SHARED RESOURCES FOR SCIENTISTS NOT AT NCI FUNDED CANCER CENTERS

Release Date:  February 14, 2001

RFA:  RFA-CA-01-020
 
National Cancer Institute
 
Letter of Intent Receipt Date:  June 5, 2001
Application Receipt Date:       July 10, 2001
 
PURPOSE
 
This Request for Application (RFA) requests applications to establish cancer-
related research resources to provide new sources of technical support and 
research materials to advance cancer research.  Increasing the availability of 
core resources is expected to improve the ability of cancer investigators to 
conduct research and to thereby facilitate scientific progress. To be 
eligible, applicant institutions must not have an NCI funded Cancer Center and 
the application must identify six or more NCI funded investigators who will 
utilize the services of the proposed resource.
 
RESEARCH OBJECTIVES
 
Background
 
This initiative continues a trans-NCI effort to provide support for shared 
resources that was initiated with two program announcements issued in 1998 and 
1999 (PAR98-092, PAR99-127).  Applicable resources 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 (e.g., RO1s). Support for shared resources is 
usually provided as part of: 1) National Cancer Institute (NCI) supported 
Cancer Centers or SPOREs, where shared resources benefit a wide range of 
basic, clinical, prevention and control research; 2) large multi-project 
program grants such as P01s; and 3) sophisticated shared equipment by the 
National Center for Research Resources (NCRR) at the NIH.  These opportunities 
are limited and/or unavailable to approximately half of the NCI-supported 
investigators, particularly those at institutions that do not have NCI funded 
Cancer Centers.

Objectives and Scope

The objective of this RFA is to provide an equal opportunity to establish 
shared resources for scientists doing cancer relevant research in institutions 
that do not have an NCI funded Cancer Center.  It is anticipated that the 
availability of core resources will be of increasing importance as more and 
more sophisticated, high cost methodologies and technologies are introduced 
and become essential to the biomedical research enterprise.  Applicants can 
propose creating a completely new resource, adding a new component to an 
existing resource or expanding an existing resource to increase its cancer 
specific use.  To the extent possible, the expected utilization of the 
resource should be estimated and the basis for those estimates provided in the 
application.  The creation of a resource advisory group to oversee the 
operation of the resource is strongly encouraged. User charges are appropriate 
when their intent is to recapture costs of providing resource materials or 
services to the community.

Appropriate resources 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 animal models (e.g., transgenic, knockout and xenograft 
models and animals susceptible to cancer of particular tumor sites) to a 
defined group of researchers.  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. 

The resource should be available to investigators other than the six 
identified NCI funded users at the applicant institution (see Special 
Requirements below).  The resource can also be made available to 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 sufficient specimens were available, 
the resource could be made available to additional researchers, including 
those at other institutions.  

SPECIAL REQUIREMENTS

Required NCI Funded Users:
 
Applications for resources under this RFA must specify a group of six or more 
NCI funded users with appointments at the applicant institution.  The 
application must identify the six users, document their NCI funding (grant 
number, PI, title, abstract and end date) and clearly justify their need for 
the resource. Applicants must clearly describe the impact of the technology or 
instrumentation on ongoing research projects.  

Requests for Equipment, Administrative or Technology Development Costs:

Equipment and administrative and technology development costs are allowable 
under this RFA.  However applicants must demonstrate that the requested funds 
clearly relate to developing a resource that provides investigators with 
products or services.  Applications that request nothing more than the 
purchase of shared equipment or funds to cover administrative costs or funds 
to develop new technologies will not be considered responsive. 

MECHANISM OF SUPPORT

This RFA 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 RFA may not exceed 5 
years.  The anticipated award date is April 1, 2002.  Because the nature and 
scope of the research proposed in response to this RFA may vary, it is 
anticipated that the size of an award will vary also.    At this time, it is 
not known if competing renewal applications will be accepted and/or if this 
RFA will be reissued. 

Budget Caps: 

Institutional Cap:  An institution may submit more than one application, but 
the sum of all direct cost resource support, including third party Facilities 
and Administrative (F&A) 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 for the fiscal year in which the application is 
submitted).  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.   This cap applies only to annual regular operating 
costs and does not include the one-time purchase of equipment.

Individual Cap: Applications in response to this RFA are limited to $200,000 
direct cost including any requested equipment.  Projects that exceed this 
amount must provide evidence of funding from another source for costs in 
excess of the individual cap.

FUNDS AVAILABLE
 
The NCI intends to commit approximately $3,000,000 in FY 2002 to fund 10 to 15 
new and/or competing continuation grants in response to this RFA.  An 
applicant may request a project period of up to 5 years and a budget for 
direct costs of up to $200,000 per year, excluding Facility and Administrative 
costs on consortium arrangements.  Because the nature and scope of the 
research proposed may vary, it is anticipated that the size of each award will 
also vary.  Although the financial plans of the NC I provide support for this 
program, awards pursuant to this RFA are contingent upon the availability of 
funds and the receipt of a sufficient number of meritorious applications.

ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by domestic 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. 
Racial/ethnic minority individuals, women, and persons with disabilities are 
encouraged to apply as Principal Investigators.  Institutions with currently 
funded P30 Cancer Center Support Grants are not eligible.  Only domestic 
institutions are eligible to apply.

INQUIRIES
 
Inquiries concerning this RFA are encouraged.  The opportunity to clarify any 
issues or questions from potential applicants is welcomed.

Direct inquiries regarding programmatic issues to:
 
Roger L. Aamodt, Ph.D.      
Division of Cancer Treatment and Diagnosis 
National Cancer Institute 
6130 Executive Boulevard, Room 6035A
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 
6116 Executive Blvd., Room 8109, MSC-8329
Rockville, MD 20852 (express courier)
Bethesda MD 20892-8329
Telephone (301) 496-3428
Fax: (301) 402-0275
Email: tf12w@nih.gov

Direct inquiries regarding fiscal matters to:

Debbie Dunne
Grants Administration Branch 
National Cancer Institute 
6120 Executive Boulevard, 
Room 243 
Rockville, MD  20852 (express/courier)
Bethesda, MD  20892-7399 
Telephone:  (301) 496-3154 
FAX:  (301) 496-8601 
Email: Dunned@mail.nih.gov 

LETTER OF INTENT

Prospective applicants are asked to submit, by June 5, 2001, 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 RFA 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 plan the review.
 
The letter of intent is to be sent to Roger Aamodt at the address  listed 
under INQUIRIES by the letter of intent receipt date.
 
SCHEDULE

Letter of Intent Receipt:         June 5, 2001
Application Receipt:              July 10, 2001
Peer Review Date:                 October/November 2001
Review by NCAB Advisory Board:    February 2002
Earliest Anticipated Start Date:  April 2002
 
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 RFA label available in the PHS 398 (rev. 4/98) application form must be 
affixed to the bottom of the face page of the application.  Type the RFA 
number on the label.  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 RFA title and number must be typed on 
line 2 of the face page of the application form and the YES box must be 
marked.  The sample RFA label available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to 
allow for this change. Please note this is in pdf format.

Applicants should completely describe the proposed resource, identify 
potential users and clearly document their procedures for determining who may 
have access to the products or services that will be provided by the resource.  
It is important that the application clearly describes the user community and 
the benefits of the proposed resource to that community.  Plans to manage the 
resource, set standards, provide quality control and address other critical 
factors must also be provided.

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
(20817 for express service)

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

Ms. Toby Friedberg
Referral Officer 
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8109, MSC 8329
Bethesda, MD  20892-8329
Rockville, MD  20852 (for express/courier service)

Applications must be received by July 10, 2001.  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 RFA that is essentially the same as one currently pending initial 
review, unless the applicant withdraws the pending application.  The CSR will 
not accept any application that is essentially the same as one already 
reviewed.  This does not preclude the submission of substantial revisions of 
applications already reviewed, but such applications must include an 
introduction addressing the previous critique.
 
REVIEW CONSIDERATIONS
 
Upon receipt, applications will be reviewed for completeness by CSR and 
responsiveness by the National Cancer Institute.  Incomplete and/or non-
responsive applications will be returned to the applicant without further 
consideration.  

Applications that are complete and responsive to the RFA will be evaluated for 
scientific and technical merit by an appropriate peer review group convened by 
the Division of Extramural Activities of the National Cancer Institute in 
accordance with the review criteria stated below.  As part of the initial 
merit review, all applications will 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 second level review by the 
National Cancer Advisory Board (NCAB).
 
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 better 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.

Review Criteria
 
The five criteria to be used in the evaluation of grant applications are 
listed below.
 
1.  Significance: 

o  Does the proposed resource address an important scientific need?

o  Is the need for the proposed resource adequately justified?

o  What is the evidence that user needs could not have been easily 
satisfied in other ways?

o  What is the added benefit of the resource to the user projects?

o  Will the resource materially advance progress in the field?

2.  Innovation: 

o  Does this application propose a new type of resource not previously 
available?
 
o  Does this resource propose novel 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.) 

o  Is the conceptual framework for the resource well thought out? 

o  Are appropriate plans in place for record-keeping  and/or acquiring 
reagents, biological constructs, animals, assays, specimens, data, 
technologies, etc.?

o  What procedures are in place for evaluating requests to use the 
resource? 

o  What plans are described to assure quality control and equitable access 
to the resource? 

4.  Investigators: 
What are the qualifications of the resource leader(s) and key personnel to 
organize and maintain the resource, maintain quality control and equitable 
access, and manage record-keeping.
 
5.  Environment: 
Is the environment adequate? For example, describe the adequacy of the 
facilities and equipment for the resource, and outside scientific expertise, 
if any, to advise on governance, management and function of the resource.

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

o  The adequacy of plans to include both genders and minorities and their 
subgroups as appropriate for the scientific goals of the research.  Plans for 
the recruitment and retention of subjects will also be evaluated

o  The reasonableness of the proposed budget and duration in relation to the 
proposed research

o  The adequacy of the proposed protection of humans, animals or the 
environment., to the extent they may be adversely affected by the project 
proposed in the application.
  
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.       

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 sub- populations 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 indicating 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 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); 
a complete copy of the updated Guidelines is available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The 
revisions relate to NIH defined Phase III clinical trials and require: a) all 
applications or proposals and/or protocols to provide a description of plans 
to conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethnic groups, including subgroups if applicable; and b) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.

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/guide/notice-files/not98-024.html. 

Investigators may also obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.

REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS

All investigators proposing research involving human subjects should read the 
policy that was published in the NIH Guide for Grants and Contracts, June 5, 
2000 (Revised August 25, 2000), available at the following URL address 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

URLS IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained within 
specified page limitations.  Unless otherwise specified in an NIH 
solicitation, Internet addresses (URLs) should not be used to provide 
information necessary to the review because reviewers are under no obligation 
to view the Internet sites.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

HEALTHY PEOPLE 2010

The Public Health Service (PHS) is committed to achieving the health promotion 
and disease prevention objectives of "Healthy People 2010," a PHS-led national 
activity for setting priority areas. This RFA, SHARED RESOURCES FOR SCIENTISTS 
NOT AT NCI FUNDED CANCER CENTERS, is related to priority area of cancer.  
Potential applicants may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople/.
 
AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance Nos. 
93.393, 93.394, 93.395, 93.396 and 93.399.   Awards are made under 
authorization of Sections 301 and 405 of the Public Health Service Act as 
amended (42 USC 241 and 284) and administered under NIH grants policies and 
Federal Regulations 42 CFR 52 and 45 CFR Parts 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 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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