MCHB HRSA-24-052 (UC1) NBS Co-Propel_Final.pdf

U.S. Department of Health and Human Services

NOTICE OF FUNDING OPPORTUNITY

Fiscal Year 2024

Maternal and Child Health Bureau

Division of Services for Children with Special Health Needs

Cooperative Newborn Screening System Priorities Program (NBS Co-Propel)

Funding Opportunity Number: HRSA-24-052

Funding Opportunity Type(s): New

Assistance Listing Number: 93.110

Application Due Date: February 23, 2024 Ensure your SAM.gov and Grants.gov registrations and passwords are current immediately!

We won’t approve deadline extensions for lack of registration.

Registration in all systems may take up to 1 month to complete.

Issuance Date: November 21, 2023

Loraine Swanson, MPH Public Health Analyst, Division of Services for Children with Special Health Needs Call: 404-234-3557 Email: LSwanson@hrsa.gov

See Section VII for a complete list of agency contacts.

Authority: 42 U.S.C. § 300b-8 (§ 1109 of the Public Health Service Act).

mailto:LSwanson@hrsa.gov

HRSA-24-052 NBS Co-Propel i

508 COMPLIANCE DISCLAIMER

Persons using assistive technology may not be able to fully access information in this file. For assistance, email or call one of the HRSA staff listed in Section VII Agency Contacts.

SUMMARY

Funding Opportunity Title: Cooperative Newborn Screening System Priorities Program (NBS Co-Propel)

Funding Opportunity Number: HRSA-24-052

Assistance Listing Number: 93.110

Due Date for Applications: February 23, 2024

Purpose: The purpose of the NBS Co-Propel Program is to strengthen the NBS system to provide screening, counseling, and health care services to newborns and children with, or at risk for, heritable disorders and help them achieve the best possible outcomes.

Program Objective(s): Funding will support up to 10 recipients to 1) address state/territory-specific challenges and pursue priorities to enhance, improve, and expand their Newborn Screening (NBS) System; 2) increase timely collection and reporting of NBS specimens to improve early diagnosis and treatment for individuals with heritable conditions identified through NBS; and

3) support long-term follow-up for individuals with Severe Combined Immunodeficiency and other NBS conditions that link public health agencies, clinicians, and meaningfully engages and partners with families.

Eligible Applicants: Eligible applicants include: (1) a state or a political subdivision of a state; (2) a consortium of 2 or more states or political subdivisions of states; (3) a territory; (4) a health facility or program operated by or pursuant to a contract with or award from the Indian Health Service; or (5) any other entity with

HRSA-24-052 NBS Co-Propel ii appropriate expertise in newborn screening, as determined by the Secretary, including community-based organizations, tribes, and tribal organizations.

Per 42 U.S.C. § 201, the term “state” includes, in addition to the several states, only the District of Columbia, Guam, the Commonwealth of Puerto Rico, the Northern Mariana Islands, the Virgin Islands, American Samoa, and the Trust Territory of the Pacific Islands (Federated States of Micronesia, the Republic of the Marshall Islands, and Republic of Palau).

See Section III.1 of this notice of funding opportunity (NOFO) for complete eligibility information.

Anticipated FY 2024 Total Available Funding:

$4,000,000

We’re issuing this notice to ensure that, should funds become available for this purpose, we can process applications and award funds appropriately. You should note that we may cancel this program notice before award if funds are not appropriated.

Estimated Number and Type of Award(s):

Up to 10 cooperative agreements

Estimated Annual Award Amount:

$345,000 - $500,000 per year subject to the availability of appropriated funds

• $345,000 annually for a single state/territory.

• $422,500 annually for a consortium of 2 states/territories or an organization partnered with a single state/territory.

• $500,000 annually for a consortium of 3 or more states/territories or an organization with appropriate expertise in newborn screening partnered with a consortium of 2 or more states/territories (reflecting direct and indirect costs per year).

HRSA-24-052 NBS Co-Propel iii

Cost Sharing or Matching Required:

No

Period of Performance: July 1, 2024, through June 30, 2028

(4 years)

Agency Contacts:

Business, administrative, or fiscal issues:

Denise Boyer Grants Management Specialist Division of Grants Management Operations, OFAM Email: dboyer@hrsa.gov

Program issues or technical assistance:

Loraine Swanson Public Health Analyst, Division of Services for Children with Special Health Needs, Maternal and Child Health Bureau Email: LSwanson@hrsa.gov

Application Guide

You (the applicant organization / agency) are responsible for reading and complying with the instructions included in this NOFO and in HRSA Application Guide (Application Guide). Visit HRSA’s How to Prepare Your Application page for more information.

Technical Assistance

We have scheduled the following webinar:

Wednesday, January 31, 2024 2:30 – 3:30 p.m. ET

Weblink: https://hrsa-gov.zoomgov.com/j/1613337712?pwd=cE9RVWRxUXRFZElXcS9EbkdSZmx1Zz09

Attendees without computer access or computer audio can use the following dial-in information:

Call-In Number: 1-833-568-8864 Meeting ID: 04192399

We will record the webinar.

mailto:dboyer@hrsa.gov mailto:LSwanson@hrsa.gov http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf https://www.hrsa.gov/grants/apply-for-a-grant/prepare-your-application https://hrsa-gov.zoomgov.com/j/1613337712?pwd=cE9RVWRxUXRFZElXcS9EbkdSZmx1Zz09 https://hrsa-gov.zoomgov.com/j/1613337712?pwd=cE9RVWRxUXRFZElXcS9EbkdSZmx1Zz09

HRSA-24-052 NBS Co-Propel iv

Table of Contents

I. PROGRAM FUNDING OPPORTUNITY DESCRIPTION

1. PURPOSE

2. BACKGROUND

II. AWARD INFORMATION

1. TYPE OF APPLICATION AND AWARD

2. SUMMARY OF FUNDING

III. ELIGIBILITY INFORMATION

1. ELIGIBLE APPLICANTS

2. COST SHARING OR MATCHING

3. OTHER

IV. APPLICATION AND SUBMISSION INFORMATION

1. ADDRESS TO REQUEST APPLICATION PACKAGE

2. CONTENT AND FORM OF APPLICATION SUBMISSION

i. Project Abstract

ii. Project Narrative

iii. Budget

iv. Budget Narrative

v. Attachments

3. UNIQUE ENTITY IDENTIFIER (UEI) AND SYSTEM FOR AWARD MANAGEMENT (SAM)

4. SUBMISSION DATES AND TIMES

5. INTERGOVERNMENTAL REVIEW

6. FUNDING RESTRICTIONS

V. APPLICATION REVIEW INFORMATION

1. REVIEW CRITERIA

2. REVIEW AND SELECTION PROCESS

3. ASSESSMENT OF RISK

VI. AWARD ADMINISTRATION INFORMATION

1. AWARD NOTICES

2. ADMINISTRATIVE AND NATIONAL POLICY REQUIREMENTS

3. REPORTING

VII. AGENCY CONTACTS

VIII. OTHER INFORMATION

APPENDIX A: PAGE LIMIT WORKSHEET

HRSA-24-052 NBS Co-Propel 1

I. Program Funding Opportunity Description

1. Purpose

This notice announces the opportunity to apply for funding under the Cooperative Newborn Screening System Priorities Program (NBS Co-Propel).

The purpose of this program is to strengthen the newborn screening (NBS) system to provide screening, counseling, and health care services to newborns and children with, or at risk for, heritable disorders and help them achieve the best possible outcomes.

Funding will support up to 10 recipients to 1) address state/territory-specific challenges and pursue priorities to enhance, improve, and expand their NBS System; 2) increase timely collection and reporting of NBS specimens to improve early diagnosis and treatment for individuals with heritable conditions identified through NBS; and 3) support long-term follow-up (LTFU) for individuals with Severe Combined Immunodeficiency (SCID) and other NBS conditions that link public health agencies, clinicians, and meaningfully engages and partners with families.

Goal

NBS Co-Propel builds on previously funded HRSA grants to strengthen collaborations between state/territory public health agencies and with NBS partners such as universities, non-profits, or other institutions with expertise in NBS to achieve a common goal: to improve access to services and outcomes for children identified with a heritable condition through NBS so they are healthy, growing, and thriving.1

NBS Co-Propel has two focus areas:

Focus Area 1 includes activities related to improving collection of specimens, testing of specimens, and reporting out of results, including improving the timeliness of these activities; and implementing screening for newly added RUSP conditions.

Focus Area 2 includes activities related to improving short-term follow-up2 through long-term follow-up3 and helping families understand and navigate the process from confirmation of a diagnosis to treatment, and through follow-up across the lifespan.

These activities include expanding access to diagnosis and treatment resources for providers and families of infants with SCID and other NBS disorders with a focus on

1 For the purposes of this NOFO, thriving is defined as “a child is able to meet their potential, be happy, healthy, joyful, curious and strong”. United Nations. (1989). Convention on the Rights of the Child, UN General Assembly Document A/RES/44/25. New York:

United Nations. Available at: http://www.un.org/documents/ga/ res/44/a44r025.htm (accessed July 2023) 2 For the purposes of this NOFO, short-term follow-up refers to the process of ensuring that all newborns are screened, that an appropriate follow-up caregiver is informed of results, that confirmatory testing has been completed, and that the infant has received a diagnosis and, if necessary, treatment. Bellcross, Cecelia A. et al. “Infrastructure and Educational Needs of Newborn Screening Short-Term Follow-Up Programs Within the Southeast Regional Newborn Screening & Genetics Collaborative: A Pilot Survey.” Healthcare (Basel) 3.4 (2015): 964–972. Web.

3 For the purposes of this NOFO, long-term follow-up comprises the assurance and provision of quality chronic disease management, condition-specific treatment, and age-appropriate preventive care throughout the lifespan of individuals identified with a condition included in newborn screening. Kemper AR, Boyle CA, Aceves J, et al. Long-term follow-up after diagnosis resulting from newborn screening: statement of the US Secretary of Health and Human Services’ Advisory Committee on Heritable Disorders and Genetic Diseases in Newborns and Children. Genet Med. 2008; 10:259–261 https://www.hrsa.gov/advisory-committees/heritable-disorders/newborn-screening-timeliness

HRSA-24-052 NBS Co-Propel 2 reaching underserved populations, and empowering families to actively engage at all levels of the NBS system.4

Program Objectives

• By June 2028, increase by 5 percent the number of NBS specimens collected within 48 hours of birth.5

• By June 2028, increase by 10 percent the presumptive positive results for time-critical conditions that are communicated immediately to the newborn’s healthcare provider but no later than five days of birth.

• By June 2028, increase by 5 percent of all NBS results (normal and out-of-range) that are reported within 7 days of birth, overall and for all races and ethnicities.

• By June 2028, state/territory NBS program collects and reports on at least one NBS Long Term Follow Up Quality Indicator for at least one heritable condition identified through dried blood spot screening.

• By June 2028, state/territory NBS program has a data collection plan developed in collaboration with NBS Excel to measure the percentage of 3-year-old children with at least one heritable condition identified through NBS who are thriving.

All data and plans must be submitted to the recipient of NBS Excel (HRSA-23-077).6

For more details, see Program Requirements and Expectations.

2. Background

The Cooperative Newborn Screening System Priorities Program (NBS Co-Propel) is authorized by 42 U.S.C. § 300b-8 (§ 1109 of the Public Health Service Act).

About MCHB and Strategic Plan

The HRSA Maternal and Child Health Bureau (MCHB) administers programs with focus areas in maternal and women’s health, adolescent and young adult health, perinatal and infant health, child health, and children with special health care needs. To achieve its mission of improving the health and well-being of America’s mothers, children, and families, MCHB is implementing a strategic plan that includes the following four goals:

Goal 1: Assure access to high quality and equitable health services to optimize health and well-being for all MCH populations.

4 Family engagement is defined as patients, families, their representatives, and health professionals working in active partnership at various levels across the health care system to improve health and health care.”

5 In 2015, the Advisory Committee on Heritable Disorders in Newborns and Children (Committee) established goals and timeframes to achieve timely diagnosis and treatment of screened conditions and to avoid associated disability, morbidity and mortality. The Committee also suggested a target of 95% initial newborn screening specimens should be collected within 48 hours of birth.

Grantees are expected to work towards achieving this target.

6 NewSTEPs, Association of Public Health Laboratories, https://www.newsteps.org/ https://www.newsteps.org/

HRSA-24-052 NBS Co-Propel 3

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.

To learn more about MCHB and the bureau’s strategic plan, visit Mission, Vision, and Work | MCHBhttps://mchb.hrsa.gov/about-us/mission-vision-work.

Children and Youth with Special Health Care Needs Blueprint for Change

The Blueprint for Change: A National Framework for a System of Services for Children and Youth with Special Health Care Needs establishes a national agenda to ensure that every child gets the services they need to play, go to school, and grow up to become a healthy adult. The Blueprint for Change outlines strategies in four critical areas that will strengthen the systems serving CYSHCN: health equity; quality of life and well-being for CYSHCN and their families; access to services; and financing of services.

The Blueprint for Change provides a framework to guide NBS programs as they move towards tracking long-term outcomes, including development and well-being for children identified with a heritable disorder. This work requires partnering with families, those with lived experience, health care and other service providers, payers, and others in the field to build state and system-level capacity.

Learn more by reading the Blueprint for Change Pediatrics Supplement.

Program Background

Newborn screening (NBS) saves lives and improves infants’ health outcomes.7 Early identification and treatment of conditions identified through NBS can mitigate life-altering health impacts. States and territories screen over 3.6 million babies8 and identify approximately 12,9009 infants with heritable conditions annually. HRSA oversees the Advisory Committee on Heritable Disorders in Newborns and Children, which advises the Department of Health and Human Services on the most appropriate application of universal newborn screening tests, technologies, policies, guidelines, and standards. This includes identification of disorders to include on the Recommended Uniform Screening Panel (RUSP) based on evidence that supports the potential net benefit of screening, the ability of states to screen for the disorder, and the availability of effective treatments.

Most states and territories screen for the majority of conditions on the. As of June 2023, all state NBS programs screen for at least 31 out of 37 core RUSP conditions and 40 states screen for at least 34 out of 37 core RUSP conditions.10

7 Kemper AR, Boyle CA, Brosco JP, Grosse SD. Ensuring the Life-Span Benefits of Newborn Screening. Pediatrics. 2019;144(6):

e20190904.

8 Osterman MJK, Hamilton BE, Martin JA, Driscoll AK, Valenzuela CP. Births: Final data for 2020. National Vital Statistics Reports;

vol 70 no 17. Hyattsville, MD: National Center for Health Statistics. 2022 9 Sontag MK, Yusuf C, Grosse SD, et al. Infants with Congenital Disorders Identified Through Newborn Screening — United States, 2015–2017. MMWR Morb Mortal Wkly Rep 2020; 69:1265–1268. DOI: http://dx.doi.org/10.15585/mmwr.mm6936a6 10 For more information on what states screen for see Data Visualizations | NewSTEPs https://mchb.hrsa.gov/about-us/mission-vision-work%22%EF%B7%9FHYPERLINK%20%22https:/mchb.hrsa.gov/about-us/mission-vision-work https://mchb.hrsa.gov/about-us/mission-vision-work%22%EF%B7%9FHYPERLINK%20%22https:/mchb.hrsa.gov/about-us/mission-vision-work https://mchb.hrsa.gov/about-us/mission-vision-work https://publications.aap.org/pediatrics/issue/149/Supplement%207 http://dx.doi.org/10.15585/mmwr.mm6936a6 https://www.newsteps.org/data-center/data-visualizations?q=resources/data-visualizations

HRSA-24-052 NBS Co-Propel 4

The six (6) components of a successful NBS system are education, screening, short-term follow-up, diagnostic confirmation, management (long-term follow-up), and evaluation/continuous quality improvement. State/territory NBS programs coordinate across multiple key stakeholders, including families, state public health agencies, public health laboratories, and health care providers. Most state/territory NBS programs have made improvements across the six components, however some face challenges and experience resource barriers to maintain quality standards, screen for additional conditions, and/or achieve equity in short and long term follow up to screening. These states may benefit from partnerships with other states, universities, non-profits, or institutions with NBS expertise

In April 2015, the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) established NBS timeliness goals11:

1. Presumptive positive results for time critical conditions should be communicated immediately to the newborn’s healthcare provider but no later than 5 days of life.

2. Presumptive positive results for all other conditions should be communicated to the newborn’s healthcare provider as soon as possible but no later than 7 days of life.

3. All NBS tests should be completed within 7 days of life with results reported to the healthcare provider as soon as possible.

In February 2018, the Follow-up and Treatment Workgroup to the ACHDNC recommended the development and use of quality improvement measures for LTFU of individuals identified through NBS programs to assess and improve LTFU of conditions identified through NBS12.

The Blueprint for Change emphasizes the value and importance of incorporating meaningful outcomes on quality of life and well-being, and partnering with families and individuals with lived experience at all levels of care to improve family and child well-being and quality of life.13 The NBS system of services relies on partnership between families and providers where information provided to families is high quality, “accurate, comprehensive, up-to-date, and evidence-based,”14 and communicated in an appropriate, timely, culturally sensitive way. Meeting the needs of children and their families requires improved communication among health and other allied service professionals to lead to a future where “service systems prioritize quality of life and

11 For more information on the ACHDNC NBS timeliness goals see the HRSA ACHDNC Newborn Screening Timeliness Goals 12 For more information on LTFU measurements see https://www.hrsa.gov/sites/default/files/hrsa/advisory-committees/heritable-disorders/reports-recommendations/role-quality-measures-nbs-sept2018-508c.pdf 13 Coleman, C. L., Morrison, M., Perkins, S. K., Brosco, J. P., & Schor, E. L. (2022). Quality of Life and Well-being for Children and Youth with Special Health Care Needs and Their Families: A Vision for the Future. Pediatrics, 149 (Supplement 7).

https://doi.org/10.1542/peds.2021-056150g 14 Early Hearing Detection and Intervention Act of 2017, Public Health Service Act, Title III, Section 399M (as added by P.L. 106- 310, Sec. 702; as amended by P.L. 111-337 and P.L. 115-71. Retrieved from: https://www.congress.gov/115/plaws/publ71/PLAW- 115publ71.pdf https://www.hrsa.gov/advisory-committees/heritable-disorders/index.html https://www.newsteps.org/sites/default/files/case-definitions/qi_source_document_time_critical_disorders_0.pdf https://www.hrsa.gov/advisory-committees/heritable-disorders/newborn-screening-timeliness.html https://www.hrsa.gov/sites/default/files/hrsa/advisory-committees/heritable-disorders/reports-recommendations/role-quality-measures-nbs-sept2018-508c.pdf https://www.hrsa.gov/sites/default/files/hrsa/advisory-committees/heritable-disorders/reports-recommendations/role-quality-measures-nbs-sept2018-508c.pdf https://doi.org/10.1542/peds.2021-056150g https://www.congress.gov/115/plaws/publ71/PLAW-115publ71.pdf https://www.congress.gov/115/plaws/publ71/PLAW-115publ71.pdf

HRSA-24-052 NBS Co-Propel 5 support the flourishing of CYSHCN and their families.”15

II. Award Information

1. Type of Application and Award

Application type(s): New

We will fund you via a cooperative agreement.

A cooperative agreement is like a grant in that the agency awards money, but is different in that the agency is more substantially involved with program activities.

Aside from monitoring and technical assistance (TA), the agency also gets involved in these ways:

• Participating in the planning and development of project activities during the period of performance.

• Participating in at least monthly meetings and regular communication with the award recipient to assess progress in meeting the goals and objectives of this initiative.

• Reviewing policies and procedures, activities, emerging issues, and tools designed and implemented during the period of performance.

• Reviewing gaps identified and TA needs of state/territory NBS programs at the end of year 1 and reviewing actionable steps for implementation proposed by the recipient.

• Reviewing the data collection and evaluation plan, including progress to achieving proposed outcomes, data collected, and measures of success.

• Participating, when appropriate, in meetings, conference calls, and other sessions conducted during the period of performance, including but not limited to steering committee meetings, TA sessions, quality improvement meetings, etc.

• Reviewing and editing, as appropriate, all written documents and presentations developed by the recipient prior to submission for publication or public dissemination, including revisions to existing resources. Assisting in the establishment of partnerships that may be necessary for carrying out the project, including with other federal agencies or programs within HRSA or HHS.

15 McLellan, SE., Mann, MY., Scott, JA., Brown, TW. A blueprint for change: guiding principles for a system of services for children and youth with special health care needs and their families. Pediatrics.2022;149 (suppl 7) e2021056150C

HRSA-24-052 NBS Co-Propel 6

• Providing substantial input on the composition of the project steering committee or other workgroups.

You must follow all relevant federal regulations and public policy requirements. Your other responsibilities will include:

• Meeting with the HRSA project officer at the start of the period of performance to review the current strategies and to ensure the project and goals align with HRSA priorities for this activity.

• Collaborating with HRSA personnel in the planning and development of project activities including, but not limited to: identifying emerging issues; developing strategies and tools for interoperability; participating in TA and quality improvement activities; engaging and promoting leadership by families and individuals with heritable disorders in program activities and committees; offering NBS education support for families and parents; identifying topics for publications; and project evaluation.

• Producing and disseminating project findings through publishing articles, reports, and/or presentations and adhering to HRSA guidelines pertaining to acknowledgement and disclaimer on all products produced by HRSA awards (see Acknowledgement of Federal Funding in Section 2.2 of HRSA’s SF-424 Application Guide).

• Completing activities proposed in response to the project requirements and scope of work to meet the project goals and objectives.

• Collaborating with HRSA on ongoing review of activities, budget items, procedures, information/publications, and other documents prior to dissemination, contracts, and interagency agreements.

• Participating in meetings and conference calls with HRSA, conducted during the period of performance, to provide regular updates on progress in meeting goals and objectives; and provide quarterly updates on NBS data to HRSA leadership.

• Collaborating with other federal and non-federal NBS experts, grantees, families, contractors, and state/territory NBS programs (particularly the Centers for Disease Control and Prevention (CDC) and CDC-funded organizations and the National Institutes of Health and NIH-funded organizations) on NBS activities, as well as the recipient of NBS Excel (HRSA-23-077) and Family Engagement and Leadership in Systems of Care award (HRSA-23-078).16

• If an award recipient receives funds from the CDC for NBS activities, funds must be tracked separately between the programs to ensure that federal funds are not expended twice or more for the same activities.

16 Family Voices https://familyvoices.org/felsc/

HRSA-24-052 NBS Co-Propel 7

2. Summary of Funding

We estimate $4,000,000 will be available each year to fund 10 recipients. You may apply for a ceiling amount of up to $345,000 annually for a single state/territory, $422,500 annually for 2 states/territories or an organization partnered with a single state/territory, and $500,000 annually for a consortium of 3 or more states/territories or an organization partnered with 2 or more states/territories (reflecting direct and indirect costs per year). If multiple political subdivisions within a single state apply as a consortium, this counts as a single state/territory application, and you may apply for a ceiling amount of up to $345,000.

The period of performance is July 1, 2024, through June 30, 2028 (4 years).

This program notice depends on the appropriation of funds. If funds are appropriated for this purpose, we will proceed with the application and award process.

Support beyond the first budget year will depend on:

• Appropriation

• Satisfactory progress in meeting the project’s objectives

• A decision that continued funding is in the government’s best interest

45 CFR part 75 - Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards applies to all HRSA awards.

If you’ve never received a negotiated indirect cost rate, you may elect to charge a de minimis rate of 10 percent of modified total direct costs (MTDC)*. You may use this for the life of the award. If you choose this method, you must use it for all federal awards until you choose to negotiate for a rate. You may apply to do so at any time. See Section 4.1.v. Budget Narrative in the Application Guide.

*Note: One exception is a governmental department or agency unit that receives more than $35 million in direct federal funding.

III. Eligibility Information

1. Eligible Applicants

You can apply if your organization is in the United States and is a state or political subdivision; a consortium of two or more states or political subdivision of states; a territory; a health facility or program operated by or pursuant to a contract with or grant from the Indian Health Services; or any other entity with appropriate expertise in NBS as determined by the Secretary, including a faith-based organization, tribe, or tribal organization. Per 42 U.S.C. § 201, the term “state” includes, in addition to the several states, only the District of Columbia, Guam, the Commonwealth of Puerto Rico, the Northern Mariana Islands, the Virgin Islands, American Samoa, and the Trust Territory https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-75 https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-75

HRSA-24-052 NBS Co-Propel 8 of the Pacific Islands (Federated States of Micronesia, the Republic of the Marshall Islands, and Republic of Palau).

2. Cost Sharing or Matching

Cost sharing or matching is not required for this program.

3. Other

An applicant may NOT apply for funding as a recipient under this program if they are funded under NBS Propel (HRSA-23-065) or NBS Excel (HRSA-23-077). If an applicant receives funding under one of these two funding opportunities, its application will be considered non-responsive and will not be considered for funding under this NBS Co- Propel NOFO.

We may not consider an application for funding if it contains any of the following non-responsive criteria:

• Exceeds the funding ceiling amount

• Fails to satisfy the deadline requirements referenced in Section IV.4

Multiple Applications

We will only review your last validated application before the Grants.gov due date.

IV. Application and Submission Information

1. Address to Request Application Package

We require you to apply online through Grants.gov. Use the SF-424 workspace application package associated with this notice of funding opportunity (NOFO). Follow these directions: How to Apply for Grants. If you choose to submit using an alternative online method, see Applicant System-to-System.

Note: Grants.gov calls the NOFO “Instructions.”

Select “Subscribe” and enter your email address for HRSA-24-052 to receive emails about changes, clarifications, or instances where we republish the NOFO. You will also be notified by email of documents we place in the RELATED DOCUMENTS tab that may affect the NOFO and your application. You’re responsible for reviewing all information that relates to this NOFO.

2. Content and Form of Application Submission

Application Format Requirements Submit your information as the Application Guide and this program-specific NOFO state. Do so in English and budget figures expressed in U.S. dollars. There’s an Application Completeness Checklist in the Application Guide to help you.

https://www.grants.gov/ https://www.grants.gov/applicants/grant-applications/how-to-apply-for-grants https://www.grants.gov/system-to-system/applicant-system-to-system/

HRSA-24-052 NBS Co-Propel 9

Application Page Limit The total number of pages that count toward the page limit shall be no more than 50 pages when we print them. We won’t review any pages that exceed the page limit.

Using the pages within the page limit, HRSA will determine eligibility using Section III.

Eligibility Information of the NOFO.

These items don’t count toward the page limit:

• Standard OMB-approved forms you find in the NOFO’s workspace application package

• Abstract (standard form (SF) "Project_Abstract Summary”)

• Indirect Cost Rate Agreement

• Proof of non-profit status (if it applies)

If there are other items that don’t count toward the page limit, we’ll make this clear in Section IV.2.vi Attachments.

If you use an OMB-approved form that isn’t in the HRSA-24-052 workspace application package, it may count toward the page limit.

Applications must be complete and validated by Grants.gov under HRSA-24-052 before the deadline.

Debarment, Suspension, Ineligibility, and Voluntary Exclusion Certification

• When you submit your application, you certify that you and your principals17 (for example, program director, principal investigator) can participate in receiving award funds to carry out a proposed project. That is, no federal department or agency has debarred, suspended, proposed for debarment, claimed you ineligible, or you have voluntarily excluded yourself from participating.

• If you fail to make mandatory disclosures, we may take an action like those in 45 CFR § 75.371. This includes suspending or debarring you.18

• If you can’t certify this, you must include an explanation in Attachment 1: Other Relevant Documents.

(See Section 4.1 viii “Certifications” of the Application Guide)

Program Requirements and Expectations In addition to addressing the goals, purpose, and objectives of the NBS program listed above, recipients must use funds to support the enhancement, improvement and or expansion of any or all six (6) components of a successful NBS System: education, screening, short-term follow-up, diagnostic confirmation, management (long-term follow-

up) and evaluation/continuous quality improvement. This includes ensuring NBS timeliness, supporting the implementation of new conditions added to the RUSP, 17 See definitions at eCFR :: 2 CFR 180.995 -- Principal. and eCFR :: 2 CFR 376.995 -- Principal (HHS supplement to government-wide definition at 2 CFR 180.995).

18 See also 2 CFR parts 180 and 376, 31 U.S.C. § 3354, and 45 CFR § 75.113.

https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=4d52364ec83fab994c665943dadf9cf7&ty=HTML&h=L&r=PART&n=pt45.1.75#se45.1.75_1371 https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=4d52364ec83fab994c665943dadf9cf7&ty=HTML&h=L&r=PART&n=pt45.1.75#se45.1.75_1371 https://www.ecfr.gov/current/title-2/subtitle-A/chapter-I/part-180/subpart-I/section-180.995 https://www.ecfr.gov/current/title-2/subtitle-B/chapter-III/part-376/subpart-I/section-376.995 https://www.ecfr.gov/current/title-2/subtitle-B/chapter-III/part-376/subpart-I/section-376.995 https://www.ecfr.gov/current/title-2/subtitle-A/chapter-I/part-180 https://www.ecfr.gov/current/title-2/subtitle-B/chapter-III/part-376 https://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title31-chapter33&edition=prelim https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-75/subpart-B/section-75.113

HRSA-24-052 NBS Co-Propel 10 facilitating electronic data sharing/exchange among public health and clinical databases to decrease loss to follow-up, and ensuring infants, children, and their families have access to appropriate services. In addition, recipients are required to implement the following:

Collaborate with recipient of HRSA-23-077 NBS Excel to include:

• Execute a data use agreement, with appropriate privacy and security safeguards, with the HRSA-23-077 NBS Excel recipient and submit NBS data and information on all newborns screened from 2024-2028. Data collected from all state/territory NBS programs will be used to enhance NBS performance and identify barriers to achieving health equity and equitable access to NBS services for all infants and families.

• Recipients must securely submit de-identified standardized data from state/territory NBS programs annually to the NBS Excel recipient. NBS data includes case definitions and other quantitative and qualitative NBS data. Data elements and definitions will be determined in consultation with the NBS Excel funding recipient within the first year of the period of performance. Baseline data will be established in Year 1. In addition, the following state specific data must be submitted annually:

o Number of days from birth to treatment19 for individuals across all races and ethnicities identified with an NBS-screened condition in your state.

o Percent of presumptive positive results for all other conditions that are communicated to the newborn’s healthcare provider as soon as possible, but no later than 7 days of birth.

o Collaborate with other Co-Propel Grantees and HRSA-23-077 NBS Excel recipient to develop a data collection plan to measure the number of 3-year-old children with at least one heritable condition identified through NBS who are thriving. NBS Excel will develop a definition of thriving to be used by Co-Propel.

o Participate in HRSA-23-077 NBS Excel-led quality improvement activities and continuity of operations planning exercises, attend all NBS Excel-led meetings, and collaborate with the NBS Excel recipient on national level activities and workgroups.

• Engage and support families and individuals with heritable disorders in program advisory committees, working groups, program planning, and other related

19 Treatment is defined as “Medical Intervention: Any interaction by a medical professional with the infant’s family that changes the current care for the infant based on the newborn screening results and/or the presumptive diagnosis for a specific disorder.

Intervention may occur in a medical setting or may include changes in care per phone conversations. Examples include advising parents to not let a newborn fast following an abnormal MCADD newborn screen, or initiating antibiotic therapy in the case of an abnormal sickle cell newborn screen. Medical intervention may precede a formal diagnosis and does not include additional newborn screen specimen collection.” Newborn Screening Quality Indicators Appendix A. (updated May 24, 2022).

https://www.newsteps.org/media/26/download?inline https://www.newsteps.org/media/26/download?inline

HRSA-24-052 NBS Co-Propel 11 activities to ensure that they are included in the planning, implementation, and evaluation of activities funded under this program.

• Address equitable access to treatment and follow-up services resulting from NBS to address, mitigate, and/or prevent disparities.

• Collaborate, coordinate, and link systems and stakeholders that comprise and support the NBS system such as dried blood spot screening, hearing screening, pulse oximetry screening, NBS laboratories, NBS follow-up programs, Title V programs, birthing hospitals, clinicians, vital records, early intervention, etc., in order to assess the effectiveness of screening, treatment, counseling, testing, follow-up and specialty services for newborns and children at risk for heritable disorders.

• Implement activities to strengthen the integration of child health information systems and NBS interoperability among NBS programs, public health, and clinical practice.

• Address emerging issues in NBS and/or public health emergencies that impact

NBS.

• Collaborate with other federally funded NBS focused programs in your state, such as those funded by the Centers for Disease Control and Prevention and National Institutes of Health.

If you are the lead for a national, regional, or multistate partnership application, you must identify and demonstrate formal, written partnerships (i.e., memoranda of understanding/agreement) with the 1 (one), 2 (two), or 3 (three) or more state/territory NBS programs you are supporting and implement subaward agreements with those states within the first 3 months of the period of performance if funded.

Program-Specific Instructions Include application requirements and instructions from Section 4 of the Application Guide (budget, budget narrative, staffing plan and personnel requirements, assurances, certifications, and abstract). Also include the following:

i. Project Abstract

Use the Standard OMB-approved Project Abstract Summary Form that you’ll find in the workspace application package. Don’t upload the abstract as an attachment or it may count toward the page limit. For information you must include in the Project Abstract Summary Form, see Section 4.1.ix of the Application Guide.

NARRATIVE GUIDANCE

The following table provides a crosswalk between the narrative language and where each section falls within the review criteria. Make sure you’ve addressed everything. We may consider any forms or attachments you reference in a narrative section during the merit review.

HRSA-24-052 NBS Co-Propel 12

Narrative Section Review Criteria

Introduction Criterion 1: NEED

Organizational Information Criterion 5: RESOURCES/CAPABILITIES

Need Criterion 1: NEED

Approach Criterion 2: RESPONSE

Work Plan Criterion 2: RESPONSE and Criterion 4: IMPACT

Resolution of Challenges Criterion 2: RESPONSE

Evaluation and Technical Support Capacity

Criterion 3: EVALUATIVE MEASURES and

Criterion 5: RESOURCES/CAPABILITIES

Budget Narrative Criterion 6: SUPPORT REQUESTED

ii. Project Narrative

This section must describe all aspects of the proposed project. Make it brief and clear.

Provide the following information in the following order. Please use the section headers.

This ensures reviewers can understand your proposed project.

Introduction -- Corresponds to Section V’s Review Criterion (1) Need

Briefly describe the purpose of the proposed project.

Organizational Information -- Corresponds to Section V’s Review Criterion

(5) Resources/Capabilities o Briefly describe your mission, structure, and scope of current activities.

Explain how these elements all contribute to the organization’s ability to carry out the program requirements and meet program expectations.

Include a project organizational chart.

o If you propose to serve multiple states, include in Attachment 5: Project Organizational Chart, a list of the state/territory NBS Programs with whom you will work and a description of the roles and responsibilities of your organization to each partner state/territory NBS Program. Include documentation (for example, memoranda of understanding/agreement) from each state/territory NBS program that clearly describes their participation on the project in Attachment 4: Letters of Agreement, Memoranda of Understanding, and/or Descriptions of Proposed/Existing Contracts.

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HRSA-24-052 NBS Co-Propel 13 o Discuss how you’ll follow the approved plan, as outlined in the application, account for the federal funds, and record all costs to avoid audit findings.

o Describe collaboration with key stakeholders in planning, designing, and implementing all activities, including development of the application and further, the extent to which these contributors reflect the cultural, racial, linguistic, and geographic diversity of the population and communities served.

o Describe qualifications, expertise, and experience working with NBS stakeholders including families, medical professionals, state/territory NBS programs, other federally funded NBS-focused programs, disease specific advocacy groups, and the general public.

o Describe your infrastructure to support short and long-term follow-up activities and measurement and/or that of each state/territory included in the application.

o Describe your plan for engaging and compensating families and/or individuals with heritable disorders in proposed activities and/or that of each state/territory included in the application.

Need -- Corresponds to Section V’s Review Criterion (1) Need o Outline the needs of the NBS system at the state/territory level of the states/territories being supported in the project.

o Describe the target population and their unmet health needs. Use and cite demographic data whenever possible to support the information provided.

o Discuss any relevant barriers within each state/territory NBS system that the project hopes to overcome.

o In addition, describe your ability to address NBS timeliness, collection of NBS data, implementing new conditions, providing short and long term follow up and any other emerging need and/or that of each state/territory included in the application.

Approach -- Corresponds to Section V’s Review Criterion (2) Response o Tell us how you will address the stated needs and meet the Program Requirements and Expectations described in this NOFO.

o As it makes sense, include strategies for ongoing staff training, outreach, collaborations, clear communication, and information sharing.

o If you are the lead of a national, regional, or multistate partnership application, include plans for supporting and providing funding (i.e., subawards) to state(s)/territory(ies) to implement grant related activities.

HRSA-24-052 NBS Co-Propel 14 o Propose a plan for continuing the project when federal funding ends. We expect you to keep up key elements of your projects, e.g., strategies or services and interventions, which have led to improved practices and outcomes for the target population.

In addition to the above, describe your plan to accomplish the following activities:

o Collaborating with the HRSA-23-077 NBS Excel recipient to implement a data use agreement and submit aggregate NBS data and information about your NBS program on an annual basis.

o Collaborating with the HRSA-23-077 NBS Excel recipient to develop a data collection plan to measure the number of 3-year-old children identified with at least one heritable condition identified through NBS who are thriving.

o Providing support to the specific state/territory NBS programs listed in your application.

o Addressing health equity and equitable access to NBS services for infants and families.

o Addressing NBS timeliness goals and implementing new conditions.

o Engaging families and individuals with heritable disorders in program activities.

Work Plan -- Corresponds to Section V’s Review Criteria (2) Response and (4) Impact o Describe how you’ll achieve each of the objectives during the period of performance. You find these in the Approach section.

o Use a timeline that includes each activity and identifies who is responsible for each. As needed, identify how key stakeholders will help plan, design, and carry out all activities, including the application.

Resolution of Challenges -- Corresponds to Section V’s Review Criterion (2) Response

Discuss challenges that you are likely to encounter in designing and carrying out the activities described in the work plan. Explain approaches that you will use to resolve them.

Evaluation and Technical Support Capacity -- Corresponds to Section V’s Review Criteria (3) Evaluative Measures and (5) Resource/Capabilities

Provide a performance measurement and evaluation plan that demonstrates how you will, if awarded, fulfill the expectations and requirements for performance

HRSA-24-052 NBS Co-Propel 15 measurement and evaluation described in the Program Requirements and Expectations section. This plan should include the following:

• Monitoring: how you will track project-related processes, activities, and milestones and use data to identify actual or potential challenges to implementation. Provide an initial list of measures (indicators, metrics) you will use to monitor progress; this list may include required measures listed in the Program Requirements and Expectations.

• Performance Measurement: your plan for measuring and tracking program goals and objectives outlined in the Purpose section. This plan should include required and/or proposed measures outlined in the Program Requirements and Expectations Section and plans for the timely collection and reporting of all measures.

• Program Evaluation: your program evaluation plans and methods for completing the activities outlined in the Program Requirements and Expectations Section.

• Continuous Quality Improvement: your plans for using and incorporating information from performance measurement and evaluation to inform and improve processes and outcomes.

o Describe your capacity to collect and manage data in a way that allows for accurate and timely monitoring, performance measurement, and evaluation. This includes plans for establishing baseline data and targets.

Include a description of the available resources (for example, organizational profile, collaborative partners, staff skills and expertise, budget), systems, and key processes you will use for monitoring, performance measurement, and evaluation (for example, data sources, data collection methods, frequency of collection, data management software).

o Indicate your ability to provide data annually to NBS Excel, HRSA-23-077.

iii. Budget

The Application Guide directions may differ from those on Grants.gov.

Follow the instructions in Section 4.1.iv Budget of the Application Guide and any specific instructions listed in this section. Your budget should show a well-organized plan.

Reminder: The total project or program costs are all allowable (direct and indirect) costs used for the HRSA activity or project. This includes costs charged to the award and non-federal funds used to satisfy a matching or cost-sharing requirement (which may include MOE, if applicable).

Program Income

HRSA-24-052 NBS Co-Propel 16

You must use any program income generated from awarded funds for approved project-related activities. Use program income under the addition alternative (45 CFR § 75.307(e)(2)). Find post-award requirements for program income at 45 CFR § 75.307.

Specific Instructions

The Cooperative Newborn Screening System Priorities Program (NBS Co-Propel) requires the following:

As required by the Consolidated Appropriations Act, 2023 (P.L. 117-328), Division H, § 202, “None of the funds appropriated in this title shall be used to pay the salary of an individual, through a grant or other extramural mechanism, at a rate in excess of Executive Level II.” Effective January 2023, the salary rate limitation is $212,100. As required by law, salary rate limitations may apply in future years and will be updated.

iv. Budget Narrative

See Section 4.1.v. of the Application Guide.

In addition, Cooperative Newborn Screening System Priorities Program requires the following:

• No more than 30 percent of the full direct cost budget can be used to purchase or maintain newborn screening equipment.

• The budget narrative should include travel dollars for NBS staff to attend one national meeting hosted by the NBS Excel per year.

v. Attachments

Provide the following attachments in the order we list them.

Most attachments count toward the application page limit. Indirect cost rate agreement and proof of non-profit status (if it applies) are the only exceptions. They won’t count toward the page limit.

Clearly label each attachment. Upload attachments into the application. Reviewers won’t open any attachments you link to.

Attachment 1: Work Plan

Attach the project’s work plan. Make sure it includes everything that Section IV.2.ii.

Project Narrative details. If you’ll make subawards or spend funds on contracts, describe how your organization will document funds.

Attachment 2: Staffing Plan and Job Descriptions for Key Personnel (see Section 4.1. of HRSA’s Application Guide)

Keep each job description to one page as much as possible. Include the role, responsibilities, and qualifications of proposed project staff. Describe your organization’s timekeeping process. This ensures that you’ll comply with federal standards related to recording personnel costs.

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