dd12-002 foa final 1.4.12.doc

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 1. Overview Information

Announcement Type

New

Key Dates Publication Date

To receive notification of any changes to RFA-DD-12-002, 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

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

Awards are made under the authorization of Section 301(a) and 317C of the PHS Act (42 USC section 241(a) and 247b-4, as amended).

Background

Currently, there are approximately 7,000 low prevalence/high impact conditions reported for the U.S. population collectively affecting about 25 million people. In the United States, a condition is low prevalence/high impact when its number of cases at a given time does not reach 200,000 [1]. In comparison, the number of cases for a common disease such as diabetes amounted to nearly 26 million for the U.S. in 2010 [2]. With similar collective prevalence to diabetes in the U.S. population, low impact/high prevalence conditions express a severity and reach that have a major public health impact in our country. Many of these conditions start early in life and drastically reduce life expectancy and quality of life. They also may induce physical or mental impairments that limit autonomy and last a lifetime and significantly narrow the range of opportunities for education and employment among affected individuals, diminishing their options for independent adult living. The negative impact of low prevalence/high impact conditions usually extends to the relatives of affected individuals and society in general as individuals with these conditions often require continued health care, support services, and economic support. Health care for individuals with low prevalence/high impact conditions can be costly and labor intensive, putting it out of reach for most affected families. For example, the 2006 average annual medical expenditure for people with actively managed cystic fibrosis, aged below 65 years, was about $48,000. That is 22 times as much as the average medical expenditure of a person of comparable age without the disease [3]. And the cost of treatment for some low prevalence/high impact diseases can be as high as $400,000 per year [4]. In comparison, the 2007 average annual medical expenditure for a person with diagnosed diabetes was $11,744 ($6,649 can be attributed to diabetes). This is 2.3 times as much as the medical expenditure among people without diabetes [5]. Hence, the health and economic impact per person can be considerably higher for a low prevalence/high impact disease than for a common disease.

The cost of researching, developing, and dispensing treatments for diseases is usually high and the low prevalence/high impact diseases market is considered too small to recoup such cost and generate a profit. Low prevalence/high impact conditions have often received little attention from the research community, the medical establishment, the pharmaceutical industry, and the public health community. Historically, much of the attention dedicated to low prevalence/high impact conditions has been driven by support groups, advocacy groups and patients’ organizations. In this regard, these groups and organizations have played a primary role in funding research, promoting legislation, educating the public, and designing public health policy [6].

Despite the difficulty of defining them as a public health problem, there are notable success stories in the use of a public health approach toward low prevalence/high impact conditions in the United States: (1) The newborn screening program has progressed from the screening of one condition in one county in 1962 to the screening of up to 50 conditions in all 50 states today [7]; (2) The enactment of the Orphan Drug Act in 1983 [8] and the Rare Diseases Act in 2002 [9]. Since the passage of the Orphan Drug Act more than 300 products have been approved for the treatment of low prevalence/high impact conditions, compared with only 10 products in the decade preceding this act [4]); (3) Major advances in several fields such as diagnosis, nutrition, and medical treatment have significantly increased patients’ life expectancy; for example, the median age at death for individuals with cystic fibrosis has improved from 6 months in 1959 to 27 years in 2008. Moreover, on average, current 11 year-old cystic fibrosis patients are expected to live to age 50 [10]; and (4) The knowledge of disease mechanisms unveiled by studying low prevalence/high impact diseases may contribute to the treatment of millions of people in the general population; for example, the understanding of the cause of familial hypercholesterolemia led to the development of statins, a widely used class of cholesterol-lowering drugs [11].

Despite these successes, it is important to note that a public health approach to low prevalence/high impact conditions still faces important obstacles [12]. The epidemiology and surveillance of these conditions is not on a par with the epidemiology and surveillance of common conditions. Collectively, low prevalence/high impact disorders constitute a large albeit heterogeneous group of conditions whose progression over the life course we know very little about. The proportion of affected individuals could be substantial (6-8% of the population [13]) but accurate prevalence estimates are difficult to obtain. A recent attempt to estimate prevalence of low prevalence/high impact conditions in Europe was hampered by unreliable data, inconsistent sources of information, and inadequate epidemiological studies [14]. Surveillance is the first step toward producing robust information about disability related diseases in populations. Because of their low prevalence, it would be impractical to develop a separate surveillance system for each condition. A more efficient approach is a joint surveillance system for several low prevalence/high impact conditions at once. Such a surveillance system would be valuable in generating information in the following categories [15]:

· Descriptive epidemiology (prevalence, incidence, trends)

· Links to services

· Links to health and development outcomes

· Links to research

· Evaluation of interventions

· Planning and projections

· Education and policy

Purpose

The purpose of this research is to design and test the feasibility of a surveillance system for congenital and inherited conditions that have low prevalence but high health and economic impact in the U.S. population that will support description of this population across the lifespan. Initial design of this surveillance system will focus on three conditions which exemplify different types of disorders: e.g. spina bifida is an example of a neurological condition affecting mobility; muscular dystrophy is an example of a neuromuscular condition; and fragile X syndrome is an example of a condition affecting cognition and behavior. The project will develop a prototype surveillance system that, if found effective, can serve as a model for other low prevalence/high impact conditions. There is currently no system or integrated approach to identify and describe persons affected by these conditions, thus limiting opportunities to understand, intervene, and improve health services and public health outcomes for those people affected with these conditions and their families. A system focused on low prevalence/high impact conditions may assist public health practitioners, clinicians, and other groups to: describe the epidemiology and the features of secondary health conditions associated with these disorders; monitor the progress of public health interventions, develop screening strategies for the detection of new cases, inform policies aimed at improving the healthcare delivered to these patients, and address potential differences or disparities in the impact of these conditions on the population. In short, this research effort will explore how different systems and data sources may be used to improve health services and health outcomes among people affected with selected conditions and their relatives.

This program addresses the “Healthy People 2020” focus area(s) of:

Disability and Health:

DH–2: Increase the number of Tribes, States, and the District of Columbia that have public health surveillance and health promotion programs for people with disabilities and caregivers.

Public Health Infrastructure

PHI-7: (Developmental) Increase the proportion of population-based Healthy People 2020 objectives for which national data are available for all major population groups.

PHI-8: Increase the proportion of Healthy People 2020 objectives that are tracked regularly at the national level.

PHI-13: Increase the proportion of Tribal, State, and local public health agencies that provide or assure comprehensive epidemiology services to support essential public health services.

The proposed research aligns with the goal of the National Center on Birth Defects and Developmental Disabilities to: Characterize the problem, incidence, prevalence, and distribution of priority health conditions to inform public health research, priority setting and program monitoring. It also aligns with the priorities of the division that will host this project, the Division of Human Development and Disability: 1) Reduce disparity in health indicators, including obesity, in children, youth and adults with disabilities; and 2) Improve developmental outcomes of all children.

Through this announcement, the CDC intends to fund application(s) that have the potential to yield high impact research by reducing the public health burden due to low prevalence/high impact diseases.

Scientific Knowledge to Be Achieved Through This Funding Opportunity

The creation of an integrated surveillance system for low prevalence/high impact conditions could serve as a model for other similar conditions, leading to wider understanding of their progression over the life course and subsequent more targeted public health interventions which may have a major impact on the health and economy of a large segment of the U.S. population. Our knowledge of this new type of surveillance system will allow the assessment and monitoring of effects generated by these conditions over time in our society, a fundamental step in establishing a public health approach to addressing these conditions. It will also provide data that contributes to the planning and evaluation of policies and interventions aimed at improving health services and health outcomes among people affected by these conditions.

Research Objectives and Approach

The goal of this research is to design and pilot test a surveillance system for low prevalence and high impact congenital and inherited low prevalence/high impact conditions using spina bifida, muscular dystrophy, and fragile X syndrome as three representative conditions.

· Objective 1: Identify existing local, regional, and national data sources and existing surveillance systems for these three target conditions. Collaboration with state departments of health, particularly those with birth defects surveillance activities is strongly encouraged.

· Objective 2: Identify gaps and deficiencies in these existing data sources and surveillance systems.

· Objective 3: Develop and execute a plan to integrate all major data sources into a functional surveillance system for the three target conditions simultaneously. The system may include a core module, formed by elements common to all three conditions, and extension modules, formed by elements particular to each condition. The plan should be designed so that it is not dependent on unique data sources available in only one state, rather it could be envisioned as a multi-state approach, and should include an approach to de-duplicate data from multiple sources.

Objective 4: Pilot test the surveillance system, and develop a report with recommendations regarding the feasibility of a national surveillance system. The findings should describe the data sources examined, barriers encountered to integrate the data sources, and a summary of pilot data including identification of important gaps in information or systems. The recommendations should address specifically:

a) The potential usefulness of the surveillance system for state health departments,

b) The potential usefulness of the surveillance system for other interested public and private organizations operating at local, state, and national level,

c) The feasibility of using the platform designed for the surveillance of the three target conditions for other high impact/low prevalence diseases, and

d) The potential link between this surveillance system and public health priorities such as addressing health disparities and improving developmental outcomes in children.

References

1. http://rarediseases.info.nih.gov/

2. Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011. http://www.cdc.gov/diabetes/pubs/factsheet11.htm.

3. Ouyang L, Grosse SD, Amendah DD, Schechter MS. Healthcare expenditures for privately insured people with cystic fibrosis. Pediatric Pulmonology 2009; 44: 989-996.

4. Haffner ME, Torrent-Farnell J, Maher PD. Does orphan drug legislation really answer the needs of patients? Lancet 2008; 371: 2041-2044.

5. American Diabetes Association. Economic Costs of Diabetes in the U.S. in 2007. Diabetes Care 2008; 31:1-20.

6. Aymé S, Groft S. Empowerment of patients: lessons from the rare disease community. Lancet 2008; 371: 2048-2051.

7. Bradford LT, Adams J. Newborn Screening in North America. J Inherit Metab Dis 2007; 30: 447-465.

8. http://history.nih.gov/research/downloads/PL97-414.pdf

9. http://history.nih.gov/research/downloads/PL107-280.pdf

10. Barr HL, Britton J, Smyth AR, Fogarty AW. Association between socioeconomic status, sex, and age at death from cystic fibrosis in England and Wales (1959 to 2008): cross sectional study. BMJ 2011; 343:d4662.

11. Lander ES. Interview. PNAS 2011; 108: 11319.

12. Jackson JM, Crider KS, Olney RS. Population-based surveillance for rare congenital and inherited disorders: models and challenges. Adv Exp Med Biol 2010; 686:133-150.

13. Forrest CB, Bartek RJ, Rubinstein J, Groft SC. The case for a global rare-disease registry. Lancet 2011; 377: 1057-1059.

14. Schieppati A, Henter JI, Daina E, Aperia A. Why rare diseases are an important medical and social issue. Lancet 2011; 371: 2039-2041.

15. Buehler JW. Surveillance. In: Rothman KJ, Greenland S, Lash TL, eds. Modern Epidemiology. 3rd Edition. Philadelphia, PA: Lippincott Williams and Wilkins; 2008: chap 22.

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

Total funds available for the entire program are $800,000. One award will be issued for this FOA. The funding amount may be up to $400,000 (direct and indirect) each year of the award.

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

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 eligible.

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).

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 CIO 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., M/S K-46 Atlanta, GA 30341

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

Email: mab5@cdc.gov

FedEx address

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 consist 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.

All instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Adobe_VerB.pdf) 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.

Appendix

Do not use the appendix to circumvent page limits. A maximum of 10 PDF documents are allowed in the appendix. Additionally, up to 3 publications may be included that are not publically available. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Applicants’ research plan should address activities that will be conducted over the entire 2-year project period. The applicants’ research plan should address activities they will conduct over the entire project period and must include the following:

1) Describe approach to identifying existing local, regional, and national data sources or existing surveillance systems for the three target conditions.

2) Describe each data source, including accessibility, the data elements (variables) available from each source or system, and the analyses that have been done with them. Document key similarities and differences among the data sources and data elements for the three conditions.

3) Describe how to identify gaps and deficiencies in the completeness, quality, and public health usefulness of these existing data sources or surveillance systems.

4) Describe an approach to fill the gaps and remedy the deficiencies. Examine the need for developing new data sources or new methods to collect data related to these three conditions. Identify approaches to establishing a denominator (population base) for the surveillance system.

5) Describe approach for integrating all major data sources into a functional surveillance system for all three conditions simultaneously and how duplicate cases will be removed. Include a rationale for the proposed structure and selection of proposed data elements. The system may include a core module, common to all three conditions, and extension modules, specific to each condition. The approach should be able to be used in various states – approach can’t depend on unique data sources in a single state.

6) Describe how to conduct a pilot test of the surveillance system and evaluate its success in capturing information on the three target conditions.

7) Prepare a plan to disseminate the findings including: a final report with recommendations addressing the feasibility of implementing a national surveillance system for the three target conditions, at least one scientific publication, and at least one scientific presentation.

8) Describe a management and staffing plan that includes roles and responsibilities for each key team member.

9) Describe the project’s timeline with specific activities and expected accomplishments for each year.

10) Provide a budget that includes at least one trip per year to Atlanta, Georgia.

Page Limitations

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

Research Strategy component of the Research Plan narrative is limited to 25 pages.

Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files with a maximum of 35 pages for all appendices.

Format for Attachments

Designed to maximize system-conducted validations, multiple separate attachments are required for a complete application. When the application is received by the agency, all submitted forms and all separate attachments are combined into a single document that is used by peer reviewers and agency staff.

CDC require all text attachments to the Adobe application forms be submitted as PDFs and that all text attachments conform to the agency-specific formatting requirements noted in the SF424 (R&R) Application Guide (Part I, Section 2) (http://grants.nih.gov/grants/guide/url_redirect.htm?id=12000).

Failure to follow these requirements may lead to rejection of the application during agency validation or delay in the review process.

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 (http://www.grants.gov/), the online portal to find and apply for grants across all Federal agencies. The eRA Commons systems retrieve the application from Grants.gov and check the application against CDC business rules. If no errors are found, the application will be assembled in the eRA Commons for viewing by the applicant before moving on for further CDC processing.

If errors are found, the applicant will be notified in the eRA Commons. They must make required changes to the local copy of their application and submit again through Grants.gov. Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Once you can see your application in the Commons, be sure to review it carefully as this is what the reviewer will see. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11123).

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, 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 CDC 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 (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11142).

5. Funding Restrictions

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

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

Funds for research involving human subjects will be restricted until a Federalwide Assurance and Institutional Review Board Approval(s) are in place.

6. Other Submission Requirements and Information Application Submission

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 (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11144).

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.

Applicants are reminded to enter the approved Federal Wide Assurance (FWA) that the applicant has on file with the Office for Human Research Protections, if available. If the applicant has a FWA number, enter the 8-digit number. Do not enter the FWA before the number. If a Project/Performance Site is engaged in research involving human subjects, the applicant organization is responsible for ensuring that the Project/Performance Site operates under and appropriate Federal Wide Assurance for the protection of human subjects and complies with 45 CFR Part 46 and other CDC human subject related policies described in Part II of this Application Guide and in the HHS Grants Policy Statement.

See more resources to avoid common errors and submitting, tracking, and viewing applications: http://grants.nih.gov/grants/ElectronicReceipt/avoiding_errors.htm or http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm 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.

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 (http://www.cdc.gov/about/organization/mission.htm), 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).

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.

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?

Does the applicant demonstrate knowledge of surveillance systems and justify the need for establishing a low prevalence/high impact-condition surveillance system in the U.S.?

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?

Does the team bring complementary and integrated expertise to the project? Does the principal investigator (PI) have experience with surveillance systems involving a variety of sources? Does the PI have extensive, demonstrable experience in collecting, integrating, managing, and analyzing datasets from multiple sources of information? Does the project team include members with expertise in biostatistics and epidemiology? Does the project team include members with clinical expertise in the low prevalence/high impact conditions relevant to this project?

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?

Does the methodology include innovations specifically for the surveillance of low prevalence/high impact conditions?

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?

Is the plan adequate to carry out the proposed objectives? How complete and comprehensive is the plan for the 2-year period? Is the timeline realistic?

Does the applicant demonstrate the ability to access the proposed data sources? Does the plan demonstrate current or potential agreements with federal, state, public and private partners for access to data relevant to low prevalence/high impact conditions?

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 host institution have demonstrable capability to carry out low prevalence/high impact-condition surveillance in the U.S. population?

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.

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 (http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar1).

If your proposed research involves the use of human data and/or biological specimens, you must provide a justification for your claim that no human subjects are involved in the Protection of Human Subjects section of the Research Plan.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the policy on the Inclusion of Women and Racial and Ethnic Minorities in Research (http://www.cdc.gov/OD/foia/policies/inclusio.htm).

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11150).

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.

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. The applicant can obtain guidance for completing a detailed justified budget on the CDC website, at the following Internet address: http://www.cdc.gov/od/pgo/funding/budgetguide.htm.

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:

· Undergo a selection process in which only those…