Opportunity Information: Apply for RFA EH 15 002
Apply for RFA EH 15 002
- The Centers for Disease Control and Prevention in the health sector is offering a public funding opportunity titled "Development and validation of laboratory procedures using next generation sequencing technologies to assess genes causing severe combined immune deficiency (SCID) in state newborn screening laboratories" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.070 Environmental Public Health and Emergency Response.
- This funding opportunity was created on Mar 6, 2015 and posted on Feb 4, 2015.
- Applicants must submit their applications by Apr 6, 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 $350,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $350,000.00 in funding.
- 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).
- State governments,County governments,City or township governments,Special district governmentsIndependent school districts,Public and State controlled institutions of higher education,Native American tribal governments (Federally recognized),Public housing authorities/Indian housing authorities,Native American tribal organizations (other than Federally recognized tribal governments),Nonprofits having a 501(c)(3) status with the IRS, other than institutions ofhigher education,Nonprofits without 501(c)(3) status with the IRS, other than institutions ofhigher education,Private institutions of higher education,For profit organizations other than small businesses,Small businesses,Others (see text field entitled Additional Information on Eligibility for clarification),Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility
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Opportunity Summary:
The Centers for Disease Control and Prevention (CDC) funding opportunity RFA EH 15 002 supports a single cooperative agreement project focused on bringing next generation sequencing (NGS) into the day to day workflow of state newborn screening laboratories as a second tier test for babies who screen positive for severe combined immune deficiency (SCID) and related primary immunodeficiencies. The central idea is to move beyond an initial screen alone and add a more detailed genetic assessment that can help clarify which infants are truly affected, which genes may be involved, and how quickly the health system should act. By developing and validating practical laboratory procedures for NGS in the newborn screening setting, the project is meant to show whether this approach is feasible, reliable, and useful in real public health labs that handle high volumes and need fast turnaround times.
The activity is framed as applied public health laboratory development rather than basic research. The award is intended to develop, improve, and implement NGS based methods that can be used after an initial positive screen for SCID or other primary immunodeficiencies. In newborn screening, initial tests are designed to be sensitive so that few affected babies are missed, but that can mean more false positives or ambiguous results that require follow up. This FOA targets that gap by encouraging the use of NGS as a second tier tool to provide more definitive information about genes known to cause SCID and other severe immune disorders, helping labs and clinicians interpret positive screens and prioritize urgent care.
A major goal is evaluation of NGS in the specific environment of state newborn screening laboratories, where constraints like cost per sample, staffing, training, quality control, confirmatory testing standards, data interpretation, and reporting rules are different from those in research laboratories. CDC is looking for results that can be translated into practical guidance for other state programs, not just a successful method in one location. The expected output is evidence and experience that helps the broader newborn screening community judge whether NGS can be implemented responsibly and effectively as a standard second tier option for SCID follow up.
The public health purpose is tied directly to clinical outcomes. SCID is a medical emergency because babies can appear healthy at birth but have profound immune defects that can lead to severe infections early in life. Earlier, more accurate identification can speed confirmatory diagnosis and treatment, including interventions like protective measures, infection prevention strategies, and potentially curative therapies such as hematopoietic stem cell transplantation when appropriate. By improving how quickly and accurately newborn screening programs can assess babies who screen positive, the FOA ultimately aims to improve treatment timing and outcomes for infants with SCID or other serious primary immunodeficiencies.
Administratively, this is a discretionary funding opportunity using a cooperative agreement mechanism, which typically means CDC expects substantial involvement in the project through collaboration, technical input, or coordinated activities. The total estimated funding is $350,000, with the award floor and ceiling both set at $350,000, and CDC anticipated making one award. There is no cost sharing or matching requirement listed. The opportunity was posted February 4, 2015, with an application closing date of April 6, 2015, and it was archived May 6, 2015.
Eligibility was broad and included many types of entities that could support or operate newborn screening and public health laboratory work. Eligible applicants included state, county, and local governments; public and state controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities; nonprofit organizations with and without 501(c)(3) status; for profit organizations other than small businesses; small businesses; and other applicants as described in the additional eligibility language. The program is associated with CFDA number 93.070, Environmental Public Health and Emergency Response, reflecting CDCs public health mission rather than a purely clinical reimbursement or hospital based program.
For access issues or questions about the announcement, the contact listed was CDCs Technical Information Management Section (TIMS) within the Procurement and Grants Office, reachable by phone at 770 488 2700 or by email at PGOTIM@cdc.gov, during business hours Monday through Friday, 7:00 a.m. to 4:30 p.m. Eastern Time.
Frequently Asked Questions (FAQs) - CDC RFA EH 15 002
1. What is CDC RFA EH 15 002?
RFA EH 15 002 is a CDC funding opportunity that supports a single cooperative agreement project focused on integrating next generation sequencing (NGS) into the routine workflow of state newborn screening laboratories. The emphasis is on using NGS as a second tier test for infants who screen positive for severe combined immune deficiency (SCID) and related primary immunodeficiencies.
2. What is the main purpose of this funding opportunity?
The purpose is to develop, improve, implement, and validate practical NGS-based laboratory procedures that can be used after an initial positive newborn screen for SCID or other primary immunodeficiencies. The goal is to determine whether NGS can be used feasibly, reliably, and usefully in high-volume public health newborn screening labs with fast turnaround needs.
3. Why is NGS being considered as a second tier test for SCID?
Initial newborn screening tests are designed to be highly sensitive so that few affected infants are missed, but that sensitivity can lead to false positives or ambiguous results requiring follow-up. NGS is being promoted here as a second tier tool to provide more definitive genetic information about genes known to cause SCID and other severe immune disorders, improving interpretation of positive screens and helping prioritize urgent care.
4. What does "second tier test" mean in this opportunity?
In this context, a second tier test is an additional laboratory test performed after an infant has an initial positive screening result. The second tier test is intended to clarify the initial finding by providing more detailed information, such as genetic variants in genes associated with SCID and related disorders.
5. Is this opportunity funding basic research?
No. The activity is described as applied public health laboratory development rather than basic research. The focus is on developing and validating methods that work in real-world newborn screening laboratory environments.
6. What types of outcomes is CDC looking for from the project?
CDC is looking for evidence and operational experience that can be translated into practical guidance for other state newborn screening programs. The desired outcome is not only a successful approach at a single site, but information that helps the broader newborn screening community assess whether NGS can be implemented responsibly and effectively as a standard second tier option for SCID follow-up.
7. What laboratory setting is this project meant to address?
The project is specifically aimed at state newborn screening laboratories and the realities they face, including high sample volumes and the need for fast turnaround times, along with constraints such as cost per sample, staffing, training, quality control, confirmatory testing standards, data interpretation, and reporting rules.
8. How does this opportunity connect to public health and clinical outcomes?
SCID is described as a medical emergency because infants can appear healthy at birth while having profound immune defects that can lead to severe infections early in life. More accurate and earlier identification can speed confirmatory diagnosis and treatment decisions, including protective measures, infection prevention strategies, and potentially curative therapies such as hematopoietic stem cell transplantation when appropriate.
9. What is the funding mechanism for this opportunity?
The opportunity uses a cooperative agreement mechanism. This typically means CDC expects substantial involvement in the project through collaboration, technical input, or coordinated activities.
10. How many awards did CDC expect to make?
CDC anticipated making one award.
11. What is the total amount of funding available?
The total estimated funding is $350,000.
12. What are the award floor and ceiling amounts?
Both the award floor and the award ceiling are set at $350,000.
13. Is cost sharing or matching required?
No cost sharing or matching requirement is listed for this opportunity.
14. When was the opportunity posted and when did it close?
The opportunity was posted on February 4, 2015. The application closing date was April 6, 2015.
15. What is the archive date for this funding opportunity?
The opportunity was archived on May 6, 2015.
16. Who was eligible to apply?
Eligibility was broad and included state, county, and local governments; public and state controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities; nonprofit organizations with and without 501(c)(3) status; for-profit organizations other than small businesses; small businesses; and other applicants as described in the additional eligibility language.
17. What program identifier (CFDA) is associated with this opportunity?
The program is associated with CFDA number 93.070, Environmental Public Health and Emergency Response.
18. Who can be contacted for access issues or questions about the announcement?
The contact listed is CDC's Technical Information Management Section (TIMS) within the Procurement and Grants Office.
19. What are the TIMS contact details?
Phone: 770-488-2700
Email: PGOTIM@cdc.gov
20. What are the TIMS business hours?
Monday through Friday, 7:00 a.m. to 4:30 p.m. Eastern Time.
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