cdc-rfa-eh15-1504 amend 1.pdf

Centers for Disease Control and Prevention

National Center for Environmental Health

Newborn Screening for Severe Combined Immunodeficiency (SCID)

CDC-RFA-EH15-1504

Application Due Date: 05/20/2015

Newborn Screening for Severe Combined Immunodeficiency (SCID)

CDC-RFA-EH15-1504

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.

Required Registrations 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-EH15-1504. 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) B. Funding Opportunity Title:

Newborn Screening for Severe Combined Immunodeficiency (SCID) C. Announcement Type: New - Type 1 This announcement is only for non-research domestic activities supported by CDC. If research is proposed, the application will not be considered Research for this purpose is defined at http://www.cdc. gov/od/ science / integrity/ docs/cdc- policy- distinguishing- public- health- research- nonresearch. pdf.

D. Agency Funding Opportunity Number:

CDC-RFA-EH15-1504

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: 05/20/2015, 11:59 p.m. U.S. Eastern

Standard Time, at www.grants.gov.

3. Date for Informational Conference Call: 04/02/2015 Informational conference call to be held on 4/2/2015 at 1pm Eastern Time. Call in number:

1-866-745-4890. Passcode: 1564117

G. Executive Summary:

1. Summary Paragraph:

Severe combined immunodeficiency (SCID) is a treatable condition 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.

As of January 2015, 27 states and the District of Columbia include SCID as part of their statewide newborn screening panel. CDC will initiate a funding opportunity awarding up to $600,000 through cooperative agreements to state or territorial public health newborn screening programs that do not currently conduct statewide SCID newborn screening. Awarded funds will support awardees to purchase needed laboratory equipment and supplies to begin newborn screening for SCID and will support awardees to train and educate appropriate laboratory staff, public health professionals, and health care providers.

The intent of this funding opportunity announcement is to increase the number of states and territories in the United States that include SCID screening as part of their newborn screening program, resulting in a greater number of newborns that are screened, identified, and referred for treatment for SCID.

The purpose of Amendment 1 (appended to the bottom of the FOA, see page 28) is to provide additional clarifying information based on questions received from potential applicants during the https://foa.grantsolutions.gov/announcementmodule/www.grants.gov https://foa.grantsolutions.gov/announcementmodule/www.grants.gov 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 pre-application informational conference call or as a result of direct communication with the Project Officer.

a. Eligible Applicants: Open Competition

b. FOA Type: Cooperative Agreement

c. Approximate Number of Awards: 4

d. Total Project Period Funding: $1,200,000

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

f. Number of Years of Award: 2

g. Estimated Award Date: 09/01/2015

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

1. Background

a. Overview

Newborn screening programs test infants for diseases that require immediate medical treatment but are not apparent at birth. More than 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.

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 (MICH)-32: Increase appropriate newborn blood-spot screening and follow-up testing. Funding for states or territories to implement newborn screening for SCID will result in more newborns screened, identified, and referred for treatment. For more information, see www.healthypeople.gov

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) http://www.healthypeople.gov http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders/recommendedpanel/index.html http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders/recommendedpanel/index.html

e. Relevant Work

This activity builds on previous successful CDC-funded projects to implement newborn screening for SCID in state or territorial 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. Through this funding opportunity announcement, CDC intends to further increase the number of states or territories that include SCID in their newborn screening programs.

2. CDC Project Description

a. Approach

Strategies and Activities Short-term outcomes Long-term outcomes

Build capacity

Purchase laboratory equipment and supplies

Train and educate

Train laboratory professionals Educate public health community Educate health care providers

**Increased number of laboratory scientists with knowledge and skill in conducting newborn screening for SCID.

**Increased number of newborn screening programs with laboratory capacity and performance capability to conduct newborn bloodspot screening for SCID.

**Increased number of states with active, sustainable SCID newborn screening programs.

**Increased number of newborns screened for SCID.

**Increased number of newborns referred to the medical community for SCID follow-up.

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

**Indicates outcome to be accomplished during the project period.

i. Purpose

Primary participation by state or territorial laboratories with newborn screening programs is essential to the purpose of the FOA: to increase the number of states and territories with active SCID newborn screening programs and ultimately improve health outcomes for infants born with SCID.

ii. Outcomes

Increased number of laboratory scientists with knowledge and skill in conducting newborn screening for SCID.

Increased number of newborn screening programs with laboratory capacity and performance capability to conduct newborn bloodspot screening for SCID.

Increased number of states with active, sustainable SCID newborn screening programs.

Increased number of newborns screened for SCID.

Increased number of newborns referred to the medical community for SCID follow-up.

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

iii. Strategies and Activities

Build newborn screening laboratory capacity

Awardee should purchase appropriate laboratory equipment and supplies to implement SCID screening.

Train and educate public health, medical, and laboratory staff in preparation for SCID screening

Train laboratory professionals on appropriate methods to screen for SCID in the newborn screening laboratory setting.

Educate the public health community in preparation for SCID screening.

Educate health care providers who may provide care for children who test positive for SCID.

1.Collaborations

Applicants should provide evidence of support from appropriate collaborators via letters of support, MOAs, MOUs, etc.

a. With CDC-funded programs:

Applicants should consider collaboration with existing SCID programs, such as state programs currently (Georgia, Oklahoma, Virginia) or previously funded (Wisconsin, Massachusetts, Michigan, Minnesota) by CDC, to share expertise and program challenges and successes. Applicants should also consider collaborating with the CDC Molecular Assessment Program, which provides guidance, technical expertise, and on-site assessment to state public health programs implementing molecular testing techniques.

b. With organizations external to CDC:

Applicants should consider appropriate collaboration with and support from newborn screening stakeholders to accomplish diverse activities. Potential collaborators may include, but are not limited to: academic institutions, professional organizations, non-profit organizations, advocacy groups, parent support groups, community groups, public health officials, health care providers. Engagement with these groups will confirm stakeholder support to implement and sustain a SCID screening program.

2. Target Populations

N/A

a. Inclusion

N/A

iv. Funding Strategy (for multi-component FOAs only)

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 capacity to screen for SCID and increase the number of newborns screened for this condition.

Key performance metrics will include:

Build newborn screening laboratory capacity

Equipment necessary for SCID testing is purchased and installed Supplies necessary for SCID testing are purchased Appropiate staff are hired SCID test is developed and validated with acceptable test sensitivity and specificity

Train and educate public health, medical, and laboratory staff in preparation for SCID screening

SCID screening protocol is developed and disseminated Laboratory staff are trained to perform SCID testing Newborn screening program staff are educated about SCID screening Health care providers who may provide care for children who test positive for SCID are educated about SCID screening

Outcome measures will include:

Number of new laboratory scientists with knowledge and skill in conducting newborn screening for

SCID.

Number of new newborn screening programs with laboratory capacity and performance capability to conduct newborn bloodspot screening for SCID.

Number of new states with active, sustainable SCID newborn screening programs.

Number of newborns screened for SCID through this FOA.

Number of newborns referred to the medical community for SCID follow-up through this FOA.

ii. Applicant Evaluation and Performance Measurement Plan

Applicants must develop a plan to evaluate their proposed process for implementation of screening and related outcomes that is consistent with the CDC strategy. Applicants’ evaluation and performance measurement plan should include:

• Description of how key program partners will be engaged in the evaluation and performance measurement planning processes

• Description of the type of evaluations to be conducted

• Description of key evaluation questions to be answered

• Description of potentially available data sources and feasibility of collecting appropriate evaluation and performance data

• Description of how evaluation findings will be used for continuous program improvement

• Description of how performance will be measured against proposed timelines

c. Organizational Capacity of Awardees to Execute the Approach

Applicants must have access to an active public health newborn screening program that does not currently include SCID as part of the screening panel. Applicants must indicate the ability, in terms of laboratory space, staff, and technical expertise, and the legal authority that enables their program to expand their newborn screening program to include SCID. Applicants must indicate the ability to sustain the SCID screening program after the end of the funding period.

d. Work Plan

Applicants must construct a logical, stepwise work plan, including a timeline for month-over-month activities during the 24 month funding period. At a minimum the work plan should address activities and timelines to support achievement of FOA outcomes. Activities must be in alignment with the FOA logic model and should have appropriate performance measures or milestones for accomplishing tasks.

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:

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.

Other activities deemed necessary to monitor the award, if applicable.

These activities may include 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 monthly conference calls, work plans, performance measures and evaluation plans, and timelines to monitor progress toward outcomes. CDC will also 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 active SCID 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 monthly conference calls.

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:

3. Fiscal Year: 2015 Estimated Total Funding: $600,000

4. Approximate Total Fiscal Year Funding: $600,000

5. Approximate Project Period Funding: $1,200,000

6. Total Project Period Length: 2 year(s)

7. Expected Number of Awards: 4

8. Approximate Average Award: $150,000 Per Project Period

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

10. Award Floor: $75,000 Per Project Period

11. Estimated Award Date: 09/01/2015 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).

12. Budget Period Length: 12 month(s)

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

C. Eligibility Information

1. Eligible Applicants Eligibility Category: State governments

County governments City or township governments Special district governments Independent school districts Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities

Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education For profit organizations other than small businesses Small businesses Others (see text field entitled "Additional Information on Eligibility" for clarification) Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"

Government Organizations:

State (includes the District of Columbia) Local governments or their bona fide agents Territorial governments or their bona fide agents in 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.

State controlled institutions of higher education American Indian or Alaska Native tribal governments (federally recognized or state-recognized)

Non-government Organizations:

American Indian or Alaska native tribally designated organizations

Other:

Private colleges and universities Community-based organizations Faith-based organizations

2. Additional Information on Eligibility

Applicants must be able to implement and sustain a new newborn screening program for SCID in a U.S.

state or territory. Applicants must represent or be an administrative partner to an established state or territorial newborn screening program. Applicants from states or territories that currently include SCID on their newborn screening panel are not eligible to apply. Applicants currently receiving funds to implement SCID in their state are eligible to apply for this award, provided that the funds are used for different purposes.

The award ceiling for this FOA is $300,000. CDC will consider any application requesting an award higher than this amount as non- responsive and it will receive no further review. If a pre-application is required, then specify here and include it in the special eligibility requirements section. (http:// www.hhs.gov/ asfr/ ogapa/ aboutog/ hhsgps107.pdf)

3. Justification for Less than Maximum Competition http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf

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. Required Registrations

Additional materials that may be helpful to applicants: http://www.cdc.gov/od/pgo/funding/docs/Financial ReferenceGuide.pdf.

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 usually requires not more than five 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 through www.grants.gov, the official HHS E-grant website. Registration information is located at the "Get Registered" option at www.grants.gov.

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

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

3. Application Package http://www.cdc.gov/od/pgo/funding/docs/FinancialReferenceGuide.pdf http://www.cdc.gov/od/pgo/funding/docs/FinancialReferenceGuide.pdf http://www.grants.gov http://fedgov.dnb.com/webform/displayHomePage.do https://www.SAM.gov http://www.Grants.gov http://www.grants.gov http://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 PGO staff at 770-488-2700 or e-mail PGO PGOTIM@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 FOA, it will not be processed. PGO 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 PGO.

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

b. Application Deadline Due Date for Applications: 05/20/2015, 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 Informational Conference Call: 04/02/2015

Informational conference call to be held on 4/2/2015 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://www.cdc.gov/grants/interestedinapplying/applicationprocess.html.

Complete the applicable assurances and certifications on an annual basis, name the file “Assurances and Certifications” and upload it as a PDF file 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.

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 (No page limit and not included in Project Narrative 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.

http://www.grants.gov https://foa.grantsolutions.gov/announcementmodule/PGOTIM@cdc.gov%20 http://www.grants.gov http://www.cdc.gov/grants/interestedinapplying/applicationprocess.html http://www.grants.gov/ http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx

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 (Maximum of 20 pages, single spaced, Calibri 12 point, 1-inch margins, number all pages. Content beyond 20 pages will not be considered. The 20 page limit includes the work plan. For a multi-component FOA, maximum page limit is 25.)

The Project Narrative must include all of the bolded headings shown in this section. 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 must submit a Project Narrative with the application forms. Applicants must name this file “Project Narrative” and upload it at 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 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.

Outcomes are the results that the program intends to achieve. All outcomes must indicate the intended direction of change (e.g., increase, decrease, maintain). (See the logic model in the Approach section of the CDC Project Description.)

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 CDC Project Description: Strategies and Activities section.)

1. Collaborations Applicants must describe how they will collaborate with programs and organizations either internal or external to CDC.

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.

Applicants must file letters of support, as appropriate, name the file “Letters of Support”, and upload it as a PDF file at www.grants.gov.

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

2. Target Populations 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. Refer back to the CDC Project Description section – Approach: Target Population.

Applicant must target a US state or territory population.

c. Applicant Evaluation and Performance Measurement Plan Applicants must provide an overall evaluation and performance measurement plan that is consistent with the CDC Evaluation and Performance Measurement Strategy section of the CDC Project Description of this FOA. Data collected must be used for ongoing monitoring of the award to evaluate its effectiveness, and for continuous program improvement.

The plan must:

Affirm the ability to collect the performance measures and respond to the evaluation questions specified in the CDC strategy. (For guidance regarding the Paperwork Reduction Act, please visit http://www.hhs.gov/ocio/policy/collection/infocollectfaq.html) Describe how key program partners will participate in the evaluation and performance measurement planning processes.

Describe how evaluation findings will be used for continuous program quality improvement.

Where the applicant chooses to, or is expected to, take on specific evaluation studies:

Describe the type of evaluation(s) (i.e., process, outcome, or both) to be conducted.

Describe key evaluation questions to be addressed by these evaluations.

Describe other information relevant to the evaluation (e.g., measures, data sources)

Awardees will be required to submit a more detailed evaluation and performance measurement plan within the first 6 months of the project, as outlined in the reporting section of the FOA.

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

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

11. Work Plan (Included in the Project Narrative’s 20 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.

Applicants must name this file "Work Plan" and upload it as a PDF file at www.grants.gov.

Applicant must address the organizational capacity requirements as described in the CDC Project Description.

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

12. Budget Narrative Applicants must submit an itemized budget narrative, which may be scored as part of the Organizational Capacity of Awardees to Execute the Approach. 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 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). The CDC will not reimburse indirect costs unless the recipient has an indirect cost rate covering the applicable activities and period.

For guidance on completing a detailed budget, see Budget Preparation Guidelines at:http://www.cdc.gov/grants/interestedinapplying/applicationresources.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 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 additional funds, Federal or otherwise, to implement SCID screening in their state or territory, applicant must indicate use of CDC funds is for activities not covered by other funds.

13. Tobacco and Nutrition Policies http://www.cdc.gov/grants/interestedinapplying/applicationresources.html http://www.phaboard.org

13. Tobacco and Nutrition Policies Awardees are encouraged to implement tobacco and nutrition policies.

Unless otherwise explicitly permitted under the terms of a specific CDC award, no funds associated with this FOA may be used to implement the optional policies, and no applicants will be evaluated or scored on whether they choose to implement these optional policies.

CDC supports implementing evidence-based programs and policies to reduce tobacco use and secondhand smoke exposure, and to promote healthy nutrition. CDC encourages all awardees to implement the following optional recommended evidence-based tobacco and nutrition policies within their own organizations. The tobacco policies build upon the current federal commitment to reduce exposure to secondhand smoke, specifically The Pro-Children Act, 20 U.S.C. 7181-7184, that prohibits smoking in certain facilities that receive federal funds in which education, library, day care, health care,or early childhood development services are provided to children.

Tobacco Policies:

Tobacco-free indoors: Use of any tobacco products (including smokeless tobacco) or electronic cigarettes is not allowed in any indoor facilities under the control of the awardee.

1.

Tobacco-free indoors and in adjacent outdoor areas: Use of any tobacco products or electronic cigarettes is not allowed in any indoor facilities, within 50 feet of doorways and air intake ducts, and in courtyards under the control of the awardee.

2.

Tobacco-free campus: Use of any tobacco products or electronic cigarettes is not allowed in any indoor facilities or anywhere on grounds or in outdoor space under the control of the awardee.

3.

Nutrition Policies:

Healthy food-service guidelines must, at a minimum, align with HHS and General Services Administration Health and Sustainability Guidelines for Federal Concessions and Vending Operations.

These guidelines apply to cafeterias, snack bars, and vending machines in any facility under the control of the awardee and in accordance with contractual obligations for these services (see: http://www.gsa.gov/ graphics/pbs/Guidelines_for_ Federal_ Concessions_and_Vending _ Operations.pdf).

1.

Resources that provide guidance for healthy eating and tobacco-free workplaces are:2.

http://www.cdc.gov/ nccdphp/dnpao/hwi/ toolkits/ tobacco/index.htm http://www. thecommunityguide.org/ tobacco/index.html http:// www.cdc.gov /obesity /strategies /food-serv-guide.html

14. Health Insurance Marketplaces A healthier country is one in which Americans are able to access the care they need to prevent the onset of disease and manage disease when it is present. The Affordable Care Act, the health care law of 2010, creates new Health Insurance Marketplaces, also known as Exchanges, to offer millions of Americans affordable health insurance coverage. In addition, the law helps make prevention affordable and accessible for Americans by requiring health plans to cover certain recommended preventive services without cost sharing.

Outreach efforts will help families and communities understand these new options and provide eligible individuals the assistance they need to secure and retain coverage as smoothly as possible. For more information on the Marketplaces and the health care law, visit: www.HealthCare.gov.

15. Intergovernmental Review

Executive Order 12372 does not apply to this program.

16. Pilot Program for Enhancement of Employee Whistleblower Protections http://www.gsa.gov/graphics/pbs/Guidelines_for_Federal_Concessions_and_Vending_Operations.pdf http://www.gsa.gov/graphics/pbs/Guidelines_for_Federal_Concessions_and_Vending_Operations.pdf http://www.cdc.gov/nccdphp/dnpao/hwi/toolkits/tobacco/index.htm http://www.thecommunityguide.org/tobacco/index.html http://www.cdc.gov/obesity/strategies/food-serv-guide.html http://www.HealthCare.gov

16. 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 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.

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.

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 is not allowed.

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 http:// www.cdc.gov /grants /additional requirements /index.htm l#ar12 for detailed guidance on this prohibition and http://www. cdc.gov/ grants /documents/Anti- Lobbying _Restrictions_ for_CDC_ Grantees_July _2012.pdf

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 may be used to purchase laboratory equipment.

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. 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 PGO 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 PGO TIMS staff at 770- 488-2700 or by e-mail at pgotim@cdc.gov, Monday through Friday, 7:30 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 http://www.Grants.gov http://www.Grants.gov http://www.Grants.gov http://www.Grants.gov http://www.Grants.gov a.m.–4:30 p.m., except federal holidays. Electronic applications will be considered successful if they are available to PGO 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 generated at the time of application submission or the Applicant User Guide, Version 1.1, page 102.

http:// www.grants.gov /documents /19/18243 /Grantsgov ApplicantUserGuide .pdf /ce754626 -c2aa-44bc- b701 -30a75bf428c8

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 1-800-518-4726 or by e-mail at support@www.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 1-800-518-4726 or e-mail them at support@www.grants.gov for assistance. After consulting with the Contact Center, if the technical difficulties remain unresolved and electronic submission is not possible, applicants may e-mail or call CDC GMO/GMS, before the deadline, and request permission to submit a paper application. Such requests are handled on a case-by-case basis.

An applicant’s request for permission to submit a paper application must:

Include the www.grants.gov case number assigned to the inquiry1.

Describe the difficulties that prevent electronic submission and the efforts taken with the www.grants.gov Contact Center to submit electronically; and

2.

Be postmarked at least three calendar days before the application deadline. Paper applications submitted without prior approval will not be considered. If a paper application is authorized, PGO will advise the applicant of specific instructions for submitting the application (e.g., original and two hard copies of the application by U.S. mail or express delivery service).

3.

E. Review and Selection Process

1. Review and Selection Process: Applications will be reviewed in three phases.

http://www.Grants.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/documents/19/18243/GrantsgovApplicantUserGuide.pdf/ce754626-c2aa-44bc-b701-30a75bf428c8 http://www.grants.gov/documents/19/18243/GrantsgovApplicantUserGuide.pdf/ce754626-c2aa-44bc-b701-30a75bf428c8 http://www.Grants.gov http://www.Grants.gov mailto:support@www.grants.gov http://www.grants.gov http://www.grants.gov mailto:support@www.grants.gov

a. Phase I Review All applications will be reviewed initially for completeness by CDC PGO staff and will be reviewed jointly for eligibility by the CDC NCEH and PGO. Incomplete applications and applications that do not meet the eligibility criteria will not advance to Phase II review. Applicants will be notified that their applications did not meet eligibility or published submission requirements.

b. Phase II Review A review panel will evaluate complete, eligible applications in accordance with the criteria below.

i. Approach

ii. Evaluation and Performance Measurement

iii. Applicant’s Organizational Capacity to Implement the Approach

i. Approach Maximum Points: 50

Is the proposed approach likely to produce a new SCID newborn screening program in a U.S. state or territory by the end of the 2 year project period?

Does the applicant present a reasonable need for the requested funds in order to implement a new SCID screening program?

Does the work plan include a logical, stepwise process to implement SCID screening?

Does the applicant propose a reasonable timeline?

Are appropriate partnerships and collaborations indicated and supported?

Are all proposed activities consistent with the program strategy?

ii. Evaluation and Performance Management [25 points] Maximum Points: 25

Does the applicant present a reasonable plan to continuously measure their performance against the proposed timeline?

Does the applicant present a reasonable plan to evaluate their overall process to implement screening during the award?

Does the applicant present a reasonable plan to evaluate the implemented screening program?

iii. Applicants Organizational Capacity to Implement the Approach [25 points]

Maximum Points: 25

Does the applicant satisfactorily address the issue of public health authority to screen for SCID?

Does the applicant have access to a U.S. territory or state population for newborn screening?

Does the applicant have the infrastructure necessary to expand the existing newborn screening program to include SCID?

Does the applicant have or indicate a plan to obtain appropriate technical expertise to implement the SCID newborn screening…