NCI MENTORED CAREER DEVELOPMENT AWARD FOR UNDERREPRESENTED MINORITIES (K01)

RELEASE DATE:  October 30, 2002 (see modification NOT-CA-03-023)

PA NUMBER:  PAR-03-016

EXPIRATION DATE:  This PAR will expire on October 2, 2005, unless reissued. 
NIH Grants policies apply to these awards.

National Cancer Institute (NCI)
 (http://www.nci.nih.gov/)
  
This Program Announcement (PA) replaces PAR-01-016, which was published in 
the NIH Guide on November 17, 2000.

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 Peer Review Process
o Review Criteria
o Award Criteria
o Non-Competing Renewals
o Supplemental Guidelines for Transition to "Phase II" (Independent)
o Review Considerations for a "Phase II" Application
o Required Federal Citations

PURPOSE OF THIS PA

The Comprehensive Minority Biomedical Branch (CMBB), Office of Centers, 
Training and Resources (OCTR), Office of the Deputy Director for Extramural 
Sciences (ODDES), National Cancer Institute (NCI), invites career development 
award applications (K01) from underrepresented minority research scientists 
who have been recipients of an NIH Research Supplement for Underrepresented 
Minority Award, any National Research Service Award (individual F31/F32 or 
institutional T32 supplement) or can demonstrate that they have been 
supported in a mentored capacity within any research grant equivalent to an 
NIH peer-reviewed research grant (e.g., ACS research grant).  This award is 
for candidates who seek additional support in the basic, clinical, prevention 
and/or population sciences in a mentored research environment with the option 
to continue with bridging support for their first independent research 
position.  Successful candidates will be provided with special opportunities 
to enhance their knowledge and understanding of the NIH/NCI peer review 
system and to develop the skills required to prepare other grant applications 
(e.g., R01; R03; R21).

This award is a novel program that is intended to support and enhance the 
likelihood of success for underrepresented minority investigators who have 
committed to basic, clinical, and prevention and population-based research 
careers in cancer.

RESEARCH OBJECTIVES

Substantial national and local efforts have been made and are continuing to 
be made to reduce cancer morbidity and mortality in the general population. 
However, in spite of these efforts, projections for 2002 indicated that 
1,284,900 cancers were expected to be diagnosed in the United States and 
555,500 Americans were expected to die of this disease.

Past patterns of cancer incidence and mortality predict that a 
disproportionate share of this increase in U.S. cancer incidence and 
mortality will be borne by minorities. Specifically, past and current SEER 
data show that Hispanic Americans have excessive cancer incidences of the 
prostate, breast, lung and bronchus, colon and rectum, and cervix. Native 
Americans from New Mexico show excessive cancer rates for prostate, breast, 
colon and rectum, ovary, kidney, and renal pelvis cancers, with the incidence 
rate for gall bladder cancer being the highest of any racial group.  Alaska 
Natives have the highest cancer incidence rates among any racial group for 
cancer of the colon and rectum. Finally, cancer mortality rates for all sites 
for African Americans are almost 1.4 times greater than for Whites.

A reduction in the overall cancer mortality rate in minority populations 
would substantially impact known cancer statistics.  A major obstacle to 
developing a stronger national minority cancer research effort has been the 
lack of significant strategic training programs for minority students and 
scientists in cancer research.  Greater involvement of minority candidates  
who possess the appropriate cultural perspectives is integral to a successful 
national minority cancer research effort  involving more minority patients 
and populations.  Prior to 2000, progress in realizing a significant increase 
in the number of competitive minority cancer researchers had been 
disappointing, however, this mechanism establishes a new pathway of 
recruiting, training and retaining minority students and investigators into 
research fields that address problems pertinent to the biology, etiology, 
pathogenesis, prevention, diagnosis, control and treatment of human cancer 
and who can conduct independent competitive cancer programs.  

MECHANISM OF SUPPORT 

Support for this program will be provided through the NIH K01 career 
development award mechanism.  Planning, direction, and execution of the 
program will be the responsibility of the candidate and her/his mentor on 
behalf of the applicant institution.  

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

ELIGIBLE INSTITUTIONS 

You may submit (an) application(s) if your institution has any of the 
following characteristics: 

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government or comparable institutions with 
a well established cancer research career development program and qualified 
faculty in basic research to serve as mentors  
o Domestic

The institution must have well-established basic, clinical, and/or prevention 
and population-based cancer research programs and qualified faculty to serve 
as mentors.  The candidate, mentor and institutional representative must be 
able to propose an appropriate cancer research/career development program 
that will maximize the use of relevant cancer research and educational 
resources.  The institution must be able to demonstrate a commitment to the 
development of the research careers of junior underrepresented minority 
research scientists in biomedical cancer research.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

This award is designed to provide an intensive, supervised research 
experience for underrepresented minority individuals who possess a research 
or health professional doctoral degree (or its equivalent) to acquire cancer 
research experience in basic, clinical, prevention and/ or population 
sciences.   

Underrepresented minorities are defined as individuals belonging to a 
particular ethnic or racial group that has formally been determined by the 
applicant institution to be underrepresented in biomedical and behavioral 
research.  The NCI wishes to point out that African Americans (Blacks), 
Hispanic Americans, American Indian and Alaska Natives, and Native Hawaiian 
and Other Pacific Islanders are underrepresented nationally in biomedical and 
behavioral research.  Awards will be limited to individuals who are citizens, 
non-citizen alien nationals, or permanent residents of the United States.  
Individuals on temporary or student visas are not eligible.  Women and 
persons with disabilities are encouraged to apply as principal investigators.

The candidate must have been a recipient of an NIH Research Supplement for 
Underrepresented Minorities Award, or any NIH National Research Service Award 
(e.g., F31, F32, or T32 supplement), or the candidate must be able to 
demonstrate that he/she has been mentored within any research grant 
equivalent to an NIH peer-reviewed research grant (e.g., ACS research grant). 

The candidate must be nominated by institutions on the basis of 
qualifications, interests, accomplishments and motivation, and based upon the 
candidate's intent to conduct a research project highly relevant to cancer 
biology, etiology, pathogenesis, prevention, diagnosis and/or treatment that 
has the potential for establishing an independent research program.
 
The candidate must have a mentor with extensive research experience who has 
an appreciation of the cultural, socioeconomic and research background of the 
individual candidate and the candidate must be willing to devote a minimum of 
75 percent full-time professional effort conducting research and research 
career development.

Ineligible individuals include former and current Principal Investigators on 
NIH Research Project grants (R01), comparable Career Development Awards 
(e.g., K07, K08, K22, K23) or First Awards (e.g., R29s) in the last five 
years.   Former or current Principal Investigators on NIH Small Grants (e.g., 
R03s) or Exploratory/Developmental Grants (e.g., R21s), sub-projects on 
Program Project Grants (e.g., P01s), Specialized Center Grant (e.g., P50s), 
or Center Grant (P30) and their equivalents remain eligible.

SPECIAL REQUIREMENTS 
 
A.  Program:

The NCI Mentored Career Development Award (K01) for Underrepresented 
Minorities can be used by postdoctoral candidates who need five full years of 
mentored support or by more advanced postdoctoral candidates who need 
additional mentored research experiences but also plan to use the award to 
make a transition to an independent position.  Accordingly, the award 
provides up to five consecutive 12-month appointments with the option of 
involving one or two phases: A mentored phase (Phase I) for one to five years 
or a mentored phase of one or more years followed by a transition to an 
independent position (Phase II) in subsequent years. Candidates choosing to 
apply for Phase I or a combination of Phase I and Phase II must include the 
appropriate phases in their research plan.  Candidates will participate in 
mentored research activities, which should include writing and submitting 
manuscripts for publication and presenting at scientific meetings.  In 
addition, candidates will be expected to observe or participate (depending 
upon prior research experience and/or level of independence and without 
additional compensation) in the NCI/NIH peer review process, as well as to 
participate annually in workshops focused on preparing, writing and 
submitting NIH grant applications; these activities will be coordinated 
and/or sponsored by the CMBB.

Candidate:  Candidates must devote at least 75 percent of their professional 
effort to cancer-related research and peer review activities consistent with 
the objectives of this award.  For the purposes of this award, full-time 
professional effort provides protected time away from normal activities (e.g. 
administrative, clinical, and teaching assignments). The 75 percent effort 
includes activities consistent with development of the minority candidate 
into a competitive independent scientist (e.g. acquisition of laboratory 
skills and didactic courses).  The remainder (25 percent) may be devoted to 
teaching or other research pursuits as long as they are consistent with the 
objectives of the award (i.e. to train a research scientist who can compete 
successfully for NIH support).  Both the didactic and the research phases of 
an award period must be designed to develop the necessary knowledge and 
research skills in the basic, clinical, prevention or population-based cancer 
research field relevant to the career goals of the candidate.  

Mentor:  The application must include mentoring appropriate to both Phase I 
and Phase II of the award; that is, mentoring in preparation to become an 
independent scientist and mentoring to guide the candidate in an independent 
position in the development of a research program competitive for peer-
reviewed research support.  The mentor must be a senior or mid-level faculty 
member with research competence and/or experience appropriate to his/her 
role.  

Candidates must identify a suitable sponsor (i.e., mentor) with extensive 
research experience who has an appreciation of the cultural, socioeconomic 
and research background of the individual candidate.  The mentor, with input 
from the candidate, will be responsible for the planning, direction, and 
execution of a tailored career development plan specific to the applicant's 
particular career development needs.  Where feasible, women and 
underrepresented minority mentors should be involved as role models.

Because of the focus on progression to independence as researchers, 
candidates for the K01 should propose, together with their mentor, a period 
of study and career development consistent with the previous research and 
clinical experience of the candidate, and as appropriate, sensitive to the 
individual needs related to his/her cultural, socioeconomic heritage. For 
example, a candidate with limited experience in a given field of research may 
find a 5-year phased developmental program that includes a designated period 
of specialized didactic training followed by a research experience that is 
very closely monitored by the mentor necessary to insure that the candidate 
will attain independence.  Candidates with cultural and socioeconomic 
backgrounds that may isolate them from their peers or impede their progress 
should be given individual attention to ensure that they ultimately are able 
to perform and interact as effectively as any other candidate being trained 
in the institution as biomedical researchers.  A candidate with previous 
research experience and training may not require extensive additional 
didactic preparation, and may benefit from a program that focuses primarily 
on an intensive, supervised cancer research experience.  All programs must be 
tailored to meet the individual needs of each minority individual to provide 
the opportunity for him/her to gain the skills and knowledge necessary to 
carry out high quality cancer research. The candidate and the mentor are 
jointly responsible for the preparation of the plan for this program. The 
mentor must carefully monitor the candidate's progress through the career 
development program.  If necessary, an advisory committee can be formed to 
assist with the development of a program that meets the candidate's needs and 
to monitor the candidate's progress through the career development program. 
The didactic and research components of both phases must develop new 
knowledge and research skills in scientific areas relevant to the career 
goals of the minority candidate.

B.  Allowable Costs:

Salary:  This award will provide salary up to $75,000 annually plus fringe 
benefits.  The total salary requested must be based on a full-time, 12 month, 
staff appointment.  The candidate must spend a minimum of 75 percent effort 
conducting cancer research studies, with the remaining effort being devoted 
to activities related to the development of a successful research career.  

The salary must be consistent both with the established salary structure at 
the institution and with salaries actually provided by the institution from 
its own funds to other staff members of equivalent qualifications, rank, and 
responsibilities in the department concerned.  If full-time, 12 month 
salaries are not currently paid to comparable staff members, the salary 
proposed must be appropriately related to the existing salary structure.

The institution may supplement the NIH salary contribution up to a level that 
is consistent with the institution's salary scale; however, supplementation 
may not be from Federal funds unless specifically authorized by the Federal 
program from which such funds are derived.  Because the salary amount 
provided by this award is based on the full-time institutional salary, no 
other PHS funds may be used for salary supplementation.  Institutional 
supplementation of salary must not require extra duties or responsibilities 
that would interfere with the purpose of the K01.  Under expanded 
authorities, however, institutions may re-budget funds within the total costs 
awarded to cover salaries consistent with the institution's salary scale.

Research Development Support:  During Phase I of the award, $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; d) travel to research meetings or for training, and e) 
travel to an annual two-day NCI awardee meeting and/or peer review related 
training expenses.  The amount of this support will increase to $50,000 in 
Phase II when the Principal Investigator moves to an independent research 
environment, as opposed to the environment provided by a mentor.  This could 
be an independent research position either at the same institution or at a 
different institution.

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

Facilities and Administration 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, the 
NCI/CMBB may begin requesting information essential to an assessment of the 
effectiveness of this program.  Accordingly, recipients are hereby notified 
that they may be contacted after the completion of this award for periodic 
updates on various aspects of their employment history, publications, support 
from research grants or contracts, honors and awards, professional 
activities, and other information helpful in evaluating the impact of the 
program.

D.  Other Income:

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

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

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

o The funds may be paid to miscellaneous receipts of the U.S. Treasury.  
Checks should be made payable to the Department of Health and Human Services, 
NIH and forwarded to the Director, Division 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 that 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 re-budgeted.  The NCI 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 NCI.

E.  Special Leave:

Leave to another institution, including a foreign laboratory, may be 
permitted if the proposed experience is directly related to the purpose of 
the award.  Only local, institutional approval is required if such leave does 
not exceed 3 months.  For longer periods, prior written 
approval of the NCI is required.  To obtain prior approval, the award 
recipient must submit a letter to the NCI describing the plan, which must be 
countersigned by his or her department head and the appropriate institutional 
official.  A copy of a letter or other evidence from the institution at which 
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 the 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, for 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 a rate 
of 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.  

Furthermore, the awardee must submit assurance of his or 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, the NIH funding 
component 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 purposes 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 must submit to the NCI in advance 
of the change a written request for transfer, which is countersigned by the 
appropriate institutional business official including a statement of the 
reasons for the change and the new sponsor's name and biographical sketch.  
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.  Additionally, the new 
sponsor must have the appropriate research expertise to supervise the program 
and sufficient research support to ensure continuation of the research 
program to the end of the award (initial award) period.  Staff within the NCI 
will review this request and may require a review by an initial review group 
and/or the National Cancer Advisory Board.  Upon approval of this request, a 
new career award PHS-398 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 for 
the time remaining within the existing award period.

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 to document the need for 
substitution, the new mentor's qualifications for supervising the program, 
the new mentor's sensitivity to any cultural or socioeconomic factors that 
may impede the progress of the candidate, and the level of support for the 
candidate's career 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. 

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

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/program issues to:

Ms. Belinda M. Locke
Program Director, Comprehensive Minority Biomedical Branch
National Cancer Institute
6116 Executive Boulevard, Suite 7031
Bethesda, MD 20892-8350
Rockville, MD 20852 (express/courier service)
Telephone:  (301) 496-7344
FAX:  301-402-4551
Email: lockeb@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
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. Barbara Fisher
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Room 243
Bethesda, MD 20892-7150
Rockville, MD 20852 (express/courier service)
Telephone:  301-846-1015
FAX:  301-846-5720
Email:  fisherb@gab.nci.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
using Section IV "Research Career Award" instructions and forms (rev. 5/01).  
The PHS 398 is available at 
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 710-0267, 
Email: GrantsInfo@nih.gov.

Potential candidates are strongly encouraged to contact the program staff 
person listed under INQUIRIES. Such contact should occur early in the 
planning phase of application preparation. Such contact will help ensure that 
applications are responsive to the goals and policies of this announcement.

Applicants who will be using the resources within a General Clinical Research 
Center (GCRC) during the course of the award should include a letter of 
agreement from either the GCRC program director or the principal investigator 
for the application.

To identify the application as a response to this program announcement, check 
"YES" on item 2 of page one of the application and enter the title and number 
of this PA.

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

THE APPLICATION MUST ADDRESS THE FOLLOWING ISSUES:

CANDIDATE
o Describe the candidate's commitment to a career in basic, clinical and/or 
population-based cancer research (candidates with clinical degrees (e.g., 
M.D.) may wish to consider the Mentored Clinical Scientist Award for 
Underrepresented Minorities (K08) Award and candidates interested in patient-
oriented  research may wish to consider the Mentored Patient-Oriented 
Research for Underrepresented Minorities Career Development Award (K23), as 
more appropriate alternatives relative to their stage of development and 
career goals;

o Describe the candidate's research background, and how it relates to the 
objectives and plans of the candidate -- note any cultural, socioeconomic, or 
ethnic issues, as appropriate, that have already affected or may affect the 
pace of the candidate's career development;

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

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

o Describe immediate and long-term career objectives, explaining how the 
award will contribute to their attainment;

o Provide letters of recommendation.  Three sealed letters of recommendation 
in which the following issues are addressed:

- The adequacy of the candidate's scientific background for the proposed 
research and career goals;

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

- 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.);

- Evidence of the candidate's originality and innovativeness in pursuing a 
research problem;

- VERY IMPORTANTLY, the candidate's special potential to develop, establish 
and manage an independent research program.

CAREER DEVELOPMENT PLAN

The career development plan should be a joint effort between the applicant 
and his/her mentor and carefully tailored to the candidate's needs, which 
should factor in any cultural, socioeconomic and/or ethnic experiences that 
may impede the candidate's progress during his/her development as an 
independent research scientist engaged in cancer research.

o Present a systematic plan that covers Phase I (mentored, dependent) and, if 
appropriate, Phase II (mentored, independent) of this Program.  This plan 
should incorporate the prior research training and experience of the 
candidate to provide a basis for the need for further career development to 
become an independent investigator focusing on research that is clearly 
relevant to cancer.  The plan should provide a description of the research 
and training experiences that will occur during Phase I and Phase II of the 
proposed period of support, and the candidate must present a convincing case 
that, he/she will have a high probability of developing the research skills 
and ability needed to work in a collaborative environment and become a 
successful, independently supported investigator.  The plan must include a 
statement regarding the proposed length of the phases; if Phase II is 
proposed in the application, it must begin on the anniversary award date of 
the second, third or fourth year of the grant.

o Indicate a minimum commitment of at least 75 percent professional effort to 
research career development activities.  The candidate should give a clear 
overall description of the types of research/research training activities 
that he/she will be involved in within the 75 percent effort versus an 
overall description of  "other activities" and the percent effort involved. 

RESEARCH PLAN

Must Include:

o Describe the research plan using Form PHS 398 following instructions for 
the  Specific Aims, Background and Significance, Progress Report/Preliminary 
Studies, Research Design and Methods.  The candidate must consult with the 
mentor regarding the development of this section.  The research plan must be 
clearly relevant to cancer biology, etiology, pathogenesis, prevention, 
diagnosis, and/or treatment.  It must be clear as to whether all or parts of 
the Research Plan will remain as activities of the candidate when the 
transition to an independent position is made or whether the candidate will 
be expected to develop an entirely new project in the independent position.

MENTOR'S STATEMENT

o Include a signed statement from the mentor(s) with information on research 
qualifications and previous experience as a research supervisor.  The 
applications must also include information to describe the mentor's research 
support as related to the candidate's research plan and the specific nature 
of the supervision and mentoring that the candidate will receive during Phase 
I of the proposed award period.  This information must detail how the career 
plan will build upon the candidates unique research background, take into 
account unique cultural, socioeconomic heritage, of the candidate, as 
appropriate, and enhance the candidates research development toward 
independence.

o Provide similar information of any co-mentor.  If more than one mentor is 
proposed, the respective areas of expertise and responsibility should be 
described;

o Describe in this statement specifically whether all or parts of the 
research project being conducted by the candidate will remain as activities 
of  that individual when the transition to an independent position is made or 
whether the candidate will be expected to develop an entirely new project in 
the independent position.

ENVIRONMENT AND INSTITUTIONAL COMMITMENT

The sponsoring institution must document a strong, well-established research 
and training program related to the candidate's area of interest and a high-
quality research environment with staff capable of productive collaboration 
with the candidate. The sponsoring institution must provide a statement of 
commitment to the candidate's development into a productive independent 
investigator. The institutional statement also must commit to provision of 
release time from normal teaching or administrative duties necessary to meet 
the 75 percent effort requirement of this award.   The institutional 
statement should clearly indicate activities included within the 75 percent 
protected time.

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

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

BIOGRAPHICAL SKETCH

o A biographical sketch is required for the candidate and mentor(s).  For the 
candidate, include information on research projects completed and/or research 
grants participated in during the last five years that are relevant to the 
proposed project and demonstrate an uninterrupted involvement of research 
before submitting this application (see ELIGIBILITY REQUIREMENTS).

TRAINING IN THE RESPONSIBLE CONDUCT OF RESEARCH

Candidates must describe plans to receive instruction in the responsible 
conduct of research. These plans must detail the proposed subject matter, 
format, frequency, and duration of instruction. No award will be made if an 
application lacks this component.

BUDGET

The total direct costs requested must be consistent with this K01 program 
announcement and the award limits of the NCI.  Budget requests must be 
provided according to the instructions in form PHS 398, Section IV 
Instructions for the Research Career Awards.  The request for tuition and 
fees, books, travel, research development support, etc., must be justified 
and specified by category.  Applications seeking information on award limits 
should contact the fiscal representative listed in the INQUIRIES section at 
the end of this announcement.

SENDING AN APPLICATION TO THE NIH:

Submit a signed, typewritten original of the application, including the 
reference letters, the checklist, and three signed photocopies in one package 
to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
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)

APPLICATION PROCESSING: Applications must be received by the date(s) listed 
on the first page of this PA.  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.

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.) (https://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 https://grants.nih.gov/grants/guide/notice-files/
NOT-OD-02-012.html.

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 review.

Applications that are complete and adhere to the guidelines of this PA will 
be evaluated for scientific and technical merit by an appropriate peer 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 process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications under 
review, will be discussed and assigned a priority score; and
 
o Those that receive a priority score will undergo a second level review by 
the National Cancer Advisory Board.

REVIEW CRITERIA

CANDIDATE 

o Quality and breadth of the candidate's research, academic and/or clinical 
record, including publications, as a foundation for developing as an 
independent cancer researcher;

o Commitment of the candidate to an independent cancer research career in 
terms of effort and future plans that will be focused on problems clearly 
relevant to cancer;

o Appropriateness of the dedicated 75 percent effort to the successful 
development as a cancer researcher; and

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

o Recommendations of three well-established scientists attesting to the 
special potential of the individual to pursue an independent career in cancer 
research.
 
CAREER DEVELOPMENT PLAN
 
o Appropriateness of the content, the phasing, and the proposed duration of 
the minority candidate's career development plan in relation to his/her 
experience, background, and stated career goals; 

o Adequacy of special considerations in the Plan that tailor it to the 
special needs of the minority candidate's experience and background, 
including any important cultural, ethnic and/or socioeconomic factors, as 
appropriate, that could effect the progress of the candidate's successful 
development

o The need for the proposed research experience;

o Likelihood that the plan will contribute substantially to the scientific 
development of the candidate and the achievement of scientific independence;

o Conformity of the plan to 75 percent effort devoted to research/research 
training activities;

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

o Likelihood of successful planning, writing and submitting of traditional 
grant applications.

RESEARCH PLAN

Reviewers should recognize that minority candidates are likely to have 
variable degrees of research experience.  Those with more limited experience 
are less likely to prepare a plan with the breadth and depth of that 
submitted by more experienced investigators unless the mentor plays a 
significant role.  All plans must include fundamentally sound research 
approaches but reviewers should consider the applicant's research experience, 
cultural background, as appropriate, and especially evidence that the mentor 
is committed and involved (see Mentor/Co-mentor below);

o Degree of relevance of the research plan to developing an independent 
cancer research program as it relates to the cancer biology, etiology, 
pathogenesis, prevention, diagnosis, and/or treatment;

o A sound research project that is consistent with the development plan for 
an independent career in cancer research and commensurate with the 
candidate's level of research development;

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

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

o Attention to and implications of what aspects of the project will remain 
with the candidate as an independent investigator, especially if the 
applicant proposes to transition to Phase II.

o Adequacy of plans for the provisions for the protection of human and animal 
subjects and the safety of the research environment and conformance with the 
NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research and Inclusion of Children Participating in Research Involving Human 
Subjects

o Appropriateness of the mentor's research qualifications in the area of the 
proposed research.
   
MENTOR/CO-MENTOR

The application must include a signed statement from the mentor(s) including 
information on research qualifications and previous experience as a research 
supervisor.  The applications must also include information to describe the 
mentor's research support related to the candidate's research plan and nature 
of the supervision that will occur during the mentored phase of the proposed 
award period;

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

o Evidence that the mentor has participated in the development of the Career 
Plan, is sensitized to providing any individual needs (i.e., because of 
his/her cultural, socioeconomic or ethnic background) of the minority 
candidate, as appropriate, and is willing personally to go beyond the 
traditional efforts that a mentor dedicates to a trainee in his/her research 
environment;

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

o Quality and extent of the mentor's proposed role in providing guidance and 
advice to the candidate during the entire period of the award;

o Previous experience in fostering and developing cancer researchers;

o History of research productivity and peer reviewed support;

o Adequacy of existing support for Phase I of the proposed research project.

o Adequacy and clarity of the mentor's statement describing what aspects of 
the Research Plan will remain with the candidate when his/her transition is 
made to an independent position. This statement should also 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 in the independent position.

ENVIRONMENT AND INSTITUTIONAL COMMITMENT
 
o Adequacy of research facilities and the availability of appropriate 
educational opportunities;
 
o Quality and relevance of the environment for scientific and professional 
development of the candidate;

o Degree of evidence that the applicant institution's commitment to the 
scientific development of the candidate is strong, as evidenced by it's 
willingness to ensure that any individual) needs (i.e., because of his/her 
cultural, socioeconomic, ethnic background) of the minority candidate, as 
appropriate, are being provided and that the candidate will be integrated 
with care and sensitivity into the institution's research programs; and 
assurances that the institution intends the candidate to be an integral part 
of the research program; and

o Appropriateness of the applicant institution's commitment to ensuring that 
75 percent of the candidate's time is dedicated to research career 
development and not to other activities unrelated to research, as evidenced 
by a clear listing of activities expected of the candidate within the 75 
percent research effort and other activities that will be included in the 
remaining 25 percent effort.  

TRAINING IN THE RESPONSIBLE CONDUCT OF RESEARCH

o Quality of the proposed training in the responsible conduct of research.

BUDGET

o Justification of the requested budget in relation to career development 
goals and research aims and plans.

ADDITIONAL REVIEW CRITERIA

In addition to the above criteria, your application will also be reviewed 
with respect to the following:

PROTECTIONS:  The adequacy of the proposed protection for humans, animals, or 
the environment, to the extent they may be adversely affected by the project 
proposed in the application.

INCLUSION:  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.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria included in the 
section on Federal Citations, below)

AWARD CRITERIA

Applications will compete for available funds with all other recommended 
applications.  The NCI will notify the applicant of the National Cancer 
Advisory Board's action shortly after its meeting.  The following will be 
considered in making decisions: 

o Scientific merit of the proposed project as determined by peer review;

o Results of the secondary review by NCAB;

o Availability of funds; 

o Relevance to program priorities;

NON-COMPETING RENEWALS

Funding beyond the first year of the award is contingent upon satisfactory 
progress during the preceding year, as documented in the required Progress 
Report.  The Progress Report (PHS form 2590) will be evaluated based upon and 
should include:

o Demonstration of scientific progress toward the aims of the research.  The 
candidate is responsible for a brief summary of the studies and results 
obtained during the prior funding period;  

o A list of accomplishments such as publications, inventions, or project-
generated resources should be provided;

o A brief explanation of plans to address the specific aims during the next 
year of support;

o A short description of candidate's involvement in research/research 
training activities during the prior funding period in relation to the 
content, phasing and duration of the originally proposed Career Development 
Plan.  This must also address how weaknesses in the plan as identified by 
peer reviewers in the Summary Statement have been addressed and corrected.  
Include formal coursework, informal instruction in specific research skills, 
scientific seminars, etc..  In addition, a concise description of the 
candidate's participation in "other activities" during the report period 
should be included.  The percent effort devoted to research/research training 
and to other activities, respectively, must be clearly stated; 

o Description of  similar activities for the next year of  support with a 
clear indication of percent effort devoted to research/research training and 
other activities respectively; and

o The sponsor's report, briefly detailing the candidate's progress and 
performance during the prior year of support in terms of development into an 
independent investigator.  Progress should be delineated in relation to the 
originally proposed Career Development Plan and Research Plan and, should 
describe how weaknesses in these plans as identified by peer reviewers in the 
Summary Statement have been addressed and corrected.  The sponsor should 
clearly substantiate that the candidate has at least 75 percent protected 
time toward research/research training.

SUPPLEMENTAL GUIDELINES FOR TRANSITION TO PHASE II (INDEPENDENT)

These guidelines apply only to the non-competing years in which a transition 
to an independent position is requested.  Other non-competing applications 
should be completed in accordance with the guidelines for streamlined (SNAP) 
applications outlined in PHS form 2590

Transition Request Application Procedure:

The application procedure for the initial NCI Mentored Career Development 
Award for Underrepresented Minorities cannot be used for the transition to 
Phase II independent status.  Therefore, follow the supplemental application 
guidelines below for this aspect of the Award:

The candidate may transition into an independent research position at the 
same or another institution.  When the candidate is remaining in the same 
institution, transition applications are to be submitted on the Application 
for Continuation Grant Form PHS 2590 (rev. 4/98 and subsequent revisions), 
including the additional instructions for Research Career Award Applications 
starting on page IV-1.  

When the candidate is changing institution, the application form to use is 
the Form PHS 398, and it should be submitted from the new grantee 
institution.  

However, the NCI (see INQUIRIES) will provide a transfer application kit, 
which includes the Form PHS 398, for this purpose.  Transition applications 
MUST be submitted two months prior to the anniversary date of the second, 
third or fourth year of the award.

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

Records Management Center
Grants Administration
National Cancer Institute
Executive Plaza South, Suite T-42 MSC 7107
Bethesda, MD 20892-7107

Special instructions for completion of the transition request application:

o To associate the application with a transition request, enter "NCI MENTORED 
CAREER DEVELOPMENT AWARD FOR UNDERREPRESENTED MINORITIES (K01) PHASE II" on 
Line 1, Form Page 1.  Approval for transition to Phase II will be based upon 
the candidate's obtaining an independent research position with dedicated 
laboratory space and by Program Staff's review of the transition request 
application.  Applications must include:

o An itemized listing with associated projected costs for all items on Form 
Page 2 (DETAILED BUDGET FOR NEXT BUDGET PERIOD).  Also see Instructions;

o A Biographical Sketch (Form Page 4):  Provide 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 
that are relevant to the proposed project.

o A Progress Report Summary (Form Page 5): Follow guidelines in Instructions.

Additional instructions:

- The Progress Report Summary section should be as short as possible.  
However, because of the unique reporting requirements for the "Phase II" 
application, the section may exceed two pages;

- Studies and Results (Item b):  The information provided must clearly 
justify a transition to the  Phase II of the award;

- Plans (Item b): Follow the guidelines in the Instructions.  Additional 
information to be provided is as follows:

o Describe how the scope of the independent project initiated during Phase II 
will be changed in comparison with Phase I 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 relevance of the research plan to cancer biology, etiology, 
pathogenesis, prevention, diagnosis, and/or treatment;

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; 

o Provide a statement, from the Chairperson of the department to which the 
awardee has been recruited, describing the type of faculty position offered 
and if it is a tenure-track position (or equivalent); the responsibilities of 
the position; the research facilities that will be provided for exclusive use 
by the awardee, (and, if the transition does not involve a change of 
sponsoring institution, the relationship of these facilities to those of the 
applicant's Phase I mentor); additional non-PHS research related 
departmental/institutional support that will be provided for technical 
support staff, equipment, animals, etc; relationship of the awardee's 
research program to ongoing programs within the department; career plans for 
the awardee;

o Identify the individual who will serve as an "institutional mentor" to the 
candidate in assuring that he/she makes the transition to a faculty position 
effectively and is provided with essential advice while developing an 
independent research program; 

o Provide a statement from the institution ensuring that a minimum of 75 
percent of the candidate's effort will be devoted directly to research, with 
the remaining percent effort being devoted to activities related to the 
successful development of a research career;

o If the independent position involves a change of sponsoring institution, 
officials from the new institution must additionally document a strong, well-
established program in biomedical research related to cancer, including a 
high quality research environment with staff capable of productive 
collaboration with the candidate.

(Candidates planning a change of institution must contact NCI program staff 
prior to submission of the Phase II application).

o Provide a sealed statement from the Phase I 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.

REVIEW CONSIDERATIONS FOR A "PHASE II" APPLICATION

Applications received will require NCI staff approval before the transition 
award to an independent position is activated. 

o A statement from the mentor(s) verifying that the candidate is ready to 
pursue an independent research career;

o The clear relevance of the new Research Plan to cancer biology, etiology, 
pathogenesis, prevention, control, diagnosis and treatment;

o The soundness of  the "Letter of Commitment" from the institution, in 
providing the candidate with protected time (i.e., with no less than 75 
percent effort dedicated to the development of a research program and with 
the remaining effort to be used in research related activities) and 
describing arrangements with the candidate regarding 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;
  
o The qualification of the "institutional mentor" who will help the candidate 
make the transition to an independent faculty position;

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 this application.

Award Criteria for a "Phase II" Application:

Funding decisions will be made by NCI program staff on the basis of 
successfully addressing the review considerations above.  NCI program staff 
will notify the applicant for the Phase II to independent status of their 
action on the application.  The transition to Phase II will take effect on 
the anniversary date of the grant.

REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND 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 Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998: https://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: 
https://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 AMENDMENT "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 
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete 
copy of the updated Guidelines are available at 
https://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 
https://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 (Revised August 25, 2000) at 
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.  A 
continuing education program in the protection of human participants in 
research in now 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 https://grants.nih.gov/grants/stem_cells.htm and at 
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Guidance 
for investigators and institutional review boards regarding research involving 
human embryonic stem cells, germ cells, and stem cell-derived test articles 
can be found at https://grants.nih.gov/grants/guide/notice-files/
NOT-OD-02-044.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 
https://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.

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, 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 
https://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.

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