oppCDC-RFA-EH18-1804-cfda93.065-cidCDC-RFA-EH18-1804-instructions.pdf

Centers for Disease Control

National Center for Environmental Health

Newborn Screening New Condition Implementation: Capacity Building and Quality

Improvement through Data Harmonization

CDC-RFA-EH18-1804

Application Due Date: 06/29/2018

Newborn Screening New Condition Implementation: Capacity Building and Quality

Improvement through Data Harmonization

CDC-RFA-EH18-1804

TABLE OF CONTENTS

Part I. Overview Information A. Federal Agency Name B. Funding Opportunity Title C. Announcement Type D. Agency Funding Opportunity Number E. Catalog of Federal Domestic Assistance (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 "Send Me Change Notifications Emails" link to ensure they receive notifications of any changes to CDC-RFA-EH18-1804. 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:

Newborn Screening New Condition Implementation: Capacity Building and Quality Improvement through Data Harmonization 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)).

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-EH18-1804

E. Catalog of Federal Domestic Assistance (CFDA) Number:

93.065 F. Dates:

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

2. Due Date for Applications: 06/29/2018, 11:59 p.m. U.S. Eastern

Standard Time, at www.grants.gov.

3. Date for Informational Conference Call:

Informational conference call to be held on 5/14/2018 at 1pm Eastern Time. Call is expected to last less than one hour. Call in number: 1-866-745-4890. Passcode: 1564117

G. Executive Summary:

1. Summary Paragraph:

The U.S. Department of Health and Human Services Advisory Committee on Heritable Disorders in Newborns and Children (HHS ACHDNC) recommends specific disorders for inclusion on every newborn screening panel. As of February 2018, more than 80% of U.S.

states and territories do not include on their newborn screening panels any of the recent HHS ACHDNC-recommended conditions, including Pompe Disease, Mucopolysaccharidosis Type 1, X-linked Adrenoleukodystrophy, and Spinal Muscular Atrophy.

The intent of this NOFO is to increase the number of newborn screening laboratories in U.S.

states and territories that test for new HHS ACHDNC-recommended newborn screening 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 conditions.

CDC will support up to 10 recipients to implement tests for additional HHS ACHDNC-recommended newborn screening conditions, as authorized by the state, into state newborn screening panels. 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 HHS ACHDNC-recommended newborn screening conditions.

a. Eligible Applicants: Open Competition

b. NOFO Type: Cooperative Agreement

c. Approximate Number of Awards: 10

d. Total Period of Performance Funding: $4,000,000

e. Average One Year Award Amount: $200,000

f. Total Period of Performance Length: 2

g. Estimated Award Date: 09/14/2018

h. Cost Sharing and / or Matching Requirements: N Cost sharing or matching funds are not required for this program. Although no statutory matching requirement for this NOFO exists, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged.

Part II. Full Text A. Funding Opportunity Description

Part II. Full Text

1. Background

a. Overview State and territorial newborn screening programs screen newborns for conditions that are not readily apparent at birth but require immediate medical treatment. Almost 4 million newborns are screened annually in the United States, and thousands of infants and children are saved from disability and death through early detection and treatment. Newborn screening practices, including the types of disorders for which newborns are screened, vary from state to state.

The U.S. Department of Health and Human Services Advisory Committee on Heritable Disorders in Newborns and Children (HHS ACHDNC) recommends that specific disorders are included on every newborn screening panel. As of February 2018, more than 80% of U.S. states and territories do not include on their newborn screening panels any of the recent HHS ACHDNC-recommended conditions, including Pompe Disease, Mucopolysaccharidosis Type 1, X-linked Adrenoleukodystrophy, and Spinal Muscular Atrophy.

CDC successfully funded the first state to add Severe Combined Immunodeficiency (SCID) to a state newborn screening panel in 2008 and 9 additional states between 2008 and 2018. Due in part to direct CDC support, all states in the U.S. will be screening for SCID by the end of 2018.

The approach of this NOFO will follow the successful model established to support states to add SCID--to provide funding for laboratory equipment, supplies, training, and education while providing direct technical support toward implementation of HHS ACHDNC-recommended newborn screening conditions.

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

c. Healthy People 2020 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. For more information, see https://www.healt hypeople.gov/2020/topics-objectives/topic/maternal-infant-and-child-health/objectives

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 2008 CDC awarded funding via RFA-EH-08-002 to two states to demonstrate the feasibility of statewide newborn screening for severe combined immunodeficiency (SCID). In 2011 CDC supported two additional states through RFA-EH-11-001 to implement SCID newborn screening programs in their states. In 2013 CDC provided non-research funds via RFA-EH-13-1303 to three additional states to build capacity and implement SCID programs. In 2015 CDC provided non-research funds via RFA- EH-15-1504 to three more states to implement newborn screening for SCID and provided research funds via RFA-EH-15-002 to a state to develop and validate laboratory procedures using next generation sequencing technologies to assess genes causing SCID in state newborn screening laboratories. In 2017 CDC provided non-research funds via RFA-EH-17-1703 to five states to increase newborn screening laboratory capability to detect SCID using next generation sequencing technologies.

2. CDC Project Description https://www.healthypeople.gov/2020/topics-objectives/topic/maternal-infant-and-child-health/objectives https://www.healthypeople.gov/2020/topics-objectives/topic/maternal-infant-and-child-health/objectives http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders/recommendedpanel/index.html http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders/recommendedpanel/index.html

a. Approach

Bold indicates period of performance outcome.

Strategies and Activities Short-term outcomes Long-term outcomes

Build capability

Purchase laboratory equipment and supplies o Validate laboratory methods

Train and educate

Train laboratory professionals

Quality improvement and data harmonization

Active collaboration between state newborn screening laboratories and CDC Newborn Screening Quality Assurance Program

Increased number of state newborn screening programs with laboratory capability to perform newborn screening for conditions recommended by the U.S. Department of Health and Human Services Advisory Committee on Heritable Disorders in Newborns and Children (HHS

ACHDNC).

Increased number of laboratory scientists with knowledge and skills to perform newborn screening for conditions recommended by the HHS

ACHDNC.

Increased number of newborns screened for conditions recommended by the HHS ACHDNC.

New approaches to newborn screening quality improvement including data harmonization.

Increased number of newborns with newborn screening conditions that demonstrate improved outcomes and/or receive life-saving treatment.

Improved newborn screening tests.

i. Purpose This NOFO is intended to increase the 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.

ii. Outcomes

Increased number of state newborn screening programs with laboratory capability to perform newborn screening for conditions recommended by the U.S. Department of Health and Human Services Advisory Committee on Heritable Disorders in Newborns and Children (HHS ACHDNC).

Increased number of laboratory scientists with knowledge and skills to perform newborn screening for conditions recommended by the HHS ACHDNC.

Increased number of newborns screened for conditions recommended by the HHS

ACHDNC.

New approaches to newborn screening quality improvement including data harmonization.

iii. Strategies and Activities Build capability 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, and 3) details about significant activities that must occur in advance of laboratory method validation studies and state-wide implementation of new newborn screening conditions.

The timeline for state-wide implementation of new newborn screening conditions must include a go-live date before the end of the 24 month project period and would ideally occur within 18-20 months of award to promote opportunities for post-implementation collaboration, support, and quality improvement.

Plans for continued screening of newborns for new newborn screening conditions should extend beyond the funded period.

Train and educate Proposed plans, at a minimum, should include: 1) assuring laboratory staff have the necessary training and technical knowledge to screen newborns for new newborn screening conditions, 2) assuring newborn screening follow-up staff are prepared for state-wide implementation of new conditions, 3) assuring clinicians who will diagnose and treat referred newborns are aware and prepared for the addition of new newborn screening conditions to the newborn screening panel.

Quality improvement and data harmonization Proposed plans should include a strategy for working with CDC Newborn Screening Quality Assurance Program staff to improve the quality of newborn screening testing within and across newborn screening laboratories. Proposed quality improvement plans may include use of

CDC newborn screening dried blood spot quality control materials to harmonize mass spectrometry results across laboratories or other collaborative quality improvement efforts to harmonize data and/or improve newborn screening testing in the U.S.

During the first 60 days of the 2 year award period, CDC Newborn Screening Quality Assurance Program staff will work with recipients to finalize proposed plans.

1. Collaborations

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

Active collaboration with the CDC Newborn Screening Quality Assurance Program is a requirement of this NOFO. Applicants must propose plans to work with CDC Newborn Screening Quality Assurance Program staff on quality improvement and/or data harmonization activities.

b. With organizations not funded by CDC:

For applicants not directly affiliated with a newborn screening program (i.e., applicants who have an administrative partnership with a newborn screening program), evidence of the existing administrative partnership must be included with the application. Evidence of a partnership with a newborn screening program should include a memorandum of understanding (MOU), memorandum of agreement (MOA), or other formal documentation. Applicants must file the MOU or MOA, as appropriate, name the file “MOUs/MOAs”, and upload it as a PDF file at www.grants.gov.

Additional collaboration is not required, but access to subject matter experts knowledgeable about methods used to detect new newborn screening conditions will be scored as part of the proposal evaluation. Applicants should consider collaboration with entities that currently screen for new newborn screening conditions.

2. Target Populations U.S. state or territory populations.

a. Health Disparities N/A

iv. Funding Strategy N/A

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy Quality improvement and data harmonization

CDC will determine whether recipients successfully attain desired performance and outcome https://www.grants.gov/ success during the project period. Process measures and outcome measures will be evaluated to guide continuous program improvement and determine the success of this NOFO.

PERFORMANCE MEASURES (related to strategies and activities from logic model) Build capability

Are plans for purchasing supplies and equipment finalized?

Did the laboratory purchase all needed supplies and equipment?

Are new laboratory methods validated and ready for state-wide implementation?

Has the laboratory implemented state-wide screening for new newborn screening conditions?

Train and educate

Are plans for training laboratory, follow-up, and clinical staff finalized?

Are laboratory, follow-up, and clinical staff trained and ready to begin screening for selected new newborn screening conditions?

Quality improvement and data harmonization

Are plans for collaboration with CDC toward quality improvement and data harmonization finalized?

Is the recipient actively collaborating with the CDC Newborn Screening Quality Assurance Program toward improved newborn screening tests and harmonized data?

OUTCOME MEASURES (related to short-term outcomes from logic model) Increased number of state newborn screening programs with laboratory capability to perform newborn screening for conditions recommended by the U.S. Department of Health and Human Services Advisory Committee on Heritable Disorders in Newborns and Children (HHS ACHDNC).

How many state newborn screening programs gained laboratory capability and began state-wide screening for new newborn screening conditions?

Increased number of laboratory scientists with knowledge and skills to perform newborn screening for conditions recommended by the HHS ACHDNC.

How many laboratory scientists gained knowledge and skills to perform new newborn screening tests?

Increased number of newborns screened for conditions recommended by the HHS

ACHDNC.

How many newborns were screened for new newborn screening conditions?

New approaches to newborn screening quality improvement including data harmonization.

How many new approaches to improved newborn screening tests and data harmonization were implemented?

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, within the first 6 months of award, as described in the Reporting Section of this NOFO.

c. Organizational Capacity of Recipients to Implement the Approach Applicants should demonstrate, either by direct affiliation or through an administrative partnership, access to an established state or territorial newborn screening program. Applicants should include the size of the population that would be affected by adding new newborn screening conditions through this cooperative agreement. Applicants should https://www.cdc.gov/grants/additionalrequirements/ar-25.html indicate how they will obtain needed subject matter expertise to implement new newborn screening conditions. Applicants should include a discussion of laboratory space and staffing needed to add newborn screening conditions.

d. Work Plan Applicants must construct a logical, stepwise work plan that includes a timeline showing expected activities in each of the 24 project period 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.

State-wide implementation must occur before the end of the project period and would ideally occur within 18-20 months of award to promote opportunities for post-implementation support, collaboration, and quality improvement.

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.

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)

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: 2018

4. Approximate Total Fiscal Year Funding: $2,000,000

5. Approximate Period of Performance Funding: $4,000,000

This amount is subject to the availability of funds.

Estimated Total Funding: $4,000,000

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

7. Expected Number of Awards: 10

8. Approximate Average Award: $200,000 Per Budget Period

9. Award Ceiling: $300,000 Per Budget Period

This amount is subject to the availability of funds.

10. Award Floor: $150,000 Per Budget Period

11. Estimated Award Date: 09/14/2018

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 FOA.

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

3. Justification for Less than Maximum Competition N/A

4. Cost Sharing or Matching Cost Sharing / Matching Requirement: No Cost sharing or matching funds are not required for this program. Although no statutory matching requirement for this NOFO exists, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged.

5. Maintenance of Effort Maintenance of effort is not required for this program.

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 www.SAM.gov.

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 “Get Registered” 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

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 https://www.grants.gov/ http://fedgov.dnb.com/webform/displayHomePage.do https://www.sam.gov/portal/public/SAM/ https://grants.gov/ https://www.grants.gov/ https://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

DUNS number 2 System for

Award Management

(SAM)

formerly Central Contractor Registration

(CCR)

1. Retrieve organizations DUNS number

2. Go to www.sam.gov 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 behalf of the organization

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

MUST

obtain a

DUNS

number and

SAM

account before applying on grants.gov)

Register early!

Log into grants.gov and check AOR status until it shows you have been approved

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. If Internet access is not available, or if the online forms cannot be accessed, applicants may call the CDC OGS staff at 770-488- 2700 or e-mail OGS ogstims@cdc.gov for assistance. Persons with hearing loss may access CDC telecommunications at TTY 1-888-232-6348.

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 http://www.sam.gov https://fsd.gov/fsd-gov/home.do https://fsd.gov/fsd-gov/home.do https://fsd.gov/fsd-gov/home.do https://www.grants.gov mailto:ogstims@cdc.gov 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: 06/29/2018 , 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 Informational conference call to be held on 5/14/2018 at 1pm Eastern Time. Call is expected to last less than one hour. Call in number: 1-866-745-4890. Passcode: 1564117

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 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.

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., 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, https://www.grants.gov http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx https://www.grants.gov http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx 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 LOI is not requested or 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 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 https://www.grants.gov https://www.grants.gov https://www.grants.gov

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. The Paperwork Reduction Act of 1995 (PRA): Applicants are advised that any activities involving information collections (e.g., surveys, questionnaires, applications, audits, data requests, reporting, recordkeeping and disclosure requirements) from 10 or more individuals or non-Federal entities, including State and local governmental agencies, and funded or sponsored by the Federal Government are subject to review and approval by the Office of Management and Budget. For further information about CDC’s requirements under PRA see http://www.hhs.gov/ ocio/policy/collection/.

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, data management plan (DMP), and other relevant data information (e.g., performance measures proposed by the applicant).

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 the DMP elements) within the first 6 months of award, as described in the Reporting Section of this NOFO.

d. Organizational Capacity of Applicants to Implement the Approach Applicants must address the organizational capacity requirements as described in the CDC Project Description.

11. Work Plan (Included in the Project Narrative’s page limit) Applicants must prepare a work plan consistent with the CDC Project Description Work Plan section. The work plan integrates and delineates more specifically how the recipient plans to carry out achieving the period of performance outcomes, strategies and activities, evaluation and performance measurement.

12. Budget Narrative http://www.hhs.gov/ocio/policy/collection/

Applicants must submit an itemized budget narrative. When developing the budget narrative, applicants must consider whether the proposed budget is reasonable and consistent with the purpose, outcomes, and program strategy outlined in the project narrative. The budget must include:

Salaries and wages Fringe benefits Consultant costs Equipment Supplies Travel Other categories Contractual costs Total Direct costs Total Indirect costs

Indirect costs could include the cost of collecting, managing, sharing and preserving data.

Indirect costs on grants awarded to foreign organizations and foreign public entities and performed fully outside of the territorial limits of the U.S. may be paid to support the costs of compliance with federal requirements at a fixed rate of eight percent of MTDC exclusive of tuition and related fees, direct expenditures for equipment, and subawards in excess of $25,000.

Negotiated indirect costs may be paid to the American University, Beirut, and the World Health Organization.

If applicable and consistent with the cited statutory authority for this announcement, applicant entities may use funds for activities as they relate to the intent of this NOFO to meet national standards or seek health department accreditation through the Public Health Accreditation Board (see: http://www.phaboard.org). Applicant entities to whom this provision applies include state, local, territorial governments (including the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau), or their bona fide agents, political subdivisions of states (in consultation with states), federally recognized or state-recognized American Indian or Alaska Native tribal governments, and American Indian or Alaska Native tribally designated organizations. Activities include those that enable a public health organization to deliver public health services such as activities that ensure a capable and qualified workforce, up-to-date information systems, and the capability to assess and respond to public health needs. Use of these funds must focus on achieving a minimum of one national standard that supports the intent of the NOFO. Proposed activities must be included in the budget narrative and must indicate which standards will be addressed.

Applicants must name this file “Budget Narrative” and upload it as a PDF file at www.grants.gov. 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. Applicants must name this file “Indirect Cost Rate” and upload it at www.grants.gov.

http://www.phaboard.org

If applicant is a recipient of other federal or non-federal funds to support new newborn screening condition implementation or newborn screening quality improvement initiatives, applicant must describe how funds from different sources will be used in a complementary manner without duplication.

13. Funds Tracking Proper fiscal oversight is critical to maintaining public trust in the stewardship of federal funds.

Effective October 1, 2013, a new HHS policy on subaccounts requires the CDC to set up payment subaccounts within the Payment Management System (PMS) for all new grant awards.

Funds awarded in support of approved activities and drawdown instructions will be identified on the Notice of Award in a newly established PMS subaccount (P subaccount). Recipients will be required to draw down funds from award-specific accounts in the PMS. Ultimately, the subaccounts will provide recipients and CDC a more detailed and precise understanding of financial transactions. The successful applicant will be required to track funds by P-accounts/sub accounts for each project/cooperative agreement awarded. Applicants are encouraged to demonstrate a record of fiscal responsibility and the ability to provide sufficient and effective oversight. Financial management systems must meet the requirements as described 2 CFR 200 which include, but are not limited to, the following:

Records that identify adequately the source and application of funds for federally-funded activities.

Effective control over, and accountability for, all funds, property, and other assets.

Comparison of expenditures with budget amounts for each Federal award.

Written procedures to implement payment requirements.

Written procedures for determining cost allowability.

Written procedures for financial reporting and monitoring.

14. Intergovernmental Review Executive Order 12372 does not apply to this program.

15. Pilot Program for Enhancement of Employee Whistleblower Protections Pilot Program for Enhancement of Employee Whistleblower Protections: All applicants will be subject to a term and condition that applies the terms of 48 Code of Federal Regulations (CFR) section 3.908 to the award and requires that recipients inform their employees in writing (in the predominant native language of the workforce) of employee whistleblower rights and protections under 41 U.S.C. 4712.

16. Copyright Interests Provisions This provision is intended to ensure that the public has access to the results and accomplishments of public health activities funded by CDC. Pursuant to applicable grant regulations and CDC’s Public Access Policy, Recipient agrees to submit into the National

Institutes of Health (NIH) Manuscript Submission (NIHMS) system an electronic version of the final, peer-reviewed manuscript of any such work developed under this award upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. Also at the time of submission, Recipient and/or the Recipient’s submitting author must specify the date the final manuscript will be publicly accessible through PubMed Central (PMC). Recipient and/or Recipient’s submitting author must also post the manuscript through PMC within twelve (12) months of the publisher's official date of final publication; however the author is strongly encouraged to make the subject manuscript available as soon as possible. The recipient must obtain prior approval from the CDC for any exception to this provision.

The author's final, peer-reviewed manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process, and all graphics and supplemental material associated with the article. Recipient and its submitting authors working under this award are responsible for ensuring that any publishing or copyright agreements concerning submitted articles reserve adequate right to fully comply with this provision and the license reserved by CDC. The manuscript will be hosted in both PMC and the CDC Stacks institutional repository system. In progress reports for this award, recipient must identify publications subject to the CDC Public Access Policy by using the applicable NIHMS identification number for up to three (3) months after the publication date and the PubMed Central identification number (PMCID) thereafter.

17. Funding Restrictions

Restrictions that must be considered while planning the programs and writing the budget are:

Recipients may not use funds for research.

Recipients may not use funds for clinical care except as allowed by law.

Recipients may use funds only for reasonable program purposes, including personnel, travel, supplies, and services.

Generally, recipients may not use funds to purchase furniture or equipment. Any such proposed spending must be clearly identified in the budget.

Reimbursement of pre-award costs generally is not allowed, unless the CDC provides written approval to the recipient.

Other than for normal and recognized executive-legislative relationships, no funds may be used for:

o publicity or propaganda purposes, for the preparation, distribution, or use of any material designed to support or defeat the enactment of legislation before any legislative body o the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence the enactment of legislation, appropriations, regulation, administrative action, or Executive order proposed or pending before any legislative body

See Additional Requirement (AR) 12 for detailed guidance on this prohibition and additional guidance on lobbying for CDC recipients.

The direct and primary recipient in a cooperative agreement program must perform a http://www.cdc.gov/grants/additionalrequirements/index.html#ar12 http://www.cdc.gov/grants/documents/Anti-Lobbying_Restrictions_for_CDC_Grantees_July_2012.pdf substantial role in carrying out project outcomes and not merely serve as a conduit for an award to another party or provider who is ineligible.

In accordance with the United States Protecting Life in Global Health Assistance policy, all non-governmental organization (NGO) applicants acknowledge that foreign NGOs that receive funds provided through this award, either as a prime recipient or subrecipient, are strictly prohibited, regardless of the source of funds, from performing abortions as a method of family planning or engaging in any activity that promotes abortion as a method of family planning,…