Opportunity Information: Apply for HRSA 15 098
Apply for HRSA 15 098
- The Health Resources and Services Administration in the health sector is offering a public funding opportunity titled "Improving Timeliness of Newborn Screening Diagnosis" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.110 Maternal and Child Health Federal Consolidated Programs.
- This funding opportunity was created on Apr 13, 2015 and posted on Feb 11, 2015.
- Applicants must submit their applications by Apr 13, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $1,800,000.00 to eligible and selected applicants.
- 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).
- As stated in section 1109(b) of the PHS Act, (42 U.S.C. 300b 8(b)), eligible applicants include a state or a political subdivision of a state a consortium of two (2) or more states or political subdivisions of states a territory a health facility or program operated by or pursuant to a contract with or grant from the Indian Health Service or, any other entity with appropriate expertise in newborn screening, as determined by the Secretary. Appropriate expertise is further explained in Section IV, Program Narrative Introduction and Organizational Information as well as in Section V, Application Review Information, Review Criteria, Criterion 5 Resources and Capabilities of this FOA.
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Opportunity Summary:
The Health Resources and Services Administration (HRSA) grant opportunity titled Improving Timeliness of Newborn Screening Diagnosis (Funding Opportunity Number HRSA-15-098) is a discretionary cooperative agreement intended to speed up how quickly babies with a presumptive positive newborn screening (NBS) result receive diagnostic confirmation and, when needed, treatment. The central idea is that newborn screening only protects infants if results move rapidly from the lab to the health care provider and then into confirmatory testing and clinical care. HRSA designed this initiative to push state newborn screening systems toward faster, more reliable timelines, with a particular focus on time-sensitive conditions where delays can lead to severe outcomes.
The program will fund one awardee organization to act as a national facilitator and coordinator for collaborative learning and quality improvement (QI) work across newborn screening programs. Rather than funding many separate state projects directly, HRSA is funding a single entity that can organize a multi-state improvement effort, spread practical strategies, provide technical assistance, and help states measure and improve performance. The overarching goal is to increase the number of states that meet the timeliness recommendations issued by the Secretarys Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC), and to increase the number of infants who receive timely diagnosis and treatment after a presumptive positive result.
A key part of this opportunity is aligning state practice with the Committee recommendations on how fast screening results should be communicated and reported. The timeline targets described in the announcement are: for time-critical conditions, presumptive positive results should be communicated immediately to the childs health care provider, but no later than day 5 of life; for all other conditions, presumptive positive results should be communicated as soon as possible, but no later than day 7 of life; and all newborn screening results should be reported within 7 days of life. The announcement notes that these recommendations were to be finalized on February 12, 2015, and the funded organization is expected to follow the final version.
The expected work plan is broad and operational. The awardee must facilitate implementation of practice-based strategies and coordinate QI projects aimed at improving timeliness of screening, diagnosis, and treatment in at least 20 state newborn screening programs. Importantly, the QI approach is not meant to be isolated within the lab alone; it must involve state NBS programs and other stakeholders within each state to start and sustain improvement activities. This reflects how delays often occur at handoffs, such as specimen collection, shipping, lab processing, reporting, locating the correct provider, contacting families, and arranging confirmatory testing.
Another major responsibility is partnership building. The awardee is expected to engage public and private partners at federal, state, and local levels to drive QI in newborn screening and to coordinate related activities, including developing and sharing educational materials, best practices, and lessons learned. The program also requires creation of an ongoing forum for technical assistance, training, communication, and collaboration among stakeholders, with explicit attention to timeliness challenges that can worsen health disparities. The announcement highlights underserved settings such as rural and tribal communities, where geographic distance, limited specialty access, and communication barriers can make meeting strict timelines harder, and where improvement support may have an outsized impact.
Dissemination is a defined deliverable rather than an optional add-on. The awardee must develop and distribute educational and training resources tied to newborn screening processes, including items like publications, educational materials, standard operating procedures, toolkits, presentations, best-practice summaries, evaluation materials and reports, webinar and conference call content, QI tools, and data collection instruments used for required performance measurement. The intent is to make effective approaches easy for states to adopt, adapt, and scale without reinventing tools from scratch.
Data infrastructure and measurement are also central to the project. The awardee must develop a data strategy that collects newborn screening timeliness data from participating states and supports the use of real-time (or near real-time) data for continuous quality improvement. In practice, this means helping states define consistent measures, capture key timestamps (for example: birth, specimen collection, specimen receipt, testing completion, result reporting, provider notification, confirmatory testing, treatment initiation), and then use those measures to identify bottlenecks and track progress over time. The awardee is also expected to coordinate with other federal and federally supported newborn screening initiatives, including collaborative efforts with the CDC, NIH, and HRSA Maternal and Child Health Bureau-funded programs, to reduce duplication and align methods where possible.
In terms of basic grant details, this opportunity was posted February 11, 2015, with an application due date of April 13, 2015, and an estimated total funding amount of $1,800,000. HRSA anticipated making one award. There is no cost sharing or matching requirement listed. The CFDA number is 93.110 (Maternal and Child Health Federal Consolidated Programs). Because this is a cooperative agreement, applicants should expect substantial federal involvement during the project period, typically through ongoing collaboration, guidance, and shared accountability for deliverables and outcomes.
Eligibility is intentionally broad, reflecting the need for specialized expertise and national coordination capacity. Under section 1109(b) of the Public Health Service Act, eligible applicants include a state or political subdivision of a state, a consortium of two or more states or political subdivisions, a territory, an Indian Health Service-operated or -supported health facility or program, or another entity with appropriate expertise in newborn screening as determined by the Secretary. In practical terms, this leaves room for a range of capable organizations, as long as they can demonstrate the technical depth, partnerships, staffing, and infrastructure to coordinate multi-state QI work and to manage data, training, and dissemination at scale.
Overall, the opportunity is aimed at strengthening the last-mile performance of newborn screening systems: not whether states screen, but whether results and follow-up move quickly enough to protect infants, especially those with time-critical disorders. The single funded organization is expected to function as a national improvement backbone, helping at least 20 states adopt proven strategies, measure timeliness consistently, learn from one another, and reduce preventable delays that stand between a presumptive positive screen and timely clinical action.
Frequently Asked Questions (FAQs)
What is the purpose of the HRSA grant "Improving Timeliness of Newborn Screening Diagnosis" (HRSA-15-098)?
This cooperative agreement is intended to speed up how quickly infants with a presumptive positive newborn screening (NBS) result receive diagnostic confirmation and, when needed, treatment. The focus is on making sure screening results move rapidly from the laboratory to the health care provider and then into confirmatory testing and clinical care, especially for time-sensitive conditions where delays can lead to severe outcomes.
Who is HRSA planning to fund under this opportunity?
HRSA anticipated making one award. The funded organization is expected to serve as a national facilitator and coordinator for multi-state collaborative learning and quality improvement (QI) work across newborn screening programs.
Why does the program fund a single national awardee instead of many state projects?
Rather than funding many separate state projects directly, HRSA designed this opportunity to fund one entity that can organize a multi-state improvement effort, spread practical strategies, provide technical assistance, and help states measure and improve performance. The intent is to accelerate learning, reduce duplicated effort, and support consistent measurement and dissemination across states.
What outcomes is HRSA trying to improve?
The overarching goals are to increase the number of states that meet timeliness recommendations issued by the Secretary's Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC), and to increase the number of infants who receive timely diagnosis and treatment after a presumptive positive screen.
What timeliness targets are referenced in the announcement?
The announcement describes timeline targets aligned to SACHDNC recommendations, including:
- For time-critical conditions: presumptive positive results should be communicated immediately to the child's health care provider, but no later than day 5 of life.
- For all other conditions: presumptive positive results should be communicated as soon as possible, but no later than day 7 of life.
- All newborn screening results should be reported within 7 days of life.
Do applicants need to follow the final SACHDNC timeliness recommendations?
Yes. The announcement notes that the recommendations were expected to be finalized on February 12, 2015, and the funded organization is expected to follow the final version.
How many state newborn screening programs must be involved?
The awardee must coordinate QI projects aimed at improving timeliness of screening, diagnosis, and treatment in at least 20 state newborn screening programs.
Is the quality improvement work limited to the newborn screening laboratory?
No. The QI approach is not meant to be isolated within the lab alone. It must involve state NBS programs and other stakeholders within each state to start and sustain improvement activities, reflecting that delays can occur at handoffs across the full screening-to-care pathway.
What kinds of process delays is the project intended to address?
The announcement highlights that delays can occur during specimen collection, shipping, laboratory processing, reporting, locating the correct provider, contacting families, and arranging confirmatory testing and treatment. The project is meant to identify and reduce these bottlenecks.
What is the expected role of the awardee organization?
The awardee serves as a national improvement "backbone" by facilitating implementation of practice-based strategies, coordinating QI projects across states, providing technical assistance and training, supporting data collection and performance measurement, and disseminating tools and lessons learned.
What partnership expectations are included in the opportunity?
The awardee is expected to engage public and private partners at federal, state, and local levels to drive QI in newborn screening. The awardee must also coordinate related activities such as developing and sharing educational materials, best practices, and lessons learned.
Is a technical assistance or learning forum required?
Yes. The program requires creation of an ongoing forum for technical assistance, training, communication, and collaboration among stakeholders focused on improving timeliness in newborn screening follow-up.
How does the program address health disparities and underserved communities?
The announcement calls for explicit attention to timeliness challenges that can worsen health disparities, including challenges in rural and tribal communities. These settings may face geographic distance, limited specialty access, and communication barriers that make it harder to meet strict timelines.
What dissemination deliverables are required?
Dissemination is a defined deliverable. The awardee must develop and distribute educational and training resources tied to newborn screening processes. Examples listed include publications, educational materials, standard operating procedures, toolkits, presentations, best-practice summaries, evaluation materials and reports, webinar and conference call content, QI tools, and data collection instruments used for required performance measurement.
What data and measurement responsibilities are included?
The awardee must develop a data strategy that collects newborn screening timeliness data from participating states and supports use of real-time (or near real-time) data for continuous QI. This includes helping states define consistent measures, capture key timestamps, and use those measures to identify bottlenecks and track progress over time.
What types of timestamps or milestones might be included in timeliness measurement?
The announcement provides examples of key timestamps such as birth, specimen collection, specimen receipt, testing completion, result reporting, provider notification, confirmatory testing, and treatment initiation.
Is coordination with other federal newborn screening initiatives expected?
Yes. The awardee is expected to coordinate with other federal and federally supported newborn screening initiatives, including collaborative efforts with the CDC, NIH, and HRSA Maternal and Child Health Bureau-funded programs, to reduce duplication and align methods where possible.
What is the funding amount and number of awards?
The estimated total funding amount is $1,800,000, and HRSA anticipated making one award.
When was the opportunity posted and when were applications due?
The opportunity was posted on February 11, 2015. The application due date was April 13, 2015.
Is there a cost sharing or matching requirement?
No cost sharing or matching requirement is listed in the provided opportunity summary.
What is the CFDA number for this program?
The CFDA number is 93.110 (Maternal and Child Health Federal Consolidated Programs).
What does it mean that this award is a cooperative agreement?
Because this is a cooperative agreement, applicants should expect substantial federal involvement during the project period, typically through ongoing collaboration, guidance, and shared accountability for deliverables and outcomes.
Who is eligible to apply?
Under section 1109(b) of the Public Health Service Act, eligible applicants include: a state or political subdivision of a state; a consortium of two or more states or political subdivisions; a territory; an Indian Health Service-operated or -supported health facility or program; or another entity with appropriate expertise in newborn screening as determined by the Secretary.
Does the eligibility language allow non-government organizations to apply?
The eligibility description includes "another entity with appropriate expertise in newborn screening as determined by the Secretary," which leaves room for a range of capable organizations as long as they can demonstrate the expertise and national coordination capacity described in the announcement.
What capabilities should an applicant be prepared to demonstrate?
Based on the stated expectations, an applicant should be prepared to demonstrate technical depth in newborn screening and follow-up processes, staffing and infrastructure to coordinate multi-state QI work, the ability to manage data collection and performance measurement, and capacity to provide training, technical assistance, and dissemination at scale.
What is the main focus of the initiative: screening coverage or follow-up performance?
The opportunity is aimed at strengthening the "last-mile" performance of newborn screening systems, focusing on whether results and follow-up move quickly enough to protect infants after a presumptive positive screen, rather than whether states conduct screening in the first place.
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