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FAQs: FY 2021 State Newborn Screening Interoperability Implementation Program Notice of Funding Opportunity (HRSA-21-085)


Our program already links with vital records and immunizations but is hoping to use this money as an opportunity to develop new connections to support long-term follow-up for positive NBS infants. Is the goal of this grant to provide money to states that need help making those initial connections with vital records, immunizations, and birth defects, or is our idea for more advanced interoperability also of interest to receive support?

Yes, the goal of this grant is inclusive of supporting activities to improve the effectiveness of screening and building of state-level capacity to assess and report on follow-up services.

Refer to NOFO pages 2 and 8.

Our primary goals with the INBSI project are to (1) set up electronic test ordering with birthing hospitals and to (2) improve specimen tracking. If awarded the grant, we would use a majority of the funds to compensate birthing hospitals for the resources required to set up infrastructure for electronic data transfer on their end. Would this be an acceptable use of the grant? Is that within the scope of the grant?

Please take a look at the Program-specific instructions beginning on page 7 as that describes the expectations of grantees who are funded under this program. Also, take a look at the program objectives. Your proposal should address the objectives listed on page 1.

Could you clarify what is meant by “state public health database”? Is that only referring to state government agency databases, or could that also include birthing hospitals’ medical records, which would be accessed to order newborn screening tests?

The NOFO is written broadly with purpose and applicants must show how the proposed activities support the goal, purpose, and overall intent of the NOFO. We encourage you to consider applying if you believe that your proposal will meet the goals, purpose, objectives, and activities required in the NOFO.

Eligible applicants include “any other entity with appropriate expertise in newborn screening, as determined by the Secretary.” We are a non-profit with 501(c)(3) designation. Would our organization be considered eligible based on the above experiences?

Regarding your question about eligibility, specifically around “any other entity with appropriate expertise in newborn screening, as determined by the secretary.” (NOFO pages iii, and 4).

Applicants should demonstrate their expertise in newborn screening in the application. We'd also like to point you to the additional approval factors on page 5. If you believe that your organization has appropriate expertise in newborn screening and meets this assurance, we encourage you to apply.

I am working with our Lab folks and I wanted to confirm your definition of “train newborn screening staff in informatics.” General definition of Informatics is the science of using data, information, and knowledge to improve human health and the delivery of health care services. From the grant perspective, are you referring to training the staff on the steps and teams involved in the NBS process, the data flow, storage, and retrieval of data? How is the data used in each of those steps?

For the “train newborn screening staff in informatics” requirement, we do mean informatics generally, as you have defined. However, this does not preclude training for staff in informatics as it more directly relates to the Newborn Screening system/process.

Regarding the new guidelines for the project abstract (according to HRSA 424 Guide dated 3/15/21). Effective 4/22, the guidelines change to “provide a summary of application in the Project Abstract box use 4,000 characters or less” Do the “current instructions” that remain in the guide also apply? For example, info about where in the SF424 to upload the Abstract (box 15) and the information that’s required at the top of the abstract (project title, applicant name, address, etc.) The application doesn’t include “project abstract box” as identified in the new guidance.

All NOFOs issued/posted before April 22, 2021, will follow the “current instructions” as designated by the SF 424 guidance and do not fall under the new guidance. The abstract for HRSA-21-085 remains an attachment with the required elements at the top per the instructions provided in section ix. See the Project Abstract of the SF 424 guidance.

Should the INBSI Program Team expect that the 4 implementing states will need to go through the Technical Assistance planning process with the INBSI Program?

Under the cooperative agreement, the 4 implementing states are required to work with both the Innovations in Newborn Screening Interoperability Program (INBSI) program and other recipients of the HRSA-21-085 to share information and best practices on data interoperability relating to heritable disorders/newborn screening. One of the required activities under this award also states the recipient shall participate in training and technical assistance activities, workgroups, meetings, and learning collaboratives conducted by the INBSI Program. It is up to the states to determine to what degree they engage with the INBSI program so long as they meet this requirement. The NOFO also requires the recipient to attend annual meetings convened by the INBSI program.

Do recipients need to go through the formal application process to enroll in the INSBI Program? Should the INBSI Program Team plan to sync up our next application period with the announcement of 4 implementing states (recipients of HRSA-21-085)?

It will be up to the recipients to determine the degree in which they engage with the INBSI program, for both the development of their state interoperability plan and the implementation of that plan. While the NOFO requires recipients to participate in INBSI training and technical assistance activities, it does not require them to formally enroll in the program. This does not preclude them from going through the formal application process and enrolling in the full INBSI program.

We anticipate announcements to be made in August. If this falls within the INBSI program timeline for the next application period, that would be great for recipients who plan to enroll in the INBSI program. However, we don’t expect the INBSI program to alter or delay timelines to sync with the Implementation award announcements.

Do you expect there to INBSI representation on the steering committees the accepted states set up?

It is up to the recipient to identify relevant stakeholders for the steering committee. The NOFO offers a list of recommended organizations and state agencies, including information technology/informatics experts and subject matter experts in interoperability. And while we hope to see INBSI representation, it is not a requirement of the NOFO and again up to the recipients’ discretion.

Is there a mandatory annual HRSA meeting associated with this grant? If so, will there be a virtual option and how many folks are required/expected to attend from each awarded entity/state?

The annual meeting required under this funding will be held by the Innovations in Newborn Screening Interoperability Program (INBSI). Whether or not the annual meeting will be held In-Person or Virtually in 2022 is yet to be determined and will depend on the Federal Emergency Pandemic status. The number of individuals from each awarded state/entity required to participate is not specified in the NOFO and up to the awardee’s discretion. Applicants may provide an estimate for travel funds to annual meetings within the budget and depending on how the meetings are planned after award. The awardee has flexibility in re-budgeting so that travel is covered.

We are interested in responding to the HRSA-21-085 program. We believe that we are eligible to apply because we have expertise in newborn screening. We note that the guidance states the following: “…any other entity with appropriate expertise in newborn screening, as determined by the Secretary.” Is there a way to be sure the Secretary considers our organization to have the appropriate expertise in newborn screening?

Applicants must describe their expertise in newborn screening within the application. HRSA will determine eligibility. We also remind you of the additional approval factors to consider on page 5 of the NOFO.

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