Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH)

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

Title: Establishing Exploratory NCMHD Research Centers of Excellence (P20)

Announcement Type
This is a modification of RFA-MD-05-003, which was previously released February 10, 2005.

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

Request For Applications (RFA) Number: RFA-MD-06-003

Catalog of Federal Domestic Assistance Number(s)
93.307

Key Dates
Release Date: July 7, 2006
Letters of Intent Receipt Date: September 23, 2006
Application Receipt Date: October 23, 2006
Peer Review Date: February-March, 2007
Council Review Date: September 2007
Earliest Anticipated Start Date: September 30, 2007
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: October 24, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


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
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

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

The National Center on Minority Health and Health Disparities (NCMHD) invites applications for establishing exploratory NCMHD research centers (P20). The Minority Health and Health Disparities Research and Education Act of 2000 authorized the NCMHD to establish centers of excellence. The first NCMHD centers of excellence were centers of excellence in partnerships for community outreach, research on health disparities, and training. These centers, first established in 2002, have since become known as NCMHD Project EXPORT centers and all but five will soon complete the first cycle of NCMHD funding. The NCMHD now seeks to establish centers of excellence more clearly focused on research excellence, specifically research for improving minority health and for eliminating health disparities. There are clear and pressing needs for research with a high likelihood for improving minority health or eliminating health disparities. These NCMHD research centers of excellence will focus primarily on minority health and health disparities research and secondarily on research training and community engagement and outreach. This centers of excellence program will support exploratory research exploring the multiple and complex factors contributing to minority health and health disparities. These factors are expected to include biological, environmental, behavioral and social factors acting independently or dependently, across multiple social contexts, and across multiple social levels. The exploratory NCMHD research centers of excellence established under this RFA will, as do the NCMHD Project EXPORT centers, contribute to the Department of Health and Human Services initiatives for eliminating health disparities.

Exploratory NCMHD research centers of excellence should propose to conduct original and innovative basic laboratory, behavioral, clinical, or population based research directed toward improving minority health, eliminating health disparities, or both, on any of the following diseases or conditions: cardiovascular disease, stroke, cancer, diabetes, HIV/AIDS, infant mortality, mental health, and obesity. Research associated with lung and liver diseases, psoriasis, sclerodema, and glomerular injury is also encouraged when significant disparities for racial and ethnic populations and medically underserved populations are known to exist. Research cutting across two or more of the above diseases or conditions and that includes interventional studies, or trials or that leads to novel interventions is also of interest. Previously or currently NCMHD funded applicants are encouraged to request funds for continuing promising research initiated under NCMHD center of excellence funding.

These NCMHD awards will provide resources for:

The P20 grant award provides a means by which an institution or consortium of institutions can: 1) integrate and centralize ongoing minority health and health disparities research and related research-based activities into a single interdisciplinary and transdisciplinary research enterprise; 2) establish novel partnerships with organizations and communities for conducting original and innovative cutting-edge research leading to improvements in minority health, the elimination of health disparities, or both; 3) enhance and strengthen existing research training activities for preparing researchers from minority and health disparity populations to conduct meritorious minority health and health disparities research; and 4) strengthen community and institutional partnerships for improving minority health and the health of health disparity populations.

Background

The mission of the National Center on Minority Health and Health Disparities (NCMHD) is to promote minority health and to eliminate health disparities. The NIH defines health disparities as differences in the incidence, prevalence, morbidity, mortality, and burden of diseases and other adverse health conditions that exist among specific population groups (See, http://www.nih.gov/about/hd/strategicplan.pdf , page 7). The specific population groups are African Americans, American Indians, Alaska Natives, Asian Americans, Hispanic Americans, Native Hawaiians, Pacific Islanders, subpopulations of all of the above, and medically underserved populations (i.e., socio-economically disadvantaged individuals in rural and urban areas). These populations are hereafter referred to as health disparity populations. Additional background information can be found in previous NCMHD RFAs establishing centers of excellence, see RFA MD-02-002, http://grants.nih.gov/grants/guide/rfa-files/RFA-MD-02-002.html, and MD-03-002, http://grants.nih.gov/grants/guide/rfa-files/RFA-MD-03-002.html.

The NCMHD Project EXPORT Program was the first NCMHD centers of excellence program. This program was initiated in 2002 and currently supports 26 resource-related centers (R-24s), 26 exploratory centers (P-20s), and 23 comprehensive centers (P60s), located in 27 states, the District of Columbia, Puerto Rico, and the U.S Virgin Islands. The NCMHD EXPORT centers conduct research independently and in formal partnership with one or more institutional partners, provide training opportunities to researchers and junior faculty from health disparity populations, engage in health promotion and health information dissemination activities, and have established partnerships with community based organizations. According to published research findings, these centers are conducting research involving all health disparity populations and all of the priority diseases and conditions identified by the Department of Health and Human Services. This initiative provides opportunities to accelerate these and other efforts by continuing to support original, innovative, leading-edge research to improve minority health and to eliminate health disparities.

It is expected that new biomedical and behavioral knowledge will be discovered for improving minority health and for eliminating health disparities within and across the priority areas of cardiovascular disease, stroke, cancer, diabetes, HIV/AIDS, infant mortality, mental health, and obesity, as well as lung and liver diseases, psoriasis, sclerodema, and glomerular injury. New knowledge is also expected to result from the continuing research projects initiated under previous NCMHD centers of excellence support.

Healthy People 2010 identified the following six critical determinants of health: biology, behaviors, the social environment, the physical environment, policies, and access to care. It is expected that research conducted at exploratory NCMHD research centers will discover new knowledge on the interactions of significant biological factors with behavioral and social variables, how they affect each other, and how these interactions influence and contribute to minority health conditions and health disparities. This new knowledge is expected to lead to the development of new biopsychosocial interventions and strategies for improving minority health and eliminating health disparities.

Applicants may want to consider the following topics for research. These are examples and are not meant to suggest priority research areas, nor are they comprehensive or restrictive.

Applicants should describe the center, its scientific focus, for example, minority health, health disparities, or both, its goals and objectives, the type of research to be conducted, disciplines involved, disease areas, determinants, etc. In addition, the applicant should provide for any given disease, condition, or significant activity the improvement expected over the relevant baseline, assuming baseline data are available. Describe the dedicated facilities to be utilized by the center. If requesting a shared resources core or additional center components provide the appropriate rationale. Provide and discuss the documentation submitted to meet the eligibility requirements for establishing a center independently or as the lead applicant in a partnership or consortium.

The NCMHD, through this RFA, will make a substantial investment in these exploratory NCMHD research centers and expects similar commitments of the institution(s) to the center. Discuss and provide evidence; for example, a letter from the provost, of the institutional commitments to the center, including the recognition of the center as a formal organizational component, the provision of space, positions and discretionary resources, the authorities of the director; the status of the director in comparison to department chairs; reporting structures, and responsibilities of institutional leaders to ensure the long-term stability of the center, and plans for assuring the continued commitment of the center in the event of a change in directorship.

If establishing a partnership, discuss briefly the history of previous partnerships with the proposed partners, if any, and the rationale, scientific and geodemographic, for partnering. Describe how the partnership was established, and describe the complementary institutional strengths and expertise; for example, strengths and expertise in basic, clinical, or population-based research, research training, community engagement, etc, as appropriate, that contribute to the likelihood that this partnership will achieve the proposed scientific goals and objectives and thereby make significant contributions to improving minority health or eliminating health disparities. Describe efforts that have been taken to ensure the success of the partnership generally and the steps taken to ensure that it is and will remain a true partnership throughout the course of the award. Describe any official letters of understanding established between the partnering institutions and any significant inter-institutional commitments. Applicants should decide what and how much is appropriate to include about the partnership in this section versus the administrative core.

Previously funded NCMHD Project EXPORT centers must include a separate section for a summary progress report generally describing how the success of the center has been measured, what the center considers its most important successes and accomplishments, and how these accomplishments have contributed to realizing the funded goals and objectives of the center. For example, describe recent scientific discoveries and successes, accomplishments in research training, including winning of grants by NCMHD supported investigators, and accomplishments in community outreach, dissemination, and pipeline development efforts. Describe improvements in the infrastructure for conducting minority health or health disparities research established at the institution or in the community using NCMHD funding. Discuss how this infrastructure is sufficient for accomplishing the proposed goals and objectives to be supported under this RFA. If a significant decrease in a health disparity or a significant improvement in minority health has been realized, provide the baseline data supporting such results. While the page count of the progress report does not count against the 15 page maximum, applicants should be as succinct as possible, utilize tables and graphs, and report on only the most significant accomplishments to be assessed by reviewers. Include in the progress report a table listing the title of all research projects, including pilot projects, funded with NCMHD dollars to date; include the name of the PI, title of project, health disparity population studied, and a listing of all publications resulting from each project. Indicate whether NCMHD was acknowledged in the publications listed. If the table exceeds two pages, provide examples of select titles and report in another table the total number of publications resulting from NCMHD funded research efforts. Given the differences in grant awards, goals and objectives, funding levels, and the number and types of personnel supported by the NCMHD Project EXPORT, applicants should provide a table summarizing the total man-hours, and dollars, contributing to the outcomes and progress of the center.

Applicants should describe the administrative structure of the center and the roles and responsibilities of all key personnel. The administrative core is responsible for 1) the allocation and oversight of all Center resources, 2) establishing and maintaining all partnerships, center advisory boards, cores, and training and community activities essential to the success of the Center, 3) the selection of the core center faculty and the minority health or health disparities research to be conducted within the center, and 4) overseeing the process for the solicitation, review, and selection of all pilot projects. All exploratory NCMHD research centers are expected to establish and maintain a website. Additionally, through the efforts of the administrative core, each NCMHD center is expected to become a valued, trusted, institution-wide resource for expanding the capacity and competence of the institution, and that of NIH funded researchers and students in conducting minority health and health disparities research. The center director is also expected to interact with the administrative leadership of the institution to enhance the success of the center.

Activities required for the smooth operation of a center should be included in the administrative core if not appropriate as a core level activity. For example, if there is a documented need for shared resources but not a shared resources core, then this function should be housed within the administrative core.

An exploratory NCMHD center of excellence must have one-three full research projects - judged meritorious by peer review. Pilot projects, described more fully below, are also supported. In the narrative, describe the process used for soliciting and selecting the full research project(s) and the pilot projects submitted in this application. Use the PHS 398 format for research grants for all full research projects. There is a 25-page maximum for each full research project proposed. If a continuing project, provide a progress report, following the guidance provided in the PHS 398.

Applicants are encouraged to develop research projects addressing significant problems in minority health or health disparities within the areas or conditions stated above (see the second paragraph, Section I.1, Part II). Research within or cutting across two or more of the priority areas or conditions is encouraged. Support can be requested for continuing NCMHD funded research projects and for pilot research projects seeking to move to a more significant funding level. A single principal investigator or multiple co-investigators may conduct the proposed research. The research team can include senior and junior faculty, post-doctoral or other trainees, as well as community members, all with the appropriate justification. Each full research project will be reviewed on its own merit and must include a budget, and a narrative budget justification, and include the role and responsibilities of all of the members of the research team.

Expected improvements in health relative to an existing baseline measure for the health disparity population(s) under study should be provided when possible. For example, if research involves an intervention documented to be effective for only 50% of a given population, the applicant should make the case for increasing the effectiveness to 75%, and address the basis for the expected improvement given existing barriers known to the field.

Abstracts of proposed pilot projects should be included in the research core. Pilot projects provide the center with a means of seeding emerging research areas in minority health or health disparities or both, 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, no more than approximately 30% of the direct cost budget can be provided for pilot projects within any one year without the permission of the NCMHD program director. The plan for soliciting pilot projects must include handling requests from PIs at partnering institutions and include provisions for mentoring when appropriate. It is recognized that pilot projects may terminate at different times, typically within 1-2 years; however, in some cases a period longer than two years, as determined by the center director or advisory committee, may be needed to complete the proposed research. Pilot project PIs may commit up to 50% time and effort during a given 9 month or 12 month period depending on existing contractual agreements. The proposed research must not overlap research funded from another source and should not be considered as “overload”.

Undergraduate/Graduate Students. Training components for students may include establishing academic term and/or summer training opportunities. The enhancement of existing curricula to include subjects related to minority health and health disparities may be proposed. The development of curricula for preparing students to conduct research on minority health or health disparities is of special interest. For consortia arrangements, 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. Up to 50% time and effort may be requested for MSI faculty at a partnering institution to engage in research.

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, training initiatives should represent true collaborations that function across institutional boundaries.

The mission of each Community Engagement/Outreach Core is expected to vary depending on the needs and capabilities of the community and of the applicant institution. Each activity within this core should address a research question rather than simply provide a service. In disseminating health information to a minority or health disparities community, an applicant might seek to determine what dissemination methods are most effective in preventing, reducing or eliminating health disparities. Is it important to disseminate health science research information in a culturally sensitive way? What fraction of the community actually uses the information? Applicants should describe how the use and effectiveness of the disseminated information would be measured. Accordingly, this core may focus on 1) how to access and build public trust; 2) how to engage the community for potential participation in clinical studies and for eventual partnering in the conduct of community-based health disparity interventions; and 3) engaging the community in science education activities (e.g., K-12 science programs within area middle schools, high schools, or adult community groups).

NCMHD research centers may develop exploratory research programs for disseminating health information, as well as sponsor activities that encourage community participation in research 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. Ideally, research findings within the research core will lead ultimately to the development of novel interventional strategies effective in improving minority health, eliminating disparities, or both.

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 level 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. Research-based strategies for engaging the health provider community in improving minority health or eliminating health disparities at the local, regional or state levels should also be considered.

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

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the P20 award mechanism(s).

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

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

Awards to be made under this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

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 support.

2. Cost Sharing or Matching

Cost sharing is not required. The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria

This competition is open to all eligible institutions, including eligible past and current recipients of NCMHD Project EXPORT awards (P60, P20, and R24s) funded in 2002, 2003, or 2004. NCMHD Project EXPORT grantees funded in FY 2005 are not eligible to participate in this competition. Institutions may only hold, as the lead institution, a single NCMHD P20 award of any kind. Institutions holding a Research Infrastructure In Minority Institutions (RIMI) grant may apply but the RIMI grant must be terminated prior to making an NCMHD research center award. Current NCMHD Project EXPORT (P20s) grantees will have an existing center of excellence award terminated before an award is made under this RFA. The sole or lead applicant responsive to this RFA:

Additionally, there are specific eligibility criteria established by law that must be satisfied in order to receive an award as the sole or lead applicant under this RFA. Pursuant to Public Law 106-525, awards under this program can only be made to institutions of higher learning having a history of enrolling and graduating racial and ethnic minority and socioeconomically disadvantaged students from their degree programs. The recruitment of racial and ethnic minority faculty and staff is also a priority at such institutions. In previous RFAs establishing NCMHD Project EXPORT Comprehensive Centers, institutions having the above priorities were referred to as designated institutions. In this RFA, designated institutions are now referred to as eligible institutions, meaning these institutions are eligible to establish a center independently as the sole applicant or as the lead applicant in a partnership or consortium. The four operational characteristics previously set forth for designated institutions have been restated as eligibility criteria. Responsive applicants will be able to document that, for the past four years, they have:

Applicants not able to provide documentation satisfying all of the above criteria should establish a partnership or consortium with an eligible institution serving as the lead applicant. Applicants are invited to contact the program official listed in this RFA for assistance in identifying the necessary documentation prior to submission of an application. Applications from applicants not meeting the above eligibility criteria will be considered non-responsive and will be returned without peer review. Applications lacking sufficient documentation to establish the eligibility of the applicant will be considered non-responsive and will be returned without peer review.

An eligible institution may only submit a single application as the sole or lead institution. If more than one application is received identifying the same institution as the sole applicant or as the lead applicant in a partnership or consortium, all applications from this institution may be returned without review. In such cases, NCMHD will contact the appropriate institutional official to identify which application is to be accepted. There are no limitations on the number of partnerships an institution may establish. An applicant may be the lead institution on one application and be a non-leading partner or consortium member on another. However, duplicative costs are not allowed. Applicants will be required to resolve any real or potential overlap issues prior to the making of an award.

Applicants submitting competing continuations and are currently the sole institution on a P60 or P20 NCMHD Project EXPORT centers of excellence award are not required to submit the above requested documentation; they are deemed eligible by having previously received the NCMHD Project EXPORT award. Applicants submitting competing continuations that are part of a formal partnership currently funded under either the P60 or P20 NCMHD Project EXPORT program are not required to submit the above documentation if they are continuing the partnership(s) established at the time of funding under the NCMHD Project EXPORT Program. If the initial partnership is not being continued then the applicant must submit the above requested documentation.

DEFINITIONS

The definitions below are intended to clarify concepts that are expressed in this RFA.

APPLICANT INSTITUTION: The applicant institution is the entity at which the NCMHD center will be physically and/or integrated into its administrative structure. The Director must have his/her primary appointment at the applicant institution.

COLLABORATING INSTITUTION: The collaborating institution is the institution with which the applicant institution has partnered.

PREDOMINANTLY MINORITY SERVING INSTITUTION: A predominantly minority serving institution is an academic, health care, or research institution with an enrollment and/or faculty that consists predominantly of racial and ethnic minorities.

HEALTH DISPARITY POPULATIONS: African Americans, Alaskan Natives, American Indians, Asian Americans, Hispanic Americans, Native Hawaiians, Pacific Islanders, and other medically underserved populations, which includes socioeconomically disadvantaged individuals in rural and urban areas. (P.L. 106-525)

PARTNERSHIP AND CONSORTIUM ARRANGEMENTS: When a grant application includes research activities that involve more than one institution it is considered a partnership or consortium effort, depending on the number of institutions involved. Such activities are encouraged in this RFA.

HISPANIC-SERVING INSTITUTION: A Hispanic-Serving Institution (HSI) is defined as a non-profit institution that has at least 25% Hispanic full-time equivalent (FTE) enrollment, and of the Hispanic student enrollment at least 50% are low income. Low income is defined as 150% of the poverty level as determined by the Bureau of the Census at http://www.census.gov/hhes/poverty/povdef.html.

DESIGNATED INSTITUTION: See Public Law 106-525.

Distributions of NCMHD Centers - Geodemographic Goals and Considerations

In selecting partners to address minority health and health disparities, applicants should give consideration to the diverse geodemographic characteristics of potential partners and that of communities. A distinctive characteristic of NCMHD programs is the commitment to both engage and harness the research strengths, capabilities, and commitments of local degree granting institutions to meet the research needs of minority and health disparity communities located within designated geographic regions across the United States and its territories. Applicants are encouraged to give careful consideration to establishing centers that match the collective research strengths, capabilities, and commitments of the lead institution, and its partners, to the diverse demographic characteristics and diverse research needs of local minority and health disparity populations. Some key demographic goals are described below:

OR

OR

Any institution meeting the eligibility criteria and demographic goal C should consider partnering or forming a consortium with one or more Tribal Colleges and Universities (TCUs) or with a research-intensive institution not meeting the eligibility criteria. In previous RFAs, non-eligible institutions were referred to as non-designated institutions. Non-designated institutions are institutions of higher learning that do not meet the criteria outlined above but which have substantial federal research support and/or research infrastructure as reflected in the report on research institutions: http://mup.asu.edu/research2005.pdf.

The following urls may be helpful to institutions seeking partnerships with minority institutions: For a listing of Historically Black Colleges and Universities (HBCUs) see the following website address: http://www.ed.gov/about/inits/list/whhbcu/edlite-list.html. A listing of TCUs may be found at:

http://www.ed.gov/about/inits/list/whtc/edlite-tclist.html . While there are no official lists of minority serving institutions maintained by the federal government, a website provided by the Office of Civil Rights lists many of the recognized minority serving institutions, including institutions having high Hispanic enrollments; see http://www.ed.gov/about/offices/list/ocr/edlite-minorityinst.html.

Section IV. Application and Submission Information


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) 435-0714, 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. The Table of Contents should be modified to include the major headings described in the application; i.e., Research Core and should include the title and Principal Investigator for each full research project and each pilot project.

Applicants that responded to a previous RFA for establishing an NCMHD center of excellence (RFA MD-02-002, MD-03-002 or MD-05-003) but were not funded should submit a new application responsive to this RFA. Previously or currently funded NCMHD Project EXPORT grantees should apply as if submitting a competing continuing application, although RFAs are not formally re-competed. 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 advancing minority health or eliminating health disparities and have programmatic activities in the two mandatory cores (administrative and research).

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
Letters of Intent Receipt Date: September 23, 2006
Application Receipt Date: October 23, 2006
Peer Review Date: February-March, 2007
Council Review Date: September 2007
Earliest Anticipated Start Date: September 30, 2007

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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:

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

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. 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)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At the time of submission, two additional copies of the application and all five copies of the appendix, comprised of unbound materials, with separators between documents, must be sent to:

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: N/A

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.

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.

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.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

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.

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.

6. Other Submission Requirements

Not applicable.

Section V. Application Review Information


1. Criteria

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

The following will be considered in making funding decisions:

2. Review and Selection Process

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:

Applications recommended by the National Advisory Council on Minority Health and Health Disparities will be considered for funding on the basis of the overall scientific merit of the application as determined by peer review, as well as such considerations as program balance, relevance to the mission and goals of the NCMHD, geo-demographics, research program priorities, continuity of support, and availability of funds.

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.

The initial review for scientific and technical merit of applications will emphasize three major aspects: (1) the review of each core component: administrative, research, research training (if applicable), and community outreach (if applicable); (2) the quality of the research projects within the core research program; and (3) the review of the proposed center as an integrated whole working together to focus on improving minority health, eliminating health disparities, or both and its potential to favorably establish or enhance the fields of minority health or health disparities research at the institution.

The ADMINISTRATIVE CORE will be evaluated with the following criteria:

Approach: Are the arrangements and organizational structure adequately developed, well reasoned and appropriate to the aims of the project? Does the application describe how day-to-day management will be accomplished? Are the plans to facilitate and monitor attainment of center objectives appropriate? Are contractual and consortium arrangements adequately described, if applicable? What is proposed for long-term management and periodic evaluation of goal attainment?

Investigator: Are the qualifications, experience, commitment and administrative competence of the Administrative Core Director appropriate? Is there an appropriate time and effort commitment made by the Administrative Core Director? If applicable, is there evidence that the researchers and faculty of the partnering institutions have worked closely together in the preparation of the application or will do so in meeting the proposed objectives?

Environment: Is institutional commitment to the pursuit of minority health and health disparities research and other proposed activities, including provision of resources, administrative authority and recognition, convincing?

The RESEARCH CORE will be evaluated with the following criteria:

Approach: Are the goals of the Research Core explained in the context of potential to contribute to improving minority health, the elimination of health disparities, or both? Is there evidence that the applicant utilized an effective process for selecting the full research projects and pilot projects submitted in the application? What are the quality control and oversight mechanisms in place for ongoing projects?

Investigator: Are the qualifications, experience, commitment and administrative competence of the Research Core Director appropriate? Is there an appropriate time and effort commitment made by the Research Core Director? Are there adequate plans for communication and cooperation among investigators?

Environment: Are there appropriate plans for resource allocation? Does the scientific environment in which the work will be done contribute to the probability of success? If the research sites are not all located on a single campus, do the additional sites contribute to the probability of success?

The RESEARCH SUBPROJECTS within the RESEARCH CORE will be evaluated with the following criteria:

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 concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? What is the relevance to minority health and health disparities?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the project original and innovative, e.g., does it challenge existing paradigms or clinical practice or 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?

Investigator: Are the investigators appropriately trained and well suited to carry out this work? Is the work 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?

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

The optional cores (RESEARCH TRAINING CORE, COMMUNITY ENGAGEMENT CORE), if included, will be evaluated with the following criteria:

Significance: What is the added value derived from the addition of the optional core(s)? Is there evidence that the institution is well positioned for the additional core(s)?

Approach: Are the arrangements and organizational structure adequately developed, well reasoned and appropriate to the aims of the program? Do the proposed cores benefit from unique features of the scientific environment, subject populations, or employ useful collaborative arrangements?

Investigator: Are the qualifications, experience, commitment and administrative competence of the Core Director appropriate? Is there an appropriate time and effort commitment made by the Core Director? Are there adequate plans for communication and cooperation among core participants?

CENTER AS AN INTEGRATED WHOLE will be evaluated with the following criteria:

Significance: Do the center’s research goals address an important problem? Is there potential for favorably impacting the fields of minority health and health disparities research?

Approach: Does the center demonstrate a multidisciplinary approach appropriate for its goals? Is the coordination among the administrative and other cores adequately explained? Is there synergistic potential among the center’s research components? Is there justification for each research and core component in terms of the overall goals of the center? Does the center have the potential to achieve a whole greater than the sum of its parts? For COMPETING RENEWAL APPLICATIONS: Has adequate progress been made in achieving the stated goals of the previously funded center and its concomitant research projects and activities?

Innovation: Will the center make a unique contribution or fill a significant gap in the areas of minority health and health disparities research?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Do the investigators bring complementary and integrated expertise to the project? Is the center Director capable of providing the scientific leadership and administrative oversight required to lead a center?

Environment: Is the academic and physical environment in which the research will be conducted, including availability of space, equipment, research subjects, and materials well defined? Is there evidence of institutional commitment to the pursuit of health disparities research for the long-term? Is the environment within and around the institution suitable for the advancement of health disparities research? Is there evidence of true collaboration with institutional partners, if applicable?

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:

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.

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: 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 will not be assessed by the reviewers. The presence of a data-sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

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.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

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

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

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 (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the 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 Also 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 (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).

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.

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, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

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

2. Peer Review Contacts:

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: N/A

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

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 (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.

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.

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 October 1, 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.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).

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. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for 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:
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.

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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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