THE HOWARD TEMIN AWARD

RELEASE DATE:  April 14, 2003

PA NUMBER:  PAR-03-104 

EXPIRATION DATE:  July 2, 2006, (Expiration date has been extended, see NOT-CA-05-023)

National Cancer Institute (NCI)  
 (http://www.nci.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER:  93.398

This Program Announcement (PAR) replaces PAR-00-066, which was published in 
the NIH Guide on February 22, 2000.

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism(s) 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 Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA 

The goal of the National Cancer Institute's (NCI) Howard Temin Award is to 
bridge the transition from a mentored research environment to an independent 
basic cancer research career for scientists who have demonstrated unusually 
high potential during their initial stages of training and development.  This 
special award is aimed at fostering the research careers of outstanding junior 
scientists in basic research who are committed to developing research programs 
directly relevant to the understanding of human biology and human disease as 
it relates to the etiology, pathogenesis, prevention, diagnosis, and treatment 
of human cancer.  The major objective of the award is to sustain and advance 
the early research careers of the most promising M.D.s and Ph.D.s while they 
consolidate and focus their independent research programs and obtain their own 
research grant support.  To achieve this objective, the Howard Temin Award 
offers candidates up to five years to gain additional skills and knowledge in 
human cancer research during a period of one to three years in a mentored 
environment, followed by transition to the equivalent of a junior faculty 
position to develop an independent research program.

RESEARCH OBJECTIVES

The National Cancer Institute is interested in encouraging basic scientists to 
become involved in research related to the etiology, pathogenesis, prevention, 
diagnosis, control and treatment of human cancer.  In the past, the major 
effort of the NCI has been to encourage medically trained individuals to 
become involved in basic research problems at the most fundamental biological 
levels, but there has been no effort to encourage scientists trained in the 
basic sciences to focus on problems of direct relevance to the clinical 
sciences or the prevention, control and population sciences.  The continued 
success of future cancer research will depend upon the increased ability of 
the cancer biomedical research community to effectively translate observations 
in the laboratory into patient and population research settings.   Basic 
scientists who focus their research on human biology and human disease and who 
are well trained to work with more applied scientists (clinical researchers, 
prevention researchers) will be an essential component of the translational 
research enterprise.   The Howard Temin Award also encourages postdoctoral 
individuals exclusively trained in the basic sciences to refocus their 
research careers on problems of direct relevance to human cancer prevention, 
detection, diagnosis, and treatment.  Specifically, the Howard Temin Award 
provides an opportunity for basic scientists to train under a mentor 
experienced in human cancer research, transition to an independent research 
position and acquire research support focused on issues and problems directly 
relevant to human cancer.

MECHANISM OF SUPPORT 

This PA will use the NIH K01 award mechanism.  Planning, direction, and/or 
execution of the program will be the responsibility of the applicant and 
his/her mentor.  

Applicants may request up to five 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.  
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 (refer to 
"Non-Competing Renewals").  NIH Grant policies apply to these awards.

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 may be submitted on behalf of candidates by domestic, non-
Federal 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 

Foreign institutions are not eligible to apply.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Individuals with the appropriate degree(s) and the skills, knowledge, and 
resources necessary to carry out the proposed research are invited to work 
with their institution to develop an application for support.  Individuals 
from underrepresented racial and ethnic groups as well as individuals with 
disabilities are always encouraged to apply for NIH programs.   

The candidate must have a research or a health professional doctoral degree or 
its equivalent, must have completed at least three years of postdoctoral 
research at the time of award, and must have demonstrated highly productive 
research activity and high potential for establishing an independent research 
program in the period after the doctorate.  

Candidates must be able to identify an individual with extensive experience in 
human cancer research who can serve as a mentor for the initial mentored phase 
of this award.

The candidate's research proposal must DIRECTLY relate to etiology, 
pathogenesis, prevention, diagnosis, control and treatment of HUMAN cancer.  
Work developing or refining model systems will be supported only if the 
proposed research objectives actively test the relevance of the model to human 
cancer.  

Candidates who are not U.S. citizens, non-citizen nationals, or permanent 
residents MAY APPLY for this award.  However, candidates must be U.S. citizens 
or non-citizen nationals, or must have been lawfully admitted for permanent 
residence, in order for the actual grant award to be made.  Individuals 
admitted for permanent residence must be able to produce documentation of 
their immigration status such as an Alien Registration Receipt Card (I-151 or 
I-551) or some other verification of legal admission as a permanent resident.  
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 to receive this award.

ELIGIBLE individuals include former or current principal investigators on NIH 
Small Grants (i.e., R03s) or Exploratory/Developmental Grants (i.e., R21s).  
Current recipients of an NCI Preventive Oncology/Population Sciences Career 
Development (K07) Award, or a Mentored Clinical Research Scientist Career 
Development (K08) Award who are engaged in basic research may apply during the 
last two years of the career development award budget period.  The career 
development award will be terminated upon acceptance of a Howard Temin Award.
  
INELIGIBLE individuals include former or current principal investigators on 
NIH research projects (i.e., R01s), FIRST Awards (i.e., R29s), Mentored 
Patient-Oriented Research Career Development (K23) Award, NCI Transition 
Career Development Award (K22), sub-projects on Program Project Grants (i.e., 
P01s) or Center Grants (i.e., P30s, P50s) and their equivalents.

SPECIAL REQUIREMENTS
 
A. Program

The award provides up to five consecutive 12-month appointments.  At least 75 
percent of the recipient's full-time professional effort must be devoted to 
the career development plan/research proposed in the Temin application and the 
remainder devoted to activities related to the development of a successful 
research career focused on human cancer research.  The candidate may find it 
appropriate to include didactic experiences as part of the career development 
plan.

Environment: The institution must have a well-established track record of 
conducting research directly relevant to human cancer and faculty who are 
highly experienced in human cancer research and can serve as mentors.  The 
candidate, mentor and institution must be able to describe a career 
development program that takes maximum advantage of the research and 
educational resources relevant to the candidate's career development.

Mentor(s): The mentor must be an individual with extensive direct experience 
in human cancer research. Women and minority mentors should be involved as 
role models whenever feasible. The recipient must receive appropriate 
mentoring for at least the first year of the grant and for no more than the 
first three years.  The candidate may move to the unmentored (independent) 
research phase only on the award anniversary dates of the second, third and 
fourth year of support.  See the SUPPLEMENTAL GUIDELINES FOR TRANSITION TO THE 
UNMENTORED STATE below.  

B. Allowable Costs:

Salary: The Temin 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 spend a minimum of 75 percent 
professional effort on the career development plan/research proposed in the 
Temin application.  The remaining percent effort must be 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.

Research Development Support: During the mentored phase of the award, 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; and (d) travel to research meetings 
or for training.  The amount of this support will increase to a maximum of 
$50,000 per year when the principal investigator transitions to the unmentored 
(independent) research phase, either at the same institution or at a different 
institution.

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.

C. Evaluation:  

In carrying out its stewardship of human resource related programs, NIH may 
need to obtain information essential to an assessment of the effectiveness of 
this program.  Recipients are hereby notified that they may be contacted 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, 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.

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 
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 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.

F. Termination or Change 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.

Awardees planning a change of institution are urged to contact the NCI Program 
Director (name listed in Notice of Grant Award) to discuss the transfer and 
obtain instructions.  The required paperwork must be submitted by the new 
institution far enough in advance of the requested effective date to permit 
review.  The period of support requested at the new institution 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.

G. Change of Mentor:

When a mentor at the grantee institution is to be replaced, the institution 
must submit a letter from the proposed mentor documenting the need for 
substitution, the new mentor's qualifications for supervising the program, and 
the new mentor's research support that will provide a funded research 
environment appropriate for the candidate's development. The letter must also 
document that the specific aims of the research program will remain within the 
scope of the original peer reviewed research program.  NCI staff will review 
the request and will notify the grantee institution of the results of the 
evaluation.

H. Reporting Requirements:

If the application is funded, additional reporting requirements for 
continuation of this project are listed in the section titled "NON-COMPETING 
RENEWALS".

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. Cynthia Pond
Program Director, Cancer Training Branch
National Cancer Institute
6116 Executive Boulevard, Suite 7011
Bethesda, MD 20892-8346
Rockville, MD 20852 (express/courier service)
Telephone:  (301) 496-8580
FAX:  301-402-4472
Email: pondc@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. Catherine Blount
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Room 243
Bethesda, MD 20892-7150
Rockville, MD 20852 (express/courier service)
Telephone:  301-496-3179
FAX:  301-496-8601
Email:  blountc@mail.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001 or subsequent revisions) and instructions 
found in Section IV. "Research Career Award".  The PHS 398 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.

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.

ADDITIONAL REQUIREMENTS

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  Provide only total direct costs on Form Page 5 (Budget for Entire Proposed 
Period of Support)

o  Under justification (Form Page 5), provide (in narrative format) detailed 
information and justification for all items included in the budget, such as 
tuition, fees, books, travel, and research development support.  

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 with the application that include 
the following:

o  Description of the adequacy of the candidate's scientific background for 
the proposed research and career goals.

o  Description of the quality of the candidate's scientific productivity and 
achievements (e.g. publications, intellectual contributions to the research 
environment).

o  Discussion of the candidate's ability to work with other scientists in 
various interactive situations (e.g., seminars, journal clubs), on 
collaborative research projects, and with support staff (e.g., technicians, 
nurses, secretaries, etc.).

o  Evidence of the candidate's originality and innovativeness in pursuing a 
research problem.

o  Description of the candidate's special potential to develop and manage an 
independent research program.

THE CANDIDATE

o  Describe the candidate's commitment to a career in basic research directly 
relevant to human biology and cancer;

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 plans of 
the candidate;

o  Discuss the innovativeness and quality of the candidate's research efforts 
to this point in his/her research career;

o  Present a systematic plan that covers the mentored and unmentored phases of 
this Program.  This plan must incorporate the prior research training and 
experience of the candidate, and provide an explanation for the need for 
further career development. The plan must provide a description of the 
research and training experiences that will occur during the mentored and 
unmentored phases.  The plan must present a convincing case that, as a result 
of these experiences, the candidate will have a high probability of developing 
the research skills and ability needed to work in a collaborative environment 
and become a successful independent cancer researcher. The plan must include a 
statement regarding the proposed length of the mentored and unmentored phases; 
the unmentored phase must begin on the anniversary award date of the second, 
third or fourth year of the grant.

o  Document prior instruction in or proposed plans for instruction in the 
responsible conduct of research in terms of subject matter and duration of 
instruction.  No award can be made if an application lacks this component.

STATEMENT(S) BY MENTOR, CO-MENTOR(S), CONSULTANT(S), AND COLLABORATOR(S) 

o  Mentor/Co-mentor(s):  The application must include signed statement(s) from 
the primary mentor and any co-mentor(s), if proposed, providing information on 
their research qualifications and previous experience as research 
supervisor(s).  This information should demonstrate how these qualifications 
and existing research support will be used to assist the candidate to achieve 
the objectives of his/her career development and research plans.  This 
information should clearly establish that the mentor has extensive direct 
experience in human cancer research. Co-mentors, if proposed, must 
specifically address the nature of their role in the career development plan 
and how the responsibility for the candidate's development is shared and 
coordinated with the primary mentor.  

The statement of the primary mentor should specifically describe whether all 
or parts of the research project being conducted by the candidate will go with 
the candidate when the transition to an independent position is made or 
whether the candidate will be expected to develop an entirely new project 
during the independent phase of the award.  

Specific information (e.g. grants) on the active/pending research support of 
the mentor(s) related to the candidate's research plan should not be included 
in this statement, but should be provided in the corresponding biosketches.  

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

o  In a clear statement, provide assurance that the candidate will be able to 
spend a minimum of 75 percent of total professional effort on the career 
development plan/research proposed in the Temin application, with the 
remaining percent effort devoted to activities related to the development of a 
successful research career.

RESEARCH PLAN

o  Describe the research plan, clearly explaining the direct relevance of the 
research to human biology and human cancer disease.  Work developing or 
refining model systems will be supported only if the proposed research 
objectives actively test the relevance of the model to human cancer.  

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 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)

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 change in practice is effective immediately.  
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 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 
for adherence to the guidelines of this PA by the NCI program staff.  
Applications not adhering to the guidelines of this PA, and those 
applications that are incomplete as determined by CSR or by NCI program 
staff, will be returned to the applicant without further consideration.

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 Receive a written critique
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 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 Statements by 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.  

CANDIDATE 

o  Strength of the candidate's statement regarding his/her commitment to a 
basic cancer research career focused on problems directly relevant to human 
biology and human cancer disease.

o  Strength of the evidence presented by the candidate of interaction and 
collaboration with other scientists.

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

o  Strength of the recommendations of three well-established scientists 
attesting to the special potential of the individual to become an independent 
investigator.

o  Likelihood that the career development plan will contribute substantially 
to the scientific development of the candidate and the achievement of 
scientific independence in a field directly relevant to human biology and 
human cancer disease.
 
o  Adequacy of prior or proposed training in the responsible conduct of 
research.

o  Appropriateness of the proposed durations of the mentored and unmentored 
phases.

o  Appropriateness of the proposed activities during the mentored and 
unmentored phases for a five year award.

STATEMENTS BY MENTOR, CO-MENTOR(S), CONSULTANT(S), AND COLLABORATOR(S) 

o  Appropriateness of the qualifications of the mentor(s) in the area of the 
proposed research and of the mentor(s) as someone who has extensive, direct 
experience in human cancer research.
  
o  Quality, nature and extent of the previous experience of the mentor(s), 
especially as it relates to training successful cancer researchers. 

o  Quality, nature and extent of the supervision that will occur during the 
mentored phase of the proposed award period. 

o  Adequacy of existing peer-reviewed research of the mentor(s) to provide an 
appropriately funded environment for the mentored phase of the candidate's 
career development.

o  Adequacy and clarity of the statement of the mentor(s) describing what 
aspects of the Research Plan will remain with and facilitate the transition 
of the candidate to an independent position. 

o  Adequacy and clarity of similar information provided by any co-mentor, as 
well as description of respective areas of expertise and responsibility.

ENVIRONMENT AND INSTITUTIONAL COMMITMENT TO THE CANDIDATE

o  Quality of the environment for scientific and professional development.

o  Adequacy of research facilities.

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

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

o  Degree of relevance of the research plan to understanding the etiology, 
pathogenesis, prevention, detection, diagnosis, and/or treatment of human 
cancer.

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

o  Usefulness of the research plan as a vehicle for enhancing existing 
research skills.

o  Potential of the research plan to help the candidate develop into an 
independent career directly relevant to human cancer research.    

o  Adequacy of the application's attention to children, gender, and minority 
issues when human subjects are involved.

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 CONSIDERATIONS 

BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the career development plan and 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

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".  The PHS 2590 is available at 
http://grants.nih.gov/grants/funding/2590/2590.htm.  

GUIDELINES FOR TRANSITION TO INDEPENDENT (UNMENTORED) PHASE

These guidelines apply only to the non-competing years in which a transition 
to an independent position is requested.  The unmentored phase of career 
development must begin on the anniversary date of the second, third or fourth 
year of the award.  The annual progress report for this year, called a 
transition application, must include additional material related to the 
transition.  Transition applications require approval by NCI program staff 
before transition to the independent phase can occur.  Additional peer review 
may also be necessary if changes in the research plan are proposed. 

Different instructions apply when the candidate is changing institutions at 
the time of transition to independence (see below).  To ensure that the 
transition occurs smoothly, it is strongly suggested that candidates planning 
a change of institution contact NCI program staff prior to submission of the 
transition application.
 
TRANSITIONING TO INDEPENDENCE AT THE SAME INSTITUTION

When the candidate is remaining in the same institution, transition 
applications are to be submitted on form PHS 2590.  Follow the instructions 
for "Non-competing Grant Progress Reports" with these ADDITIONAL special 
instructions:

FACE PAGE

o  To associate the application with a transition request, enter "NCI HOWARD 
TEMIN AWARD (K01) TRANSITION" on Line 1.

DETAILED BUDGET FOR NEXT BUDGET PERIOD

o  Provide an itemized listing with associated projected costs for all items 
on Form Page 2.  

BIOGRAPHICAL SKETCH

o  Provide a biosketch for all key personnel to be involved in the research 
project.  Provide information on research projects completed and/or research 
grants participated in during the last five years.

PROGRESS REPORT SUMMARY

This section should be keep as short as possible.  However, due to the unique 
reporting requirements for the transition application, the section may exceed 
two pages. 

Items a-j: as directed in PHS 2590 with the following additional material:

Item b. Studies and Results

o  Provide detailed information that clearly justifies a transition to the 
unmentored phase of the award.

Item d. Plans

o  Describe how the scope of the project initiated during the unmentored phase 
will be changed in response to the increased level of research support 
provided in the mentored phase of this award.  Provide detailed research plans 
if there is a major change in research scope of the original peer reviewed 
research plan.

o  Describe the DIRECT relevance of the research plan to the etiology, 
pathogenesis, detection, prevention, diagnosis, and/or treatment of human 
cancer.

o  Describe how the proposed research and research-related activities should 
contribute to the scientific development of the candidate, and the development 
of an independently funded research program.

o  Describe long term research career goals, including the timing of 
submission of applications for investigator-initiated research grants.

Item j. Mentor's Report

o  Provide a sealed statement from the mentor recommending the candidate for 
the transition.  This recommendation should be based on the scientific 
productivity of the candidate under his/her mentorship, and on the mentor's 
detailed evaluation that the candidate is ready to develop an innovative and 
independently-supported research program.  THIS LETTER SHOULD BE MAILED 
DIRECTLY TO THE NCI PROGRAM DIRECTOR FOR THE CANDIDATE'S HOWARD TEMIN AWARD.

ENVIRONMENT AND INSTITUTIONAL COMMITMENT - TRANSITION

o  Provide a signed statement from the Chairperson of the Department to which 
the awardee has been recruited describing the type of faculty position offered 
and whether it is a tenure-track position (or equivalent); the 
responsibilities of the position; the laboratory facilities that will be 
provided for exclusive use by the awardee and the relationship of these 
facilities to the laboratories of the applicant's former mentor; additional 
non-PHS research related departmental/institutional support that will be 
provided (i.e. technical support staff, equipment, animals); the relationship 
of the awardee's research program to ongoing programs within the institution; 
and career plans for the awardee.

o  Provide a statement from the institution ensuring that a minimum of 75 
percent of the candidate's professional effort will be devoted directly to the 
career development plan/research proposed in the Temin application, with the 
remaining percent effort being devoted to activities related to the 
development of a successful research career.

Submit a signed, typewritten original of the signed application and two signed 
photocopies in one package to:

Records Management Center
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Suite T-42 MSC 7107
Bethesda, MD 20892-7107 (Express mail, use Rockville, MD  20852)

TRANSITIONING TO INDEPENDENCE WITH CHANGE OF INSTITUTION

When the candidate is changing institution, transition applications are to be 
submitted on form PHS 398 (rev. 5/2001 or subsequent revisions) and 
instructions found in Section IV. "Additional Instructions for Preparing 
Individual Research Career (RCA) Applications – "K"Series".  The PHS 398 is 
available at http://grants.nih.gov/grants/funding/phs398/phs398.html In 
addition, candidates must provide a progress report. 

1. PHS 398 – as directed in PHS 398 with the following special instructions:

FACE PAGE

o  To associate the application with a transition request, enter "NCI HOWARD 
TEMIN AWARD (K01) TRANSITION" on Line 1.

DETAILED BUDGET FOR NEXT BUDGET PERIOD

o  Provide an itemized listing with associated projected costs for all items 
on Form Page 2.  

BIOGRAPHICAL SKETCH

o  Provide a biosketch for all key personnel involved in the project.  

OTHER SUPPORT

o  Provide Other Support Format Page 7-GG for all key personnel. 

2. PROGRESS REPORT 

There is no set format for the progress report. Candidates may use Item 4 
"Progress Report Summary" found in Section IV. "Additional Instructions for 
Preparing Continuation Research Career Award (RCA) Progress Reports" of form 
PHS 2590 as a template.  The PHS 2590 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html.  Use of the Progress 
Report Summary, with the additional items below, will provide all the 
necessary information.  

Items a-j: as directed in PHS 2590 with the following additions:

Item b. Studies and Results

o  Provide detailed information that clearly justifies a transition to the 
unmentored phase of the award.

Item d. Plans

o  Describe how the scope of the project initiated during the unmentored phase 
will be changed in response to the increased level of research support 
provided in the mentored phase of this award.  Provide detailed research plans 
if there is a major change in research scope of the original peer reviewed 
research plan.

o  Describe the DIRECT relevance of the research plan to the etiology, 
pathogenesis, detection, prevention, diagnosis, and/or treatment of human 
cancer.

o  Describe how the proposed research and research-related activities should 
contribute to the scientific development of the candidate, and the development 
of an independently funded research program.

o  Describe long term research career goals, including the timing of 
submission of applications for investigator-initiated research grants.

Item j. Mentor's Report

o  Provide a sealed statement from the mentor recommending the candidate for 
the transition.  This recommendation should be based on the scientific 
productivity of the candidate under his/her mentorship, and on the mentor's 
detailed evaluation that the candidate is ready to develop an innovative and 
independently-supported research program.  THIS LETTER SHOULD BE MAILED 
DIRECTLY TO THE NCI PROGRAM DIRECTOR FOR THE CANDIDATE'S HOWARD TEMIN AWARD.

ENVIRONMENT AND INSTITUTIONAL COMMITMENT - TRANSITION

o  Provide a signed statement from the Chairperson of the Department to which 
the awardee has been recruited describing the type of faculty position offered 
and whether it is a tenure-track position (or equivalent); the 
responsibilities of the position; the laboratory facilities that will be 
provided for exclusive use by the awardee; additional non-PHS research related 
departmental/institutional support that will be provided (i.e. technical 
support staff, equipment, animals); the relationship of the awardee's research 
program to ongoing programs within the institution; and career plans for the 
awardee.

o  Provide a statement from the institution ensuring that a minimum of 75 
percent of the candidate's professional effort will be devoted directly to the 
career development plan/research proposed in the Temin application, with the 
remaining percent effort being devoted to activities related to the 
development of a successful research career.

o  Provide documentation of a strong, well-established institutional program 
in biomedical research related to cancer, including a high quality research 
environment with scientists capable of productive collaboration with the 
candidate and the furtherance of the candidate's goals to establish an 
independent research program directly relevant to human cancer.

Submit a signed, typewritten original of the signed application and two signed 
photocopies in one package, to the grants specialist whose name appears on the 
Notice of Grant Award, at:

Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Room 243
Bethesda, MD 20892-7150
Rockville, MD 20852 (express/courier service)
  
REVIEW CRITERIA FOR A "TRANSITION" APPLICATION

o  Adequacy of candidate's progress toward meeting the career development 
goals and research aims of the original application as they relate to a 
research career directly relevant to human cancer.

o  Adequacy of the mentor(s)' statement regarding the candidate's scientific 
productivity. 

o  Strength of mentor(s)' recommendation for transition to independence.

o  Soundness of the commitment from the institution to provide the candidate 
with the following:
protected time (minimum 75 percent effort); a permanent (preferably tenure-
track) position; adequate facilities for conducting  the proposed research 
program; and additional resources conducive to the development of a research 
project and establishment of a successful research career in human cancer.

o  The adequacy of the plans for inclusion of women, children, and minorities 
in any clinical or population research activities, as applicable.

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

o  If the transition involves a change of sponsoring institution, the 
adequacy of research facilities and training opportunities at the new 
institution, the strength of the institution's cancer research  program, and 
the availability of staff capable of productive collaboration with the 
candidate and the furtherance of candidate's goals to establish an independent 
research program directly relevant to human cancer.

AWARD CRITERIA FOR A "TRANSITION" APPLICATION

Funding decisions will be made by NCI staff based on satisfaction of the 
review criteria above.  NCI staff will notify the candidate regarding action 
taken on the transition application.  If the transition to the independent 
phase is not recommended for approval, program staff may determine that the 
mentored phase be continued, funding be withheld until suitable arrangements 
are made, or the award terminated.  The transition to the unmentored phase 
will take effect on the anniversary date of the grant.

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.

MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (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://grants.nih.gov/grants/stem_cells.htm 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 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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