CDC-RFA-EH20-2004.pdf

Centers for Disease Control and Prevention

National Center for Environmental Health

Enhancing Disease Detection in Newborns: Building Capacity in Public Health Laboratories

CDC-RFA-EH20-2004

Application Due Date: 05/14/2020

Enhancing Disease Detection in Newborns: Building Capacity in Public Health Laboratories

CDC-RFA-EH20-2004

TABLE OF CONTENTS

Part I. Overview Information A. Federal Agency Name B. Funding Opportunity Title C. Announcement Type D. Agency Funding Opportunity Number E. Assistance Listings (CFDA) Number F. Dates G. Executive Summary

Part II. Full Text A. Funding Opportunity Description B. Award Information C. Eligibility Information D. Application and Submission Information E. Review and Selection Process F. Award Administration Information G. Agency Contacts H. Other Information I. Glossary

Part I. Overview Information Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Subscribe" button link to ensure they receive notifications of any changes to CDC-RFA- EH20-2004. Applicants also must provide an e-mail address to www.grants.gov to receive notifications of changes.

A. Federal Agency Name:

Centers for Disease Control and Prevention (CDC) / Agency for Toxic Substances and Disease Registry (ATSDR) B. Notice of Funding Opportunity (NOFO) Title:

Enhancing Disease Detection in Newborns: Building Capacity in Public Health Laboratories C. Announcement Type: New - Type 1 This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be considered. For this purpose, research is defined at https ://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf.

Guidance on how CDC interprets the definition of research in the context of public health can be found at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html (See section 45 CFR 46.102(d)).

New Non-Research

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-EH20-2004

E. Assistance Listings (CFDA) Number:

93.065 F. Dates:

1. Due Date for Letter of Intent (LOI): N/A

2. Due Date for Applications: 05/14/2020, 11:59 p.m. U.S. Eastern

Standard Time, at www.grants.gov.

3. Date for Informational Conference Call:

March 20, 2020 from 2 - 3 PM EDT.

Join by phone: (770) 488-3600; Conference ID 2451716# Join by Skype: Join Skype Meeting

G. Executive Summary:

1. Summary Paragraph:

This NOFO will increase the capacity and capability of state and territorial newborn screening laboratories to test for newborn screening conditions as recommended by the U.S. Department of Health and Human Services (HHS) Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC), and those that might be added to individual state panels by state-level advisory committees or state legislatures. Early detection of these conditions, whose symptoms are not clinically observable at birth, save thousands of infants and children from disability and death through early detection and treatment. With this 2-year funding opportunity, CDC intends to support up to 8 recipients to add HHS ACHDNC-recommended newborn https://www.grants.gov https://www.grants.gov https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html https://www.grants.gov https://webconf.cdc.gov/ceh9/FCB062GJ screening conditions to their state or territorial newborn screening panel. CDC intends to work collaboratively with recipients to enhance state and territorial newborn screening laboratory capability to implement these and future HHS ACHDNC -recommended newborn screening conditions. CDC also intends to work collaboratively with recipients to improve the quality of newborn screening testing in the U.S., in part through data harmonization efforts. This funding will result in a greater number of newborns that are appropriately screened, identified, and referred for treatment for condition detected through state newborn dried blood spot screening.

a. Eligible Applicants: Open Competition

b. NOFO Type: Cooperative Agreement

c. Approximate Number of Awards: 8

d. Total Period of Performance Funding: $6,000,000

e. Average One Year Award Amount: $375,000

f. Total Period of Performance Length: 2

g. Estimated Award Date: 09/30/2020

h. Cost Sharing and / or Matching Requirements: N

Part II. Full Text A. Funding Opportunity Description

Part II. Full Text

1. Background

a. Overview This NOFO will increase the capacity and capability of state and territorial newborn screening laboratories to test for newborn screening conditions as recommended by the U.S. Department of Health and Human Services Advisory Committee on Heritable Disorders in Newborns and Children (HHS ACHDNC), and those that might be added to state panels by state-level advisory committees or state legislatures. As of December 2019, 46% of states and territories still do not include any of the recent HHS ACHDNC-recommended conditions—Pompe Disease, Mucopolysaccharidosis Type 1, X-linked Adrenoleukodystrophy, and Spinal Muscular Atrophy—on their newborn screening panels. Early detection of these conditions, whose symptoms are not clinically observable at birth, save thousands of infants and children from disability and death through early detection and treatment. Advanced biochemical and molecular technologies improve disease detection for newborns, and newborn screening programs must provide accurate interpretation of complex biomarker profiles, develop analytic and interpretive tools for genetic testing, and manage complex data systems. Harmonization brings together data in different formats and naming conventions and transforms them into a cohesive data set and there is a need for harmonization of results across laboratories and testing platforms to aid in biomarker interpretation.

Building capacity and capability of state and territorial newborn screening laboratories includes adding new conditions and improving the performance of existing tests for current conditions.

Applicants may propose newborn screening activities based on one, two, or all of the following strategies:

A. Build newborn screening laboratory capacity to screen for new U.S. recommended uniform screening panel (RUSP) conditions; and/or B. Enhance newborn screening test performance on dried blood spots to improve disease detection; and/or C. Improve state laboratories’ ability to interpret newborn screening test results on dried blood spots.

Depending on the strategies adopted, the expected outcomes of this NOFO may include 1) Full implementation of one or more newborn screening conditions recently added to the U.S. RUSP;

2) Increased number of newborns screened for conditions recommended on the U.S. RUSP; 3) Improved performance of newborn screening laboratory tests on dried blood spots; and 4) Improved data processing, data management, and data analysis in state newborn screening laboratories.

CDC intends to work collaboratively with recipients to enhance state and territorial newborn screening laboratory capability to implement current and future HHS ACHDNC-recommended newborn screening conditions. CDC also intends to work collaboratively with recipients to improve the quality of newborn screening testing in the U.S., in part through data harmonization efforts.

b. Statutory Authorities Section 317 (k)(3) of the Public Health Service Act, [42 U.S.C. 247b (k)(2)]

c. Healthy People 2030 This NOFO directly addresses Healthy People 2020 priority area Maternal, Infant, and Child Health (MICH)-32: Increase appropriate newborn blood-spot screening and follow-up testing.

Funding for states or territories to enhance newborn screening will result in more newborns screened, identified, and referred for treatment.

d. Other National Public Health Priorities and Strategies This activity is consistent with the U.S. Department of Health and Human Services Advisory Committee on Heritable Disorders in Newborns and Children recommendations for conditions on the Recommended Uniform Screening Panel (http://www.hrsa.gov/advisorycommittees/mchba dvisory/heritabledisorders/recommendedpanel/index.html)

e. Relevant Work This activity builds on previous successful CDC-funded projects to implement or enhance newborn screening in state newborn screening laboratories. In 2018, CDC awarded non-research EH18-1804 to seven states to add and/or improve newborn screening for Pompe Disease, Mucopolysaccharidosis Type 1, X-linked Adrenoleukodystrophy, and Spinal Muscular Atrophy.

This award increased number of laboratory scientists with knowledge and skills to perform http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders/recommendedpanel/index.html http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders/recommendedpanel/index.html newborn screening for conditions recommended by the HHS ACHDNC, increased number of newborns screened for conditions recommended by the HHS ACHDNC and introduced new approaches to newborn screening quality improvement including data harmonization.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

Strategies

Short-Term/Intermediate Outcomes (2 years)*

Long-term Outcomes

A. Build newborn screening laboratory capacity to screen for new U.S. recommended uniform screening panel (RUSP) conditions

AND/OR

Full implementation of one or more newborn screening conditions recently added to the U.S.

RUSP.

Increased number of newborns screened for conditions recommended on the U.S. RUSP.

B. Enhance newborn screening test performance on dried blood spots to improve disease detection

AND/OR

Improved performance of newborn screening laboratory tests on dried blood spots.

C. Improve state laboratories’ ability to interpret newborn screening test results on dried blood spots.

Improved data processing, data management, and data analysis in state newborn screening laboratories.

Newborn screening laboratories are better positioned to adapt to changing technologies and increased demand for public health newborn screening.

Newborns are referred for appropriate treatment and management in a timely manner.

Infant mortality due to conditions detected via public health newborn screening decrease.

Children diagnosed with rare disorders via public health newborn screening achieve appropriate developmental milestones.

*Applicants will be responsible for achieving only the bolded outcomes that are related to their chosen strategies.

i. Purpose This NOFO will increase the capacity and capability of newborn screening laboratories to test for newborn screening conditions as recommended by the U.S. Department of Health and Human Services Advisory Committee on Heritable Disorders in Newborns and Children. This NOFO will also improve newborn screening test performance and test interpretation of dried blood spot newborn screening.

ii. Outcomes During the period of performance, a successful recipient will execute the strategies and produce outcomes to improve capabilities and capacities of public health newborn screening laboratories.

Depending on strategies selected, recipients should work toward the bolded short-term outcomes outlined in the logic model. The short-term period of performance includes the following:

Full implementation of one or more newborn screening conditions recently added to the

U.S. RUSP.

Increased number of newborns screened for conditions recommended on the U.S. RUSP.

Improved performance of newborn screening laboratory tests on dried blood spots.

Improved data processing, data management, and data analysis in state newborn screening laboratories.

iii. Strategies and Activities Applicants should propose activities consistent with strategies and activities below. The proposed activities may include any combination of the activities indicated in A, B, and/or C: Applicants can focus on a single strategy or choose to include multiple strategies as indicated in A, B, and/or C.

During the period of performance, a successful recipient will execute proposed strategies and activities to improve capabilities and capacities of public health newborn screening laboratories.

Depending on strategies selected, recipients should work toward the bolded short-term outcomes outlined in the logic model. Applicants will be responsible for achieving only the bolded outcomes that are related to their chosen strategies.

Strategy A. BUILD NEWBORN SCREENING LABORATORY CAPACITY TO SCREEN

FOR NEW U.S. RECOMMENDED UNIFORM SCREENING PANEL (RUSP)

CONDITIONS

This strategy is to support a state’s incorporation of a new RUSP condition onto the state newborn screening panel. Proposed plans, at a minimum, should include: 1) details about purchasing laboratory equipment and supplies needed to add new newborn screening conditions,

2) details about laboratory methods that will be used to detect new newborn screening conditions or processes by which the newborn screening laboratory will choose appropriate laboratory methods, 3) planning details about significant activities that must occur to support laboratory method validation studies, screening algorithms and state-wide implementation of new newborn screening conditions, 4) assuring laboratory staff are trained on methods needed to screen newborns for newly-added newborn screening conditions, 5) developing newborn screening follow-up materials for state-wide implementation of new conditions, including providing education for clinicians who will diagnose and treat referred newborns upon the addition of new conditions to the newborn screening panel.

The following are examples of activities and outputs that could support implementation of screening for new conditions:

Purchase or lease any laboratory equipment, reagents and supplies.

Retrofit laboratory space Fund laboratory personnel, as needed, to perform public health newborn screening on dried blood spots Train laboratory staff on new protocols.

Develop methods and follow-up algorithms Modify LIMS for new newborn screening protocols.

Work with state follow-up program to develop and promote materials to inform hospitals, pediatricians and specialty providers, and families about roll-out of new tests.

Strategy B. ENHANCE NEWBORN SCREENING TEST PERFORMANCE ON DRIED

BLOOD SPOTS TO IMPROVE DISEASE DETECTION.

The scope of this strategy is focused on developing newborn screening testing methods to improve screening algorithms, and to detect markers of current or anticipated conditions on the RUSP. This includes quality improvement strategies such as modifying existing 1st tier and/or 2nd tier tests to improve detection of newborn screening disorders or leading a collaboration to harmonize the interpretation of biochemical markers.

Any proposed quality improvement activities in the workplan may include use of CDC newborn screening dried blood spot quality control materials to harmonize test results across laboratories or other collaborative quality improvement efforts to harmonize data and/or improve newborn screening testing in the U.S.

Examples of activities and outputs that could be included under this strategy are:

Create new or adapting existing 1st tier tests to increase disease detection capability, e.g., o Adapt the T-Cell Receptor Excision Circle (TREC) assay to include spinal muscular atrophy (SMA) detection;

o Adapt the amino acid/acylcarnitine test to include guanidinoacetate methyltransferase (GAMT) deficiency biomarkers, succinylacetone, or homocysteine; o o Create a new method to detect cerebrotendinous xanthamosis, Duchenne muscular dystrophy, congenital cytomegalovirus infection, or other condition not yet on the

RUSP.

Create new or adapt a second- or third-tier newborn screening laboratory method, e.g.

o implement a test to detect a panel of second-tier biomarkers for several diseases o implement a molecular method to detect known gene variants of a newborn screening disease.

Create methods using alternative testing platforms that could enhance multiplex biomarker detection, e.g.

o metabolomics or o genomics.

Lead a quality improvement collaborative project to address harmonization challenges or promote “best practices” within the program

Strategy C. IMPROVE STATE LABORATORIES’ ABILITY TO INTERPRET

NEWBORN SCREENING TEST RESULTS

The purpose of this strategy is to enhance disease detection of high-risk newborns through the development of improved data-driven, decision-making tools and resources. This strategy may be used to fund health information systems infrastructure—i.e. the people, processes, procedures, tools, facilities and technology — which support the creation, use, transport, storage, and destruction of information. Any proposed health information system infrastructure activities should be reflected in the detailed budget submitted by applicants.

Activities under this strategy could include

Create dashboards, data visualization aids, tracking and trending tools to monitor key performance indicators

Develop data analytics tools and resources to assist with data management and analysis to automate routine manual public health laboratory newborn screening activities, Develop tools and resources to support state newborn screening laboratories’ interpretation of DNA variants and/or biochemical profiles

1. Collaborations

a. With other CDC programs and CDC-funded organizations:

N/A

b. With organizations not funded by CDC:

Collaboration with newborn screening programs in other states is not required, but access to subject matter experts knowledgeable about methods to used detect new newborn screening conditions will be assessed and scored as part of the application review and selection process.

Applicants must provide an MOU, MOA, or letters of support to verify, or as evidence for collaboration with other organizations and explain how each collaboration would assist recipient in implementing activities and achieving the NOFO period of performance outcomes. Applicants must file the MOU, MOA, or letters as appropriate, name the file as either “[Organization] MOU/MOA/Letter”, and upload it as a PDF file at www.grants.gov.

2. Target Populations

Applicants should clearly identify the state, territory, and/or tribal lands that they plan to serve.

a. Health Disparities This NOFO aims to reduce geographic health disparities by assisting states and territories implement new newborn screening disorders to their respective panels. This NOFO encourages the inclusion of rural, tribal, ESOL populations, and persons with disabilities.

iv. Funding Strategy N/A

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy CDC will determine whether recipients successfully attain desired performance and outcome success during the period of performance. Process measures and outcome measures will be evaluated to guide continuous program improvement and determine the success of this NOFO.

PROCESS MEASURES

The following are included examples of process measures for STRATEGY A, Build newborn screening laboratory capacity to screen for new U.S. recommended uniform screening panel (RUSP) conditions:

Complete consult with CDC NSMBB to finalize plan for purchase of supplies and equipment.

Complete purchase of supplies and equipment.

Validate new laboratory methods and ensure ready for state-wide implementation.

Develop educational materials necessary for parents and providers for a new disorder.

Develop processes in public health program and clinic to act on positive samples.

Finalize plans for training laboratory, follow-up, and clinical staff.

Complete training for laboratory, follow-up, and clinical staff on new newborn screening conditions.

Implement state-wide screening for new newborn screening conditions.

The following are included as examples of process measures for STRATEGY B, enhance newborn screening test performance on dried blood spots to improve disease detection:

Consult with CDC NSMBB to finalize approach for primary, secondary or tertiary screening.

Purchase equipment or supplies to develop tier testing for improved test performance.

Validate new laboratory methods and ensure ready for state-wide implementation.

Develop educational materials necessary for parents and providers for a new disorder.

Develop processes in public health program and clinic to act on positive samples.

Finalize methods to improve test performance.

Implement new methods.

The following are examples of process measures for STRATEGY C, improve state laboratories’ ability to interpret newborn screening test results on dried blood spots:

Finalized plans for collaboration with CDC toward quality improvement and data harmonization.

Collaboration with CDC with the CDC Newborn Screening Quality Assurance Program toward improved newborn screening tests and harmonized data has begun and is ongoing.

OUTCOME MEASURES

Recipients are only expected to provide outcome measures relevant to the strategies (A, B, and/or C) that they have selected. Recipients must submit outcome performance measures related to the short-term outcomes from the logic model:

Strategy A:

o Full implementation of one or more newborn screening conditions recently added to the U.S. Recommended Uniform Screening Panel.

Go-Live date achieved for new condition(s) o Increased number of newborns screened for conditions recommended on the U.S.

Recommended Uniform Screening Panel.

# of newborns screened for new conditions Strategy B:

o Improved performance of newborn screening laboratory tests on dried blood spots.

What is the documented improvement in screening test sensitivity and specificity?

How many new approaches to improved newborn screening tests?

Strategy C:

o Improved data processing, data management, and data analysis in state newborn screening laboratories.

How many approaches to data harmonization were implemented?

What is the documented decrease in time to call out appropriate screen result?

ii. Applicant Evaluation and Performance Measurement Plan Applicants must provide an evaluation and performance measurement plan that demonstrates how the recipient will fulfill the requirements described in the CDC Evaluation and Performance Measurement and Project Description sections of this NOFO. At a minimum, the plan must describe:

How applicant will collect the performance measures, respond to the evaluation questions, and use evaluation findings for continuous program quality improvement.

How key program partners will participate in the evaluation and performance measurement planning processes.

Available data sources, feasibility of collecting appropriate evaluation and performance data, and other relevant data information (e.g., performance measures proposed by the applicant)

Plans for updating the Data Management Plan (DMP), if applicable, for accuracy throughout the lifecycle of the project. The DMP should provide a description of the data that will be produced using these NOFO funds; access to data; data standards ensuring released data have documentation describing methods of collection, what the data represent, and data limitations; and archival and long-term data preservation plans. For more information about CDC’s policy on the DMP, see https://www.cdc.gov/grants/additionalrequirements/ar-25.html.

Where the applicant chooses to, or is expected to, take on specific evaluation studies, they should be directed to:

Describe the type of evaluations (i.e., process, outcome, or both).

Describe key evaluation questions to be addressed by these evaluations.

Describe other information (e.g., measures, data sources).

Recipients will be required to submit a more detailed Evaluation and Performance Measurement plan, including a DMP, if applicable, within the first 6 months of award, as described in the Reporting Section of this NOFO.

Applicants must provide an evaluation and performance measurement plan that demonstrates how the recipient will fulfill the requirements described in the CDC Evaluation and Performance Measurement and Project Description sections of this NOFO. At a minimum, the plan must describe:

How applicant will collect the performance measures, respond to the evaluation questions, and use evaluation findings for continuous program quality improvement. The can include measures collected as part of regular program performance measures.

How key program partners will participate in the evaluation and performance measurement planning processes. This could include working with the CDC Newborn Screening and Molecular Biology Branch and APHL.

Available data sources, feasibility of collecting appropriate evaluation and performance data, and other relevant data information (e.g., performance measures proposed by the applicant).

Data resulting from test validation.

Plans for updating the Data Management Plan (DMP), if applicant will be sharing data with other states and/or CDC, for accuracy throughout the lifecycle of the project. The DMP should provide a description of the data that will be produced using these NOFO funds; access to data; data standards ensuring released data have documentation describing methods of collection, what the data represent, and data limitations; and archival and long-term data preservation plans. For more information about CDC’s policy on the DMP, see https://www.cdc.gov/grants/additionalrequirements/ar-25.html.

Recipients will be required to submit a more detailed Evaluation and Performance Measurement plan, including a DMP, within the first 6 months of award, as described in the Reporting Section of this NOFO.

https://www.cdc.gov/grants/additionalrequirements/ar-25.html

Where the applicant chooses to, or is expected to, take on specific evaluation studies, they should be directed to:

Describe the type of evaluations (i.e., process, outcome, or both).

Describe key evaluation questions to be addressed by these evaluations.

Describe other information (e.g., measures, data sources).

c. Organizational Capacity of Recipients to Implement the Approach Applicants should indicate support for proposed newborn screening activities as evidenced by legislation or other support (e.g. state advisory board or Board of Health) from the state.

Applicants should indicate collaborative relationships inside and outside of the state to support their proposed newborn screening activities.

Applicants should provide experience, background, and the curricula vitae for key staff to indicate ability to carry out all activities of the newborn screening program. Upload curricula vitae for key staff as pdf files labeled as CV or Resume to www.grants.gov.

Applicants should describe a current or proposed advisory committee.

Applicants should address how the proposed newborn screening activities will be sustained after the period of performance.

d. Work Plan Applicants must construct a logical, stepwise work plan that includes a timeline showing expected activities in each of the 24 period of performance months. The timeline should include all significant project related activities, showing a clear month-over-month progression of activities from award to state-wide implementation of the selected new newborn screening conditions. For each activity, the workplan will include Strategy and Activity, the appropriate Process Measure (from Evaluation and Performance Measurement), Responsible Team Member(s), and Completion Date.

State-wide implementation must occur before the end of the period of performance and would ideally occur within 18-20 months of award to promote opportunities for post-implementation support, collaboration, and quality improvement. CDC will provide feedback and technical assistance to award recipients to finalize the work plan activities post-award.

Period of Performance Outcome:

[from Outcomes section and/or logic model]

Outcome Measure:

[from Evaluation and Performance Measurement section]

Strategies and Activities

Process Measure [from Evaluation and Performance

Responsible Position / Party

Completion Date

Measurement section]

1.

2.

3.

e. CDC Monitoring and Accountability Approach Monitoring activities include routine and ongoing communication between CDC and recipients, site visits, and recipient reporting (including work plans, performance, and financial reporting).

Consistent with applicable grants regulations and policies, CDC expects the following to be included in post-award monitoring for grants and cooperative agreements:

Tracking recipient progress in achieving the desired outcomes.

Ensuring the adequacy of recipient systems that underlie and generate data reports.

Creating an environment that fosters integrity in program performance and results.

Monitoring may also include the following activities deemed necessary to monitor the award:

Ensuring that work plans are feasible based on the budget and consistent with the intent of the award.

Ensuring that recipients are performing at a sufficient level to achieve outcomes within stated timeframes.

Working with recipients on adjusting the work plan based on achievement of outcomes, evaluation results and changing budgets.

Monitoring performance measures (both programmatic and financial) to assure satisfactory performance levels.

Monitoring and reporting activities that assist grants management staff (e.g., grants management officers and specialists, and project officers) in the identification, notification, and management of high-risk recipients.

Monitoring activities include routine and ongoing communication between CDC and recipients, site visits, and recipient reporting (including work plans, performance, and financial reporting).

Consistent with applicable grants regulations and policies, CDC expects the following to be included in post-award monitoring for grants and cooperative agreements:

Tracking recipient progress in achieving the desired outcomes.

Ensuring the adequacy of recipient systems that underlie and generate data reports.

Creating an environment that fosters integrity in program performance and results.

Monitoring may also include the following activities deemed necessary to monitor the award:

Ensuring that work plans are feasible based on the budget and consistent with the intent of the

Ensuring that recipients are performing at a sufficient level to achieve outcomes within stated timeframes.

Working with recipients on adjusting the work plan based on achievement of outcomes, evaluation results and changing budgets.

Monitoring performance measures (both programmatic and financial) to assure satisfactory performance levels.

Monitoring and reporting activities that assist grants management staff (e.g., grants management officers and specialists, and project officers) in the identification, notification, and management of high-risk recipients.

CDC will use ongoing communication with recipients, including regular e-mail correspondence, monthly conference calls with recipients, and site visits (if needed) to monitor project progress.

Work plans, performance measures and evaluation plans, and timelines will also be used to evaluate progress toward stated outcomes.

f. CDC Program Support to Recipients (THIS SECTION APPLIES ONLY TO

COOPERATIVE AGREEMENTS)

Organize monthly conference calls with recipients.

Assist in designing, developing, and evaluating laboratory methods, especially with respect to quality assurance/quality control, integration with the CDC Newborn Screening Quality Assurance Program, and consultation with the CDC Molecular Assessment Program.

Engage in efforts to harmonize newborn screening laboratory results across laboratories using CDC quality control materials.

Engage in efforts to improve the quality of existing and emerging newborn screening laboratory methods.

Facilitate communication among recipients and with other state newborn screening programs.

Promote compatibility of laboratory data from multiple sources by providing common reference materials.

Provide assistance in development of training materials on laboratory methods, evaluations, risk communication, and other topics for state public health newborn screening programs.

B. Award Information

1. Funding Instrument Type: Cooperative Agreement CDC's substantial involvement in this program appears in the CDC Program Support to Recipients Section.

2. Award Mechanism: U88

3. Fiscal Year: 2020

4. Approximate Total Fiscal Year Funding: $3,000,000

5. Approximate Period of Performance Funding: $6,000,000

This amount is subject to the availability of funds.

Estimated Total Funding: $6,000,000

6. Approximate Period of Performance Length: 2 year(s)

7. Expected Number of Awards: 8

8. Approximate Average Award: $375,000 Per Budget Period

9. Award Ceiling: $500,000 Per Budget Period

This amount is subject to the availability of funds.

10. Award Floor: $250,000 Per Budget Period

11. Estimated Award Date: 09/30/2020

12. Budget Period Length: 12 month(s)

Throughout the project period, CDC will continue the award based on the availability of funds, the evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the federal government. The total number of years for which federal support has been approved (project period) will be shown in the “Notice of Award.” This information does not constitute a commitment by the federal government to fund the entire period. The total period of performance comprises the initial competitive segment and any subsequent non-competitive continuation award(s).

13. Direct Assistance Direct Assistance (DA) is not available through this NOFO.

C. Eligibility Information

1. Eligible Applicants Eligibility Category: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"

Additional Eligibility Category:

2. Additional Information on Eligibility

Applicants must represent or be an administrative partner to an established state or territorial newborn screening program. If an applicant is not a governmental state or territorial newborn screening program, the applicant must supply an MOU, MOA, or letter to indicate they represent or are an administrative partner to an established state or territorial newborn screening program or it will be considered non-responsive in the review process. Upload document labeled ADMINPART.pdf to www.grants.gov.

3. Justification for Less than Maximum Competition

4. Cost Sharing or Matching Cost Sharing / Matching Requirement: No

5. Maintenance of Effort

D. Application and Submission Information

1. Required Registrations An organization must be registered at the three following locations before it can submit an application for funding at www.grants.gov.

a. Data Universal Numbering System:

All applicant organizations must obtain a Data Universal Numbering System (DUNS) number.

A DUNS number is a unique nine-digit identification number provided by Dun & Bradstreet (D&B). It will be used as the Universal Identifier when applying for federal awards or cooperative agreements.

The applicant organization may request a DUNS number by telephone at 1-866-705-5711 (toll free) or internet at http:// fedgov.dnb. com/ webform/ displayHomePage.do. The DUNS number will be provided at no charge.

If funds are awarded to an applicant organization that includes sub-recipients, those sub-recipients must provide their DUNS numbers before accepting any funds.

b. System for Award Management (SAM):

The SAM is the primary registrant database for the federal government and the repository into which an entity must submit information required to conduct business as a recipient. All applicant organizations must register with SAM, and will be assigned a SAM number. All information relevant to the SAM number must be current at all times during which the applicant has an application under consideration for funding by CDC. If an award is made, the SAM information must be maintained until a final financial report is submitted or the final payment is received, whichever is later. The SAM registration process can require 10 or more business days, and registration must be renewed annually. Additional information about registration procedures may be found at https://www.sam.gov/SAM/.

c. Grants.gov:

The first step in submitting an application online is registering your organization at www.grants.gov, the official HHS E-grant Web site. Registration information is located at the https://www.grants.gov/ http://fedgov.dnb.com/webform/displayHomePage.do https://www.sam.gov/SAM/ https://grants.gov/ https://www.grants.gov/

"Applicant Registration" option at www.grants.gov.

All applicant organizations must register at www.grants.gov. The one-time registration process usually takes not more than five days to complete. Applicants should start the registration process as early as possible.

Step System Requirements Duration Follow Up 1 Data

Universal Number System

(DUNS)

1. Click on http:// fedgov.dnb.com/ webform

2. Select Begin DUNS search/request process

3. Select your country or territory and follow the instructions to obtain your DUNS 9-digit #

4. Request appropriate staff member(s) to obtain DUNS number, verify & update information under DUNS number

1-2 Business Days

To confirm that you have been issued a new DUNS number check online at (http:// fedgov.dnb.com/ webform) or call 1-866-705-5711

2 System for Award Management

(SAM)

formerly Central Contractor Registration

(CCR)

1. Retrieve organizations DUNS number

2. Go to https://www.sam.gov/SAM/ and designate an E-Biz POC (note CCR username will not work in SAM and you will need to have an active SAM account before you can register on grants.gov)

3-5 Business Days but up to 2 weeks and must be renewed once a year

For SAM Customer Service Contact https://fsd.gov/ fsd-gov/ home.do Calls:

866-606-8220

3 Grants.gov 1. Set up an individual account in Grants.gov using organization new DUNS number to become an authorized organization representative (AOR)

2. Once the account is set up the E-BIZ POC will be notified via email

3. Log into grants.gov using the password the E-BIZ POC received and create new password

4. This authorizes the AOR to submit applications on

Same day but can take 8 weeks to be fully registered and approved in the system (note, applicants

MUST

obtain a

DUNS

number and

Register early!

Log into grants.gov and check AOR status until it shows you have been approved http://www.grants.gov https://www.grants.gov/ http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform https://www.sam.gov/SAM/ https://fsd.gov/fsd-gov/home.do https://fsd.gov/fsd-gov/home.do https://fsd.gov/fsd-gov/home.do behalf of the organization SAM account before applying on grants.gov)

2. Request Application Package Applicants may access the application package at www.grants.gov.

3. Application Package Applicants must download the SF-424, Application for Federal Assistance, package associated with this notice of funding opportunity at www.grants.gov.

4. Submission Dates and Times If the application is not submitted by the deadline published in the NOFO, it will not be processed. Office of Grants Services (OGS) personnel will notify the applicant that their application did not meet the deadline. The applicant must receive pre-approval to submit a paper application (see Other Submission Requirements section for additional details). If the applicant is authorized to submit a paper application, it must be received by the deadline provided by

OGS.

a. Letter of Intent Deadline (must be emailed or postmarked by) Due Date for Letter of Intent: N/A

b. Application Deadline Due Date for Applications: 05/14/2020 , 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov. If Grants.gov is inoperable and cannot receive applications, and circumstances preclude advance notification of an extension, then applications must be submitted by the first business day on which grants.gov operations resume.

Date for Information Conference Call March 20, 2020 from 2 - 3 PM EDT.

Join by phone: (770) 488-3600; Conference ID 2451716# Join by Skype: Join Skype Meeting

5. CDC Assurances and Certifications All applicants are required to sign and submit “Assurances and Certifications” documents indicated at http://wwwn.cdc.gov/ grantassurances/ (S(mj444mxct51lnrv1hljjjmaa)) /Homepage.aspx.

Applicants may follow either of the following processes:

Complete the applicable assurances and certifications with each application submission, name the file “Assurances and Certifications” and upload it as a PDF file with at https://www.grants.gov https://www.grants.gov https://www.grants.gov https://webconf.cdc.gov/ceh9/FCB062GJ http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx www.grants.gov Complete the applicable assurances and certifications and submit them directly to CDC on an annual basis at http://wwwn.cdc.gov/ grantassurances/ (S(mj444mxct51lnrv1hljjjmaa))/ Homepage.aspx

Assurances and certifications submitted directly to CDC will be kept on file for one year and will apply to all applications submitted to CDC by the applicant within one year of the submission date.

Risk Assessment Questionnaire Requirement CDC is required to conduct pre-award risk assessments to determine the risk an applicant poses to meeting federal programmatic and administrative requirements by taking into account issues such as financial instability, insufficient management systems, non-compliance with award conditions, the charging of unallowable costs, and inexperience. The risk assessment will include an evaluation of the applicant’s CDC Risk Questionnaire, located at https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdf, as well as a review of the applicant’s history in all available systems; including OMB-designated repositories of government-wide eligibility and financial integrity systems (see 45 CFR 75.205(a)), and other sources of historical information. These systems include, but are not limited to: FAPIIS (https://www.fapiis.gov/), including past performance on federal contracts as per Duncan Hunter National Defense Authorization Act of 2009; Do Not Pay list; and System for Award Management (SAM) exclusions.

CDC requires all applicants to complete the Risk Questionnaire, OMB Control Number 0920- 1132 annually. This questionnaire, which is located at https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdf, along with supporting documentation must be submitted with your application by the closing date of the Notice of Funding Opportunity Announcement. If your organization has completed CDC’s Risk Questionnaire within the past 12 months of the closing date of this NOFO, then you must submit a copy of that questionnaire, or submit a letter signed by the authorized organization representative to include the original submission date, organization’s EIN and DUNS.

When uploading supporting documentation for the Risk Questionnaire into this application package, clearly label the documents for easy identification of the type of documentation. For example, a copy of Procurement policy submitted in response to the questionnaire may be labeled using the following format: Risk Questionnaire Supporting Documents _ Procurement Policy.

Duplication of Efforts Applicants are responsible for reporting if this application will result in programmatic, budgetary, or commitment overlap with another application or award (i.e. grant, cooperative agreement, or contract) submitted to another funding source in the same fiscal year.

Programmatic overlap occurs when (1) substantially the same project is proposed in more than one application or is submitted to two or more funding sources for review and funding consideration or (2) a specific objective and the project design for accomplishing the objective are the same or closely related in two or more applications or awards, regardless of the funding source. Budgetary overlap occurs when duplicate or equivalent budgetary items (e.g., https://www.grants.gov http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdf https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdf equipment, salaries) are requested in an application but already are provided by another source.

Commitment overlap occurs when an individual’s time commitment exceeds 100 percent, whether or not salary support is requested in the application. Overlap, whether programmatic, budgetary, or commitment of an individual’s effort greater than 100 percent, is not permitted.

Any overlap will be resolved by the CDC with the applicant and the PD/PI prior to award.

Report Submission: The applicant must upload the report in Grants.gov under “Other Attachment Forms.” The document should be labeled: "Report on Programmatic, Budgetary, and Commitment Overlap.”

6. Content and Form of Application Submission Applicants are required to include all of the following documents with their application package at www.grants.gov.

7. Letter of Intent A letter of intent is not required as part of the application for this NOFO.

8. Table of Contents (There is no page limit. The table of contents is not included in the project narrative page limit.): The applicant must provide, as a separate attachment, the “Table of Contents” for the entire submission package.

Provide a detailed table of contents for the entire submission package that includes all of the documents in the application and headings in the "Project Narrative" section. Name the file "Table of Contents" and upload it as a PDF file under "Other Attachment Forms" at www.grants.gov.

9. Project Abstract Summary (Maximum 1 page) A project abstract is included on the mandatory documents list and must be submitted at www.grants.gov. The project abstract must be a self-contained, brief summary of the proposed project including the purpose and outcomes. This summary must not include any proprietary or confidential information. Applicants must enter the summary in the "Project Abstract Summary" text box at www.grants.gov.

10. Project Narrative (Unless specified in the "H. Other Information" section, maximum of 20 pages, single spaced, 12 point font, 1-inch margins, number all pages. This includes the work plan. Content beyond the specified page number will not be reviewed.)

Applicants must submit a Project Narrative with the application forms. Applicants must name this file “Project Narrative” and upload it at www.grants.gov. The Project Narrative must include all of the following headings (including subheadings): Background, Approach, Applicant Evaluation and Performance Measurement Plan, Organizational Capacity of Applicants to Implement the Approach, and Work Plan. The Project Narrative must be succinct, self-explanatory, and in the order outlined in this section. It must address outcomes and https://www.grants.gov https://www.grants.gov https://www.grants.gov activities to be conducted over the entire period of performance as identified in the CDC Project Description section. Applicants should use the federal plain language guidelines and Clear Communication Index to respond to this Notice of Funding Opportunity. Note that recipients should also use these tools when creating public communication materials supported by this NOFO. Failure to follow the guidance and format may negatively impact scoring of the application.

a. Background Applicants must provide a description of relevant background information that includes the context of the problem (See CDC Background).

b. Approach

i. Purpose Applicants must describe in 2-3 sentences specifically how their application will address the public health problem as described in the CDC Background section.

ii. Outcomes Applicants must clearly identify the outcomes they expect to achieve by the end of the project period, as identified in the logic model in the Approach section of the CDC Project Description.

Outcomes are the results that the program intends to achieve and usually indicate the intended direction of change (e.g., increase, decrease).

iii. Strategies and Activities Applicants must provide a clear and concise description of the strategies and activities they will use to achieve the period of performance outcomes. Applicants must select existing evidence-based strategies that meet their needs, or describe in the Applicant Evaluation and Performance Measurement Plan how these strategies will be evaluated over the course of the project period.

See the Strategies and Activities section of the CDC Project Description.

1. Collaborations Applicants must describe how they will collaborate with programs and organizations either internal or external to CDC. Applicants must address the Collaboration requirements as described in the CDC Project Description.

2. Target Populations and Health Disparities Applicants must describe the specific target population(s) in their jurisdiction and explain how such a target will achieve the goals of the award and/or alleviate health disparities. The applicants must also address how they will include specific populations that can benefit from the program that is described in the Approach section. Applicants must address the Target Populations and Health Disparities requirements as described in the CDC Project Description.

c. Applicant Evaluation and Performance Measurement Plan

Applicants must provide an evaluation and performance measurement plan that demonstrates how the recipient will fulfill the requirements described in the CDC Evaluation and Performance Measurement and Project Description sections of this NOFO. At a minimum, the plan must describe:

How applicant will collect the performance measures, respond to the evaluation questions, and use evaluation findings for continuous program quality improvement.