CDC-RFA-EH17-1703.pdf

Image Description: Centers for Disease Control

Centers for Disease Control

National Center for Environmental Health

Increasing Newborn Screening Laboratory Capability to Detect Severe Combined Immunodeficiency (SCID) Using Next Generation Sequencing Technologies

CDC-RFA-EH17-1703

Application Due Date: 05/31/2017

Increasing Newborn Screening Laboratory Capability to Detect Severe Combined Immunodeficiency (SCID) Using Next Generation Sequencing Technologies

CDC-RFA-EH17-1703

TABLE OF CONTENTS

Part I. Overview Information Federal Agency NameA.

Funding Opportunity TitleB.

Announcement TypeC.

Agency Funding Opportunity NumberD.

Catalog of Federal Domestic Assistance (CFDA) NumberE.

Dates F.

Executive Summary G.

Part II. Full Text Funding Opportunity Description A.

Award Information B.

Eligibility Information C.

Application and Submission Information D.

Review and Selection Process E.

Award Administration Information F.

Agency Contacts G.

Other Information H.

Glossary I.

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-EH17-1703. 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. Funding Opportunity Title:

Increasing Newborn Screening Laboratory Capability to Detect Severe Combined Immunodeficiency (SCID) Using Next Generation Sequencing Technologies 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 http://www.cdc.gov/od/science/integrity /docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf.

D. Agency Funding Opportunity Number:

CDC-RFA-EH17-1703

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: 05/31/2017, 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 4/11/2017 at 1pm Eastern Time. Call in number:

1-866-745-4890. Passcode: 1564117

G. Executive Summary:

1. Summary Paragraph:

In 2010 the United States Secretary of Health and Human Services approved SCID as the 30th core condition on the Recommended Uniform Screening Panel, a list of disorders recommended for testing by every newborn screening program in the United States.

As of January 2017, 43 states include SCID as part of their statewide newborn screening panel, and all 50 states have plans to begin screening for SCID in the near future.

CDC previously funded 10 states to initiate newborn screening for SCID. CDC also provided funding to evaluate the feasibility of using next generation sequencing technologies to screen for SCID and other primary immunodeficiencies.

With this funding opportunity, CDC will support 4 newborn screening public health laboratories to purchase next generation sequencing and other laboratory equipment in support of enhanced newborn screening for SCID and other primary immunodeficiencies.

https://foa.grantsolutions.gov/www.grants.gov https://foa.grantsolutions.gov/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 http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf http://www.grants.gov

The intent of this funding opportunity announcement is to increase the number of states and territories in the United States with the capability to test for SCID and other primary immunodeficiencies using next generation sequencing technologies.

This funding will result in a greater number of newborns that are appropriately screened, identified, and referred for treatment for SCID and other primary immunodeficiencies.

a. Eligible Applicants: Open Competition

b. FOA Type: Cooperative Agreement

c. Approximate Number of Awards: 4

d. Total Project Period Funding: $600,000

e. Average One Year Award Amount: $150,000

f. Total Project Period Length: 1

g. Estimated Award Date: 09/30/2017

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 FOA 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 Newborn screening programs test newborns for diseases that are not readily apparent at birth but require immediate medical treatment. Almost 4 million newborns are tested 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.

SCID is a deadly disease that affects one in 40,000-100,000 infants and is treatable if detected early in life.

In 2010, the Secretary’s Advisory Committee on Heritable Disorders in Newborn Screening and Children and the United States Secretary of Health and Human Services approved SCID as the 30th core condition on the Recommended Uniform Screening Panel, a list of disorders recommended for testing by every newborn screening program in the United States. Every state in the U.S. is either already screening for SCID or has plans to begin screening for SCID by the end of 2017.

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

c. Healthy People 2020 This FOA directly addresses Healthy People 2020 priority area Maternal, Infant, and Child Health

This FOA 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 for SCID, other primary immunodeficiencies, and other newborn screening conditions will result in more newborns screened, identified, and referred for treatment. For more information, see https://www.healthypeople.gov/2020/topics-objectives/topic/maternal-infant-and-child-healt h/objectives

d. Other National Public Health Priorities and Strategies This activity is consistent with the Secretary of Health and Human Services’ adoption of SCID as a core condition 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 for SCID in newborn screening laboratories. In 2008 CDC awarded funding via RFA-EH-08-002 to Wisconsin and Massachusetts to demonstrate the feasibility of statewide newborn screening for SCID.

In 2011 CDC supported Michigan and Minnesota 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 Georgia, Oklahoma, and Virginia to build capacity and implement SCID programs. In 2015 CDC provided non-research funds via RFA-EH-15-1504 to Louisiana, Nevada, and North Carolina to implement newborn screening for SCID and provided research funds via RFA-EH-15-002 to develop and validate laboratory procedures using next generation sequencing technologies to assess genes causing SCID in state newborn screening laboratories.

2. CDC Project Description

a. Approach

Bold indicates project period outcome.

Strategies and Activities Short-term outcomes Long-term outcomes

Build capability Purchase laboratory equipment and supplies Validate laboratory methods

Train and educate Train laboratory professionals

***Increased number of laboratory scientists with knowledge and skills to perform newborn screening for SCID using

NGS.

***Increased number of state newborn screening programs with laboratory capability to perform newborn screening for SCID using NGS.

***Increased number of newborns with SCID that receive second tier testing using NGS.

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

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

***Indicates outcome related to this FOA.

i. Purpose This FOA is intended to increase the capability of newborn screening public health laboratories to test for SCID and other primary immunodeficiencies using next generation sequencing technologies.

ii. Outcomes Increased number of laboratory scientists with knowledge and skills to perform newborn screening for SCID using NGS.

Increased number of state newborn screening programs with laboratory capability to perform newborn screening for SCID using NGS.

Increased number of newborns with SCID that receive second tier testing using NGS.

iii. Strategies and Activities Build Capability

During the 12 month award period, awardees will be expected to refine their plans in collaboration with CDC staff and then implement the finalized plan to purchase and begin using laboratory equipment to enhance the capability of their newborn screening laboratory to detect newborns with SCID and other primary immunodeficiencies using next generation sequencing technologies.

The intent of this award is provide funds that will increase the overall capability of the newborn screening laboratory. Plans for use of purchased equipment should extend beyond the funded period and may include testing for conditions in addition to SCID.

Train and Educate

During the 12 month award period, awardees should acquire and demonstrate technical knowledge and expertise necessary to use next generation sequencing technologies in their newborn screening laboratory.

1. Collaborations

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

Collaboration is not required but will be reviewed as part of the proposal evaluation. Applications would be strengthened by collaboration with the New York newborn screening program which was awarded CDC funds to develop and validate laboratory procedures using next generation sequencing technologies to assess genes causing SCID via RFA-EH-15-002.

b. With organizations not funded by CDC:

Collaboration is not required but will be reviewed as part of the proposal evaluation. Applicants should consider collaboration with other laboratories that have experience and subject matter expertise using next generation sequencing technologies.

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 CDC will determine whether awardees successfully attain desired performance and outcome success during the project period. Process measures and outcome measures will be evaluated to guide continuous program improvement and determine the success of this funding opportunity announcement to improve laboratory capability to screen for SCID and other primary immunodeficiencies using next generation sequencing technologies (NGS).

PERFORMANCE MEASURES

Is the plan for purchasing equipment finalized?

Is the staff training plan finalized?

Is equipment purchased?

Is equipment installed?

Is equipment fully operational?

Are staff trained to use equipment?

Are trained staff using the equipment as part of the newborn screening program to detect SCID using

NGS?

OUTCOME MEASURES

How many laboratory scientists gained knowledge and skills to perform newborn screening for SCID using NGS?

How many state newborn screening programs gained laboratory capability to perform newborn screening for SCID using NGS.

How many newborns with SCID received second tier testing using NGS.

ii. Applicant Evaluation and Performance Measurement Plan Applicants must provide an evaluation and performance measurement plan that demonstrates how the awardee will fulfill the requirements described in the CDC Evaluation and Performance Measurement and Project Description sections of this FOA. 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 FOA 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).

Awardees 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 FOA.

c. Organizational Capacity of Awardees to Implement the Approach Applicants must have access to an active public health newborn screening program that includes SCID as part of the screening panel. Applicants must indicate the ability, in terms of laboratory space, staff, and technical expertise, to enhance their screening for SCID using next generation sequencing technologies. Applicants must indicate their intent to continue using purchased equipment after the funding period.

d. Work Plan Applicants must construct a logical, stepwise work plan, including a timeline for month-over-month activities during the 12 month funding period.

e. CDC Monitoring and Accountability Approach Monitoring activities include routine and ongoing communication between CDC and awardees, site visits, and awardee 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 awardee progress in achieving the desired outcomes.

Ensuring the adequacy of awardee 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:

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

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 awardees are performing at a sufficient level to achieve outcomes within stated timeframes.

Working with awardees 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 grantees.

CDC will use ongoing communication with awardees, including regular e-mail correspondance, quarterly conference calls with all awardees, 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. CDC will ensure the adequacy of awardee systems that underlie and generate data and reports related to this award.

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

AGREEMENTS)

• Facilitate communication among awardees and with other newborn screening programs

• Assist in designing, developing, and evaluating laboratory methods, especially with respect to Quality Assurance/Quality Control (QA/QC), integration with the CDC Newborn Screening Quality Assurance Program, and consultation with the CDC Molecular Assessment Program.

• 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.

• Organize quarterly conference calls with all awardees.

B. Award Information

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

Support to Awardees Section.

2. Award Mechanism: U88

3. Fiscal Year: 2017

4. Approximate Total Fiscal Year Funding:

$600,000

5. Approximate Project Period Funding:

$600,000

This amount is subject to the availability of funds.

Estimated Total Funding: $600,000

6. Total Project Period Length:

1 year(s)

7. Expected Number of Awards:

8. Approximate Average Award:

$150,000 Per Project Period

9. Award Ceiling: $150,000 Per Project Period

This amount is subject to the availability of funds.

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

11. Estimated Award Date: 09/30/2017

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 awardee (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 project period 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 The authorizing statute allows awards to States, political subdivisions, and other public and nonprofit private entities. Further, awardees must represent or be an administrative partner to an established state or territorial newborn screening program that currently screens for SCID in a U.S. state or territory. Applicants should provide a letter certifying they represent or are an administrative partner to an established state or territorial newborn screening program.

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 FOA 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-awardees, those sub-awardees 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 an awardee. 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

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 1-866-705-5711Image Description:

http://www.grants.gov/ http://fedgov.dnb.com/webform/displayHomePage.do https://www.sam.gov/portal/public/SAM/ http://grants.gov/ http://www.grants.gov/ http://www.grants.gov/ http://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 member(s) to obtain DUNS number, verify & update information under 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:

866-606-8220Image Description:

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

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 http://www.sam.gov https://fsd.gov/fsd-gov/home.do https://fsd.gov/fsd-gov/home.do

AOR to submit applications on behalf of the organization

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 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 770-488-2700Image Description: or e-mail OGS ogstims@cdc.gov for assistance. Persons with hearing loss may access CDC telecommunications at TTY 1-888-232-6348Image Description: .

4. Submission Dates and Times If the application is not submitted by the deadline published in the FOA, 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: 05/31/2017 , 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 4/11/2017 at 1pm Eastern Time. 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) http://www.grants.gov http://www.grants.gov mailto:ogstims@cdc.gov http://www.grants.gov http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx 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, 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 nor required as part of the application for this FOA.

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 project period as identified in the CDC Project Description section. Applicants should use the federal plain language guidelines and Clear Communication Index to respond to this Funding Opportunity Announcement. Note that awardees should also use these tools when creating public communication materials supported by this FOA. Failure to follow the guidance and format may negatively impact scoring of the application.

http://www.grants.gov http://www.grants.gov

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 project period 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 awardee will fulfill the requirements described in the CDC Evaluation and Performance Measurement and Project Description sections of this FOA. 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 http://www.hhs.gov/ocio/policy/collection/ 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).

Awardees 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 FOA.

Applicants must name this file "CVs/Resumes" or "Organizational Charts" and upload it at www.grants.gov.

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 awardee plans to carry out achieving the project period outcomes, strategies and activities, evaluation and performance measurement.

12. Budget Narrative 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 will not be reimbursed under grants to foreign organizations, international organizations, and foreign components of grants to domestic organizations (does not affect indirect cost reimbursement to the domestic entity for domestic activities).

For guidance on completing a detailed budget, see Budget Preparation Guidelines at: http:// www.cdc.gov /grants /interested in applying /application resources.html.

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 FOA 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 http://www.grants.gov/ http://www.cdc.gov/grants/interestedinapplying/applicationresources.html http://www.cdc.gov/grants/interestedinapplying/applicationresources.html http://www.phaboard.org

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 FOA. 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 Grantees under such a plan. Applicants must name this file “Indirect Cost Rate” and upload it at www.grants.gov.

If applicant is a recipient of federal or other funds to support state newborn screening activities, applicant must indicate use of CDC funds is for activities not covered by other funds.

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). Grantees will be required to draw down funds from award-specific accounts in the PMS. Ultimately, the subaccounts will provide grantees 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 grantees 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:

Awardees may not use funds for research.

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

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

Generally, awardees 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 awardee.

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

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 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 awardees.

The direct and primary recipient in a cooperative agreement program must perform a 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.

Funds should be used to purchase laboratory equipment and supplies.

http://www.cdc.gov/grants/additionalrequirements/index.html#ar12 http://www.cdc.gov/grants/documents/Anti-Lobbying_Restrictions_for_CDC_Grantees_July_2012.pdf http://www.cdc.gov/grants/documents/Anti-Lobbying_Restrictions_for_CDC_Grantees_July_2012.pdf

Funds should be used to purchase laboratory equipment and supplies.

Projects that involve the collection of information from 10 or more individuals and are funded by a grant/cooperative agreement will be subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act.

18. Data Management Plan As identified in the Evaluation and Performance Measurement section, applications involving data collection must include a Data Management Plan (DMP) as part of their evaluation and performance measurement plan. The DMP is the applicant’s assurance of the quality of the public health data through the data’s lifecycle and plans to deposit data in a repository to preserve and to make the data accessible in a timely manner. See web link for additional information:

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

19. Other Submission Requirements

a. Electronic Submission: Applications must be submitted electronically at www.grants.gov. The application package can be downloaded at www.grants.gov. Applicants can complete the application package off-line and submit the application by uploading it at www.grants.gov. All application attachments must be submitted using a PDF file format. Directions for creating PDF files can be found at www.grants.gov. File formats other than PDF may not be readable by OGS Technical Information Management Section (TIMS) staff.

Applications must be submitted electronically by using the forms and instructions posted for this funding opportunity at www.grants.gov.

If Internet access is not available or if the forms cannot be accessed online, applicants may contact the OGS TIMS staff at 770- 488-2700 or by e-mail at ogstims@cdc.gov, Monday through Friday, 7:30 a.m.–4:30 p.m., except federal holidays. Electronic applications will be considered successful if they are available to OGS TIMS staff for processing from www.grants.gov on the deadline date.

b. Tracking Number: Applications submitted through www.grants.gov are time/date stamped electronically and assigned a tracking number. The applicant’s Authorized Organization Representative (AOR) will be sent an e-mail notice of receipt when www.grants.gov receives the application. The tracking number documents that the application has been submitted and initiates the required electronic validation process before the application is made available to CDC.

c. Validation Process: Application submission is not concluded until the validation process is completed successfully. After the application package is submitted, the applicant will receive a “submission receipt” e-mail generated by www.grants.gov. A second e-mail message to applicants will then be generated by www.grants.gov that will either validate or reject the submitted application package. This validation process may take as long as two business days. Applicants are strongly encouraged to check the status of their application to ensure that submission of their package has been completed and no submission errors have occurred. Applicants also are strongly encouraged to allocate ample time for filing to guarantee that their application can be submitted and validated by the deadline published in the FOA. Non-validated applications will not be accepted after the published application deadline date.

If you do not receive a “validation” e-mail within two business days of application submission, please contact www.grants.gov. For instructions on how to track your application, refer to the e-mail message https://www.cdc.gov/grants/additionalrequirements/ar-25.html http://www.Grants.gov http://www.Grants.gov http://www.Grants.gov http://www.Grants.gov http://www.Grants.gov mailto:ogstims@cdc.gov http://www.Grants.gov http://www.Grants.gov http://www.Grants.gov http://www.Grants.gov http://www.Grants.gov http://www.Grants.gov generated at the time of application submission or the Grants.gov Online User Guide.

http:// www.grants.gov/help/html/help/index.htm? callingApp=custom#t= Get_Started%2FGet_Started. htm

d. Technical Difficulties: If technical difficulties are encountered at www.grants.gov, applicants should contact Customer Service at www.grants.gov. The www.grants.gov Contact Center is available 24 hours a day, 7 days a week, except federal holidays. The Contact Center is available by phone at 1-800-518-4726Image Description: or by e-mail at support@grants.gov. Application submissions sent by e-mail or fax, or on CDs or thumb drives will not be accepted. Please note that www.grants.gov is managed by HHS.

e. Paper Submission: If technical difficulties are encountered at www.grants.gov, applicants should call the www.grants.gov Contact Center at 1-800-518-4726Image Description: or e-mail them at support@grants.gov for assistance.