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Native American Research Centers for Health; New Request for Application of Funds

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Key Dates: Letter of Intent Deadline: May 1, 2004; Application Deadline: June 18, 2004.

Overview

The Indian Health Service (IHS), with the National Institute of General Medical Sciences (NIGMS) of the National Institutes of Health, and the Agency for Healthcare Research and Quality (AHRQ) announces an initiative to support the Native American Research Centers for Health (NARCH) grant. This funding mechanism will develop opportunities for conducting research and research training to meet the needs of American Indian/Alaska Native (AI/AN) communities. Competing grant applications for Fiscal Year (FY) 2005 will be accepted with a receipt date of June 18, 2004. There will be only one funding cycle for FY 2005. Awards will be subject to the availability of funds and grants will be administered in accordance with applicable Office of Management and Budget (OMB) Circulars, Department of Health and Human Services grant regulations at 45 CFR parts 74 and 92, the Public Health Service Grants Policy Statement, and other applicable Departmental, IHS, AHRQ and NIH policies and procedures such as the regulations governing protection of human subjects at 45 CFR part 46.

This initiative is described in the Catalog of Federal Domestic Assistance Start Printed Page 8461Nos. 93.933 and 93-375. Sections 301(a) and 405 of the Public Health Service Act, as amended authorize these awards, and these are administered under PHS grants policies and Federal Regulations 42 CFR part 52c, 45 CFR part 74, and 45 CFR part 92. See also Senate Appropriations Committee Report, No. 92-316, July 29, 1971, Executive Order 12900, Educational Excellence for Hispanic Americans February 22, 1994, Executive Order 12876, Historically Black Colleges and Universities, November 1, 1993, and Executive Order 13021, October 21, 1996, and Outline of Work Plan, August 18, 1998, White House Initiative on Tribal Colleges and Universities. Applications are not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-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.

I. Funding Opportunity Description

The NARCH initiative will support partnerships between AI/AN Tribes or Tribally-based organizations such as the National Indian Health Board and Area Health Boards, and institutions that conduct intensive academic-level biomedical, behavioral and health services research. These partnerships are called Native American Research Centers for Health (NARCH). The purposes of the NARCH initiative are:

1. To develop a cadre of AI/AN scientists and health professionals engaged in biomedical, clinical, behavioral and health services research who will be competitive in securing NIH and AHRQ funding;

2. To increase the capacity of both research-intensive institutions and AI/AN organizations to work in partnership to reduce distrust by AI/AN communities and people toward research; and

3. To encourage competitive research linked to the health priorities of the AI/AN organizations and to reducing health disparities.

These purposes will be achieved by supporting student development projects, faculty/researchers development projects, and research projects (including pilot projects) developed by each NARCH partnership.

II. Award Information

The estimated funds (total costs) available for the first year of support for the entire initiative is expected to be over $ 2.2 million in Fiscal Year 2005. The actual amount may vary, depending on the response to the RFA and availability of funds.

An application may request a project period not to exceed four years of support, and direct costs not to exceed $800,000 in the first year. Direct costs to the applicant include the entire cost of each subcontract—that is, each subcontract's direct cost plus the subcontract's appropriate Facilities and Administration (F&A) cost. Because it is anticipated that all budget requests will exceed $250,000, the modular grant requirements would not apply to this RFA. A minimum of 30 percent of the grant funds must remain with the applicant organization.

Awards under this initiative will be administered using the competing institutional grant mechanism of the IHS, and will be reviewed using the NIH S06 mechanism. The responsibility for planning, directing, and executing the program, as well as data acquisition and analysis and evaluation of the proposed program, lies solely with the applicant organization. The maximum grant period may not exceed four years, with the opportunity for a competing renewal at the end of that period.

III. Eligibility Information

The proposed NARCH must be a working partnership of the AI/AN organization and of the research-intensive institution. Applicants eligible to receive a NARCH award are the AI/AN organizations of the partnerships. As the grantee, the AI/AN organizations will define criteria and eligibility for participation in all aspects of the partnership, consistent with this announcement. A minimum of 30 percent of the grant funds must remain with that AI/AN organization, that is, no more than 70 percent may be subcontracted to other institutions or organizations.

1. Eligible Applicants

The AI/AN applicant must be one of the following:

A. A federally recognized Indian Tribe; or

B. A Tribally sanctioned non-profit Tribal organization; or

C. A non-profit national or area Indian health board; or

D. A consortium of two or more of those Tribes, Tribal organizations, or health boards.

Applicants are strongly encouraged to establish eligibility of their proposed applications prior to submission. Inquiries about eligibility should be addressed to Phillip L. Smith, M.D., M.P.H., at (301) 443-0222.

2. Cost Sharing or Matching

The proposed NARCH must have:

A. A Community and Scientific Advisory Council with more than 50 percent of its membership being appointed by the AI/AN applicant.

B. The proposed NARCH may include additional affiliated organizations, e.g., Tribal colleges, additional colleges or universities, additional Tribes, or other Indian communities or organizations.

NARCH applicants are encouraged to have an affiliation with an applicable component of the IHS for technical and other in-kind support, such as linking data from IHS and others to understand better the health status of the involved Tribes or communities.

3. Other (Required)

A. The Research-Intensive Partner must: be an accredited public or private nonprofit university or other institution that has an established record of conducting research into the health problems of AI/AN; have demonstrated a commitment to enhancing the capability of AI/AN faculty/researchers, students, investigators, and communities to engage in biomedical, behavioral, clinical and health services research; and have demonstrated a commitment to mentoring AI/AN faculty/researchers, students, and investigators.

B. Principal Investigator: The Principal Investigator, the individual responsible for the administration (including fiscal management) of the overall project, must have his/her primary appointment with the AI/AN applicant organization. Special arrangements of employment, such as inter-organizational personnel agreements, are permissible. The Principal Investigator may be, but is not required to be, the NARCH Program Director or a Research Project Investigator.

C. NARCH Program Director: The NARCH Program Director is the individual responsible for the day-to-day leadership and management of the research and training programs within the proposed NARCH. The Program Director may be, but is not required to be, the Student and Faculty/Researcher Development Director or a Research Project Investigator. Start Printed Page 8462

D. Student and Faculty/Researcher Development Director and Participants: The NARCH initiative is an institutional developmental grant mechanism that places an emphasis on the continual development of students and faculty/researchers. In order to be included as the Student and Faculty Development Director, the prospective director must have a faculty/researcher appointment at the research-intensive institution or equivalent appointment at the AI/AN organization or other consortium partner, and must demonstrate that he/she has the knowledge, skills, and capabilities to mentor students and faculty/researchers and to generate and direct development and mentoring programs. The Student and Faculty Development Director may be the NARCH Program Director. Faculty/researchers and students should be supported in research education activities that improve their skills and abilities to be successful at the next stage of their professional development. To be included as a participant for faculty/researcher development in the proposed NARCH, the individual must have a faculty/researcher appointment at the research-intensive institution or equivalent appointment at the AI/AN organization or other consortium partner.

E. Research Project Investigators: The NARCH initiative is an institutional developmental grant mechanism that places an emphasis on continual improvement of the research competitiveness of the research investigators. In order to be included as a research project investigator in the proposed NARCH, a prospective investigator must have a faculty appointment at the research-intensive institution or equivalent appointment at the AI/AN organization or other consortium partner, and must show that he/she has the need, based on institutional, departmental, and professional development plans, to enhance his/her research knowledge, skills, and capabilities by engaging in the proposed research program and associated activities.

F. Tribal Approval of the Application: It is the policy of the IHS that all research involving AI/AN Tribes be approved by the Tribal governments with jurisdiction. Therefore, the following documentation is required as part of the application:

  • For a federally recognized Indian Tribe—a resolution of support from the Tribal government must be part of the application. Applications that involve more than one Indian Tribe must include resolutions of support from all participating Tribes.
  • For an eligible consortium of Tribes—a resolution of support from each Tribe of the consortium must be included.
  • For a Tribally sanctioned non-profit Tribal organization—specific Tribal resolution(s) of support will not be required if the current Tribal resolution(s) under which the organization operates encompasses the proposed application. (A copy of the current operational resolution(s) must be submitted with the application.) An official signed resolution must be received by the Grants Management Branch, IHS, no later than June 18, 2004 at the Reyes Building, 801 Thompson Avenue, Rockville, MD 20852-1627. A grant will not be awarded unless the signed resolution is received by this date.
  • For a non-profit national or area Indian health board, or a consortium of those eligible Indian health boards—a resolution is not required. However, the applicant organization must submit a letter of support signed by the executive director of each health board involved, specifically citing the research project proposed. Each AI/AN organization that derives benefit from the grant must also submit such a letter.

G. Mechanism of Support: Awards under this initiative will be administered using the competing institutional grant mechanism of the IHS, and will be reviewed using the NIH S06 mechanism. The responsibility for planning, directing, and executing the program, as well as data acquisition and analysis and evaluation of the proposed program, lies solely with the applicant organization. The maximum grant period may not exceed four years, with the opportunity for a competing renewal at the end of that period.

IV. Application and Submission Information

1. Address To Request Application Package

NARCH Program Director,

801 Reyes Building, TMP Suite 450,

Rockville, MD 20852.

2. Content and Form of Application Submission

A. The purposes of the NARCH initiative must include:

  • To develop a cadre of AI/AN scientists and health professionals engaged in biomedical, clinical, behavioral and health services research that is competitive to NIH funding;
  • To increase the capacity of both research-intensive institutions and AI/AN organizations to work in partnership to reduce distrust by AI/AN communities and people toward research; and
  • To encourage competitive research linked to the health priorities of the AI/AN partner and to reducing health disparities.

B. A proposed NARCH, therefore, may include any or all of the following components: student development projects; faculty/researcher development projects; research projects (including pilot projects); and “core” administrative facility.

C. The content of the application should explain the components of the application, and how they help meet the purposes of the NARCH initiative.

  • A description should be provided of the current state of the research and research training enterprise at the proposed NARCH and its institutional and community partners, including faculty/researcher and student profiles.
  • A clear statement should be presented of the overall goals, specific measurable objectives, and anticipated milestones. These elements should be presented in the context of needed improvements in the partners' organizational infrastructure and environment for research.
  • Documentation should be provided to establish that the research-intensive partner is an institution with a record of conducting research into the health of AI/ANs, and that it has a demonstrated commitment to the special encouragement of, and assistance to, AI/AN faculty/researchers, students, investigators, and communities for enhancing their capacity to engage in biomedical, behavioral and health services research.
  • Documentation about the nature of the partnership itself should be included, such as: the process to develop the application and proposed NARCH itself, the past and future efforts to increase the capacity of the partners to improve their partnership, and to contribute to the success of the NARCH.
  • A plan for assessment of the benefits of the activities by the proposed NARCH on specific, measurable outcomes identified in the application should be provided. IHS and NIGMS recognize that Tribes, Tribally-based organizations, and research-intensive institutions are diverse in their missions, their health and economic Start Printed Page 8463statuses, and their cultures. Such an assessment could include a self-study by the proposed NARCH and its partners, which focuses on fact-finding, program evaluation, and recommendations for improvement in key areas.
  • Strategies for determining the initial and ongoing success of their efforts for organizational development should also be presented. It is expected that each proposed NARCH will develop its own set of strategies that best match its circumstances.

Guidance and suggestions for program evaluation of a proposed NARCH can be obtained from http://www.the-aps.org/​education/​promote/​promote.html.

Applicants are strongly urged to contact NARCH initiative staff at an early stage to request the specific supplementary instructions for the PHS 398 for the NARCH grants. Application kits and supplementary instructions may be obtained from the initiative contacts listed under VII. Agency Contacts.

  • The PHS 398 (updated 9/09/03) research grant application instructions and forms at http://grants.nih.gov/​grants/​funding/​phs398/​phs398.html are to be used in applying for these grants. This version of the PHS 398 is available in an interactive, searchable, PDF format. The NIH will return applications that are not submitted in the 09/09/03 updated format. For further assistance contact Grants Info, telephone (301) 435-0714, e-mail: GrantsInfo@nih.gov.
  • “DUNS” number

Applications must be prepared using the PHS 398 research grant application instructions and forms (updated 09/09/03). As of October 1, 2003, applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the Web site at http://www.dunandbradstreet.com/​. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at http://grants.nih.gov/​grants/​funding/​phs398/​phs398.html in an interactive format. For further assistance contact Grants Info, Telephone (301) 435-0714, e-mail: GrantsInfo@nih.gov.

Internet applications for a DUNS number can take up to 30 days and this could cause organizations to lose opportunities to apply, or delay them until the next round. It is significantly faster to obtain one by phone.

You will need the following information to request a DUNS number:

  • Organization name
  • Organization address
  • Organization telephone number
  • Name of CEO, Executive Director, President, etc. (The person in charge)
  • Legal structure of the organization
  • Year organization started
  • Primary business (activity) line
  • Total number of employees.

D. The RFA label available at http://grants1.nih.gov/​grants/​funding/​phs398/​label-bk.pdf in the PDF format, must be affixed to the bottom-face page of the application. Type this RFA number: “NOT GM-04-107” on the label. Failure to use this label could delay processing the application and it may not reach the review committee in time for review. In addition, the “Native American Research Centers for Health” and the RFA number must be typed on line 2 of the face page of the application form and the YES box must be marked.

E. Student Development Projects: If student development projects are proposed, the NARCH application should describe new programs, modifications, or additions, to existing programs of the partners that encourage and facilitate AI/AN students to enter, advance, and remain in research careers. Such projects might include, but are not limited to, providing employment as research assistants in research projects of research-active mentors with an explicit mentoring plan, providing other mentoring with an explicit mentoring plan, providing workshops to improve technical or communication skills, providing motivating seminars or journal clubs highlighting problems of interest to students, providing contact with role models, and providing opportunities to travel to present results at national scientific meetings.

If research mentorships or apprenticeships are proposed, the application should clearly document the experience, proposed commitment, and quality of the mentors in providing guidance and advice to students (including responsible conduct of research and research integrity, teaching, and protection of human subjects), and in fostering the development of academic and/or community-based AI/AN researchers.

The application should describe how the development plans for the student will meet both the individual's professional development goals, and one purpose of the NARCH initiative: to develop a cadre of AI/AN scientists and health professionals.

The application must have an evaluation plan for the project(s) that indicates the anticipated outcomes relative to the current baseline data. For example, one outcome might be the improved retention of students in science majors. The application should indicate the anticipated (quantitative) improvement relative to the current retention rate.

A student in a NARCH Student Development Project must be a full-time or part-time student officially enrolled in an educational program leading to an undergraduate or graduate degree, or in a post-doctoral educational program, or (if well justified) in late high school. A helpful book about mentoring science students is found at http://books.nap.edu/​catalog/​5789.html.

F. Faculty/Researcher Development Projects: If faculty/researcher development projects are proposed, the NARCH application should describe the need, proposed activity, and anticipated outcomes. Faculty/researcher development projects might include, but are not limited to, short-term mentored research experiences in the lab of an active NIH-extramurally-funded researcher with an explicit mentoring plan, long-term general mentoring under an explicit mentoring plan, or attendance at workshops or courses or national meetings needed for acquiring specific skills or methodologies needed for prospective research.

As with student development projects, the application should document the experience, proposed commitment, and quality of the mentors, teachers, or experience in providing guidance and advice to faculty/researcher, and in fostering the development of academic and community-based AI/AN research.

The application must also describe the evaluation plan for the faculty/researcher development project.

The application must clearly describe how the development plans for faculty/researcher will meet both the individual's professional development goals, and two purposes of the NARCH initiative: to develop a cadre of AI/AN scientists and health professionals, and to enhance the partnership of the proposed NARCH.

G. Research Projects: NARCH applications may include a maximum of five (5) regular research projects and a maximum of five (5) pilot research projects. Unlike regular research projects, a pilot research project is limited in scope and is not expected to have preliminary data. It is also limited to a budget of no more than $50,000 direct costs per year for four years. The pilot research project is intended for Start Printed Page 8464faculty/researchers without current research support. Support for faculty/researchers participating in pilot research projects is preparatory to seeking more substantial funding from NIH research grant programs (e.g., Academic Research Enhancement Award [AREA], K, and R01 awards), as well as funding from other agencies and private sources. Funds received from the proposed NARCH to support pilot research projects may not be used to supplement ongoing research projects. A NARCH application need not include both research projects and pilot research projects. Applications for only pilot research projects or for only research projects may be submitted. Individual project investigators may propose either a research project or a pilot research project, but not both.

Research projects (including pilot research projects) proposed under this initiative must be in research areas normally funded by any of the National Institutes of Health or the Agency for Healthcare Research and Quality (AHRQ). Research projects addressing health disparities and the health priorities of the AI/AN partner are especially encouraged.

A listing of grants recently funded by NIH may be found at CRISP (Computer Retrieval of Information on Scientific Projects), a searchable database of federally funded biomedical research projects conducted at universities, hospitals, and other research institutions. It may be accessed at (http:/crisp.cit.nih.gov/). Grants funded by AHRQ can also be found on CRISP as well as on GOLD (Grants On-Line Database) which can be found at (http://www.gold.ahrq.gov/​).

Each research project or pilot research project should follow the instructions provided in PHS 398 (updated 09/09/03) for preparing research grant applications. The professional development goals must clearly describe specific objectives and milestones which should include, but are not limited to, improving competitiveness in acquiring grant support. The applicant should describe how successful completion of the proposed research project will improve the research skills, and will help develop the students and faculty/researcher, thus contributing to the overall goals and specific measurable objectives of the proposed NARCH.

Each research project or pilot research project must follow the IHS policy concerning Tribal approval, that all research involving AI/AN Tribes be approved by the Tribal governments with jurisdiction. That is, each grantee must include a resolution of approval from the Tribal government[s], or (if applicable) a letter of support signed by the director of the eligible AI/AN organization, or both (if applicable) for projects that involve people or community[ies] of an AI/AN Tribe, or an eligible non-profit organization.

3. Submission Dates and Times

A. Letter of Intent Deadline: May 1, 2004.

Prospective applicants are asked to submit a letter of intent that includes the title of the proposed NARCH, the name, address, and telephone number of the Principal Investigator and its Program Director, the identities of the partners and of key personnel, and the number and title of this RFA. The letter of intent must be received by Dr. Michael R. Martin at the Center for Scientific Review, MSC 7892, Room 6160, 6701 Rockledge Drive, Bethesda, MD 20892-7892, telephone: (301) 594-7945, Fax: (301) 480-2065, e-mail: mm72k@nih.gov, before 6 p.m. EST on May 1, 2004. Letters may be submitted by mail, fax or e-mail.

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 the IHS and NIH Center for Scientific Review (CSR) staffs to estimate the potential review workload and avoid conflict of interest in the review.

B. Application and Resolution Deadline: June 18, 2004.

The applications must be received before 6 p.m. EST on June 18, 2004. If an application is received after that date, it will be returned to the applicant without review. To be considered timely, an application must be sent on or before the deadline date. If sent timely (with documented proof of mailing) but received after the deadline, an application will be accepted for review only if it is received in time for orderly processing. Competing applications not meeting the deadline date specified in the announcement are considered late applications and will not be considered for funding under that announcement.

The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique.

4. Intergovernmental Review

This funding opportunity is not subject to Executive Order 12372, “Intergovernmental Review of Federal Programs.” A State approval is not required.

5. Funding Restrictions

Grantees are allowed a reasonable period of time in which to submit required financial and performance reports.

Failure to submit required reports within the time allowed may result in suspension or termination of an active grant, withholding of additional awards for the project, or other enforcement actions such as withholding of payments or converting to the reimbursement method of payment. Continued failure to submit required reports may result in the imposition of special award provisions, or cause other eligible projects or activities involving that grantee organization, or the individual responsible for the delinquency to not be funded.

Failure to obtain prior approval for change in Scope, Principal Investigator, Grantee Institutions, Successor in Interest, or Recipient Institute Name, undertaking any activities disapproved or restricted as a condition of the award, may result in fund restrictions.

Allowable Administrative Cost

Certain administrative costs for managing a comprehensive program are allowable and may vary, depending upon the size and complexity of the program's activities. The costs budgeted for NARCH grants and subcontracts may not duplicate items already budgeted in other cost centers of the AI/AN, research-intensive, and subcontracted organizations and institutions, such as accounts which make up the Facilities and Administration (F&A) cost pool. The grantee organization receiving the award must be prepared to provide documentation showing the direct relationship of proposed costs to the program, and that costs of this type are charged in a uniform manner to all other grants at all institutions and organizations participating in the award.

  • Salary (up to 25 percent effort, although it should generally be less) for the NARCH Program Director is allowable for that portion of time or effort specifically employed in directing the proposed NARCH. (The 25 percent limit does not include salary for being a research investigator.) Limited salary support for secretarial or clerical help is Start Printed Page 8465allowable only when in direct support of the proposed NARCH. For guidance, applicants should refer to the OMB Circular appropriate for them, A-87 (Cost Principles for State, local, and Indian Tribal Governments), at http://www.whitehouse.gov/​omb/​circulars or A-122 (Cost Principles for Non-Profit Organizations), http://www.whitehouse.gov/​omb/​circulars, or should contact the grants management officer under INQUIRIES.
  • Costs for evaluation activities are allowable, as are costs for the Community and Scientific Advisory Council. All applications must include costs associated with one annual meeting per year in Rockville, MD, of NARCH directors and their key scientific personnel.
  • Student Development Costs. Student (graduate, undergraduate, and high school, if well justified) remuneration through salary/wages for participation in research experiences may be requested, provided all the following conditions are met:
  • The student is performing necessary work involved in the research.
  • There is an employer-employee relationship between the student and the proposed NARCH or its partners. The total compensation is reasonable for the work performed.
  • It is the practice of the proposed NARCH or its partners to provide compensation for all students in similar circumstances, regardless of the source of support for the activity.

Graduate students, but not undergraduate students, are allowed tuition costs as part of a compensation package. When requesting support for a graduate student, the NARCH application should provide, in the budget justification section of the application, the basis for the compensation level. The IHS staff will review the requested compensation level and, if it is reasonable and justified, will provide compensation up to a maximum of $45,000 (http://grants.nih.gov/​grants/​guide/​notice-files/​not98-168.html). Post-doctoral students should be compensated at a rate commensurate with that of other post-doctoral employees with similar degrees and experience at the research-intensive institution.

It is the expectation of the IHS, NIGMS and AHRQ that students who are enrolled in an accredited graduate program, as part of a proposed NARCH, will not be excluded from support from other non-federal or federal graduate training sources (such as loans and assistance under the Veterans' Adjustment Benefit Act or Pell Grants) for which they are eligible. Graduate and post-doctoral students cannot concurrently hold another federally-sponsored stipend or fellowship or any other federal award that duplicates the NARCH support.

  • Faculty/Researcher Development Costs. Costs to support faculty/researcher development activities, such as workshops or courses, national meetings, or short-term research experiences in the laboratory of an active NIH-extramurally-funded researcher needed for acquiring specific skills or methodologies needed for prospective research, are allowable. Such costs might include tuition, travel and per diem costs, as well as salary support appropriate to the percent effort needed for the activity. Also, allowable are costs such as travel and per diem associated with short-term research experiences in the laboratory of an active extramurally funded researcher.
  • Research Project Costs. Direct costs associated with research and pilot research projects are allowable when adequate justification is provided. These include faculty/researcher salaries, reimbursed according to percent effort. Summer salary support can be paid provided the institution's academic schedule permits such release and when the institution approves. The maximum summer-salary support provided by the program cannot exceed the equivalent of three months at 100 percent effort, or time specified by the institution as its policy. Grant funds may not be used to increase or supplement faculty/researcher academic year salaries. Salary support for technical assistance and costs for consultants, if justified, are allowable. Costs for equipment to be used to carry out the proposed research are allowable.
  • Costs for Core Scientific Services. Costs for core scientific services to support two or more projects are allowable. Costs for multi-user research equipment are also allowable. A plan for access to the multi-user equipment, its maintenance, management and use must be included. To aid in the review, it is suggested that a tabular summary show the estimated or actual proportional use of this equipment by each project, and other investigators and students. Justify this core component by discussing ways in which these centralized services improve quality, bring about an economy of effort, and/or save overall costs as compared to their inclusion as part of each research project. Personnel costs to maintain and service the equipment are an allowable cost. Support for very large pieces of equipment, however, may be restricted by the NARCH budget. Plans to maintain the shared core scientific services and facility beyond the grant period should be discussed.
  • Cost for Supplies. Costs for supplies, including costs for animals, necessary to carry out the proposed research may be included. Travel costs for the investigator(s) are permitted when direct benefits to the program are expected, and when adequate justification is provided. Alterations and Renovations costs (up to $40,000) are allowable only when essential for conduct of the proposed research. Other permitted costs include animal maintenance (unit care costs and number of care days), donor fees, publication costs, computer charges, rentals and leases, equipment maintenance, and service contracts.
  • Consortium and Contract Arrangements. Consortium arrangements that may involve personnel costs, supplies, and other allowable costs, including F & A costs; contractual costs for support services, such as the laboratory testing of biological materials, clinical services, data processing, or core administrative services, are allowable expenses. Consortia and contractual costs with Native health organizations, tribes and/or research institutions in Canada are allowable expenses.
  • Pilot Research Projects. The intent of pilot research projects is to lead to regular research projects funded as part of the center grant or as freestanding grants. For pilot research projects, applications may request support for up to $50,000 (direct costs) per year. This support is non-renewable.
  • Subcontracts. The grant recipient may issue subcontracts to other organizations (such as the research-intensive institution of the partnership), as long as at least 30 percent of the grant remains with the AI/AN organization; that is, no more than 70 percent may be subcontracted.

F. Unallowable Costs: Unallowable costs for research projects (including for pilots projects) include costs for student development, textbooks, journals, memberships, and Internet subscription costs, as well as other costs prohibited by OMB Circulars A-87 or A-122 as applicable. Employees of the applicant organization may not serve as paid consultants but may be paid. Start Printed Page 8466

The pilot research project is intended for faculty/researcher without current research support. Therefore, investigators with significant current support from other mechanisms such as the R01 and research funding from other extramural sources are not eligible, and the costs therefore are not allowable. Release time for preparing proposals or mini-research projects, not submitted, as pilot projects, is not allowed.

6. Other Submission Requirement

The administrative personnel, facilities, and programs of the overall NARCH should be described. It is permissible, but not necessary to have a set of core support programs that provide common scientific services to two or more NARCH projects.

Submit a typed and signed original application, including the Checklist, and one (1) single-sided photocopy of the entire application (including Appendices and supporting documents) in one package to: Grants Management Branch, Indian Health Service, Reyes Building, 801 Thompson Avenue, Rockville, MD 20852-1627 (zip code is unchanged for express/courier services), Telephone: (301) 443-5204.

Also, at the time of submission, send four (4) additional single-sided photocopied and signed applications, including the Checklist, Appendices, and supporting documentation to: Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6160—MSC 7892, Bethesda, MD 20892-7720, Bethesda, MD 20817 (for express or courier service). Telephone: (301) 594-7945.

V. Application Review Information

Upon receipt, IHS and NIH staff will administratively review applications for completeness and responsiveness. Applications that are incomplete, non-responsive to this RFA, or do not follow the guidelines of the PHS form 398 (updated 09/09/03) or of the supplementary instructions for NARCH grants, will be returned to the applicant without further consideration.

Applications will be evaluated in accordance with the criteria stated below for scientific and technical merit by appropriate peer review groups convened by the CSR. The National Advisory General Medical Sciences Council will conduct the second level of review.

1. Criteria

Priorities for funding will be based on the scientific and technical merit of the application, the assessed potential of investigators in the developmental stages of their careers, and the likelihood that the proposed NARCH can further the purposes of the NARCH initiative. Awards will be made only to organizations with financial management systems and management capabilities that are acceptable under PHS policy. Awards will be administered under the PHS Grants Policy Statement.

2. Review and Selection Process

A. Review of Student and Faculty/Researcher Development Plans: The anticipated effectiveness of the proposed NARCH in making a difference relative to the current base-line data (based in part on previous experience of the partners) will be assessed. Factors to be considered include:

  • The appropriateness of the content, phasing, quality, and duration of the student or faculty/researcher development plans in the NARCH application to achieve the scientific development of the faculty/researcher, post-doctoral, pre-doctoral, undergraduate, and (if well justified) high school students; and
  • The experience, proposed commitment, and quality of the mentoring plan and of individual mentors of the partners in providing mentoring, guidance, and advice to candidates (including training in responsible conduct of research and research integrity, teaching, and protection of human subjects), and in fostering the development of academic and community-based AI/AN researchers.

B. Review of Research Projects: The NIH has announced procedures to be used for the review of research grant applications (NIH Guide, Volume 26, Number 22, June 27, 1997 or see http://grants.nih.gov/​grants/​guide/​notice-files/​not97-010.html). For NARCH applications, the five criteria listed in this announcement will be used for the scientific review of research projects and pilot research projects. The review of research projects and pilot research projects will be the same except that applications for pilot studies may be smaller in scope and would not be expected to have preliminary data.

The purposes of the NARCH initiative are:

  • To develop a cadre of AI/AN scientists and health professionals engaged in biomedical, behavioral and health services research;
  • To increase the formation of partnerships between AI/AN and research-intensive institutions; and
  • To encourage competitive research that address the health priorities and health disparities in the AI/AN population.

In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these purposes. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.

  • Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field?
  • Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the application acknowledge potential problem areas and consider alternative tactics? For pilot research projects, are the proposed aims reasonable, and is there potential to lead to more substantial funding?
  • Innovation: Does the project employ novel concepts, approaches, or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies?
  • Investigator: Is the investigator 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 (if any)?
  • Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support?

In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following:

  • The adequacy of plans, if research on human subjects is involved, to include both genders and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated.
  • The reasonableness of the proposed budget and duration in relation to the proposed research.
  • The adequacy of the proposed protection for humans, animals or the Start Printed Page 8467environment, to the extent they may be adversely affected by the project proposed in the application.
  • The adequacy of the proposed plan to share data, if appropriate.

In reviewing the overall Center, the initial scientific review group will examine evidence of the partners' commitment to the purposes of the NARCH initiative to develop a cadre of AI/AN scientists and health professionals engaged in biomedical, clinical, behavioral and health services research that is competitive for NIH funding; to increase the capacity of both research-intensive institutions and AI/AN organizations to work in partnership to reduce distrust by AI/AN communities and people toward research; and to encourage competitive research linked to the health priorities of the AI/AN partner and to reducing health disparities. The evidence will include:

  • The quality of the partnership of the institutional and community partners, and the quality of the involvement of the Community and Scientific Advisory Council, as demonstrated by documentation of (for instance): the intellectual and tangible contributions and activities of the partners, and of the Council, in developing the application and the proposed NARCH; the interactions of the partners, and of the members of the Council, in meetings (such as those to develop the application and proposed NARCH); the past activities and future plans to increase the capacity of the partners and of the Council; the plans for future contributions and activities by the partners, and by the Council, in furthering the goals of the proposed NARCH; and the plans for future development of the partnership itself;
  • The experience and commitment of the institutional and community partners to recruit, retain, and advance AI/AN faculty/researcher and students, to support faculty/researcher and student research efforts, and to increase the role of the involved AI/AN communities in the plans of the proposed NARCH;
  • The appropriateness of the plan for evaluating the impact of the proposed NARCH, including the quality of baseline data and milestones for accomplishments, and a system to track the future course of program participants; and
  • The potential of the proposed NARCH to be a regional and national resource, including: Capacity to provide quality research training and mentoring for integrated promotion and development of AI/AN research careers from undergraduate (or if well justified, high school) through post-doctoral levels; attainment of quality research linked to health priorities of the AI/AN partner and to reducing health disparities; plans for research information dissemination and education activities; and plans for the development of research networks to support the scientific aims of the proposed NARCH.

3. Anticipated Announcement and Award Dates

Anticipated Announcement Date: March 15, 2004.

Anticipated Award Date: May 1, 2005.

VI. Award Administration Information

1. Award Notices

Grants Management will not award a grant without an approved application in conformance with regulatory and policy requirements and which describes the purpose and scope of the project to be funded. When the application is approved for funding, the Grants Management Office will prepare a Notice of Grant Award with special terms and conditions binding upon the award and refer to all general terms applicable to the award.

2. Administrative and National Policy Requirements

A. Inclusion of Women and Minorities in Research Involving Human Subjects: It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical, clinical, behavioral and health services research projects involving human subjects, unless a clear and compelling rationale and justification is provided 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 P.L. 103-43). Because the NARCH initiative targets AI/AN people and communities, a minority population, only the policy of inclusion of women applies to this RFA. The IHS has fully accepted the OHRP policy regarding human subjects. The OHRP Web site is http://ohrp.osophs.dhhs.gov/​g-topics.htm.

All investigators proposing research involving human subjects should read the UPDATED “NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research,” published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/​grants/​guide/​notice-files/​NOT-OD-00-048.html). The complete Guidelines are available at http://grants1.nih.gov/​grants/​funding/​women_​min/​guidelines_​amended_​10_​2001.htm. The revisions relate to NIH defined Phase III clinical trials and require:

  • All applications or proposals and/or protocols to 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
  • All investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

B. Inclusion of Children as Participants in Research Involving Human Subjects: It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects' research, conducted or supported by the NIH, unless there are scientific or ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted.

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” that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/​grants/​guide/​notice-files/​not98-024.html. Investigators may obtain copies of these policies from the initiative staff listed under INQUIRIES. Initiative staff may also provide additional relevant information concerning the policy.

C. 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site.

D. Public Access to Research Data Through the Freedom of Information Act: The 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:

  • First produced in a project that is supported in whole or in part with Federal funds; and
  • Cited publicly and officially by a Federal agency in support of an action that has the force and effect of law Start Printed Page 8468(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.

E. Allowable Administrative Cost: Certain administrative costs for managing a comprehensive program are allowable and may vary, depending upon the size and complexity of the program's activities. The costs budgeted for NARCH grants and subcontracts may not duplicate items already budgeted in other cost centers of the AI/AN, research-intensive, and subcontracted organizations and institutions, such as accounts which make up the Facilities and Administration (F&A) cost pool. The grantee organization receiving the award must be prepared to provide documentation showing the direct relationship of proposed costs to the program, and that costs of this type are charged in a uniform manner to all other grants at all institutions and organizations participating in the award.

  • Salary (up to 25 percent effort, although it should generally be less) for the NARCH Program Director is allowable for that portion of time or effort specifically employed in directing the proposed NARCH. (The 25 percent limit does not include salary for being a research investigator.) Limited salary support for secretarial or clerical help is allowable only when in direct support of the proposed NARCH. For guidance, applicants should refer to the OMB Circular appropriate for them, A-87 (Cost Principles for State, local, and Indian Tribal Governments), at http://www.whitehouse.gov/​omb/​circulars or A-122 (Cost Principles for Non-Profit Organizations), http://www.whitehouse.gov/​omb/​circulars, or should contact the grants management officer under INQUIRIES.
  • Costs for evaluation activities are allowable, as are costs for the Community and Scientific Advisory Council. All applications must include costs associated with one annual meeting per year in Rockville, MD, of NARCH directors and their key scientific personnel.
  • Student Development Costs. Student (graduate, undergraduate, and high school if well justified) remuneration through salary/wages for participation in research experiences may be requested, provided all the following conditions are met:
  • The student is performing necessary work involved in the research.
  • There is an employer-employee relationship between the student and the proposed NARCH or its partners. The total compensation is reasonable for the work performed.
  • It is the practice of the proposed NARCH or its partners to provide compensation for all students in similar circumstances, regardless of the source of support for the activity.

Graduate students, but not undergraduate students, are allowed tuition costs as part of a compensation package. When requesting support for a graduate student, the NARCH application should provide, in the budget justification section of the application, the basis for the compensation level. The IHS staff will review the requested compensation level and, if it is reasonable and justified, will provide compensation up to a maximum of $45,000 (http://grants.nih.gov/​grants/​guide/​notice-files/​not98-168.html). Post-doctoral students should be compensated at a rate commensurate with that of other post-doctoral employees with similar degrees and experience at the research-intensive institution.

It is the expectation of the IHS, NIGMS and AHRQ that students who are enrolled in a accredited graduate program, as part of a proposed NARCH, will not be excluded from support from other non-Federal or Federal graduate training sources (such as loans and assistance under the Veterans' Adjustment Benefit Act or Pell Grants) for which they are eligible. Graduate and post-doctoral students cannot concurrently hold another federally-sponsored stipend or fellowship or any other Federal award that duplicates the NARCH support.

  • Faculty/Researcher Development Costs. Costs to support faculty/researcher development activities, such as workshops or courses, national meetings, or short-term research experiences in the laboratory of an active NIH-extramurally-funded researcher needed for acquiring specific skills or methodologies needed for prospective research, are allowable. Such costs might include tuition, travel and per diem costs, as well as salary support appropriate to the percent effort needed for the activity. Also, allowable are costs such as travel and per diem associated with short-term research experiences in the laboratory of an active extramurally funded researcher.
  • Research Project Costs. Direct costs associated with research and pilot research projects are allowable when adequate justification is provided. These include faculty/researcher salaries, reimbursed according to percent effort. Summer salary support can be paid provided the institution's academic schedule permits such release and when the institution approves. The maximum summer-salary support provided by the program cannot exceed the equivalent of three months at 100 percent effort, or time specified by the institution as its policy. Grant funds may not be used to increase or supplement faculty/researcher academic year salaries. Salary support for technical assistance and costs for consultants, if justified, are allowable. Costs for equipment to be used to carry out the proposed research are allowable.
  • Costs for Core Scientific Services. Costs for core scientific services to support two or more projects are allowable. Costs for multi-user research equipment are also allowable. A plan for access to the multi-user equipment, its maintenance, management and use must be included. To aid in the review, it is suggested that a tabular summary show the estimated or actual proportional use of this equipment by each project, and other investigators and students. Justify this core component by discussing ways in which these centralized services improve quality, bring about an economy of effort, and/or save overall costs as compared to their inclusion as part of each research project. Personnel costs to maintain and service the equipment are an allowable cost. Support for very large pieces of equipment, however, may be restricted by the NARCH budget. Plans to maintain the shared core scientific services and facility beyond the grant period should be discussed.
  • Cost for Supplies. Costs for supplies, including costs for animals, necessary to carry out the proposed research may be included. Travel costs for the investigator(s) are permitted when direct benefits to the program are Start Printed Page 8469expected, and when adequate justification is provided. Alterations and Renovations costs (up to $40,000) are allowable only when essential for conduct of the proposed research. Other permitted costs include animal maintenance (unit care costs and number of care days), donor fees, publication costs, computer charges, rentals and leases, equipment maintenance, and service contracts.
  • Consortium and Contract Arrangements. Consortium arrangements that may involve personnel costs, supplies, and other allowable costs, including F&A costs; contractual costs for support services, such as the laboratory testing of biological materials, clinical services, data processing, or core administrative services, are allowable expenses. Consortia and contractual costs with Native health organizations, tribes and/or research institutions in Canada are allowable expenses.
  • Pilot Research Projects. The intent of pilot research projects is to lead to regular research projects funded as part of the center grant or as freestanding grants. For pilot research projects, applications may request support for up to $50,000 (direct costs) per year. This support is non-renewable.
  • Subcontracts. The grant recipient may issue subcontracts to other organizations (such as the research-intensive institution of the partnership), as long as at least 30 percent of the grant remains with the AI/AN organization; that is, no more than 70 percent may be subcontracted.

F. Unallowable Costs: Unallowable costs for research projects (including for pilots projects) include costs for student development, textbooks, journals, memberships, and Internet subscription costs, as well as other costs prohibited by OMB Circulars A-87 or A-122 as applicable. Employees of the applicant organization may not serve as paid consultants but may be paid.

The pilot research project is intended for faculty/researcher without current research support. Therefore, investigators with significant current support from other mechanisms such as the R01 and research funding from other extramural sources are not eligible, and the costs therefore are not allowable. Release time for preparing proposals or mini-research projects, not submitted, as pilot projects, is not allowed.

G. Qualifications of the NARCH Program Director and Key Personnel: As leader of the research and research training for the proposed NARCH, the NARCH Program Director is expected to possess certain essential qualifications such as:

  • Strong leadership skills, including scientific leadership experience and a strong academic and scientific background, as exemplified, ideally, by scientific publications and a record of peer-reviewed scientific support;
  • The knowledge of and personal working relationship with the AI/AN Tribes or communities involved in the NARCH research, and with the partners of the proposed NARCH;
  • Strong mentoring and supervision skills, to exercise responsibility for mentoring activities, organization of communicating skills programs, special methods workshops, tracking of student career plans, etc.; and
  • Knowledge of IHS and NIH policies, including those concerning human participants in research, human biological material, animals, hazardous materials, and Tribal review and approval of research.

The names and qualifications of the NARCH Program Director, the Student and Faculty/Researcher Development Director and directors of individual projects within the program (where appropriate), and any other key personnel, should be listed in the application under the Key Personnel section. Biographical Sketches of these individuals, including other grant support, should be included.

3. Reporting

The NARCH Program Office and the Grants Management have requirements for the progress reports and financial reports based on the terms and conditions of the grant. Grantees are responsible and accountable for accurate reporting of the Progress Reports and Financial Status Reports which are generally due annually. Financial Status Report (SF 269) are due 90 days after each budget period and the final SF 269 must be verified from the grantee records on how the value was derived.

Grantees are allowed a reasonable period to time in which to submit required financial and performance reports.

Failure to submit required reports within the time allowed may result in suspension or termination of an active grant, withholding of additional awards for the project, or other enforcement actions such as withholding of payments or converting to the reimbursement method of payment. Continued failure to submit required reports may result in the imposition of special award provisions, or cause other eligible projects or activities involving that grantee organization, or the individual responsible for the delinquency to not be funded.

Failure to obtain prior approval for change in Scope, Principal Investigator, Grantee Institutions, Successor in Interest, or Recipient Institute Name, undertaking any activities disapproved or restricted as a condition of the award, may result in fund restrictions.

VII. Agency Contact(s)

1. Questions on the initiative, regarding IHS NARCH issues and policies, may be directed to: Alan Trachtenberg, M.D., M.P.H., Research Program Director, Indian Health Service, 801 Thompson Avenue, TMP, Suite 450, Rockville, MD 20852-1750, Telephone: (301) 443-0222, Fax: (301) 443-1522, e-mail: atrachte@hqe.ihs.gov.

2. Questions on grants management and fiscal matters may be directed to: Sylvia Ryan, Grants Management Branch, Indian Health Service, Reyes Building, 801 Thompson Avenue, Rockville, MD 20852-1627, Telephone: (301) 443-5204, Fax: (301) 443-9602, e-mail: sryan@hqe.ihs.gov.

3. Questions on NIGMS issues and policies, may be directed to: Clifton A. Poodry, Ph.D., Minority Opportunities in Research Division, National Institute of General Medical Sciences, 45 Center Drive, Suite 2AS.37, MSC 6200, Bethesda, MD 20892-6200, Telephone: (301) 594-3900, Fax: (301) 480-2753, e-mail: poodryc@nigms.nih.gov.

4. Questions on the review of Applications may be directed to: Michael R. Martin, Ph.D., Director, Division of Physiological Systems, Center for Scientific Review, MSC 7892, Room 6160, 6701 Rockledge Drive, Bethesda, MD 20892-7892, Telephone: (301) 594-7945, Fax: (301) 480-2065, e-mail: mm72k@nih.gov.

5. Questions on Health Services Research and AHRQ policies may be directed to: Wendy Perry, Office of the Director, Agency for Healthcare Research and Quality, Room 3012, 540 Gaither Road, Rockville, MD 20850, Telephone: (301) 427-1216, Fax: (301) 427-1210, e-mail: wperry@ahrq.gov.

VIII. Other Information

1. 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 Request for Application (RFA) announcement is related to one or more of the priority areas. Potential applicants may obtain a Start Printed Page 8470copy of “Healthy People 2010” at http://www.health.gov/​healthypeople/​.

2. Technical Assistance Workshop

The IHS and NIH intend to conduct technical assistance and information sharing workshops about this grant initiative in March, and May, 2004 in at least two regional centers. Potential grantees wanting to attend one of these workshops will have to provide names and the eligible organization to Ms. Sylvia Ryan, at telephone number (301) 443-5204 or Fax (301) 443-9602, or by e-mail to sryan@hqe.ihs.gov as soon as possible and no later than March 15, 2004. This notification will help the IHS and the NIH to determine the best times and locations for potential grantees' training and to have adequate workshop supplies. The details of the workshops and locations will be posted (as they are finalized) on the IHS Research Program Web site at http://www.ihs.gov/​medicalprograms/​research.

3. Context

The AI/AN Tribal nations and communities have long experienced poorer health status than other Americans. Although major gains of reducing health disparities were made in the last half of the twentieth century, most gains stopped by the mid 1980s (Trends in Indian Health 1998-99) and a few diseases, e.g., diabetes, worsened. “All Indian” rates contain marked variation among the “IHS Areas” or regions (Regional Differences in Indian Health 1998-99); variation by Tribe exists within Areas as well. The Trends and Regional Differences reference can be found at the IHS website at http://www.ihs.gov/​publicInfo/​publications/​index.asp. Although the “All Indian” mortality rates for all cancers are about 20 percent lower than the U.S. rates for all races, there is variation among IHS Areas for specific cancers; moreover, the favorable AI/AN mortality rates for some cancers may be due to markedly lower incidence rates partly offset by higher case-fatality rates. Unfamiliarity with modern health care may adversely influence health status among the elderly, the low-income elderly, and Tribes, and also may reduce the acceptability of health research among them. The daunting tasks confronting Tribes, researchers, and health care and public health programs in the beginning of the twenty-first century are to resume the reduction of health disparities that had occurred up to the 1980s, to reverse the worsening in a few diseases, to maintain and strengthen the favorable status, and to reduce the disparities among and within Areas and Tribes.

Factors known to contribute to health status and disparities are complex, and include underlying biology, physiology, and genetics, as well as ethnicity, culture, socioeconomic status, gender/sex, age, geographical access to care, and levels of insurance. Additional factors known to contribute to health status and disparities include: family, home, and work environments; general or culturally specific health practices; social support systems; lack of access to culturally-appropriate health care; and attitudes toward health. Yet none of these alone or in combination accounts for all documented differences.

Health disparities of AI/ANs may also reflect a lack of research relevant to improve their health status. Many AI/ANs distrust research for historical reasons. One approach that combats this distrust is to ensure that Tribes are senior partners in training and research that involves them, as for example in community-based participatory research. This approach is especially helpful to design both training relevant to researchers from Tribal communities, and research relevant to the health needs of the communities.

The mission of NIH is to acquire new knowledge that will lead to better health by understanding the processes underlying health and disease that in turn will help prevent, detect, diagnose, and treat disease and disability. The NARCH initiative works toward the NIH mission by supporting research that discovers the interrelationships among the many factors that contribute to health and disease, and by helping train and promote researchers concerned with AI/AN health.

The Agency for Healthcare Research and Quality (AHRQ), formerly the Agency for Health Care Policy and Research (AHCPR), a component of the U.S. Department of Health and Human Services, is the Federal Government's focal point for research to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. AHRQ accomplishes this mission through the establishment of a broad base of scientific research to: (1) Improve clinical practice, (2) improve the health care system's ability to provide access to and deliver high quality, high-value health care, and (3) provide policymakers with the ability to assess the impact of system changes on outcomes, quality, access to, cost, and use of health care services. An important element in AHRQ's portfolio is research (including demonstrations) that identifies successful strategies for translating evidence into sustainable improvements in clinical practice and outcomes.

4. IHS Research Program Objectives

Due to the complexity of factors contributing to the health and disease of AI/ANs, and to their health disparities compared with other Americans, the collaborative efforts of the agencies of the Department of Health and Human Services, and the collaboration of researchers and AI/AN communities, are needed to achieve significant improvements in the health status of AI/AN people. To accomplish this goal, in addition to objectives set by the Tribe, Tribal Organization or Indian Health Board, the NARCH will pursue the following program objectives:

A. To develop a cadre of AI/AN scientists and Health Professionals—Offering opportunities to develop more AI/AN scientists and health professionals engaged in research, and to conduct biomedical, clinical, behavioral and health services research that is responsive to the needs of the AI/AN community and the goals of this initiative; Faculty/researchers and students at each proposed NARCH will develop investigator-initiated, scientifically meritorious research projects, including pilot research projects, and will be supported through science education projects designed to increase the numbers of, and to improve the research skills of, investigators involved with AI/ANs.

B. To enhance Partnerships—Recent community-based participatory research suggests that AI/AN communities can work collaboratively in partnership with health researchers to further the research needs of AI/ANs. Fully utilizing all cultural and scientific knowledge, strengths, and competencies, such partnerships can lead to better understanding of the biological, genetic, behavioral, psychological, cultural, social, and economic factors either promoting or hindering improved health status of AI/ANs, and generate the development and evaluation of interventions to improve their health status.

C. To Reduce Health Disparities— In the amended Indian Health Care Improvement Act, Public Law (Pub. L.) 94-437, IHS was legislatively mandated to improve the delivery of effective health care to AI/ANs. In the NIH Revitalization Act of 1993, NIH was encouraged to increase the number of under-represented minorities participating in biomedical, clinical, behavioral and health services research, including studies on drug abuse and alcoholism, and the examination of the role of resiliency in the prevention and treatment of those conditions. Also, the “Initiative to Eliminate Racial and Start Printed Page 8471Ethnic Disparities in Health” by HHS (http://raceandhealth.hhs.gov/​) encouraged NIH to help reduce health disparities. In its 1999 reauthorizing legislation, AHRQ was directed to conduct and support research to identify and reduce health care disparities (Pub. L. 106-525). NIH published the “Strategic Research Plan and Budget to Reduce and Ultimately Eliminate Health Disparities, Fiscal Years 2002-2006” at (http://www.ncmhd.nih.gov). Finally, the “NIGMS Strategic Plan for Reducing Health Disparities” (http://www.nigms.nih.gov/​news/​reports/​health_​disparities.html) presents an NIGMS role in health disparity reduction through its focused programs on research infrastructure to increase the number and capabilities of under-represented minority health researchers. In response to these priorities, the IHS, NIGMS and AHRQ have established a collaboration to support Native American Research Centers for Health. Reducing health disparities among AI/AN communities and individuals may be fostered by greater understanding of how to enhance their strengths and resiliencies. While AI/AN communities have relied on health research and medical science to reduce health disparities, they also have relied on their own psychological, organizational, and cultural assets and strengths to survive major harms and disruptions over the centuries, and to rebound from insults to health. For research about resiliencies, see http://www.nida.nih.gov/​ResilandRiskWG/​ResilandRiskWG.html.

References for Background Information:

Anderson, N.B. Levels of analysis in health science: A framework for integrating sociobehavioral and biomedical research. Annals of the New York Academy of Sciences, 1998, 840, 563-576.

Ballantine, B., Ballantine, I. (Eds.), Thomas, D.H., Miller, J., White, R., Nabokov, P., Deloria, P.J. (Text by), Joseph, A.M. (Intro.) The Native Americans: An Illustrated History. Turner Publishing, Inc. Atlanta, GA, 1993.

Freeman, W.L. The role of community in research with stored tissue samples. Weir R (Ed.) Stored tissue samples: Ethical, legal, and public policy implications. University Iowa Press. Iowa City, IA, 1998, 267-301.

Gazmararian, J.A., Baker, D.W., Williams, M.V., Parker, R.M., Scott, T.L., Green, D.C., Fehrenbach, S.N., Ren, J. & Koplan, J.P. Health literacy among Medicare enrollees in a managed care organization. Journal of the American Medical Association, 1999, 281, 545-551.

Haynes, M.A. & Smedley, B.D. (Eds.) The Unequal Burden of Cancer: An Assessment of NIH Programs for Ethnic Minorities and the Medically Underserved. Institute of Medicine. National Academy Press. Washington, DC, 1999.

Macaulay, A.C., Commanda, L.E., Freeman, W.L., Gibson, N., McCabe, M.L., Robbins, C.M., & Twohig, P.L., (for the) North American Primary Care Research Group. Participatory research maximizes community and lay involvement. British Medical Journal, 1999, 319, 774-778.

Minority Economic Profiles. U.S. Bureau of the Census, Population Division. Issued July 24, 1992. (Tables 1990 CPH -L-92, 93, 94 and 95).

NIH Publication 98-4247. Women of Color Health Data Book. Office of Research On Women's Health, Office of the Director, National Institutes of Health, 1998.

Trends in Indian Health 1998-99. Program Statistics Team, Office of Public Health, Indian Health Service, 2001.

Regional Differences in Indian Health 1998-99. Program Statistics Team, Office of Public Health, Indian Health Service, 2000.

Weiss, B.D., Reed, R.L., & Kligman, E.W. Literary skills and communication methods of low-income older persons. Patient Education and Counseling, 1995, 25, 109-119.

Williams, D.R. & Collins, C. U.S. Socioeconomic and Racial Differences in Health: Patterns and Explanations. Annual Review of Sociology, 1995, 21, 349-386.

Williams, M.V., Parker, R.M., Baker, D.W., Parikh, N.S., Pitkin, K., Coates, W.C., & Nurss, J.R. Inadequate functional health literacy among patients at two public hospitals. Journal of the American Medical Association, 1995, 274, 1677-1682.

Start Signature

Dated: February 17, 2004.

Michel E. Lincoln,

Deputy Director, Indian Health Service.

End Signature End Preamble

[FR Doc. 04-3867 Filed 2-23-04; 8:45 am]

BILLING CODE 4160-16-P