RFA-DD-17-001PublicationAmendment.pdf

Centers for Disease Control

National Center on Birth Defects and Developmental Disabilities Extramural Research Program Office

Coordinating Center for Research to Promote the Health of Children with Birth Defects and People with

Developmental and Other Disabilities

RFA-DD-17-001

Application Due Date: 02/22/2017

Coordinating Center for Research to Promote the Health of Children with Birth Defects and People with Developmental and Other Disabilities

RFA-DD-17-001

TABLE OF CONTENTS

Part 1. Overview Information Key Dates Required Application Instructions Executive Summary

Part 2. Full Text Section I. Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 1. Overview Information Participating Organization(s) Centers for Disease Control Components of Participating Organizations National Center on Birth Defects and Developmental Disabilities Extramural Research Program Office

(NCBDDD ERPO)

National Center on Birth Defects and Developmental Disabilities (NCBDDD) Funding Opportunity Announcement (FOA) Title Coordinating Center for Research to Promote the Health of Children with Birth Defects and People with Developmental and Other Disabilities Activity Code Amendment 1. February 9, 2017.

Appendix 2 "Questions from Potential Applicants and CDC Responses" added to Section VIII. "Other Information".

U19

Funding Opportunity Announcement Type New Funding Opportunity Announcement Number

RFA-DD-17-001

Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.073 Category of Funding Activity:

Health FOA Purpose The National Center on Birth Defects and Developmental Disabilities (NCBDDD) seeks to develop an external coordinating center for research and dissemination of information that supports the Center’s mission and advances scientific and research agenda by conducting research across a network of universities and other institutions of higher learning that specialize in birth defects, blood disorders, and developmental and other types of disability research.

Key Dates Publication Date: To receive notification of any changes to RFA-DD-17-001, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link. An email address is needed for this service.

Letter of Intent Due Date: 01/20/2017

Application Due Date: 02/22/2017

On-time submission requires that electronic applications be error-free and made available to CDC for http://www.grants.gov

On-time submission requires that electronic applications be error-free and made available to CDC for processing from eRA Commons on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov/eRA Commons no later than 5:00 PM U.S. Eastern Time. Note:

HHS/CDC grant submission procedures do not provide a period of time beyond the application due date to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

Scientific Merit Review: 04/07/2017

Secondary Review: 05/05/2017

Estimated Start Date: 09/30/2017

Expiration Date: 02/23/2017 Due Dates for E.O. 12372: Executive Order 12372 does not apply to this program.

Required Application Instructions It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this FOA. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Note: The Research Strategy component of the Research Plan is limited to 25 pages.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348

Executive Summary Purpose. The National Center on Birth Defects and Developmental Disabilities (NCBDDD) seeks to develop an external coordinating center for research and dissemination of information that supports the Center’s mission and advances its scientific and research agenda by conducting research across a network of universities and other institutions of higher learning that specialize in birth defects, blood disorders, developmental and other types of disability research .

Mechanism of Support. Cooperative Agreement Funds Available and Anticipated Number of Awards. The estimated total level of funding (direct and indirect for entire project period in dollars) that is available for the FOA is $15,025,000. An Award issued under this FOA is contingent upon availability of funds and a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of each award may also vary.

One award will be made.

Budget and Project Period. The estimated total funding (direct and indirect) for the first budget period, 09/30/2017 through 09/29/2018, is $675,000 for one award. The estimated total funding (direct and indirect) for the entire project period, 09/30/2017 through 09/29/2022, is $15,025,000.

Application Research Strategy Length: Page limits for the Research Strategy are clearly specified in Section IV. Application and Submission Information of this announcement.

Eligible Institutions/Organizations. Institutions/organizations listed in Section III are eligible to apply.

Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. NOTE: CDC does not make awards to individuals directly. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply.

http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#SectionIV http://era.nih.gov/commons/index.cfm#SectionIII1A with disabilities are always encouraged to apply.

Number of PDs/PIs. Applications may include more than one PI; however, the first PI listed on the application will be the “contact PI” for all correspondence. Any additional PIs are permitted, but would be referred to as Co-PIs.

Number of Applications. Only one application per institution (normally identified by having a unique DUNS number) is allowed.

Application Type. New.

Special Date(s). N/A Application Materials. See Section IV.1 for application materials. Please note that Form D is to be used when downloading the application package.http://grants.nih.gov/grants/funding/424/index.htm #inst Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: (770) 488-2783.

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority This program is authorized under Sections 301 and 317 [C] of the Public Health Service Act, (42 U.S.C., Section 241 and 247b-4) as amended.

1. Background and Purpose Created by the Children’s Health Act of 2000, CDC’s National Center on Birth Defects and Developmental Disabilities (NDBDDD) seeks to promote the health and well-being of babies, children, and adults by studying and addressing the causes of birth defects; helping children reach their potential by understanding developmental disabilities; reducing complications of blood disorders; and improving the health of people living with disabilities. In collaboration with our many national, state, local and professional organization partners, NCBDDD strives to identify the risk factors and causes of these conditions to enhance the potential for healthy and productive living for all. NCBDDD envisions a future where babies are born healthy.

Children reach their potential. And everyone thrives.

Saving Babies through Birth Defects Prevention and Research

Major birth defects (BD) are conditions that cause structural changes in one or more parts of the body; are present at birth; and have a serious adverse effect on health, development, or functional ability. About 1:33 babies are born with a birth defect. Birth defects are a leading cause of infant death, accounting for more than one of every five infant deaths. In addition, babies born with birth defects have a greater chance of illness and long term disability than babies without birth defects.

Helping Children Reach Their Potentional by Understatnding Developmental Disabilities

Developmental disabilities are a diverse group of conditions that include mental and/or physical impairments. People with developmental disabilities have problems with major life activities such as communication, mobility, learning, and independent living. Developmental disabilities begin prior to 22 years of age and usually last throughout a person’s lifetime. Autism Spectrum Disorders (ASDs), are a group of developmental disabilities that can cause significant social, communication, and behavioral challenges.

CDC estimates that an average of 1:68 children in the United States (U.S.) have an ASD.

Additionally NCBDDD focuses on protecting people who are especially vulnerable to health risks, in particular young children. The early years of life (birth to 5 years of age) are critical to a child’s cognitive, social, and emotional development. CDC works with partners to develop public health tools and interventions that give all children the opportunity to reach their full potential http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm#SectionIV1 http://grants.nih.gov/grants/funding/424/index.htm#inst http://grants.nih.gov/grants/funding/424/index.htm#inst

Protecting People and Preventing Complications of Blood Disorders

Blood disorders, including bleeding and clotting disorders and hemoglobinpathies, such as sickle cell disease affects millions of people each year in the United States, cutting across the boundaries of age, race, sex, and socioeconomic status. Men, women, and children of all backgrounds live with the complications associated with these conditions, many of which are painful and potentially life-threatening. With proper preventive actions and early intervention, many of these disorders and their complications could, to a large extent, be eliminated. We are dedicated to reducing the public health burden resulting from these conditions by contributing to a better understanding of blood disorders and their complications; ensuring that prevention programs are developed, implemented, and evaluated; ensuring that information is accessible to consumers and health care providers; and encouraging action to improve the quality of life for people living with or affected by these conditions.

Improving the Health of People with Disabilities

People can acquire disabilities at any point throughout their life through injury, illness, chronic conditions and later-onset conditions. As a group, the 54 million adults in the U.S. living with disabilities experience worse health outcomes and quality of life than those without disabilities. Since the beginning, NCBDDD has provided sound science and program support for disability as a public health priority, striving for a balanced approach between primary prevention of disabilities and the prevention of secondary conditions.

NCBDDD is committed to identifying and addressing the unique challenges to health experienced by people with disabilities across the lifespan.

Purpose

The purpose of this cooperative agreement award is to develop a central NCBDDD Coordinating Center to actively outreach and establish innovative partnerships with academic and other researchers to expand upon the scientific knowledge to promote the health and well-being of babies, children, and adults by studying and addressing the causes of birth defects; helping children reach their potential by understanding developmental disabilities; reducing complications of blood disorders; and improving the health of people living with disabilities.

Healthy People 2020 and other National Strategic Priorities The applicable Healthy People 2020 goals and objectives:

Access to Health Services goal: Improve access to comprehensive, quality health care services.

Blood Disorders goal: Prevent illness and disability related to blood disorders and the use of blood products.

Disability and Health goal: Maximize health, prevent chronic disease, improve social and environmental living conditions, and promote full community participation, choice, health equity, and quality of life among individuals with disabilities of all ages.

Early and Middle Childhood goal: Document and track population-based measures of health and well-being for early and middle childhood populations over time in the United States.

Health Related Quality of Life and Well Being goal: Improve health-related quality of life and well-being for all individuals.

Hearing and Other Sensory or Communication Disorders goal: Reduce the prevalence and severity of disorders of hearing and balance; smell and taste; and voice, speech, and language.

Maternal, Infant, Child Health (MICH) objectives:

Increase abstinence from alcohol, cigarettes, and illicit drugs among pregnant women Increase the proportion of women delivering a live birth who received preconception care services and practiced key recommended preconception health behaviors MICH Disability and Other Impairments: MICH objectives 25 through-29.5

MICH Health Services: MICH objective 30.2, MICH objective 31, and MICH objective 32.

Social Determinants of Health goal: Create social and physical environments that promote good health for all.

Substance Abuse goal: Reduce substance abuse to protect the health, safety, and quality of life for all, especially children.

Tobacco Use goal: Reduce illness, disability, and death related to tobacco use and secondhand smoke exposure.

For further information on Health People 2020 please vist: https://www.healthypeople.gov/2020/topics-objec tives

Public Health Impact Accomplishing the objectives of this cooperative agreement will:

Enhance the conduct and coordination of important research by developing an organizational platform that can improve administrative efficiencies and focus research and programmatic efforts on critical NCBDDD priorities and populations;

1.

Expand the use of scientifically valid health intervention and promotion strategies aimed at improving the well-being of children, youth, and adults with disabilities and their families; and

2.

Improve communication and dissemination of scientific data aimed at improving the health of populations served by NCBDDD through the use of experts to stakeholders and other audiences.

3.

Relevant Work This cooperative agreement will build on the previous cooperative agreements, DD07-003 and DD12-006, by supporting the Center’s mission and advancing it’s scientific and research agenda.

The National Center on Birth Defects and Developmental Disabilities (NCBDDD) through this Funding Opportunity Announcement (FOA) seeks to develop an external coordinating center for research, research translation and dissemination of information that supports the Center’s mission and advances its scientific and research agenda. This mechanism has been very successful in advancing the research agenda of NCBDDD under previous cooperative agreements. Using the coordinating center strategy gives NCBDDD the flexibility, efficiency, and reach to conduct important research across a broad network of universities and other institutions of higher learning that specialize in birth defects, hereditary blood disorders, developmental and other types of disability research.

2. Approach The purpose of this program is to strengthen the nation’s capacity to carry out public health research in the areas of birth defects; complication of blood disorders; developmental disabilities; and improving the health of people living with disabilities across the lifespan. The activities will vary over the years of the award depending on funding, but the overall objectives are for one awardee to:

Establish a coordinating center for research;1.

Advance evidence-based practices and policies that promote the health and well-being of the populations served by NCBDDD;

2.

Conduct research in support of NCBDDD priorities;3.

Communicate and disseminate information with and for stakeholders and other audiences; and4.

Evaluate and report on progress and findings. 5.

During Year One of the award - the grant recipient will be expected to establish an organizational infrastructure, recruit and hire scientific and professional staffs and set processes and procedures in place to develop and conduct research activities. Given the focus on developing organizational capacities, the grantee and its subrecipients will be expected to conduct a limited number of research projects. Projects proposed https://www.healthypeople.gov/2020/topics-objectives https://www.healthypeople.gov/2020/topics-objectives and its subrecipients will be expected to conduct a limited number of research projects. Projects proposed may begin in year one and can have a duration of no more than five years, based on the scope of the cooperative agreement. The project period of subsequent projects may not exceed the project period for the overall award.

During Years Two through Five of the award the grant recipient will be expected to have the infrastructure in place to accommodate the potential for additional research, translation and dissemination activities. In years two through five, the CDC will specify research project areas in the continuing application guidance and the grant recipient will forward all research proposals to the CDC to review, consider and select. In Year Five, new research projects will be limited to those that can be completed at the end of 12-months. At the conclusion of the 12-month period, the awardee will have up to 6-months to complete the analysis and submit the research findings.

Funding may vary dramatically from year to year, whether increasing or decreasing, based on the number, timeframe and scope of CDC activities to be funded as well as funding availability. CDC estimates between three to six new research projects per year, starting in Year Two. In years two through five new proposed research projects may be submitted as part of the non-competing continuation application using (Appendix I)-Research Proposal Template. CDC will use an external review process to assess the scientific merit of each new research proposal.

Objectives/Outcomes Under this cooperative agreement, the funded coordinating center and its network of researchers will develop research proposals and projects in support of the initiatives and mandates of NCBDDD. Knowledge achieved through this FOA will be related to:

1) Improving surveillance and tracking systems that monitor incidence, prevalence and clinically meaningful information on birth defects, blood disorders, and developmental and other disabilities;

2) Expanding understanding of birth defects risk factors and causal pathways for birth defects, blood disorders, and developmental and other of disabilities.

3) Developing or improving methods of prevention or interventions to promote health and quality of life associated with disability or conditions resulting in disability; and

4) Improving dissemination that increases awareness and translational policy development in areas related to birth defects, blood disorders, and developmental or other disabilities, and improving health impact.

Objective 1: Establish a coordinating center for research, research translation and dissemination.

a) Identify and implement methods, guidance and infrastructure necessary to support public health research, research translation and dissemination of scientific information;

b) Develop and manage the process for evaluating research applications, including a rigorous review process to identify the most meritorious proposals aimed at accomplishing FOA objectives;

c) Oversee component projects conducted directly by the recipient organization and by sub-recipient organizations;

d) Develop and manage the process for tracking, reporting, and evaluating the progress of each research project at least quarterly; and

e) Assure that the coordinating center infrastructure supports all evaluation and monitoring activities.

Objective 2: Conduct and facilitate research in support of NCBDDD strategic priorities related to birth defects, blood disorders, and developmental and other types of disability research.

Through the development and support of a broad network of experts, address NCBDDD strategic priorities.

The intent of the cooperative agreement is to have a disseminated network of researchers across the nation; therefore not more than 10% of the research project proposals can originate from the Coordinating

Center’s organization. The research may include applied and public health research that develops and evaluates disability-related health promotion and disease intervention and control strategies that are community and population based. It can involve testing interventions for efficacy, effectiveness, or translational power; may focus on primary and secondary or tertiary risk factor research; or may provide insight and test strategies to improve health and prevent disease through approaches that involve changes to individual behavior, policy, or environmental structure, health systems, or socio-economic factors.

Research may provide initial evidence of the efficacy or effectiveness of a health promotion or prevention strategy, raise current evidence to a higher level, or provide evidence of the effectiveness of a practice base strategy. It may also include etiological research if there is a clear gap in the knowledge about main determinants of birth defects, blood disorders, and developmental or other types of disability, or disease or conditions related to the disability. It may use the principles of community-based participatory research.

Year One research: The grantee and its sub-recipients will be expected to conduct not more than three research projects. Projects proposed may begin in year one and can have a duration of no more than five years, based on the scope of the cooperative agreement. Proposed projects for Year One should be submitted in the application using the Research Proposal Template in Appendix I. Project proposals should be included in Appendix B with a brief overview included for each in Research Strategy section.

Objective 3: Communicate and disseminate research opportunities and findings for stakeholders and other audiences.

a) Using a broad network of experts, stakeholders, and other partners, communicate and disseminate opportunities to conduct research and share research findings.

b) Identify data and information from the funded projects that supports potential policy that can be disseminated to inform and educate stakeholders.

c) Develop platforms to share research findings with stakeholders and other audiences, including in peer-reviewed journals.

Objective 4: Evaluate Coordinating Center and supported project activities

a) Develop a focused evaluation plan for the Coordinating Center and its supported project activities.

That includes:

A logic model1.

Goals, objectives and activities that are specific, measurable, achievable, realistic and time-limited

(SMART);

2.

A description of mechanisms for engaging project researchers in evaluation activities;3.

Coordinating Center and supported project specific evaluation questions;4.

Evaluation methods; and5.

A description of how the evaluation results are intended to be used.6.

b) Track progress, outcome and the impact of funded projects, focusing on outcomes and stated goals; and

c) Report progress and outcome as part of regular communication with NCBDDD. Should the agency, consistent with grants regulations, wish to obtin copies or access to materials, data, or other research materials, the recipient or subrecipients should be able to readily produce said materials for the agency in a reasonable timeframe.

Target Population Women of reproductive age and pregnant women;1.

Women of reproductive age and pregnant women;1.

Infants, children, youths and adults with birth defects, blood disorders, and developmental and other disabilities, including mobility impairments and intellectual and/or sensory disabilities;

2.

Persons affiliated with organizations serving NCBDDD priority populations; and3.

Health care and public health practitioners.4.

Where appropriate, researchers within the coordinating center’s network, selected to conduct research on behalf of NCBDDD programs, will be encouraged to include non-English speaking populations; lesbian, gay, bisexual, and transgender (LGBT) populations; people with limited health literacy, and/or other hard to reach traditionally underserved populations.

Collaboration/Partnerships Applicants are expected to form or expand innovative partnerships between researchers to accomplish FOA objectives, including implementing and disseminating research findings resulting from this cooperative agreement. Where possible, applicants should provide letters of support from the proposed researchers as well as any other affiliated partners to indicate their full cooperation as members of the proposed research team. When applicable, this should include support for access to the data required for the evaluation or access to other data sources or populations needed to accomplish study objectives.y

Evaluation/Performance Measurement Applicants are expected to develop a general use logic model clearly specifying domains of inputs, activities, outputs, and outcomes for activities related to this project; and develop and describe a realistic and focused evaluation plan that is aligned with the logic model for each proposed project. Applicants are expected to develop a plan to ensure that individual research projects selected for funding through the Coordinating Center develop individual evaluation plans and tracking methods that will measure process, outcome, and where feasible the impact of supported projects focusing on stated goals and objectives. These evaluation plans should describe the purpose of the evaluation, to include the objectives and activities, description of mechanism for engaging stakeholders in evaluation activities, evaluation methods, and a description of how evaluation results are intended to be used.

Translation Plan Applicants are expected to develop a plan for research translation. This plan should include an approach to ensure that all research proposals submitted to the coordinating center include a proposed translation plan to communicate research findings to stakeholders and other appropriate audiences. The translation plan should address submission of draft manuscripts, research abstracts, key findings summary documents, data, and other relevant documents or products produced to communicate the research findings from each funded project.

The Coordinating Center is expected to work with its network of researchers to identify and use effective health communication and policy translation strategies that will raise awareness of public health practices that may lead to promising interventions, improved health outcomes, and reduced disparities amongst the populations served by NCBDDD.

Section II. Award Information

Funding Instrument Type: Cooperative Agreement A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed:

New - An application that is submitted for funding for the first time. Includes multiple submission attempts within the same round.

Estimated Total Funding: $15,025,000 Each year the awardee and CDC will establish a coordinated work plan that details the length and scope of each funded project with milestones that will serve as a guide for identifying and tracking projects and progress.

Budget Year

Infrastructure

Budget

Approximate Number of Projects

Estimated

Research Budget

Estimated Total Budget Ceiling

1 $225,000 3 $450,000 $675,000

2 $275,000 6-9 $1,650,000 $1,925,000

3 $275,000 9-12 $3,150,000 $3,425,000

4 $300,000 12-15 $4,650,000 $4,950,000

5 $300,000 12-15 $3,750,000 $4,050,000

TOTAL $15,025,000

Anticipated Number of Awards:

The estimated total funding (direct and indirect costs) for the first budget period is approximately $675,000 and the estimated total funding (direct and indirect) for the entire project period is $15,025,000.

It is anticipated that one award(s) will be made under this FOA DD17-001.

Funding may vary dramatically from year to year, whether increasing or decreasing; based on the number, timeframe and scope of CDC activities to be funded as well as funding availability.

Awards issued under this FOA are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

Award Ceiling: $675,000 Per Budget Period Award Floor: $225,000 Per Budget Period Total Project Period Length:

5 year(s)

Throughout the project period, CDC's commitment to continuation of awards will depend on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and CDC’s determination that continued funding is in the best interest of the Federal government.

HHS/CDC grants policies as described in the HHS Grants Policy Statement (http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category: State governments

County governments City or township governments Special district governments http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

Special district governments Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) 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

Additional Eligibility Category:

The following types of Higher Education Institutions are always encouraged to apply for CDC support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education:

Nonprofits (Other than Institutions of Higher Education)

Governments:

Eligible Agencies of the Federal Government U.S. Territory or Possession

Other:

Native American tribal organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations Foreign Organizations: a Foreign Organization is a public or private organization, whether non-profit or for-profit, located in a country other than the United States (U.S.) and its territories that is subject to the laws of the country in which it is located, irrespective of the citizenship of project staff or place of performance.

Bona Fide Agents: a Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with "Other Attachment Forms" when submitting via www.grants.gov.

2. Foreign Organizations Foreign Organizations are not eligible to apply.

Foreign components of U.S. Organizations are not eligible to apply.

For this announcement, applicants may include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

3. Special Eligibility Requirements

Applicant must have demonstrated public health research capacity.

Applicant must have or establish a partner network to conduct public health research.

Applicant must have the financial capability to rapidly award funding to sub-recipients with approved research projects.

4. Justification for Less than Maximum Competition N/A

5. Responsiveness To demonstrate existing public health research capacity, use the Research & Related Senior/Key Person Section of the SF424 (R&R) to describe the expertise of the PI and/or co-PI in conducting or managing the conduct of public health research projects within the last 5 years.

To demonstrate access to the proposed partner network, the applicant must provide letters of support from existing or potential research partners.

To demonstrate financial capability to rapidly award funding to sub-recipients, applicant must provide a letter from their finance officer assuring the applicant’s ability to award sub-recipient funds within 30 days of approving a proposal.

An application that exceeds the upper value of the specified dollar range will be considered non-responsive and will not receive further review.

If your application is incomplete or non-responsive to the special eligibility requirement listed in this section, it will not enter into the review process.

Applications with budgets exceeding the ceiling will not enter into the review process.

6. Required Registrations Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: https://eportal.nspa.nato. int/AC135Public/Docs/US%20Instructions%2 0for%20NSPA%20NCAGE.pdf System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, https://www.sam.gov/portal/SAM/#1.

https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://www.sam.gov/portal/SAM/%231 annually, https://www.sam.gov/portal/SAM/#1.

Grants.gov eRA Commons

All applicant organizations must register with Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes.

The “one-time” registration process will take three to five days to complete. However, it is best to start the registration process at least two weeks prior to application submission.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization. All registrations must be successfully completed and active before the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

7. Universal Identifier Requirements and System for Award Management (SAM) All applicant organizations must obtain a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements.

The DUNS number is a nine-digit number assigned by Dun and Bradstreet Information Services. An AOR should be consulted to determine the appropriate number. If the organization does not have a DUNS number, an AOR should complete the US D&B D-U-N-S Number Request Web Form or contact Dun and Bradstreet by telephone directly at 1-866-705-5711 (toll-free) to obtain one. A DUNS number will be provided immediately by telephone at no charge. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a DUNS number.

Additionally, all applicant organizations must register in the System for Award Management (SAM).

Organizations must maintain the registration with current information at all times during which it has an application under consideration for funding by CDC and, if an award is made, until a final financial report is submitted or the final payment is received, whichever is later. SAM is the primary registrant database for the Federal government and is the repository into which an entity must provide information required for the conduct of business as a recipient. Additional information about registration procedures may be found at the SAM internet site at https://www.sam.gov/index.html.

If an award is granted, the grantee organization must notify potential sub-recipients that no organization may receive a subaward under the grant unless the organization has provided its DUNS number to the grantee organization.

8. Eligible Individuals (Project Director/Principal Investigator) in Organizations/Institutions Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for HHS/CDC support.

9. Cost Sharing This FOA does not require cost sharing as defined in the HHS Grants Policy Statement (http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf).

10. Number of Applications As defined in the HHS Grants Policy Statement,(http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf), applications received in response to the same funding opportunity announcement generally are scored individually and then ranked with other applications under peer review in their order of relative programmatic, technical, or scientific merit. HHS/CDC will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

https://www.sam.gov/portal/SAM/%231 http://www.Grants.gov https://public.era.nih.gov/commons/public/login.do?TYPE=33554433&REALMOID=06-1edb031f-46c7-44b3-b803-60b537de74d2&GUID=&SMAUTHREASON=0&METHOD=GET&SMAGENTNAME=-SM-938PYmoLVb4VrDeXo04LZUDVDvc%2b3899ByInEAjuSUvWNIGfB2zRpWiCivYGCogG&TARGET=-SM-http%3a%2f%2fpublic%2eera%2enih%2egov%2fcommons http://www.Grants.gov http://fedgov.dnb.com/webform https://www.sam.gov/index.html the pending application.

Only one application per institution (normally identified by having a unique DUNS number) is allowed.

Section IV. Application and Submission Information

1. Address to Request Application Package Applicants must download the SF424 (R&R) application package associated with this funding opportunity from www.Grants.gov.

If access to the Internet is not available or if the applicant encounters difficulty accessing the forms on-line, contact the HHS/CDC Office of Grants Services (OGS) Technical Information Management Section (TIMS) staff at (770) 488-2700 or ogstims@cdc.gov for further instructions. Hours: Monday - Friday, 7am – 4:30pm U.S. Eastern Time. CDC Telecommunications for the hearing impaired or disabled is available at: TTY 1-888-232-6348.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide http://grants.nih.gov/grants/how-to-apply-application-guide.htm and here:

http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf, except where instructed in this Funding Opportunity Announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

The forms package associated with this FOA includes all applicable components, mandatory and optional.

Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF 424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

In conjunction with the SF424 (R&R) components, CDC grants applicants should also complete and submit additional components titled “PHS398.” Note the PHS398 should include assurances and certifications, additional data required by the agency for a complete application. While these are not identical to the PHS398 application form pages, the PHS398 reference is used to distinguish these additional data requirements from the data collected in the SF424 (R&R) components. A complete application to CDC will include SF424 (R&R) and PHS398 components. These forms can be downloaded from http://grants.nih.gov/grants/forms.htm

3. Letter of Intent Due Date for Letter of Intent: 01/20/2017

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CIO staff to estimate the potential review workload and plan the review.

By the date listed above and in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Name of the Applicant

Descriptive title of proposed research

Name, address, and telephone number of the PD(s)/PI(s)

Descriptive title of each proposed Year 1 research project (up to 3)

Name, address and telephone number of the PI for each research project

Names of other key personnel http://www.Grants.gov mailto:pgotim@cdc.gov http://grants.nih.gov/grants/how-to-apply-application-guide.htm http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf http://grants.nih.gov/grants/forms.htm

Participating institutions

Number and title of this funding opportunity

The letter of intent should be sent to:

Natalie Darling

Scientific Program Official

Extramural Research Program Operations and Services

Centers for Disease Control and Prevention

4770 Buford Highway, NE

Mailstop F-80

Atlanta, GA 30342

Telephone: (770)-488-5740

Email: ndh6@cdc.gov

4. Required and Optional Components A complete application has many components, both required and optional. The forms package associated with this FOA in Grants.gov includes all applicable components for this FOA, required and optional.

5. PHS 398 Research Plan Component The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Plan that consists of 16 components. Not all 16 components of the Research Plan apply to all Funding Opportunity Announcements (FOAs). Specifically, some of the following 16 components are for Resubmissions or Revisions only. See the SF 424 (R&R) Application Guide http://grants.nih.gov/grants/how-to-apply-application-guide.htm and here:

http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf for additional information. Please attach applicable sections of the following Research Plan components as directed in Part 2, Section 1 (Funding Opportunity Announcement Description).

Follow the page limits stated in the SF 424 (R&R) unless otherwise specified in the FOA. As applicable to and specified in the FOA, the application should include the bolded headers in this section and should address activities to be conducted over the course of the entire project, including but not limited to:

1. Introduction to Application (for Resubmission and Revision ONLY) - provide a clear description about the purpose of the proposed research and how it addresses the specific requirements of the FOA.

2. Specific Aims – state the problem the proposed research addresses and how it will result in public health impact and improvements in population health.

3. Research Strategy – the research strategy should be organized under 3 headings: Significance, Innovation and Approach. Describe the proposed research plan, including staffing and timeline.

4. Inclusion Enrollment Report (Renewal and Revision applications ONLY)

5. Progress Report Publication List (for Continuation ONLY)

Human Subjects Section

6. Protection of Human Subjects

7. Inclusion of Women and Minorities http://grants.nih.gov/grants/how-to-apply-application-guide.htm http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf

7. Inclusion of Women and Minorities

8. Targeted/Planned Enrollment Table (for New Application ONLY)

9. Inclusion of Children

Other Research Plan Sections

10. Vertebrate Animals

11. Select Agent Research

12. Multiple PD/PI Leadership Plan.

13. Consortium/Contractual Arrangements

14. Letters of Support

15. Resource Sharing Plan(s)

16. Appendix

Component 4 (Inclusion Enrollment Report) applies only to Renewal and Revision applications for clinical research. Clinical research is that which is conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies). Follow the page limits in the SF 424 (R&R) Application Guide unless otherwise specified in the FOA. All instructions in the SF424 (R&R) Application Guide http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf must be followed along with any additional instructions provided in the FOA.

Applicants that plan to collect public health data must submit a Data Management Plan (DMP) in the Resource Sharing Plan section of the PHS 398 Research Plan Component of the application. A DMP is required for each collection of public health data proposed. Applicants who contend that the public health data they collect or create are not appropriate for release must justify that contention in the DMP submitted with their application for CDC funds.

The DMP may be outlined in a narrative format or as a checklist but, at a minimum, should include:

• Descriptions of the data to be produced in the proposed project

• How access will be provided to the data (including provisions for protection of privacy, confidentiality, security, intellectual property, or other rights)

• Use of data standards that ensure all released data have appropriate documentation that describes the method of collection, what the data represent, and potential limitations for use

• Plans for archival and long-term preservation of the data, or explaining why long-term preservation and access cannot be justified Examples of DMPs may be found here: University of California https://dmp.cdlib.org/, or USGS, http://www.usgs.gov/datamanagement/plan/dmplans.php

Research Plan Applicant’s research plan should address activities that will be conducted over the entire project period and should include the following items:

Year One research: The applicant will be expected to conduct not more than three research projects.

Projects proposed may begin in year one and can have a duration of no more than five years, based on the scope of the cooperative agreement. Proposed projects for Year One should be submitted in the application using the Research Proposal Template in Appendix I. Project proposals should be included in appendix B with a brief overview included for each in Research Strategy section.

1. List research topics (title and PI) in the Research Strategy (the standard 25 pages) and

2. Provide research topic narratives in Appendix B, using a 6 page limit for each. Address specific requirements outlined in the FOA.

http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf%20 http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf https://dmp.cdlib.org/ http://www.usgs.gov/datamanagement/plan/dmplans.php

1) Establish a Coordinating Center for conducting research. Provide a description of how the coordination body of the network of research will operate, including a plan for reviewing and recommending potential research and programs in collaboration with NCBDDD. The plan should include:

a) Development of a process and mechanism to conduct effective and timely public health research review and model demonstrations in birth defects, developmental disabilities, blood disorders, and the prevention of secondary conditions among people who have a disability;

b) Describe the methods, guidance, and infrastructure necessary to support public health research.

This may include office space, personnel, equipment, and other resources;

c) Describe the process for developing and managing the process for identification, solicitation, and evaluation of proposals, including a rigorous review process to identify the most meritorious proposals to accomplish FOA objectives;

d) Describe component projects…