HRSA-22-079: State Awards

HRSA-22-079: State Awards is sponsored by U.S. Department of Health and Human Services (HHS). Supports state agencies and programs overseeing child welfare, maternal and child health, substance use and mental health treatment, and other family-serving human service programs.

U.S. Department of Health and Human Services # Maternal and Child Health Bureau # Division of Services for Children with Special Health Needs # Regional Hemophilia Network (Project 1) # Funding Opportunity Number: HRSA-22-068 # National Hemophilia Program Coordinating Center (Project 2) # Funding Opportunity Number: HRSA-22-079 # Funding Opportunity Type(s): Competing Continuation, New # Assistance Listings (AL/CFDA) Number: 93.

110 # NOTICE OF FUNDING OPPORTUNITY # Application Due Date: January 24, 2022 Ensure your SAM. gov and Grants. gov registrations and passwords are current immediately!

HRSA will not approve deadline extensions for lack of registration. Registration in all systems may take up to 1 month to complete. Issuance Date: October 26, 2021 Senior Public Health Analyst Division of Services for Children with Special Health Needs Telephone: (301) 443-6829 Email: kmclaughlin@hrsa.

gov See Section VII for a complete list of agency contacts. Authority: 42 U.S.C. § 701 (a)(2) (Title V, § 501(a)(2) of the Social Security Act) HRSA-22-068 and HRSA-22-079 i # 508 COMPLIANCE DISCLAIMER Note: Persons using assistive technology may not be able to fully access information in this file.

For assistance, please email or call one of the HRSA staff listed in Section VII. Agency Contacts . The Health Resources and Services Administration (HRSA) is accepting applications for two separate projects to be awarded in fiscal year (FY) 2022 - HRSA-22-068, the Regional Hemophilia Network (RHN) (Project 1) and HRSA-22-079, the National Hemophilia Program Coordinating Center (NHPCC) (Project 2).

The purpose of these programs is to improve access to coordinated, evidence-based care for patients with hemophilia and related bleeding or clotting disorders and their families.

This announcement includes instructions for two separate award competitions: HRSA-22-068: The Regional Hemophilia Network (RHN) (Project 1): Eight regional award recipients will establish and maintain a regional network of hemophilia treatment centers (HTCs) to strengthen the reach and impact of the HTCs and their ability to provide evidence-based care to individuals seen in these centers.

HRSA-22-079: The National Hemophilia Program Coordinating Center (NHPCC) (Project 2): One national coordinating center will strengthen the capacity of the RHN and HTC comprehensive care teams through targeted technical assistance (TA), programmatic support, and data collection to assess patient outcomes.

Funding Opportunity Titles/Numbers: HRSA -22 -068: Regional Hemophilia HRSA-22-079: The National Hemophilia Program Coordinating Center (Project 2) Due Date for Applications: January 24, 2022 Anticipated Total Annual Available FY 2022 Funding: HRSA -22 -068, Project 1: $4,000,000 HRSA-22-079, Project 2: $740,000 HRSA-22-068 and HRSA-22-079 ii Estimated Number and Type of Award(s): HRSA -22 -068, Project 1: Regional Hemophilia Network: Eight (8) grants HRSA-22-079, Project 2 : One (1) cooperative agreement Estimated Award Amount: HRSA -22 -068, Project 1: Up to $500,000 per year subject to the availability of appropriated funds HRSA-22-079, Project 2: Up to $740,000 per year subject to the availability of appropriated funds Cost Sharing/Match Required: No Period of Performance: June 1, 2022 through May 31, 2027 Eligible Applicants: Any domestic public or private entity, including an Indian tribe or tribal organization (as those terms are defined at 25 U.S.C.

§ 450b) is eligible to apply. See 42 CFR § 51a. 3(a).

Domestic faith-based and community-based organizations are eligible to apply. See Section III. 1 of this notice of funding opportunity (NOFO) for complete eligibility information.

You (the applicant organization/agency) are responsible for reading and complying with the instructions included in HRSA’s SF-424 Application Guide , available online, except where instructed in this NOFO to do otherwise.

HRSA has scheduled the following technical assistance: Project 1: Regional Hemophilia Network Webinar Day and Date: Monday, November 8, 2021 Call-In Number: 1-833-568-8864 HRSA-22-068 and HRSA-22-079 iii Participant Code: 11647129 Weblink: https://hrsa-gov.zoomgov. com/j/1606594024? pwd=bldqQUUxUWJCcEVOZVJmaFhSWk4zU T09 HRSA will record the webinar and make it available at: https://mchb.

hrsa. gov/fundingopportunities/default. aspx .

Project 2: National Hemophilia Program Coordinating Center Webinar Day and Date: Friday, November 5, 2021 Time: 11 a. m. – 12 p.

m. ET Call-In Number: 1-833-568-8864 Participant Code: 57390339 Weblink: https://hrsa-gov.zoomgov. com/j/1611288084?

pwd=LzQ0TmlZY2g2RThkQUdjTEVmSUJwdz 09 HRSA will record the webinar and make it available at: https://mchb. hrsa. gov/fundingopportunities/default.

aspx HRSA-22-068 and HRSA-22-079 iv I. PROGRAM FUNDING OPPORTUNITY DESCRIPTION ................................ ..........................

1 1. P URPOSE ................................................................................................ ............................

1 2. B ACKGROUND ................................................................................................ ......................

3 II. AWARD INFORMATION ................................................................................................ .........

6 1. T YPE OF APPLICATION AND AWARD ................................................................ ......................

6 2. S UMMARY OF F UNDING ................................................................................................ ........

6 III. ELIGIBILITY INFORMATION ................................................................................................ ..

8 1. E LIGIBLE APPLICANTS ................................................................................................ ..........

8 2. COST SHARING /M ATCHING ................................................................................................ ...

8 3. OTHER ................................................................................................................................ 8 IV.

APPLICATION AND SUBMISSION INFORMATION ................................ .............................. 9 1.

A DDRESS TO REQUEST APPLICATION PACKAGE ................................................................ .... 9 2.

C ONTENT AND F ORM OF APPLICATION SUBMISSION ................................ .............................. 9 i.

Project Abstract ........................................................................................................ 10 ii. Project Narrative .......................................................................................................

11 iii. Budget ...................................................................................................................... 19 iv.

Budget Narrative ...................................................................................................... 20 v. Program-Specific Forms ...........................................................................................

18 vi. Attachments. ............................................................................................................

20 3. D UN AND B RADSTREET DATA UNIVERSAL NUMBERING SYSTEM (DUNS) NUMBER T RANSITION TO THE UNIQUE ENTITY I DENTIFIER (UEI) AND SYSTEM FOR AWARD MANAGEMENT (SAM) ....... 22 4.

S UBMISSION DATES AND T IMES .......................................................................................... 23 5. I NTERGOVERNMENTAL REVIEW ...........................................................................................

23 6. F UNDING RESTRICTIONS .................................................................................................... 23 V.

APPLICATION REVIEW INFORMATION ............................................................................. 25 1. R EVIEW CRITERIA ..............................................................................................................

25 2. REVIEW AND SELECTION PROCESS .................................................................................... 30 3.

A SSESSMENT OF RISK ........................................................................................................ 30 VI. AWARD ADMINISTRATION INFORMATION ......................................................................

31 1. A WARD NOTICES ............................................................................................................... 31 2.

ADMINISTRATIVE AND NATIONAL POLICY REQUIREMENTS .................................................... 31 3. R EPORTING .......................................................................................................................

33 VII. AGENCY CONTACTS ......................................................................................................... 35 VIII.

OTHER INFORMATION ........................................................................................................... 36 HRSA-22-068 and HRSA-22-079 1 # I.

Program Funding Opportunity Description This notice announces the opportunity to apply for funding for two separate projects to be awarded in fiscal year (FY) 2022 - HRSA-22-068, the Regional Hemophilia Network (RHN) (Project 1); and HRSA-22-079, the National Hemophilia Program Coordinating Center (NHPCC) (Project 2).

The purpose of these programs is to improve access to coordinated, evidence-based care for patients with hemophilia and related bleeding or clotting disorders and their families. This announcement includes instructions for applying to two separate awards . You may only apply for HRSA-22-068 or HRSA-22-079, but not both projects.

The goal of these awards is to improve access to coordinated, evidence-based care for individuals with hemophilia and related bleeding or clotting disorders and their families.

HRSA-22-068: Regional Hemophilia Network Program (Project 1) The goal of HRSA-22-068 is to establish regional networks of hemophilia treatment centers (HTCs) to improve the health and well-being for children, youth, and adults with hemophilia and related bleeding disorders and clotting disorders. HRSA will fund up to eight recipients will be funded for HRSA-22-068, one recipient per region.

The eight HRSA-designated Hemophilia Regions 1 are: • New England: Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont, New Jersey, New York, Puerto Rico, US Virgin Islands • Mid-Atlantic: Delaware, DC, Maryland, Pennsylvania, Virginia, West Virginia • Southeast: Alabama, Florida, Georgia, Mississippi, Kentucky, North Carolina, South Carolina, Tennessee • Great Lakes: Indiana, Michigan, Ohio • Northern States: Illinois, Minnesota, North Dakota, South Dakota, Wisconsin • Great Plains: Arkansas, Louisiana, Oklahoma, Texas, Iowa, Kansas, Missouri, Nebraska • Mountain States: Alaska, Idaho, Oregon, Washington, Arizona, Colorado, Montana, New Mexico, Utah, Wyoming • Western States and Territory: California, Hawaii, Nevada, and the Pacific Islands > 1The Hemophilia Regions are defined by HRSA using a combination of the Public Health Service Regions and similarity in numbers of patients and numbers of hemophilia treatment centers .

HRSA-22-068 and HRSA-22-079 2 Each recipient is expected to be responsible for identifying, establishing, and monitoring a network of HTCs in the region.

In collaboration with the NHPCC, recipients are expected to provide monitoring oversight, technical assistance (TA), education, and quality improvement opportunities for HTC staff on staff development issues, best practices for disease management and evidence-informed treatment guidelines, and patient and family education.

HRSA-22-079: National Hemophilia Program Coordinating Center Program (Project 2) The goal of HRSA-22-079 is for one recipient to provide subject matter expertise, technical assistance and programmatic support to the RHNs through a national coordinating center.

HRSA-22-079 will enhance coordination across the regions, increase the programs’ ability to respond to emerging needs in the field, and strengthen the capacity of the RHN and HTC comprehensive care teams through targeted TA and by tracking national, regional, and patient-level data to assess patient outcomes.

The NHPCC also provides an ongoing forum for national education, communication, and collaboration that assists in increasing the evidence base on care for patients seen in HTCs. HRSA-22-068, Project 1: Each successful recipient is expected to: • By May 2027, increase by 10 percent from baseline, the number of underserved 2 individuals who receive comprehensive care clinic visits.

• By May 2027, reduce by two percent, the number of patients with hemophilia that experience more than four joint bleeds annually. • By May 2027, 100 percent of HTCs are participating in and contributing appropriate data to the national transition 3 quality improvement project.

• By May 2027, increase by 25 percent from baseline, the number of individuals 12 years and older seen in a comprehensive care clinic that have a health care transition plan.

> 2Definition of Underserved Communities: “The populations sharing a particular characteristic, as well as geographic communities that have been systematically denied a full opportunity to participate in aspects of economic, social, and civic life, as exemplified by the list in the preceding definition of ‘equity.

Executive Order 13985 on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government, 86 FR 7009, at § 2(b) (Jan. 20, 2021), https://www. govinfo.

gov/content/pkg/FR-2021-01-25/pdf/2021-01753. pdf . Additionally, please See HRSA definition for Medically Underserved Areas/Populations: https://data.

hrsa. gov/tools/shortage-area/mua-find > 3Health care transition is the process of moving from a child to an adult model of health care with or without a transfer to a new clinician. Transition from pediatric to adult health care is part of a larger theoretical framework for transition affecting all youth, young adults, and families, and can include transitions in non-health settings, e.g., education, employment, and living situations.

White PH, Cooley WC; Transitions Clinical Report Authoring Group; American Academy of Pediatrics; American Academy of Family Physicians; American College of Physicians. Supporting the Health Care Transition From Adolescence to Adulthood in the Medical Home. Pediatrics.

2018;142(5):e20182587 HRSA-22-068 and HRSA-22-079 3 HRSA-22-079, Project 2: The successful recipient is expected to: • By May 31, 2023, develop and manage an online, shared workspace for both regional and HTC staff to share best practices and ongoing grant project activities.

• By May 31, 2023, develop a centralized data collection system and repository that contains grant project data and enables authorized RHN/NHPCC users to create and disseminate data reports. • By May 31, 2023, develop and launch a national quality improvement project for regional implementation for increasing the number of individuals 12 years and older seen in a comprehensive care clinic that have a healthcare transition plan.

If you are a competing continuation applicant for HRSA-22-068, Project 1 or HRSA-22-079, Project 2, use baseline data for the last year of the current (i.e., immediately preceding) project to establish the new benchmark for the objectives listed above. If you are a new applicant, you will collect and provide baseline data to HRSA to establish the benchmark for the objectives listed above by the end of year 1 of the award.

For more details, see Program Requirements and Expectations . Program is authorized by 42 U.S.C. §701 (a)(2) (Title V, § 501(a)(2) of the Social Security Act.

Goal 1: Assure access to high quality and equitable health services to optimize health and well-being for all MCH populations Goal 2: Achieve health equity for MCH populations Goal 3: Strengthen public health capacity and workforce for MCH Goal 4: Maximize impact through leadership, partnership, and stewardship This program addresses MCHB’s goals to assure access to high quality and equitable health services to optimize health and well-being for all MCH populations, achieve health equity for MCH populations, strengthen public health capacity and workforce for MCH, and maximize impact through leadership, partnership, and stewardship.

As noted above, the program aims to improve access to high quality and equitable care in HTCs to optimize the health and well-being of all individuals living with hemophilia and other related bleeding and clotting disorders, including underserved populations.

The program provides a network of multi-disciplinary comprehensive care teams and seeks to increase the number of providers offering evidence-based care through targeted provider education and training.

The regions and the NHPCC provide national HRSA-22-068 and HRSA-22-079 4 leadership through these activities by strengthening the capacity of HTC infrastructure, tracking national, regional, and patient-level program data to assess and improve patient outcomes, and disseminating best practices through program activities and participation in collaborative federal efforts. https://mchb. hrsa.

gov/about . Hemophilia is a rare, inherited bleeding disorder affecting as many as 40,000 persons, mostly males, in the U.S. 4 If left untreated, hemophilia can cause uncontrolled bleeding and is associated with high direct costs from hospitalizations, outpatient visits, and drug treatments, as well as high indirect costs from diminished work productivity and absenteeism from work and school.

Joint bleeds are the leading cause of disability in patients with mild, moderate, and severe hemophilia. 5 Given the complexity of hemophilia and the cost of treatment, it is important that individuals receive coordinated, comprehensive, multi-disciplinary care. 6 Optimal care to prevent these complications requires a multi-disciplinary team approach.

The National Hemophilia Foundation’s (NHF) Medical and Scientific Advisory Committee has developed guidelines for care - Standards and Criteria for the Care of Persons with Congenital Bleeding Disorders . 7 All HTC subrecipients are expected to follow these guidelines for the treatment of individuals with hemophilia and other congenital bleeding disorders.

The guidelines describe the core team of allied health professionals and the integrated care services that patients with these disorders should > 4LA Schieve, et al. Evaluation of CDC’s Hemophilia Surveillance Program — Universal Data Collection (1998–2011) and Community Counts (2011–2019), United States Surveillance Summaries / September 4, 2020 / 69(5);1–18. https://www.

cdc. gov/mmwr/volumes/69/ss/ss6905a1. htm?

s_cid=ss6905a1_w > 5Srivastava, A et al. WFH Guidelines for the Management of Hemophilia, 3rd edition. Haemophilia.

2020: 26(Suppl 6): 1- 158. https://doi. org/10.

1111/hae. 14046 . > 6Guh S et al.

Health care expenditures for Medicaid-covered males with haemophilia in the United States, 2008. Haemophilia. 2012 Mar;18(2):276-83.

Epub 2011 Dec 21. > https://pubmed. ncbi.

nlm. nih. gov/22188641/ > 7National Hemophilia Foundation.

Medical and Scientific Advisory Council (MASAC), MASAC Document #132: Standards and Criteria for the Care of Persons with Congenital Bleeding Disorders. Revised and Approved by MASAC on March 24, 2002 and by the NHF Board of Directors on April 15, 2002. > https://www.

hemophilia. org/healthcare-professionals/guidelines-on-care/masac-documents/masac-document-132-standards-and-criteria-for-the-care-of-persons-with-congenital-bleeding-disorders HRSA-22-068 and HRSA-22-079 5 receive. The guidelines emphasize family and patient education, transitional services, and psychosocial services.

For the purpose of this NOFO, HTCs are clinical centers that see patients and receive HRSA funds through any of the eight Regions. HTC subrecipients and their multi-disciplinary teams are expected to demonstrate skills and knowledge that are used in the care of individuals with bleeding disorders.

This includes preventive medicine, carrier detection, genetic and prenatal counseling, telemedicine, patient education and engagement in care, blood product use, and recognizing and managing complications of therapy. HTCs also treat other bleeding and clotting disorders including Von Willebrand Disease, factor deficiency, and platelet disorders, such as thrombocytopenia.

MCHB is committed to promoting equity in health programs for mothers, children, and families. The projects described in this NOFO aim to improve access to equitable care for individuals with hemophilia and related bleeding and clotting disorders and their families, with a focus on outreach to the underserved.

As such, the definition of equity provides a foundation for the development of programs that intend to reach underserved communities and improve equity among all communities.

In our programs, equity is defined as the consistent and systematic fair, just, and impartial treatment of all individuals, including individuals who belong to underserved communities that have been denied such treatment, such as Black, Latino, Indigenous and Native American persons, Asian Americans and Pacific Islanders and other persons of color; members of religious minorities; lesbian, gay, bisexual, transgender, and queer (LGBTQ+) persons; persons with disabilities; persons who live in rural areas; and persons otherwise adversely affected by persistent poverty or inequality.

8 The 340B Drug Pricing Program The 340B Drug Pricing Program 9 (340B Program) requires drug manufacturers to provide covered outpatient drugs to eligible health care organizations (i.e., covered entities) at significantly reduced prices and enables covered entities to stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.

Covered entities are defined in section 340B(a) of the Public Health Service Act. Covered entities must annually recertify their eligibility with HRSA’s Office of Pharmacy Affairs (OPA). If there is a change in a covered entity's eligibility status, the covered entity must immediately notify OPA and should stop purchasing drugs through the 340B Program.

Note: Pursuant to 45 C. F. R.

§ 75. 307(e)(2), 10 “Addition. With prior approval of the HHS awarding agency (except for IHEs and nonprofit research institutions, as described in > 8Executive Order 13985 on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government, 86 FR 7009, at § 2(a) (Jan.

20, 2021), https://www. govinfo. gov/content/pkg/FR-2021-01-25/pdf/2021-01753.

pdf . > 9HRSA 340B Drug Pricing Program. Accessed June 1, 2021.

https://www. hrsa. gov/opa/index.

html > 10 Electronic Code of Federal Regulations. Accessed: May 7, 2021. https://www.

ecfr. gov/cgi-bin/text-idx? node=pt45.

1. 75&rgn=div5 HRSA-22-068 and HRSA-22-079 6 paragraph (e) of this section), program income may be added to the federal award by the federal agency and the non-federal entity. The program income must be used for the purposes and under the conditions of the federal award.

” Recipients are to add program income revenue to the funds committed to the project or program to “further eligible project and program objectives. ” More specifically, reportable net program income is to be used for patient health, education, and supportive services necessary to provide comprehensive care to patients with hemophilia or related clotting and bleeding disorders served by the HTCs.

Any proposed use of program income must be submitted to HRSA for Prior Approval through HRSA’s Electronic Handbooks (EHBs). Standard procedures for these submissions will be further elaborated during the Kick-Off Conference Call after recipients have received their Notice of Award. Please refer to https://mchb.

hrsa. gov/maternal-child-health-initiatives/hemophilia for the Hemophilia Program Financial Monitoring Documents for use with this program. 1.

Type of Application and Award Type(s) of applications sought: Competing Continuation, New HRSA will provide funding for HRSA-22-068, Regional Hemophilia Network Program in the form of a grant. HRSA will provide funding for HRSA-22-079, the National Hemophilia Program Coordinating Center in the form of a cooperative agreement.

A cooperative agreement is a financial assistance mechanism where HRSA anticipates substantial involvement with the recipient during performance of the contemplated project.

HRSA-22-068 and HRSA-22-079 7 HRSA involvement for HRSA-22-079, Project 2 will include : • Participating in meetings conducted during the period of the cooperative agreement; • Collaborating with recipients in developing activities and procedures to be established and implemented for accomplishing the goals and objectives of the project; • Reviewing information on project activities, reports, and products prior to dissemination; • Participating in dissemination of project information; • Providing assistance in establishing and facilitating effective collaborative relationships with federal and state agencies, and especially HRSA award projects; and • Providing technical assistance and support to recipients to ensure they are compliant with NOFO requirements and do not duplicate the work of other HRSA-funded projects.

The cooperative agreement recipient’s responsibilities will include: • Conducting all tasks as they relate to the goals and activities of HRSA-22-079, Project 2 listed in the Purpose section and in the Methodology section of this notice of funding opportunity (NOFO); • Collaborate with all recipients participating in HRSA-22-068, Project 1; • Reviewing, on a continuous basis, activities and procedures to be established and implemented for accomplishing the program’s goals, objectives, and activities; • Providing ongoing, timely communication and collaboration with the federal project officer; • Working with the federal project officer to review information on program activities, reports, and products prior to dissemination; • Establishing contacts that may be relevant to the project’s mission; • Facilitating partnerships with federal and non-federal entities and other HRSA-funded programs relevant to the program activities; and • Meeting deadlines for information requests and reports as required by HRSA.

HRSA estimates approximately $500,000 to be available annually to fund eight recipients. You may apply for a ceiling amount of up to $500,000 total cost (includes both direct and indirect, facilities, and administrative costs) per year.

This program notice is subject to the appropriation of funds, and is a contingency action taken to ensure that, should funds become available for this purpose, HRSA can process applications and award funds appropriately. HRSA-22-068 and HRSA-22-079 8 The period of performance is June 1, 2022, through May 31, 2027 (5 years).

Funding beyond the first year is subject to the availability of appropriated funds for HRSA-22-068, Project 1, in subsequent fiscal years, satisfactory progress, and a decision that continued funding is in the best interest of the Federal Government. HRSA estimates approximately $740,000 to be available annually to fund one recipient.

The actual amount available will not be determined until enactment of the final FY 2022 federal appropriation. You may apply for a ceiling amount of up to $740,000 total cost (includes both direct and indirect, facilities and administrative costs) per year.

This program notice is subject to the appropriation of funds, and is a contingency action taken to ensure that, should funds become available for this purpose, HRSA can process applications and award funds appropriately. The period of performance is June 1, 2022, through May 31, 2027 (5 years).

Funding beyond the first year is subject to the availability of appropriated funds for HRSA-22-079, Project 2 in subsequent fiscal years, satisfactory recipient performance, and a decision that continued funding is in the best interest of the Federal Government. All HRSA awards are subject to the Uniform Administrative Requirements, Cost Principles, and Audit Requirements at 45 CFR part 75 .

See HRSA Grants Policy Bulletin 2017-03 Indirect Cost Rate Agreements in the NOFO . # III. Eligibility Information Cost sharing/matching is not required for either HRSA-22-068, Project 1, or HRSA-22-079, Project 2.

HRSA may not consider an application for funding if it contains any of the non-responsive criteria below: • Exceeds the ceiling amount • Fails to satisfy the deadline requirements referenced in Section IV. 4 NOTE: Multiple applications from an organization are not allowable. HRSA-22-068 and HRSA-22-079 9 HRSA will only accept your last validated electronic submission, under the correct funding opportunity number, before the Grants.

gov application due date as the final and only acceptable application. Applicants should only apply to one of the two announcements listed in this NOFO, HRSA-22-068, Project 1 or HRSA-22-079, Project 2. Please make sure you submit your application to the correct announcement number.

Applications submitted to the wrong competition will be deemed nonresponsive. HRSA will not consider funding applicants that apply to both announcements. # IV.

Application and Submission Information 1. Address to Request Application Package HRSA requires you to apply electronically. HRSA encourages you to apply through Grants.

gov using the SF-424 workspace application package associated with this notice of funding opportunity (NOFO) following the directions provided at Grants. gov: HOW TO APPLY FOR GRANTS . are ultimately responsible for reviewing the For Applicants page for all information relevant to this NOFO.

2. Content and Form of Application Submission Application Format Requirements Section 4 of HRSA’s SF-424 Application Guide provides general instructions for the budget, budget narrative, staffing plan and personnel requirements, assurances, certifications, etc. You must submit the information outlined in the HRSA SF-424 Application Guide in addition to the program-specific information below.

You are responsible for reading and complying with the instructions included in HRSA’s SF-424 Application Guide except where instructed in the NOFO to do otherwise. You must submit the application in the English language and in the terms of U.S. dollars (45 CFR § 75. 111(a)).

See Section 8. 5 of the HRSA SF-424 Application Guide for the Application Completeness Checklist. Application Page Limitation The total size of all uploaded files included in the page limit may not exceed the equivalent of 60 pages when printed by HRSA.

The page limit includes the project and budget narratives, and attachments required in the Application Guide and this NOFO. HRSA-22-068 and HRSA-22-079 10 Please note: Effective April 22, 2021, the abstract is no longer an attachment that counts in the page limit. The abstract is the standard form (SF) "Project Abstract Summary.

” Standard OMB-approved forms included in the workspace application package do not count in the page limit. If you use an OMB-approved form that is not included in the workspace application package for HRSA-22-068 or HRSA-22-079, it may count against the page limit. Therefore, we strongly recommend you only use Grants.

gov workspace forms associated with this NOFO to avoid exceeding the page limit. Indirect Cost Rate Agreement and proof of non-profit status (if applicable) do not count in the page limit. It is therefore important to take appropriate measures to ensure your application does not exceed the specified page limit.

Any application exceeding the page limit of 60 will not be read, evaluated, or considered for funding.

Debarment, Suspension, Ineligibility, and Voluntary Exclusion Certification 1) You certify on behalf of the applicant organization, by submission of your proposal, that neither you nor your principals are presently debarred, suspended, proposed for debarment, declared ineligible, or voluntarily excluded from participation in this transaction by any federal department or agency.

2) Failure to make required disclosures can result in any of the remedies described in 45 CFR § 75. 371 , including suspension or debarment. (See also 2 CFR parts 180 and 376, and 31 U.S.C.

§ 3321). 3) If you are unable to attest to the statements in this certification, you must include an explanation in Attachment 12: Other Relevant Documents . See Section 4.

1 viii of HRSA’s SF-424 Application Guide for additional information on all certifications.

Program Requirements and Expectations # Program-Specific Instructions In addition to application requirements and instructions in Section 4 of HRSA’s SF-424 Application Guide (including the budget, budget narrative, staffing plan and personnel requirements, assurances, certifications, and abstract), include the following: Use the Standard OMB-approved Project Abstract Summary Form 2.

0 that is included in the workspace application package. Do not upload the abstract as an attachment or it will count toward the page limitation. For information required in the Project Abstract Summary Form, see Section 4.

1. ix of HRSA’s SF-424 Application Guide . HRSA-22-068 and HRSA-22-079 11 For Both HRSA-22-068, Project 1 and HRSA 22-079, Project 2: To ensure that you fully address the review criteria, the table below provides a crosswalk between the narrative language and where each section falls within the review criteria.

Any forms or attachments referenced in a narrative section may be considered during the objective review.

Narrative Section Review Criteria Needs Assessment (1) Need Work Plan (2) Response and (4) Impact Resolution of Challenges (2) Response Evaluation and Technical Support (3) Evaluative Measures and (5) Resources/Capabilities Organizational Information (5) Resources/Capabilities Budget Narrative (6) Support Requested If applicable, otherwise completely delete this row (7) Specific Review Criteria – if any, the narrative should describe in what section these are to be described This section provides a comprehensive description of all aspects of the proposed project.

It should be succinct, self-explanatory, consistent with forms and attachments, and organized in alignment with the sections and format below so that reviewers can understand the proposed project. Successful applications will contain the information below.

Please use the following section headers for the narrative:  INTRODUCTION -- Corresponds to Section V’s Review Criterion Need For both HRSA-22-068, Project 1 and HRSA-22-079, Project 2 State the project for which you are applying. Briefly describe the purpose of the proposed project, the methods to be used, and the projected outcomes.

HRSA-22-068 and HRSA-22-079 12  NEEDS ASSESSMENT -- Corresponds to Section V’s Review Criterion Need For both HRSA-22-068, Project 1 and HRSA-22-079, Project 2 Outline the needs of the region and nationally. Describe and document the target population, any unmet health care and access needs, and any emerging issues. Use and cite demographic data whenever possible to support the information provided.

Discuss any relevant barriers experienced by individuals with hemophilia, their families, and the hemophilia treatment center (HTC) comprehensive care teams. This section will help reviewers understand the community and/or organization that you will serve with the proposed project.

In addition to above, HRSA-22-068, Project 1 should describe: • The changes in incidence and prevalence of hemophilia and related bleeding and clotting disorders within the target population, unmet health needs, and barriers to receiving care at HTCs through comprehensive care clinics. • The state of the HTC workforce in your region, highlighting any education, training, and sustainability issues.

In addition to above, HRSA-22-079, Project 2 should describe: • The need for patient education and up-to-date information on hemophilia and related bleeding and clotting disorder diagnostic and treatment options. • Regional and HTC staff technical assistance and educational needs on quality improvement and best practices in bleeding disorder care.

 METHODOLOGY -- Corresponds to Section V’s Review Criterion Response For HRSA-22-068, Project 1 and HRSA-22-079, Project 2 • Propose methods that you will use to address the stated needs and meet each of the previously described program requirements and expectations in this NOFO.

As appropriate, include development of effective tools and strategies for ongoing staff training, outreach, collaborations, clear communication, and information sharing/dissemination with efforts to involve patients, families, and communities. If applicable, include a plan to disseminate reports, products, and/or project outputs so key target audiences receive the project information.

• Describe a plan to collate, develop, and distribute (via public/private workspace) hemophilia-specific educational resources on grant topics for HTC comprehensive care teams, primary care medical home providers, patients, their families and other key stakeholders such as consumer advocacy groups, and public/private insurers. (e.g., reducing joint bleeds, transition, patient and family engagement, and medical home.)

• Describe methods to identify, prioritize, and address emerging issues of importance, including increasing access to, and the improvement of, services for persons with hemophilia and related bleeding and clotting disorders through outreach to underserved populations. HRSA-22-068 and HRSA-22-079 13 • Propose a plan for project sustainability after the period of federal funding ends. HRSA