Center of Excellence NOFO FAQ_rev 5_23_24.pdf

1/18/2024_DRAFT

NSMBB Center of Excellence to Enhance Disease Detection in Newborns

NOFO (CDC-RFA-EH24-0044)

FAQs

General

1. Is a letter of intent required/due?

A Letter of Intent (LOI) is requested, but not required, as part of the application for this NOFO. The

LOI allows the CDC program staff to estimate and prepare for the review of submitted applications.

LOIs must be sent via email to Cindy Hinton (ceh9@cdc.gov). The LOI deadline is April 26, 2024.

2. Will CDC award multiple awards across more than one jurisdiction?

While the NOFO requires partnerships with other jurisdictions, only one entity will be awarded funding. The awardee is expected to partner with other jurisdiction(s) through formal agreements according to local, state, and federal laws.

3. Who is eligible to apply for funding under this Notice of Funding Opportunity (NOFO)?

This NOFO is open competition. Please refer to the “Eligibility” section in the NOFO announcement for detailed eligibility information.

4. Can a for profit organization apply?

No, the statutory authority provided is Section 317(k)(2) of the Public Health Service Act, [42 U.S.C.

247b (k)(2)]. For Profit Private Entities are not included as eligible recipients in this grant authority.

5. When is the start date for CDC-RFA-EH24-0044?

The start date for CDC-RFA-EH24-0044 is September 30, 2024, with an estimated award date of on or around July 30, 2024 (the date by which the Notice of Award will be issued by CDC’s Office of

Grant Services).

6. Is there a deadline for submitting questions for this NOFO?

Questions may be submitted up to two (2) weeks before the application deadline, though it would be advisable to send them as soon as possible to allow for timely responses.

mailto:ceh9@cdc.gov

7. How can I make sure I will be notified if changes are made to the NOFO?

In Grants.gov, click on the “Login to Subscribe” link on the Synopsis page and log in. That will sign you up for email notifications regarding the NOFO. This does not affect the application process in any way, but if changes are made to the opportunity, you will receive notification.

8. What are the required components of the application?

Several components are required. All applications must have a Project Narrative that includes all of the following headings (including subheads):

• Background,

• Approach,

• Applicant Evaluation and Performance Measurement Plan,

• Work Plan, and

• Organizational Capacity of Applicants to Implement the Approach.

The Project Narrative must be succinct, self-explanatory, and in the order outlined in the section

“Application and Submission Information.” Other required documentation include:

• Resumes/CVs,

• Bona Fide agent status documentation,

• Required Certifications (CLIA or CAP),

• Letter(s) of support

• Indirect cost rate, and

• Budget Narrative.

9. How many letters of support are required for the application?

At least one (1) letter of support is required. Applications with no letters of support will be considered non-responsive.

10. Is the SAM number and unique entity identifier (UEI) the same?

There is no SAM number and applicants must have a Unique Entity Identifier (UEI) at the time of application submission (SF-424, field 8c). The UEI number is a twelve-digit number assigned by

SAM.gov. When applying for Federal awards or cooperative agreements, all applicant organizations must obtain a UEI number as the Universal Identifier. UEI number assignment is free. Additional information is available on the GSA website, SAM.gov, and Grants.gov-Finding the UEI.

11. Do I have to renew my UEI or SAM registration?

https://www.gsa.gov/about-us/organization/federal-acquisition-service/technology-transformation-services/integrated-award-environment-iae/iae-systems-information-kit/unique-entity-identifier-update https://sam.gov/content/home https://grantsgovprod.wordpress.com/2021/09/14/how-to-find-an-applicants-uei-within-grants-gov/

You do not have to renew a UEI number. However, the SAM registration must be renewed annually.

12. What is the font type required for the writing?

As stated in the Section “Application Contents & Format” of the NOFO, text should be single spaced, 12-point font, 1-inch margins, and number all pages.

13. Does the Work Plan also need to be in 12-point font, or can it be in a smaller font?

The Work Plan can be in smaller font.

14. Can you explain a little more about the review and selection process?

All applications will be initially reviewed for eligibility and completeness by the CDC Office of Grant

Services (OGS). Complete applications will be evaluated by a CDC Objective Review Panel using criteria noted in the “Application Review” Section of the NOFO. The Objective Review Panel will consist of CDC staff that work outside of the Newborn Screening and Molecular Biology Branch (i.e., staff that work in different CDC programs and offices). Lastly, CDC will complete a risk review to ensure each applicant can manage federal funds appropriately.

Budget

15. Are there any specific staffing and/or FTE requirements for staff positions that applicants must budget for?

The Organizational Capacity section describes the need to have qualified staff that can manage program and resources ensuring the administrative, financial, and staff support necessary to sustain activities. This includes describing an adequate Staffing Plan, providing CVs/Resumes for any proposed personnel, an Organizational Chart, and a project management structure that clearly defines staff roles and reporting structure, and as it specifically applies to this funding opportunity. It must describe previous experience in management and application of innovations and implementation to public health specific to newborn screening blood spot. Dedicated staff must be explicitly included in the proposed Work Plan and Budget.

16. Is the indirect cost rate based on the agency’s federally approved indirect rate?

Yes, as stated in the NOFO Budget Narrative section, “If requesting indirect costs in the budget, a copy of the indirect cost-rate agreement is required. If the indirect costs are requested, include a copy of the current negotiated federal indirect cost rate agreement or a cost allocation plan approval letter for those Recipients under such a plan.”

17. Can funds be used to purchase laboratory equipment for the required partner jurisdictions?

No, funds may not be used to purchase equipment for or on behalf of partner jurisdictions.

18. Can funds be used to purchase time/use of equipment via a contract?

Yes, funds may be used to purchase time or use of laboratory equipment via contract.

19. When applying, are applicants limited to the maximum funding identified in the funding structure?

Yes, applicants submitting a budget exceeding the stated maximum funding amount for this NOFO can be deemed unresponsive.

Program Strategies & Activities

20. What is ED3N?

ED3N is the Enhanced Data-Driven Disease Detection project that is being developed by CDC’s

Newborn Screening and Molecular Biology Branch. ED3N is designed to serve as a secure, central, and national platform for the NBS community, containing a data warehouse and data sharing resources for NBS data, and will include three functional modules (biochemical data, molecular data, and clinical data) that are intended to support NBS program best practices. The molecular module addresses challenges associated with identification and curation of variants to inform interpretations by offering guided NBS-specific variant interpretation, re-interpretation, and reporting tools. This will allow NBS programs a collaborative platform to interpret and compare variants across programs. ED3N is a CDC led data modernization initiative that aims to improve detection of at-risk newborns by addressing analytic challenges and harmonizing testing and interpretative processes, which will allow for timelier diagnostic and intervention for an increasing number of diseases.

21. Are all Strategies, Activities, and Outcomes listed in the logic model required?

The bolded outcomes are those we expect you to achieve during the four-year period of performance.

22. What is a partner jurisdiction?

A partner jurisdiction refers to a jurisdiction with defined NBS related needs (i.e., laboratory methods/analysis/interpretation, capacity, and other testing challenges) that the Center is working with to advance NBS practices.

23. Is there a minimum number of required partner jurisdictions?

Applicant must partner with a minimum of one (1) additional jurisdiction to provide enhanced/expanded screening services/support.

24. What is the difference between bridge and expanded screening?

Bridge screening refers to services provided during a period of public health emergency.

Expanded screening refers to newborn screening provided by the Center of Excellence for a period of time to partner jurisdiction(s) to enhance/improve/advance laboratory methods/analysis/interpretation and/or other relevant laboratory challenges.

25. What are some examples of advanced technologies that the recipient could plan to implement to improve/enhance NBS?

Advanced technologies in newborn screening refers to technological innovations leading to improvements in at least one of the following areas: analytical sensitivity, analytical accuracy, throughput, clinical sensitivity or specificity, and/or multiplexing of NBS disorders into one assay. Examples include but are not limited to the following:

• High Resolution Mass Spectrometry (HRMS)

• (Differential) Ion Mobility

• Ultrafast chromatographic or electrophoretic separations to use for 1st tier screening

• Direct sampling devices that can be interfaced with mass spectrometry such as acoustic ejection or high speed autosamplers.

• Automation of emerging approaches with applicability to newborn screening such as peptide immunoaffinity enrichment coupled with selected reaction monitoring mass spectrometry (Immune-SRM)

26. What is meant by data harmonization?

Data harmonization occurs when data across different formats and naming conventions are combined, transforming into a cohesive and comparable data set. Currently, the lack of harmonization and standardization of NBS data across sectors and jurisdictions makes it hard to show a clear picture of the status of NBS for individual jurisdictions and for the country.

27. What is a Coordinating Group and who should it consist of?

A Coordinating Group will support and review the work of the Center of Excellence, including but not limited to reviewing proposed plans and activities and mitigating decisions and agreements as needed. The Coordinating Group will include CDC representatives, parent representatives, the Center of Excellence Project Director, representative(s) from partner jurisdiction(s), and representative(s) from relevant APHL work groups.

28. What are educational videos referring to and who should be in the videos?

Educational videos will be an optional output of the Center of Excellence in the final years of the Cooperative Agreement. These videos may include parents/families of children who were identified by newborn screening (particularly families that were captured due to the work of the Center of Excellence during the 4-year Cooperative Agreement).

29. Do pilots need to be conducted for both biochemical and molecular technologies?

Yes, as the funded Center, you will be expected to focus on and conduct pilots covering both biochemical and molecular related activities. This will involve collaborating as needed with other jurisdictional public health laboratories and relevant partners to:

• Perform a landscape and gap analysis

• Pilot and implement methods to enhance NBS practices

• Evaluate the impact of advanced technologies (molecular and biochemical NBS platforms)

• Share findings with the NBS community

Evaluation

30. Is the Data Management Plan (DMP) submitted as an attachment?

No, the Data Management Plan (DMP) is a required part of the Project Narrative and not a separate attachment. Please note this is a draft plan, and the recipient will be given an opportunity to provide a more detailed DMP with their Evaluation and Performance Measurement Plan 6 months post award.

31. For the strategies in the Evaluation and Performance Measurement Plan, we are required to develop evaluation questions. Do these need to address the overarching evaluation questions?

Yes, the Evaluation and Performance Measurement Plan should address the overarching evaluation questions as described in the Evaluation and Performance Measurement section of the NOFO.

Applicants are also expected to develop specific evaluation questions that correspond to the outcomes and performance measures in the logic model.

32. Will the recipient report on performance measures for all strategies?

Applicants are required to address all strategies and report all short- and intermediate-term performance measures. Applicants should provide baselines, one-year targets and data sources for all performance measures. Recipients will report performance measures annually to CDC to support the assessment of progress over the four-year performance period.

33. Are we responsible for long-term outcomes?

As indicated in the logic model, the recipient will be responsible for only the bolded short, intermediate, and long-term outcomes within this cooperative agreement.

34. How will CDC solicit input for performance measures definitions?

CDC will provide draft definitions for performance measures based on evidence, previously used, indicators or measures, and programmatic experience. CDC will seek input from the recipient and collaborate to operationalize the measures after funding is awarded. We want to ensure that all recipients receive guidance that operationalizes all performance measures within a reasonable timeframe for collecting and reporting Year 1 data. Therefore, the recipient will need to work closely with CDC on a rapid timeline in Year 1.

35. Do we need to use the Data Management Plan (DMP) template provided by CDC or can we create our own individual DMP layouts inclusive of the content laid out in the template?

Applicants need to address each required element of the DMP but are not required to use the CDC template. Applicants will provide a draft DMP that includes all the items listed in the CDC template and submit a detailed DMP with their Evaluation and Performance Measurement Plan 6-months post award.