SHARED RESOURCES FOR SCIENTISTS OUTSIDE NCI CANCER CENTERS

Release Date:  July 23, 1998

PA NUMBER:  PAR-98-092

P.T.

National Cancer Institute

Letter of Intent Receipt Date:  October 9, 1998
Application Receipt Date:  November 13, 1998

THIS PROGRAM ANNOUNCEMENT (PA) USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS
AND INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS AND MUST
BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA.

PURPOSE

Successful cancer research depends on the availability of, and access to, shared
resources.  These include, but are not limited to, complex technologies,
specialized databases, instrumentation facilities, human tissue specimens and
animal models.  These high-cost, fundamental infrastructure needs can rarely be
justified in NIH individual research project grant applications.  Support for
shared resources is usually provided to:  1) members of NCI Cancer Centers or
SPOREs where shared resources benefit a wide range of basic, clinical, prevention
and control research; 2) investigators in large multi-project program grants such
as P01s; and 3) groups that justify their need for sophisticated, high cost
equipment to the National Center for Research Resources (NCRR) at the NIH.  These
opportunities are limited and are unavailable to approximately half of the NCI-
supported investigators, particularly those at institutions without NCI funded
Cancer Centers.

The objective of this program announcement (PA) is to provide groups of six or
more NCI funded investigators in institutions that do not have NCI funded Cancer
Centers with additional shared resource support.  Increasing the availability of
core resources is expected to improve the ability to conduct research and thereby
facilitate scientific progress.  This PA requests applications to establish
cancer-related research resources to provide new sources of technical support and
research materials to advance cancer research.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2000," a PHS-led national
activity for setting priority areas.  This PA, Shared Resources for Scientists
Outside NCI Cancer Centers, is related to the priority area of cancer.  Potential
applicants may obtain a copy of "Healthy People 2000" (Full Report:  Stock No.
017-001-00474-0 or Summary Report:  Stock No. 017-001-00473-1) through the
Superintendent of Documents, Government Printing Office, Washington, DC 20402-
9325, Telephone 202-512-1800.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic, for-profit and non-profit, public and
private organizations, such as universities, colleges, hospitals, laboratories,
units of state and local governments, and eligible agencies of the Federal
government.  Foreign institutions are not eligible to apply.  Racial/ethnic
minority individuals, women, and persons with disabilities are encouraged to
apply as principal investigators.  All applicants must document that at least six
NCI funded investigators at the applicant institution have need for the proposed
resource.  Once the needs of the core user group of six NCI (R01 or P01 project)
funded investigators are accommodated, the resource may be opened to additional
users at the applicant institution and to investigators at other institutions. 
Applications will only be accepted from institutions that currently are not
supported by NCI Cancer Center Support Grants (CCSGs or P30) or planning grants
(P20).  Note that there is also a cap based on the institutions total NCI
support.  It is anticipated that this PA will be re-issued for a November 1999
receipt date.

MECHANISM OF SUPPORT

The Resource Related Support grants mechanism (R24) will be used.  This mechanism
supports research projects to enhance the capability of resources to serve
biomedical research.  Specific R24 application instructions have been modified
to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined
by the NIH.  The modular grant concept establishes specific modules in which
direct costs may be requested as well as a maximum level for requested budgets. 
Only limited budgetary information is required under this approach.  The
just-in-time concept allows applicants to submit certain information only when
there is a possibility for an award.  It is anticipated that these changes will
reduce the administrative burden for the applicants, applicant institutions,
reviewers, and Institute staff.

Appropriate activities include establishing shared technologies, databases,
instrumentation facilities, tissue resources and other shared activities that
make resources more readily available to the research community.  Approximately
$3 million total cost will be available for the first year of this program
announcement, which should fund 10-15 resource related grants.  The funds
requested should be based on the requirements of the project and the requested
costs should be fully justified.  NCI direct cost support will be limited to
$200,000 for each application.  For projects whose costs exceed $200,000, the
availability of the necessary additional institutional or other support must be
documented in a letter of commitment from the applicant institution or from
another funding source.

Budget Cap: An institution can submit more than one application, but the sum of
resource support requested cannot exceed 10% of its NCI-sponsored direct cost
research base (all grant and contract mechanisms), as derived from the NCI's
financial data base.  If more than one resource grant is submitted, each must
have a different PI and provide substantially different products or services. 
While the same six NCI funded users can be listed for more than one resource,
their need for access to each resource must be clearly justified.  This cap
applies only to annual regular operational costs.  One-time purchase of equipment
as an integral part of a resource will not count against the cap.

For this PA, funds must be requested in modules of $25,000 (direct cost) and no
more than eight modules ($200,000 direct costs) per year may be requested.  A
feature of the modular grant concept is that no escalation is provided for future
years, and all anticipated expenses for all years of the project must be included
within the number of modules being requested. Only limited budgetary information
will be required and any budget adjustments made by the Initial Review Group will
be in modules of $25,000.  Instructions for completing the Biographical Sketch
have also been modified.  In addition, Other Support information and the
application Checklist page are not required as part of the initial application. 
If there is a possibility for an award, necessary budget, Other Support and
Checklist information will be requested by NCI staff following the initial
review.

Awards will be administered under the PHS grants policy as stated in Public
Health Service Grants Policy Statement, DHHS Publication No. (OASH) 94-50,000
(Rev.) April 1, 1994.

The APPLICATION PROCEDURES section of this PA provides specific details of
modifications to standard PHS 398 application kit instructions. Applicants are
expected to furnish their own estimates of time required to achieve the
objectives of the proposed research project.  Since a variety of approaches would
represent valid responses to this PA, it is anticipated that there will be a
range of costs among individual grants awarded.

RESEARCH OBJECTIVES

Applications are sought to establish resources to facilitate cancer research. 
Applications for resources under this PA may request funding to serve a pre-
defined group of six NCI funded investigators located at one institution.  The
need for the resource must be justified, the six potential users identified and
their funding documented.  Beyond that requirement, the resource may be opened
to any segment of the cancer research community.  For example a defined group of
six NCI funded investigators could develop an effective shared collection and
distribution system to provide efficient access to appropriate colon cancer
specimens.  If sufficient specimens were available, the resource could be
expanded to serve additional researchers, including those at other institutions.
The creation of a resource advisory group is encouraged when appropriate.  User
charges are appropriate when the intent is to recapture costs of providing
resource materials or services to the community.  When possible, the anticipated
level of use of the resource should be estimated and the basis for those
estimates provided.  Appropriate resources may include, but are not limited to,
the following:

o  Tissue and Data Resources:  Centralized facilities to provide human tissue
specimens to a defined group of investigators.  Applicants should demonstrate
that the proposed tissue resource will improve access to otherwise unavailable
specimens and/or provide increased economy over existing resources.

o  Unique database resources supporting research activities:  Facilities to
collect, store, analyze and quality control clinical and research data. 
Applicants should clearly describe the critical issues being addressed, the
importance of the resource and the user community.

o  Agent development:  Resources to provide radiopharmaceutical services, support
IND-directed toxicology studies, or produce, supply, and/or evaluate novel
therapeutic or diagnostic agents.  For example, a core resource to provide
researchers with clinical grade reagents (monoclonal antibody, recombinant
protein, peptide or a unique linker) for their studies.

o  Assay support for research activities:  Facilities to efficiently provide
centralized high quality, standardized clinical or biological assays which will
provide researchers with a uniform basis for comparison of their results. 
Applicants should detail critical factors (e.g., stability of samples, validation
of assays, quality control) and demonstrate that samples can be transported,
stored, and assayed and present plans to maintain data records and report
results.

o  Animal models for diagnostic or therapeutic applications:  Facilities to
produce and distribute to a defined group of researchers animal models (e.g.,
transgenic, knockout and xenograft models and animals susceptible to cancer of
particular tumor sites).  Funding may cover the additional costs of producing and
delivering animal models.  Commercial for-profit or not-for-profit animal
suppliers are not eligible to apply.

o  Technology or instrumentation development:  Core facilities to provide
researchers with access to state-of-the-art instrumentation and technology for
cancer research.  Applicants must clearly describe the impact of the technology
or instrumentation on ongoing research projects.  Applications to purchase
conventional shared equipment or to develop new technologies will be considered
unresponsive.

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 and behavioral
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 new
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public
Law 103-43).

All investigators proposing research involving human subjects should read the
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical
Research," which have been published in the Federal Register of March 28, 1994
(FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23,
Number 11, March 18, 1994.  Investigators also may obtain copies of the policy
from the program staff listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.

NIH POLICY AND GUIDELINES ON THE 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 clear and compelling reasons not to include them.  This
policy applies to all initial (Type 1) applications submitted for receipt dates
after October 1, 1998.

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://www.nih.gov/grants/guide/notice-files/not98-024.html

LETTER OF INTENT

Prospective applicants are asked to submit, by October 9, 1998, a letter of
intent that includes a descriptive title of the proposed research, the name,
address, and telephone number of the Principal Investigator, the identities of
other key personnel and participating institutions, and the number and title of
the PA in response to which the application may be submitted.  Although a letter
of intent is not required, is not binding, and does not enter into the review of
a subsequent application, it allows NCI staff to estimate the potential review
workload and helps to avoid conflicts of interest in the review.

The letter of intent is to be sent to:

Roger L. Aamodt, Ph.D.
Division of Cancer Treatment and Diagnosis
National Cancer Institute
Executive Plaza North
6130 Executive Boulevard, Room 700
Bethesda, MD  20892-7399
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 496-7147
FAX:  (301) 402-7819

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev.
5/95) and will be accepted at the November 13, 1998 application deadline. 
Application kits are available at most institutional offices of sponsored
research and may be obtained from the Division of Extramural Outreach and
Information Resources, National Institutes of Health, 6701 Rockledge Drive, Suite
6095, MSC 7910, Bethesda, MD 20892, telephone 301/710-0267, email:
grantsinfo@nih.gov.  The PHS 398 form is also available at:
https://grants.nih.gov/grants/funding/phs398/forms_toc.html.

The title and number of the program announcement must be typed in line 2 on the
face page of the application and the YES box must be checked.

All grants will be awarded as modular grants.  The modular grant concept
establishes specific modules (increments) in which direct costs may be requested
and a maximum level for requested direct cost.  Only limited budgetary
information is required in the application; a detailed budget need not be
provided.

BUDGET INSTRUCTIONS

Sample budgets and justification page will be provided upon request from Ms.
Victoria Price at the address listed under INQUIRIES.

The total direct costs must be requested in accordance with the program
guidelines and the modifications made to the standard PHS 398 application
instructions described below:

o  FACE PAGE
As a reminder, Item 7 should be completed to indicate Modular Direct Costs
requested and Item 8 should reflect Total Costs (Modular Direct plus F&A costs).

o  DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD
Do not complete Form Page 4 of the PHS 398 (rev 5/95).  It is not required nor
will it be accepted at the time of application.

o  BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT
Do not complete the categorical budget tables on Form page 5 of the PHS 398 (rev.
5/95).  Only the requested total direct costs line for each year must be
completed based on the number of $25,000 modules being requested.  Applicants may
not request a change in the amount of each module.  A maximum of 8 modules
($200,000 direct costs) per year may be requested and each applicant may request
up to FIVE years of support for this PA.  Generally, the direct cost budgets will
remain constant throughout the life of the project (i.e., the same number of
modules requested for all budget periods).  Any necessary escalation (e.g., cost
of living increases) should be considered when determining the number of modules
to be requested.  However, in the event that the nature of the research proposed
requires an increase in the number of modules requested in any future year, the
increase must be clearly stated in the application and a clear justification must
be provided.  Total Direct Costs for the Entire Proposed Project Period should
be shown in the box provided.

o  BUDGET JUSTIFICATION

-  Budget justifications should be provided under "Justifications" on Form Page
5 of the PHS 398.

-  List the names, role on the project and proposed percent effort for all
project personnel (salaried or unsalaried) and provide a narrative justification
for each person based on his/her role on the project.  Under the justification
for the principal investigator, indicate if you are a new investigator (i.e., an
investigator without prior R29 or R01 support).

-  Identify all consultants by name and organizational affiliation and describe
the services to be performed.

-  Provide a general narrative justification for individual categories
(equipment, supplies, etc.) required to complete the work proposed.  More
detailed justifications should be provided for high cost (over $50,000) items. 
Any large one-time purchases, such as large equipment requests, must be
accommodated within these limits.

o  CONSORTIUM/CONTRACTUAL COSTS - If collaborations or subcontracts are involved
that require transfer of funds from the grantee to other institutions, it is
necessary to establish formal subcontract agreements with each collaborating
institution.  A letter of collaboration from each collaborating institution
should be submitted with the application.  Only the percentage of the
consortium/contractual TOTAL COSTS (direct and indirect) relative to the total
DIRECT COSTS of the overall project needs to be stated at this time. The
following example should be used to indicate the percentage cost of the
consortium, "The consortium agreement represents 27% of the overall $175,000
direct costs requested in the first year."  A budget justification for the
consortium should be provided as described in the "Budget Justification" section
above (no Form Page 5 required for the consortium).  Indicate whether the
consortium will be in place for the entire project period and identify any future
year changes in the percentage relative to the parent grant.

If there is a possibility for an award, the applicant will be requested to submit
a budget page identifying the actual direct and indirect costs for all years of
the consortium.  Total subcontract costs need not be calculated in $25,000
modules.  However, when subcontract funds are added to the parent grant budget,
the total direct cost amount must be included in the number of $25,000 modules
requested.

o  BIOGRAPHICAL SKETCH - A biographical sketch is required for all key personnel,
following the modified instructions below.  Do not exceed the two-page limit for
each person.

-  Complete the educational block at the top of the form page;

-  List current position(s) and those previous positions directly relevant to the
application;

-  List selected peer-reviewed publications directly relevant to the proposed
project, with full citation;

-  The applicant has the option to provide information on research projects
completed and/or research grants participated in during the last five years that
are relevant to the proposed project.

o  OTHER SUPPORT - Do not complete the "Other Support" pages (Form Page 7). 
Selected other support information relevant to the proposed research may be
included in the Biographical Sketch as indicated above.  Complete Other Support
information will be requested by NCI staff if there is a possibility for an
award.

o  CHECKLIST - No "Checklist" page is required as part of the initial
application.  A completed Checklist will be requested by NCI staff if there is
a possibility for an award.

o  The applicant should provide the name and phone number of the individual to
contact concerning fiscal and administrative issues if additional information is
necessary following the initial review.

Applications not conforming to these guidelines will be considered unresponsive
to this PA and will be returned without further review.

The completed original application and three legible copies must be sent or
delivered to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040-MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)

At the time of submission, two additional copies of the application must also be
sent to:

Ms. Toby Friedberg
Division of Extramural Activities
National Cancer Institute
6130 Executive Boulevard, Room 636
Bethesda, MD  20892-7399
Rockville, MD  20852 (for express/courier service)

REVIEW CONSIDERATIONS

Applications will be reviewed for scientific and technical merit by the Division
of Extramural Activities of the National Cancer Institute, in accordance with the
standard NIH peer review procedures.  Following scientific-technical review, the
applications will receive a second-level review by the National Cancer Advisory
Board.

As part of the initial merit review, a process may be used by the initial review
group in which applications will be determined to be competitive or non-
competitive based on their scientific merit relative to other applications
received in response to the PA.  Applications judged to be competitive will be
discussed and be assigned a priority score.  Applications determined to be non-
competitive will be withdrawn from further consideration and the Principal
Investigator and the official signing for the applicant organization will be
notified.

The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.

Simplified peer review criteria will be for these applications, as follows:

1.  The merit of and need for the proposed resource, including: design of the
resource, conceptual framework and approaches, added benefit of the resource to
the user projects, and evidence that the user needs could not be easily satisfied
in other ways

2.  Plans to oversee operation of the resource and organizational plans for
implementing them, including plans for providing researchers with the reagents
or services, plans to maintain quality control, procedures for evaluating
requests to use the resource and other pertinent factors to assure quality and
equitable access to the resource

3.  Qualifications of the resource leader(s) and key personnel

4.  Overall scientific quality of the scientists and funded projects proposed to
utilize the resource

5.  Adequacy of the facilities

These applications will be reviewed as modular research grants.  There will be
no requirement for or review of a detailed, itemized budget; budget cuts will be
made in $25,000 increments according to the reviewers' perception of appropriate
cost, need, and quality.

For projects exceeding the $200,000 cap, there must be documentation of
institutional or other co-funding to cover the costs above the cap.

The initial review group will also examine the provisions for the protection of
human and animal subjects, the safety of the research environment, and the
adequacy of plans to include both genders, minorities and their subgroups, and
children as appropriate for the scientific goals of the research or justification
for exclusions.  Plans for recruitment and retention of subjects will also be
evaluated.

AWARD CRITERIA

Applications will compete for available funds with all other approved
applications.  The following will be considered in making funding decisions: 
Quality of the proposed resource as determined by peer review, availability of
funds, and programmatic needs.

INQUIRIES

Inquiries are encouraged.  The opportunity to clarify any issues or questions
from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Roger L. Aamodt, Ph.D.
Division of Cancer Treatment and Diagnosis
National Cancer Institute
6130 Executive Boulevard, Room 700
Bethesda, MD  20892-7399
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 496-7147
FAX:  (301) 402-7819
Email:  ra32u@nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Victoria Price
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Room 243
Bethesda, MD  20892-7399
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 496-7800 Ext. 252
FAX:  (301) 496-8601
Email:  vp14v@nih.gov

Direct Inquiries regarding review matters to:

Ms. Toby Friedberg
Division of Extramural Activities
National Cancer Institute
6130 Executive Boulevard, Room 636, MSC-7399
Bethesda, MD  20892-7399
Rockville, MD  20850 (for express/courier service)
Telephone:  (301) 496-3428
FAX:  (301) 402-0275
Email:  tf12w@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.394, 395.  Awards are made under authorization of the Public Health Service
Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC
241 and 285) and administered under PHS grants policies and Federal Regulations
42 CFR 52, 45 CFR Part 74 and part 92.  This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health Systems
Agency review.

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

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