Indian Health Service Research Program; Grants Application Announcement

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Indian Health Service

RIN 0905-ZA17

Indian Health Service Research Program; Grants Application

Announcement

AGENCY: Indian Health Service, HHS.

ACTION: Notice of Competitive Grant and Cooperative Agreement

Applications for the Indian Health Service (IHS) Research Program.

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SUMMARY: The IHS announces that competitive applications for fiscal

year (FY) 1995 are now being accepted for the IHS Research Program

authorized by section 208 of the Indian Health Care Improvement Act, as

amended, 25 U.S.C. 1621g. There will be only one funding cycle for FY

1995. Grants and Cooperative Agreements shall be administered in

accordance with applicable Office of Management and Budget (OMB)

circulars and HHS policies. This program is within the Catalog of

Federal Domestic Assistance Number 93.905. Executive Order 12372

requiring intergovernmental review is not applicable to this program.

The Administration's budget request for FY 1995 includes $300,000

for the Indian Health Service Research Program. It is anticipated that

$300,000 will be available to support approximately 15 competing awards

averaging $20,000.

This program announcement is subject to the appropriation of funds.

This notice is being published early because awards to IHS components

are made by special allotments which must be expended by September 30

of the FY. Research awards must be issued early in each FY to allow

researchers full use of funds.

The Public Health Service (PHS) is committed to achieving the

health promotion and disease prevention objectives of Healthy People

2000, a PHS-led activity for setting priority areas. This program

announcement is directly related to many priority areas, including

nutrition, alcohol and other drugs, unintentional injuries, oral

health, maternal and infant health, heart disease and stroke, cancer,

diabetes and chronic disabling conditions, human immunodeficiency virus

infection, sexually transmitted diseases, clinical preventive services,

and surveillance and data systems. Potential applicants may obtain a

copy of Healthy People 2000 (Full Report; Stock No. 017-001-00474-0) or

Healthy People 2000 (Summary Report; Stock No. 017-001-00473-1) through

the Superintendent of Documents, Government Printing Office,

Washington, DC 20402-9325 (Telephone 202-783-3238).

DATES:

A. In accordance with OMB Circular A-102, Grants and Cooperative

Agreements for State and Local Governments, interested parties are

invited to comment on the proposed funding emphases. This comment

period is 30 days; written comments received by April 18, 1994, will be

considered before the final funding emphases are established. No funds

will be allocated or selections made until a final notice is published

stating what funding emphases will be applied. Written comments on the

proposed funding emphases should be addressed to: William L. Freeman,

M.D., Director, IHS Research Program, 5300 Homestead Road, NE.,

Albuquerque, NM 87110-1293. All comments received will be available for

public inspection and copying at the above address, weekdays (except

Federal holidays) between the hours of 7:30 a.m. and 4:30 p.m.,

Mountain Standard Time, beginning approximately 2 weeks after

publication of this notice.

B. A pre-application is due on or before April 18, 1994. The pre-

application is required of all applicants, including applicants for a

competitive renewal. The purposes of the pre-application are: (1) To

establish communications between the IHS and the applicant; (2) to

determine the applicant's eligibility; and (3) to determine how well

the project can compete with other similar pre-applications. The pre-

application will consist of: (1) the Standard Form 424 (cover sheet),

sections 1., 2., 5., 6., 7., 8., 11., and 15.; (2) a Research Plan (see

section I); and (3) the Importance and Utility section (see section J).

In meeting this pre-application deadline, it is the researcher's

responsibility to assure that Grants Management Branch, Division of

Acquisition and Grants Operations, IHS, receives the original pre-

application and the appropriate IHS Research and Publication Committees

(RPCs) simultaneously receive a copy of the pre-application. The RPCs

will use the same review criteria as the Indian Health Research Study

Section. The review criteria are discussed under Section M. Review

Process, of this announcement. An applicant submitting a pre-

application may be declared ineligible to submit an application, based

on the results of the pre-application review.

C. An original and 2 copies of the completed final grant

application must be received by the Grants Management Branch, Division

of Acquisition and Grants Operations, IHS, suite 100, 12300 Twinbrook

Parkway, Rockville, MD 20852, on or before June 30, 1994.

Pre-applications and applications shall be considered as meeting

the deadline if they are either: (1) Received on or before the deadline

with hand carried applications received by close of business 5 p.m., or

(2) postmarked on or before the deadline and received in time to be

reviewed along with all other timely pre-applications and applications.

A legibly dated receipt from a commercial carrier or the U.S. Postal

Service will be accepted in lieu of a postmark. Private metered

postmarks will not be accepted as proof of timely mailing.

Pre-applications and applications received after the announced

closing date(s) will not be considered for funding and will be returned

to the applicant.

Additional Dates

D. Pre-application Review Period: On or about April 18-May 18,

1994.

E. Comments on pre-application to applicants: On or about June 1,

1994.

F. Application Reviews: IHS Study Section: On or about September

13-15, 1994.

G. Applicants notified of results (approved, approved unfunded, or

disapproved): On or about November 16, 1994.

H. Earliest anticipated starting date: On or about December 1,

1994.

FOR FURTHER INFORMATION CONTACT:

A. Programmatic: Tina Dickerson, Assistant Research Program

Coordinator, Office of Health Program Research and Development, 7900

South J. Stock Road, Tucson, AZ 85746-9352, (602) 295-2501, or the

following Area Research Coordinators:

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Research office:

Indian health area offices, and states served contact(s) and telephone

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Aberdeen Area Office, Federal Building, Thomas Welty, M.D. (Rapid

1154th Ave., SE., Aberdeen, SD 57401, North City), (605) 348-1900

Dakota, South Dakota, Nebraska, Iowa. Ext 401, FAX (605) 348-

8833.

Alaska Area Native Health Service, P.O. Box 7- David H. Barrett, M.D.,

741, Anchorage, AK 99501, Alaska. (907) 257-1251 Ext. 263,

FAX (907) 257-1781.

Albuquerque Area Office, IHS, 505 Marquette Gary Morigeau, (505) 766-

NW., Suite 1502, Albuquerque, NM 87102, New 2544, FAX (505) 766-

Mexico, Colorado. 2157.

Bemidji Area Office, IHS, 203 Federal John L. Robinson, D.D.S.,

Building, Bemidji, MN 56601, Minnesota, (218) 759-3441, FAX

Michigan, Wisconsin. (218) 759-3511.

Billings Area Office, IHS, P.O. Box 2143, James D. Vesbach, D.D.S.,

Billings, MT 59103, Montana, Wyoming. (406) 657-6900, FAX

(406) 657-6333.

California Area Office, IHS, 1825 Bell John Yao, M.D., (916) 978-

Street, Sacramento, CA 95825, California. 4202, Ext 107, FAX (916)

978-4434.

Nashville Area Office, IHS, 711 Stewarts William Betts, Ph.D.,

Ferry Pike, Nashville, TN 37217, (615) 736-2487, FAX

Mississippi, North Carolina, Florida, New (615) 736-2391.

York, Maine, Rhode Island, Louisiana,

Massachusetts, Connecticut, Texas, Alabama.

Navajo Area Office, IHS, P.O. Box G, Window Douglas G. Peter, M.D.,

Rock, AZ 86515, Navajo Reservation. (602) 871-5811, FAX

(602) 871-5872.

Oklahoma City Area Office, IHS, 3625 NW 56th Clark Marquart, M.D.,

Street, Five Corporate Plaza, Oklahoma City, (405) 945-6820, FAX

OK 73112, Oklahoma, Kansas, Texas. (405) 945-6870.

Phoenix Area Office IHS, 3738 N. 16th Street, N. Burton Attico, M.D.,

Phoenix, AZ 85016, Arizona, Nevada, Utah. (602) 640-2187, FAX

(602) 640-2137.

Phoenix Indian Medical Center, 4212 N. 16th Roy Teramoto, M.D., (602)

Street, Phoenix, AZ 85016, Arizona (only 263-1551, FAX (602) 263-

PIMC). 1648.

Portland Area Office, IHS, 2201 Sixth Avenue, Ernest H. Kimball,

Room 300, Seattle, WA 98121, Washington, M.P.H., (206) 615-2791,

Oregon, Idaho. FAX (206) 615-2784.

Office of Health Program, Research and John Kittredge, M.D.,

Development, 7900 South J. Stock Road, (602) 295-2406, FAX

Tucson, AZ 85746-9352, Southern Arizona. (602) 295-2602.

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B. Grants and Business: M. Kay Carpentier, Grants Management

Branch, Division of Acquisition and Grants Operations, IHS, suite 100,

12300 Twinbrook Parkway, Rockville, MD 20852, (301) 443-5204.

(Telephone calls to these numbers are not toll-free.)

SUPPLEMENTARY INFORMATION: This announcement provides information on

the general program goals, eligibility requirements, research emphases,

availability of funds application process, and review process for the

IHS Research Program for FY 1995.

A. General Program Goals

1. To support practice and community-based research projects likely

to improve the health of American Indians and Alaska Natives (AI/AN)

served by the IHS. Projects that are basic science or laboratory

research are not considered as conforming to the program goals, and

will be returned to the applicant.

2. To develop research skills among IHS and tribal health

professionals. The applicant, as the direct and primary recipient of

PHS funds, must perform a substantive role in carrying out project

activities and not merely serve as a conduit for an award to another

party, or to provide funds to another party.

B. Eligibility

The grant application process affords Indian tribes and tribal

organizations which have contracts with the IHS under the Indian Self-

Determination Act, 25 U.S.C. 450 et seq., an equal opportunity to

compete with IHS components for research funds. Awards to tribal

contractors will be made as grants or cooperative agreements. The IHS

components will receive special allotments of funds to carry out

approved research activities.

C. Research Emphases

Grants or special allotments will be made under this announcement

with special but not exclusive regard to the following IHS research

emphases for FY 1995.

1. Studies of documented high importance to the community in which

the research is to be done.

2. Studies with high relevance for the AI/AN populations. (The

series ``The Research Agenda for Indian Health'' in the IHS Primary

Care Provider, lists many relevant research subjects. Reprints are

available from the IHS Research Program and the Area Research Offices.)

3. For studies that involve problems that are both social and

medical (e.g., dysfunctional families), research on factors that enable

the community or individuals to overcome the problems.

4. Competing continuations of previously-funded research projects.

D. Fund Availability, Period of Support, and Funding Level

Subject to the availability of FY 1995 funds, $300,000 will be

available to support approximately 15 research grants to tribes and

special allotments to IHS components and up to 5 demonstrative

cooperative agreements to tribes. (Cooperative agreements are financial

assistance awards that require the substantial programmatic involvement

of the Federal Government. Specific programmatic involvement by the IHS

in a project will be negotiated with an approved applicant before award

of a cooperative agreement. This involvement will include the statement

of the study question(s) and objective(s); the adequacy of the research

literature; the research design and methods proposed; the management,

quality control, and analysis of the data sources; the development of

new methods and information; the importance of community involvement;

the applicability of the research to AI/AN people; the budget

sufficiency; and the adequacy of the principal investigator and

research team.)

The detail required in a research project application and funding

needs for the project differ widely between experienced and

inexperienced researchers. Therefore, we anticipate two levels of

project application and funding. This will allow both the inexperienced

and experienced researchers to apply for grants and to compete with

others of similar expertise. The grant application must designate for

which level the researcher is applying.

(1) The first level is for a one year pilot research project. This

level is for less experienced researchers and for less complex and

detailed applications. A less experienced researcher is defined as an

investigator who has never received a funded research award in his or

her own right. The Research Plan and Importance & Utility sections of

the pilot research project application should be of less detail and

complexity than expected for the small grant research project

application; only biographical sketches, not Curriculum Vitae, are

required. The anticipated maximum funding for a pilot research project

is $15,000.

(2) The second level is for a small grant research project. This

level is for more experienced researchers. A more experienced

researcher is defined as an investigator who has received at least one

funded research award in his or her own right. The Research Plan and

Importance and Utility sections of the small grant research project

application must be complete and discussed in detail. The small grant

project application should be more complete, and have more detail and

complexity, than the pilot research project application. The

anticipated maximum funding for a small grant research project is

$50,000 per year. The project may be planned for up to three years with

a competing continuation application for each succeeding year.

Research projects are normally funded for a 1 year project period.

No cost extensions can be requested by the researcher to finish work

that has encountered unanticipated delays. All applicants must compete

annually; however, among applications of similar merit, priority will

be given to applicants for a competing continuation of a previously-

funded research project. No projects may be funded for more than 3

years.

E. The Complete Application

The information collection requested in the narrative of the

application is approved under OMB clearance #0937-0189. An IHS Research

Grant Application Kit, including required form PHS 5161-1 (rev. 7/92),

may be obtained from the Grants Management Branch, Division of

Acquisition and Grants Operations, IHS, Twinbrook Metro Plaza, suite

100, 12300 Twinbrook Parkway, Rockville, MD 20852, telephone (301) 443-

5204.

All applications must include the following:

--Completed Standard Forms 424 and 424A.

--A one-page research project abstract. (See section F. Abstract,

below.)

--A table of contents.

--A detailed budget for the project period. (See section G. Budget,

below.)

--One-page biographical sketches of all key personnel. (See section H.

Key Personnel and Research Team, below.)

--A research plan. (See section I. Research Plan, below.)

--A description of the health problems addressed by, and the utility

of, the research. (See section J. Importance and Utility, below.)

--Documentation of approvals, support, and clearances. (See section K.

Documentation of Approvals, Support, and Clearances, below.)

--A description of how human subjects, if any, are protected from

research risks. (See section L. Protection of Human Subjects, below.)

--Appendices, to include:

--Resumes (Curriculum Vitae) of key personnel; and

--A list of all anticipated consultants, collaborators, and contractual

agreements.

F. Abstract

The abstract may not exceed one single-spaced typewritten page. It

should summarize the application, and should answer the basic questions

``who, what, when, where, how, and costs.'' The abstract should help

the reviewers understand the application as a coherent whole. The

abstract should be written last, to ensure that it is an accurate

summary, even though it is placed in the application packet before the

sections its summarizes.

G. Budget

An itemized estimate of costs and justification for the proposed

research project by line item must be provided on form PHS 5161-1

(effective date 7/92). A narrative justification must be submitted for

costs. Indicate needs by listing individual items and quantities

necessary. The budget should be sufficient, but not exceed what is

necessary to complete the research project. the budget is not intended

as a vehicle for the purchase of expensive computer and other

equipment. These purchases are allowable only with IHS prior approval.

The budget should include additional resources in the organization(s)

that will be applied to the research study, e.g., in-kind staff,

physical resources such as telephones, and consultations. The budget

should be developed after the Research Plan is written, even though it

is placed in the application packet before the Research Plan section.

H. Key Personnel and Research Team

The biographical sketch of each key person may not exceed one

single-spaced typewritten page. Each sketch should include the person's

qualifications, training, and experience relevant to the research

project, and the person's time that will be devoted to the project.

``Key personnel'' include the principal investigator, co-investigators,

and significant consultants and contractors. The biographical sketches

should help the reviewers understand the capabilities of the research

team to manage, carry out, and complete the project successfully.

Include in Appendices both the resumes (Curriculum Vitae) of the key

personnel, and a list of all anticipated consultants, collaborators,

and contractual agreements.

The instructions for the preparation of the Research Plan section

and Importance and Utility section are to be used in lieu of the

instructions on pages 19-20 of the PHS 5161-1.

The two sections together may not exceed 25 single-spaced

typewritten pages in length.

I. Research Plan

The Research Plan section of the application must include the

following sub-sections: (1) The specific aims of the research plan,

with study question(s) and objective(s) stated; (2) the background in

research literature for the study; (3) a progress report (for competing

continuation applicants only); (4) the research design and methods to

be used; (5) data sources, management quality control, and analysis;

and (6) originality (if applicable). The Plan should be well organized,

clearly written, and succinct. The plan should address how the

Scientific Integrity of the project will be maintained. It should

contain all information necessary for reviewers to understand fully the

research plan without being familiar with the IHS or tribal health

programs.

1. Specific Aims: statement of study question(s) and objective(s).

State the study question(s) and objective(s) of the research

clearly and precisely. The rest of the Research Plan should follow

logically from the study question(s).

2. Background in Research Literature:

Give a brief but comprehensive review of existing research and

knowledge related to the study question(s). Previous related work by

members of the team, including data from a pilot phase, should be

included in the review. Describe the conclusions to be drawn from, and

the applicability of, that review to the research project. References

should be cited in standard format. (See Index Medicus, or N Eng J Med

1991; 324:424-428; copies are available from the Area and National

Research Offices.)

3. Progress report (for competing continuation studies only).

Give the progress of the funded research project to date. Indicate

how the final objective(s) of the research will be achieved.

4. Research design and methods to be used.

Briefly define the research design, and why it is appropriate for

the objective(s) of the research. Describe the research methods in

detail. The description should include: (a) The population to be

studied; (b) the inclusion and exclusion criteria for selecting study

subjects; (c) the sampling techniques; (d) selection of controls (if

any); (e) the definition of the independent and dependent variables (if

any) and how to measure them; (f) the validation of interventions (if

any); and (g) the definition of the expected outcomes or effects (if

any) and how to measure them. Briefly discuss how to account for

alternative explanations of expected findings. Provide sample size

calculations (if needed), and evidence that the research can achieve

the projected size. Give a project timeline, with completion dates of

all major tasks.

5. Data sources, management, quality control, and analysis.

Describe in detail the data sources, management, quality control

and analysis. The description should include: (a) The data to be

collected, by whom, and at which points in the study; (b) the data

sources, and how access to the sources will be attained; (c) the

procedures to collect, receive, code, and prepare the data for

analysis; (d) the contents of interviews (if they are to be done), and

the connection between the interview question and the variables to be

studied; (e) how the data will be made secure; (f) how completeness of

the data will be assured and low response rates dealt with; (g) how

accuracy of the data will be measured and assured; (h) the plan for

analysis; (i) the statistical analyses to be done (if any); and (j) the

non-statistical analyses to be done (if any, e.g., in qualitative

research). Include a copy of the data collection instruments, if

available, or the instruments to be modified by the research project

(if any), in the application's appendices.

6. Originality.

If this research will develop new methods or directly lead to new

information for research in general (not just about AI/AN people),

briefly discuss that significance.

J. Importance and Utility

The Importance and Utility section of the application must include

the following sub-sections: (1) The importance of the health problem(s)

addressed by the research for the community(ies) involved; (2) the

importance of the health problems addressed by the research for all AI/

AN people and for the IHS Area; (3) the rationale for the setting of

the study; (4) the utility of the product of the project and of the

experience doing the project, to the community(ies) and service unit(s)

(SUs) involved; and (5) the utility of the product of the project, and

of the experience doing the project, to the IHS and other AI/AN people.

The Importance and Utility section should be well organized, clearly

written, and succinct. It should contain all information necessary for

reviewers to understand fully both the importance of the health

problem(s) addressed by the research project and its expected utility,

without being familiar with the IHS or tribal health programs.

1. Importance of the health problem(s) for the community(ies)

involved.

Using quantitative evidence, briefly document the importance of the

health problem(s) addressed by the research project among the range of

health problems of the community(ies) in which the research project

will be done.

2. Importance of the health problem(s) for all AI/AN people and for

the IHS Area.

Using quantitative evidence, briefly document the importance of the

health problem(s) addressed by the research project among the range of

health problems of all or major groups of AI/AN people, and by the AI/

AN people of the IHS Area.

3. Setting of the study.

Briefly discuss why the study should be done only, or be done best,

in an AI/AN population, and why in the proposed community(ies).

4. Utility of the product and experience to the community(ies) and

SUs involved.

Briefly define the expected utility of the product (e.g., new

information) or of the experience (e.g., new research skills,

capabilities, resources, or liaisons to do practice-based or community-

based research) to the community(ies) and/or SUs involved.

5. Utility of the product and experience to the IHS and other AI/AN

people.

Briefly define the expected utility of the product (e.g., new

information) or of the experience (e.g., new research skills

capabilities, resources, or liaisons to do practice-based or community-

based research) to the IHS and/or other AI/AN people.

K. Documentation of Approvals, Support, and Clearances

1. Tribal approval.

The research project must have the full understanding, documented

approval, and support of the Indian tribe(s) or Alaska village(s)

involved. Documented approval must be evidenced by a signed and dated

Tribal Resolution, done no more than 12 months before December 1, 1994.

If more than one tribe is involved, evidence of support from all tribes

affected must be submitted with the application. Applications by tribal

organizations will not require resolution(s) if the current tribal

resolution(s) under which they operate would encompass the proposed

grant activities. A statement of proof or a copy of the current

operational resolution must accompany the application.

2. Letters of cooperation, collaboration, or assistance.

If other research programs are to be involved in the research

project, letters confirming the specific nature and extent of

cooperation, collaboration, or assistance must be submitted.

3. Service Unit Director approval.

All applicants must provide letter(s) of approval from the Director

of any SUs involved in or affected by the research project.

4. Area Contracting Officer clearance.

The IHS components which apply must obtain a letter of clearance

from the Area Contracting Officer if any purchasing, contracting, or

consultant hiring actions will be requested in the research project.

This letter of clearance must be included with the submitted proposal.

5. Area Director approval.

The IHS components applying must also obtain a signed Form 424 in

Section 18.d-e. from the Area RPC as evidence of the IHS Area

Director's approval. This is in accordance with Part 1--General,

Chapter 7, research Activities, Sub Part 1-7.4 A. of the IHS Manual

which establishes the Area RPC as the Area Director's reviewing

authority for research proposals.

L. Protection of Human Subjects

The application shall contain assurances that the applicant will

comply with the following:

1. Regulations to protect all human subjects of the research.

If the research project will involve human subjects, the applicant

must submit for approval the completed protocol to the applicable IHS

Area Institutional Review Board(s) (IRB). If one or more co-

investigator(s) is (are) from an institution that has a permanent IRB

(i.e., has a Multiple Project Assurance [MPA]), the applicant must

submit form HHS 596 to that IRB as well. All IRB approvals must be

secured prior to funding of the proposal. (See section M. Review

Process, below.) It is recommended that any applicant who proposes to

involve human subjects, or who is not sure if the project meets the

definition of research involving human subjects in 45 CFR part 46,

contact the appropriate Area Research Coordinator listed in this

announcement for technical assistance as the application is being

developed.

2. Maintenance of data confidentiality, anonymity (if indicated),

and subject privacy.

Applicants must describe the process to maintain the

confidentiality of data collected, the protection of patient records,

and the privacy of human subjects. If subjects are to be protected by

anonymity, applicants must describe the process to maintain anonymity.

M. Review Process

1. Review by authorized Institutional Review Boards (IRB).

All applications involving human subjects will be reviewed by the

authorized Area or National IRBs in the IHS for compliance with

requirements to protect human subjects contained in 45 CFR 46, and as

specified in the IHS MPA. It is suggested but not required that the

application be sent to the appropriate Area (IRB(s) 2 (two) months

before the deadline, for the IRB review of the proposal to permit

making the changes before the final submission. The IRB will review

only IRB issues, not purely technical methods. Any applications

involving investigators from institutions with IRBs with MPAs and

involving human subjects must also be reviewed by the IRBs of the

respective institution(s). The researcher should contact non-IHS IRBs

for their deadline requirements. No research project can be funded by

IHS unless it has been approved by, and has met the conditions of, all

applicable IRBs.

2. Review by the Indian Health Research Study Section (IHRSS).

Applications meeting eligibility requirements that are complete,

responsive, and conform to this program announcement will be reviewed

for merit by the IHRSS appointed by the IHS to review these

applications. The IHRSS review will be conducted in accordance with the

IHS objective review procedures. The technical review process ensures

selection of quality research projects in a national competition for

limited funding. The IHRSS will include at least 60 percent non-IHS,

Federal or non-Federal, individuals, all experts in research. For each

application, the IHRSS will decide to disapprove, or to defer pending

more information, or to approve the project. If the IHRSS decides to

approve the project, it will review the application against established

criteria, and will assign a numerical score to the application. The

members of the IHRSS will use the following criteria and weights to

make the score.

Weights:

(Criteria ``a'' through ``f'' refer to section I. Research Plan.)

4................... a. Specific Aims: statement of study question(s) and objective(s).

Are the study questions stated clearly and precisely? Does the rest of the Research

Plan follow logically from the study questions?

10.................. b. Background in Research Literature:

Does the background in research literature include the important existing research and

knowledge relevant to the study question(s), and pilot data applicable)? Do the

conclusions follow from the review?

4................... c. Progress Report (for competing continuation studies only).

What is the progress to date? Is the report timely? Does the progress report

demonstrate that investigators will achieve the objective(s) of the research?

15.................. d. Research design and methods to be used.

Does the Research Plan adequately describe the research design? Is the proposed

approach appropriate for the objective(s) of the research? Does the Plan adequately

describe: The population to be studied; the inclusion and exclusion criteria, and how

the investigators will determine inclusion and exclusion, the sampling techniques;

selection of controls (if any); the definition of the independent and dependent

variables (if any) and how to measure them; the interventions (if any) and how to

assure that they are done in fact; and the definition of the expected outcomes or

effects (if any) and how to measure them? Are these methods appropriate to achieve

the objective(s) of the research? Are sample size calculations included, if needed?

Is the projected sample size achievable, and sufficient to achieve the objective(s)

of the research? Does the Plan adequately account for alternative explanations of

expected findings? Is the application's timeline, with completion dates of all major

tasks, appropriate and feasible?

10.................. e. Data sources, management, quality control, and analysis.

Does the Research Plan adequately describe: the data to be collected, by whom, and at

what time; the data sources, and how access to the sources will be attained; the

procedures to collect, receive, code, and prepare for analysis of the data; the

contents of interviews (if they were to be done), and the connection between the

interview question and the variables to be studied; how the data will be made secure;

how completeness of the data will be assured and low response rates dealt with; how

accuracy of the data will be measured and assured; the plan for analysis; the

statistical analyses to be done (if any); and the non-statistical analyses to be done

(if any)? Are these plans appropriate and adequate for the research questions?

4................... f. Originality.

Will this research likely develop new methods, or directly lead to new information,

useful for research in general?

(Criteria ``g'' through ``K'' refer to section J. Importance and Utility.)

10.................. g. Importance of the health problem(s) for the community(ies) involved.

Are the health problems addressed by the research project of high importance in the

community(ies) involved?

9................... h. Importance of the health problem(s) for all AI/AN people and the IHS Area.

Are the health problems addressed by the research project of high importance in all or

major segments of AI/AN people, and in the IHS Area?

4................... i. Setting of the study.

Should the research be done only, or be done best, in an AI/AN population, and in the

proposed community(ies)?

10.................. j. Utility of the product and experience to the community(ies) and SUs involved.

Does the research project have a high expected utility of the product (e.g., new

information) or of the experience (e.g., new research skills, capabilities,

resources, or liaisons to do practice-based or community-based research) to the

community(ies) and/or SUs involved?

5................... k. Utility of the product and experience to the IHS and other AI/AN people.

Does the research project have a high expected utility of the product (e.g., new

information) or of the experience (e.g., new research skills, capabilities,

resources, or liaisons to do practice-based or community-based research) to the IHS,

to the IHS Area, and/or to other AI/AN people?

5................... l. Budget. (This criterion refers to section G. Budget.)

Is the proposed budget sufficient to do the project? Is the proposed budget excessive?

Is the proposed budget being used for the purchase of computers or other expensive

equipment? If the research project is a competing continuation, are the additional

years necessary? Is the cost justified by the expected benefit?

10.................. m. Key Personnel and Research Team. (This criterion refers to section H. Key Personnel

and Research Team.)

Does the principal investigator have the training, experience, and time necessary to

do and to manage the proposed research project? Does the research team have the

capabilities to carry out and complete the project successfully?

N. Results of the Review

The recommendations of the IHRSS will be forwarded to the Associate

Director, OHPRD, for final review and approval. The Associate Director

will also consider the recommendations from the appropriate Area

Research Committee and the Grants Management Office. Applicants will be

notified of their approval with funds, or approval without funds, on or

about November 16, 1994. A Notice of Grant Award will be issued

approximately 10 days prior to the start date. Unsuccessful applicants

will be notified in writing of disapproval on or about November 16,

1994. A brief explanation of the reasons why the application was not

approved will be provided along with the name of the IHS official to

contact if more information is desired.

Dated: December 10, 1993.

Michel E. Lincoln,

Acting Director.

[FR Doc. 94-6384 Filed 3-17-94; 8:45 am]

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