dd11-007 foa final amendment i 12-14-2010.doc

Amendment I made 12.14.10

· Application due date, page 2

· Scientific Merit Review, page 3

· Secondary Review, page 3

· Expiration Date, page 3

· CDC anticipates conducting a pre-application conference call to help prospective applicants prepare for the new Cooperative Agreement DD-11-007.

Participant Call In:

CALL DATE; JANUARY 13, 2011

CALL TIME: 2:30 PM EASTERN TIME

CALL DURATION: 1 HOUR 30 MINUTES

LEADER: MICHAEL A. BROWN

Toll-Free Number: 1-877-907-9881

PASSCODE: 3119795#

To facilitate conversion to HTML, text formatting in this document is limited. To apply formatting, highlight the text and apply the style (described below).

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Strong Emphasis: Both bold and italics text – please use this as a substitution for underlined text which should be avoided in web pages because users confuse underlined text with hyperlinks.

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Bullet: Bulleted and indented text

Double Indent Bullet: Use for bullets when the section is already indented once (e.g. bullets under a List Paragraph)

Heading 4: Use for headings of any elements/fields you add to the FOA

Heading 4 Indent: Indented version of Heading 4 (aligns with List Paragraph)

Title: Use only for the title and number of the FOA

Normal: Use for all text, except as described above.

If you apply a style and you later want to remove the style, highlight the text and apply the normal style. If clicking the normal style does not remove all formatting, press the two keys, Ctrl and Spacebar, at the same time while text is highlighted.

Hidden text in all capital letters is specific ERPO guidance.

Department of Health and Human Services

Part 1. Overview Information

For other OpDivs add the relevant components (centers/offices) at the end of the list, following the same format.

National Center on Birth Defects and Developmental Disabilities (NCBDDD)

U19 Research Program Cooperative Agreements

Announcement Type

New Keep relevant text; enter previous FOA Number if a reissuance

Delete the non-relevant choices (RFA/PA. Fill in Fiscal Year (FY). For a CIO RFA, insert the RFA number for NNN. Leave the FOA number as NNN and it will be assigned by PGO staff.

Go ahead and add your number.

Insert appropriate number for CFDA

http://www.grants.gov/search/category.do e.g.:

Health

Please limit this field to a brief description of ¼ to ½ page in length. Brevity is appreciated. THIS SHOULD BE THE FIRST BULLET FROM THE OLD EXECUTIVE SUMMARY

Key Dates Publication Date

November 18, 2010PGO will add this information when posted. This field is not available for CIO edit.

The Letter of Intent due date must be at least one month (assume 30 days in one month) before application due date, and generally at least one month after posting date. If not applicable, replace “Month Day, Year” with “Not Applicable”

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 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).

Date is expected to be three months (minimum two months) after publication of the announcement (assume 30 days in one month).

Or:

Executive Order 12372 does not apply to this program.

Rarely applicable See THIS IS ONLY USED WHEN STATE HEALTH DEPARTMENTS ARE INVOLVED for details.

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.

Insert as applicable and include the page limits:

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 “Apply Electronically” Text and link inserted here by PGO.

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 Part 2. Full Text of Announcement Section I. Funding Opportunity Description

Recommended length: 1-5 pages. Present the purpose of the funding opportunity in paragraph form, addressing all of the items below. Please keep in mind that readers will appreciate clarity and brevity. The following headers may be useful in preparing this section:

Purpose/Research objectives (describe the nature and need of the research opportunity)

Specific Areas of Research Interest (include examples of research topics. In such cases, add a statement indicating that appropriate topics “include but are not limited to those listed below.”

This section may also address scientific knowledge to be achieved through research supported by the special program and types of research and experimental approaches that are being sought to achieve the objectives.

In this section Use the following headings and add text below The Add CIO(s) Here NCBDDD of CDC within HHS is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010." This RFA addresses “Healthy People 2010” priority area(s) of Disability and Secondary Conditions; Maternal, Infant, and Child Health; and to Prevent Birth Defects and Developmental Disabilities, and is in alignment with NCBDDD performance goal(s)). For more information, http://www.healthypeople.gov/document/ and http://www.whitehouse.gov/omb/mgmt-gpra/. In addition, this RFA addresses a number of high impact public health areas, including the CDC Health Protection Goal for Healthy People in Every Stage of Life, whereby all people, and especially those at greater risk of health disparities, will achieve their optimal lifespan with the best possible quality of health in every stage of life. For more information, see http://www.cdc.gov/osi/goals/people/index.html.

This FOA is consistent with the following congressional language: “The Committee encourages the CDC to focus its efforts on identifying ongoing needs, effective treatments and positive outcomes for families by increasing epidemiological research, surveillance, screening efforts, and the introduction of early interventions and support for individuals living with fragile X Syndrome and Associated Disorders. The Committee commends the CDC's current collaboration with NICHD and the newly formed Fragile X Clinical & Research Consortium. The Committee encourages the CDC to focus funds within the Fragile X program on the continued growth and development of initiatives that support health promotion activities and foster rapid, high-impact translational research practice for the successful treatment of Fragile X Syndrome and Associated Disorders, including ongoing collaborative activities with the Fragile X Clinical & Research Consortium” (House Report 111-220). Add Priority Area(s) Here.

Nature of the Research Opportunity This is the purpose of the FOA This FOA solicits proposals to support a Consortium with two primary objectives: 1) promote longitudinal data collection from fragile X clinical centers, and 2) support a comprehensive data management and analysis center. Patient, parent, clinician, and laboratory reported data will be collected, analyzed, and disseminated to increase knowledge about the impact of fragile X syndrome across the lifespan.

Background This is the story so far Fragile X syndrome is a known cause of intellectual disabilities. The Surgeon General’s National Blueprint to Improve the Health of Persons with Mental Retardation identifies longstanding health disparities among people with intellectual disabilities and a gap between the health needs and the health services for this group. Research is needed to understand the needs, challenges, services used, and outcomes of people who have fragile X syndrome in order to inform public health practice.

The Fragile X Clinical and Research Consortium (FXCRC) was established in 2006 to facilitate coordinated, collaborative research for fragile X syndrome. In 2008 NIH, with input from CDC and other major stakeholders, developed the Research Plan on Fragile X Syndrome and Associated Disorders. A key recommendation from this report was support for multisite research consortia to improve the efficiency and power of current and future fragile X research. CDC provided funding through cooperative agreement RFA DD07-003 with the Association of University Centers on Disabilities to provide infrastructure support for the FXCRC to establish a system for collecting and merging a common set of data on individuals known to have fragile X syndrome, and to develop consensus-based standards for evaluation and treatment of fragile X syndrome.

The public health approach focuses on the health of populations. For a condition like fragile X where identification of affected individuals is largely incomplete, it can be challenging to develop a true population view. Given these challenges, this FOA is intended to contribute to developing a public health view of people known to have fragile X syndrome. The goal of this FOA is to track the occurrence, progression, and impact of fragile X syndrome. Collecting, analyzing, and disseminating longitudinal data about persons known to have fragile X syndrome will identify factors related to optimal outcomes and promote the three core functions of public health—assessment, policy development, and assurance. References to “people known to have fragile x syndrome” or “fragile x patients” applies to people who are seen at fragile x clinics, and have a confirmed diagnosis.

Scientific Knowledge to be Achieved through this Funding Opportunity Big goals/vision Findings from the research supported by this FOA can lead to a greater understanding of fragile X syndrome and be used to improve the lives, care, and health care of persons with fragile X syndrome; increase understanding of contributors to adverse or positive outcomes; and may provide information that could benefit other groups affected by intellectual disabilities.

Research Objectives and Approach Key steps to achieve purpose - details/framework of what we want them to explain to us in Other Submission Requirements/how they will accomplish this The intent of this FOA is to support longitudinal data collection and to implement a data management and analysis center to expand our knowledge of fragile X in ways that can be used to improve the health, development, quality of life, and social participation of people with fragile X syndrome. The approach outlined in this FOA to accomplish the research objectives is the use of a consortium. Through the consortium approach, the applicant will carry out portions of the planned research activities, but will also use one or more organizations as partners to carry out portions of the planned activities. The applicant will be responsible for coordinating the work of the partners, and must perform a substantive role in the conduct of the award.

Potential research questions to be answered may include but are not limited to the following:

1. What are the nature, frequency, and severity of adverse events (i.e. secondary conditions) among people known to have fragile X syndrome?

2. What are the interventions used to treat symptoms, improve quality of life, and promote full participation in life activities for people known to have fragile X syndrome?

3. What are the unmet needs of people known to have fragile X syndrome and their families?

4. What are the barriers to appropriate care and desired interventions for people known to have fragile X syndrome?

Objective 1: Data Collection

Develop and implement a plan to recruit and retain fragile X clinical centers from diverse geographic locations to collect longitudinal data related to the following public health research priorities:

1. Describe and characterize the natural history of disease for people known to have fragile X syndrome.

2. Describe the characteristics of the study population and its comparability to all fragile X individuals in the clinic, and to what is known about the population with fragile X syndrome.

3. Reduce secondary conditions and co-morbidities that affect people known to have fragile X syndrome including anxiety, depression, self-injurious behavior, and other conditions.

4. Identify service needs and services used for people known to have fragile X, syndrome including early intervention, educational, medical, and other services.

5. Determine the effect of service use on outcomes for people known to have fragile X syndrome.

6. Identify and reduce disparities and barriers to appropriate care among people known to have fragile X syndrome including demographic, socio-economic, geographic, and other factors influencing access and receipt of appropriate care.

The data collection plan must include a strategy for longitudinal data collection on at least 500 people aged 0-24 years known to have fragile X syndrome. The plan must also describe data collection in the following 10 domains relevant to living with fragile X syndrome:

1. Hyperarousal/Sensory issues,

2. Speech and communication,

3. Behavior,

4. Developmental assessments,

5. Family support,

6. School progress,

7. Medication,

8. Sleep,

9. Preventive health monitoring (height, weight, head circumference, blood pressure, vision, hearing, nutrition, etc), and

10. Social participation (friends, community events, recreation, peer-age organizations).

Objective 2: Data Management and Analysis

Develop and implement a data management and analysis center for receipt, processing, and analysis of patient, parent, clinician, and laboratory reported data from the participating clinics or other data sources. The application must address:

1. Data security,

2. Data quality management,

3. System development and maintenance,

4. Staff capabilities,

5. Site and user support,

6. Data sharing and availability, and

7. Data analysis and visualization support.

Objective 3: Consortium Structure, Support, and Coordination

1. Provide and oversee a national coordinator for the consortium to manage communication between clinical sites, the data collection and analysis center, and the PI.

2. Organize, coordinate, and develop agendas for monthly conference calls and semi-annual in-person meetings for the consortium.

3. Maintain a repository for consortium documents.

4. Ensure satisfactory training of staff at clinical sites.

5. Provide technical assistance to clinical investigators.

A steering committee will consist of the PI, the CDC scientific collaborator, the director of the data management and analysis center, and at least 3 fragile X clinic directors, to be determined by the PI and the CDC scientific collaborator. The steering committee will serve in a consultative role to the PI as needed.

Section II. Award Information

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

Choose one of the following:.

New

Funds Available and Anticipated Number of Awards

Indicate the total funds available for the entire program. Sometimes this area is complicated if multiple types of awards are awarded $550,000 One award will be issued under this FOA contingent on the availability of funds and submission of a sufficient number of meritorious applications.

INSERT maximum $ amount; amount that you will not exceed OR INSERT "None." This ceiling is for the first 12-month budget period. Indicate if this is direct cost only or total cost, which would include indirect costs.

INSERT any minimum $ amount, if you will not make an award smaller than a floor amount OR INSERT "None." $550,000. Ceiling for the first 12-month budget period and includes total cost (direct and indirect).

If project period is more than five years, approval is required.

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 will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants Eligible Organizations

Are you doing open or limited competition? Justification letter is required if limited competition. Delete organizations that are not eligible to apply.

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.

If foreign organizations are eligible to apply, then delete the following sentence Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are not if foreign components are not allowed, delete “not” allowed.

Add additional eligibility requirements here for institutions THIS WAS SECTION III, 1.A - WHERE WE COULD LIMIT ELIGIBILITY 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 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.

If Foreign Organizations are not allowed, delete heading above and description below (BOTH PARAGRAPHS). Otherwise do not edit Foreign (non-US) organizations must follow policies described in the HHS Grants Policy Statement, and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide.

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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the HHS Grants Policy Statement.

THIS WAS SECTION III, 2

3. Additional Information on Eligibility Number of Applications

Only one application per institution (normally identified by having a unique DUNS Number) is allowed. Applicant organization may submit more than one application, provided that each application is scientifically distinct. I AM CHANGING THE DEFAULT TO ONE APPLICATION ONLY. IF MULTIPE AWARDS (ENHANCED ACTIVITIES) THIS WILL NEED FURTHER MODIFICATION.

If the sentence above is not true, , CIO must insert a comment to change the sentence above to “Only one application per institution (normally identified by having a unique DUNS number) is allowed.”

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. HHS/CDC will not accept any application that is essentially the same as one already reviewed.

Eligible applicants must meet the following criteria, or have an established partnership with an institution that meets the following criteria:

1. Must demonstrate access to at least 500 people with fragile X syndrome through any number of clinics. Participating clinics must have a minimum of 30 patients with fragile X syndrome. Evidence of clinic participation must be provided in a letter of support from each consortium partner ensuring that they have access to at least 30 patients with fragile X syndrome.

Add Information Here related to eligibility and number of applications.

THIS WAS PREVIOUSLY “Other-Special Eligibility cRITERIA”

For an applicant to even get considered they must be responsive to the information here. Our FOA responsiveness document is developed from these criteria.

Use words like: evidence of, access to, etc.

THIS LINE MUST BE INCLUDED IF YOU HAVE SPECIAL ELIGIBILITY REQUIREMENTS HERE

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

Section IV. Application and Submission Information

1. Obtaining an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity from Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, 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.

Letter of Intent The only acceptable modifications to this section are those related to the staff contact information. Current policy does not allow any changes to the type of information requested in the Letter of Intent. If Letter of Intent is not applicable for this FOA, delete the heading above and the section below.

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 IC 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. BrownADD YOUR NAME 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., M/S K-92

Atlanta, GA 30341

Telephone: (770) 488-8115 ADD YOUR PHONE INFO Fax: (770) 488-8046

Email: mab5@cdc.gov

YOUR E-MAIL ADDRESS

FedEx address

Koger Center-Davidson Building

2858 Woodcock Blvd.

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.

Page Limitations

All page limitations described in this individual FOA must be followed.

For this FOA, the Research Strategy section is limited to 25 pages.

, insert text for page limits for the Research Strategy section of the application.

Use additional text to describe other exceptions to the page limits described in the Application Guide.

Research Plan Components Applicants’ research plan should address activities they propose to conduct over the entire project period.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:Add text in the space below (before Appendix) to supply any additional instructions related to the Research Plan, but only include information that is different from application guide.

Identify any special programmatic, performance or reporting requirements [e.g., ability to enroll a specified number of patients, special expertise or facilities required, requirements for coordination among investigators (e.g., annual meetings), etc.]. Applicants should be advised to include the cost for such items in the budget. Note: guidelines must be cleared by PGO.

THIS WAS PREVIOUSLY “OTHER SUBMISSION REQUIREMENTS.”

This is where you identify special programmatic, performance, or reporting requirements, etc. This is really where you tell them what you want them to do, and for them to respond to in their application.

Use action words like: a description of, demonstrate, describe, document, experience, identify, information on, plans, procedures, provide, report, etc.

1) Describe a brief history of the fragile X clinics that are proposed in the consortium, including geographic location and organizational structure.

2) Provide a list of all proposed performance sites, including the applicant organization and the consortium parties.

3) Describe how all clinics will work as a consortium to achieve FOA objectives. The application must then include letters of support from all participating fragile X clinic directors.

4) References to “people known to have fragile x syndrome” or “fragile X patients” applies to people who are seen at fragile x clinics, and have a confirmed diagnosis.

5) Describe demographics on the anticipated study participants (i.e., age, gender, race, and ethnicity).

6) Describe how participants will be enrolled in the study and how consent will be obtained. The awardee must be able to enroll a minimum of 500 fragile X patients by the end of the funding cycle.

7) Describe the plan to ensure at least 3 years of longitudinal data collection on 50% of the 500 fragile X patients.

8) Describe what measures will be taken to retain the recruited patients for follow up each year.

9) Describe the methodology for collecting patient data and strategies for obtaining complete data on each patient.

10) Describe the methodology to compare clinic patients participating in the research study and clinic patients not participating in the research study. Include demographics and other factors that may influence the generalizability of research findings.

11) Describe any relationships with local fragile X or other parent or advocacy groups, and how they will be involved in this project. If involved, then letters of support should be provided.

12) Describe how clinics would approach using or incorporating research findings into practice.

13) Describe the research questions to be addressed by longitudinal data collection.

14) Demonstrate the capacity of the data management and analysis center to assess the data and to help identify the data elements needed to address key analysis issues.

15) Demonstrate the informatics capability to manage the collection, storage, and comparability of information from multiple clinical centers.

16) Describe your plan for data security.

17) Describe how the consortium will provide quality assurance/quality control (QA/QC) with the multiple data collection sites.

18) Describe the data management system to be used.

19) Include a management and staffing plan that describes the roles and capacity of staff members. Include staff capabilities to provide site and user support.

20) Describe the data sharing plan.

21) Create a data oversight committee to provide direction on issues concerning key data elements to be collected, data access, and management of publications

22) Describe the process for clinical investigator and data management and analysis center interaction.

23) Describe any other research currently being done by the consortium and potential for collaboration with this project.

17) Describe the administrative responsibilities of the full time consortium national coordinator. Describe how the national coordinator will plan, organize, and take minutes during monthly committee conference calls and semi-annual in-person consortium meetings. Describe plans for the national coordinator to perform site visits at fragile X clinical centers.

18) Describe how consortium documents will be updated, managed, and accessed.

19) Describe plans to disseminate results.

20) Describe plans to provide CDC an annual report regarding progress toward research participant and site recruitment goals.

21) Describe plans to provide CDC an annual report on data elements of public health interest, to be determined by the PI and CDC scientific collaborator.

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide, with the following modifications:

Delete the text block above and bullet below if not adding any changes to the Appendix instructions. If you are making changes, fill in text below.

· No publications or other printed material, with the exception of pre-printed questionnaires or surveys, may be included in the Appendix.

If applicable, add Information in the bullet above about requirements for other content and form that is in addition to and different from that described in SF424. Use Style Heading 4 for the names of application sections. DELETE THE LAST BULLET IF NOT NEEDED.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process is provided in the SF424 (R&R) Application Guide.

Note: HHS/CDC grant submission procedures do not provide a period of time beyond the grant 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).

The application package is not complete until it has passed the Grants.gov/eRA Commons validation process. This process and email notifications of receipt and validation or rejection may take two (2) business days. Applicants are strongly encouraged to allocate additional time prior to the submission deadline to submit their applications and to correct errors identified in the validation process. Applicants are encouraged also to check the status of their application submission to determine if the application packages are complete and error-free. Applicants who encounter system errors when submitting their applications must attempt to resolve them by contacting the Grants.gov Contact Center (1-800-518-4726; support@grants.gov). If the system errors cannot be resolved, applicants must contact PGO TIMS for guidance at least 3 calendar days before the deadline date.

4. Intergovernmental Review (E.O. 12372) This initiative is not subject to intergovernmental review.

Or:

5. Funding Restrictions

All HHS/CDC awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

Pre-award costs are allowable only as described in the HHS Grants Policy Statement.

Add additional information about funding restrictions. If any of these restrictions become part of the terms of award, that must be stated in Section VI.1. Delete this block if there is no additional information.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:

All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to CDC.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the CDC Procurement and Grants Office (PGO) and responsiveness by PGO and the Center, Institute or Office of the CDC. Applications that are incomplete and/or nonresponsive will not be reviewed.

Add information here related to responsiveness if applicable.

Add any other Submission Requirements and Information; include heading (and description. Do not include information about the CONTENT and FORM of the application, which should instead be placed above in Section IV.2. Content and Form.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the CDC mission, all applications submitted to the CDC in support of public health research are evaluated for scientific and technical merit through the CDC peer review system.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Overall Impact is not editable.

Scored Review Criteria Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field. Here is what the peer reviewers are going to be evaluating the application on. Add more here if the generic are not adequate. These would come from other submission requirements.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Additional Questions may be added.

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the project? Have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Additional Questions may be added.

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Additional Questions may be added.

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Additional Questions may be added.

Does the application provide a satisfactory plan for recruitment and retention of fragile X clinics toward the goal of longitudinal data collection on 500 people known to have fragile X syndrome?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Does the consortium structure, support, and coordination plan facilitate the research objectives?

Additional Questions may be added.

IMPORTANT: Any reordering or rewording of the existing text above (this does not include any information you have added) should be discussed and cleared with the Scientific Review Officer, the GMO, and PGO TIMS before publication as it may require technical changes in the eRA review modules.

Additional Scored Review Criteria may be added but criterion scores for these criteria will not be captured by IAR and must instead be calculated by Review Staff..

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Additional Review Criteria may be added Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the HHS/CDC Requirements under AR-1 Human Subjects Requirements.

Inclusion of Women and Minorities

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders. For additional information on review of the Inclusion section, please refer to the Inclusion of Women and Racial and Ethnic Minorities in Research.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Additional Review Considerations As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score. Additional Review Considerations may be added.

Resource Sharing Plans

HHS/CDC policy requires that recipients of grant awards make unique research resources and data readily available for research purposes to qualified individuals within the scientific community after publication. Please see:

http://www.cdc.gov/od/foia/policies/sharing.htm. Investigators responding to this funding opportunity should include a plan on sharing research resources and data.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process Applications will be evaluated for scientific and technical merit by an appropriate peer review group, in accordance with CDC peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications will: Delete first bullet if all applications will be discussed (no streamlining of applications); otherwise do not modify the bullet.

· Undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review), will be discussed and assigned an overall impact/priority score.

· Receive a written critique.

Applications will be assigned to the appropriate HHS/CDC Center, Institute, or Office. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review. The following will be considered in making funding decisions:

· Scientific and technical merit of the proposed project as determined by scientific peer review.

· Availability of funds.

· Relevance of the proposed project to program priorities.

This is what we called funding preferences – how we could fund out of order (i.e. geographic diversity, racial/ethnic diversity, etc.).

For any additional considerations in funding decisions, add a bullet and enter text such as “Compliance with resource sharing policies.”

DELETE THE LAST BULLET ABOVE IF YOU DO NOT USE IT.

Indicate if this award will include special terms and conditions that differ from the agency’s usual terms and conditions. Include Programmatic Priorities and Other Cost Limitations (e.g., excluding Facilities & Administrative costs for R13s). See also Section IV.5. “Funding Restrictions.”

3. Anticipated Announcement and Award Dates After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

Information regarding the disposition of applications is available in the HHS Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, HHS/CDC will request "just-in-time" information from the applicant as described in the HHS Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs specified in the FOA document.

2. Administrative and National Policy Requirements

All HHS/CDC grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA. For these terms of award, see the HHS Grants Policy Statement Part II: Terms and Conditions of Award, Overview of Terms and Conditions of Award and Requirements for Specific Types of Grants. Additional requirements are available at the following internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm.

Cooperative Agreement Terms and Conditions of Award Indicate if this FOA is not for a cooperative agreement and this section (from here to Reporting) can be removed.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and CDC grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial CDC programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the HHS/CDC purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities.