SHARED RESOURCES FOR SCIENTISTS OUTSIDE NCI CANCER CENTERS

Release Date:  July 13, 1999

PA NUMBER:  PAR-99-127

National Cancer Institute

Letter of Intent Receipt Date:  October 21, 1999
Application Receipt Date:  November 18, 1999

This program announcement (PA) replaces PAR-98-092, which was published in NIH
Guide on July 23, 1998.

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 National Cancer
Institute (NCI) supported 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 equipment to the National
Center for Research Resources (NCRR) at the NIH.  These opportunities are
limited and unavailable to approximately half of the NCI-supported
investigators, particularly those at institutions without NCI funded Cancer
Centers.

The objective of this PA is to provide institutions that do not have NCI
funded Cancer Centers or planning grants with additional shared resource
support.  Increasingly, the availability of core resources can be 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.  To be eligible, applicants must identify six or
more NCI funded investigators (principal investigators of R01 or P01 grants or
NCI contracts) who will utilize the services of the proposed resource.

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), or at
http://www.crisny.org/health/us/health7.html.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic, for-profit and non-profit
organizations, public and private, 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 R01, P01 or N01 principal investigators have need
for the proposed resource.  In addition to the core user group of six or more
funded investigators, the resource should be made available to additional
users at the applicant institution and may be opened 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 Cancer Center Planning Grants (P20).  NOTE that there is also a cap on the
direct cost amount of all applications from any applicant institution, based
on the total NCI funding received by that institution.

MECHANISM OF SUPPORT

This PA will use the National Institutes of Health (NIH) research resource
grant (R24).  Responsibility for the planning, direction, and execution of the
proposed project will be solely that of the applicant.  The total project
period for an application submitted in response to this PA may not exceed 5
years.  The anticipated award date is July 2000.

Because the nature and scope of the research proposed in response to this PA
may vary, it is anticipated that the size of an award will vary also.  This PA
is one-time solicitation.  Future unsolicited competing continuation
applications will compete with all investigator-initiated applications and be
reviewed according to the customary peer review procedures.

BUDGET CAP: The funds requested should be based on the requirements of the 
project and the requested costs should be fully justified.  NCI direct cost 
support for each individual application will be limited to $200,000.  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.  An 
institution may submit multiple applications, but the sum of all direct cost 
resource support, including third party indirect costs, requested cannot exceed 
10% of its total NCI direct cost research base at the time of submission 
(funding for all grant and contract mechanisms).  If multiple research grants 
are submitted, each must have a different principal investigator and must 
provide substantially different products or services.  While the same 
individuals may be listed among the six NCI supported users on more than one 
application, their need for each resource must be clearly justified.  The 10% 
institutional cap applies only to annual regular operating costs and does not 
include a one-time purchase of equipment.

RESEARCH OBJECTIVES

Background

Applications are sought to establish resources to facilitate cancer research. 
Applications for resources under this PA must define a group of six or more
NCI funded investigators located at the applicant institution.  The need for
the resource by the defined group of funded investigators must be clearly
justified, the six or more users identified and their NCI funding documented
(grant number, PI, title, abstract and end date) in the application.  The
resource should be made available to other investigators at the applicant
institution and may be made available to other users beyond the applicant
institution or to the entire research community.  For example, a defined group
of eight NCI funded investigators could develop an effective shared collection
and distribution system to provide efficient access to appropriate colon
cancer specimens.  If there were sufficient specimens available, the resource
could be made available to additional researchers, including those at other
institutions.  The creation of a resource advisory group is strongly
encouraged.  In addition applicants should clearly document the procedures
that they will put in place to determine who may have access to products or
services from the proposed resource.  User charges are appropriate when the
intent is to recapture costs of providing resource materials or services to
the community.  To the extent possible, the expected utilization of the
resource should be estimated and the basis for those estimates provided in the
application

Appropriate resources include, but are not limited to the following:

- 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.

- 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.

- 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.

- 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.

- 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.

- 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 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, available on the web at the following URL address:
http://grants.nih.gov/grants/guide/1994/94.03.18/notice-nih-guideline008.html

Investigators may also obtain copies of the policy from the program staff
listed under INQUIRIES.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by the
NIH, unless there are scientific and ethical 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://grants.nih.gov/grants/funding/children/children.htm

LETTER OF INTENT

Prospective applicants are asked to submit, by October 21, 1999, 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, the information that it contains allows
NCI staff to estimate the potential review workload and avoid conflict of
interest in the review.

The letter of intent is to be sent to the program staff listed under
INQUIRIES.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used in
applying for these grants.  Applications 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, MSC 7910, Bethesda, MD 20892-7910, telephone
301/435-0714, email: grantsinfo@nih.gov.  For those applicants with internet
access, the 398 kit may be found at http://grants.nih.gov/grants/forms.htm

The PA label available in the PHS 398 (rev. 4/98) application form must be
affixed to the bottom of the face page of the application.  Failure to use
this label could result in delayed processing of the application such that it
may not reach the review committee in time for review.  In addition, the PA
title and number must be typed on line 2 of the face page of the application
form and the YES box must be marked.

Submit a signed, typewritten original of the application, including the
Checklist, and three signed, photocopies, in one package to:

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

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

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

Applications must be received by November 18, 1999.  If an application is
received after that date, it will be returned to the applicant without review. 
The Center for Scientific Review (CSR) will not accept any application in
response to this PA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application.  The
CSR will not accept any application that is essentially the same as one
already reviewed.  This does not preclude the submission of substantial
revisions of applications already reviewed, but such applications must include
an introduction addressing the previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by CSR. 
Incomplete applications will be returned to the applicant without further
consideration.

Applications will be evaluated for scientific and technical merit by an
appropriate peer review group convened by the National Cancer Institute in
accordance with the review criteria stated below.  As part of the initial
merit review, a process will be used by the initial review group in which
applications receive a written critique and undergo a process in which only
those applications deemed to have the highest scientific merit, generally the
top half of the applications under review, will be discussed assigned a
priority score, and receive a second level review by the National Cancer
Advisory Board.

Review Criteria

The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.  The
reviewers will comment on the following aspects of the application in their
written critiques in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals.  Each of these
criteria will be addressed and considered by the reviewers in assigning the
overall score weighting them as appropriate for each application.  Note that
the application does not need to be strong in all categories to be judged
likely to have a major scientific impact and thus deserve a high priority
score.  For example, an investigator may propose to carry out important work
that by its nature is not innovative but is essential to move a field forward.

1.  Significance:  Does the proposed resource address an important scientific
need? Is that need adequately justified? Could the need have been easily
satisfied in other ways? Will the resource add benefit to the user projects?
Will the resource support progress in the field?

2. Innovation:  Does this application propose a resource not previously
available to the researcher users?  Does this resource propose creative or
improved methods, such as more effective means of collection, information
storage and retrieval, or advertisement and utilization strategies?

3.  Approach: (Plans to oversee operation of the resource and organizational
plans for implementing them.)  Are the conceptual framework, design, methods
and analyses for the resource adequately developed well integrated and
appropriate to the aims of the project?  Are appropriate plans in place for
acquiring reagents, biological constructs, animals, assays, specimens, data,
technologies, etc.  And or recordkeeping?  Are procedures in place for
evaluating requests to use the resource and assuring equitable access?  Are
plans described for appropriate quality control of the resource products or
services?

4. Investigators:  Are the qualifications of the resource leader(s) and key
personnel well suited to organize and maintain the resource, maintain quality
control and equitable access, and manage record keeping?

5. Environment:  Does the environment contribute to the probability of
success? Are the facilities and equipment for the resource adequate? Is
outside scientific expertise available to advise on governance, management and
function of the resource?  Does the proposed resource take advantage of unique
features of the institutional environment or employ useful collaborative
arrangements? Is there evidence of institutional support for this resource?

The initial review group will also examine: the appropriateness of proposed
project budget and duration; the adequacy of plans to include both genders and
minorities and their subgroups as appropriate for the scientific goals of the
research and plans for the recruitment and retention of subjects; the adequacy
of plans for including children as appropriate for the scientific goals of the
research, or justification for exclusion; the provisions for the protection of
human and animal subjects; and the safety of the research environment.

AWARD CRITERIA

Applications will compete for available funds with all other recommended
applications assigned to the NCI.  The following will be considered in making
funding decisions:  Quality of the proposed resource as determined by peer
review, availability of funds, and program priority.

SCHEDULE

Letter of Intent Receipt Date:    October 21, 1999
Application Receipt Date:         November 18, 1999
Review by NCAB Advisory Board:    June 2000
Earliest Anticipated Start Date:  July 2000

INQUIRIES

Inquiries are strongly encouraged to determine the responsiveness of proposed
applications to the PA.  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 review issues to:

Ms. Toby Friedberg
Referral Officer
Division of Extramural Activities
National Cancer Institute
Executive Plaza North, Room 636
6130 Executive Blvd., MSC-7399
Rockville, MD 20852 (express courier)
Bethesda MD 20892-7399
Telephone (301) 496-3428
Fax: (301) 402-0275
Email: tf12w@nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Kelli Oster
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. 261
FAX:  (301) 496-8601
Email: kelli.oster@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.394, 93.395.  Awards are made under authorization of the Sections 301 and
405 of the Public Health Service Act as amended (42 USC 241 and 284) and
administered under PHS grants policies and Federal Regulations 42 CFR 52 and
45 CFR Part 74 and 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 and contract recipients to provide a
smoke-free workplace and promote the non-use of all tobacco products.  In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking
in certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care or early
childhood development services are provided to children.  This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.


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