Opportunity Information: Apply for HRSA 16 062
Apply for HRSA 16 062
- The HHS-HRSA in the health sector is offering a public funding opportunity titled "Newborn Screening Implementation Program Regarding Conditions Added to the Recommended Uniform Screening Panel (RUSP)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.110.
- This funding opportunity was created on Mar 28, 2016 and posted on Mar 28, 2016.
- Applicants must submit their applications by May 27, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
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Opportunity Summary:
The Newborn Screening Implementation Program Regarding Conditions Added to the Recommended Uniform Screening Panel (RUSP) is a federal funding opportunity from HHS HRSA (Funding Opportunity Number HRSA-16-062) designed to speed up and strengthen statewide newborn screening for three specific conditions that were added to the RUSP: Pompe disease, Mucopolysaccharidosis I (MPS I), and X-linked Adrenoleukodystrophy (X-ALD). The central public health purpose is straightforward: increase the number of babies who are screened early, identified quickly, and connected to appropriate diagnostic evaluation and treatment as soon as possible, so that outcomes improve and families get timely guidance and support.
This opportunity is structured as a cooperative agreement, meaning the award recipient is expected to work closely with HRSA and other national partners rather than operating in isolation. The program is aimed at building real-world implementation capacity, not just producing reports or pilot data. Core goals include helping newborn screening systems integrate these three conditions into routine screening workflows, expanding the workforce (especially lab scientists and short-term follow-up staff) who can competently run the tests and manage early follow-up, and improving coordination across public health programs and clinical networks that receive and act on screen-positive results.
A major requirement is that the funded program must deliver technical assistance, education, and financial support to at least 15 state newborn screening programs (including state and/or local programs, and potentially programs serving territories and tribes) that have not fully implemented screening for Pompe, MPS I, and/or X-ALD at the time of the project. These states must also show they are realistically prepared to fully implement screening within about 12 to 24 months. Importantly, participating states can implement screening for one, two, or all three conditions, depending on their readiness and needs, but the overall effort must increase the number of newborns who receive appropriate screening and follow-up for these disorders.
The announcement also spells out what "fully implemented" means for this program. A state is considered fully implemented for Pompe, MPS I, or X-ALD when it can screen all newborns in its jurisdiction for the condition, has a functioning clinical referral network to confirm diagnoses and provide treatment, and has an education and awareness approach for both families and health care providers, including support for families who receive a screen-positive result. In other words, success is not just turning on a lab test; it is establishing an end-to-end system that reliably moves from screening to diagnosis to care, while also communicating clearly with clinicians and families.
On the operational side, the awardee must create and carry out a plan to identify which states and local programs need support and then provide that support, potentially through sub-awards. A specific timeline requirement is included: the program must enter into sub-award agreements with state newborn screening programs or other appropriate entities within five months of receiving the award. Those sub-awards are expected to accelerate integration of screening and short-term follow-up by the end of the grant period and to train and equip the broader community involved in newborn screening and early care. That includes laboratory personnel, newborn screening program officials, follow-up coordinators, primary care clinicians, and other health care providers who will be responsible for next steps after an initial positive screen.
Education and communication are treated as central deliverables, not optional extras. The funded program must engage parents, families, and patient advocacy organizations to develop and deliver education and awareness materials that are culturally sensitive and written at appropriate literacy levels. These materials must cover the basics of newborn screening, the diagnostic evaluation process, and available treatment and follow-up options for each condition, recognizing that families may be dealing with stress, uncertainty, and complex medical information immediately after a screen-positive result. In parallel, the program must develop and share guidance for health care providers about newborn screening and the clinical pathway after screening, including the reality that some identified infants may have later-onset forms of disease and therefore require thoughtful long-term follow-up planning.
Another key emphasis is practical implementation support for laboratories and follow-up systems. The program must facilitate integration of screening for Pompe, MPS I, and X-ALD by providing technical assistance to newborn screening labs, supporting the development of case definitions, and disseminating best practices so that states do not have to reinvent processes independently. To strengthen coordination and shared learning, the awardee is required to hold and cover the logistical costs for at least one joint meeting per year that brings together sub-awardees and other relevant stakeholders to share implementation progress, barriers, solutions, and emerging practices.
Finally, the opportunity is designed to connect state efforts to national infrastructure and to reduce fragmentation. The program must facilitate communication among sub-awardees and encourage collaboration with states that have already fully implemented screening for these conditions, as well as with key federal and non-federal partners that support quality assurance and data systems. The announcement specifically references resources such as the Newborn Screening Translational Research Network, CDC's Newborn Screening Quality Assurance Program, and multiple MCHB-supported efforts (including the Regional Genetics and Newborn Screening Collaboratives, the national coordinating center, the Newborn Screening Data Repository and Technical Assistance Center, and the Clearinghouse of Newborn Screening Information). A required component is evaluation: measuring progress toward the broader national objective of achieving newborn screening for Pompe disease, MPS I, and X-ALD across all states and territories.
In summary, this HRSA cooperative agreement focuses on accelerating nationwide adoption of newborn screening for three RUSP conditions by funding a single awardee to coordinate a multi-state implementation push. The work combines sub-awards to states, hands-on technical assistance, workforce training, standardized practices and definitions, ongoing stakeholder meetings, strong family and provider education, and formal evaluation, all aimed at ensuring more newborns are screened and connected to timely diagnosis, treatment, and appropriate follow-up.
Frequently Asked Questions (FAQs)
What is the Newborn Screening Implementation Program regarding conditions added to the RUSP?
It is a federal funding opportunity from HHS HRSA (Funding Opportunity Number HRSA-16-062) that focuses on speeding up and strengthening statewide newborn screening implementation for three conditions that were added to the Recommended Uniform Screening Panel (RUSP): Pompe disease, Mucopolysaccharidosis I (MPS I), and X-linked Adrenoleukodystrophy (X-ALD).
What is the main public health purpose of this opportunity?
The purpose is to increase the number of babies who are screened early, identified quickly, and connected to appropriate diagnostic evaluation and treatment as soon as possible, so outcomes improve and families receive timely guidance and support.
Which conditions are specifically covered by this program?
The program is specifically focused on implementing newborn screening for Pompe disease, Mucopolysaccharidosis I (MPS I), and X-linked Adrenoleukodystrophy (X-ALD).
What type of award is this (grant vs. cooperative agreement)?
This opportunity is structured as a cooperative agreement. That means the recipient is expected to work closely with HRSA and other national partners rather than operating independently.
What does a cooperative agreement mean for the funded work?
It means the awardee is expected to coordinate and collaborate with HRSA and national partners and focus on real-world implementation capacity. The emphasis is on getting screening and follow-up systems operating in routine practice, not only producing reports or pilot data.
What are the core goals of the program?
Core goals include integrating these three conditions into routine newborn screening workflows, expanding the workforce (especially laboratory scientists and short-term follow-up staff), and improving coordination across public health programs and clinical networks that handle screen-positive results.
How many state newborn screening programs must be supported?
The funded program must deliver technical assistance, education, and financial support to at least 15 state newborn screening programs (including state and/or local programs, and potentially programs serving territories and tribes) that have not fully implemented screening for Pompe, MPS I, and/or X-ALD at the time of the project.
Do participating states have to implement screening for all three conditions?
No. Participating states can implement screening for one, two, or all three conditions depending on their readiness and needs. The overall effort, however, must increase the number of newborns who receive appropriate screening and follow-up for these disorders.
What does it mean for a state to be "fully implemented" for Pompe, MPS I, or X-ALD?
A state is considered fully implemented when it can screen all newborns in its jurisdiction for the condition, has a functioning clinical referral network to confirm diagnoses and provide treatment, and has an education and awareness approach for families and health care providers, including support for families who receive a screen-positive result.
Is "full implementation" just turning on a laboratory test?
No. The program defines success as an end-to-end system: screening all newborns, confirming diagnoses through an established clinical network, connecting infants to treatment, and communicating effectively with clinicians and families (including support after a screen-positive result).
Which states are expected to be included as sub-awardees?
The program must identify and support states and local programs that have not fully implemented screening for Pompe, MPS I, and/or X-ALD and that are realistically prepared to fully implement screening within about 12 to 24 months.
How quickly must sub-awards be executed after the award is made?
The program must enter into sub-award agreements with state newborn screening programs or other appropriate entities within five months of receiving the award.
What is the role of sub-awards in this program?
Sub-awards are expected to accelerate integration of screening and short-term follow-up by the end of the grant period, and to train and equip the community involved in newborn screening and early care.
Who is expected to benefit from training and workforce development under this program?
The program is expected to train and support laboratory personnel, newborn screening program officials, follow-up coordinators, primary care clinicians, and other health care providers responsible for next steps after an initial positive screen.
What kinds of education and awareness materials are required?
The funded program must engage parents, families, and patient advocacy organizations to develop and deliver education and awareness materials that are culturally sensitive and written at appropriate literacy levels. Materials must cover newborn screening basics, diagnostic evaluation, and treatment and follow-up options for each condition.
Why does the program emphasize family-facing communication?
Because families may be dealing with stress, uncertainty, and complex medical information immediately after a screen-positive result. The program requires materials and approaches that support families through that period and help them understand next steps.
Is provider education also required?
Yes. The program must develop and share guidance for health care providers about newborn screening and the clinical pathway after screening, including planning for long-term follow-up when infants are identified with later-onset forms of disease.
What implementation support is expected for newborn screening laboratories?
The program must facilitate integration of screening for Pompe, MPS I, and X-ALD by providing technical assistance to newborn screening labs, supporting the development of case definitions, and disseminating best practices so states do not have to reinvent processes independently.
Does the program require stakeholder meetings?
Yes. The awardee is required to hold and cover the logistical costs for at least one joint meeting per year that brings together sub-awardees and other relevant stakeholders to share progress, barriers, solutions, and emerging practices.
How does the program promote coordination and reduce fragmentation across states?
The program must facilitate communication among sub-awardees, encourage collaboration with states that have already fully implemented screening, and connect state efforts with key federal and non-federal partners that support quality assurance and data systems.
Which national resources and partners are referenced as part of the expected coordination?
The opportunity references the Newborn Screening Translational Research Network, CDC's Newborn Screening Quality Assurance Program, and multiple MCHB-supported efforts, including the Regional Genetics and Newborn Screening Collaboratives, the national coordinating center, the Newborn Screening Data Repository and Technical Assistance Center, and the Clearinghouse of Newborn Screening Information.
What role does evaluation play in this cooperative agreement?
Evaluation is a required component. The program must measure progress toward the national objective of achieving newborn screening for Pompe disease, MPS I, and X-ALD across all states and territories.
What does the opportunity prioritize overall: research or implementation?
The opportunity prioritizes real-world implementation capacity. It is aimed at integrating screening and follow-up into routine statewide systems, expanding workforce readiness, and strengthening coordination and education, rather than focusing primarily on generating pilot findings or reports.
Who is the single awardee expected to support?
The opportunity is designed for a single awardee to coordinate a multi-state implementation push by providing technical assistance, education, and financial support (including via sub-awards) to at least 15 state newborn screening programs that are not yet fully implemented for one or more of the three conditions.
What is the intended outcome for newborns and families?
The intended outcome is that more newborns are screened and that those with screen-positive results are identified quickly and connected to diagnostic evaluation, treatment, and appropriate follow-up, while families receive timely and understandable guidance and support.
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