Grant Disclosures'' in subject line), Fax: (202) 205-0604 
(Include ``Mandatory Grant Disclosures'' in subject line) or Email: 
[email protected]

    Failure to make required disclosures can result in any of the 
remedies described in 45 CFR 75.371 Remedies for noncompliance, 
including suspension or debarment (see 2 CFR part 180 and 2 CFR part 
376).

VII. Agency Contacts

    1. Questions on the programmatic issues may be directed to: Ms. 
Carmen Licavoli Hardin, Acting Director, Indian Health Service, 
Division of Diabetes Treatment and Prevention, 5600 Fishers Lane, Mail 
Stop: 08N34A&B, Rockville, MD 20897, Phone: 1-844-IHS-DDTP (1-844-447-
3387), Fax: 301-594-6213, Email: [email protected].
    2. Questions on grants management and fiscal matters may be 
directed to: Donald Gooding, Senior Grants Management Specialist, 
Indian Health Service, Division of Grants Management, 5600 Fishers 
Lane, Mail Stop: 09E70, Rockville, MD 20857, Phone: 301-443-2298, 
Email: [email protected].
    3. Questions on systems matters may be directed to: Paul Gettys, 
Deputy Director, Indian Health Service, Division of Grants Management, 
5600 Fishers Lane, Mail Stop: 09E70, Rockville, MD 20857, Phone: (301) 
443-2114; or the DGM main line (301) 443-5204, E-Mail: 
[email protected].

VIII. Other Information

    The Public Health Service strongly encourages all grant, 
cooperative agreement, and contract awardees to provide a smoke-free 
workplace and promote the non-use of all tobacco products. In addition, 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities (or in some cases, any portion of the facility) in 
which regular or routine education, library, day care, health care, or 
early childhood development services are provided to children. This is 
consistent with the HHS mission to protect and advance the physical and 
mental health of the American people.

Elizabeth A. Fowler,
Acting Director, Indian Health Service.
[FR Doc. 2022-17403 Filed 8-11-22; 8:45 am]
BILLING CODE 4165-16-P


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