Expired RFA-MD-09-002: NCMHD Endowment Program for Increasing Research and Institutional Resources Capacity in Section 736 Health Professions Schools (NCMHD Research Endowment Fund) (S21)

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov/)

Components of Participating Organizations
National Center on Minority Health and Health Disparities (NCMHD) (http://ncmhd.nih.gov/)

Title: NCMHD Endowment Program for Increasing Research and Institutional Resources Capacity in Section 736 Health Professions Schools (NCMHD Research Endowment Fund) (S21)

Announcement Type
This Funding Opportunity Announcement (FOA) is a reissue of RFA-MD-08-001

Update: The following update relating to this announcement has been issued:

May 27, 2011 - This RFA has been reissued as RFA-MD-11-006.

Request for Applications (RFA) Number: RFA-MD-09-002

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.307

Key Dates
Release/Posted Date: January 27, 2009
Opening Date: February 23, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): February 23, 2009
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date(s): March 23, 2009
AIDS Application Due Date(s): Not Applicable
Peer Review Date(s): April-May 2009
Council Review Date(s): May 2009
Earliest Anticipated Start Date(s): July 2009
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: March 24, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Purpose. The purpose of this program is to build capacity and research infrastructure and to facilitate minority health research and research regarding other health disparity populations at eligible institutions, but not to directly support the research itself.
Mechanism of Support. This FOA will utilize the S21 Capacity Building mechanism.
Funds Available and Anticipated Number of Awards. The NCMHD intends to commit approximately $15 million in FY 2009 to fund approximately three new and/or competitive continuation awards in response to this FOA.
Budget and Project Period. An applicant institution may request a project period of up to three years and a budget for direct costs that is determined by the use of a formula.
Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.
Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/ organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
Number of PDs/PIs. More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the application. The contact Principal Investigator must be a senior administrative official such as the President, Chancellor, Academic Vice President, or Dean of the applicant institution.
Number of Applications. Only one application per institution.
Resubmissions. Resubmission applications are not permitted in response to this FOA.
Renewals. Renewal applications will be permitted in response to this FOA.
Special Date(s). This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates.
Application Materials. See Section IV.1 for application materials.
General Information. For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites:
- SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm
- General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/
Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: (301) 451-5936.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research and Capacity Building Objectives

Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contacts
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research and Capacity Building Objectives

The Endowment Program is part of a strategy to address the specific concerns of Congress as outlined in Public Law 106-525 that include, but are not limited to:

Closing of the gap between the burden of illness and death experienced by African Americans, American Indians and Alaska Natives, Asian Americans, Hispanic Americans, Native Hawaiians and Pacific Islanders and other medically-underserved populations (i.e., socio-economically disadvantaged individuals from rural and urban areas) as compared to the nation as a whole.
Promoting minority health and health disparities research capacity and infrastructure among institutions designated Section 736 of the Public Health Service (PHS) Act (see Section III, Eligible Institutions, for definitions).
Adding or expanding programs that effectively overcome educational and financial resource barriers to promote a diverse and strong scientific workforce for the 21st Century.
Enhancing the recruitment and retention of qualified individuals from health disparity populations that are currently underrepresented in the scientific workforce.
Assisting in the recruitment of more scientists from health disparity populations in the fields of biomedical and behavioral research and other areas of the scientific workforce.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism of Support

This FOA will use the S21 Capacity Building award mechanism. The Applicant and Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

S21 Capacity Building Awards

Section 736 institutions (see Section III, Eligible Institutions, for definitions) are eligible to use income generated from the endowment fund to build research infrastructure, support students from health disparity populations which includes students from racial and ethnic groups and socio-economically disadvantaged students - and enhance educational programs. Endowment fund income may not be used to directly support research or research projects. For example, under this mechanism, endowment income may be used to strengthen teaching programs in the biomedical and behavioral sciences and related disciplines, improve physical plants, acquire equipment for instruction and research, improve student recruitment and retention, improve faculty recruitment and retention, establish endowed chairs and programs, improve instruction delivery systems and information technology. When planning to implement any activities using income from the endowment fund, the institution must demonstrate that the activities will enhance minority health and/or health disparities research activities.

This FOA uses Just-in-Time information concepts (see SF424 (R&R) Application Guide). It also uses the non-modular budget format.

2. Funds Available

The NCMHD intends to commit approximately $15 million in FY 2009 to fund approximately 3 applications with a direct cost of up to $5 million. Applicant institution may only request direct costs. Indirect costs will not be provided. An applicant may request a project period up to three years.

The maximum award that an institution can request is contingent upon a formula which considers the size of its institutional corporate or system-wide endowment and the extent to which it serves students from health disparity populations, particularly with respect to the percentage of such students that graduate from its health professions and graduate science degree programs. The three most important factors that determine the size of the request for an endowment grant award are:

The Institution s Health Disparity Student Index (HDSI)
The Institution s Endowment Award Index
The size of a funding unit for an Endowment Grant Award

The applicant’s requested endowment award amount calculations, formula, and data comprising the formula elements (e.g., system-wide health professions and graduate science programs graduate statistics, system-wide endowment, etc.) are required as part of the full application. NCMHD encourages applicants, when calculating requested endowment awards, to contact the program official listed in Section VII, Agency Contacts if further guidance is needed. Please refer to Attachment #1 for further explanation and a sample calculation.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004.

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

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

Other(s):

Any public/private institution of higher education designated under Section 736 of the PHS Act with a Program of Excellence in Health Professions Education for Underrepresented Minority Individuals, and a corporate/system-wide endowment that is less than/or equal to 50 percent of the national endowment average of institutions that conduct biomedical research or training of health professionals (i.e., $216,917,000). The endowment award supports the institutional component that manages the eligible section 736 program.

Only one application per institution will be accepted for review and only one award will be made to an institution based on the merit of its application and the availability of funds. Institutions cannot use the value of the endowment of one campus or component of a campus of the institution to qualify for an award. For example, if an eligible Section 736 entity, as identified in the HRSA Notice of Grant Award, is a health science program at one campus of a multi-campus institution, which includes a school of medicine, a school of pharmacy and other components, the institution may not use the value of the school of pharmacy’s or campus’s endowment but must use the system-wide endowment when submitting data to be applied by NCMHD to determine the endowment funds to award under this FOA. Because this is an institutional award, the value of the institutional corporate or system-wide endowment assets of the Section 736 institution must meet the program eligibility criteria.

The Applicant organization must be located in the U.S.

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the 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 NIH support.

More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

The contact Principal Investigator must be a senior administrative official such as the President, Chancellor, Academic Vice President or Dean of the applicant institution. This is a special requirement of the NCMHD Research Endowment program.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Number of Applications. Only one application per institution.

Resubmissions. Resubmission applications are not permitted in response to this FOA.

Renewals. Renewal applications will be permitted for this FOA.

Institutional Endowment Assets of Section 736 Institutions

For the purpose of determining the eligibility thresholds for this FOA, the endowment assets of institutions that conduct similar biomedical research or training of health professionals were assessed. The data for this assessment were taken from the results of the National Association of College and University Business Officials (NACUBO) 2007 Endowment Study (http://www.nacubo.org/). The NACUBO Endowment Study is widely recognized as the industry standard for tracking the performance and management of college and university endowment assets Based on the NCMHD analysis, system-wide endowment assets with an estimated average value of $523,834,000 will be considered the national average ; and $261,917,000 is 50 percent of that amount. Pursuant to section 485E (h) (2) (A) of Public Law 106-525 the corporate or system-wide endowment must be less than/or equal to one-half of the national average of endowment funds at institutions that conduct similar biomedical research or training of health professionals. Therefore, institutions with corporate or system-wide endowments that exceed $261,917,000 may not apply for an endowment grant award during this period.

Definitions

Section 736 Institutions:

Institutions with funded Programs of Excellence in Health Professions Education for underrepresented Minority Individuals, a program authorized under section 736 of the Public Health Service Act (42 U.S.C. 293).

Minority Health Disparities Research:

Basic, clinical, and behavioral research on minority health conditions, including research to prevent, diagnose, and treat such conditions.

Health Disparities Research:

Basic, clinical, and behavioral research on health disparity populations (including individual members and communities of such populations) that relates to health disparities, including the causes of such disparities and methods to prevent, diagnose, and treat such disparities.

Minority health conditions:

The term minority health conditions, with respect to individuals who are members of minority groups, means all diseases, disorders, and such other conditions (including with respect to mental health and substance abuse): that are unique to, more serious, or more prevalent in such individuals; for which the factors of medical risk or types of medical intervention may be different for such individuals, or for which it is unknown whether such factors or types are different for such individuals; or with respect to which there has been insufficient research involving such individuals as subjects or insufficient data on such individuals.

Institutional Endowment:

Institutional endowment refers to corporate or system-wide endowment fund that is the sum total of the endowment assets of all campuses and their components. This includes, but is not limited to, endowments managed by an institution’s foundations/associations as well as state university systems. The corporate or system-wide endowment for the entire institution, including multi-campuses, is the correct required value.

Institutional Component Endowment:

An institutional component endowment refers to the endowment assets of a single component of an institution; for example, the component of the institution where the HRSA Center of Excellence resides. An institution may have multiple components, for example: a school of medicine, a school of dentistry, a school of engineering, a school of law, etc. For some multi-campus systems, there may be components at each campus.

Health Disparity Population:

A health disparity population means a population that, as determined by the NCMHD Director after consultation with the Director of the Agency for Healthcare Research and Quality, has a significant disparity in the overall rate of disease incidence, prevalence, morbidity, mortality, or survival rates in the population as compared to the health status of the general population.

Health Disparity Students:

Health disparity students include students from racial and ethnic minority and health disparities populations. For purposes of the endowment, the term socio-economically disadvantaged student is used interchangeably with health disparity student. The NCHMD Director and the Director of the Agency for Research on Healthcare Quality are responsible for validating the consideration of any other a group as a health disparity group. See Public Law 106-525. Foreign students are not included.

Racial and Ethnic Minorities (or Minority Groups):

American Indians and Alaska Natives, Asian Americans, African Americans, Hispanics, Native Hawaiians and other Pacific Islanders. Hispanic means individuals whose origin is Mexican, Puerto Rican, Cuban, Central or South American, or other Spanish-speaking country.

Socio-economically disadvantaged student:

For the purpose of the endowment program, the term socio-economically disadvantaged student may be used interchangeably with health disparity students. An individual from a socio-economically disadvantaged background is defined as an individual who comes from an environment that has inhibited the individual from obtaining the knowledge, skills, and abilities required to enroll in and graduate from a health professions school, or from a program providing undergraduate or graduate education or training in an allied health profession, or from a graduate sciences program; or comes from a family with an annual income at/below a level based on low-income thresholds according to family size published by the U.S. Bureau of the Census, adjusted annually for changes in the Consumer Price Index, and adjusted by the Secretary for use in all health professions programs. (The Secretary periodically publishes these income levels in the Federal Register).

Section IV. Application and Submission Information

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the Apply for Grant Electronically button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

Grants.gov (http://www.grants.gov/applicants/get_registered.jsp) and
eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm)

PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.

Several additional separate actions are required before an applicant can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Registered

Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.
If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.
Direct questions regarding Grants.gov registration to:
Grants.gov Customer Support
Contact Center Phone: 800-518-4726
Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
Email [email protected]

2) Organizational/Institutional Registration in the eRA Commons

To find out if an organization is already Commons-registered, see the "List of Grantee Organizations Registered in NIH eRA Commons.
Direct questions regarding the Commons registration to:
eRA Commons Help Desk
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
Email [email protected]

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

The individual(s) designated as PDs/PIs on the application must be registered also in the NIH eRA Commons.
Each PD/PI must hold a PD/PI account in the Commons. Applicants should not share a Commons account for both an Authorized Organization Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have both a PD/PI role and an NIH Internet Assisted Review (IAR) role, both roles should exist under one Commons account.
This registration/affiliation must be done by the AOR/SO or his/her designee who is already registered in the Commons.

Both the PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.
For further assistance, contact GrantsInfo -- Telephone 301-710-0267; Email: [email protected].
Telecommunications for the hearing impaired: TTY: (301) 451-5936

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist

Optional Components:
PHS398 Cover Letter File

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs

When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Information for the Contact PD/PI should be entered in item 15 of the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan [Section 14 of the Research Plan Component in the SF424 (R&R)], must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award (NoA).

Applications Involving a Single Institution

When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: February 23, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): February 23, 2009
Application Due Date(s): March 23, 2009
Peer Review Date(s): April-May 2009
Council Review Date(s): May 2009
Earliest Anticipated Start Date(s): July 2009

3.A.1. Letter of Intent

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.

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.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Nathan Stinson, Jr. PhD, MD, MPH
Division of Extramural Activities and Scientific Programs
National Center on Minority Health and Health Disparities
National Institutes of Health
6707 Democracy Boulevard, Suite 800 MSC 5465
Bethesda, MD 20892-5465
Telephone: (301) 594-8704
Fax: (301) 480-4049
Email: [email protected]

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow Steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

In order to expedite the review, applicants are requested to notify the NCMHD Referral Office by email ([email protected]) when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the application image to determine if any further action is necessary.

If everything is acceptable, no further action is necessary. The application will automatically move forward to the Division of Receipt and Referral in the Center for Scientific Review for processing after two weekdays, excluding Federal holidays.
Prior to the submission deadline, the AOR/SO can Reject the assembled application and submit a changed/corrected application within the two-day viewing window. This option should be used if it is determined that some part of the application was lost or did not transfer correctly during the submission process, the AOR/SO will have the option to Reject the application and submit a Changed/Corrected application. In these cases, please contact the eRA Help Desk to ensure that the issues are addressed and corrected. Once rejected, applicants should follow the instructions for correcting errors in Section 2.12, including the requirement for cover letters on late applications. The Reject feature should also be used if you determine that warnings are applicable to your application and need to be addressed now. Remember, warnings do not stop further application processing. If an application submission results in warnings (but no errors), it will automatically move forward after two weekdays if no action is taken. Some warnings may need to be addressed later in the process.
If the two-day window falls after the submission deadline, the AOR/SO will have the option to Reject the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn t transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue.
f the AOR/SO chooses to Reject the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted, but it will be subject to the NIH late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment.
Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two weekdays.

Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the IC. Incomplete and non-responsive applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons . The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm (see also Section VI.3. Reporting).

Pre-award costs are not applicable to this award.

6. Other Submission Requirements and Information

Budget Information

This FOA calls for the budget to be itemized in multiple sections. Each budget section addresses a specific aspect of the grant. With regard to the initial budget period, spell out and justify the actual budget request (which is the same as the requested endowment corpus). This justification must explain, using the formula in Attachment #1, how the requested endowment award amount was calculated and the formula must be shown. All data used to determine the award amount (Health Disparity Student Index/HDSI, Corporate or System-wide Institutional Endowment) must be easily identifiable within the body of the application. The direct costs requested for each year of the project period should reflect only the endowment corpus not projected income. For example, if you receive $1 million each year for three years, the 1st year direct costs budget will be $1 million, year 2 will be $1 million, and year 3 will be $1 million. These yearly requested direct costs are entered under the appropriate year on the total direct costs line on Form pages 4 and 5. The maximum direct costs are $5 million per year.

The requested total direct costs for the entire endowment project period should be placed in the SF424 (R&R) (Cover component) under Total Estimated Project Funding. Each year’s anticipated investment income should be placed on the SF424 Research & Related Budget component.

The budget must be described again in the application within the required 5-year Strategic Plan for the endowment grant project. This detailed budget specifies how projected endowment income, at a given level, will be spent to support programmatic activities and achieve program objectives. The detailed budget in the 5-year Strategic Plan should relate project expenses to grant objectives and describe what objectives and program purposes are being supported by the grant and/or the institution and to what extent.

Application Research Plan Component Length: The S21 application Research Plan component of the PHS398 (Items 2-5) may not exceed 25 pages, including tables, graphs, figures, diagrams, and charts.

Renewal Applications (Competing Continuation)

Within the 25 page research plan limit, renewal applications (formerly competing continuation) must include in the application a section that summarizes the annual progress reports of the currently funded Endowment project submitted to the NCMHD. The summary should provide relative to the endowment program: the beginning and ending dates for the period(s) covered; a recap of the specific priority objectives during that time period, attainment of these aims, and challenges or obstacles encountered in reaching these aims; actual versus projected endowment interest income and specifically how, if applicable, not meeting earnings goals impacted attainment of priority objectives; significant unexpected outcomes (positive or negative); significant accomplishments; and the overall impact of the award on your institution.
A separate budget section for the expected expenditures of previous years cumulative endowment program income.
If the applicant plans to continue activities supported by previous competitive segments endowment grant, those activities must be included as part of the new 5-Year Strategic Plan.

Attachments

Research & Related Other Project Information

Institutional Profile

The institutional profile must include a separate attachment for the following areas:

Financial profile of the institution that includes justification of eligibility as a HRSA Section 736 institution;
Explanation of the institution’s commitment to the programmatic aspects of the proposed endowment fund program contained in the 5-Year Strategic Plan;
An investment policy statement;
Rationale for proposed use of endowment income;
Student and faculty profile;
Short description of the various disciplines; and
Description of the physical plant. This information should be provided as attachments (there must be a minimum of three attachments with the application).

Guidance in addressing the above-mentioned areas included in the institutional profile is provided below.

Financial Profile

The financial profile must include:

Certified or notarized letter/report from an independent auditor with original signatures stating the dollar amount of the applicant’s institutional corporate or system-wide endowment assets. This document must include a statement reflecting the dollar amount of all endowment funds of the corporate institution that are managed by the applicant institution, private non-profit foundations and/or public entities established by or for the benefit of the institution. In addition, if an applicant institution is a part of a state university system, the certified letter or report must contain an explanation as to how the component benefits from state appropriations, specifically how state appropriations strengthen the institution’s infrastructure, capacity and programs. The application may be judged as unresponsive and may be returned without review for failure to include this information.
Certified or notarized letter/report from an independent auditor with original signatures stating the dollar amount of the endowment assets of the institutional component (i.e., School of Medicine or School of Pharmacy, etc.) within which the Program of Excellence in Health Professions Education for Underrepresented Minority Individuals resides.
A copy of the institution’s current HRSA Notice of Grant Award.
Certified or notarized letter/report from an independent auditor with original signatures stating the amount of the institution’s State, Federal, and private research and development dollars. This should include the amount of funds allocated to the institution’s professional and graduate science programs system-wide.
The average dollar amount expenditures per student system-wide. In addition, provide an accounting of the factors that comprise the cost of educating a student and the costs directly associated with them.

5-Year Strategic Plan

Applicants must develop a 5-Year Strategic Plan that establishes priorities for the use and growth of endowment fund income. Note: endowment fund income cannot be used to directly fund research projects of any type. The required elements of this Strategic Plan are:

The institution’s Mission Statement for the plan.
An Overview of the institution’s strategy for building capacity and research infrastructure to facilitate minority health and health disparities research.
The Area(s) of Emphasis in priority order addressed by the plan.
The Rationale that explains the public health need, scientific opportunity, and /or the institution’s reason for pursuing the area(s) of emphasis. This should include an explanation as to how the plan will contribute to increasing minority health and health disparities activities at the institution.
Clearly identified Objectives related to the area(s) of emphasis, with an indication of relative priority.
An Action Plan that consists of: (1) a description of the concrete steps your institution will take to achieve each Objective; (2) a timeline for achieving key targets of the Objective; and (3) an estimated date by which the Objective is expected to be accomplished. An estimate of total dollars needed to achieve each Objective for each of the five years of the Strategic Plan should be included in the narrative for the Action Plan.
A description of Performance Measures that will be utilized to demonstrate the accomplishments of each Objective.
A description of the Outcome Measures that will be utilized to demonstrate the accomplishments of each Objective.
A Detailed Budget and Justification that specifies how projected endowment income, at a given level, will be spent to support programmatic activities and achieve program objectives. The detailed budget should relate project expenses to grant objectives and describe what objectives and program purposes are being supported by the grant and/or the institution and to what extent.

Investment Policy Statement

Present a plan for investing the proposed endowment corpus. Indicate long-term and short-term investment goals and expected rate of return. The investment plan should be balanced and take into consideration the volatility of markets. Given the high significance placed on retaining the market value of the endowment corpus, at a minimum, care should be taken to develop an investment and spending plan to ensure that the market value of the corpus is not invaded. Institutions with limited experience in establishing and managing endowment funds are encouraged to consult with institutions and/or other entities that have expertise in establishing and managing such funds.

It is permissible to pool the NCMHD endowment corpus with other endowment assets held by the institution for investment purposes. In these cases, the proportionate income (or units) of the NCMHD research endowment fund should be separately accounted for and used only for the purposes specified within this FOA. Additions to the fund from any successive NCHMD Endowment award should be administered in accordance with this practice.

Use of Endowment Income

Provide details on the expected impact of the endowment upon the institution, in accordance with the 5-Year Strategic Plan.

Student Profile

The student profile must include:

Institution system-wide student enrollment by race, ethnicity and socio-economically disadvantaged students.
Institution system-wide student enrollment at health professions and graduate sciences programs by race and ethnicity and socio-economically disadvantaged students. In particular, indicate the number of socio-economically disadvantaged students enrolled in the institution’s health professions and graduate science programs that are NOT racial and ethnic minorities. For the purposes of this FOA, foreign students are not racial/ethnic minorities.
Institution system-wide student graduate numbers from the health professions and graduate sciences program(s) and graduation data from the rest of the graduate biomedical and behavioral health science programs each year, for the last five years, by race and ethnicity and socio-economically disadvantaged students. In particular, indicate the actual number of socio-economically disadvantaged students that graduated over the last five years that were NOT racial and ethnic minorities.
Institution system-wide graduates for the last five years.

Faculty Profile

The faculty profile must include:

Institution system-wide faculty statistics by race and ethnicity, and level (tenured, non-tenured; full time or part time, etc.).
Institution system-wide statistics of faculty in the health professions and graduate biomedical and behavioral health sciences programs by race and ethnicity, and by level (tenure, non-tenured; full time or part time, etc). For the purposes of this FOA, foreign faculty are not racial/ethnic minorities.

Answer to human subject involvement should be no. (warning in e-submission).

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD(s)/PI(s) to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

PHS398 Research Plan Component Sections

Page limitations of the PHS398 Research Plan component must be followed as outlined in the SF424 (R&R) Application Guide. While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

Appendix Materials

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not comply with the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.)

(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact (see Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.)

(b) Sharing Model Organisms: Regardless of the amount requested, all applications in which the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible (see Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.)

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (NOT-OD-07-088) and http://grants.nih.gov/grants/gwas/.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications that are complete and responsive to this FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCMHD and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

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 a priority score;
Receive a written critique; and
Receive a second level of review by the National Advisory Council on Minority Health and Health Disparities.

Applications submitted in response to this FOA will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:

Scientific merit of the proposed project as determined by peer review.
Availability of funds.
Relevance of the proposed project to program priorities.

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, and weighted as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the 5-Year Strategic Plan enhance and expand research and/or institutional resource capacity in minority health and/or health disparities research and in other areas of focus?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs?

Will the institution’s activities as identified in the 5-Year Strategic Plan further the institution’s minority health and/or health disparities research agenda?

Will the activities identified in the plan expand or develop programs that address and/or mitigate educational and financial resource barriers; thus promoting a diverse and strong biomedical and bio-behavioral workforce for the 21st Century?

Will the activities identified in the plan enhance and expand research capacity in minority health and/or health disparities research and in other areas of focus (i.e., research training opportunities, improvements in physical plant, support of health disparities and other types of research)?

Will the activities identified in the plan facilitate the recruitment of more scientists from health disparity populations in the fields of biomedical, behavioral, and social sciences research (if applicable)?

Are the proposed uses of the endowment funds appropriate to the goals of enhancement of biomedical, behavioral and health disparities research?

Is the proposed management of the endowment fund and effectiveness of investment strategy appropriate to achieve appropriate growth potential while taking into consideration the volatility of the markets?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the PD(s)/PI(s) and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Do(es) the PD(s)/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific and training environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the rating:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See the Human Subjects Sections of the PHS398 Research Plan component of the SF424 (R&R).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See the Human Subjects Sections of the PHS398 Research Plan component of the SF424 (R&R)

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the adequacy of the plans for their care and use will be assessed. See the Other Research Plan Sections of the PHS398 Research Plan component of the SF424 (R&R).

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. The priority score should not be affected by the evaluation of the budget.

2.C. Resource Sharing Plan(s)

The following resource sharing policies do not apply to this FOA because this grant program does not directly support research:

Data Sharing Plan. Not Applicable
Sharing Model Organisms. Not Applicable
Genome Wide Association Studies (GWAS). Not Applicable

3. Anticipated Announcement and Award Dates
Not Applicable

Section VI. Award Administration Information

1. Award Notices

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 NIH eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

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. See Section IV.5., Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.

Guidelines for Implementation

NCMHD Research Endowment grants are made to create a permanent endowment fund to support research and institutional resources capacity building specified in Section I, Funding Opportunity Description of this FOA. Amounts which may be expended each year are to be determined pursuant to spending rules under the law of the State in which the institution is located, subject to the special limitation on expenditures during the first year following the Notice of Grant Award, which is set forth below.

To ensure maximum growth of the endowment fund, the following guidelines govern how a NCMHD Research Endowment is to be implemented. The following Terms and Conditions will be incorporated into the Notice of Grant Award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

Direct costs of this award are restricted: Except to the extent permissible by the spending rules under the law of the State in which the institution is located and the spending rule adopted by the recipient institution, the endowment corpus may not be expended for any reason. See Attachment #2 for a sample form of endowment spending rule. Funds to be utilized will be the income and capital appreciation distributable under the institution s spending rule as a result of the investment of the endowment corpus as proposed in the grantee’s 5-year strategic plan that is part of the application and that establishes priorities for the use of the endowment fund. Income and capital appreciation earned must be reported as Program Income in accordance with the NIH Grants Policy Statement guidelines.
Funds must be invested, according to the Investment Policy Statement and the 5-year strategic plan included in the grantee’s application, no later than 90 days after the start date of the endowment grant.
Any income and capital appreciation realized in the initial year of the award is not to be expended to support programmatic activities until it has accrued for one full year from the budget period start date listed on the initial notice of grant award. For each year of funding during its project period, programmatic activities may be supported, in general, by part of the income and capital appreciation earned on the previous year’s investment as determined under the spending rule. For instance, if an institution receives an award of $1 million per year, for three consecutive years, no programmatic activities could receive support from the endowment income and capital appreciation until Year 2. Year 2 programs could be supported by distributions of the income and capital appreciation earned on the initially invested $1 million under the institution’s spending rule. Year 3 activities would be supported by income and capital appreciation accrued on the endowment corpus. Programmatic activities in subsequent years could be similarly supported by income and capital appreciation earned on the endowment corpus.
In the case of situations in which investment conditions result in the endowment corpus having a net market value less than the value of the funds at the time of their receipt, action should be taken in order to preserve the endowment corpus.
Prior written approval is required from NCMHD for any deviations from the 5-year strategic plan submitted in the competing application.
A continuation progress report is required two months before the beginning of the next budget period of the grant. This report must include progress during the budget period in accordance with the submitted 5-year strategic plan.
For renewal awards, the endowment amount for the new project period is added to the previous accumulated endowment corpus and only a single continuation progress report that encompasses all activities is submitted.

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 NIH Grants Policy Statement. Progress reports must contain a description of the activities being supported by the grant. Prior written approval from the NCMHD is required for any deviation from the five-year strategic plan as submitted in the competing application. In addition to the standard reports (e.g., PHS 2590, Financial Status Report/FSR) required of all grantees, research endowment grantees need to provide specific information related to the type and amount of investments of the fund, the amount of fund income and the amount and purpose of expenditures of fund income.

Due to the unique nature of the endowment program, 20 years of annual progress reporting is required after the end of the project period. The entire endowment fund corpus must be maintained and not spent for twenty years after the grant’s project period end date. After the end of the twenty year period, while the grantee institution is encouraged to preserve the corpus, the institution may use the endowment fund corpus for any purpose that expands or develops the institution’s minority health and/or health disparities research capacity.

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.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research (program), peer review, and financial or grants management issues:

1. Scientific/Research Contact(s):

Nathan Stinson, Jr. PhD, MD, MPH
Division of Extramural Activities and Scientific Programs
National Center on Minority Health and Health Disparities
National Institutes of Health
6707 Democracy Boulevard, Suite 800 MSC 5465
Bethesda, MD 20892-5465
Telephone: (301) 594-8704
Fax: (301) 480-4049
Email: [email protected]

2. Peer Review Contact(s):

Prabha Atreya, PhD
Chief, Office of Scientific Review
National Center on Minority Health and Health Disparities
National Institutes of Health
6707 Democracy Boulevard, Suite 800
Bethesda, MD 20892-5465
Telephone: (301) 594-8696
FAX: (301) 480-4049
Email: [email protected]

3. Financial/Grants Management Contact(s):

Priscilla Grant, JD, CRA
Chief Grants Management Officer
National Center on Minority Health and Health Disparities
National Institutes of Health
6707 Democracy Boulevard, Suite 800
Bethesda, MD 20892-5465
Telephone: (301) 594-8412
FAX: (301) 480-4049
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:

Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:

Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:

Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants ( NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:

Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies and local institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Policy for Genome-Wide Association Studies (GWAS):

NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

Sharing of Model Organisms:

NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh-Dole Act (see the NIH Grants Policy Statement. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Access to Research Data through the Freedom of Information Act:

The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are: (1) first produced in a project that is supported in whole or in part with Federal funds; and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Inclusion of Women And Minorities in Clinical Research:

It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:

The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:

NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):

Criteria for Federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy Requirement:

In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:

The Department of Health and Human Services (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:

All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

Healthy People 2010:

The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:

This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:

NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.

Attachments:

1. Sample Calculation of Endowment Awards

2. Sample Form of Endowment Spending Rule

Attachment #1
RFA MD-09-002

SAMPLE CALCULATIONS:
ENDOWMENT GRANT AWARDS FOR ELIGIBLE INSTITUTIONS

The purpose of this document is to describe the methodology that eligible institutions should use in calculating the amount of endowment funds to request.

ELIGIBILITY CRITERIA:

Pursuant to PL 106-525 institutions that have total/system-wide endowments less than/or equal to 50 percent of the national average of endowments for institutions that conduct similar biomedical research or training of health professionals are eligible to participate in the NCMHD Endowment Program.

ASSUMPTIONS:

1) The maximum amount that an institution can request in endowment funds in an application depends on the extent to which they serve racial and ethnic minority and socio-economically students, particularly with respect to the percent of such students that graduate from their health professions and graduate science degree programs.

2) The three most important factors that determine the size of the request for an endowment grant are:

The Institution’s Health Disparity Student Index (HDSI)

HDSI = System-wide total of racial and ethnic minority graduates from health professions and graduate science degree programs on all campuses + system-wide graduates from other health disparity groups in health professions and graduate science degree programs on all campuses over 5 years (i.e. socio-economically disadvantaged students)] divided by (the total graduates system-wide from all campuses over five years] x 100.¹

Sample Calculation of the Health Disparity Student Index (HDSI)

5 year total graduation numbers for racial/ethnic minority and socio-economically disadvantaged health professions/graduate science programs = 1428

5 year institutional system-wide total graduation numbers = 19,550

HDSI = (1428/19,550) x 100 = 7.3

2. The System-wide Endowment Index

Endowment Index = HDSI / (Institutional Endowment/l0,000,000)

To ensure that the Endowment Index is a number with a value near or above 1, the value of the institution endowment is divided by a factor of 10,000,000.

HDSI
Corporate/system-wide Endowment = Endowment Index (EI)
10,000,000

See the sample calculation below.

University of XYZ’s HDSI = 7.3
University of XYZ’s corporate/system-wide endowment = $123,500,000

EI = 7.3/ (123,500,000/10,000,000) = 7.3/12.35 = 0.59 (rounded up to 1.0 since value less than 1)

3. The number of Funding Units for an Endowment Grant Award

Each Funding Unit equals $312,000. Institutions may request one funding unit of endowment funds for each EI value of 1 and above, up to a maximum of 16 funding units.

a. Institutions with El values of less than 1 may assume an EI value of 1.

b. Institutions with EI values greater than 16 may assume an EI value of 16.

c. The maximum number of funding units that can be requested is 16 (e.g., 16 x $312,500).

Sample Calculations (EI rounded up or down to the nearest tenth)

Institution	Estimated Health Disparity Student Index*	Endowment Amount (x 1,000)	Estimated Endowment Index (EI)	Maximum Endowment Request: (EI x $312,500)
Institution XYZ (above)	7.3	123,500	1	$312,000
Institution A	85	63,000	13.5	$4,218,750.00
Institution B	90	424,000	2.1	$656,250.00
Institution C	75	248,000	3.0	$937,500.00
Institution D	100	4,885	205 (16)	$5,000,000.00
Institution E	85	2,542	334 (16)	$5,000,000.00

SPECIAL CONSIDERATIONS:

The national average for endowments at institutions that conduct similar biomedical research or train health professionals is $523,834,000 and $261,917,000 is 50 percent of that value.

DEFINITIONS:

Health Disparity Students:
Health disparity students include students from racial and ethnic minority and health disparities populations. For purposes of the endowment, the term socio-economically disadvantaged student is used interchangeably with health disparity student. The NCHMD Director and the Director of the Agency for Research on Healthcare Quality are responsible for validating the consideration of any other a group as a health disparity group. See Public Law 106-525. Foreign students are not included.

Racial and Ethnic Minority:
American Indians and Alaska Natives, Asian Americans, African Americans, Hispanics, Native Hawaiians and other Pacific Islanders. Hispanic means individuals whose origin is Mexican, Puerto Rican, Cuban, Central or South American, or other Spanish-speaking country.

Socio-economically disadvantaged student:
For the purpose of the endowment program, the term socio-economically disadvantaged student may be used interchangeably with health disparity students. An individual from a socio-economically disadvantaged background is defined as an individual who comes from an environment that has inhibited the individual from obtaining the knowledge, skills, and abilities required to enroll in and graduate from a health professions school, or from a program providing undergraduate or graduate education or training in an allied health profession, or from a graduate sciences program; or comes from a family with an annual income at/below a level based on low-income thresholds according to family size published by the U.S. Bureau of the Census, adjusted annually for changes in the Consumer Price Index, and adjusted by the Secretary for use in all health professions programs. (The Secretary periodically publishes these income levels in the Federal Register).

¹Socio-economically disadvantaged students are those that have Health Professions Student Loans (HPSL); Loans for Disadvantaged Student Programs; Scholarships for Individuals with Exceptional Financial Need; Federal Perkins Loans or other specific loans or scholarships designated for disadvantaged students.

Attachment #2
RFA MD-09-002

SAMPLE FORM OF ENDOWMENT SPENDING RULE

Amounts allocated for current spending will be determined by applying a rate of 5 percent to the three-year moving average of the fiscal year-end fair market value of each endowment fund in the university’s endowment pool.

Beginning with the first year in which the spending rule is implemented for a particular fund, the spending amount is to be determined as follows:

The average fair value of the fund will be determined as of the last day of the most recent three fiscal years. If the fund was not in existence as of the last day of the university’s most recent three fiscal years, the values will be determined as for the average of the last two years or on the basis of the most recent single year, as appropriate given the time at which the fund was endowed.
The amount to be allocated for spending during the current year is then calculated by applying 5 percent to the average fair market value of the fund as so determined.
Notwithstanding the foregoing, amounts to be allocated for spending may only be generated by gains in a fund. If the value of a fund is below that of its historic dollar value, distributions pursuant to the foregoing formula may not be made in amounts which exceed such realized and unrealized gains. In such circumstances, however, ordinary income which the fund receives from dividends and interest may nonetheless be expended.

In subsequent years, the amount determined in the foregoing manner will be divided by four and applied to the fund on March 31, June 30, September 30, and December 31, to provide for quarterly distributions.

Any cash or cash-equivalent donations received by the university will be invested in the university’s cash management pool until the last day of the first calendar quarter after receipt. Appropriate interest earnings for the time the donation was invested in the cash management pool will be allocated for spending.