MOLECULAR AND CELLULAR BIOLOGY OF METASTATIC TUMOR CELLS
 
Release Date:  November 21, 2000

PA NUMBER:  PA-01-020
 
National Cancer Institute
National Institute of Diabetes and Digestive and Kidney Diseases

THIS PA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES 
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED 
WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA.

This Program Announcement (PA) replaces PA-98-029, which was published in NIH 
Guide Feb 27, 1998.
 
PURPOSE
 
The National Cancer Institute (NCI) and the National Institute of Diabetes 
and Digestive and Kidney Diseases (NIDDK) invite exploratory/developmental 
grant applications to study the molecular and cellular biology of metastatic 
tumor cells.  This special initiative is designed to promote collaborations 
and facilitate scientific interchange between investigators, one with 
experience in the biology of metastasis and the other in a more basic 
scientific discipline such as molecular or cellular biology, or biochemistry.  
Therefore, prospective
Principal Investigators need to identify a research collaborator.

This PA will expire on October 2, 2002, unless reissued.  NIH Grants policies 
apply to these awards.

RESEARCH OBJECTIVES

The goal of this initiative is to provide funds for preliminary research 
projects that will form the basis of future R01 applications to investigate 
metastasis.  The intent is to (1) foster collaborative research between 
investigators with basic molecular and cellular biological and biochemical 
research experience, and those with experience in metastasis research, and 
(2) increase the number of laboratories and investigators addressing issues 
of metastasis.

The scope of the research may encompass the application of any aspect of 
molecular and cellular biology and biochemistry to the investigation of 
metastasis biology. Bone is a major site of metastasis for many tumors, 
particularly hormone responsive tumors such as prostate and breast.   NCI and 
NIDDK are interested in fostering collaborations among bone endocrinologists 
and cancer researchers to exploit the implications of new understanding of 
hormonal regulation of  bone cells and matrix for inhibiting metastasis to 
bone.  Applications should be for preliminary data gathering or pilot 
feasibility studies, and should be founded on the combined research 
experience of the Principal Investigator and his/her collaborator.  The 
application should specifically address how the application meets the intent 
of the initiative, e.g., the development of a new collaboration between an 
investigator with basic molecular and cellular biological and biochemical 
research experience and one with experience in metastasis research.  
Furthermore, the research collaborator should address how the proposed 
research will relate
to and integrate with other ongoing research in his/her laboratory.  Just as 
the initiative is intended to foster a research collaboration, the 
application itself should clearly be the product of in-depth discussions and 
input from both the research collaborator and the Principal Investigator.

MECHANISM OF SUPPORT

Support of this program will be through the National Institutes of Health 
(NIH)
exploratory/development research grant (R21).  Applicants will be responsible 
for the planning, direction, and execution of the proposed project. Awards 
will be administered under NIH grants policy as stated in the NIH Grants 
Policy Statement, NIH Publication No. 99-8, October 1998.

The Exploratory/Developmental Research Grants program (R21) provides limited 
funds for short-term research projects.  These grants provide an opportunity 
for initiating studies that may be preliminary in nature.  Research 
investigators in relevant fields are invited to apply for these grants in 
order to develop preliminary data that could form the basis of future 
research project grant (R01) applications.

The direct costs per year for each application funded by the NCI must not 
exceed $75,000.  The total project period for an application funded by the 
NCI in response to this PA may not exceed two years and is not renewable.

The Principal Investigator must be accountable to the applicant organization 
officials for the proper conduct of the project.  The research collaborator 
must be named and their time and effort should be listed on the budget page.

Specific application instructions have been modified to reflect "MODULAR 
GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. 
Complete and detailed instructions and information on Modular Grant 
applications can be found at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by foreign and 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.  Racial/ethnic minority individuals, 
women, and persons with disabilities are encouraged to apply as principal 
investigators. 

INQUIRIES
 
Inquiries are encouraged.  The opportunity to clarify any issues or questions 
from potential applicants is welcome.
 
Direct inquiries regarding programmatic issues to:
 
Suresh Mohla, Ph.D.
Chief, Tumor Biology and Metastasis Branch
Division of Cancer Biology
National Cancer Institute
EPN, Suite 5000
Bethesda, MD  20892
Telephone:  (301) 435-1878
FAX:  (301) 480-0864
Email:  sm82e@nih.gov
 
Direct inquiries regarding fiscal matters to:
 
Mr. Brian Albertini
Grants Management Specialist
National Cancer Institute
Executive Plaza South, Room 243
Bethesda, MD  20892
Telephone:  (301) 496-7239
Email:   albertib@gab.nci.nih.gov

Direct inquiries regarding programmatic issues for NIDDK  to:

Ronald Margolis, Ph.D.
Senior Advisor, Molecular Endocrinology
Division of Diabetes, Endocrinology, and Metabolism
NIDDK 
6707 Democracy Boulevard, Rm. 6107 MSC 5460
Bethesda, MD 20892-5460
Telephone:  (301) 594-8819
FAX:  301-435-6047
E-mail:  rm76f@nih.gov

Direct inquiries regarding fiscal matters for NIDDK  to:

Cheryl Chick
Division of Extramural Activities 
NIDDK
6707 Democracy Boulevard, Rm. 606 MSC 5460
Bethesda, MD 20892-5460
Telephone:  (301) 594-8825
FAX:  301-480-3504
E-mail:  ChickC@extra.niddk.nih.gov
 
APPLICATION PROCEDURES
 
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, reviewers and Institute 
staff. The research grant application form PHS 398 (rev. 4/98) is to be used 
in applying for these grants, with the modifications noted below. 
Applications will be accepted at the standard application deadlines (February 
1, June 1 and October 1) as indicated in the application kit. 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.

Applicants are strongly encouraged to call the program contacts listed in 
INQUIRIES below with any questions regarding the adherence to the guidelines 
of their proposed project to the goals of this PA.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS 

BUDGET INSTRUCTIONS

Modular Grant applications will request direct costs in $25,000 modules, up 
to a total direct cost request of $75,000 per year. 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:  Items 7a and 7b should be completed, indicating Direct Costs 
(in $25,000 increments) and Total Costs [Modular Total Direct plus Facilities 
and Administrative (F&A) costs] for the initial budget period.  Items 8a and 
8b should be completed indicating the Direct and Total Costs for the entire 
proposed period of support.

o  DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 
4 of the PHS 398.  It is not required and will not be accepted with the 
application.

o  BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the
categorical budget table on Form Page 5 of the PHS 398.  It is not required 
and will not be accepted with the application.

o  NARRATIVE BUDGET JUSTIFICATION -  Prepare a Modular Grant Budget Narrative 
page (see http://grants.nih.gov/grants/funding/modular/modular.htm for sample 
pages). At the top of the page, enter the total direct costs requested for 
each year.  This is not a form page.

o  Under Personnel, list all project personnel, including their names, 
percent of effort, and roles on the project. No individual salary information 
should be provided. However, the applicant should use the NIH appropriation 
language salary cap and the NIH policy for graduate student compensation in 
developing the budget request.

For Consortium/Contractual costs, provide an estimate of total costs (direct 
plus facilities and administrative) for each year, each rounded to the 
nearest $1,000. List the individuals/organizations with whom consortium or 
contractual arrangements have been made, the percent effort of all personnel, 
and the role on the project. Indicate whether the collaborating institution 
is domestic or foreign.  The total cost for a consortium/contractual 
arrangement is included in the overall requested modular direct cost amount. 
Include the Letter of Intent to establish a consortium.

Provide an additional narrative budget justification for any variation in the 
number of modules requested.

o  BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by 
reviewers in the assessment of each individual's qualifications for a 
specific role in the proposed project, as well as to evaluate the overall 
qualifications of the research team.  A biographical sketch is required for 
all key personnel, following the instructions below.  No more than three 
pages may be used for each person.  A sample biographical sketch may be 
viewed at:  http://grants.nih.gov/grants/funding/modular/modular.htm.

- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on 
research
projects ongoing or completed during the last three years;
- List selected peer-reviewed publications, with full citations.

o  CHECKLIST -  This page should be completed and submitted with the 
application. If the F&A rate agreement has been established, indicate the 
type of agreement and the date. All appropriate exclusions must be applied in 
the calculation of the F&A costs for the initial budget period and all future 
budget years.

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 title and number of the PA 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 five signed, exact, single-sided 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) 
  
REVIEW CONSIDERATIONS
 
Applications will be assigned on the basis of established PHS referral 
guidelines. Applications will be evaluated for scientific and technical merit 
by an appropriate scientific review group convened in accordance with the 
standard NIH peer review procedures. 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 applications under review, will be discussed, 
assigned a priority score, and receive a second level review by the 
appropriate national advisory council or board.  

Review Criteria
 
The five criteria to be used in the evaluation of grant applications are 
listed below.
 
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 this study address an important problem? If the aims 
of the application are achieved, how will scientific knowledge be advanced?  
What will be the effect of these studies on the concepts or methods that 
drive this field?
 
2.  Approach.  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics?
 
3.  Innovation.  Does the project employ novel concepts, approaches or 
method?  Are the aims original and innovative? Does the project challenge 
existing paradigms or develop new methodologies or technologies?
 
4.  Investigator.  Is the investigator appropriately trained and well suited 
to carry out this work?  Is the work proposed appropriate to the experience 
level of the principal investigator and other researchers (if any)?
 
5.  Environment.  Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements? Is there evidence of institutional 
support?

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, and children as appropriate for the 
scientific goals of the research and plans for the recruitment and retention 
of subjects;  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 approved 
applications.  The following will be considered in making funding decisions:  
Quality of the proposed project as determined by peer review, availability of 
funds, and program priority.

The following additional factors will be considered for applications assigned 
to
the NCI:

--In order to increase the number of laboratories and investigators with 
potential for a long-term commitment to metastasis research, preference in 
funding will be given to those investigators that are early in their research 
careers

--The extent to which the proposed research develops collaborations that 
address the purpose of the initiative

--How the proposed research relates to and integrates with other ongoing 
research in the research collaborator's laboratory

Applications will compete for available funds with all other recommended 
applications assigned to that IC.  The following will be considered in making 
funding decisions:  Quality of the proposed project 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 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 
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 are 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 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. 

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.

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 PA, MOLECULAR AND 
CELLULAR BIOLOGY OF METASTAIC CELLS, 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 No. 
93.396, Cancer Biology, and  No. 93.847 for the Division of Diabetes, 
Endocrinology, and Metabolic Diseases in NIDDK.  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 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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