CANCER PREVENTION, CONTROL, BEHAVIORAL AND POPULATION SCIENCES CAREER 
DEVELOPMENT AWARD

RELEASE DATE:  February 03, 2004 (see extension of expiration date NOT-CA-06-024 and NOT-CA-06-009)

PA NUMBER:  PAR-04-055 (This PA has been reissued as PA-06-381)

EXPIRATION DATE:  June 1, 2006, unless reissued.

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION: 
National Institutes of Health (NIH) 
 (http://www.nih.gov)
 
COMPONENT OF PARTICIPATING ORGANIZATION:  
National Cancer Institute (NCI/NIH) 
 (http://www.nci.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER:  93.398

This Program Announcement (PA) replaces PAR-01-135, which was published 
in the NIH Guide on September 4, 2001.

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA

The purpose of the Cancer Prevention, Control, Behavioral and Population 
Sciences Career Development Award (K07) is to support the career 
development of investigators who have made a commitment to focus their 
research endeavors on cancer prevention, control, behavioral and the 
population sciences.   This is achieved by providing protected time 
through salary and research support for up to 5 years to individuals 
with a health professional or science doctoral degree who are 1) already 
proficient in GENERAL epidemiology, behavioral sciences, or other 
relevant disciplines, and now want to make use of these proficiencies in 
cancer-focused research careers in prevention, control, population 
and/or the behavioral sciences, or 2) already trained in cancer 
epidemiology, etiology, prevention, control and the behavioral and 
population sciences but are not yet fully independent investigators.  
Examples of relevant disciplines for this Program Announcement (PA) 
include any aspect of human cancer prevention (modifiable risk factors, 
new animal models and extrapolation of these models to human cancer, 
genetic predisposition to cancer and detection of precursor lesions, 
patient-oriented research focused on cancer prevention, and behavioral 
research and behavioral intervention trials in cancer prevention), 
epidemiology (biochemical, genetic, molecular), biostatistics, human 
cancer genetics, clinical oncology, human nutrition, behavioral and 
social sciences, health promotion, health services and health policy 
research; and medical decision analysis, survivorship and quality of 
life as they relate to cancer.

For the purpose of this PA, cancer control research is defined as "basic 
and applied research in the behavioral sciences that independently or in 
combination with biomedical approaches, reduces cancer risk, incidence, 
morbidity, and mortality across the lifespan and over the entire process 
of carcinogenesis from primary behavioral prevention in youth, to 
screening, treatment, and survivorship" (Report of the NCI Cancer 
Control Progress Review Group, 1998).  Additionally, patient-oriented 
research is defined as research conducted with human subjects (or on 
material of human origin such as tissues, specimens, and cognitive 
phenomena) for which an investigator directly interacts with human 
subjects.  This area of research includes 1) mechanisms of human 
disease; 2) therapeutic interventions; 3) clinical trials; and 4) the 
development of new technologies.

RESEARCH OBJECTIVES

Recognizing a need for training researchers in preventive oncology and 
the lack of multidisciplinary curricula that would be needed for this 
purpose, the National Cancer Institute (NCI) published in 1982 the 
announcement titled "Preventive Oncology Academic Award" (NIH Guide for 
Grants and Contracts, Vol. 11, No. 5, April 23, 1982).  This award 
(POAA) provided support for the development of institutional preventive 
oncology curricula focused specifically on etiologic studies and primary 
prevention of cancer.  In 1985, the NCI made two significant changes in 
the award.  First, the emphasis on support for institutional curriculum 
development was changed to support of research and career development of 
individuals who wanted to make a transition to cancer prevention and 
control research and to individuals already trained in cancer prevention 
and control who were not yet fully independent investigators.  Second, 
the original focus on cancer etiology and primary cancer prevention was 
expanded to include all cancer prevention and control sciences and 
technologies from hypothesis development through demonstration.

In 1998, the National Cancer Institute completed major external reviews 
of its programs in cancer prevention and control sciences.  The 
scientific experts who conducted these reviews identified the current 
level of support for training in cancer prevention and cancer control 
and the single discipline emphasis of these programs as being completely 
inadequate to take advantage of the new opportunities for reducing 
cancer incidence, morbidity and mortality. These experts recommended 
that the NCI increase its current level of support of education/training 
programs in cancer prevention and cancer control and generate new 
opportunities for multidisciplinary training in these disciplines of 
basic and clinical scientists in highly interdisciplinary and 
collaborative environments.  Similar recommendations regarding training 
opportunities in cancer prevention and control have been made by other 
NCI advisory groups.  In 1999, the NCI published a new K07 PA 
incorporating the recommendations made by these experts.  

The objective of the reissued K07 PA is to continue to provide a 
mechanism to support specialized didactic study and mentored research in 
scientific areas relevant to cancer prevention, cancer control, and 
behavioral and population sciences research.  Individuals lacking skills 
in data management, statistics, epidemiology, study design, clinical 
trial design, hypothesis development, etc., can be provided the 
opportunity to participate in courses designed to overcome these 
deficiencies.  The scope of the research and didactic training may 
extend from the development and experimental testing of hypotheses 
including chemoprevention trials, through the stage of confirming 
results using defined populations, to the development and demonstration 
of technology as applied to epidemiology, cancer prevention, cancer 
control, and the behavioral and population sciences as they relate to 
cancer.

MECHANISM OF SUPPORT 

This PA will use the NIH Cancer Prevention, and Control Career 
Development (K07) Award mechanism.  As an applicant, you will be solely 
responsible for planning, direction, and execution of the proposed 
program.  Applicants may request from 3 to 5 years of support.  The 
actual length of the awarded project period will depend upon the number 
of years of prior research experience and the need for additional 
experience to achieve independence.  Awards are not renewable.

This PA follows the Just-In-Time initiative for Career Awards published 
in the NIH Guide, Volume 25, Number 10, March 29, 1996. 
(http://grants.nih.gov/grants/guide/notice-files/not96-081.html). 
Applications submitted in accordance with PHS 398 (Rev. 05/2001), 
Section IV (Additional Instructions for Preparing Individual Research 
Career Award (RCA) Applications - "K" Series 
(http://grants.nih.gov/grants/funding/phs398/instructions2/p1_preparing
_individual_CDA_app.htm) are in compliance with the instructions provided in 
the 1996 Guide.  

ELIGIBLE INSTITUTIONS 

You may submit an application if your institution has any of the 
following characteristics:
   
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, 
hospitals, and laboratories 
o Units of State and local governments
o Domestic institutions/organizations
o Foreign institutions are not eligible to apply

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS  

To be eligible for an NCI K07 award, candidates must have a Ph.D. 
degree, a health professional doctoral (M.D., Dr.PH., D.D.S., D.O., 
D.V.M., Pharm. D.) degree, or equivalent, or be a doctorally prepared 
oncology nurse; and must have a research or academic appointment in the 
sponsoring institution at the time of award.  You must also be able to 
devote a minimum of 75 percent of  full-time professional effort to the 
K07 Award.  The remaining 25 percent effort can be divided among other 
research, clinical and teaching activities only if these activities are 
consistent with the goals of the K07 Award, i.e., the candidate's 
development into an independent investigator in cancer prevention, 
control, and the behavioral or population sciences. 

Only U.S. citizens or non-citizen nationals, or an individual lawfully 
admitted for permanent residence who possesses an Alien Registration 
Receipt Card (I-151 or I-551), or some other verification of legal 
admission as a permanent resident, are eligible for this award.  Non-
citizen nationals, although not U.S. citizens, owe permanent allegiance 
to the U.S.  They are usually born in lands that are not states, but are 
under U.S. sovereignty, jurisdiction, or administration.  Individuals on 
temporary or student visas are not eligible.   

Individuals from underrepresented racial and ethnic groups as well as 
individuals with disabilities are always encouraged to apply for NIH 
programs.

A candidate for an NCI K07 Award  may not simultaneously submit or have 
pending an application for any other PHS career award (e.g., K01, K08, 
K23), an NCI Transition Career Award (K22), a research project grant 
(R01, R03), or any PHS or non-Federal award that duplicates any of the 
provisions of  the K07 award.  However, K07 awardees may submit an 
application for an NCI Transition Career Development Award (K22), and 
are encouraged to actively seek independent support of their research 
programs through investigator-initiated grants during the term of this 
award.

Former or current principal investigators on any NIH research grants 
(this does not include NIH R03 or R21 grants or their equivalents) or 
non-PHS peer reviewed research grants that are over $100,000 direct 
costs per year, or project leaders on sub-projects of program project 
(P01) or center grants (P50) are NOT eligible to apply.  

SPECIAL REQUIREMENTS

A.  The sponsoring institution must have well-established research 
programs in basic, clinical, and/or cancer 
prevention/control/behavioral/population sciences.  This research 
environment should be one in which there are active research 
collaborations that exemplify a dynamic two-way exchange of information 
and ideas between laboratory and clinical and/or population research 
settings.  
  
B. Allowable Costs:

Salary:  The K07 Award will provide salary up to $75,000, plus fringe 
benefits.  The total salary requested must be based on a full-time, 12 
month staff appointment requiring the candidate to devote a minimum of 
75 percent of full-time professional effort to conducting cancer 
research with the remaining effort being devoted to activities related 
to the development of a successful research career.  The salary must be 
consistent both with the established salary structure at the institution 
and with salaries actually provided by the institution from its own 
funds to other staff members of equivalent qualifications, rank, and 
responsibilities in the department concerned.  If full-time, 12-month 
salaries are not currently paid to comparable staff members, the salary 
proposed must be appropriately related to the existing salary structure.

The institution may supplement the NIH salary contribution up to a level 
that is consistent with the institution's salary scale; however, 
supplementation may not be from Federal funds unless specifically 
authorized by the Federal program from which such funds are derived.  
Because the salary amount provided by this award is based on the full-
time institutional salary, no other PHS funds may be used for salary 
supplementation.  Institutional supplementation of salary must not 
require extra duties or responsibilities that would interfere with the 
purpose of the K07.  Under expanded authorities, however, institutions 
may rebudget funds within the total costs awarded to cover salaries 
consistent with the institution's salary scale.

Effective for all competing research grants submitted for the February 
1, 2004, deadlines and beyond, mentored career award recipients in the 
last 2 years of career award support may hold concurrent support from 
their career award and a competing NIH research grant when recognized as 
a Principal Investigator or subproject Director.  This new policy can be 
found at the following website:  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html.

Research Development Support: Up to $30,000 per year will be provided 
for the following types of expenses: (a) research expenses, such as 
supplies, equipment, and technical personnel; (b) statistical services 
including personnel and computer time; (c) tuition, fees, and books 
related to career development of the PI; and (d) travel to research 
meetings or for training.  The level of research development support may 
be negotiated downward with the acquisition of any independent grant 
support from any source.

Ancillary Personnel Support: Salary for mentors, secretarial and 
administrative assistance, etc., is NOT allowed.

Facilities and Administrative Costs:  These costs, which were formerly 
called indirect costs, will be reimbursed at eight percent of modified 
total direct costs.

C.  Evaluation:

In carrying out its stewardship of human resource-related programs, the 
NIH may begin requesting information essential to an assessment of the 
effectiveness of this program.  Accordingly, recipients are hereby 
notified that they may be contacted after the completion of this award 
for periodic updates on various aspects of their employment history, 
publications, support from research grants or contracts, honors and 
awards, professional activities, and other information helpful in 
evaluating the impact of the program.

D. Other Income: 

Fees resulting from clinical practice, professional consultation, or 
other comparable activities required by the research and research-
related activities of this award may not be retained by the career award 
recipient.  Such fees must be assigned to the grantee institution for 
disposition by any of the following methods:

o  The funds may be expended by the grantee institution in accordance 
with the NIH policy on supplementation of career award salaries and to 
provide fringe benefits in proportion to such supplementation. Such 
salary supplementation and fringe benefit payments must be within the 
established policies of the grantee institution.

o  The funds may be used for health-related research purposes.

o  The funds may be paid to miscellaneous receipts of the U.S. Treasury.  
Checks should be made payable to the Department of Health and Human 
Services, NIH and forwarded to the Director, Office of Financial 
Management, NIH, Bethesda, Maryland 20892.  Checks must identify the 
relevant award account and reason for the payment.

o  Awardees may retain royalties and fees for activities such as 
scholarly writing, service on advisory groups, or honoraria from other 
institutions for lectures or seminars, and fees resulting from clinical 
practice, professional consultation or other comparable activities, 
provided these activities remain incidental, are not required by the 
research and research-related activities of this award, and provided 
that the retention of such pay is consistent with the policies and 
practices of the grantee institution.

Usually, funds budgeted in an NIH supported research or research 
training grant for the salaries, stipends, or fringe benefits of 
individuals, but freed as a result of a career award, may not be 
rebudgeted.  The awarding component will give consideration to approval 
for the use of released funds only under unusual circumstances.  Any 
proposed retention of funds released as a result of a career award must 
receive prior written approval of the NIH awarding component.

E. Special Leave: 

Leave to another institution, including a foreign laboratory, may be 
permitted if the proposed experience is directly related to the purpose 
of the award.  Only local institutional approval is required if such 
leave does not exceed 3 months.  For longer periods, prior written 
approval of the NCI is required.  To obtain prior approval, the award 
recipient must submit a letter to NCI describing the plan, countersigned 
by his/her mentor and the appropriate institutional official.  A copy of 
a letter or other evidence from the institution where the leave is to be 
taken must be submitted to assure that satisfactory arrangements have 
been made.  Support from the career award will continue during such 
leave.

Leave without award support may not exceed 12 months.  Such leave 
requires the prior written approval of NCI and will be granted only in 
unusual situations.  Support from other sources is permissible during 
the period of leave.  Such leave does not reduce the total number of 
months of program support for which an individual is eligible.

Under unusual and pressing circumstances, an awardee may submit a 
written request to the awarding component requesting a reduction in 
professional effort below 75 percent.  Such requests will be considered 
on a case-by-case basis during the award period.  In no case will it be 
permissible to work at less than 50 percent effort.  The nature of the 
circumstances requiring reduced effort might include medical conditions, 
disability, or pressing personal or family situations such as child or 
elder care.  Permission to reduce the level of effort will not be 
approved to accommodate other sources of funding, job opportunities, 
clinical practice, or clinical training.  In each situation, the grantee 
institution must submit documentation supporting the need for reduced 
effort along with assurance of a continuing commitment to the scientific 
development of the awardee.  In addition, the awardee must submit 
assurance of his/her intention to return to (at least 75 percent) as 
soon as possible.  During the period of reduced effort, the salary and 
other costs supported by the award will be reduced accordingly.

F. Termination or Change of Institution:  

When a grantee institution plans to terminate an award, the NCI Grants 
Management Specialist listed on the Notice of Grant Award must be 
notified in writing at the earliest possible time so that appropriate 
instructions can be given for termination.  If the individual is moving 
to another eligible institution, career award support may be continued 
provided that the following conditions are met.  

o The awardee has submitted to the NCI a written request for a transfer, 
countersigned by the appropriate institutional business official, 
describing the reasons for the transfer and including the new sponsor's 
name and biosketch.  

o  The awardee must establish in this request that the specific aims of 
the research program to be conducted at the new institution are within 
the scope of the original peer-reviewed research program, and that a new 
sponsor has been identified who has the appropriate research expertise 
and support to provide adequate guidance to the awardee and research 
support for the awardee's research program. 
 
o  The awardee should contact the NCI Program Director listed in 
INQUIRIES prior to submitting the request;

o  The NCI Program Director has recommended approval of the request and 
has forwarded the request for further evaluation to the Grants 
Management Specialist listed on the Notice of Grant Award; and

o  A completed transfer application has been submitted to the Grants 
Management Specialist listed in the Notice of Grant Award far enough in 
advance of the requested effective date to allow the necessary time for 
review, establishing that all conditions of the initial award will be 
met at the new institution including the presence of a qualified mentor, 
and that the period of support requested does not exceed the time 
remaining within the existing award period.

G. Changes in Research Program:

Individual awards are made for career development at a specific 
institution in a specific research program.  A change in the specified 
scientific area of the research component of the career development 
program requires prior approval of the NCI.

A scientific rationale must be provided for any proposed changes in the 
aims of the original peer-reviewed research plan.  The new research plan 
will be evaluated by NCI staff to ensure that the plan remains within 
the scope of the original peer-reviewed research program.  If the new 
plan does not satisfy this requirement, NCI staff could recommend that 
the award be terminated.

H.  Termination of An Award

When a grantee institution plans to terminate an award, NCI must be 
notified in writing at the earliest possible time so that appropriate 
instructions can be given for termination. The Director of the NIH may 
discontinue an award upon determination that the purpose or terms of the 
award are not being fulfilled.  In the event an award is terminated, the 
Director of the NIH shall notify the grantee institution and career 
award recipient in writing of this determination, the reasons therefore, 
the effective date, and the right to appeal the decision.

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the 
opportunity to answer questions from potential applicants.  Inquiries 
may fall into three areas:  scientific/research, peer review, and 
financial or grants management issues.

o Direct your questions about scientific/research issues to:

Dr. Lester S. Gorelic
Cancer Training Branch 
National Cancer Institute
6116 Executive Boulevard, Suite 7025, MSC 8346
Bethesda, MD  20892-8346
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 496-8580
FAX:  (301) 402-0181
Email: gorelicl@mail.nih.gov

o Direct your questions about peer review issues to: 

Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (express/courier service)
Telephone: (301) 496-3428
FAX: (301) 402-0275 
Email:  ncirefof@dea.nci.nih.gov

o Direct your questions about financial or grants management matters to:

Ms. Kimery Griffin
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Room 243
Bethesda, MD 20892-7150
Rockville, MD 20852 (express/courier service)
Telephone:  301-496-3196
FAX:  301-496-8601
Email:  griffink3@mail.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001) and instructions found 
in Section IV, "Research Career Award."   Applications must have a Dun 
and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as 
the Universal Identifier when applying for Federal grants or cooperative 
agreements.  The DUNS number can be obtained by calling (866) 705-5711 
or through the website at http://www.dunnandbradstreet.com/.  The DUNS 
number should be entered on line 11 of the face page of the PHS 398 
Form.  The PHS 398 document is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an 
interactive format.  Applicants are advised that these instructions are 
provided under the section titled "Table of Contents" following the 
tables providing individual PHS Form 398 pages. For further assistance 
contact GrantsInfo, Telephone: (301) 435-0714, Email: 
GrantsInfo@nih.gov.

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

SUPPLEMENTARY INSTRUCTIONS 

In addition to the required information listed in the instructions for 
Research Career Awards in the PHS 398, all applications must include the 
following information in the respective sections:

BUDGET FOR ENTIRE PROPOSED PERIOD OF SUPPORT

o  Within the limitation of $30,000 direct costs for research 
development support, provide a detailed description, with justification, 
for all equipment, supplies and personnel that will be used to help 
achieve the career development and research objectives of this award.

THE CANDIDATE 

o  Describe the candidate's commitment to an academic career in cancer 
prevention, cancer control, epidemiology, or the behavioral/ population 
sciences as these disciplines relate to cancer prevention and control.

o  Present evidence of the candidate's ability to interact and 
collaborate with other scientists.

o  Discuss prior training and how it relates to the objectives and 
career plans of the candidate
 
o  Discuss the candidate's research efforts to this point in his/her 
research career.

LETTERS OF RECOMMENDATION

o  Include three sealed letters of recommendation from well-established 
scientists with the application addressing the above areas and any other 
evidence that the candidate has a high potential for becoming an 
independent investigator in cancer research. The mentor(s) may also 
submit letters of reference, but these letters will be considered 
independently of the three recommendations. All letters should be 
attached to the front page of the application.

CAREER DEVELOPMENT PLAN

o  Present a systematic plan that shows a logical progression from the 
candidate’s prior research and training experiences to the training and 
research experiences that will occur during the K07 award period to 
independent investigator status.  This plan must provide justification 
of the need for further career development to become an independent 
investigator.  The candidate should consult with the mentor in the 
preparation of this plan.

o  Document prior instruction in or propose plans for instruction in the 
responsible conduct of research in terms of subject matter and duration 
of  instruction.   An award cannot be made if an application lacks this 
component.  

RESEARCH PLAN

o  Describe the research plan using Form PHS 398 (rev. 5/01 or 
subsequent revisions) following instructions for the Specific Aims, 
Background and Significance, Progress Report/Preliminary Studies, 
Research Design and Methods.  The candidate should consult with the 
mentor regarding the development of this section.  A sound research 
project that is consistent with the candidate's level of research 
development and objectives of their career development plan must be 
provided.

STATEMENT(S) BY MENTOR(S)/ CONSULTANT(S)/COLLABORATOR(S) 

o  The application must include a statement from the mentor providing: 
1)  information on their research qualifications and previous experience 
as a research supervisor; 2) a mentoring plan describing the nature of 
the supervision and mentoring that will occur during the proposed award 
period and for ensuring that the applicant will be able to create a 
niche for themselves in a specific area of research during the K07 
award; 3) assurance that the applicant will be able to move at least a 
portion of their K07-supported research to their first independent 
research position. Information on the mentor’s active/pending research 
support related to the candidate’s research plan should not be included 
in this statement, but should be provided in the mentor’s biographical 
sketch .  

o  Similar information must be provided by any co-mentor. If more than 
one mentor is proposed, the respective areas of expertise and 
responsibility of each should be described.

o  Consultant(s)/Collaborator(s): Signed statements must be provided by 
each consultant/collaborator confirming their participation in the 
project and describing their specific roles.  Collaborators and 
consultants generally do not need to provide their biosketches.  
However, information should be provided clearly documenting the 
appropriate expertise in the proposed areas of consulting/collaboration. 

ENVIRONMENT AND INSTITUTIONAL COMMITMENT TO THE CANDIDATE

o  Describe the resources and facilities that will be available to the 
candidate.

o  Describe how the research environment of the institution is 
particularly suited for the development of the candidate's research 
career and the pursuit of the proposed research plan.

o  In a clear statement, provide assurances that the candidate will be 
able to devote a minimum of seventy-five percent of his/her  in the 
development of his/her research program, with the remaining percent 
effort being devoted to activities related to the development of their 
research career.

APPLICATION RECEIPT DATES: Applications submitted in response to this 
program announcement will be accepted at the standard application 
deadlines, which are available at 
http://grants.nih.gov/grants/dates.htm.  Application deadlines are also 
indicated in the PHS 398 application kit.

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original 
of the application, three original sealed letters of reference, and 
three signed photocopies in one package to:

Center for Scientific Review (CSR)
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 and 
all copies of the appendix material must be sent to:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD  20892-8329
Rockville, MD  20852 (for express/courier service)

Appendices should be comprised of single-sided, unbound materials, with 
separators between documents.

APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER 
INSTITUTE WILL NO LONGER BE ACCEPTED.  This policy does not apply to 
courier deliveries (i.e. FEDEX, UPS, DHL, etc.) 
(http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html).  
This policy is similar to and consistent with the policy for 
applications addressed to Centers for Scientific Review as published in 
the NIH Guide Notice 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html. 

APPLICATION PROCESSING: Applications must be mailed on or before the 
receipt dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm.  The 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 a substantial revision of an 
unfunded version of an application already reviewed, but such 
application must include an Introduction addressing the previous 
critique.  

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by NCI.  Incomplete and/or non-responsive 
applications will not be reviewed. 

Applications that are complete and responsive to the PA, will be 
evaluated for scientific and technical merit by an appropriate 
scientific review group convened by the Division of Extramural 
Activities of the NCI in accordance with the review criteria stated 
below.  

As part of the initial merit review, all applications will:

o Undergo a selection process in which only those applications deemed to 
have the highest scientific merit, generally the top half of 
applications under review, will be discussed and assigned a priority 
score
o Receive a written critique
o 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.  
In the written comments, reviewers will be asked to evaluate 
applications in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals.  The 
scientific review group will address and consider each of these criteria 
in assigning the application's overall score, weighting them as 
appropriate for each application.  

o Candidate 
o Letters of reference
o Career Development Plan
o Research Plan
o Statements by former Mentor, Co-Mentor(s), Consultant(s), and 
Collaborator(s) 
o Environment and Institutional Commitment to the Candidate
o Research Plan 

The application does not need to be strong in all categories to deserve 
a high priority score. These criteria are listed in logical order and 
not in order of priority.  

CANDIDATE

o  Commitment of the candidate to an academic career in cancer 
prevention, cancer control, epidemiology, or to the behavioral or 
population sciences as these disciplines relate to cancer prevention and 
control.

o  Ability of the candidate to interact and collaborate with other 
scientists.

o  Quality of the prior scientific training and experience, including 
publications that establish the innovativeness of the candidate's 
research and a high potential for an independent research career.

o  Recommendations of three well-established scientists attesting to the 
special potential of the individual to pursue an independent career in 
cancer research.  Letters of reference submitted by mentor(s)/ co-
mentor(s) will be considered independently of the three recommendations. 

LETTERS OF REFERENCE

o Letters of reference on behalf of the candidate.

CAREER DEVELOPMENT PLAN

o  Likelihood that the plan will contribute substantially to the 
scientific development of the candidate, based on:
- Candidate's prior training and research experience;
- Appropriateness of the goals and scope of the plan to complement prior 
training/research experience and achieve the stated training and 
research objectives.

o  Appropriateness of the proposed activities for the proposed award 
period.

o  Adequacy of prior or proposed training in the responsible conduct of 
research.

RESEARCH PLAN

o  Degree of relevance of the research plan to developing an independent 
research program focused on cancer prevention, cancer control, 
epidemiology, or the behavioral/population sciences as they relate 
cancer prevention and control.

o  Usefulness of the research plan as a vehicle for enhancing existing 
research skills as described in the career development plan.

o  The originality and quality of the research hypothesis/question, 
design and methodology, judged in the context of the candidate's 
previous training and experience.

STATEMENTS BY MENTOR/CO-MENTOR(S)

o  Appropriateness of the mentor's research qualifications in the area 
of the proposed research.

o  Previous experience in fostering the development of cancer 
researchers.

o  History of research productivity and peer-reviewed support.

o  Adequacy of active/pending support for the proposed research project.

o  Strength of the mentor's statement.   

ENVIRONMENT AND INSTITUTIONAL COMMITMENT

o  Clear commitment of the institution to ensure that a minimum of 
seventy-five percent of the candidate's  will be devoted directly to 
research, with the remaining percent effort being devoted to activities 
related to the successful development of a research career.

o  Adequacy of research facilities and training opportunities.

o  Quality and relevance of the environment for scientific and 
professional development of the candidate.

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the 
following items will be considered in the determination of scientific 
merit and the priority score:

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of 
human subjects and protections from research risk relating to their 
participation in the proposed research will be assessed. (See criteria 
included in the section on Federal Citations, below).
 
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of 
plans to include subjects from both genders, all racial and ethnic 
groups (and subgroups), and children as appropriate for the scientific 
goals of the research will be assessed.  Plans for the recruitment and 
retention of subjects will also be evaluated. (See Inclusion Criteria in 
the sections on Federal Citations, below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals 
are to be used in the project, the five items described under Section f 
of the PHS 398 research grant application instructions (rev. 5/2001) 
will be assessed.  

ADDITIONAL REVIEW CONSIDERATIONS

BUDGET:  The reasonableness of the requested budget in relation to 
career development goals and research aims and plans.

AWARD CRITERIA

Applications submitted in response to a PA will compete for available 
funds with all other recommended applications.  The following will be 
considered in making funding decisions:  

o Scientific merit of the proposed project as determined by peer review;
o Availability of funds
o Relevance to program priorities.

REQUIRED FEDERAL CITATIONS 

HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated 
with reference to the risks to the subjects, the adequacy of protection 
against these risks, the potential benefits of the research to the 
subjects and others, and the importance of the knowledge gained or to be 
gained.  See 
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.

DATA AND SAFETY MONITORING PLAN:  Data and safety monitoring is required 
for all types of clinical trials, including physiologic, toxicity, and 
dose-finding studies (phase I); efficacy studies (phase II), efficacy, 
effectiveness and comparative trials (phase III). The establishment of 
data and safety monitoring boards (DSMBs) is required for multi-site 
clinical trials involving interventions that entail potential risk to 
the participants.    (NIH Policy for Data and Safety Monitoring, NIH 
Guide for Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html). 

Clinical trials supported or performed by NCI require special 
considerations.  The method and degree of monitoring should be 
commensurate with the degree of risk involved in participation and the 
size and complexity of the clinical trial.  Monitoring exists on a 
continuum from monitoring by the principal investigator/project manager 
or NCI program staff or a Data and Safety Monitoring Board (DSMB).  
These monitoring activities are distinct from the requirement for study 
review and approval by an Institutional review Board (IRB).  For details 
about the Policy for the NCI for Data and Safety Monitoring of Clinical 
trials see: http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm.  
For Phase I and II clinical trials, investigators must submit a general 
description of the data and safety monitoring plan as part of the 
research application.  See NIH Guide Notice on "Further Guidance on a 
Data and Safety Monitoring for Phase I and II Trials" for additional 
information: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html.
Information concerning essential elements of data safety 
monitoring plans for clinical trials funded by the NCI is available:  
http://www.cancer.gov/clinical_trials/.

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: 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 clinical research 
projects unless a clear and compelling 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 clinical research should read the "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for 
Grants and Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of 
clinical research; updated racial and ethnic categories in compliance 
with the new OMB standards; clarification of language governing NIH-
defined Phase III clinical trials consistent with the new PHS Form 398; 
and updated roles and responsibilities of NIH staff and the extramural 
community.  The policy continues to require for all NIH-defined Phase 
III clinical trials that: a) all applications or proposals and/or 
protocols must 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) investigators must 
report annual accrual and progress in conducting analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN 
SUBJECTS: The NIH maintains a [policy that children (i.e., individuals 
under the age of 21) must be included in all human subjects research, 
conducted or supported by 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 is available at: 
http://grants.nih.gov/grants/funding/children/children.htm

REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS: NIH 
policy requires education on the protection of human research 
participants for all investigators submitting NIH proposals for research 
involvoing human subjects.  You will find this policy announcement in 
the NIH Guide for Grants and Contracts, dated June 5, 2000 at: 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.  

HUMAN EMBRYONIC STEM CELLS: Criteria for federal funding of research on 
hESCs can be found at http://stemcells.nih.gov/index.asp and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  
Only research using hESC lines that are registered in the NIH Human 
Embryonic Stem Cell Registry will be eligible for Federal funding (see 
http://escr.nih.gov).   It is the responsibility of the applicant to 
provide, in the project description and elsewhere in the application as 
appropriate, the official NIH identifier(s) for the hESC line(s) to be 
used in the proposed research.  Applications that do not provide this 
information will be returned without review. 

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: 
The Office of Management and Budget (OMB) Circular A-110 has been 
revised to provide public access to research data through the Freedom of 
Information Act (FOIA) under some circumstances.  Data that are (1) 
first produced in a project that is supported in whole or in part with 
Federal funds and (2) cited publicly and officially by a Federal agency 
in support of an action that has the force and effect of law (i.e., a 
regulation) may be accessed through FOIA.  It is important for 
applicants to understand the basic scope of this amendment.  NIH has 
provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application 
should include a description of the archiving plan in the study design 
and include information about this in the budget justification section 
of the application. In addition, applicants should think about how to 
structure informed consent statements and other human subjects 
procedures given the potential for wider use of data collected under 
this award.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  
The Department of Health and Human Services (DHHS) issued final 
modification to the “Standards for Privacy of Individually Identifiable 
Health Information”, the “Privacy Rule,” on August 14, 2002.  The 
Privacy Rule is a federal regulation under the Health Insurance 
Portability and Accountability Act (HIPAA) of 1996 that governs the 
protection of individually identifiable health information, and is 
administered and enforced by the DHHS Office for Civil Rights (OCR). 
Those who must comply with the Privacy Rule (classified under the Rule 
as “covered entities”) must do so by April 14, 2003 (with the exception 
of small health plans which have an extra year to comply).  

Decisions about applicability and implementation of the Privacy Rule 
reside with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, 
including a complete Regulation Text and a set of decision tools on “Am 
I a covered entity?”  Information on the impact of the HIPAA Privacy 
Rule on NIH processes involving the review, funding, and progress 
monitoring of grants, cooperative agreements, and research contracts can 
be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.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.   Furthermore, we caution reviewers 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 is related to one or more of the priority areas. 
Potential applicants may obtain a copy of "Healthy People 2010" at 
http://www.healthypeople.gov/.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject 
to the intergovernmental review requirements of Executive Order 12372 or 
Health Systems Agency review.  Awards are made under the authorization 
of Sections 301 and 405 of the Public Health Service Act as amended (42 
USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR 
Parts 74 and 92. All awards are subject to the terms and conditions, 
cost principles, and other considerations described in the NIH Grants 
Policy Statement.  The NIH Grants Policy Statement can be found at 
http://grants.nih.gov/grants/policy/policy.htm 

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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