THE NCI TRANSITION CAREER DEVELOPMENT AWARD

RELEASE DATE:  December 16, 2003 

PA NUMBER:   PAR-04-040

EXPIRATION DATE:  March 2, 2006

Updates:

-June 12, 2006 (PAR-06-455) - This PAR has been reissued, see PAR-06-455
-See extension of expiration date NOT-CA-06-010


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)  
 (http://www.nci.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER:  93.398

This Program Announcement (PA) replaces PAR-01-134, 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 NCI Transition Career Development (K22) Award is to 
facilitate the transition of investigators from the mentored stage of  
career development in academic cancer research to the independent 
stage.   This is achieved by providing protected time through salary 
and research support for up to three years to: 1) postdoctoral 
individuals (who are not required to have a sponsoring institution at 
the time of application) transitioning into their first independent 
position, and 2) investigators within the first two years of their 
first independent cancer research position, to develop and initiate 
their first independently-supported cancer research programs.  The 
award targets clinicians pursuing basic science cancer research 
careers,  careers in patient-oriented cancer research, or careers in 
cancer prevention, control, behavioral or population sciences; and 
doctorally degreed (e.g., Ph.D., D.Sc.) individuals pursuing research 
careers in cancer prevention, control, behavioral or population 
sciences.  Federally employed doctorally degreed basic scientists are 
eligible candidates if they are working in research directly relevant 
to human cancer.  The unique feature of this award is that eligible 
individuals may apply without a sponsoring institution while they are 
still in a "mentored" position.  Successful postdoctoral applicants 
will be given up to 12 months to identify an independent, preferably 
tenure-track, position at a sponsoring institution before the award can 
be activated.  For postdoctoral applicants, the sponsoring institution 
for this award can be their current institution.

RESEARCH OBJECTIVES

A critical mass of clinician cancer researchers, and researchers in 
cancer prevention, control, behavioral and the population sciences 
capable of working with basic science researchers is needed to ensure 
effective translation of basic research discoveries into patient and 
population research settings if there is to be optimal progress in 
reducing cancer incidence, mortality and morbidity.  Many individuals 
in these fields need protected time to develop successful independent 
research programs.  This is particularly true for medically trained 
individuals, in general, and for doctorally degreed and medically 
trained individuals pursuing cancer research careers in the prevention, 
control, behavioral and population sciences.  Individuals in these 
research career tracks often require extended periods of mentored 
research training beyond their original doctoral degrees (e.g., M.D., 
Ph.D.’s).  As a result, upon completion of their mentored research 
training, these individuals are often at a competitive disadvantage in 
obtaining independent research support relative to their traditional 
basic science, Ph.D. counterparts, who generally have many more 
combined years of research training and experience in their field of 
expertise. Finally, the survival of clinician and Ph.D. researchers in 
these critical research areas is being threatened by the current 
economics of medical care, which is increasingly emphasizing revenue-
generating clinical practice at the expense of clinical research; and 
by a corporate culture of many of the nation's academic institutions 
that does not provide academic homes and tenure-track positions for 
prevention, control, behavioral and population scientists in the 
beginning stages of the independent phase of their research careers.

There is also a need for basic science researchers trained in human 
cancer research and who are capable of working with clinicians 
conducting cancer research and researchers in cancer prevention, 
control, behavioral, and population sciences.  These individuals are 
generally trained in the basic or quantitative sciences and have a 
substantial number of combined years of training and accumulated 
expertise in these areas of research upon and shortly after completion 
of their doctoral degree requirements.  However, these individuals need 
additional mentored training in order to be able to apply their 
training and expertise to human cancer and to initiate their first 
independent research programs in human cancer.  Basic and quantitative 
postdoctoral scientists training in extramural (i.e., non-Federal) 
institutions have access to two NCI-supported programs, the NCI Howard 
Temin Award (K01) and the Mentored Quantitative Research Career 
Development Award (K25), for this purpose. These same opportunities are 
not available to postdoctoral scientists who are Federal Employees.  In 
order to overcome this barrier, Federal Employees pursuing research 
directly relevant to human cancer may apply for the K22.  Finally, the 
NCI Career Development Award for Quantitative Scientists (K25) will be 
providing quantitative scientists their first experience in applying 
their research and technical skills to biomedical cancer research.  
These scientists may therefore require an additional period of 
protected time after the completion of the NCI K25 award to develop 
their first independent program in biomedical cancer research.  
Consequently, quantitative scientists who have been supported by the 
NCI K25 may also apply for the NCI Transition Career Development Award.

The major objectives of the NCI Transition Career Development awards 
are therefore to provide a mechanism for stabilizing the career tracks 
of the most promising of these investigators while they are 
establishing their first independent research programs; and to create 
equal access of postdoctoral scientists in basic human cancer research 
working as Federal employees to extramural career development 
opportunities.  

MECHANISM OF SUPPORT 

This PA will use the NIH Career Transition (K22) award mechanism.  
Planning, direction, and/or execution of the program will be the 
responsibility of the applicant. As an applicant you will be solely 
responsible for planning, directing, and executing the proposed 
project.  

Applicants must request three years of support.  Each award is non-
renewable and non-transferable from one Principal Investigator to 
another.  Funding beyond the first year is contingent upon satisfactory 
progress during the preceding year, as documented in the required 
progress report.  NIH Grant policies apply to these awards.  Funding in 
the third year is contingent upon submission of an R01 research grant 
application or equivalent for peer review and funding consideration 
prior to the end of the second year of support (see SPECIAL REQUIREMENTS)    

This PA follows the Just-In-Time initiative for Career Awards published 
in the NIH Guide, Volume 25, Number 10, March 29, 1996. Applications 
submitted in accordance with PHS 398 (Rev. 05/2001), Section IV 
(Additional Instructions for Preparing Individual Research Career Award 
(RCA) Applications - "K" Series, are in compliance with the 
instructions provided in the 1996 Guide Notice.  

ELIGIBLE INSTITUTIONS 

Applications with a sponsoring institution may be submitted and awards 
may be accepted on behalf of candidates by organizations with 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 Domestic institutions/organizations
o Foreign institutions are not eligible to apply.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

To be eligible to apply for this award, applicants must be: 1) 
clinicians (e.g., M.D.'s; individuals with a clinical doctoral degree 
such as doctorally degreed oncology nurses, clinical psychologists) 
pursuing basic science cancer research careers or careers in patient-
oriented cancer research; or 2) doctorally degreed individuals (e.g., 
Ph.D.'s, M.D.'s, Dr.P.H.'s) educated as cancer prevention, control, 
behavioral or population scientists.  Federally employed doctorally 
degreed (e.g., Ph.D.’s) basic scientists are eligible candidates if 
they are working in research directly relevant to human cancer. 
(Extramural basic research scientists pursuing careers directly 
relevant to human cancer should apply for the Howard Temin Award [K01] 
after consulting the following websites:  
http://grants.nih.gov/grants/guide/pa-files/PAR-03-104.html.  
http://cancertraining.nci.nih.gov/research/basicphd/phdk01.html).  
Individuals who meet the requirements above must have completed a 
minimum of TWO YEARS of postdoctoral CANCER research training and be 
ready to pursue an independent career at the time of application OR be 
in an independent faculty position for LESS THAN TWO YEARS with 
continuous previous postdoctoral CANCER research training at the time 
of the application.  

To be eligible, you must also be able to devote a minimum of 75 percent 
of full-time professional effort to the Award. The remaining 25 percent 
can be divided among other research, clinical and teaching activities 
only if these activities are consistent with the goals of the K22 
Award, i.e., the candidate's development into an independent 
investigator.

Postdoctoral trainees may apply for this award WITHOUT an institutional 
affiliation. 

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

Only U.S. citizens or noncitizen 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.  
Noncitizen 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.   

A candidate for a K22 may not simultaneously submit or have pending an 
application for any other PHS or non-Federal award that duplicates any 
of the provisions 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. Program:

Recipients of an NCI Transition Career Development Award (K22) must 
submit an R01 research grant application to the National Institutes of 
Health, or an R01 equivalent research grant application to an 
equivalent funding organization (for example, an American Cancer 
Society Research Project Grant) for peer review and funding 
consideration prior to the end of the second year of support.

B.  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.  
  
C. Allowable Costs:

Salary:  The Transition Career Development Award (K22) 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 sponsoring institution may supplement the NIH contribution up to a 
level consistent with the institution's salary scale.  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 NIH funds may be used for salary supplementation.  
Institutional supplementation of salary must not require extra duties 
or responsibilities that would interfere with or detract from the 
purpose of the award.

Effective for all competing research grants submitted for the 
February 1, 2004 deadlines and beyond, mentored career award recipients 
in the last two 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 $50,000 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; and (d) travel to research meetings or 
for training.  

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 8 percent of modified 
total direct costs.

D.  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.

E. 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, provided these activities remain 
incidental 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 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.

F. Special Leave: 

Leave to work at 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 three 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 
full-time 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 
full-time professional effort (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.

G. Termination of Institution

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.

H. Change of Institution

Individuals planning a change of institution AFTER AN AWARD HAS BEEN 
INITIATED must submit to the NCI in advance of the change a written 
request for transfer countersigned by the appropriate institutional 
business official, describing the reasons for the change.  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. Staff within the NCI will 
review this request and may require a review by an initial review group 
and the appropriate National Cancer Advisory Board. Upon approval of 
this request, the new institution must follow all of the procedures 
outlined in the section on AWARD CRITERIA for submission and NCI 
approval of a "Statement of Environment and Institutional Commitment." 
Upon approval of the "Statement", a new career award application must 
be submitted by the new institution far enough in advance of the 
requested effective date to permit review.  The period of support 
requested in the new application must be no more than the time 
remaining within the existing award period.  

A final progress report, invention statement, and Financial Status 
Report are required upon either termination of an award or 
relinquishment of an award in a change of institution situation.

I. 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, the award could be 
terminated.

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:

In the Basic Sciences:
David Eckstein, Ph.D.
Program Director, Cancer Training Branch
National Cancer Institute
6116 Executive Boulevard, Suite 7023
Bethesda, MD 20892-8346
Rockville, MD 20852 (express/courier service)
Telephone:  (301) 496-8580
Fax:  (301) 402-4472
Email: eckstein@mail.nih.gov 

In the Clinical Sciences:
Lester S. Gorelic, Ph.D. 
Cancer Training Branch
National Cancer Institute
6116 Executive Boulevard, Suite 7025, MSC 8346
Bethesda, MD  20892-7390
Rockville, MD 20852 (express/courier service)
Telephone:  (301) 496-8580
Fax:  (301) 402-4472
Email:  gorelicl@mail.nih.gov

In Cancer Prevention, Control, Behavioral, Population Sciences:
Mary Blehar, Ph.D. 
Cancer Training Branch 
National Cancer Institute
6116 Executive Boulevard, Suite 7021, MSC 8346
Bethesda, MD  20892-8346
Rockville, MD 20852 (express/courier service)
Telephone:  (301) 496-8580
Fax:  (301) 402-0181
Email: mblehar@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).  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 web site at 
http://www.dunandbradstreet.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.  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.

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.

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 $50,000 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.

BIOGRAPHICAL SKETCH

o  Provide information on research projects completed and/or research 
grants participated in during the last five years that are relevant to 
the proposed project.

LETTERS OF REFERENCE

Three letters of reference must be provided from established scientists 
familiar with the candidate's potential and capability to become a 
successful independent investigator. These letters should be provided 
in sealed envelopes attached to the front page of the application.

THE CANDIDATE 

o  (Only for applicants already in an independent position) Describe 
the current position in terms of its ability to enable the candidate to 
continue to pursue an INDEPENDENT career in CANCER research.

o  Identify whether you are a clinician pursuing a basic science 
career; a clinician pursuing a clinical research/translational research 
career; an individual pursuing a career in prevention, control, 
behavioral or population research; or a postdoctoral candidate working 
in basic research as a Federal employee. 

o  Describe all activities during the "mentored" period (and, if 
applicable, during your first independent research position) of CANCER 
research training. Include all research experiences and mentors, any 
pertinent didactic experiences and any other experiences designed to 
acquire critical skills, techniques and scientific perspectives for 
pursuing an independent career in the chosen area of CANCER RESEARCH 
(e.g., basic research, clinical or patient-oriented research, and 
prevention, control, and population research).

o  Describe your scientific productivity during the mentored period of 
career development (and, if applicable, during your first independent 
position).

o  Establish your potential to manage an independent research program.

o  Establish your ability to become an independent investigator during 
the three year term of the award.

o  Describe your ability to interact and collaborate with other 
scientists.

o  Document your ability to make a commitment of at least 75 percent 
effort of full-time professional effort to the career objectives of 
this award.

o Document your prior instruction in or proposed 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 an original research plan in basic, clinical, cancer 
prevention or cancer control research; or in behavioral or population 
sciences research directly related to cancer.  The research plan must 
be described as outlined in form PHS 398 including sections on the 
Specific Aims, Background and Significance, Progress Report/Preliminary 
Studies, Research Design and Methods.

o  Describe how the proposed research extends the mentored research 
training (and, if applicable, the research conducted in your first 
independent research position) that has been completed into new 
concepts and ideas. The proposed research could consist of pilot 
studies.  However, the applicant must clearly describe how these pilot 
studies would serve as a vehicle for meeting the Special Requirement of 
this K22 Award for submission of an investigator-initiated  research 
grant application prior to the end of the second year of the award. 

o  Describe the equipment, specialized facilities, and personnel 
resources that will be needed to conduct the proposed research.

o  Describe the plans for inclusion of women, minorities, and children 
in any clinical or population research activities.

o  Describe the plans for protection of humans, animals, or the 
environment to the extent they may be adversely affected by activities 
proposed in the application.

STATEMENT(S) BY CONSULTANT(S), AND COLLABORATOR(S) 

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
(Required at the time of application for candidates who have identified 
a sponsoring institution)  

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, as proposed in the research plan of the application.   This 
should include a brief discussion (one paragraph) of the depth and 
breadth of cancer research being conducted at the institution.

o  Provide a clear statement by the sponsoring institution that the 
candidate will be able to spend a minimum of 75 percent of full-time 
professional effort on the proposed career development plan/research, 
with the remaining percent effort devoted to activities related to the 
development of a successful research career.

o   Provide a clear statement by the institution that describes the 
commitment to the career progression of the candidate (e.g., tenure 
track position).

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 the NCI.  Incomplete and/or non-responsive 
applications will be returned to the applicant without further 
consideration.

Complete and responsive applications submitted for this PA will be 
assigned on the basis of established PHS referral guidelines.   
Appropriate scientific review groups convened in accordance with the 
standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) 
by the Division of Extramural Activities at the NCI will evaluate 
applications for scientific and technical merit.  

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

In the written comments, reviewers will be asked to evaluate the 
following aspects of the application: 

o Candidate 
o Letters of reference
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 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.  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  (Only for candidates already in an independent position) Suitability 
of  the position for the candidate to pursue an independent research 
career.

o  Quality of the mentored period of CANCER research training (or of 
the mentored period of training and current research if currently in 
your first independent research position) in terms of  research 
experience(s), didactic experiences and other experiences (e.g., 
special skills, perspectives, techniques) that will enhance the 
candidate's ability to pursue an independent CANCER research career in 
the chosen area of  research (e.g., basic research; clinical or patient 
oriented research; or prevention, control, behavioral, and population 
sciences research).

o  Scientific productivity during the mentored period (and, if 
applicable while in your first independent research position) of career 
development.

o  Potential ability to successfully manage an independent research 
project.

o  Ability to interact and collaborate with other scientists.

o  The potential to become a successful independent investigator during 
the 3-year term of this award.

LETTER OF REFERENCE

o Letters of reference on behalf of the candidate.

STATEMENTS BY CONSULTANT(S) AND COLLABORATOR(S) 

o  Appropriateness of the qualifications of the consultants/ 
collaborators in the area of the proposed research.
  
ENVIRONMENT AND INSTITUTIONAL COMMITMENT TO THE CANDIDATE (Only for 
applicants with a sponsoring institution)

o  Quality of the environment for scientific and professional 
development.

o  Adequacy of research facilities.

o  Documentation of  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.  

o  Adequacy of the track record of the institution in the conduct of 
cancer research.

o Adequacy and clarity of the applicant institution's assurance that 
the investigator will spend a minimum of 75 percent of full-time 
professional effort on the proposed career development plan/research, 
with the remaining percent effort devoted to activities related to the 
development of a successful research career.

RESEARCH PLAN

o  The originality, innovativeness and scientific merit of the proposed 
Research Plan relative to the experience level of the applicant.

o  Extent to which the research plan goes beyond the mentored 
environment and will test new concepts and ideas.

o  The medical and/or health significance of the Research Plan to 
Cancer.

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 proposed budget and the requested 
period of support in relation to the proposed research.

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

The NCI will notify candidates who have competed successfully for 
funding with a "Letter of Intent to Commit Funds."  Candidates in a 
postdoctoral position will then have one year from the date of the 
letter to find an institution that offers a position, preferably 
tenure-track, suitable for enhancing a research career.  For a 
candidate who already has a position in a sponsoring institution, 
negotiations with the institution will begin without delay.

Negotiations will be initiated by asking the candidate's institution to 
submit a "Statement of Environment and Institutional Commitment" to the 
NCI.  This statement will be evaluated by NCI staff using the following 
criteria:

o  Documentation of a strong, well-established research program related 
to the candidate's area of interest, including a high-quality research 
environment with staff capable of productive collaboration with the 
candidate;

o  Documentation of active research collaborations that exemplify a 
dynamic two-way exchange of  information and ideas between laboratory 
and clinical and/or population research settings;  

o  Agreement of the institution's statement of commitment of equipment, 
physical and personnel resources with the peer-reviewed recommendation 
of  needs;

o  Adequacy of the institutional commitment to the required 75 percent 
of full-time professional effort requirement of this award for the 
development of an independently funded research program;

o  Adequacy of the arrangements with the candidate to provide a 
permanent, preferably tenure-track, position; adequate facilities for 
conducting a research program, and additional resources conducive to 
the development of a research project and establishment of a successful 
research career.

For postdoctoral candidates, if the NCI approves the "Statement of 
Environment and Institutional Commitment" offered by the institution, 
the institution will be asked to submit a completed PHS Form 398 
application.  For candidates who already have a position in a 
sponsoring institution, the NCI only needs to approve the Statement.  
After NCI approval and subject to the availability of funds, the 
institution will receive an award.  At the time of the award to the 
grantee institution in support of the K22, any current award held or 
other support provided for the mentored training of the candidate will 
be terminated.

NON-COMPETING GRANT PROGRESS REPORTS

Funding beyond the first year of the award is contingent upon 
satisfactory progress during the preceding year. Progress is documented 
on form PHS 2590 (rev. 5/2001 or subsequent revisions) and instructions 
found in Section IV. "Additional Instructions for Preparing 
Continuation Research Career Award (RCA) Progress Reports" under Table 
of Contents.  The form PHS 2590 is available at 
http://grants.nih.gov/grants/funding/2590/2590.htm.

Additionally, funding beyond the second year of the award is contingent 
upon submission of an R01 research grant application to the National 
Institutes of Health, or an R01 equivalent research grant application 
to an equivalent funding organization (for example, an American Cancer 
Society Research Project Grant) for peer review and funding 
consideration prior to the end of the second year of support. 
Documentation that the awardee has submitted an R01-type research grant 
application for funding should minimally be a copy of the face page of 
the application with all required institutional signatures.

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. 
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 the NIH, unless there are scientific and 
ethical reasons not to include them. This policy applies to all initial 
(Type 1) applications submitted for receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should 
read the "NIH Policy and Guidelines" on the inclusion of children as 
participants in research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm. 

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH 
policy requires education on the protection of human subject 
participants for all investigators submitting NIH proposals for 
research involving human subjects.  You will find this policy 
announcement in the NIH Guide for Grants and Contracts Announcement, 
dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.  
A continuing education program in the protection of human participants 
in research is available online at: http://cme.nci.nih.gov/

HUMAN EMBRYONIC STEM CELLS (hESC): 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.health.gov/healthypeople.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of  
Federal Domestic Assistance No. 93.398 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 
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 described at http://grants.nih.gov/grants/policy/policy.htm 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 

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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