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NIH GUIDELINES ON THE INCLUSION OF WOMEN AND MINORITIES AS SUBJECTS IN CLINICAL RESEARCH - UPDATED AUGUST 2, 2000.

NIH GUIDELINES ON THE INCLUSION OF WOMEN AND MINORITIES AS SUBJECTS IN CLINICAL RESEARCH - UPDATED AUGUST 2, 2000.

Release Date: August 2, 2000

NOTICE: OD-00-048

National Institutes of Health

NOTE: A complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm

INTRODUCTION

In March, 1994, NIH issued a policy on the inclusion of women and minorities as subjects in clinical research (http://grants.nih.gov/grants/guide/notice-files/not94-100.html). NIH experience has indicated that inclusion has been accomplished, but that results of planned analyses of NIH defined Phase III clinical trials need to be more consistently reported. This document updates and provides further guidance on planning, conducting, and reporting the analysis of sex/gender and/or race/ethnicity differences in the intervention effect in NIH Phase III clinical trials (see Definitions, Section V-A below).

The following reference published since the 1994 Guidelines provides additional background information. "Inclusion of Women and Minorities in Clinical Trials and the NIH Revitalization Act of 1993 - The Perspective of NIH Clinical Trialists." Freedman, et.al., Controlled Clinical Trials, 16:277 (1995).

Effective Date:

This policy update is effective immediately for active grants, cooperative agreements and contracts. Beginning with the October, 2000 receipt date, grant, cooperative agreement and contract submissions must adhere to the updated policy.
The following is a restatement of the policy and definitions from the guidelines with the noted changes in bold type:

III. POLICY

A. Research Involving Human Subjects

It is the policy of NIH that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification establishes to the satisfaction of the relevant Institute/Center Director that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. Exclusion under other circumstances may be made by the Director, NIH, upon the recommendation of an Institute/Center Director based on a compelling rationale and justification. Cost is not an acceptable reason for exclusion except when the study would duplicate data from other sources. Women of childbearing potential should not be routinely excluded from participation in clinical research. All NIH-supported biomedical and behavioral research involving human subjects is defined as clinical research. This policy applies to research subjects of all ages.

The inclusion of women and members of minority groups and their subpopulations must be addressed in developing a research design appropriate to the scientific objectives of the study. The research plan should describe the composition of the proposed study population in terms of sex/gender and racial/ethnic group, and provide a rationale for selection of such subjects. Such a plan should contain a description of the proposed outreach programs for recruiting women and minorities as participants.

B. NIH Phase III Clinical Trials

Under the statute, when an NIH defined Phase III clinical trial (see Definitions, Section V-A) is proposed, evidence must be reviewed to show whether or not clinically important sex/gender and/or race/ethnicity differences in the intervention effect are to be expected. This evidence may include, but is not limited to, data derived from prior animal studies, clinical observations, metabolic studies, genetic studies, pharmacology studies, and observational, natural history, epidemiology and other relevant studies.

Section III.B. of these Guidelines (NIH Phase III Clinical Trials Policy) will be cited in the terms and conditions of all awards for grants, cooperative agreements and contracts supporting NIH Phase III clinical trials.

Cost is not an acceptable reason for exclusion of women and minorities from clinical trials.

Investigators must consider the following when planning, conducting, and reporting an NIH Defined Phase III clinical trial. Based on prior studies, one of the three situations below will apply:

1. Prior Studies Support the Existence of Significant Differences

If the data from prior studies strongly support the existence of significant differences of clinical or public health importance in intervention effect among subgroups (sex/gender and/or racial/ethnic subgroups), the primary question(s) to be addressed by the proposed NIH Phase III clinical trial and the design of that trial must specifically accommodate this. For example, if men and women are thought to respond differently to an intervention, then the Phase III clinical trial must be designed to answer two separate primary questions, one for men and the other for women, with adequate sample size for each.

The Research Plan in the application or proposal must include a description of plans to conduct analyses to detect significant differences in intervention effect. The final protocol approved by the Institutional Review Board (IRB) must include these plans for analysis. The award will require that the results of subset analyses must be reported to NIH in Progress Reports, Competitive Renewal Applications (or Contract Renewals/Extensions), and in the required Final Progress Report.

Inclusion of the results of subset analyses is strongly encouraged in all publication submissions. If the analysis reveals no subset differences, a brief statement to that effect, indicating the subsets analyzed, will suffice.

2. Prior Studies Support No Significant Differences

If the data from prior studies strongly support no significant differences of clinical or public health importance in intervention effect between subgroups, then sex/gender and/or race/ethnicity will not be required as subject selection criteria. However, the inclusion and analysis of sex/gender and/or racial/ethnic subgroups is still strongly encouraged.

3. Prior Studies Neither Support nor Negate Significant Differences

If the data from prior studies neither strongly support nor strongly negate the existence of significant differences of clinical or public health importance in intervention effect between subgroups, then the NIH Phase III clinical trial will be required to include sufficient and appropriate entry of sex/gender and/or racial/ethnic subgroups, so that valid analysis of the intervention effect in subgroups can be performed. However, the trial will not be required to provide high statistical power for each subgroup.

The Research Plan in the application or proposal must include a description of plans to conduct the valid analyses of the intervention effect in subgroups. The final protocol approved by the IRB must include these plans for analysis. The award will require that the results of subset analyses must be reported to NIH in Progress Reports, Competitive Renewal Applications (or Contract Renewals/Extensions), and in the required Final Progress Report.

Inclusion of the results of subset analyses is strongly encouraged in all publication submissions. If the analysis reveals no subset differences, a brief statement to that effect, indicating the subsets analyzed, will suffice.

V. DEFINITIONS

Throughout the section of the statute pertaining to the inclusion of women and minorities, terms are used which require definition for the purpose of implementing these guidelines. These terms, drawn directly from the statute, are defined below.

A. NIH Defined Clinical Trial

For the purpose of these guidelines, an NIH defined "clinical trial" is a broadly based prospective Phase III clinical investigation, usually involving several hundred or more human subjects, for the purpose of evaluating an experimental intervention in comparison with a standard or control intervention or comparing two or more existing treatments. Often the aim of such investigation is to provide evidence leading to a scientific basis for consideration of a change in health policy or standard of care. The definition includes pharmacologic, non-pharmacologic, and behavioral interventions given for disease prevention, prophylaxis, diagnosis, or therapy. Community trials and other population-based intervention trials are also included.

B. Research Involving Human Subjects

All NIH-supported biomedical and behavioral research involving human subjects is defined as clinical research under this policy.

Under this policy, the definition of human subjects in Title 45 CFR Part 46, the Department of Health and Human Services regulations for the protection of human subjects applies: "Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information." These regulations specifically address the protection of human subjects from research risks. It should be noted that there are research areas (Exemptions 1-6) that are exempt from these regulations. However, under these guidelines, NIH-supported biomedical and behavioral research projects involving human subjects which are exempt from the human subjects regulations should still address the inclusion of women and minorities in their study design.

Therefore, all biomedical and behavioral research projects involving human subjects will be evaluated for compliance with this policy. Research involving the collection or study of existing data, documents, records, pathological specimens, diagnostic specimens, or tissues which are individually identifiable also is included within the term "research involving human subjects."

C. Valid Analysis

The term "valid analysis" means an unbiased assessment. Such an assessment will, on average, yield the correct estimate of the difference in outcomes between two groups of subjects. Valid analysis can and should be conducted for both small and large studies. A valid analysis does not need to have a high statistical power for detecting a stated effect. The principal requirements for ensuring a valid analysis of the question of interest are:

D. Significant Difference

For purposes of this policy, a "significant difference" is a difference that is of clinical or public health importance, based on substantial scientific data. This definition differs from the commonly used "statistically significant difference," which refers to the event that, for a given set of data, the statistical test for a difference between the effects in two groups achieves statistical significance. Statistical significance depends upon the amount of information in the data set. With a very large amount of information, one could find a statistically significant, but clinically small difference that is of very little clinical importance. Conversely, with less information one could find a large difference of potential importance that is not statistically significant.

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NIH MODULAR GRANT APPLICATIONS: MODIFICATIONS AND UPDATE

NIH MODULAR GRANT APPLICATIONS: MODIFICATIONS AND UPDATE

Release Date: July 24, 2000

NOTICE: OD-00-046

National Institutes of Health

Since the original announcement by the National Institutes of Health in December 1998 of Modular Grant Applications, about 25,000 applications (R01, R03, R21, R15) have been submitted in the new modular format. We have received applications for four of the standard investigator-initiated rounds as well as many receipt dates for Request for Applications (RFAs) and Program Announcements (PAs). Throughout this period, we have received many questions/comments/concerns/inquiries to our e-mail address, modulargrants@nih.gov and many hits to our modular grant website, http://grants.nih.gov/grants/funding/modular/modular.htm.

As we now move to the full two-year phase of this new application format, there is a need to modify and clarify some of our original instructions and guidance to applicants and applicant institutions.

This Notice addresses five issues regarding modular grant applications.

A. MODIFICATIONS TO THE BUDGET NARRATIVE JUSTIFICATION PAGE

Provide budget narrative for ALL personnel by position, role, and level of effort. This includes consultants and any "to be appointed" positions.

Discussion: The original guidance requested budget narrative only for KEY personnel. We found the definition used to identify KEY personnel varied widely from Institution to Institution. Since personnel generally account
for 65-70 percent of the direct costs of a grant award, providing a budget narrative for ALL personnel should be of great value to reviewers and NIH staff. In addition, this change will result in standard information for personnel in all applications. This modification is effective for all appropriate investigator-initiated applications and responses to RFAs and PAs submitted on or after September 1, 2000. RFAs and PAs released prior to September 1 will have contained our earlier reference to KEY personnel, but this notification will apply to them as well. In the future, all RFAs and PAs to be released will reference the requirement for ALL personnel to be discussed on the budget narrative page.

B. CONSEQUENCES OF SUBMISSION OF NON-COMPLIANT MODULAR GRANT APPLICATIONS

The modular grant application instructions require limited budgetary information and almost 95% of the applicants followed those instructions. Those applications that were not prepared according to the instructions have to date, been accepted for peer review. Administrative notes have been placed on summary statements to alert applicants of their failure to comply with the new application instructions. In order to ensure that all applications are treated in an equitable manner, the following new procedure is being implemented:

Effective for the receipt dates beginning September 1, 2000, applications not in compliance with the modular application instructions will be returned to the applicant institution by the Center for Scientific Review. Applications
revised and resubmitted to NIH in a timely manner may remain in the intended review cycle.

An application will be considered NON-COMPLIANT if:

1. The requested direct cost budget is not in modules of $25,000 for all years of support for requests up to $250,000 per year.

2. A detailed itemized categorical budget is provided.

3. The Budget Narrative Justification page includes an itemized justification for one or more of the following: equipment, supplies, travel, other expenses, etc. but the number of modules requested in each year is the same, or the information is not intended to explain the request for a different number of modules in one or more years.

4. OTHER SUPPORT pages are supplied, in addition to or in the absence of the section in the Biographical Sketch identifying "Research Projects Ongoing or Completed During the Last Three Years."

5. The Biographical Sketch lists "Current and Pending Support" instead of or in addition to the required information.

C. UPDATE ON THE INITIAL PEER REVIEW OF MODULAR GRANT APPLICATIONS

The first review cycle of modular grant applications generated a wide variety of opinions and reactions from applicants, reviewers, and Institutional sponsored research officials. Comments ranged from support and encouragement to serious concerns involving every aspect of the modular application process. In order to respond to these comments, a MODULAR GRANT APPLICATION UPDATE: PEER REVIEW was prepared and can be found at the Modular Grant website

http://grants.nih.gov/grants/funding/modular/modular_peer_review_update.pdf

This update has been distributed to all Center for Scientific Review (CSR) review groups, appropriate Institute scientific review groups, and to all Scientific Review Administrators. It includes information on the review of
modular applications with respect to how budget adjustments are to be recommended, overlap issues, preliminary data on the number of modules and direct costs requested, and most importantly, historical data on the pattern of direct cost awards for R01s by budget category. We are continuing to monitor all aspects of the process as this, the first full fiscal year of implementation comes to a close.

D. CLARIFICATION TO THE CHECKLIST INSTRUCTIONS

Applicant institutions should calculate the Facilities and Administrative(F&A) costs using the current negotiated F&A rate, less exclusions, for the initial budget period and all future budget periods. It is not necessary to list the exclusions on the Checklist nor anywhere in the application.

E. REMINDERS FOR MODULAR GRANT APPLICATIONS

1. Budget Narrative Justification page - this is not a Form page at this time. Use a blank sheet to recreate the sample. 2. Include a letter of commitment or intent if there is a subcontract/consortium.

3. Biosketches should be submitted for KEY personnel, including consultants.

4. Follow the guidance included in the PHS 398 instructions regarding page limitations and font size.

5. Any RFA or PA issued since December 1, 1998 that involves modular grant applications will state that fact. Any appropriate active PAs released before that time will also require submission in the modular format.

6. Reviewers will be instructed to disregard any budget or budget narrative justifications not in compliance with the modular application instructions.

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NIH SALARY LIMITATION ON GRANTS, COOPERATIVE AGREEMENTS, AND CONTRACTS

SALARY LIMITATION ON GRANTS, COOPERATIVE AGREEMENTS AND CONTRACTS

Release Date: January 6, 2000

NOTICE: OD-00-011

National Institutes of Health

The purpose of this notice is to provide updated information regarding the salary limitation as it relates to NIH grant and cooperative agreement awards. This information also applies to extramural research and development contract awards. The last notice in the NIH Guide for Grants and Contracts regarding the salary limitation was published December 22, 1998.

Fiscal Year (FY) 2000 is the eleventh consecutive year for which there is a legislatively mandated provision for the limitation of salary. Specifically, the Department of Health and Human Services (HHS) Appropriation Act for FY 2000, Public Law 106-113, restricts the amount of direct salary of an individual under an NIH grant or cooperative agreement (hereafter referred to as a grant) or applicable contract to Executive Level II of the Federal Executive Pay scale. For FY 2000 awards the Executive Level II salary level is $136,700 for the period October 1 through December 31, 1999. Effective January 1, 2000, the Executive Level II salary level increased to $141,300.

For FY 1999 awards, the legislatively imposed salary limitation was linked to Executive Level III of the Federal Executive Pay scale, which was set at a level of $125,900 for the period October 1, 1998 through December 31, 1999. Effective January 1, 2000, this level was raised to $130,200. Direct salary is exclusive of fringe benefits and facilities and administrative (F&A) expenses, also referred to as indirect costs. NIH grant/contract awards for applications/proposals that request direct salaries of individuals in excess of the applicable RATE per year will be adjusted in accordance with the legislative salary limitation and will include a notification such as the following:

According to the FY 2000 HHS Appropriations Act, "None of the funds appropriated in this title for the National Institutes of Health and the Substance Abuse and Mental Health Services Administration shall be used to pay the salary of an individual, through a grant or other extramural mechanism, at a rate in excess of Executive Level II of the Federal Executive Pay Scale."

The term "salary" means "direct salary" which is exclusive of fringe benefits and F&A expenses. "Direct salary" has the same meaning as the term "institutional base salary." An individual's institutional base salary is the annual compensation that the applicant organization pays for an individual's appointment, whether that individual's time is spent on research, teaching, patient care, or other activities. Base salary excludes any income that an individual may be permitted to earn outside of duties to the applicant organization.

In summary, the following reflects the time frames associated with the existing salary caps:

FY 1999 Awards (Executive Level III)

October 1, 1998 through December 31, 1999	$125,900
January 1, 2000 and beyond	$130,200

FY 2000 Awards (Executive Level II)

October 1, 1999 through December 31, 1999	$136,700
January 1, 2000 and beyond	$141,300

The following are examples of the adjustments that NIH will make when salaries exceed the current salary limitation:

EXAMPLE 1. INDIVIDUAL WITH FULL-TIME APPOINTMENT (based on grant award/contract issued after January 1, 2000 with a $141,300 salary limitation)

Individual's institutional base salary for a FULL-TIME (twelve month) appointment Research effort requested in application/proposal - 50%

$150,000

Direct Salary requested Fringe benefits requested (25% of salary) Subtotal

$ 75,000 $ 18,750 $ 93,750

Applicant organization's F&A (indirect) costs at a rate of 45% of subtotal

$ 42,188

Amount requested - salary plus fringe benefits plus associated F&A (indirect) costs

$135,938

If a grant/contract is to be funded, the amount included for the above individual will be calculated as follows:

Direct salary - restricted to a RATE of multiplied by effort (50%) to be devoted to project Fringe benefits (25% of allowable salary) Subtotal

$141,300 $  70,650 $  17,663 $  88,313

Associated F&A (indirect) costs at 45% of subtotal

$ 39,741

Total amount to be awarded due to salary limitation

$128,054

Amount of reduction due to salary limitation ($135,938 requested minus $128,054 awarded)

$ 7,884

EXAMPLE 2. INDIVIDUAL WITH HALF-TIME APPOINTMENT (based on a grant award/contract issued after January 1, 2000 with a $141,300 salary limitation)

Individual's institutional base salary for a HALF-TIME appointment (50% of a full-time twelve month appointment)

$ 75,000

Research effort requested in application/proposal 30%

Direct Salary requested Fringe benefits requested (25% of salary) Subtotal

$ 22,500 $ 5,625 $ 28,125

Applicant organization's F&A (indirect) costs at a rate of 45% of subtotal

$ 12,656

Amount requested - salary plus fringe benefits plus associated F&A (indirect) costs

$ 40,781

If a grant/contract is to be funded, the amount included in the award for the above individual will be calculated as follows:

Direct salary - restricted to a RATE of multiplied by 50% appointment by 30% effort to be devoted to project Fringe benefits (25% of allowable salary) Subtotal

$141,300 $ 21,195 $ 5,299 $ 26,494

Associated F&A (indirect) cost at 45% of subtotal

$ 11,922

Total amount to be awarded due to salary limitation

$ 38,416

Amount of reduction due to salary limitation $40,781 requested minus $38,416 awarded)

$ 2,365

Implementation of new salary limitation:

Questions & Answers

1. Can I rebudget grant funds or bill contracts issued with FY 1999 funds to allow for the increase from $125,900 to $130,200?
Yes, provided funds are available and the increase is warranted. Prorated figures should be used for the applicable months, i.e., the $130,200 level is effective for budget periods that extend beyond January 1, 2000.

2. If a grant award (competing or non-competing) has already been issued in FY 2000, will an adjustment be made?
No adjustments will be made; however, rebudgeting is allowable.

3. If an application/proposal fails to provide needed salary information, will an adjustment be made based on the new rates?
No adjustment will be made if an application fails to provide adequate information regarding the individual's salary level.

4. Does the NIH appropriation language link the salary cap to a Federal Executive Level or to a dollar level? The link is to the Federal Executive Level pay scale (i.e., Executive Level III for FY 1999 and Executive Level II or FY 2000).

5. As the cap is linked to Federal Executive Levels, can grantees/contractors with ongoing awards rebudget/bill up to the various salary caps, based on the fiscal year of the award and the time of the salary expense?
Yes, salary may be charged in accordance with the prevailing FY cap(s), as long as the levels are consistent with the individual's institutional base pay. The following provides an example.

A competitive grant or a contract, using FY 1999 funds, requested salary in excess of the cap and was awarded with an August 1, 1999 start date reflecting a salary level of $125,900. The grantee/contractor may charge salary at a rate of $125,900 per annum through December 31, 1999. Effective January 1, 2000, salary may be charged at a rate of $130,200 per annum through July 31, 2000. Effective with the FY 2000 non-competing award or contract, salary may be charged at the rate of $141,300 per annum.

6. Will grantees be permitted to submit revised budgets reflecting higher base salaries?
Not as a general rule. NIH policy states that grantees should always reflect actual base salaries in the requested budgets or provide an explanation indicating that actual institutional base salary exceeds the current salary limitation. As a general rule, NIH will use the information available in the existing application and make adjustments for salary cap based on information available at the time of award.

INQUIRIES

Questions concerning this notice or other policies relating to grants or contracts should be directed to the grants management or contracts management office in the appropriate NIH Institute or Center.

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NATIONAL RESEARCH SERVICE AWARD (NRSA) STIPEND INCREASE AND OTHER BUDGETARY CHANGES EFFECTIVE FOR FISCAL YEAR 2000

NATIONAL RESEARCH SERVICE AWARD (NRSA) STIPEND INCREASE AND OTHER BUDGETARY CHANGES EFFECTIVE FOR FISCAL YEAR 2000

Release Date: December 23, 1999

NOTICE: OD-00-008

National Institutes of Health
Agency for Healthcare Research and Quality
Health Resources Services Administration

The budgetary changes described below for Fiscal Year 2000 NRSA awards affect the stipend levels, the formula for calculating the NIH contribution to the combined cost of tuition, fees, and health insurance for all trainees and fellows as well as the institutional allowance and training related expenses for predoctoral trainees and fellows. Also, beginning with NRSA awards made in FY 2000, costs associated with family health insurance will be allowable. Implementation of each of these features is described separately in this notice.

IT SHOULD BE NOTED THAT THE DESCRIBED BUDGETARY CHANGES ARE EFFECTIVE ONLY FOR NRSA AWARDS MADE WITH FY 2000 FUNDS. Retroactive adjustments or supplementation of stipends or other budgetary categories with NRSA funds for an award made prior to October 1, 1999 is not permitted. Budgetary adjustments for training grant and fellowship awards, therefore, will be made only at the time of the FY 2000 award. Adjustments of stipends and other benefits for trainees will be made only at the time of appointment or reappointment to training grants made with FY 2000 funds.

STIPENDS: Effective with all awards made on or after October 1, 1999, the following annual stipend levels apply to all individuals receiving support through institutional research training grants or individual fellowships, including the Minority Access to Research Career (MARC) and Career Opportunities in Research (COR) programs. These awards are made under the authority of Section 487 of the Public Health Service Act.

The new stipends are as follows:

Career Level		Stipend for FY 2000
Undergraduates in the MARC and COR programs
Freshmen/Sophomores Juniors/Seniors		$6,948 $9,732
Predoctoral		$15,060
Postdoctoral Years of Experience
0 1 2 3 4 5 6 7 or more		$26,916 $28,416 $33,516 $35,232 $36,936 $38,628 $40,332 $42,300

Competing and non-competing awards issued on or after October 1, 1999, which used the previous stipend schedule, will be revised by the awarding component to reflect the new stipend levels. The new stipend levels are to be used in the preparation of future competing and non-competing NRSA institutional training grant and individual fellowship applications. They will be administratively applied to all applications now in the review process.

FAMILY HEALTH INSURANCE: On NRSA awards, self-only health insurance has been an allowable cost when health insurance was required for all persons in a similar training status regardless of the source of support (see http://grants.nih.gov/grants/guide/1997/97.05.16/notice-nih-national-6.html). In order to adjust policies to facilitate the recruitment of women and individuals from disadvantaged backgrounds as required by Section 487 of the Public Health Service Act (as amended); the NIH will begin to allow costs associated with family health insurance. Beginning with NRSA awards made from FY 2000 funds, family health insurance will be an allowable cost for trainees and fellows who have families and are eligible for family health insurance coverage at the awardee or sponsoring institution. Self-only health insurance will continue to be an allowable cost for trainees and fellows without families. Beginning with new and competing awards in FY 2000, institutions may include the cost of family health insurance for predoctoral and postdoctoral trainees and predoctoral fellows who are eligible for this coverage in the calculation of the combined cost of tuition, fees, and health insurance. As in the past, the tuition, fees, and health insurance cost category will not be adjusted in non-competing applications (see http://grants.nih.gov/training/nrsaguidelines/nrsa_app.htm - appe1).

For individual postdoctoral fellows, the cost of health insurance is an allowable cost within the institutional allowance (see http://grants.nih.gov/grants/guide/notice-files/NOTICE-NOT-97-002.html). Beginning with competing and non-competing awards made in FY 2000, the cost of family health insurance is also allowable under this cost category for individual postdoctoral fellows with families. Future applications for individual postdoctoral fellowships need not be changed to reflect costs associated with family health insurance.

TUITION FORMULA: To partially offset the additional costs of family health insurance, the formula by which NIH calculates its contribution to the combined costs associated with tuition, fees and health insurance will be changed. For all competing and non-competing awards made in FY 2000, the NIH will award 100% of the combined costs of tuition, fees, and health insurance up to $3,000 and 60 percent of the combined costs above $3,000. Grantees are reminded that the tuition formula is used for award calculation purposes only. Actual reimbursement is not limited to this formula.

INSTITUTIONAL ALLOWANCE AND TRAINING RELATED EXPENSES: On individual predoctoral fellowships, the institutional allowance will be increased from $2,000 to $2,500. On institutional training grants, for predoctoral trainees, the Training Related Expenses for predoctoral trainees will be increased from $1,500 to $2,000 per trainee. These adjustments will be applied to all competing and non-competing NRSA awards made with FY 2000 funds. As in the past, the institutional allowance on predoctoral fellowships can be used to help defray expenses associated with research supplies, equipment, travel to scientific meetings and other training related items. Similarly, the training related expenses for training grants will be used to help defray training expenses associated staff salaries, consultant costs, equipment, research supplies and staff travel. The institutional allowance and training related expenses for postdoctoral trainees and fellows will not be changed.

INQUIRIES

Questions concerning this notice or other policies relating to training grants or fellowships should be directed to the grants management office in the appropriate NIH Institute or Center.

Walter T. Schaffer, Ph.D.
Research Training Officer
National Institutes of Health
6701 Rockledge Drive, Room 6184
Bethesda, Maryland 20892-7911
Phone: 301-435-2687
FAX: 301-480-0146
EMail: ws11q@nih.gov

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CHANGE TO NIH'S STREAMLINED NONCOMPETING AWARD PROCESS (SNAP) INSTRUCTIONS

CHANGE TO STREAMLINED NONCOMPETING AWARD PROCESS (SNAP) INSTRUCTIONS

Release Date: July 20, 1999

Grants Administration

The purpose of this Guide Notice is to clarify the "Application for Continuation of a Public Health Service Grant (PHS 2590, rev. 4/98)" SNAP instructions as specified on pages 2-3 of the 2590 kit. Grantees are to submit the checklist (Form Page 6) page if there is a change in performance site and/or anticipated program income. If program income is anticipated, the application should reflect the amount and source(s).

The HTML version of the PHS 2590 has been changed to reflect this Notice. The revised page 2 of the PHS 2590 may be downloaded in Adobe Acrobat format from the OER Grants Web site at http://www.nih.gov/grants/forms.htm. Questions regarding this Guide Notice may be directed to the Grants Management Specialist identified on the Notice of Grant Award.