RELEASE DATE:  March 3, 2004

PA NUMBER:  PAR-04-070

March 2, 2006 (NOT-OD-06-046) – Effective with the June 1, 2006 submission date, 
all R03, R21, R33 and R34 applications must be submitted through using 
the electronic SF424 (R&R) application. Accordingly, this funding opportunity 
expires on the date indicated below. A replacement R03 (PAR-06-172) funding 
opportunity announcement has been issued for the submission date of June 1, 2006 
and submission dates thereafter.

See NOT-OD-06-048 for information on May 1, 2006 Submission Date for AIDS and 
AIDS-related R03 and R21 Applications.

EXPIRATION DATE:  March 2, 2006 

Department of Health and Human Services (DHHS)

National Institutes of Health (NIH) 
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Office of Dietary Supplements (ODS) 


This Program Announcement (PA) replaces PAR-01-066, which was published in 
the NIH Guide on March 7, 2001.


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


The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 
and the Office of Dietary Supplements (ODS) re-announce 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.  


The NIDDK invites recipients of its K08/K23 awards to apply for grant support 
during the final two 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. In a recent 
change in NIH policy, K awardees may now receive concurrent salary support 
from an NIH career development award and a research grant under certain 
circumstances (
However, any K08/K23 recipient who receives an R01 will no longer 
be eligible to receive an R03 under this program.  

K08/K23 recipients should also be aware that additional NIDDK R21 
( and R03 
( program announcements may 
provide alternative opportunities for research support.   


This PAR will use the National Institutes of Health (NIH) Small Grant (R03) 
Award mechanism. As an applicant, you will be solely responsible for 
planning, directing, and executing the proposed project. The total project 
period for an application submitted in response to this PAR may not exceed 
two years. Applicants may request up to $50,000 (direct costs) per year.
This PAR uses just-in-time concepts. It also uses the modular budget format. 

This is a non-renewable award, thus competing continuation applications will 
not be accepted.  


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  
o Domestic institutions/organizations
o Foreign institutions are not eligible to apply 


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 
Details of the K23 Award are given in NIH Program Announcement PA-00-004

NIDDK K08/K23 award recipients will be invited, near the beginning of their 
third year of K support, to submit an R03 application.  Awardees should 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.


We encourage your inquiries concerning this PAR 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 

o Direct your questions about scientific/research issues to:

James Hyde, Ph.D.
Division of Diabetes, Endocrinology, and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd, Room 609
Bethesda, MD  20892-5460
Telephone:  (301) 594-7692
FAX:  (301) 480-3503

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

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

Mary Frances Picciano, Ph. D.
Senior Nutrition Research Scientist
Office of Dietary Supplements
National Institutes of Health
31 Center Drive, 1B29
Bethesda, MD 20892-2086
Telephone: (301) 435-3608
Fax: (301) 480-1845

o Direct your questions about peer review issues to: 

Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 752 
Bethesda, MD  20892-5456
Telephone:  (301) 594-8897
FAX:  (301) 480-3505

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

Ms. Denise Payne
Grants Management Specialist
Division of Extramural Affairs 
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 733, MSC 5456
Bethesda, MD 20892-5456
Telephone: (301) 594-8845
FAX: (301) 480-3504


Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001). Applications must have a Dun and 
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the 
Universal Identifier when applying for Federal grants or cooperative 
agreements. The DUNS number can be obtained by calling (866) 705-5711 or 
through the web site at The DUNS number 
should be entered on line 11 of the face page of the PHS 398 form. The PHS 
398 is available at 
in an interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 710-0267, Email:

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


The Research Plan (items A-D) is limited to 15 pages.

Specific allowable costs for this R03 include:

o Salary: Salary for the PI and 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; research 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/progress report. 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 proposal. 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.

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

requesting up to $250,000 per year in direct costs must be submitted in a 
modular budget grant format.  The modular budget grant format simplifies the 
preparation of the budget in these applications by limiting the level of 
budgetary detail.  Applicants request direct costs in $25,000 modules.  
Section C of the research grant application instructions for the PHS 398 
(rev. 5/2001) at 
includes step-by-step guidance for preparing modular grants.  Additional 
information on modular grants is available at

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the checklist, and five 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)

APPLICATION PROCESSING: Applications must be mailed on or before the receipt 
dates described at The CSR will not 
accept any application in response to this PAR that is essentially the same 
as one currently pending initial review unless the applicant withdraws the 
pending application.  The CSR will not accept any application that is 
essentially the same as one already reviewed.  This does not preclude the 
submission of a substantial revision of an unfunded version of an application 
already reviewed, but such application must include an Introduction 
addressing the previous critique.  

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


Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NIDDK.  Incomplete and/or non-responsive applications 
will be returned to the applicant without further consideration.  Appropriate 
scientific review groups convened by the NIDDK in accordance with the 
standard NIH peer review procedures ( will 
evaluate applications for scientific and technical merit.  

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

o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the NDDK national advisory council  


The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to evaluate application in 
order to judge the likelihood that the proposed research will have a 
substantial impact on the pursuit of these goals.  The scientific review 
group will address and consider each of the following criteria in assigning 
the application's overall score, weighting them as appropriate for each 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
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 

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?

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?

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?

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)?

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?  

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:

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?

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).

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).

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.  


BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.


Applications submitted in response to a PAR 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


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.

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

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 
a complete copy of the updated Guidelines are available at
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 

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 

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

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on 
hESCs can be found at and at  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see   
It is the responsibility of the applicant to provide, in the project 
description and elsewhere in the application as appropriate, the official NIH 
identifier(s) for the hESC line(s) to be used in the proposed research.  
Applications that do not provide this information will be returned without 

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

Applicants may wish to place data collected under this PAR 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.

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 
( 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

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 
PAR is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at

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

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

Office of Extramural Research (OER) - Home Page Office of Extramural
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