RELEASE DATE:  August 16, 2004

PA NUMBER:  PA-04-145 


This PA has been reissued as PA-06-415 for submission of R01 applications as of 
May 22, 2006 
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. This announcement will stay active for 
only the May 1, 2006 AIDS and AIDS-related application submission date for these 
mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms 
expires on the date indicated below. Other mechanisms relating to this announcement 
will continue to be accepted using paper PHS 398 applications until the stated 
expiration date below, or transition to electronic application submission. 
Replacement R03 (PA-06-416) and R21 (PA-06-417) funding opportunity 
announcements have been issued for the submission date of June 1, 2006 and 
submission dates for AIDS and non-AIDS applications thereafter.

EXPIRATION DATE for R03 and R21 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R03 and R21 AIDS and AIDS-Related Applications: May 2, 2006 
EXPIRATION DATE for All R01 Applications: May 22, 2006

Department of Health and Human Services (DHHS)

National Institutes of Health (NIH)

National Institute of Child Health and Human Development (NICHD) 
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Nursing Research (NINR)
Office of Behavioral and Social Sciences Research (OBSSR)
National Cancer Institute (NCI) 

93.848; 93.361; 93.393


o Purpose of this PA
o Research Objectives
o Mechanisms of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations


This Program Announcement (PA) encourages the formation of partnerships 
between academic institutions and school systems in order to develop and 
implement controlled, school-based intervention strategies designed to reduce 
the prevalence of obesity in childhood. This initiative also encourages 
evaluative comparisons of different intervention strategies, as well as the 
use of methods to detect synergistic interactions between different types of 



This country is in the midst of a twin epidemic of childhood obesity and 
adolescent type 2 diabetes.  The prevalence of obesity in children, defined as 
a body mass index at or above the 95th percentile for age and gender according 
to the National Health and Nutrition Examination Survey I, has nearly 
quadrupled over the past 30 years, and the incidence of type 2 diabetes in 
adolescents has increased by a factor of ten over the past 20 years. Research 
has shown that childhood obesity tracks with fidelity into adulthood.  Other 
research in obese children has shown that weight loss is more readily 
maintained if achieved prior to, rather than after, puberty. Even more 
effective is preventing weight gain in the first place.  However, preventive 
programs may need to be initiated in elementary school, since by the time 
children reach middle school more than 20 percent of them are obese. 

This initiative is designed to encourage partnerships between academic 
institutions and school systems, for example, those school systems involved 
with the Action for Healthy Kids Program.  Such partnerships would involve 
getting baseline data on children in elementary or middle schools, devising 
and implementing intervention programs in a controlled fashion, and assessing 
dependent outcome variables at varying lengths of time after the intervention. 


School systems are ideal places to develop and evaluate innovative 
interventions designed to prevent childhood obesity. Children spend much of 
their time in school where they can be exposed to randomized, controlled 
interventions.  Entire schools within a school system can be chosen at random 
for either intervention or control conditions in order to reduce the 
possibility of cross-group contamination.

Possible areas within the school system that might be targeted for controlled 
interventions include the content of school curricula, teaching methodologies, 
staff education, physical education programs, the school environment, school 
food service programs, food service worker education, content and availability 
of vending machine snacks in school, school administrators, and parents. 

Examples of research projects that would be responsive to this solicitation 
include, but are not limited to: 

o Curriculum changes designed to improve knowledge of healthy food choices and 
active lifestyles, and behavioral modification programs designed to attain 
healthy diets and active lifestyles.  Specifically, this initiative encourages 
academic institutions and school systems to work together to develop and 
implement behavioral interventions designed to increase children's physical 
activity and/or decrease the amount of time that children devote to sedentary 
activities, such as watching television or playing computer games.  Such 
interventions might involve curriculum changes or curriculum changes coupled 
with periods of increased physical activity, either before, during or after 
school. Interventions also might be designed to induce and maintain long-term 
behavioral change regarding eating habits, food choices, exercise habits, and 

o Evaluations of various controlled dietary interventions would also be 
responsive to this PA, for example, changes in school food service programs 
for school breakfast and/or school lunch. Intervention programs designed for 
parents who prepare their children's lunches would also be responsive.

In order to detect synergistic interactions between dietary interventions and 
interventions involving physical activity, grant applications featuring 
factorial designs are encouraged.  Factorial designs could also be employed to 
detect possible synergies among various other interventions, such as 
curriculum changes, alterations in availability of various kinds of snack 
foods and drinks, and content of school breakfasts and lunches.   


This PA will use the NIH Research Project Grant (R01), Small Grant (R03) and 
Exploratory/Developmental Grant (R21) award mechanisms.  As an applicant you 
will be solely responsible for planning, directing, and executing the proposed 

The small grant (R03) research mechanism should be used for support of pilot 
and/or feasibility studies for concepts that are sound and justifiable, but 
not sufficiently developed for the R01 mechanism. The R21 mechanism is 
intended to encourage new exploratory and developmental research projects 
and/or exploration of novel hypotheses and strategies.  For example, such 
projects could assess the feasibility of a novel area of investigation or a 
new experimental system. These projects should be exploratory and novel, and 
distinct from the type of project supported through the traditional R01.

Applicants for the NIH Small Grant (R03) should follow the guidelines 
published in the NIH Guide for Grants and Contracts at:  For further 
information on the R21 mechanism, go to
This PA uses just-in-time concepts.  It also uses the modular as well as the 
non-modular budgeting formats (see  Specifically, if 
you are submitting an application with direct costs in each year of $250,000 
or less, use the modular format.  Otherwise follow the instructions for non-
modular research grant applications.  This program does not require cost 
sharing as defined in the current NIH Grants Policy Statement at


You may submit an application if your institution has any of the following 

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 or foreign institutions/organizations
o Faith-based or community-based organizations 


Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with his/her institution to 
develop an application for support.  Individuals from underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.   


We encourage your inquiries concerning this PA and welcome the opportunity 
answer questions from potential applicants.  Inquiries may fall into two 
areas:  scientific/research and financial or grants management issues:

o Direct your questions about scientific/research issues to:  

Gilman Grave, M.D.
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
6100 Executive Boulevard, 4B-11, MSC 7510
Bethesda, MD  20892-7510
Telephone: (301) 496-5593
FAX: (301) 480-9791

Charlotte Pratt, Ph.D., RD 
National Heart, Lung and Blood Institute 
Division of Epidemiology and Clinical Applications 
6701 Rockledge Drive MSC 7936, Room 8134 
Bethesda, MD 20892 
Tel: 301-435-0382 
Fax: 301-480-1669 

Robert Kuczmarski, Program Director 
National Institute of Diabetes, Digestive and Kidney Diseases
National Institutes of Health 
2 Democracy Plaza, Room 673 
Bethesda, MD 20892 
Tel: 301-451-8354 
Fax: 301-480-8300 

Yvonne Bryan, PhD, RN 
Program Director 
Office of Extramural Programs 
National Institute of Nursing Research 
National Institutes of Health, NIH/NINR 
6701 Democracy Blvd, Room 710 
One Democracy Plaza 
Bethesda, MD 209892-4870 
Tel: 301-594-6908 
Fax: 301-480-8260 

Deborah H. Olster, Ph.D., Senior Advisor 
Office of Behavioral and Social Sciences Research
Office of the Director
National Institutes of Health
Building 1, Room 256 Center Drive, NIH Campus 
Bethesda, MD 20892-0210 
Tel: 301-451-4286 
Fax: 301-402-1150 

Amy Lazarus Yaroch, Ph.D. 
Health Promotion Research Branch 
Behavioral Research Program 
Division of Cancer Control and Population Sciences 
National Cancer Institute 
6130 Executive Blvd/EPN 4074 
Bethesda, MD 20892-7335 MSC 7335 
Tel: 301-451-9530 
Fax: 301- 480-2087 

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

Lisa Moeller
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 8A17, MSC 7510
Bethesda, MD  20892-7510
Telephone: (301) 496-5482
FAX: (301) 402-0915

Holly Atherton 
Senior Grants Management Specialist 
National Heart, Lung, and Blood Institute
National Institutes of Health 
6701 Rockledge Drive, Rockledge 2 
Bethesda, Maryland 20892-7926 
Tel: 301-435-0177 
Fax: 301-480-3310 

Sharon Bourque 
Grants Management Specialist
National Institute of Diabetes, Digestive, and Kidney Disease 
National Institutes of Health 
2 Democracy Plaza, Room 719 
Bethesda, MD 20892 
Tel: 301-594-8846 
Fax: 301-480-3504 

Lawrence Haller, Grants Management Specialist 
Office of Grants/Contract Management 
National Institute of Nursing Research, NIH 
6701 Democracy Blvd, Rm. 710 
One Democracy Plaza 
Bethesda, MD 20892-4870 
Tel: 301-402-1878 
Fax: 301-451-5652 

Ms. Crystal Wolfrey 
Grants Administration Branch 
National Cancer Institute 
6120 Executive Boulevard, Suite 243 
Bethesda, MD 20892-7340 
Rockville, MD 20852 
Tel: 301-496-8634 


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 D&B number can be obtained by calling (866) 705-5711 or 
through the web site at The D&B 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 checked.

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.

up to $250,000 per year in direct costs must be submitted in a modular grant 
format.  The modular 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 

Applications requesting $500,000 or more in direct costs for any year must 
include a cover letter identifying the NIH staff member within one of NIH 
institutes or centers who has agreed to accept assignment of the application. 

Applicants requesting more than $500,000 must carry out the following steps: 

1) Contact the IC program staff at least six weeks before submitting the 
application, i.e., as you are developing plans for the study; 

2) Obtain agreement from the IC staff that the IC will accept your application 
for consideration for award; and,

3) Identify, in a cover letter sent with the application, the staff member and 
IC who agreed to accept assignment of the application.  

This policy applies to all investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended or revised version 
of these grant application types.  Additional information on this policy is 
available in the NIH Guide for Grants and Contracts, October 19, 2001 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 PA that is 
essentially the same as one currently pending initial review unless the 
applicant withdraws the pending application.  The CSR will not accept any 
application that is essentially the same as one already reviewed.  This does 
not preclude the submission of a substantial revision of an application 
already reviewed, but such application must include an Introduction addressing 
the previous critique.

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


Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review group 
convened 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 appropriate national advisory council 
or board.


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 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.  The scientific 
review group will address and consider each of these criteria in assigning the 
application's overall score, weighting them as appropriate for each 

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 forward.

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 

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:

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.)

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.)


SHARING RESEARCH DATA:  Applicants requesting $500,000 or more in direct costs 
in any year of the proposed research are expected to include a data sharing 
plan in their application. The reasonableness of the data sharing plan or the 
rationale for not sharing research data will be assessed by the reviewers. 
However, reviewers will not factor the proposed data sharing plan into the 
determination of scientific merit or priority score.

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 PA will compete for available funds 
with all other recommended applications.  The following will be considered in 
making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities


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: 

SHARING RESEARCH DATA:  Investigators submitting an NIH application seeking 
$500,000 or more in direct costs in any single year are expected to include a 
plan for data sharing or state why this is not possible 
(  Investigators should seek 
guidance from their institutions, on issues related to institutional policies, 
local IRB rules, as well as local, state and Federal laws and regulations, 
including the Privacy Rule. Reviewers will consider the data sharing plan but 
will not factor the plan into the determination of the scientific merit or the 
priority score.

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 is 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.  

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 

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 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.

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).  

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 PA 
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
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
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