dd11-010 foa final 11.18.10.doc

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Department of Health and Human Services

Part 1. Overview Information

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

National Center on Birth Defects and Developmental Disabilities (NCBDDD)

U01 Research Project Cooperative Agreements

Some activity codes may need prior approval or may have limited use, and CIO may or may not have authority for each activity code. Add the relevant activity code, if not listed above. Please see the Activity Codes, Organizational Codes, and Definitions Used in Extramural Programs for more information.

Announcement Type

New

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

The goal of this research is to improve our understanding of the association of Diamond Blackfan Anemia (DBA) genotypes with the spectrum of disease and risk for complications observed among DBA patients. This information will allow us to better educate providers, patients and families and will lead to improved treatment of this disorder. The proposed project is has two objectives. Objective one is to identify index DBA patients and obtain information regarding their course of disease as well as their family history of DBA and DBA-related phenotypes. The second objective is to conduct a family-based genetic study in this patient population that allows for more accurate phenotype-genotype correlations, than have been possible to date.

Outcomes for this study include:

1) A better understanding of the disease course and clinical spectrum of DBA

2) A better understanding of the genotype-phenotype correlation for DBA

3) Educational information for health care providers and patients with DBA

Key Dates Publication Date

November 19, 2010PGO will add this information when posted. This field is not available for CIO edit.

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

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

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

Rarely applicable See http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar7 for details.

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

Insert as applicable and include the page limits:

Note: The Research Strategy component of the Research Plan is limited to 20 pages. The Research Plan, including the Research Strategy, is limited to 25 pages.

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

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348 “Apply Electronically” Text and link inserted here by PGO.

Table of Contents

Part 1. Overview Information Part 2. Full Text of the Announcement Section I. Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The NCBDDD of CDC within HHS is committed to achieving the health promotion and disease prevention objectives of Healthy People 2020 This RFA addresses “Healthy People 2020” focus area of Blood Disorder and Blood Safety.

Purpose and Research Objectives:

Diamond Blackfan Anemia (DBA) is a bone marrow failure disorder that is an autosomal dominant condition with variable penetrance. So far, disease-causing mutations have been identified in about 50% of patients who have genetic testing completed. All disease-causing mutations have occurred in ribosomal protein (RP) genes.

The clinical phenotypes of DBA are quite heterogeneous, including multiple hematologic complications, early-onset cancer, congenital abnormalities, and growth retardation. There have been several attempts to correlate phenotype and genotype for these patients using genetic association studies, but few conclusions have been made from the results. One method for resolving this issue might be the use of family-based genetic studies.

The goal of this research is to improve our understanding of the association of DBA genotypes with the spectrum of disease and risk for complications observed among DBA patients. This information will allow for better education for providers, patients and families and will lead to improved treatment of this disorder. The research will assist in a reduction in the overall burden of the disease and, therefore, will improve public health. The proposed project has two objectives. Objective one is to identify index DBA patients and obtain information regarding their course of disease as well as their family history of DBA and DBA-related phenotypes. The second objective is to conduct a family-based genetic study in this patient population that allows for more accurate phenotype-genotype correlations, than have been possible to date.

Specific Areas of Research Interest:

1) Create a registry of DBA patients which will include information about family history, spectrum of disease, and social issues

2) Complete exhaustive DNA sequencing on a number of index cases and their affected and unaffected family members for the RP genes, for which clinical records are also available

3) Analyze the results of the genetic and clinical data for these individuals

4) Describe the clinical spectrum of individuals with DBA-causing mutations, regardless of their diagnosis

In order to achieve these objectives, the awardee will analyze demographic, clinical, family history and genetic data on all participants. Genetic sequencing will be conducted by the awardee or the laboratory they choose to partner with. Identifying information will be used for the purposes of linking the data from the surveillance tool with the corresponding participant sample. This information will not be made available to CDC.

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

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

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

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

Add information.

Section II. Award Information

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

Choose one of the following:.

New

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

$450,000 (direct and indirect costs) will be available for the proposed 3 year program, representing $150,000 for each of 3 years for 1 award.

Indicate the total funds available for the entire program.

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

$150,000 (direct and indirect costs) INSERT any minimum $ amount, if you will not make an award smaller than a floor amount OR INSERT "None."

None Applications with budgets exceeding the ceiling will be considered non-responsive, and it will not enter into the review process.

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

The proposed project period is 3 years.

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

HHS/CDC grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants Eligible Organizations

Delete organizations that are not eligible to apply.

Higher Education Institutions:

· Public/State Controlled Institutions of Higher Education

· Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for CDC support as Public or Private Institutions of Higher Education:

· Hispanic-serving Institutions

· Historically Black Colleges and Universities (HBCUs)

· Tribally Controlled Colleges and Universities (TCCUs)

· Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education

· Nonprofits (Other than Institutions of Higher Education)

For Profit Organizations

· Small Businesses

· For-Profit Organizations (Other than Small Businesses)

Governments

· State Governments

· County Governments

· City or Township Governments

· Special District Governments

· Indian/Native American Tribal Governments (Federally Recognized)

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

· Eligible Agencies of the Federal Government

· U.S. Territory or Possession

Other

· Independent School Districts

· Public Housing Authorities/Indian Housing Authorities

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

· Faith-based or Community-based Organizations

· Regional Organizations

· Non-domestic (non-U.S.) Entities (Foreign Organizations) Delete when Foreign Organizations are not allowed to apply.

· Bona Fide Agents

A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with "Other Attachment Forms" when submitting via www.grants.gov.

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

Add additional eligibility requirements here for institutions.

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

· Central Contractor Registration (CCR) – must be renewed annually

· Grants.gov

· eRA Commons

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be successfully completed and active before the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

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

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

Add additional eligibility requirements here for individuals.

2. Cost Sharing

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

3. Additional Information on Eligibility Number of Applications

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

HHS/CDC will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. HHS/CDC will not accept any application that is essentially the same as one already reviewed.

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

Applicants must provide evidence of ability to conduct genetic analyses described in the research plan. This may be demonstrated through a description of the appropriate capabilities of an investigator’s laboratory or a formal agreement with a laboratory capable of completing these analyses. A description of the applicant’s experience with similar projects or a formal agreement with a capable laboratory must be included in the application.

Add Information Here related to eligibility and number of applications. If your application is incomplete or non-responsive to the special requirements listed in this section, it will not enter into the review process.

Section IV. Application and Submission Information

1. Obtaining an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

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

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

The letter of intent should be sent to:

Donald Blackman, Ph.D.

Scientific Program Officer 4770 Buford Hwy. NE, MS K-92

Atlanta GA 30341

FedEx address:

Koger Center-Davidson Building 2858 Woodcock Blvd.

Atlanta GA 30341

Telephone: 770-488-3023 Email:

dyb7@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.

Page Limitations

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

For this FOA, the Research Strategy section is limited to 20 pages. , insert text for page limits for the Research Strategy section of the application. The complete Research Plan, including the Research Strategy, may be no more than 25 pages.

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

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

A Project Abstract must be submitted with the application forms.

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 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.

A project narrative must be submitted with the application forms.

The narrative should address activities to be conducted over the entire project period and must include:

1.

Understanding of the Public Health Burden and Impact

• Description of public health burden that the program will address

• Understanding of the need for this program and the planned activities within the target community

Clear, concise descriptions and understanding of the requirements, objectives, and purpose of this FOA

Description of the current number of individuals with DBA in the U.S.

2.

Objectives

Objectives clear and measurable to address the need and activities of this FOA

3.

Plan

Plan to carry out the proposed objectives

Complete and comprehensive plan for the entire project period

Quantitative process and outcome measures

Reasonable and achievable timeline to complete the activities in the specified project period

Description of ability to begin immediate implementation of the activities, including identification of DBA patients

Description of plan for carrying out proposed laboratory components of the project, including available space, equipment, and experience of awardee OR a formal agreement with a laboratory possessing the capabilities

4.

Methods

Methods that are specific and feasible within the project timeframe

· Specific plans for identifying and recruiting participants

· Identification of data elements that will be collected

· General description of planned analyses

· Demonstration of capability to analyze genotype/phenotype data

• Methods to address the procedures for generation of the standardized data elements and process for the dissemination of quality data

5.

Organizational and Personnel Capability

Appropriate expertise and skills.

Facilities and collaborator experience necessary to accomplish the program goals Access to an organizational infrastructure which will allow the project to identify and hire needed staff and consultants in a timely manner.

Staff roles defined and sufficient to accomplish program goals.

6. Collaborations

A clear discussion of the roles partners will play in accomplishing program objectives Evidence of current relationships with collaborators or contractors who will be part of this research Appendix

Additional information may be included in the application appendices. The appendices will not be counted toward the narrative page limit. This additional information includes:

Budget (SF 424A) and Budget Narrative (Reviewed, but not scored): provide a detailed budget which identifies and describes the basis for the anticipated costs for personnel, fringe benefits, travel, supplies, equipment, contractual, consultants, indirect, and other items.

Bona fide agent letter from state, if applicable

Memorandum of Understanding (MOU) for subawards, consultants, partnering agreements, etc.

Curricula Vitae/Resumes

Letters of Support

Organizational Charts

Indirect Cost Rate Agreement

Additional information submitted via www.Grants.gov should be uploaded in a PDF file format, and should be named:

Appendix 1 - Curricula Vitae/Resumes

Appendix 2 - Letters of Support, etc.

Appendix 3 - Bona fide agent letter from state, if applicable

Appendix 4 -.Memorandum of Understanding (MOU) for subawards, consultants, partnering agreements, etc.

No more than 10 should be uploaded per application.

3. Submission Dates and Times

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

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

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

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

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

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

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

5. Funding Restrictions

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

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

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

6. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

Add information here related to responsiveness if applicable.

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

1. Criteria

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

Overall Impact

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

Overall Impact is not editable.

Scored Review Criteria Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

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

Investigator(s)

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

Additional Questions may be added.

Innovation

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

Additional Questions may be added.

Approach

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

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

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 Questions may be added.

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

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

Additional Review Criteria

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

Additional Review Criteria may be added.

Protections for Human Subjects

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

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

Inclusion of Women, 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 Inclusion of Women and Racial and Ethnic Minorities in Research.

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.

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.

Renewals For Renewals (formerly called competing continuation applications), the committee will consider the progress made in the last funding period. If Renewals are not allowed for this FOA, replace the text with “Not Applicable”. Otherwise, do not change.

Revisions Revisions (formerly called competing supplement applications), are a request for an increase in support in a current budget period for expansion of the scope of the approved project or program or to meet an unforeseen increase in costs. The request may specify budgetary changes required for the remainder of the project period as well as for the current budget period. Supplemental applications requesting a programmatic expansion (change in scope) must undergo objective review and generally are required to compete for support; requests for administrative supplements may be awarded without objective review or competition.

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

Additional Review Considerations may be added.

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.

If Foreign Organizations are not allowed to apply for this FOA, delete the text. Otherwise, do not change.

Resource Sharing Plans

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

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

Budget and Period of Support

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

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

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

· Receive a written critique.

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

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

· Availability of funds.

· Relevance of the proposed project to program priorities.

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

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

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

2. Administrative and National Policy Requirements

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

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

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

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

· all management, administrative and scientific aspects of the project. The grantee is strongly encouraged to review the HHS grant policy statement, for aid with post award administration, at http://www.hhs.gov/grantsnet/adminis/gpd/index.htm

· coordinating project activities, technically, scientifically, and administratively at the awarded institution and at other sites that may be supported by sub-contracts to this award. The applicant will have primary authority and responsibility to define objectives and approaches; collect and analyze data; and to publish results, interpretations, and conclusions of studies under the terms and conditions of the program project award.

· obtain and document appropriate institutional human subjects protection (IRB) review and approvals throughout the study.

. 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.

An HHS/CDC/NCBDDD Collaborating Scientist will serve as a consultant and will support the research project by:

· Providing scientific and public health technical assistance in the development of the project activities.

· Advising, providing guidance, and, in some cases, providing technical assistance on methodology, statistical and data analyses, and data storage.

· Participating in project site visits and scheduled conference calls as deemed appropriate.

· Obtain IRB approvals as required by CDC when CDC is engaged in research involving human subjects.

· Serving as a resource for data templates, background literature, and other sources of information.

· As appropriate, co-authoring scientific publications or other products of the project.

An HHS/CDC/NCBDDD Project Officer will be named in the NOA to provide day-to-day programmatic, administrative, and fiscal management in support of the project as defined above.

Additionally, an agency program official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NCBDDD Extramural Research Program Office (ERPO) will appoint a Scientific Program Official (SPO) who will:

· Serve as the Scientific Program Official for the funded sites.

· Carry out continuous review of all activities to ensure objectives are being met.

· Attend committee meetings and participate in conference calls for the purposes of assessing overall progress and for program evaluation purposes.

· Provide scientific consultation and technical assistance in the conduct of the project as requested.

· Conduct site visits to determine the adequacy of the research.

· Monitor performance against approved project objectives.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the HHS Grants Policy Statement.

If additional reporting requirements need to be added, please insert a comment indicating what reporting requirements are desired. Note that additions likely will require approval by PGO.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated, no more than 90 days after the end of the project period.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Scientific/Research Contact(s)

There must be a contact for all participating CIOs.

Donald Blackman, PhD, Scientific Program Official

NCBDDD/Extramural Research Program Office

Telephone: 770-488-3023

Email: dblackman@cdc.gov

Peer Review Contact(s) Scientific Review Official

NCBDDD/Extramural Research Program Office

Telephone: 770-488-8390

Email: erpo@cdc.gov Financial/Grants Management Contact(s)

Dana Ewing

Grants Management Specialist Procurement and Grants Office

Centers for Disease Control and Prevention

Phone: (770) 488-2727

Fax: (770) 488-2777

Email: vfa8@cdc.gov There must be a contact for all participating CIOs.

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms) Contact Center Phone: 800-518-4726 Email: support@grants.gov Hours: 24 hours a day, 7 days a week; closed on Federal holidays eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues) Phone: 301-402-7469 or 866-504-9552 (Toll Free)

TTY: 301-451-5939

Email: commons@od.nih.gov Hours: Monday - Friday, 7am - 8pm Eastern Time

CDC Technical Information Management Section (TIMS) Procurement and Grants Office

Telephone 770-488-2700

Email: PGOTIM@cdc.gov Hours: Monday - Friday, 9am - 5pm Standard Time

Section VIII. Other Information

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

Authority and Regulations

This program is authorized under Sections 301, 311 and 317 (C) of the Public Health Service Act, (42 U.S.C., Sections 241, 243 and 247b-4), as amended.

Insert appropriate citation(s) above for PHSA and CFR.

Attach supplemental Federal Citations as required (optional):

Federal Citations Use of Animals in Research:

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar3 SF424: Part III, Section 2.2

Human Subjects Protection:

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar1 SF424: Part III, Section 2.1 Data and Safety Monitoring Plan:

http://grants.nih.gov/grants/guide/notice-files/not98-084.html

SF424: Part II, Section 4.1.5 Sharing Research Data:

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar25 SF424: Part III, Section 4.5 Policy for Genome-Wide Association Studies (GWAS):

http://grants.nih.gov/grants/gwas/

SF424: Part III, Section 1.5.3 Sharing of Model Organisms:

http://grants.nih.gov/grants/policy/model_organism/index.htm

SF424: Part III, Section 1.5.2 Inclusion of Women and Racial and Ethnic Minorities in Research: http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar2 SF424: Part II, Section 4.2 Inclusion of Persons Under the Age of 21 in Research: http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar28 SF424: Part II, Section 4.4 Publications:

HHS Grants Policy Statement (Intellectual Property-Rights in Data & Publications) Health Insurance Portability and Accountability Act Requirements:

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar24 SF424: Part III, Section 4.2 URLs in HHS/CDC Grant Applications or Appendices:

SF424: Part I, Section 4.2 Healthy People 2020:

http://www.health.gov/healthypeople

Authority and Regulations:

HHS Grants Policy Statement

Smoke-Free Workplace:

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar10 Public Law 103-227

Pro-Children Act of 1994.

SF424: Part III, Section 2.11

HIV/AIDS Confidentiality Provisions http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar4 HIV Program Review Panel http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar5 Patient Care http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar6 Executive Order 12372 Review http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar7 Public Health System Reporting http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar8 Paperwork Reduction Act http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar9 Lobbying Restrictions http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar12 Prohibition of Use of CDC Funds for Certain Gun Control Activities http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar13 Accounting System Requirements…