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: Request for Applications NCMHD Centers of Excellence In Partnerships for Community Outreach, Research on Health Disparities and Training (Project EXPORT Establishing Exploratory Centers)

Announcement Type: New
This is a modification of RFA-MD-03-002, which was previously released February 11, 2002.

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

• July 7, 2006 (RFA-MD-06-003) - See modification RFA-MD-06-003.

Request For Applications (RFA) Number: RFA-MD-05-003

Catalog of Federal Domestic Assistance Number(s)
93.100

Key Dates
Release Date: February 10, 2005
Letters of Intent Receipt Date(s): March 14, 2005
Application Receipt Dates(s): April 14, 2005
Peer Review Date(s): July 2005
Council Review Date(s): September, 2005
Earliest Anticipated Start Date: September 30, 2005
Expiration Date: April 15, 2005

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

A key component of the mission of the National Center on Minority Health and Health Disparities (NCMHD) is to support the NIH effort to reduce and ultimately eliminate health disparities by providing assistance to institutions for conducting basic biomedical and behavioral, clinical, social, and community-based participatory research on health disparities, improving institutional infrastructures for conducting research on health disparities and for providing research training, disseminating health information, and conducting outreach to health disparity communities. The purpose of this Project EXPORT Centers of Excellence initiative is to expand the number of NCMHD Project EXPORT Centers of Excellence. NCMHD now invites applications to establish Centers of Excellence under the P20 mechanism. Eligible applicants responsive to this RFA will contribute to accomplishing one or more of the following objectives:

• advance the science directed toward reducing, eliminating, or preventing health disparities
• accelerate the discovery of new interventions and expand the utilization/adaptation of existing evidenced-based interventions for preventing, reducing, or eliminating health disparities
• increase the number of researchers and professionals from minority and medically underserved populations trained in biomedical and behavioral research
• increase the quality of the training provided to biomedical and behavioral researchers and professionals conducting research on health disparities
• increase public trust and the dissemination and utilization of scientific and health information relevant to health disparity populations.

Each applicant may submit only one application in response to this RFA. Application materials are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance, contact GrantsInfo Telephone: (301) 710-0267; Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

For more information about this RFA contact 301-402-1366 at the NCMHD, Scientific Program Operations.

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) 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. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Arbitration Process
3. Reporting

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

Section VIII. Other Information - Required Federal Citations

1. Research Objectives

A key component of the mission of the National Center on Minority Health and Health Disparities (NCMHD) is to support the NIH in reducing and ultimately eliminating health disparities by providing assistance to institutions for conducting basic biomedical and behavioral, clinical, social, and community-based participatory research on health disparities, improving institutional infrastructures for conducting research on health disparities and for providing research training, disseminating health information, and conducting outreach to health disparity communities.

During the past three years, the NCMHD Project EXPORT Centers of Excellence Program has supported Resource-Related Research Projects (R-24s), Exploratory Center Grants (P-20s), and Comprehensive Center Grants (P60s). The Resource-Related Research awards established under RFA MD02-001 and MD-03-001 were made with the expectation that the award recipients would be better positioned to compete for awards establishing a NCMHD Project EXPORT Exploratory (P20) Center of Excellence. NCMHD now seeks to expand the number of Exploratory (P20) Centers of Excellence.

This RFA has been modified from the previously announced RFAs (MD-02-002 and MD-03-002) for establishing a NCMHD Exploratory Center of Excellence (NIH Guide: EXCELLENCE IN PARTNERSHIPS FOR COMMUNITY OUTREACH, RESEARCH ON HEALTH DISPARITIES AND TRAINING (PROJECT EXPORT - ESTABLISHING EXPLORATORY CENTERS) in several significant ways:

• Partnerships or consortia can be established but the applicant institution cannot hold a current NCMHD Project EXPORT Exploratory Center of Excellence (P20), NCMHD Project EXPORT Comprehensive Center of Excellence (P60), or Research Infrastructure at Minority Institutions (RIMI) award. Institutions having these awards or any other NIH Center grant, for example, a P20, P30, P50, or P60 related to health disparities may participate as partners or as part of a consortium; They may not be the applicant institution nor as partners receive funding for activities already funded under existing grants.
• Current NCMHD R24 awardees funded in response to either RFA MD-02-001 or RFA MD-03-001are eligible to apply, but if an award is made they must relinquish the current award.
• All Exploratory Centers (P20s) are required to have the following mandatory cores:

  Administrative Core
  Research Core
  Research Education and Training Core
  Community Partnership/Outreach Core

As for the MD-02-002 and MD-03-002 announcements, institutions having an NIH funded P50 or P60 center grant are not eligible to apply to this RFA.

Applicants that responded to a previous RFA (RFA MD-02-002 MD-03-002, or both) for establishing a NCMHD Exploratory Center of Excellence but were not funded should not follow the PHS 398 guidelines for submitting revised or amended applications. Applicants that hold current NCMHD Resource Related Center of Excellence (R24) awards must include a progress report in their application as described in PHS 398. If a progress report is not included the application will be considered non-responsive and returned without review.

The core areas and expectations are described in the following sections.

The major objectives of this RFA are to:

• advance the science directed toward reducing, eliminating, or preventing health disparities
• accelerate the discovery of new interventions and expand the utilization/adaptation of existing evidenced-based interventions for preventing, reducing, or eliminating health disparities
• increase the number of researchers and professionals from health disparity populations trained in biomedical and behavioral research
• increase the quality of the training provided to biomedical and behavioral researchers and professionals conducting research on health disparities
• increase public trust, the dissemination and utilization of scientific and health information relevant to health disparity populations

Research Topics for Consideration

Reducing, eliminating and preventing disparities within any of the DHHS special emphasis areas, cardiovascular disease, stroke, cancer, diabetes, HIV/AIDS, infant mortality, and mental health are a priority, as is the area of obesity. Research focused on exploring the contributions of genetics, nutritional deficiencies, or access to health care to health disparities is also of interest. There is an increasing need for effective interventions in these areas and applicants are encouraged to expand promising ongoing studies to include these areas or to initiate new studies in these areas. Expanding, redesigning ongoing studies or developing new research projects including the possible contributions of the social and physical environments and interactions are encouraged. Such studies are essential for both understanding the contributions of socioeconomic factors and environmental exposures to health disparities and for developing effective and practical interventions for reducing, preventing, and eliminating health disparities. The physical environment includes, but is not limited to, the natural environment, built structures, physical, chemical, and biological agents (e.g. radiation, pesticides, infectious agents, food consumption and nutrient intake, and pharmacological agents) to which communities are exposed. The social environment includes, but is not limited to, individual, institutional, community, and region-level characteristics (e.g. socioeconomic position (SEP), support systems, residential factors, institutional and political, policy, familial and cultural factors, and acculturation).

Description of a Center

EXPORT Center applications should be organized into discrete components that comprise a proposed overall program of research, training, and community partnerships/outreach. In preparing applications, previously funded applicants should build upon and expand the most promising research, training and outreach efforts developed during the NCMHD funded R24 developmental phase. Applicants that responded to a previous RFA for establishing a NCMHD Exploratory Center of Excellence (RFA MD-02-002 MD-03-002, or both) but were not funded should not follow the PHS 398 guidelines for submitting revised or amended applications. However, because of changes in this RFA relative to the two previous RFAs, applicants must take care and not simply resubmit a previously unfunded application; the applicant needs to make sure that the application is responsive to this RFA. Applications judged non-responsive by NCMHD program staff will be administratively withdrawn and will not be peer reviewed. All applications responsive to this RFA will contribute to one or more of the five major research objectives listed above and have programmatic activities in the four mandatory cores. An applicant can not propose more than the four mandatory cores.

• Administrative Core (mandatory) -- 15-page maximum

The administrative core component plays a key role in the coordination and operation of the proposed NCMHD Project EXPORT Center of Excellence. Through this core, the Center director provides substantive leadership as well as manages the administration of the budget. This core should be described in sufficient detail to assure that all proposed components and related activities will function optimally and in an interactive, synergistic manner. The role of the administrative core in meeting the objectives of this RFA and of the proposed Center of Excellence should be described clearly and logically. Activities required for the smooth operation of a Center or deemed necessary to achieve its goals and objectives but are not suitable to include in one of the other mandatory cores should be included in the administrative core.

• Research Core (mandatory) -- 15 page maximum for narrative description of the core; 25-page maximum for each full research project proposed (follow the PHS 398 research project guidelines), 15- page maximum for pilot projects (follow the PHS 398 guidelines for research projects)

An Exploratory Center of Excellence must have at least one research project. For Exploratory Centers having a single research project, the PI must have his or her primary appointment at the applicant institution and the majority of the proposed research must be conducted at the applicant institution. There is no set limit on the number of research projects that can be proposed. If an application has more than a single project it is not necessary for all PIs to have an appointment at the applicant institution or for all of the proposed research to be conducted at the applicant institution. Each full research project must be a highly focused area of investigation and may include either a single principal investigator or several investigators under the direction of a project director. Each research project proposed will be reviewed on its own merit. Thus each project must be described separately and include an individual budget. Ideally, individual research projects will be thematic, highly focused, and interrelated so that they collectively contribute to one or more of the objectives of this RFA and the goals of the proposed Center. Provide a clear description of each proposed project, including specific aims and objectives as well as how it integrates with the other Center components. All research projects should follow the PHS 398 guidelines for research projects.

New pilot projects may be included in this section, but are not mandatory. The purpose of pilot projects is to provide the Center of Excellence with a means of developing innovative scientific research, exploring new research methodologies, or pursuing new directions that could evolve into independently funded research projects. The specific number of pilot projects proposed is at the discretion of the applicant, however, all funded pilots must be started as soon as possible after an award has been made. It is recognized that pilot projects may terminate at different times. Pilot research subprojects are for investigators who: 1) are experienced researchers but are just beginning to conduct research on health disparities; 2) new to the institution and have not had previous independent research support; 3) have academic responsibilities that have precluded pursuit of a research program in health disparities; or 4) plan to make a change in their research direction that necessitates a fresh start in a new discipline relevant to health disparities or directed toward a heretofore understudied health disparity subpopulation. The pilot research project is intended for faculty without current research support related to health disparities. Investigators with significant current extramural support for conducting biomedical and behavioral research on health disparities from other NIH mechanisms such as the R01 or research funding from another agency are not eligible to submit pilot research projects. Investigators having or that have had R01 support unrelated to health disparities are eligible to submit a pilot research project.

Each application must provide sufficient information for scientific evaluation of each proposed pilot project by a peer review committee. Describe clearly how each project will contribute to one or more of the objectives of this RFA. (A pilot project description must not exceed 15 pages and should follow the PHS 398 guidelines for research projects.)

• Research Education and Training Core mandatory --25-page maximum Training activities may be provided at the undergraduate, graduate, post-doctoral, and junior faculty level or a combination of two or more of the aforementioned levels. Applicant should address how the activities in this core will contribute to accomplishing one or more of the research objectives of this RFA.
• Undergraduate/Graduate Students. Training components for students may include establishing academic term and/or summer training opportunities as well as expanding existing or creating new curricula. The development of curricula that prepare students to conduct research on health disparities is of special interest. For consortia arrangements, in particular, new research training programs might provide students the opportunity to fulfill their research requirements in research laboratories at the partner institution, or to take courses not offered at the student's home institution.
• Post-Doctoral Training. Training components may also support post-doctoral training for individuals that have earned the doctorate degree or equivalent and who are from health disparity populations.
• Faculty at Minority Serving Institutions (MSIs). With respect to faculty at MSIs, mentored research components may be developed to provide assistance in learning new methodologies or to encourage faculty participation in research. Support for new faculty research positions to build capacity in biomedical and behavioral research and research training can be requested. Applicants must justify the position(s) relative to the goals and objective of the proposed Center.

The applicant institution and its partners must demonstrate or give reasonable assurances that it has: the capacity to train predoctoral and/or postdoctoral students for careers in biomedical, behavioral, epidemiological or health services research. For partnerships and consortia, in particular, training initiatives should represent true collaborations that function across institutional boundaries.

• Community Partnership/Outreach Core (mandatory) -- 15-page maximum

The mission of each Community Partnership/Outreach Core is expected to vary depending on the needs and strengths of the community and of the applicant institution. Applicants are expected to describe, for example, how the EXPORT Center will serve as a resource to the local community for preventing, reducing or eliminating health disparities. Will it disseminate health science research information in a culturally sensitive way? Will the community use the information? How will the use and effectiveness of the disseminated information be measured? Accordingly, this core may focus on accomplishing one or more listed research objectives or other objectives related to health disparities, areas, for example, 1) building public trust, 2) development and dissemination of evidence-based culturally sensitive health information directly related to the research of the Center or general health information presented in a culturally sensitive manner; 3) encouraging and equipping the community for potential participation in clinical studies and for eventual partnering in the conduct of community-based NCMHD health disparity interventions (that is, health disparity focused community-based participatory research); and 4) sponsorship of science education outreach activities (e.g., K-12 science programs with area middle schools, high schools, or adult community groups).

EXPORT Centers may develop exploratory programs for disseminating health information, as well as sponsor activities that encourage community participation in research either as study participants or that equip community-based organizations for partnering in and/or conducting disease prevention and/or intervention activities. In particular for information dissemination purposes, the audiences should include health care students and professionals, community-based organizations and researchers at the host institution as well as investigators at other institutions. Information transfer activities may include, but are not limited to activities such as training programs, short courses, telemedicine, presentations at professional meetings and publications. Applicants should address the expected effectiveness of the proposed activities and describe how the actual effectiveness of these activities will be measured and documented. Every effort should be made to utilize existing evidence-based interventions or to adapt them for use in the target community if needed. In the absence of existing interventions, applicants should identify gaps in the field and develop innovative interventions to fill the same.

With respect to equipping health disparity communities to develop and manage their own culturally sensitive programs for educating their populations and/or participating in prevention and intervention activities, the focus could be, for example, on addressing community-based and individual risk factors for disease, chronic disease management, screening, prevention, and decision making with respect to available therapeutics. Plans to evaluate the success and/or effectiveness of the proposed community outreach/information dissemination should be described, with emphasis on the impact of the proposed activities on knowledge, attitudes, behaviors, or other relevant measures.

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

1. Mechanism(s) of Support

This funding opportunity will use the P20 award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. The anticipated award date is on or before September 30, 2005.

Research projects are expected to be fully developed and designed to test a research hypotheses in a definitive manner, similar to an R01 in scope. The pilot research project is intended for faculty without current research support related to health disparities. Investigators with significant current extramural support for conducting biomedical and behavioral research on health disparities from other NIH mechanisms such as the R01 or research funding from another agency are not eligible to submit pilot research projects.

Support for either a P20 center may be requested for an initial period of up to 5 years, followed by a competitive renewal for an additional 5-year period, pending the availability of NCMHD funding. Once awarded and during the term of the award, centers are subject to administrative review for performance, and are not transferable to another institution. Although the F&A costs associated with all contractual and consortium arrangements are considered as direct costs to the applicant organization, these will not count against the program direct costs caps. However, these costs should be indicated as instructed on PHS 398.

It is mandatory that a P20 Center have an administrative core, a research core, a research education and training core, and a community partnership/outreach core. To qualify for support, a P20 Center must have within the research core at least one research project that is determined by expert review to be scientifically meritorious. For applicants having only a single project, it is necessary that the majority of the research for this one project be conducted at the applicant institution and that the PI for this project have his or her primary appointment at the applicant institution. The number of cores for this RFA is limited to the four mandatory cores. Non-competitive renewals will be issued subject to continued availability of funds and acceptable progress toward the funded aims.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available

NCMHD expects to award a total of $ 9 million dollars in total costs through this announcement;

• 6 new awards are anticipated
• Awards to be made under this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications
• Facilities and Administrative (F & A or indirect) costs will be provided at the applicant's negotiated rates
• the funding period will not exceed five years
• the anticipated start date is on or before September 30, 2005. Funding for the years 2-5 of the award period is contingent on the awardee making satisfactory progress, assessed annually, toward the stated objectives the availability of funds, and adherence to NIH grant policies.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award will also vary. Although the financial plans of the NCMHD provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

The NCMHD intends to commit approximately $9 million dollars in total costs in FY 2005 to fund 6 new grants in response to this RFA. An Exploratory Center applicant may request a project period of up to five years and a budget for direct costs up to 1.1 million dollars per year.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html.

1. Eligible Applicants

1.A. Eligible Institutions

This RFA has been modified from the previously announced RFAs (MD-02-002 and MD-03-002) for establishing a NCMHD Exploratory Center of Excellence (NIH Guide: EXCELLENCE IN PARTNERSHIPS FOR COMMUNITY OUTREACH, RESEARCH ON HEALTH DISPARITIES AND TRAINING (PROJECT EXPORT - ESTABLISHING EXPLORATORY CENTERS). Some of the eligibility and program requirements have changed:

• Partnerships or consortia can be established but the applicant institution cannot hold a current NCMHD Project EXPORT Exploratory Center of Excellence (P20), NCMHD Project EXPORT Comprehensive Center of Excellence (P60), or Research Infrastructure at Minority Institutions (RIMI) award. Institutions having these awards or any other NIH Center grant, for example, a P20, P30, P50, or P60 related to health disparities may participate as partners or as part of a consortium; They may not be the applicant institution nor as partners receive funding for activities already funded under existing grants.
• Current NCMHD R24 awardees funded in response to either RFA MD-02-001 or RFA MD-03-001are eligible to apply, but if an award is made they must relinquish the current award.
• All Exploratory Centers (P20s) are required to have the following mandatory cores:

  Administrative Core
  Research Core
  Research Education and Training Core
  Community Partnership/Outreach Core

As for the MD-02-002 and MD-03-002 announcements, institutions having an NIH funded P50 or P60 center grant are not eligible to apply to this RFA. Eligible institutions include:

• For-profit organizations*
• Non-profit organizations*
• Public or private institutions, such as universities, colleges, hospitals, and laboratories
• Units of State government
• Units of local government
• Eligible agencies of the Federal government
• Domestic Institutions
• Faith-based or community-based organizations*

Eligible (partnering) institutions also include:

• An Indian tribe that has a recognized governing body and that performs substantial governmental functions, or an Alaska Regional Corporation (ARC), as defined in the Alaska Native Claims Settlement Act (43 U.S.C. 1601 et seq.);
• Institutions with the characteristics above and located in the District of Columbia, Puerto Rico, the Virgin Islands, the Canal Zone, Guam, America Samoa, or the Trust Territory of the Pacific Islands.

*Foreign institutions are not eligible. For-profit or non-profit state, local, and faith-based organizations and Native American tribal organizations/governments, must partner with an eligible applicant in order to participate in this RFA. Institutions with one or more active NIH P50 or P60 Center grants related to health disparities are not eligible to participate in this competition as the sole applicant or as the lead partner, however, they may participate as a partner or a member of a consortium.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution 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 programs.

2. Other-Special Eligibility Criteria

An applicant may be the leading partner on only one NCMHD Project EXPORT application. An institution may be the designated lead institution on only a single active NCMHD grant. An institution can only submit a single application in response to this announcement. Institutions having an NIH funded P50 or P60 center grant are not eligible to apply to this RFA.

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times
Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: March 14, 2005
Application Receipt Date(s): April 14, 2005
Peer Review Date: July 2005
Council Review Date: September 2005
Earliest Anticipated Start Date: September 30, 2005

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 Principal Investigator
• 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 at the beginning of this document.

The letter of intent should be sent to:

Lorrita Watson, Ph.D.
Scientific Review Administrator
NCMHD/NIH
6707 Democracy Blvd., Suite 800 MSC 5465
Bethesda, MD 20892-5465
Tel: 301-402-1366
FAX: 301-480-4049
Email: WatsonL@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Lorrita Watson, Ph.D.
Scientific Review Administrator
NCMHD/NIH
6707 Democracy Blvd., Suite 800 MSC 5465
Bethesda, MD 20892-5465
Tel: 301-402-1366
FAX: 301-480-4049
Email: WatsonL@mail.nih.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf. Personal deliveries of applications are no longer permitted.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NCMHD. Incomplete and non-responsive applications will not be reviewed. If the application is not responsive to the RFA, NIH staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle.

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.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

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 allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

Restrictions for the Research Training Core: Applicants requesting support for a Research Training Core where the budget for this core exceeds 20% of the requested direct costs must provide sufficient documentation to demonstrate that it has:

1. a significant number of members of health disparity populations enrolled as students in the institution (including those accepted for enrollment in the institution)
2. been effective in assisting such students of the institution to complete the program of education or training and receive the degree involved;
3. made significant efforts to recruit students from health disparity populations to enroll in and graduate from the institution, which may include providing means-tested scholarships and other financial assistance as needed; and
4. made a significant recruitment effort to increase the number of members from health disparity populations serving in faculty or administrative positions at the institution.

If an award is made, the applicant must agree:

1. to maintain expenditures of non-Federal amounts for such activities at a level that is not less than the level of such expenditures maintained by the institutions involved for the fiscal year preceding the fiscal year for which such institutions received such an award
2. to expend awarded amounts for the approved research training activities, or
3. expend funds for any the approved expansion, remodeling, renovation or alteration of existing facilities, or construction of new facilities as necessary for conducting research on health disparities
4. that the institution or institutions will before expending the NCMHD award, expend the federal amounts obtained from sources other than the award
5. to provide a letter of assurance to abide by the above agreements and provide documentation of the expenditures for such activities during the previous year or multiyear year period (not to exceed 5 or more years) preceding the award.

NCMHD program staff when making recommendations about funding applications will consider the adequacy of the above assurance and of the requested documentation. Program staff may negotiate modifications of the assurance with the awardee before recommending funding of an application. The final version negotiated by both will become a condition of the award of the grant. If an award is made, updated documentation demonstrating the effectiveness of the institution's ongoing efforts in the above areas will be evaluated as part of the annual administrative review of each non-competing Grant Progress Report (PHS 2590).

6. Other Submission Requirements

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

1. Criteria

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 program priorities

2. Review and Selection Process

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

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NCMHD in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

• Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.
• Receive a written critique.
• Receive a second level of review by the NCMHD Advisory Council

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, weighting them 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 high 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.

1. 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?

2. 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?

3. 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?

4. Investigators. Are the investigators 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? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

5. 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 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 priority score:

Applicants that hold current NCMHD Resource Related Center of Excellence awards (R24s) awards must include a progress report in their application as described in PHS 398. If a progress report is not included the application will be considered non-responsive and returned without review.

Progress and Accomplishments of Developmental/Planning Phase: Has the investigator been productive in documenting his/her research findings in refereed journals? Was the investigators' productivity commensurate with the level of NCMHD funding during the development/planning phase? Did the PI make acceptable progress on the funded specific aims? Has the capacity of the institution to conduct biomedical and behavioral research increased during the funding period? Has the PI provided evidence documenting a significant increase in information provided to a health disparity community for improving health? Has the PI provided evidence demonstrating that the NCMHD COE (R24) was effective in disseminating information to one or more health disparity communities in a culturally appropriate way? Is there evidence that the community utilized this information

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 Research Plan, Section E on Human Subjects in the PHS Form 398).

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 Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Other Review Criteria: In addition to the above criteria, your application will also be reviewed with respect to the following:

• Feasibility and timeliness of the proposed plan, based on the mission, recent development history and current biomedical research capability of the applicant institution.
• Adequacy of the planning process, including concept development and involvement of advisory resources.
• Appropriateness of the organizational and administrative structure established to accomplish grant goals.
• Qualifications, experience and commitment of the Program Director, and his/her ability to provide effective leadership in meeting the goals of the Center and one or more of the listed research objectives for NCMHD Project EXPORT Exploratory Centers of Excellence.
• Appropriateness of the Advisory Committee and its role (if applicable).
• Adequacy of institutional commitment to the proposed activities and the pursuit of biomedical research.
• Merit of the applicant's institutional plans for meeting one or more of the listed research objectives for NCMHD Project EXPORT Exploratory Centers of Excellence and for meeting the proposed goals and objectives for the Center.
• For non-degree granting institutions or organizations, appropriateness and feasibility of plans to establish, enhance and/or maintain collaborative agreements with doctoral degree-granting institutions.
• Strength of the evidence that the researchers and faculty of the partnering institutions worked closely together in the preparation of the application or will do so in meeting the proposed objectives.
• The degree to which the letters of support from senior faculty and/or institutional leaders were supportive of the proposed Center, its goals and objectives.
• As applicable, the adequacy of provisions made for day-to-day oversight, coordination, support and logistical services needed to make proposed partnerships, consortia, or collaborations successful.

Other Considerations Administrative Core (Mandatory)

• Adequacy of the administrative core to manage the overall Center activities.
• Appropriate justification for the core, including the duplication of existing resources or services and anticipated future use of the core.
• Qualifications of the Director of the Administrative core (if applicable), including the ability of the Center director to provide the scientific and administrative leadership for Center activities, strategies to promote scientific progress, interaction, implementation, and evaluation; and arrangement for the fiscal management of the grant.
• Proposed composition and function of the Executive Committee to support the proposed activities (if applicable).
• The proposed composition and function of the external Advisory committee to support a proposed EXPORT Center (if applicable).

Research Core (Full and Pilot projects)

• The scientific merit of the concepts for the proposed research and the importance of the information sought to the mission of the NCMHD and in meeting the one or more of the listed research objectives of this RFA.
• The process for selecting the proposed full and pilot research studies o How well the proposed research areas address a minority health or health disparities topic.
• The innovativeness and promise of the proposed methods to be used in the conduct of research. o The novelty or originality of the proposed research concepts.
• The appropriateness and justification of the requested budget for the proposed planning activities.
• The qualifications of the investigator that will conduct the proposed research projects. If required, areas in which investigators will be recruited.
• Adequacy of plans to identify and address ethical concerns related to conducting health disparities research.

Research Education and Training Core (Mandatory)

• Evidence of a strong commitment to increasing the number of researchers and professionals from health disparity populations trained in biomedical and behavioral research and to the research career development of junior faculty.
• The plans to facilitate and monitor the research career trajectory and productivity of participants at participating institutions.
• Qualifications of the investigator that will lead the research education and training core activities.

Community Partnership/Outreach (Mandatory)

• Adequacy of plans for establishing, sustaining, and evaluating research-based prevention and intervention studies with targeted communities, if applicable.
• Adequacy of plans for K-12 science education outreach, if applicable.
• Plans for disseminating health disparities research findings to participants, community groups, and lay and professional audiences in culturally appropriate ways and in ways that will increase the use of the information by the community.
• The adequacy of the plans for using evidenced-based interventions for disseminating information to the community.
• The qualifications of the leadership of the Community Partnership/Outreach core

Overall Exploratory Center of Excellence Plan, Goals and Objectives

• Evidence of collaborative and/or interdisciplinary research, and interdisciplinary approaches to the development of the NCMHD Project EXPORT Exploratory Center of Excellence and proposed goals, objectives and activities,
• Adequacy of the available resources and the quality of the research education and or training environment.
• The institutional commitment to the NCMHD Project EXPORT Exploratory Center of Excellence in terms of space, resources, administrative authority, and other necessary support, e.g., donated faculty time, and the extent to which a proposed EXPORT Center would be recognized as a major element within the organizational structure of the institution.
• The plans for developmental activities, including recruitment and expansion, insofar as the proposed research and/or training program justifies these.
• The plans for the provision of protection of human subjects and the humane care of animals (if applicable).
• Appropriateness of the requested budget for the work proposed.
• The adequacy of plans to include both genders, and if applicable, other health disparity groups, and children as appropriate for the scientific goals of the proposed research. Plans for the recruitment and retention of subjects will also be evaluated.

2.B. Additional Review Considerations

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

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates
Earliest Anticipated Start Date: September 30, 2005

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

The Notice of Grant Award will be sent either electronically or via US postal system. It will be sent to the business official indicated on the front page of the application.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

2.A. Cooperative Agreement Terms and Conditions of Award
Not applicable

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

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 program priorities

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, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Derrick C. Tabor, Ph.D.
Scientific Program Operations
Program Director
NCMHD/NIH
Bethesda, MD 20892-5465
Telephone: (301) 594-8950
FAX: (301) 480-4049
Email: tabord@mail.nih.gov

2. Peer Review Contacts:

Lorrita Watson, Ph.D.
Scientific Review Administrator
NCMHD/NIH
6707 Democracy Blvd., Suite 800 MSC 5465
Bethesda, MD 20892-5465
Tel: 301-402-1366
FAX: 301-480-4049
Email: WatsonL@mail.nih.gov

3. Financial or Grants Management Contacts:

Bryan S. Clark, MBA
Chief Grants Management Officer, NCMHD/NIH
6707 Democracy Blvd., Suite 800, MSC 5465
Bethesda, MD 20892-5465
Telephone: (301) 402-1366
Fax: (301) 480-4049
Email: Clarkb@ncmhd.nih.gov

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 (45CFR46) 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 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.

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 http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the September 30, 2004 receipt date, 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.

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 new PHS Form 398; 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.

Public 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 public 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 PA 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.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) 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 DHHS 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. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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 PA 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: (Be sure to cite any additional appropriate authorizations, regulations or policies below)
The NCMHD was established under Public Law 106-525 and authorized to support research, training, dissemination of information and other programs with respect to health disparity populations. 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 or Health Systems Agency review. 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 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 NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. 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.

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