dd14-003 amendment ii 2 25 14.pdf

CDC Research 1

Rev. 10/2012

Amendment II made on February 25, 2014

Link changed on page 16 Section IV. Application and Submission Information, All instructions in the SF424 (R&R) Application Guide. Form C should be used for the application package.

(http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Adobe_VerC.pdf)

An amendment has been made to change application due date from March 6, 2014 to March 11, 2014. Revision made on page 3, Key dates.

Amendment I made on February 18, 2014:

Questions and Answers (Attachment 1), pages 35-36

Table of Contents Part 1. Overview Information

Key Dates

Required Application Instructions

Executive Summary

Part 2. Full Text

Section I. Funding Opportunity Announcement Description

Statutory Authority

Section II. Award Information

Section III. Eligibility Information

1. Eligible Applicants

2. Foreign Organizations

3. Special Eligibility Requirements:

4. Justification for Less than Maximum Competition:

5. Responsiveness:

6. Required Registrations:

7. Universal Identifier Requirements and Central Contractor: …………………….. 11

8. Eligible Individuals (Project Director/Principal Investigator):

9. Cost Sharing

10. Number of Applications

Section IV. Application and Submission Information

2. Content and Form of Application Submission

3. Letter of Intent http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Adobe_VerC.pdf

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4. Required and Optional Components

5. PHS 398 Research Plan Component

6. Appendix

7. Page Limitations

8. Format for Attachments

9. Submission Dates and Times

10. Intergovernmental Review (E.O. 12372)

11. Funding Restrictions

12. Other Submission Requirements and Information

Section V. Application Review Information

1. Criteria

4. Review and Selection Process

5. Anticipated Announcement and Award Dates

Section VI. Award Administration Information

1. Award Notices

2. CDC Administrative Requirements

5. Reporting

Section VII. Agency Contacts

Section VIII. Other Information

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Part 1. Overview Information

Participating Organization(s)

Centers for Disease Control and Prevention (CDC)

Components of Participating Organizations

National Center on Birth Defects and Developmental Disabilities

(NCBDDD)

Division of Blood Disorders (DBD)

Funding Opportunity Announcement (FOA) Title

Pilot Interventions to Promote the Health of People with Blood Disorders

Activity Code Applications in response to this FOA will be funded using R21 activity code.

Funding Opportunity Announcement Type

New

Funding Opportunity Announcement Number

RFA-DD-14-003

Catalog of Federal Domestics Assistance (CFDA) Number(s)

93.080

Category of Funding Activity

Health

FOA Purpose The purpose of this FOA is to minimize the complications of blood http://www.cdc.gov/ http://grants.nih.gov/grants/funding/ac_search_results.htm?text_curr=r21&Search.x=0&Search.y=0&Search_Type=Activity

CDC Research 4 disorders through the development of new and potential evidence-based interventions. Topics areas of interest include:

hemophilia and thalassemia.

Key Dates

Publication Date

To receive notification of any changes to RFA-DD-14-003, return to the synopsis page of this announcement at www.grants.gov and click on the “Send Me Change Notification Emails” link. An email address is needed for this service.

Letter of Intent Due Date February 6, 2014

Application Due Date March 11, 2014, by 11:59 PM U.S. Eastern Time.

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

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

Scientific Merit Review April 2014

Secondary Review June 2014

Estimated Start Date September 1, 2014

Expiration Date March 7, 2014 http://www.grants.gov/

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Due Dates for E.O. 12372 Executive Order 12372 does not apply to this program.

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

Note: The Research Strategy component of the Research Plan is limited to 15 pages.

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

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

Executive Summary

Purpose. The purpose of this FOA is to minimize the complications of blood disorders through the development of new and potential evidence-based interventions.

Mechanism of Support. This funding opportunity will use the grant funding mechanism

(CDC R-21).

Funds Available and Anticipated Number of Awards. Total funding available for this cooperative agreement is expected to be $600,000 over the two year project period. It is anticipated that up to two awards of $150,000 each will be made to two recipients in FY

2014. Awards issued under this FOA are contingent upon the availability of funds and a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of each award may also vary. The total amount awarded and the number of awards will depend upon the number, quality, duration and cost of the applications received.

Budget and Project Period. The maximum funding amount (direct and indirect costs) is

$150,000 per award for the first 12 month budget period. An applicant may request a project period of up to two years. Total funding available for the two year project period is $300,000 per grant award. The project period will run from September 1, 2014 to August 31, 2016.

http://grants.nih.gov/grants/guide/url_redirect.htm?id=12000

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

Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1 are eligible to apply.

Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. NOTE:

CDC does not make awards to individuals directly. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply. Number of PDs/PIs. Applications may contain more than one PI, however, the first PI listed will be the “contact PI” for all correspondence.

Number of Applications. Eligible applicant institutions may submit more than one application, provided that each application is scientifically distinct.

Application Type. R21 research grant.

Special Date(s). None.

Application Materials. See Section IV.1 for application materials.

Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY:

(770) 488-2783.

Part 2. Full Text

Section I. Funding Opportunity Announcement Description

Statutory Authority This program is authorized under Section 301 [42 U.S.C. 241] of the Public Health Service Act.

1. Background and Purpose Nonmalignant blood disorders such as hemophilia and thalassemia affect tens of thousands of people each year in the United States, cutting across the boundaries of age, race, sex, and socioeconomic status. Men, women, and children of all backgrounds live with complications associated with these conditions, many of which are painful and potentially life threatening.

The purpose of this FOA is to minimize complications of hemophilia and thalassemia through the development of new and potential evidence-based interventions.

The Division of Blood Disorders (DBD) is soliciting investigator-initiated research that supports pilot studies addressing the following areas of interest:

http://grants.nih.gov/grants/guide/pa-files/PAR-11-022.html#SectionIV http://grants.nih.gov/grants/guide/pa-files/PAR-11-022.html#SectionIII1A http://grants.nih.gov/grants/guide/pa-files/PAR-11-022.html#SectionIV1

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(1) Hemophilia – Joint Disease

Hemophilia is an inherited, life-long bleeding disorder caused by a decrease in function or quantity of the blood clotting proteins Factor VIII or Factor IX. People with hemophilia have a predisposition towards spontaneous or traumatic bleeding following injuries and surgery.

Bleeding into joints results in joint damage, which leads to chronic pain and disability if not prevented. Treating with replacement products on a regular basis, referred to as prophylaxis therapy has been shown to prevent the development of joint disease in young boys with severe hemophilia. Although there have been only a few studies that address the effectiveness of exercise in improving joint mobility in people with hemophilia, the literature implies that people with hemophilia could benefit from a structured, supervised exercise program. For example, one small study of 33 subjects measured significant improvements in joint mobility as measured by range of motion, muscle strength, and distance walked after a six week supervised exercise program. People with bleeding disorders who exercise appropriately may improve their strength and flexibility which may reduce bleeding in joints and subsequent joint destruction. NCBDDD/DBD is interested in evidence-based interventions that: (1) maximize the effective use of prophylaxis to prevent joint bleeding or (2) improve/maintain joint mobility among people with hemophilia.

Interventions may be focused at either the individual or systems level or both.

(2) Thalassemia - Complications

Thalassemia is a genetic disorder in which one of the two proteins that make up hemoglobin in red blood cells is abnormal. Most forms of thalassemia produce a lifelong anemia that begins in early childhood and often must be treated with frequent transfusions.

Regular blood transfusions can lead to a buildup of iron in the blood, which may cause significant, life-threatening complications such as heart or liver disease, and infections.

Compliance with chelation therapy, to remove excess iron, takes time and can be mildly painful and have side effects including problems with vision and hearing, joint pain, and fatigue which may impact quality of life. NCBDDD/ DBD is interested in developing evidence-based interventions that: (1) improve adherence to chelation treatment regimens, or (2) minimize complications of treatment to enhance the quality of life for people with thalassemia.

Applicants must address one of the research topic areas described above and only one topic area may be included per application. Documentation of the topic area to be addressed must be clearly identified in the proposal abstract.

Healthy People 2020 and other National strategic priorities – This program addresses the “Healthy People 2020” focus areas of Blood Disorders and Blood Safety (BDBS):

available at www.healthypeople.gov [Healthy People 2020]. This FOA specifically supports objectives BDBS – 5 “Increase the proportion of persons with http://www.healthypeople.gov/

CDC Research 8 hemoglobinopathies who receive disease –modifying therapies and BDBS-16 “Reduce the proportion of persons with hemophilia who develop reduced joint mobility due to bleeding into joints.”

Public Health Impact - This FOA is intended to encourage new exploratory and developmental research projects that minimize the complications of blood disorders and lead to evidence-based practices and interventions.

Relevant work – N/A

2. Approach

Objectives/Outcomes – The purpose of this FOA is to minimize the complications of blood disorders through the development of new and potential evidence-based interventions. The outcomes of the projects and evaluation strategies will vary according to the projects that are selected for funding. However, it is anticipated that these studies will inform interventions to: (1) increase the use of prophylaxis and improve joint mobility among people with hemophilia; (2) improve adherence to chelation treatment regimens and minimize complications of treatment to enhance the quality of life for people with thalassemia.

Target population - The target population will vary based upon the proposed topic areas for research.

Collaboration/Partnerships - Collaborations between researchers, clinicians, and consumer groups are encouraged but not required and may vary according to the type of research project proposed. If collaborations are proposed, it is expected that the nature of these collaborations are clearly described in the proposal and letters of support are included in the appendices.

Evaluation/Performance measurement - All Applicants should assess the feasibility and acceptability of the proposed intervention and document the impact on behavior change and/or health outcomes.

Translation plan -– It is expected that the results from the studies will be disseminated throughout the scientific community through peer-reviewed publications, websites, and appropriate state and national conferences. It is requested that applicants include funds in their budget for the PI to travel to Atlanta for a one day meeting to present their research methods and/findings to division scientists.

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Section II. Award Information

Funding Mechanism Applications in response to this FOA will be funded using the R21 mechanism.

Grant: support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

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

Funds Available and Anticipated Number of Awards

Total estimated funding (direct and indirect costs) for the first year

(12 month budget period) is $300,000. Estimated total funding for the entire two year project period is expected to be $600,000. It is anticipated that up two awards of $150,000 each will be made to two recipients in FY 2014.

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

Ceiling and Floor of Individual Award Range

The ceiling amount for the first 12-month budget period is $150,000 (including both direct and indirect costs).

Applications with budget requests greater than the ceiling will be considered non-responsive and will not be reviewed.

The floor amount for the first 12 month budget period is $75,000 (including both direct and indirect costs).

Applications with budget requests less than the floor amount will be considered non-responsive and will not be reviewed.

Project Period Length The project period will be two years.

Throughout the project period, CDC's commitment to

CDC Research 10 continuation of awards will depend on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and CDC’s determination that continued funding is in the best interest of the Federal government.

HHS/CDC grants policies as described in the HHS Grants Policy Statement (http://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 http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html

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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.

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

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

For this announcement, applicants may not include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

3. Special Eligibility Requirements: N/A

4. Justification for Less than Maximum Competition: N/A

5. Responsiveness:

To be considered responsive to this announcement, applicants may not request funding above the ceiling amount of $150,000 per year (includes both direct and indirect costs). Incomplete applications or non-responsive applications with budgets that exceed the ceiling of the award will not be entered into the review process.

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

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System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, http://www.grants.gov/applicants/org_step2.jsp.

Grants.gov eRA Commons

All applicant organizations must register with Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes. The “one-time” registration process will take three to five days to complete. However, it is best to start the registration process at least two weeks prior to application submission.

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

7. Universal Identifier Requirements and Central Contractor Registration All applicant organizations must obtain a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number is a nine-digit number assigned by Dun and Bradstreet Information Services. An AOR should be consulted to determine the appropriate number. If the organization does not have a DUNS number, an AOR should complete the US D&B D-U-N-S Number Request Web Form or contact Dun and Bradstreet by telephone directly at 1-866-705-5711 (toll-free) to obtain one. A DUNS number will be provided immediately by telephone at no charge. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a DUNS number.

Additionally, all applicant organizations must register in the System for Award Management (SAM), the replacement system for the Central Contractor Registration (CCR) database.

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

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

http://www.grants.gov/applicants/org_step2.jsp http://grants.nih.gov/grants/guide/url_redirect.htm?id=11122 http://grants.nih.gov/grants/guide/url_redirect.htm?id=11121 http://www.grants.gov/ http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform https://www.sam.gov/index.html

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8. Eligible Individuals (Project Director/Principal Investigator) in Organizations/Institutions

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

9. Cost Sharing This FOA does not require cost sharing as defined in the HHS Grants Policy Statement (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html).

10. Number of Applications Applicant organizations may submit more than one application, provided that each application is scientifically distinct. Applicants must address one of the research topic areas described in this FOA under Part 2, Section I, 1. Background and Purpose, and only one topic area may be included per application. Documentation of the topic area to be addressed must be clearly identified in the proposal abstract.

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 pgotim@cdc.gov for further instructions. Hours: Monday - Friday, 7am – 4:30pm U.S. Eastern Standard Time. CDC Telecommunications for the hearing impaired or disabled is available at: TTY 1-888-232-6348.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/guide/url_redirect.htm?id=12000), except where instructed in this Funding Opportunity Announcement to do otherwise. Conformance to the requirements in http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html

CDC Research 14 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

3. 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:

Name of the Applicant Descriptive title of proposed research Identify FOA topic area that will be addressed in the proposal 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:

Natalie J. Darling, MPH National Center for Chronic Disease and Health Promotion and NCBDDD Extramural Research Program Operations and Services Centers for Disease Control and Prevention 4770 Buford Highway, NE M/S F-80 Atlanta, GA 30341 Telephone: (770) 488-5740 Email: ndarling@cdc.gov http://www.cdc.gov/od/pgo/funding/grants/foamain.shtm mailto:ndarling@cdc.gov

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

5. PHS 398 Research Plan Component The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Plan that consists of 16 components. Not all 16 components of the Research Plan apply to all Funding Opportunity Announcements (FOAs). Specifically, some of the following 16 components are for Resubmissions or Revisions only. See 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 as directed in Part 2, Section 1 (Funding Opportunity Announcement Description).

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

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

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

3. Research Strategy – the research strategy should be organized under 3 headings:

Significance, Innovation and Approach. Describe the proposed research plan, including staffing and timeline.

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

5. Progress Report Publication List (for Continuation ONLY)

Human Subjects Section

6. Protection of Human Subjects

7. Inclusion of Women and Minorities

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

9. Inclusion of Children

Other Research Plan Sections

10. Vertebrate Animals

11. Select Agent Research

12. Multiple PD/PI Leadership Plan.

13. Consortium/Contractual Arrangements

14. Letters of Support

15. Resource Sharing Plan(s)

16. Appendix

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Component 4 (Inclusion Enrollment Report) applies only to Renewal and Revision applications for clinical research. Clinical research is that which is conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual.

Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies). Follow the page limits in the SF 424 unless otherwise specified in the FOA.

All instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Adobe_VerC.pdf) must be followed along with any additional instructions provided in the FOA.

As per the SF424 guidelines, applicants should begin each section of the Research Plan with a section header (e.g., Introduction, Specific Aims, Research Strategy, etc) and must:

State concisely the goals of the proposed research and summarize the expected outcomes(s), including the impact that the results of the proposed research will exert on the research field(s) involved.

Explain the importance of the problem that the proposed project addresses and how the project will improve scientific knowledge and/or practice.

Describe any novel concepts, approaches or methodologies, instrumentation or interventions to be developed.

Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project. Include how the data will be collected, analyzed, and interpreted.

Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the aims

If the project is in the early stages of development, describe any strategy to establish feasibility, and address the management of any high risk aspects of the proposed

Applicants are encouraged to include an abstract/summary of their proposal. The abstract should include the purpose of the study, documentation of the topic area of interest, research objectives to be addressed, and expected outcomes, including the public health impact of the proposed research. The abstract should not exceed one page.

6. 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.

http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Adobe_VerC.pdf

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7. Page Limitations All page limitations described in this individual FOA must be followed. For this specific FOA, the Research Strategy component of the Research Plan narrative is limited to 15 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.

8. 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. Applicants should ensure that all attachments are uploaded to the system.

CDC requires 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).

9. 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.

http://grants.nih.gov/grants/guide/url_redirect.htm?id=11128 http://grants.nih.gov/grants/guide/url_redirect.htm?id=11123

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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 at 770-488-2700; www.pgotim@cdc.gov for guidance at least 3 calendar days before the deadline date.

After submission of your application package, applicants will receive a “submission receipt” email generated by Grants.gov. Grants.gov will then generate a second e-mail message to applicants which will either validate or reject their submitted application package. This validation process may take as long as two (2) business days. A third and final e-mail message is generated once the applicant’s application package has passed validation and the grantor has confirmed receipt of the application.

Unsuccessful Submissions:

If an application submission was unsuccessful, the applicant must:

1. Track his/her submission and verify the submission status (tracking should be done initially regardless of rejection or success).

a. If the status states “rejected,” do #2a or #2b.

2. Check his/her emails from both Grants.gov and eRA Commons for rejection notices.

a. If the deadline has passed, he/she should email the Grant Management Specialist listed in the FOA (pgotim@cdc.gov) explaining why the submission failed.

b. If there is time before the deadline, he/she should correct the problem(s) and resubmit as soon as possible.

10. Intergovernmental Review (E.O. 12372) This initiative is not subject to intergovernmental review (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11142).

mailto:pgotim@cdc.gov http://grants.nih.gov/grants/guide/url_redirect.htm?id=11142

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11. 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 may be allowable as an expanded authority, but only if authorized by CDC.

Funds relating to the conduct of research involving human subjects will be restricted until the appropriate assurances and Institutional Review Board approvals are in place.

Reimbursement of pre-award costs is not allowed.

12. Other Submission Requirements and Information Applicants should include funds in their budget for the PI to travel to Atlanta for a one day meeting to present their research methods and/findings to Division scientists.

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.

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

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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 incompleteand/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?

What is the potential or actual impact of the research on public health in the US?

If successful, do the research results have the potential to be scalable and reach the population at risk?

Investigator(s) http://grants.nih.gov/grants/ElectronicReceipt/avoiding_errors.htm http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm http://www.cdc.gov/about/organization/mission.htm

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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?

Is there evidence of past collaborations with the proposed research team?

Have previous research results provided high quality outputs and contributed to improvements in public health practice?

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 application challenge and seek to shift current public health practice paradigms or approaches?

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?

Where available, does the application propose to use evidence-based interventions or strategies in the research plan?

Are measures to assess outcomes included?

Are the analytic plans clear, consistent with the research questions, and appropriate for the study design and data available?

Does the application describe how the results from the research will be disseminated and ultimately used?

If the project involves clinical research, are there 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?

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

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Does the project utilize critical partnerships or collaborations?

Does the project support key stakeholder involvement throughout the research process?

2. 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 If the research 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) and the policy on the Inclusion of Persons Under21 in Research (http://aops-mas-iis.cdc.gov/Policy/Doc/policy496.pdf).

http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=/ecfrbrowse/Title45/45cfr46_main_02.tpl http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar1 http://www.cdc.gov/OD/foia/policies/inclusio.htm http://aops-mas-iis.cdc.gov/Policy/Doc/policy496.pdf http://aops-mas-iis.cdc.gov/Policy/Doc/policy496.pdf

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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.

3. 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 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.

http://grants.nih.gov/grants/guide/url_redirect.htm?id=11150 http://www.cdc.gov/od/foia/policies/sharing.htm http://www.cdc.gov/od/pgo/funding/budgetguide.htm

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4. 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…