gh12-006 final 01.12.12.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

Public Health

B. To incorporate the results of research into operational nutrition programs in humanitarian emergencies and ensure the sharing of expertise and research findings with other non-governmental agencies, donor institutions and United Nations agencies.

Key Dates Publication Date

January 12, 2012

To receive notification of any changes to RFA-GH-12-006, return to the synopsis page of this announcement at www.grants.gov and click on the “Send Me Change Notification Emails” link An email address is needed for this service.

On-time submission requires that electronic applications be error-free and made available to CDC for processing from eRA Commons on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov/eRA Commons no later than 5:00 PM U.S. Eastern Time. Note: HHS/CDC grant submission procedures do not provide a period of time beyond the application due date to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

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 12 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

Sections 307 and 317 (k) (l) and (k) (2) of the Public Health Service Act (42 U.S.C. 242 and 247 b (k) (l) and (k) (2)), as amended.

Background Acute malnutrition, defined as a weight -for-height Z score (WHZ) of <-2 (WHO standards) or presence of bilateral pitting edema, among children under five years of age, is a significant public health concern, with an estimated 50 million children suffering from and 1 million children dying from the most severe form each year. 36 million children suffer from moderate acute malnutrition (MAM) (WHZ >=-3 and <-2) and are at increased risk for morbidity and mortality

ADDIN EN.CITE

[1] . In humanitarian contexts, the situation is exacerbated by the cumulative effects of food shortages, increased morbidity from other causes and the impact of conflict and resultant insecurity and reduced access to populations.

Emergency nutrition interventions addressing moderate malnutrition are currently experiencing intense review and development, mostly inspired by advances in knowledge about Severe Acute Malnutrition or Chronic Malnutrition. Among these changes, is a gradual shift of interest from treatment towards prevention programs, the introduction of new manufactured supplementary foods and a re-focus on children of lower ages (6 to 24 or 36 months). As these new trends develop, there is a need to evaluate their impact on program quality and performance, their potential negative impact on baseline diets, as well as their impact on the nutrition status of individuals and populations. There is an important demand as well for reliable, field friendly methods to monitor the quality and impact of preventive programs on the nutritional status of children.

Purpose

The purpose of the program is to provide funding for research on moderate acute malnutrition in humanitarian emergencies.

Applicants may address one or two areas in a single application. Research topics to consider include:

· Evaluate multiple methodologies for the monitoring and evaluation of programs aimed at either the prevention or treatment of moderate acute malnutrition among children in humanitarian emergencies.

· Evaluate the effect of preventive programs using new products (ready to use foods) on baseline diets, including breastfeeding, of beneficiaries.

· Develop and pilot programs designed to treat non-complicated SAM and MAM that use the same protocol for both groups.

· Evaluate various age groups targeted for prevention programs (under 2, under 3, under 5) and assess the consequences of selecting specific age groups.

· Increase knowledge of the challenges to growth among populations affected by humanitarian emergencies and how this could inform program development and implementation.

· Evaluate the field implementation of community-based management of acute malnutrition, specifically addressing coverage, defaulting, and the program model.

The potential investigators need to include a detailed evaluation plan in the application. The purpose of an evaluation is to inform management for planning and policy decisions, to understand and improve program effectiveness and to demonstrate the impact of resource investments. The key is to design and execute an evaluation that is as objective as possible and that facilitates the rigorous assessment of the various evaluation process and outcomes components, which include: analysis of the conceptualization and the design of interventions; monitoring the process of implementation; and the assessment of the utility and impact of the program or intervention. Through this announcement, the CDC intends to fund projects that have the potential to yield high impact public health results contributing to population health improvements on a large scale.

Section II. Award Information

Funds Available and Anticipated Number of Awards

Approximate Fiscal Year Funding: $2,000,000.00 Anticipated Number of Awards: Up to 4 awards Awards issued under this FOA are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

Floor of Individual Awards Range: $100,000.00

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

Eligibility for award is limited to foreign entities located in any country affected by humanitarian emergencies or protracted conflict. The following organizations are eligible to apply:

a. Public/State Controlled Institutions of Higher Education

b. Private Institutions of Higher Education

c. Non-Domestic (non-U.S.) Entities (Foreign Organizations)

d. United Nations Agencies

Other-Special Eligibility Criteria:

At the time of submission the organizations must provide documentation proving success in the implementation of nutrition programming in humanitarian emergencies or conducting research on nutrition programming in humanitarian emergencies.

At the time of submission the organizations must provide documentation of a presence in at least 5 countries and at least 5 years of demonstrable experience in nutrition in humanitarian emergencies.

Additional requirements

Applicants are preferred to have been almost exclusively non-governmental organizations with a presence in at least 5 countries, international organizations, universities, colleges and research institutions. It is important to maintain this consistency, and ensure that the successful recipient has the related capacity and experience to continue the effort.

Successful PD/PIs, collaborators, and other researchers must have a demonstrable record and existing staff trained in public health and science related to nutrition.

Successful PD/PIs, collaborators, and other researchers must have a significant global presence, allowing it to coordinate with local governments and international organizations in the implementation of operational research related to nutrition in humanitarian emergencies, to ensure the support of professional networks.

The limited duration of this grant requires that a successful PD/PI begin work immediately upon receipt of the award, international organization, university, college, or research institution with experience operating in complex humanitarian emergencies.

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

· (Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: http://www.dlis.dla.mil/Forms/Form_AC135.asp

· 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.

Foreign Organizations

Foreign (non-US) organizations must follow policies described in the HHS Grants Policy Statement (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html), and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide.

International registrants can confirm DUNS by sending an e-mail to ccrhelp@dnb.com , including Company Name, D-U-N-S Number, and Physical Address, and Country.

Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: http://www.dlis.dla.mil/Forms/Form_AC135.asp.

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 At the time of submission the organizations must provide documentation proving success in the implementation of nutrition programming in humanitarian emergencies or conducting research on nutrition programming in humanitarian emergencies.

At the time of submission the organizations must provide documentation of a presence in at least 5 countries and at least 5 years of demonstrable experience in nutrition in humanitarian emergencies.

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

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.

Section IV. Application and Submission Information

1. Obtain 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:

Lata Kumar

Scientific Review Officer

CGH Science Office

Center for Global Health

Centers for Disease Control and Prevention

U.S. Department of Health and Human Services

1600, Clifton Road, MS D-69

Atlanta, GA 30033

Tel: 404-639-7618

E-mail: lek7@cdc.gov 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. Specific Aims

2. Research Strategy (includes Significance, Approach and Innovation)

3. Impact

4. Biographical Sketch of PD/PI and all key personnel

5. Inclusion Enrollment Report

6. Progress Report Publication List

Human Subjects Section

7. Protection of Human Subjects

8. Inclusion of Women and Minorities

9. Targeted/Planned Enrollment Table

10. 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 5 (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:

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.

Sections of Application:

A complete application will contain the following:

1) An Executive Summary of the overall purpose of this application;

A Project Abstract must be completed in the Grants.gov application forms using the SF424 application package/PHS Form 398. The project abstract must contain a summary of the proposed activity suitable for dissemination to the public. It should be a self-contained description of the research project and should contain a statement of objectives and methods to be employed. It should be informative to other persons working in the same or related fields and insofar as possible understandable to a technically literate lay reader. This abstract must not include any proprietary/confidential information.

The abstract must be submitted in the following format:

· Maximum of 2-3 paragraphs;

· Font size: 12 point unreduced, Times New Roman;

· Single spaced;

· Paper size: 8.5 by 11 inches (preferred), or generally accepted paper size; and

· Page margin size: One inch.

A Research Plan must be submitted for each project with the application forms (see Supplemental Information for this section below), per the SF424/PHS Form 398. The research plan must be uploaded in a PDF file format when submitting via Grants.gov. The Research Strategy component of the Research Plan must be submitted in the following format:

· Font size: 12 point, unreduced, Times New Roman;

· Double spaced;

· Paper size: 8.5 by 11 inches (preferred), or generally accepted paper size;

· Page margin size: One inch;

· Number all pages sequentially

1) Please use the following outline for each project:

1. The Title of the Project

2. The PD/PI of the Project

3. Senior/Key Personnel – (for the Project only)

4. Biographical sketch of all key personnel including PI

5. Specific Aims

6. Background and Significance

7. Preliminary Studies

8. Research Design and Materials

9. Significance and Impact

2) Human Subjects Sections and Other Research Plan Sections (Budget Section – budget by Project, by budget category with a written justification, in US Dollars. Plus a total budget summary; and

3) Letters of commitment from all partners, including non-governmental agencies and academic institutions.

4) Project Budget Justification:

With staffing breakdown and justification, provide a line item budget and a narrative with justification for all requested costs. Be sure to include, if any, in-kind support or other contributions provided by the national government and its donors as part of the total project, but for which the applicant is not requesting funding.

If included under the SF424 application/PHS Form 398– Budget Section, the budget justification will not count toward the Appendix page limit.

Budgets must be consistent with the purpose and must include the following: line item breakdown and justification for all personnel, i.e., name, position title, annual salary, percentage of time and effort, and amount requested.

The application must be assembled and paginated as one complete document from beginning to end. Begin page numbering with the first PHS 398 face page, followed by a comprehensive Table of Contents for the entire application beginning with the Executive Summary, Administrative Core Plan and continuing through each Project and any Appendices.

The Table of Contents should provide enough detail to readily locate specific sections/information pertinent to the application.

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 12 pages.

Supporting materials for the Research Plan narrative included as appendices may not exceed 5 PDF files with a maximum of 40 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 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).

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.

Submit your application 2 days prior to the due date to allow for the correction errors; which is March 27, 2012.

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 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.

Restrictions, which must be taken into account while writing the budget, are as follows:

· Recipients may only expend funds for reasonable program purposes, including personnel, travel, supplies, and services, such as contractual.

· The direct and primary recipient in a cooperative agreement program must perform a substantial role in carrying out project objectives and not merely serve as a conduit for an award to another party or provider who is ineligible.

· Reimbursement of pre-award costs is not allowed.

· The costs that are generally allowable in grants to domestic organizations are allowable to foreign institutions and international organizations, with the following exception: With the exception of the American University, Beirut and the World Health Organization, Indirect Costs will not be paid (either directly or through sub-award) to organizations located outside the territorial limits of the United States or to international organizations regardless of their location.

· All requests for funds contained in the budget, shall be stated in U.S. dollars. Once an award is made, CDC will not compensate foreign grantees for currency exchange fluctuations through the issuance of supplemental awards.

· Foreign grantees are subject to audit requirements specified in 45 CFR 74.26(d). A non-Federal audit is required, if during the grantees fiscal year, the grantee expended a total of $500,000.00 or more under one or more HHS awards (as a direct grantee and/or as a sub-grantee). The grantee either may have (1) A financial related audit (as defined in the Government Auditing Standards, GPO stock #020-000-00-265-4) of a particular award in accordance with Government Auditing Standards, in those case where the grantee receives awards under only one HHS program; or, if awards are received under multiple HHS programs, a financial related audit of all HHS awards in accordance with Government Auditing Standards; or (2) An audit that meets the requirements contained in OMB Circular A-133.

· A fiscal Grantee Capability Assessment may be required, prior to or post award, in order to review the applicant’s business management and fiscal capabilities regarding the handling of U.S. Federal funds.

· If research involves human subjects, funds will be restricted until a Federal Wide Assurance (FWA) and Institutional Review Board Approvals (IRB) are in place.

· Projects, if directed by CDC staff and involve the collection of information from 10 or more individuals, and are funded by a grant/cooperative agreement, will be subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act.

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.

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? What is the potential or actual impact of the research on public health globally? If successful, do the research results have the potential to be scalable and reach a large portion of the population at risk?

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? Do the investigators have a successful track record in public health research in complex humanitarian emergencies?

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?

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? Does the application propose to use evidence-based interventions or strategies in the research plan?

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?

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.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Resource Sharing Plans

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

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

Budget and Period of Support

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

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

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

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

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

· Availability of funds.

· Relevance of the proposed project to program priorities.

Funding restrictions

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

Restrictions, which applicants must take into account while writing their budgets, are as follows:

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

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

Information regarding the disposition of applications is available in the HHS Grants Policy Statement (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html).

Section VI. Award Administration Information

1. Award Notices

Any applications awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements. If the application is under consideration for funding, HHS/CDC will request "just-in-time" information from the applicant as described in the HHS Grants Policy Statement (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html).

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

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

2. Administrative and National Policy Requirements

All HHS/CDC grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA. For these terms of award, see the HHS Grants Policy Statement Part II: Terms and Conditions of Award (http://dhhs.gov/asfr/ogapa/grantinformation/hhsgps107.pdf).

Additional requirements are available at the following internet address: http://www.cdc.gov/od/pgo/funding/Addtl_Reqmnts.htm.

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

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

The PD(s)/PI(s) will have the primary responsibility for:

· Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and CDC policies.

· Overseeing all management, administrative, and scientific/programmatic aspects of the research including all data, resources and operations.

· Providing the necessary personnel and supplies to implement components and analyze the results.

· Collaborating with local senior researches, CDC researchers and community-based organizations or similar community liaison for the duration of the project period on several activities such as the development of the data-collection instruments, specimen -collection protocols, and data-management procedures.

· Working with HHS/CDC scientists to refine protocols to improve the study and other proposal components based on reviewers‘comments in the summary statement. The grantee will obtain IRB approval for all collaborators.

· Identify, recruit, obtain informed consent from, and enroll an adequate number of study participants, as determined by the study protocols and the program requirements. The grantee will obtain IRB approval for all collaborators.

· Following study participants as determined by the study protocols.

· Establishing procedures to maintain the privacy of the study participants and confidentiality of the research data. The grantee will obtain IRB approval for all collaborators.

· Agreeing to share data and specimens with CDC scientists, as well as appropriate international partners, such as the World Health Organization.

· In collaboration with HHS/CDC, present at international meetings and publish research findings in peer-reviewed scientific journals.

· Participating in conference with HHS/CDC project official(s) and research team; and attend in-person meeting with HHS/CDC co-investigators

· Collaborating with USG agency scientists to meet objectives of this agreement.

· Meeting the reporting requirements outlined in the Notice of Grant Award.

· Obtain and maintain the appropriate Institutional Review Board (IRB) or ethical review process approvals for all institutions or individuals participating in research involving human subjects.

· Sharing all data and other project and programmatic information with CDC upon request

· Retaining custody of and having primary rights to the data and software developed under this award, subject to U.S. Government rights of access consistent with current DHHS, PHS, and CDC policies.

CDC staff has substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

· Monitor the cooperative agreement.

· Collaborate with recipient to establish priorities for the development and implementation of the recipient activities, both among and within each of the areas, through…