SMALL GRANT PROGRAM FOR NIDDK K08/K23 RECIPIENTS

Release Date:  March 7, 2001

PA NUMBER:  PAR-01-066 (see replacement PAR-04-070)

National Institute of Diabetes and Digestive and Kidney Diseases
 (http://www.niddk.nih.gov/)

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

This Program Announcement replaces Program Announcement, PAR-98-087 
(Small Grant Program for K08 Recipients), which was published in the 
NIH Guide July 9, 1998.

PURPOSE

The National Institute of Diabetes and Digestive and Kidney Diseases 
(NIDDK) re-announces a program that provides NIDDK-supported K08 and 
K23 recipients the opportunity to apply for Small Grant (R03) support 
to run concurrently with the latter years of their K08/K23 award.  
Through the use of this mechanism, which allows up to $50,000 per year 
for two years in additional research development costs, the NIDDK is 
seeking to enhance the capability of its K08 and K23 award recipients 
to conduct research as they complete their transition to fully 
independent investigator status.

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.  Potential 
applicants may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople. 

ELIGIBILITY REQUIREMENTS

This mechanism is available only to investigators currently holding 
either a K08 or a K23 award from the NIDDK.  Details of the K08 Award 
are given in NIH Program Announcement PA-00-003 
(http://grants.nih.gov/grants/guide/pa-files/PA-00-003.html)
Details of the K23 Award are given in NIH Program Announcement PA-00-
004 (http://grants.nih.gov/grants/guide/pa-files/PA-00-004.html) 

NIDDK K08/K23 award recipients will be invited, near the beginning of 
their third year of K support, to submit an R03 application.  Awardees 
must have at least two years remaining on their K08/K23 at the intended 
start date of the R03.  Under certain circumstances, and on a case-by-
case basis, permission may be given for an applicant with less than two 
years remaining on their K08/K23 award to apply for the R03.

Applications may be submitted by domestic for-profit and nonprofit 
organizations, public and private, such as universities, colleges, 
hospitals, laboratories, units of State and local governments, and 
eligible agencies of the Federal Government.  Racial/ethnic minority 
individuals, women, and persons with disabilities are encouraged to 
apply as principal investigators.

MECHANISM OF SUPPORT

This PAR will use the National Institutes of Health (NIH) small grant 
(R03) award mechanism.  Responsibility for the planning, direction, and 
execution of the proposed project will be solely that of the applicant.  
The total project period for an application submitted in response to 
this PAR may not exceed two years.

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

DURATION OF PROGRAM ANNOUNCEMENT

This PAR replaces PA-DK-98-087, which was published in the NIH Guide, 
July 9, 1998.

This PAR will remain active for three years, until February 2004, at 
which time applications may no longer be submitted in response to this 
announcement.

RESEARCH OBJECTIVES

The NIDDK invites recipients of its K08/K23 awards to apply for grant 
support during the latter years of their awards through the NIDDK's 
Small Grant Program (R03).  This additional support will enable K 
awardees to either expand their current research objectives or to 
branch out to a closely related pilot study, thus demonstrating their 
growth as investigators and their independence.  This should facilitate 
the transition to fully independent investigator status.  The added 
grant support in the latter years of a K08/K23 award is expected to 
have the following benefits:

o increased fiscal independence for the K08/K23 award recipient as a 
precursor to complete independence;

o an opportunity for the recipient to generate additional publications 
and data to form the basis for an R01 application;

o an opportunity for a Scientific Review Group (SRG) to evaluate 
accomplishments made during the first two years of the K08/K23 award;

o an opportunity for the applicant to provide more detailed research 
plans for the last two years of the K award; and

o an opportunity for the applicant to demonstrate additional success in 
the peer review process during the course of their K08/K23 award.

In implementing this program, the NIDDK will pay special attention to 
several factors: (1) the institutional commitment to the career of the 
applicant; (2) the career development program itself as supported by 
the K award; and (3) the potential for the funds provided by the R03 
program to enhance the career of the applicant.

In no case will the NIDDK discourage K08/K23 recipients from applying 
for and receiving R01 support during the course of their career awards. 
However, any K08/K23 recipient who receives an R01 will not be eligible 
to receive an R03 under this program.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups 
and their sub-populations must be included in all NIH-supported 
biomedical and behavioral research projects involving human subjects, 
unless a clear and compelling rationale and justification are 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 research involving human subjects should 
read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities 
as Subjects in Clinical Research," published in the NIH Guide for 
Grants and Contracts on August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a 
complete copy of the updated Guidelines are available at  
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. 
The revisions relate to NIH defined Phase III clinical trials and 
require: a) all applications or proposals and/or protocols to provide a 
description of plans to conduct analyses, as appropriate, to address 
differences by sex/gender and/or racial/ethnic groups, including 
subgroups if applicable; and b) all investigators to report accrual, 
and to conduct and report analyses, as appropriate, by sex/gender 
and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN 
SUBJECTS.

It is the policy of NIH that children (i.e., individuals under the age 
of 21) must be included in all human subjects research, conducted or 
supported by the NIH, unless there are scientific and ethical reasons 
not to include them.  This policy applies to all initial (Type 1) 
applications submitted for receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should 
read the “NIH Policy and Guidelines on the Inclusion of Children as 
Participants in Research Involving Human Subjects” that was published 
in the NIH Guide for Grants and Contracts, March 6, 1998, and is 
available at the following URL address: 
http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Updates 
to policies can be seen at the following site: 
http://grants.nih.gov/grants/guide/notice-files/not99-082.html.  

Investigators may also obtain copies of these policies from the program 
staff listed under INQUIRIES.  Program staff may also provide 
additional relevant information concerning the policy.

URLs IN NIH GRANT APPLICATONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained 
within specified page limitations.  Unless otherwise specified in an 
NIH solicitation, internet addresses (URLs) should not be used to 
provide information necessary to the review because reviewers are under 
no obligation to view the Internet sites.  Reviewers are cautioned that 
their anonymity may be compromised when they directly access an 
Internet site.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 
(rev. 4/98) and will be accepted at the standard application deadlines 
as indicated in the application kit.  Application kits are available at 
most institutional offices of sponsored research, or may be obtained 
from the Division of Extramural Outreach and Information Resources, 
National Institutes of Health, 6701 Rockledge Drive, MSC 7910, 
Bethesda, MD 20892-7910, telephone 301-435-0714, email: 
GrantsInfo@nih.gov.

The modular grant concept establishes specific modules in which direct 
costs may be requested as well as a maximum level for requested 
budgets. Only limited budgetary information is required under this 
approach.  The just-in-time concept allows applicants to submit certain 
information only when there is a possibility for an award. It is 
anticipated that these changes will reduce the administrative burden 
for the applicants, reviewers, and Institute staff.  The research grant 
application form PHS 398 (rev. 4/98) is to be used in applying for 
these grants, with the modifications noted below.

Specific allowable costs for this R03 include:

o  Salary: none for the Principal Investigator since this is covered 
under the K08/K23. Salary for technical support is permitted, but not 
for mentor(s) salaries, or for secretarial or administrative 
assistance.

o  Research development costs: tuition, fees, and books related to 
career development; supplies and equipment; travel to research meetings 
or training; statistical services, including personnel and computer 
time.

Applications, must include the following information:

o Research accomplishments. Describe the research accomplishments to 
date under the auspices of the K08/K23 award.  This should include 
progress that has been made toward the goals of the K award as they 
were presented in the original application as evidenced by 
publications, presentations, manuscripts submitted or in preparation, 
and any collaboration(s) made possible by the K award.  

o Research plan. Describe the research goals for the final two years of 
the K award. While the original K08/K23 application provided a research 
plan, this R03 application allows the candidate the opportunity to 
provide specific, detailed information about the research plan for the 
final two years of the K award, particularly relating to how the 
additional financial resources of the R03 would affect these plans and 
enhance progress. If the original goals of the K08/K23 award have been 
modified, detail the changes and the reasons for them.  

o Environment and career development plan. The institution's continued 
commitment to the career development goals of the applicant should be 
documented. For example: What facilities are to be placed at the 
disposal of the applicant?  What educational opportunities, if 
necessary, will be available to the applicant?

o A letter from the applicant's mentor must be included.  It should 
address the applicant's progress, the applicant's potential for a 
future research career, and the mentor's continuing relationship with 
the applicant.  It is expected that, during the final two years of the 
K award, and with the added resources provided by the R03, the 
applicant will become increasingly independent of his/her mentor.

BUDGET INSTRUCTIONS

Modular Grant applications will request direct costs in $25,000 
modules, up to a total direct cost request of $50,000 per year.  The 
total direct costs must be requested in accordance with the program 
guidelines and the modifications made to the standard PHS 398 
application instructions described below:

PHS 398

o FACE PAGE: Items 7a and 7b should be completed, indicating Direct 
Costs (in $25,000 increments up to a maximum of $50,000) and Total 
Costs [Modular Total Direct plus Facilities and Administrative (F&A) 
costs] for the initial budget period.  Items 8a and 8b should be 
completed indicating the Direct and Total Costs for the entire proposed 
period of support.

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

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

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

o Under Personnel, list all project personnel, including their names, 
percent of effort, and roles on the project. No individual salary 
information should be provided. However, the applicant should use the 
NIH appropriation language salary cap and the NIH policy for graduate 
student compensation in developing the budget request.  Since the 
K08/K23 award supports the Principal Investigator’s salary, he/she 
should be listed at 10 - 25% effort as appropriate, with no salary 
support from the R03 grant.

o CONSORTIUM/CONTRACTUAL COSTS - Provide an estimate of Total Costs 
(direct plus F&A costs) for each year, each rounded to the nearest 
$1,000. List the individuals/organizations with whom consortium or 
contractual arrangements have been made, the percent effort of all 
personnel, and the role on the project. Indicate whether the 
collaborating institution is foreign or domestic. The total cost for a 
consortium/contractual arrangement is included in the overall requested 
modular direct cost amount. Include the Letter of Intent to establish a 
consortium.  

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

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

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

o The applicant should provide the name and phone number of the 
individual to contact concerning fiscal and administrative issues if 
additional information is necessary following the initial review.  

o The Program Announcement title and number must be typed on line 2 of 
the face page of the application form and the YES box must be marked.

Mail the signed, original, single-sided application, along with five 
exact, single-sided copies and five collated sets of appendix materials 
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)


The Center for Scientific Review (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 substantial revisions of applications already 
reviewed, but such applications must include an introduction addressing 
the previous critique.

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established Public Health 
Service referral guidelines.  Applications will be reviewed by the 
Center for Scientific Review (CSR) for completeness. An appropriate 
scientific review group convened by the NIDDK in accordance with 
standard NIH peer review procedures will evaluate applications for 
scientific and technical merit.  As part of the initial merit review, 
all applications will receive a written critique and undergo a process 
in which only those applications deemed to have the highest scientific 
merit, generally the top half of applications under review, will be 
discussed, assigned a priority score, and receive a second-level review 
by the NIDDK National Advisory Council.

Review Criteria

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  
In the written comments, reviewers will be asked to discuss the 
following as     aspects of the application in order to judge the 
likelihood that the proposed research will have a substantial impact on 
the pursuit of these goals.  Each of these criteria will be addressed 
and considered in assigning the overall score, weighting them as 
appropriate for each application.  Note that the application does not 
need to be strong in all categories to be judged likely to have major 
scientific impact and thus deserve a high priority score.  For example, 
an investigator may propose to carry out important work that by its 
nature is not innovative but is essential to move a field forward.

o Significance:  Does this study address an important problem?  If the 
aims of the application are achieved, how will scientific knowledge be 
advanced?  What will be the effect of these studies on the concepts or 
methods that drive this field?

o Approach:  Are the conceptual framework, design, methods, and 
analyses adequately developed, well integrated, and appropriate to the 
aims of the project?  Does the applicant acknowledge potential problem 
areas and consider alternative tactics?

o Innovation:  Does the project employ novel concepts, approaches, or 
methods?  Are the aims original and innovative?  Does the project 
challenge existing paradigms or develop new methodologies or 
technologies? 

o Investigator:  Is the investigator appropriately trained and well 
suited to carry out this work?  Is the work proposed appropriate to the 
experience level of the principal investigator and other researchers 
(if any)?

o Environment:  Does the scientific environment in which the work will 
be done contribute to the probability of success?  Do the proposed 
experiments take advantage of unique features of the scientific 
environment or employ useful collaborative arrangements?  Is there 
evidence of institutional support?

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

o Adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will 
also be evaluated.  

o The reasonableness of the proposed budget and duration to the 
proposed research.

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

The following special review criteria will be applied to these R03 
applications:

o Research accomplishments: What has the applicant accomplished to date 
toward the goals of the awarded K08/K23?  Have the research goals of 
the current application
diverged from the original K08/K23 aims?

o Scientific merit of research plan: How feasible is the research plan 
for two years of work? How likely is it that the proposed work will 
lead to an independent line of investigation for the applicant, 
distinct from that of his/her mentor?

o Potential: What is the potential of this mechanism to successfully 
prepare the applicant to be competitive for funding opportunities at 
the end of the award?  Has the institution's commitment to the 
scientific development of the applicant changed?

o Relationship to mentor: Does the mentor's letter adequately discuss 
the applicant's progress? What is the continuing relationship between 
the applicant and the mentor?

AWARD CRITERIA

Applications will compete for available funds with all other approved 
applications assigned to the National Institute of Diabetes and 
Digestive and Kidney Diseases.  The following will be considered in 
making funding decisions:

o Quality of the proposed project as determined by peer review;
o Availability of funds;
o Program priority.

INQUIRIES

Inquiries are encouraged.  The opportunity to clarify any issues or 
questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to the program director 
responsible for the K08 or K23 award:

James Hyde, Ph.D.
Division of Diabetes, Endocrinology, and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd, Room 603
Bethesda, MD  20892-5460
Telephone:  (301) 594-7692
FAX:  (301) 480-3768
Email:  jh486z@nih.gov

Judith Podskalny, Ph.D.
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd, Room 667
Bethesda, MD  20892-5450
Telephone:  (301) 594-8876
FAX:  (301) 480-8300
Email:  jp53s@nih.gov

Terry Rogers Bishop, Ph.D.
Division of Kidney, Urologic, and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 619
Bethesda, MD  20892-5458
Telephone:  (301) 594-7721
FAX:  (301) 480-3510
Email: tb232j@nih.gov  

Direct inquiries regarding fiscal matters to:

Donna Huggins
Division of Extramural Activities 
NIDDK
6707 Democracy Boulevard, Rm. 637 MSC 5456
Bethesda, MD 20892-5456
Telephone:  (301) 594-8848 
FAX:  (301) 480-3504
E-mail:  dh48v@nih.gov 

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance 
No. 93.847, 93.848, and 93.849.  Awards are under authorization of the 
Public Health Service Act, Title IV, Part A (Public Law 78-410, as 
amended by Public Law 99-158, 42 USC 241 and 285) and administered 
under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR 
Parts 74 and 92.  This program is not subject to the intergovernmental 
review requirements of Executive Order 12372 or Health Systems Agency 
review.

The PHS strongly encourages all grant and contract recipients to 
provide a smoke-free workplace and promote the non-use of all tobacco 
products.  In addition, Public Law 103-227, the Pro-Children Act of 
1994, prohibits smoking in certain facilities (or in some cases, any 
portion of a facility) in which regular or routine education, library, 
day care, health care or early childhood development services are 
provided to children.   This is consistent with the PHS mission to 
protect and advance the physical and mental health of the American 
people.

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