dd12-006 foa final amend i 4.25.12.doc

Amendment I made 4/25/12 – Appendix 2. Questions from Potential Applicants with Answers by CDC

Table of Contents

Part 1. Overview Information Part 2. Full Text of the Announcement 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 Section IX Appendices Part1. Overview Information

Announcement Type

New

93.073, 93.283

Health

Key Dates Publication Date

March 20, 2012

To receive notification of any changes to RFA-DD-12-006, 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.

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).

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar7

Overview of Project Structure

The purpose of this program is to strengthen the nation’s capacity to carry out public health research, training, and practice in the areas of birth defects, developmental and other disabilities, and promote health and development of persons with disabilities across the lifespan. The activities of the program will vary over the years of the award depending on funding, but the overall objectives are for one awardee to:

1) Establish a coordinating center for research and training;

2) Advance evidence-based practice and policies that promote the health and well being of children, youth, and adults with disabilities and their families;

3) Conduct research in support of NCBDDD priorities;

4) Train health and public health professionals;

5) Communicate and disseminate information with and for stakeholders and other audiences; and

6) Evaluate and report on findings.

During Year One of the award, the grant recipient will be expected to establish an organizational infrastructure, recruit and hire scientific and professional staff, and set processes and procedures in place to develop and conduct research activities. Given the focus on developing organizational capacity in Year One of the award, the applicant will be expected to conduct a limited number of research and public health practice projects as outlined in Objective 3. Further, during Year 1, the applicant will be expected to recruit and place two Fellows at CDC (see Objective 4), provide training and meeting support to state grantees (see Objective 5), and provide technical assistance and meeting support to improve early identification of developmental disabilities (see Objective 2). Projects proposed in Year One may begin in Year One and can have a duration of no more than five years, based on the scope of the project. The project period of subsequent projects may not exceed the project period of the overall award.

In Years Two- Five, the grant recipient will be expected to have the infrastructure in place to accommodate the potential for additional research and public health practice activities. In years 2-5, 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. Increased funding would be required to support new and on-going research and public health practice activities (see Section II Award Information for information on anticipated funding levels in each year). In year 5 new research, program, and training projects will be limited to those that can be completed in 12 months.

Funding may vary dramatically from year to year, whether increasing or decreasing; based on number, timeframe, and scope of CDC activities to be funded, as well as funding availability. CDC estimates between three to six new research projects each year, starting in Year Two. In years 2-5 new proposed research projects may be submitted as a part of the non-competing continuation application using Appendix 1 - Research Proposal Template. CDC will use an external review process to assess the scientific merit of each new research proposal. See Section VI. Award Administration Information, 3. Reporting, for more detail on non-competing continuations.

Each year the awardee and CDC will establish a coordinated workplan that details the length and scope of each funded activity with milestones that will serve as a guide for identifying and tracking projects, priorities, and progress.

The following are topical areas of interest which apply to objectives 1 through 3 that follow. The list is neither inclusive nor exclusive:

· Attention Deficit Hyperactivity Disorder,

· Autism Spectrum Disorders and Other Developmental Disabilities,

· Birth Defects: Issues related to surveillance, epidemiology, and prevention of major structural birth defects,

· Cerebral Palsy,

· Child Development,

· Congenital Cytomegalovirus,

· Congenital Heart Disease,

· Early identification of developmental disabilities,

· Developmental Screening,

· Disabilities: Issues related to people with disabilities; health promotion and intervention for persons with disabilities; secondary conditions; and aging and disability,

· Fetal Alcohol Syndrome/ Fetal Alcohol Spectrum Disorders,

· Folic Acid and Neural Tube Defects,

· Hearing Loss: Newborn screening, early interventions, genetic causes,

· Infections in Pregnancy,

· Intellectual Disability,

· Mobility Limitation Impact on Social Participation for Children with Special Health Care Needs,

· Muscular Dystrophy,

· Newborn Bloodspot Screening: metabolic, genetic,

· Obesity Measurement among People with Disabilities,

· Pediatric Genetic Conditions,

· Spina Bifida,

· Stillbirths,

· Tourette Syndrome, and

· Transitional Issues Related to Young Adulthood among People with Disabilities.

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 or in a Notice from the NIH Guide for Grants and Contracts). 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 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, 243, 247b(k)(2) and 247b-4) as amended.

Background

Created by the Children’s Health Act of 2000, CDC’s National Center on Birth Defects and Developmental Disabilities (NCBDDD) seeks to prevent birth defects and developmental disabilities, and promote the health of persons across the lifespan living with birth defects and disabilities. Collaborating with national, state, local, and professional organizations, the NCBDDD strives to identify the risk factors and causes of these conditions and to enhance the potential for full, productive living for people in these vulnerable populations.

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 one in every 33 babies is 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.

Developmental disabilities (DD) 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, self-help, and independent living. Developmental disabilities begin prior to 22 years of age and usually last throughout a person’s lifetime. Autism Spectrum Disorders (ASDs), an example, are a group of developmental disabilities that can cause significant social, communication and behavioral challenges. CDC estimates that an average of one in 110 children in the U.S. has an ASD.

In addition to developmental disabilities, people can acquire disabilities throughout their life through injury, illness, chronic conditions, or later-onset conditions. As a group, the 54 million adults in the U.S. with disabilities experience worse health outcomes and quality of life than those without disabilities. Over the past decade, 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 prevention of secondary conditions. NCBDDD is committed to identifying and addressing the unique challenges to health experienced by people with disabilities across the life span.

Scientific Knowledge to be Achieved Through This Funding Opportunity

This program addresses Healthy People 2020 priority areas of Disability and Health and Maternal, Infant, and Child Health. This FOA addresses multiple objectives including:

DH-4 (Developmental) Reduce the proportion of people with disabilities who report delays in receiving primary and periodic preventive care due to specific barriers

DH-9 (Developmental) Reduce the proportion of people with disabilities who encounter barriers to participating in home, school, work, or community activities

ENT-VSL-1 Increase the proportion of newborns who are screened for hearing loss by no later than age 1 month, have audiologic evaluation by age 3 months, and are enrolled in appropriate intervention services no later than age 6 months

MICH-1 Reduce the rate of fetal and infant deaths

MICH-11 Increase abstinence from alcohol, cigarettes, and illicit drugs among pregnant women

MICH-14 Increase the proportion of women of childbearing potential with intake of at least 400 μg of folic acid from fortified foods or dietary supplements

MICH-15 Reduce the proportion of women of childbearing potential who have low red blood cell folate concentrations MICH-16 Increase the proportion of women delivering a live birth who received preconception care services and practiced key recommended preconception health behaviors

MICH-28 Reduce occurrence of neural tube defects

MICH-29 Increase the proportion of young children with an Autism Spectrum Disorder (ASD) and other developmental delays who are screened, evaluated, and enrolled in early intervention services in a timely manner

MICH-31 Increase the proportion of children with special health care needs who receive their care in family-centered, comprehensive, coordinated systems EMC-1 (Developmental) Increase the proportion of children who are ready for school in all five domains of healthy development: physical development, social-emotional development, approaches to learning, language, and cognitive development This cooperative agreement will develop a focused program of activities in support of the initiatives and mandates of the NCBDDD, and will assist NCBDDD in fulfilling its commitment to achieve Healthy People 2020 goals. Knowledge achieved will be related to:

1) Surveillance and tracking resulting in systems that monitor incidence, prevalence, and clinically meaningful information on birth defects, developmental and other disabilities;

2) Expanding understanding of risk factors and causal pathways during early, transitional, and late developmental stages of the life course for people with conditions associated with disability;

3) Developing or improving methods of prevention or intervention of conditions; and

4) Improving dissemination that increases awareness and translational policy development in areas related to birth defects, developmental and other disabilities, and reducing health disparities among people with disabilities across the life course.

Goals and Objectives:

1) Objective 1: Establish a coordinating center for research, training, and other activities:

a) Identify and implement methods, guidance, and infrastructure necessary to support public health research, training, dissemination of scientific information, and community-based intervention projects;

b) Develop and manage the process for identifying and evaluating potential research, program, and training proposals; 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 any sub-recipient as special projects;

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

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

2) Objective 2: Advance evidence-based programs and practices that promote the health and well being of children, youth, and adults with disabilities, and their families:

Consistent with the development of Healthy Communities for general populations, this approach should emphasize the development and promotion of programs, policies, and practices that include people with disabilities and their families in community-based efforts to enhance health and wellness. Four steps to this process (Giles, Holmes-Chavez & Collins, 2009) are to: 1) invest in local communities; 2) provide a venue for local communities to learn about effective strategies, particularly those related to policy and environmental and systems changes; 3) mobilize networks for change; and 4) develop tools to assist in this mobilization in efforts to improve health equity for people with disabilities within communities.

Activities within this announcement may include:

a) Conducting health promotion activities to improve early identification of developmental disabilities and developing and implementing model programs and interventions; and

b) Developing and supporting curricula and other educational resources for health care practitioners, researchers, trainees, and other audiences to improve early identification of developmental disabilities; and to promote the health, development, well-being, health care, and environmental access of children and adults with disabilities and their families.

3) Objective 3: Conduct research in support of NCBDDD strategic priorities related to: 1. birth defects, 2. developmental and other disabilities, and 3. reducing health disparities associated with disabilities.

Propose and conduct research that addresses NCBDDD strategic priorities. The research may include applied and public health research that develops and evaluates disability-related health promotion and disease prevention and control strategies that are community and population-based. It can involve testing interventions for efficacy, effectiveness, or translational power; may focus on primary, secondary, or tertiary prevention; or may 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-based strategy. It may also include etiological research if there is a clear gap in the knowledge about main determinants of a disability, or disease or conditions related to the disability. It may use the principles of community-based participatory research (CBPR). CBPR is an established interdisciplinary research methodology in which scientists and members of a target community – in this case, the disability community – cooperate as equal partners in developing, implementing, and disseminating research especially relevant to that community. This approach has been shown to offer particular promise that research findings will be understood, embraced and adapted by members of the target community.

During Year One, research will be conducted to support and advance the strategic priorities of NCBDDD as shown below. In selecting areas to respond to, select one surveillance topic, one risk factor and causal pathways topic, and one communication, policy translation, and dissemination topic.

a) Preventing major birth defects attributable to maternal risk factors;

i) Birth defects are a leading cause of deaths in the first year of life, and can result in lifelong disability. They account for more than 139,000 hospital stays during a single year, resulting in $2.6 billion in hospital costs. Many birth defects happen very early in pregnancy, sometimes before a woman knows she is pregnant. Prevention of birth defects begins with research identifying causes and risk factors associated with birth defects. Yet, for about two-thirds of birth defects, the causes are still unknown. In addition, much is unknown about the interactions among different risk factors for birth defects. Further identifying and developing effective birth defects tracking systems are vital. Therefore, research in Year One of this project should address one of the three following research topics:

(1) Identification, diagnosing, surveillance and tracking: Identify new or proven effective approaches to recognizing and tracking birth defects;

(2) Increasing knowledge in areas of risk factors and causal pathways: Identify risk factors and interactions related to potential causal pathways associated with birth defects; and

(3) Increasing knowledge in health communication, policy translation, and dissemination: Identify factors that improve understanding and awareness of birth defects.

b) Enhancing tracking and research of DD, including ASD, to monitor changes in occurrence and contributing risk factors:

i) Developmental disabilities such as ASDs are reported to occur in all racial, ethnic, and socioeconomic groups. ASDs are on average four to five times more likely to occur in boys than in girls. Studies have shown that about one third of parents of children with an ASD noticed a problem before their child’s first birthday, and 80% saw problems by 24 months of age. While there is currently no cure for ASDs, research shows that early intervention can improve a child’s development. Early intervention services help children during their early years and include therapy to help the child talk, walk, and interact with others. Enhanced tracking and research related to ASD begins with efforts to more accurately find out how many children have ASDs, discover risk factors and causes of ASDs, and identify effective health communication that can raise awareness of the signs and symptoms and allow stakeholders to act upon this knowledge. Therefore, research in Year One of this project should address one of the three following research topics:

(1) Identification, diagnosing, surveillance and tracking: Identify more accurate means of diagnosing and tracking ASD, including improving early identification of children with ASD and other developmental disabilities;

(2) Increasing knowledge in areas of risk factors and causal pathways: Identify risk factors and causal agents associated with ASD; and

(3) Increasing knowledge in health communication, policy translation, and dissemination: Identify barriers, motivation, and information needs of parents of special population groups, health care providers, and educators to improve health communication strategies that contribute to improved early identification of ASD and other developmental disabilities.

c) Reducing disparities in health indicators such as obesity in children, youth, and adults with disabilities:

i) Disparities in health indicators have been identified for people with disabilities in areas such as obesity, tobacco use, access to mental health and other health care services, use of preventive services, levels of physical activity, and rates of injury. For example, research investigating the link between obesity and disability indicates that, for both children and adults, those at greatest risk for obesity have mobility limitations, intellectual/learning disabilities, or both. Obesity rates for children and adults with disabilities are 38 percent and 57 percent higher than rates for children and adults without disabilities. Health disparities are defined by HHS as, “Health differences closely linked with social, economic, and/or environmental disadvantage. Health disparities adversely affect groups of people who have systematically experienced greater obstacles to health based on their racial or ethnic group; religion; socioeconomic status; gender; age; mental health; cognitive, sensory, or physical disability; sexual orientation or gender identity; geographic location; or other characteristics historically linked to discrimination or exclusion.”

Disparities in health indicators have been identified for other factors, such as physical activity. Adults with disabilities engage in regular physical activities about half as often as adults without disabilities. Disparities have also been demonstrated in access to health care, with 29 percent of people with disabilities showing unmet needs compared to 12 percent of people without disabilities. Research is needed that builds evidence for interventions; effective communication to inform stakeholders; and implementation of public health programs, policies, and practices to reduce the disparity in obesity and other health indicators such as health care access. Therefore, research in Year One of this project should address one of the three following research topics:

(1) Identification, diagnosing, surveillance, and tracking: Identify more accurate means of identifying and tracking people with specific conditions associated with disability such as intellectual disabilities, certain rare conditions such as spina bifida, muscular dystrophy, or ADHD;

(2) Increasing knowledge in areas of risk factors and causal pathways: Identify risk factors and causal agents that appear to be related to health disparities for health indicators such as obesity, physical activity, or tobacco use; and

(3) Increasing knowledge in health communication, policy translation, and dissemination: Identify effective health communication and policy translation strategies that will raise awareness of public health practices that may lead to reduced disparities among health indicators for people with disabilities.

In years 2-5, 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.

4) Objective 4: Train health and public health professionals:

a) Strengthen expertise in the fields of birth defects, developmental, and other disabilities through training of professionals in public health and related fields so they have the necessary knowledge and skills to address unique needs of children, youth, and adults with disabilities and their families; and

b) Provide fellowship opportunities for professionals to work at NCBDDD on projects related to children, youth, and adults with or at risk for disabilities to support accomplishment of NCBDDD priorities. Fellowships include opportunities for graduate and post-doctorate level students, as well as academic faculty, to receive additional mentoring, training and career development and which represent unique fellowship opportunities within the CDC from among those available, given their primary focus on disability. An NCBDDD scientist will serve as a mentor to the fellows with opportunities for peer networking with other CDC fellows provide both within the NCBDDD and CDC. Fellowships will be consistent with CDC fellowship program and policies.

5) Objective 5: Communicate and disseminate intervention and other information with and for stakeholders and other audiences:

a) Convene meetings of stakeholders, including Disability and Health state grantees, to discuss and address research, policy, and programmatic issues to bring together divergent audiences toward development of a strengthened public health infrastructure;

b) Provide technical assistance to stakeholders, including Disability and Health state grantees and networks;

c) Develop and support a network of state and local experts to improve early identification and other activities that strengthen the nation's effectiveness and expertise in the fields of birth defects, developmental disabilities, and children and adults with disabilities; and

d) Provide data and information about policy and legislation that can be disseminated to educate stakeholders.

6) Objective 6: Evaluate funded activities and report on findings:

a) Develop a realistic and focused evaluation plan. The evaluation plan should include:

i) A logic model,

ii) Broad goals, objectives, and activities that are Specific, Measurable, Achievable, Realistic, and Time-limited (SMART),

iii) A description of mechanisms for engaging stakeholders in evaluation activities,

iv) Key local-level or activity-specific evaluation questions,

v) Evaluation methods, and

vi) A description of how evaluation results are intended to be used;

b) Track process, outcome, and the impact of supported programs and activities, focusing on outcomes and stated goals; and

c) Report process and outcome data quarterly to NCBDDD on activities and evaluation findings in written report(s), and peer-reviewed journals.

Potential public health impact of this opportunity:

Accomplishing the objectives of this project will:

1. 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;

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

3. Advance research on NCBDDD strategic priorities related to: a) birth defects, b) developmental and other disabilities, and c) reducing health disparities associated with disabilities, and enhance its impact on persons with disabilities and their families;

4. Develop a cadre of professionals trained in public health approaches specific to the fields of birth defects and disabilities to advance the nation’s ability to address the health needs and reduce the disparities in the health and care of persons with disabilities;

5. Improve communication and dissemination of health information aimed at improving the health of target populations served by NCBDDD through the use of key stakeholders and cutting edge tools and technologies; and

6. Assess the evidence of effectiveness of selected public health programs through rigorous evaluation and reporting of evaluation findings.

Section II. Award Information

Application Types Allowed

New

The NIH OER Glossary (http://grants.nih.gov/grants/glossary.htm) and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NCBDDD intends to commit approximately $1,700,000 including direct and indirect costs in FY2012 to fund 1 application for the first 12-month period.

An applicant may request a project period of up to 5 years. The funding amount total cost (direct and indirect) may be up to: $3,500,000 for the 2nd year; $6,000,000 for the 3rd year; $10,000,000 for the 4th year; and $8,000,000 for the 5th year of the project, to conduct a combination of new and continuing research and health promotion projects, support training, communicate and disseminate information, and to evaluate and report on findings related to each activity. The approximate total project period amount may not exceed $29,200,000 (entire project period).

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

Research projects may run from one to five years (beginning in Year One) and may not exceed the project period end date.

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

HHS/CDC grants policies as described in the HHS Grants Policy Statement (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html) will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants Eligible Organizations

Higher Education Institutions:

· Public/State Controlled Institutions of Higher Education

· Private Institutions of Higher Education

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)

For- Profit Organizations

· Small Businesses

· For-Profit Organizations (Other than Small Businesses)

Governments

· State Governments

· County Governments

· City or Township Governments

· Special District Governments

· Indian/Native American Tribal Governments (Federally Recognized)

· Indian/Native American Tribal Governments (Other than Federally Recognized)

· Eligible Agencies of the Federal Government

· U.S. Territory or Possession

Other

· Independent School Districts

· Public Housing Authorities/Indian Housing Authorities

· Native American tribal organizations (other than Federally recognized tribal governments)

· Faith-based or Community-based Organizations

· Regional Organizations

· 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.

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are not allowed.

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.

· Central Contractor Registration (CCR) – must maintain current registration in CCR to be renewed annually.

· Grants.gov

· eRA Commons

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.

Central Contractor Registration and Universal Identifier Requirements

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 Central Contractor Registry (CCR) and 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. CCR 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 CCR internet site at www.ccr.gov (https://www.bpn.gov/ccr/default.aspx).

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.

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.

2. Cost Sharing This FOA does not require cost sharing as defined in the HHS Grants Policy Statement (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html). Based on authorization language, this section should only be included in the FOA, if applicable.

3. Other Additional Information on Eligibility Number of Applications

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

As defined in the HHS Grants Policy Statement (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html), 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.

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 Procurement and Grants Office Technical Information Management Section (PGO TIMS) staff at (770) 488-2700 or Email: pgotim@cdc.gov for further instruction Hours: Monday - Friday, 7am – 4:30pm U.S. Eastern Standard Time. CDC Telecommunications for the hearing impaired or disable is available at: TTY 1-888-232-6348.

If the applicant encounters technical difficulties with Grants.gov, the applicant should contact Grants.gov Customer Service. The Grants.gov Contact Center is available 24 hours a day, 7 days a week, with the exception of all Federal Holidays. The Contact Center provides customer service to the applicant community. The extended hours will provide applicants support around the clock, ensuring the best possible customer service is received any time it is needed. You can reach the Grants.gov Support Center at 1-800-518-4726 or by email at support@grants.gov. Submissions sent by email, fax, CD’s or thumb drives of applications will not be accepted.

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/guide/url_redirect.htm?id=12000), 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 and uploaded as Attachment A from the following link: http://www.cdc.gov/od/pgo/funding/grants/foamain.shtm Letter of Intent 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 CDC staff to estimate the potential review workload and plan the review.

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

Descriptive title of proposed research Name, address, and telephone number of the PD(s)/PI(s) Names of other key personnel Participating institutions Number and title of this funding opportunity

The letter of intent should be sent to:

Michael A. Brown, MPH Extramural Research Program Office

National Center for Chronic Disease Prevention and Health Promotion

Centers for Disease Control and Prevention

U.S. Department of Health and Human Services

4770 Buford Hwy, N.E., Mailstop K-46

Atlanta, GA 30341

Telephone: (770) 488-5118 Fax: (770) 488-7863

Email: mab5@cdc.gov

FedEx address

Centers for Disease Control and Prevention

4770 Buford Hwy, NE

Building 101, Room 3113

Atlanta, GA 30341

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.

Research Plan Components/Attachments

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). See Part I, Section 5.5 of the SF 424 (R&R) Application Guide (http://grants.nih.gov/grants/guide/url_redirect.htm?id=12000) for additional information. Please attach applicable sections of the following Research Plan components:

1. Introduction to Application

2. Specific Aims

3. Research Strategy

4. Inclusion Enrollment Report

5. Progress Report Publication List

Human Subjects Section

6. Protection of Human Subjects

7. Inclusion of Women and Minorities

8. Targeted/Planned Enrollment Table

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

The Research Plan narrative is comprised of components 2, 3, and 4 above. Component 4 (Inclusion Enrollment Report) applies only to renewal and revision applications for clinical research. Note that the Research Strategy is divided into three parts: 1) Significance, 2) Innovation, and 3) Approach.

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

1) Establish a coordinating center for conducting research and training. Provide a description of how the coordinating body of a network of research and/or training institutions will operate, including a plan for reviewing and recommending potential research, program, and training projects 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 developmental and other disabilities, 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 and community-based intervention projects. 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 conducted directly by the recipient organization, or by a sub-recipient as special projects;

e) Describe the process for tracking, reporting, and evaluating the progress of each research project at least annually;

f) Describe the approach for ensuring that all supported component projects are responsive to the public health mission of NCBDDD as it relates to birth defects, developmental and other disabilities, and reducing health disparities among people with disabilities across the life course;

g) Provide an organizational chart illustrating the applicant’s internal structure, including reporting lines, and relationship with other partners or organizational members;

h) Describe the qualifications of the PD/PI and the planned percentage of time that will be devoted to the award. The PD/PI should be an established expert in disabilities or birth defects with the leadership and institutional authority to direct the activities of the award. The qualifications of the PD/PI should be documented in the form of previous experience developing and/or directing research and training, funding history, and publications in peer-reviewed journals or other reports;

i) Provide evidence of demonstrated partnerships and collaborations, to address the goals, objectives, and intent of the FOA. Examples of these partnerships or organizational memberships include partnerships with (1) states/territories/ or tribal authorities; (2) professional organizations; (3) local public health agencies;(4) academic institutions (5); consumer organizations (6); or other entities important to achieving the objectives of the FOA.

2) Advance evidence-based programs and practices that promote the health and wellbeing of children, youth, and adults with disabilities and their families.

a) Describe plans for working with partners or organizational members to promote health education messages in target audiences:

i) Describe mechanisms for selecting, funding, training, and providing technical assistance to state or local applicants to work with state and local partners to integrate early identification messages and materials into state and local programs that serve parents of young children, such as Women Infants and Children, Head Start/Early Head Start, home visiting, Individuals with Disabilities Education Act. Part C/Child Find, and others;

(1) Describe the anticipated pool of applicants, criteria for selecting successful candidates, training to be provided, resources (such as materials from NCBDDD) to be provided, and how ongoing administrative, professional, and technical support will be provided;

b) Describe planned activities for providing educational resources for health care professionals, child care professionals, and others to promote early identification of children with ASD and other developmental disabilities; and

c) Describe the approach for using the partner or organizational member networks to rapidly disseminate and replicate successful programs;

i) Describe how lessons learned from state and local partnerships for integrating health education messages about early identification can be shared and replicated throughout the applicant’s network.

3) Conduct research in support of Center priorities related to birth defects, developmental and other disabilities, and health disparities associated with disabilities.

a) For each research project proposal, provide detailed and consistent instructions. Include:

i) Specific aims, including a description of the relationship of the research project to the NCBDDD’s mission and health priorities, Healthy People 2020 focus areas, CDC public health research agenda, and the needs of the community http://www.cdc.gov/od/science/quality/docs/AdvancingTheNationsHealth.pdf. Include a specific description of the research community if it differs from the partner community;

ii) Background and significance, including how the research furthers the fields of birth defects, developmental and other disabilities, and health disparities among people with disabilities. Include evidence of community and partner support for, and endorsement of, the research topic, methods, and partnering community through letters of collaboration;

iii) Evidence of community and partner input into identification of health priorities and disparities and a description of how they will be engaged throughout the research process;

iv) A timeline for delivery

v) Information on the project team’s experience in conducting research with the community in which the project will be implemented and experience in the research topic and methods;

vi) Provide a description of the qualifications of the PD/PI and the planned percentage of time that they will devote to the award. The PD/PI should be an established researcher with the leadership and institutional authority to direct the activities of the award. The qualifications of the PD/PI should be documented in the form of previous experience developing and/or directing research.

vii) Provide a listing of key staff exclusive of the PD/PI who will be devoted to this activity. For each key personnel, describe their demonstrated knowledge, experience, and ability in the relevant area (e.g., population level surveillance, data management, analytic techniques) and subject matter expertise related to the health and well-being of people with disabilities.