COOPERATIVE HUMAN TISSUE NETWORK
 
Release Date:  March 23, 2000

RFA:  CA-01-009 (Reissued as RFA-CA-08-503)
 
National Cancer Institute
 
Letter of Intent Receipt Date:  July 13, 2000
Application Receipt Date:       August 17, 2000

PURPOSE

The Cancer Diagnosis Program of the National Cancer Institute invites 
applications for Cooperative Agreements from institutions capable of and 
interested in participating in the Cooperative Human Tissue Network (CHTN).  
The purpose of this existing national network is to collect and distribute 
benign, pre-cancerous and cancerous human tissue specimens for basic and 
developmental studies in cancer research.  The network was established to 
facilitate research by providing human tissue specimens to the general 
scientific community.  Since its establishment in 1987, the CHTN has provided 
more than 200,000 high quality specimens from a wide variety of organ sites to 
over a thousand investigators.  Basic and developmental studies in numerous 
areas of cancer research have been facilitated by the availability of these 
specimens.  The objective of this Request for Applications (RFA) is to 
continue and expand the network to ensure that specimens critical to progress 
in cancer research are available to the scientific community.

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, Cooperative Human Tissue 
Network, is related to the priority area of cancer.  Potential applicants may 
obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople/. 
 
ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic for-profit and non-profit 
organizations as well as those in Canada and Mexico, public and private, such 
as universities, colleges, hospitals, laboratories, units of State and Local 
governments, and eligible agencies of the Federal Government.  Applications 
with components involving countries other than Canada and Mexico may not be 
submitted.  Minority individuals, women, and persons with disabilities are 
encouraged to apply as Principal Investigators.

MECHANISM OF SUPPORT

The administrative and funding instrument to be used for this program will be 
a cooperative agreement (U01) in which substantial NIH scientific and/or 
programmatic involvement with the awardee during performance of the activity 
is anticipated. The Principal Investigator defines the details of the project 
within the guidelines of the RFA, retains primary responsibility for the 
performance of the activity and agrees to accept the cooperation and 
assistance of NCI staff (through the NCI Program official) in the scientific 
and technical management of the project.  Details of the responsibilities, 
relationships and governance of the project to be funded under cooperative 
agreement(s) are discussed later in this document under the section "Terms and 
Conditions of Award."
 
The total project period for applications submitted in response to the present 
RFA may not exceed 5 years.  The anticipated award date is April 1, 2001.    

This RFA is a one-time solicitation.  If it is determined that there is a 
sufficient continuing program need, the NCI may re-compete this initiative 
through the cooperative agreement or other appropriate mechanism.

FUNDS AVAILABLE

The NCI intends to commit approximately $4 Million dollars in FY 2001 to fund 
5 to 7 new and/or competitive continuation grants in response to this RFA.  An 
applicant may request a project period of up to 5 years.  Because the nature 
and scope of the project proposed may vary, it is anticipated that the size of 
individual awards will also vary.  Although the financial plans of the NCI 
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. 
 
RESEARCH OBJECTIVES
 
Background

The Cooperative Human Tissue Network (CHTN) (http://www-chtn.ims.nci.nih.gov) 
was established by the NCI in 1987 to address the increasing demand by the 
scientific community for access to high quality human tissue specimens for 
cancer research.  Often researchers are unable to establish the necessary 
clinical collaborations for access to the specimens they need.  This 
cooperative network of tissue collection laboratories was established to make 
high quality human specimens available to the general scientific community for 
basic and developmental cancer research.  The CHTN currently consists of  a 
network of five institutions that collect specimens prospectively to meet 
researchers= requests.  Normal, benign, pre-cancerous and cancerous human 
tissue with associated histopathologic and demographic data is provided to 
researchers throughout North America. The CHTN is not a tissue bank, but does 
store limited numbers of specialized tumor types, such as rare pediatric 
tumors, to ensure their availability.   Four Divisions of the CHTN are each 
assigned a geographic area of the United States from which requests for 
researchers are received.  A fifth Division, the Pediatric Division, provides 
rare pediatric tumor specimens nationwide.  In order to serve investigators as 
rapidly as possible, specimen requests that cannot be filled within a few 
weeks by the assigned Division are "networked" to all Divisions. The existing 
network has demonstrated the feasibility of the network approach for 
responding to requests for specimens.  Systems have been developed to 
facilitate efficient communication among laboratories and to share tissue 
requests and determine specimen availability.  Since its creation in 1987, the 
CHTN has become a vital resource for the cancer research community. The CHTN 
has continued to grow, providing more than 50,000 specimens in 1999. 

Efforts to define the molecular signatures of cancer cells and the continued 
emphasis on the application of molecular and other emerging technologies to 
human specimens is expected to significantly increase the demand for 
specimens.  Services, such as tissue microarrays, microdissection services, 
and RNA/DNA preparations, may also be needed.  This RFA requests applications 
to continue and expand the network in order to ensure that the necessary 
resources are available to the scientific community.  The Network is expected 
to facilitate basic discovery in cancer research as well as the development 
and application of new technologies to clinical specimens. 

Objectives and Scope:  

This RFA requests applications for cooperative agreements from organizations 
(individual institutions or consortia) capable of and interested in 
participating in the Cooperative Human Tissue Network.  The major focus of 
this cooperative tissue collection and distribution network will be to 
continue and improve access to high quality human tumor tissue with associated 
histopathologic and demographic data. The NCI will fund 5 - 7 institutions to 
work together as a network to prospectively collect and distribute high 
quality tissue specimens to investigators throughout North America.  The 
Network will provide large numbers of tumor specimens from a wide variety of 
cancers and provide researchers with access to specimens of rare tumor types. 
Normal, malignant and benign human tissue will be collected and prepared to 
meet researcher requests.  Specimens will be excess materials collected during 
the course of routine medical care or at autopsy.   The Network will not 
function as a tumor bank, but may store specimens pending the completion of 
shipments and may bank rare tumors that would not otherwise be available.  
Pre-malignant lesions, when available, can also be stored for future 
distribution to facilitate early detection research.  The Network is intended 
to provide specimens for basic and developmental studies.  Therefore, data 
routinely provided with the specimens will generally be limited to 
histopathologic and demographic information such as diagnosis, sex, age and 
race. 

Members of the Network will be expected to collaboratively establish and 
implement appropriate procedures to collect, process and handle specimens to 
assure that they are of the highest quality and suitable for a wide variety of 
studies and technologies.   In order to ensure the availability of suitable 
specimens for patient diagnosis and quality control of research specimens, the 
Principal Investigator of each participating group must be an experienced 
surgical or anatomical pathologist, actively involved in the operation of a 
pathology laboratory that has demonstrated access to human cancer tissues.  
Applicant institutions with the necessary expertise may propose to provide 
additional services such as RNA/ DNA preparations, tissue microarrays, and/or 
laser capture microdissection, these services should be carefully described 
and justified.  Although separate awards will be made to a number of 
institutions, awardees will be required to work collaboratively with other 
Network members.   Requests for specimens will be shared by network 
participants so that requests can be filled more rapidly.  Existing software 
developed by the current network will be made available to allow all members 
of the network to share requests for specimens via a computer network linking 
the participating organizations.  

General operating policies for the Network will be established by a 
Coordinating Committee that will consist of the Principal Investigators, a 
second representative from each participating institution and a representative 
from the NCI.  The Coordinating Committee will establish standards for quality 
control, define equitable policies for distributing specimens, set processing 
and handling fees, develop biohazard procedures and establish policies to 
address the legal, ethical, and human subjects issues related to the use of 
human specimens for research.  

Awardees must agree to provide specimens to the scientific community without 
any requirement for collaboration.  The costs of processing and handling, 
shipping and other appropriate costs may be charged to researchers, in 
accordance with policies established by the Coordinating Committee. 

The Network is expected to remain responsive to changes in the science.  The 
Coordinating Committee will establish mechanisms to assess the changing 
specimen needs of the scientific community and make operational changes or 
modifications of CHTN services as needed to rapidly respond to those needs. 

The Network must meet the requirements of the federal human subjects 
regulations 45CFR46, (the Common Rule, 
http://grants.nih.gov/grants/oprr/humansubjects/45cfr46.htm).  Federal 
requirements to protect human subjects apply to a much broader range of 
research than many investigators realize, including research that uses human 
specimens (such as cells, blood, and urine), residual diagnostic specimens and 
medical information.  The NIH has developed a brochure entitled,  "Research on 
Human Specimens: Are You Conducting Research Using Human Subjects?" to help 
investigators understand how the human subjects regulations apply to the 
research use of  human specimens.  This brochure can be downloaded from 
http://www-cdp.ims.nci.nih.gov/policy.html or obtained from the program 
contact listed under INQUIRIES below.  

The Network is expected to address the evolving legal, ethical and human 
subjects policy issues related to the use of human specimens for research 
purposes.  These issues have been the subject of considerable discussion in a 
variety of settings (see The National Bioethics Advisory Commission report 
entitled Research Involving Human Biological Materials: Ethical Issues and 
Policy Guidance http://www.georgetown.edu/research/nrcbl/nbac/pubs.html).  
A consensus emerging from these discussions is that informed consent beyond that 
provided in the surgical consent form is desirable for research use of 
identifiable specimens collected during routine medical care.  To address this 
issue, the Network will be expected to develop and implement improved approaches
to obtain consent for future research use of tissue.  Applications submitted in 
response to this RFA must include plans to obtain consent for future research 
use of specimens collected on this project or to sever any link between the 
specimen to be distributed to the researcher and the identity of the patient.

SPECIAL REQUIREMENTS

The Principal Investigator of each application must be an experienced surgical 
or anatomical pathologist, actively involved in the operation of a pathology 
laboratory with demonstrated access to human cancer specimens.

Terms and Conditions of Award 

The cooperative agreements awarded under this RFA will require cooperation 
between an NCI representative (the Program Coordinator) and the principal 
investigators (PI) to administer the Network and assure smooth interactions 
among the cooperating institutions.  The Program Coordinator participates as a 
member of the Coordinating Committee and assists in advising the awardees and 
facilitating communications.  These responsibilities are described more fully 
below.

a.  Awardee Rights and Responsibilities

The principal investigator (PI) of a Cooperative Human Tissue Network award 
should be an experienced surgical or anatomic pathologist with demonstrated 
access to a wide range of human cancer tissues.  The PI retains primary 
responsibility for the performance of activities supported by each award.   
Two members of each awarded research group are required to serve as members of 
the CHTN Coordinating Committee (as stipulated below) to help formulate and 
implement CHTN operating policies.  Awardees are required to have access to 
appropriate cancerous and normal human tissue specimens and to make them 
available to the research community according to the policies established by 
the CHTN Coordinating Committee.  Awardees must agree to implement procedures 
to obtain consent for future research use of specimens or to sever the link 
between the specimens to be distributed to researchers and patient identities 
according to the policies and time frames established by the Coordinating 
Committee.   Each awardee is required to submit reports summarizing their 
individual activities to the Coordinating Committee, according to the formats, 
frequencies and time frames established by the Committee.  Awardees retain 
custody and primary rights to data developed under these awards, subject to 
government (e.g., NCI, NIH or PHS) rights of access, consistent with current 
DHHS, PHS and NIH policies. 

b.  NCI Staff Responsibilities

The Program Coordinator will be designated by the Associate Director of the 
Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis.  The 
Program Coordinator=s role, as detailed throughout these terms of cooperation, 
is to advise, assist and facilitate, but not to direct the activities of the 
Network.  The Program Coordinator will attend and participate as a voting 
member in all meetings of the Coordinating Committee, and provide liaison 
between the Coordinating Committee and the participating groups. The Program 
Coordinator will assist the Coordinating Committee in developing operating 
policies and procedures and assure that those policies are acceptable to the 
NCI.  The Program Coordinator may review the operations of individual 
laboratories for compliance with quality control standards and with operating 
policies developed by the Coordinating Committee.  The Program Coordinator may 
recommend withholding of support, suspension or termination of an award for 
failure to adhere to policies established by the Coordinating Committee.  The 
Program Coordinator monitors the operation of the Network and may request the 
Coordinating Committee to consider modification of operating policies as 
required to maintain quality control or to serve new research needs of the 
scientific community.  The Program Coordinator will also serve as the NCI 
Program Director for the normal stewardship responsibilities of the project.  
An arbitration process, detailed below, is available to resolve disagreements 
between awardees and NCI staff.

c.  Collaborative Responsibilities

A  Coordinating Committee will be established to oversee the operation of the 
network.  The Coordinating Committee will act as the governing body of the 
CHTN and all participants will be bound by its actions. The Coordinating 
Committee develops Network operating policies, which must be implemented by 
the PIs at each cooperating site.  The Coordinating Committee reviews the 
operating procedures of the participating sites to ensure that they are 
compatible with the overall goals and policies of the Network, the NCI and the 
NIH.   The Coordinating Committee will a) establish uniform standards and 
policies for tissue acquisition, processing, distribution and storage, b)  
develop uniform methods of histopathological diagnosis, and assure appropriate 
control of tissue quality, c) establish strategies to market the resource, d) 
 develop policies for addressing the legal, ethical and human subjects issues 
related to the use of human specimens for research and establish biohazard 
procedures, e) develop guidelines and standards for informatics and data 
management required for operation of the Network, and f) establish procedures 
for effective communication, and g) develop other network policies as needed. 
 
The Coordinating Committee will meet initially to plan for integration of any 
new cooperating institutions and/or phaseout of current institutions and to 
review and acccept or modify currently established operating procedures and 
policies.  The Coordinating Committee will meet at least twice a year.  The 
Coordinating Committee may establish subcommittees of the CHTN as necessary. 

d.  Arbitration

Disagreements between award recipients and the NCI with regard to 
scientific/programmatic  matters (within the scope of the award) or 
implementation of proposed operating policies may be brought to arbitration. 
An arbitration panel will be formed consisting of one member selected by the 
Coordinating Committee, one member selected by the NCI, and a third member 
chosen by the other two members of the arbitration panel. The NCI arbitration 
process for the Network  in no way affects the rights of awardees to appeal 
selected postaward administrative decisions in accordance with PHS regulations 
at 42 CFR part 50, subpart D and HHS regulations at 45 CFR part 16.

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.
 
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/notice-files/not94-100.html

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

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 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

URLS IN NIH GRANTS 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.

LETTER OF INTENT
 
Prospective applicants are asked to submit, by July 13, 2000, a letter of 
intent that includes a descriptive title of the proposed project, name, 
address, and telephone number of the Principal Investigator, identities of 
other key personnel and participating institutions, and 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 subsequent applications, the information allows NCI 
staff to estimate the potential review workload and and plan the review.
 
The Letter of Intent is to be sent to Ms. Marianna J. Bledsoe at the address 
listed under INQUIRIES by the letter of intent receipt date listed.
 
APPLICATION PROCEDURES
 
The research grant application form PHS 398 (rev. 4/98) is to be used in 
applying for these grants.  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, MSC 7910, Bethesda, MD 20892-7910, telephone 
301/435-0714, E-mail: grantsinfo@nih.gov.  For those applicants with internet 
access, the 398 kit may be found at http://grants.nih.gov/grants/forms.htm 

A number of specific points related to this RFA must be addressed in the 
application.

1.  Applicants should describe their ideas for how the network as a whole 
might operate and how their site will integrate with the other network sites. 
 Applicants should describe how the proposed plans will address the needs of 
the scientific community and facilitate research progress.

2.   Applicants should describe the services they can provide and how those 
services will address the needs of the scientific community.  Describe access 
to human specimens for cancer research, including the number and types of 
specimens with associated histopathologic and demographic data that could be 
made available.

3.  Describe in detail the procedures for collecting, processing and 
distributing specimens.  In particular:   a)  document the quality control 
procedures in place at each collecting site,  b) propose a system to 
prioritize access to specimens, c) describe how requests for specimens will be 
received and shared with other network participants, and d) describe existing 
or proposed information systems to manage the resource and how they would 
facilitate the operation of the network.

4.  Applicants should propose methods for marketing the resource to the 
scientific community and include appropriate costs in the budget.

5.  In the Research plans section, applicants must address their willingness 
to accept the Terms and Conditions of Award. 

a)  Applicants should clearly address their willingness to collaborate with 
the other awardees and to serve on the Coordinating Committee and to be bound 
by its decisions.  

b)  Applicants should also address the involvement of the NCI representative 
and how they will fulfill their responsibility to work together cooperatively 
with other network participants.

c) Applicants should describe the strengths they would bring to collaborative 
network activities such as establishing CHTN policies and priorities, assuring 
quality of network services, marketing the resource, developing information 
systems to manage the resource, monitoring progress, and developing strategies 
to ensure that the resource remains responsive to researchers= needs.

6) The background, qualifications, and experience of the PIs and other key 
personnel in the collection, processing, quality control and distribution of 
specimens for research should be well described.

7)   Applicants must complete the "Human Subjects" section of the PHS 398.  
Each application must include a full discussion of the procedures in place for 
protecting human subjects under 45CFR46 and for protecting patient 
confidentiality. 

8)  The application should address the legal, ethical and human subjects 
policies issues related to the use of specimens for research.  It must include 
a proposal for obtaining consent for future research use of tissue or a plan 
to sever the link between the specimens to be provided to the researcher and 
the identities of the patients.

9)  Each application must completely describe the representation of gender, 
minorities, and children in their patient populations.

10)  For competing renewal applications, the application should include a 
discussion of progress made by the individual collaborating group and the 
specific contributions of the individual collaborating group to the Network as 
a whole.  Collaborative activities among the network participants should be 
described.

Budgetary issues:

1)  Travel funds for two people to attend three Coordinating Committee 
meetings in the first year and two Coordinating meetings per year thereafter 
should be included as a budget line item.  Travel to national meetings to take 
part in exhibits to market the CHTN should also be included.  Travel for other 
purposes may be proposed with appropriate justification.  This includes, but 
is not limited to, travel for Coordinating Committee subcommittee meetings or 
other appropriate meeting travel.

2)  Budget items may be proposed, with appropriate justification, for expenses 
to be shared by all network members.  These include, but are not limited to, 
shared costs for administrative activities, database development and 
maintenance and marketing activities.  A detailed budget justification should 
be provided for each shared budget item requested.

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.
 
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 also 
be sent to:

Ms. Toby Friedberg 
Referral Officer 
Division of Extramural Activities 
National Cancer Institute 
6116 Executive Blvd., Room 8062, MSC-8239 
Rockville, MD 20852 (express courier)
Bethesda, MD 20892-8239

Applications must be received by August 17, 2000.  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 announcement 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.

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 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 meritorious 
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.
 
Significance: Will the resource, as proposed by the applicant,  help to 
fulfill the needs of the cancer research community?  To what extent will the 
proposed resource benefit the cancer research community?  Will the proposed 
resource support progress in cancer research?

Innovation:  Does this resource, as proposed by the applicant,  provide access 
to unique resources or provide services to the general cancer research 
community which would otherwise not be available?  Does this resource propose 
creative or improved methods, such as more efficient and effective means of 
collecting high quality specimens, new approaches for obtaining informed 
consent from human subjects and maintaining confidentiality, more efficient 
and effective methods of sharing specimen requests, improved information 
systems to support resources or more effective marketing techniques or 
strategies to utilize the resource?

Approach: Are the conceptual framework, design, methods and analyses of the 
resource as proposed by the applicant adequately well integrated and 
appropriate to the goals of the RFA?   What is the merit of the proposed plans 
for the collection and distribution of specimens?  Are appropriate plans in 
place to assure the collection of large numbers of high quality specimens with 
associated demographic and histopathologic data or rare specimens which would 
otherwise not be available?  What is the merit of the proposed plans for 
quality control of specimens and/or services?  Are the proposed procedures for 
the protection of human subjects and patient confidentiality appropriate?  Are 
the proposed procedures for the evaluation of requests for specimens and other 
services reasonable and equitable?  Are the plans for cooperation and 
coordination among participating awardees and the NCI well-described and are 
they likely to be effective?

Investigators:  Is the Principal Investigator an experienced anatomic and 
surgical pathologist with access to specimens?  Are the qualifications, 
experience and proposed responsibilities of the Principal Investigator and key 
support personnel well suited to organize and maintain the resource, maintain 
quality control and equitable access, and manage record keeping?

Environment:  Does the environment contribute to the probability of success?  
Are the facilities and equipment for the resource adequate?  Does the proposed 
resource take advantage of unique features of the institutional environment or 
employ useful collaborative arrangements?  Is there evidence of institutional 
and departmental support for the effort?  

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 recommended by the National Cancer Advisory Board will be 
considered for award based upon (a) scientific and technical merit, (b) 
program relevance and balance, including in this instance, sufficient 
compatibility of features to make a successful collaborative program a 
reasonable likelihood, and (c)  availability of funds. 

SCHEDULE
 
Letter of Intent Receipt:         July 13, 2000
Application Receipt Date:         August 17, 2000
Peer Review Date:                 October or November 2000
Review by NCAB Advisory Board:    February 14, 2001
Earliest Anticipated Start Date:  April 1, 2001
 
INQUIRIES
 
Written and telephone inquiries concerning this RFA are encouraged.  The 
opportunity to clarify  any issues or questions from potential applicants is 
welcome.
 
Direct inquiries regarding programmatic issues to:
 
Marianna Bledsoe, M.A.
Division of Cancer Treatment and Diagnosis
National Cancer Institute
Executive Plaza North, Room 700
6130 Executive Boulevard
Bethesda, MD  20892-7399
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 496-7147
FAX:  (301) 402-7819
Email: mb80s@nih.gov

Direct inquiries regarding review issues to:

Ms. Toby Friedberg 

Referral Officer 
Division of Extramural Activities 
National Cancer Institute 
6116 Executive Blvd., Room 8062, MSC-8239
Rockville, MD 20852 (express courier)
Bethesda MD 20892-8239
Telephone (301) 496-3428
Fax: (301) 402-0275
Email: tf12w@nih.gov

Direct inquiries regarding fiscal matters to: 
 
Ms. Eileen M. Natoli 
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
Bethesda, MD  20892 
Telephone:  (301) 496-8791 
Fax:  (301) 496-8601
Email: Natolie@gab.nci.nih.gov
 
AUTHORITY AND REGULATIONS
  
This program is described in the Catalog of Federal Domestic Assistance No. 
93.394 Cancer Detection and Diagnosis. 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 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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Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


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