PREVENTION AND TREATMENT OF CHILDHOOD OBESITY IN PRIMARY CARE SETTINGS

RELEASE DATE:  July 20, 2004

RFA NUMBER:  RFA-HD-04-020 (see Amendment NOT-HD-04-008)

EXPIRATION DATE:  November 24, 2004

Department of Health and Human Services (DHHS)
 
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH) 
 (http://www.nih.gov)  

COMPONENTS OF PARTICIPATING ORGANIZATION:
National Institute of Child Health and Human Development (NICHD) 
 (http://www.nichd.nih.gov/)
National Center for Complementary and Alternative Medicine (NCCAM)
 (http://nccam.nih.gov/)
National Center on Minority Health and Health Disparities (NCMHD)
 (http://ncmhd.nih.gov/)
National Heart, Lung, and Blood Institute (NHLBI)
 (http://www.nhlbi.nih.gov)
National Institute of Dental and Craniofacial Research (NIDCR)
 (http://www.nidcr.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 (http://www.niddk.nih.gov/)
National Institute of Nursing Research (NINR)
 (http://www.ninr.nih.gov/)
NIH Office of Behavioral and Social Sciences Research (OBSSR)
 (http://obssr.od.nih.gov/)
NIH Office of Disease Prevention (ODP) 
 (http://odp.od.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.865; 93.213; 93.307; 
93.837; 93.121; 93.848; 93.361 

LETTER OF INTENT RECEIPT DATE:  October 25, 2004
APPLICATION RECEIPT DATE:  November 23, 2004

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanisms of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA

Research projects responsive to this solicitation would test intervention 
programs delivered in primary care practices, including dental practices, to 
improve dietary and physical activity behaviors of pediatric patients in order 
to prevent excessive weight gain in children at risk for obesity and/or to 
prevent further weight gain or to promote weight loss in children who are 
already obese. Intervention programs to be tested should be feasible for 
delivery in a wide range of primary care practice settings, such as a 
pediatrician's office, a family physician's office, a dentist's office, a 
managed care organization, or a primary care clinic. Interventions should 
promote reduction in dietary energy intake, increased energy expenditure 
through physical activity, increased physical fitness, decreased sedentary 
behaviors, and/or modification of other behaviors that would lead to an 
increase in the proportion of children with age-appropriate body weight for 
stature when evaluated against a control/comparison group not exposed to the 
intervention.

RESEARCH OBJECTIVES

Background

Levels of childhood overweight have nearly tripled since 1970. Approximately 
15 percent of children and adolescents ages six to 19 years are now 
overweight, with an additional 15 percent considered at risk for overweight. 
For children ages two to 19 years, overweight is defined as a BMI equal to or 
greater than the 95th percentile of the 2000 CDC growth charts for age and 
gender based on previous national surveys, and, at risk for overweight is 
defined as a BMI equal to or greater than the 85th percentile to less than the 
95th percentile. For purposes of this RFA, the terms ‘overweight’ and ‘obese’ 
are used interchangeably.

Research has shown that obesity in childhood tracks into adulthood, carrying 
along with it increased susceptibility to hypertension, dyslipidemia, and 
glucose intolerance. In fact, the striking increase in the prevalence of 
childhood obesity over the past 30 years has been associated with a marked 
increase in the incidence of type 2 diabetes among adolescents. In order to 
slow or reverse the increase in childhood obesity and the health risks 
associated with pediatric obesity, it will be necessary to treat childhood 
obesity as soon as it is detected. Even more appealing would be the prevention 
of childhood obesity entirely by identifying children at risk and providing 
interventions designed to prevent inappropriate weight gain. 

Because almost all children receive their health care in primary care 
settings, development of effective and feasible strategies for prevention and 
treatment of childhood obesity that could be initiated and/or delivered 
primarily within those settings represents an important opportunity for 
addressing this major public health problem.

The development of overweight in children and adolescents has a multi-
factorial etiology. Therefore, the prevention and management of pediatric 
overweight will require a multi-faceted approach. Family/home, school, 
community, media/advertising, and other environments all may play a role in 
influencing children's energy intake and expenditure. Because overweight is 
recognized as a health condition that poses increased risks for other adverse 
health conditions, greater attention must be given to the role of the primary 
pediatric health care provider as a key agent in the prevention, treatment, 
and management of overweight among children and adolescents.

Although involvement of the primary care provider may seem obvious, there are 
various barriers and challenges to effective overweight prevention and 
treatment by this sector. The primary care provider may be a pediatrician, 
family physician, nurse practitioner, dentist, or physician's assistant. 
Primary health care providers generally do not receive comprehensive training 
in the intensive behavioral intervention approaches that are recommended for 
the successful prevention or treatment of overweight. Primary health care 
providers generally do not have the time required to assess, intervene, and 
monitor progress related to dietary preferences and practices, physical 
activity and sedentary behaviors, and the underlying socio-cultural, familial, 
psychological, economic, behavioral, environmental, and other determinants of 
children's diet and physical activity. Health care providers generally are not 
reimbursed by third party payers to provide preventive or therapeutic 
counseling services for obesity, or to employ a multi-disciplinary team within 
their practices to provide appropriate services. Although the challenges are 
many, research is needed to enhance the role of the pediatric primary care 
provider as an influential agent for the prevention and treatment of pediatric 
overweight.

Scope

Intervention programs to be tested should be feasible for delivery in a wide 
range of primary care practice settings and should target obesity prevention 
or weight reduction in already overweight pediatric patients. Children and 
adolescents who are overweight (BMI equal to or greater than the 95th 
percentile for sex and age), at-risk for overweight (BMI equal to or greater 
than the 85th percentile to less than the 95th percentile for sex/age), or at 
increased risk due to their trajectory of weight gain, parental obesity, or 
maternal history of gestational or type 2 diabetes mellitus will be targeted. 
Applications focusing on minority populations at increased risk for obesity, 
as well as underserved populations (such as families in rural areas), are 
encouraged. The initial evaluation and at least some aspects of the 
intervention should be carried out by the primary care provider (physician, 
nurse practitioner, dentist, or physician's assistant), but other types of 
providers and settings could be included in the intervention (for example, 
classes run by a behaviorist; referral to a hospital-based dietitian; referral 
to a community recreation center, to a school-based intervention program, or 
to a commercial weight loss program). Linkage to ongoing primary care research 
networks, where available, is encouraged, as is interaction with community-
based health coalitions and with schools that have initiated intervention 
programs. It is likely that the type and intensity of interventions proposed 
will be dependent on whether the goal is primary prevention in children who 
are at increased risk for overweight or treatment of a child who is already 
overweight and who may have comorbid conditions.

All intervention packages must be feasible to institute in a primary care 
pediatric practice (for example, a small-group practice or larger clinic). 
Interventions that take place entirely within specialized pediatric obesity 
treatment centers will not be considered responsive to this RFA. Interventions 
should be hypothesis-driven and based on previous research, and should be 
appropriate to the developmental stage of the at-risk child or adolescent.

To be considered responsive, proposed studies should be designed to test 
interventions at the individual/family-level (e.g., patient education and 
counseling programs delivered directly to the patients and their families) 
and/or to test institutional or clinic-based interventions, i.e., 
interventions that target the process and delivery of care, such as screening 
and charting approaches for overweight/obesity, referral processes for 
education/counseling (e.g., to dietitians or nurses), policies about 
appointment duration, individualized case management systems, approaches to 
follow-up scheduling, etc. 

Because family-based behavioral approaches relevant to adoption and 
maintenance of healthful diets and physical activity are crucial to successful 
long-term behavior change, such approaches should be incorporated in the 
proposed intervention(s). Examples of such approaches include individualized 
goal setting, self-monitoring, and enhancement of social support.

Each application must propose its own specific research question and methods, 
including specific aims, description of and justification for the proposed 
intervention program and to whom it is directed, the primary and other 
outcomes to be measured, intervention process measurements, the informed 
consent processes, and statistical methods to be used, including justification 
of the sample size and power.

The R21 (exploratory/developmental) mechanism may be used for applications 
that propose smaller studies to test the acceptability and feasibility of 
intervention programs in clinical practice settings. For 
exploratory/developmental studies, the intervention must be carried out for a 
minimum of 12 weeks, with a minimum follow-up of one year. Identification of 
barriers to treatment (health care provider-related, child-related, and 
parent-related) and development of appropriate barrier-reducing strategies are 
encouraged. These smaller studies may use intermediate outcome measures, such 
as degree to which screening and counseling are delivered or patient-centered 
outcomes such as quality of life or satisfaction with treatment, which may be 
obtained from surveys of patients, chart reviews, and/or surveys of providers. 
Wherever feasible, R21 studies should attempt to collect data on objective 
outcome measures such as change in BMI (or BMI SD), body composition, physical 
activity (as measured through fitness testing, accelerometer, or pedometer 
use), as well as collection of data on dietary intake and behavior change 
through the use of well-validated self-report measures.  The NIDCR will only 
accept R21 applications in response to this RFA and only those that fit these 
requirements and do not propose to conduct small clinical trials.

Full-scale trials supported by the R01 mechanism must include an intervention 
of at least 12 weeks and follow-up of at least two years, and the primary 
outcome must be change in BMI (or BMI SD) and/or body composition. For R21s 
and R01s, secondary outcomes might include (but are not limited to) variables 
such as changes in plasma lipids, insulin resistance, or blood pressure, 
biomarkers indicative of changes in fruit/vegetable consumption, quality of 
life, assessment of psychiatric co-morbidity, changes in knowledge, attitudes, 
and behaviors, etc. Evaluation of the impact of weight management 
interventions on the psychosocial well-being of children and families, 
including evaluating the impact of the intervention on eating disordered 
behaviors and/or body dissatisfaction, is also encouraged. All applicants for 
an R01 are encouraged to describe plans for a cost-effectiveness evaluation of 
the intervention.

All studies, regardless of the funding mechanism, must include a 
control/comparison group to enable a valid assessment of the effects of the 
intervention being tested. To ensure proper attention to ethical 
considerations, it is desirable that the control/comparison group receive a 
minimal intervention, or at least recommendations or materials regarding the 
standard of care.

For studies testing institutional or clinic-based interventions, investigators 
are encouraged to allocate physicians or practices, rather than individuals, 
to intervention and control/comparison conditions as the unit of randomization 
to avoid contamination of the control/comparison group; if this approach is 
taken, the application must address statistical and consent issues related to 
the unit of assignment. 

Examples of research projects that are responsive to this RFA include, but are 
not limited to, the following: 

o Office-based programs providing on-site dietary and/or physical activity 
intervention designed to prevent weight gain in children at risk for obesity. 

o Family-based interventions carried out in a primary care setting to promote 
weight loss or limit weight gain in overweight children/adolescents. 

o Office-based interventions designed to limit sedentary behaviors and/or to 
increase physical activity. 

o Collaborations between primary health care providers/clinics and non-clinic 
sites, such as hospital-based dietitians, a community recreation center, a 
qualified complementary or alternative practitioner or a commercial weight-
loss program. 

o Carefully controlled pharmacological interventions carried out in a primary 
care setting in combination with lifestyle interventions that are designed to 
induce or sustain weight loss in obese children. 

o Projects designed to detect synergistic interactions between dietary 
interventions and interventions that involve decreased sedentary behavior 
and/or increased physical activity. 

o Interventions designed to improve screening for obesity in primary care 
settings. 

o Interventions to address physician, parent, and child barriers to acceptance 
of weight management interventions and to improve adherence to dietary and 
physical activity recommendations. 

o Studies that evaluate the impact of weight management interventions on the 
psychosocial well-being of children and families, including quality of life 
and measures evaluating the development of eating disordered behaviors and/or 
body dissatisfaction. 

o Office-based projects that include components of behavior modification, 
particularly projects designed to reduce sedentary activities, especially time 
spent watching television, surfing the internet or playing videogames, and 
those designed to encourage children to be more physically active. 

o Projects in which providers of dental care offer counseling to reduce the 
use of calorically dense snack foods and sugar-sweetened beverages. 

o Studies of existing interventions that have demonstrated either prevention 
or treatment efficacy (e.g., increase in proportion achieving target BMI 
percentile) adapted from the research setting for translation or dissemination 
in the primary care setting. Such studies must include a plan to evaluate 
cost-effectiveness.

o Studies evaluating complementary or alternative medicine (CAM) approaches to 
weight maintenance and the prevention and treatment of overweight or obesity 
in children.  Of particular interest are those CAM approaches used by 
qualified practitioners of CAM (e.g., meditation, naturopathy, acupuncture, 
etc.) in a primary care setting.   

MECHANISM OF SUPPORT

This RFA will use the NIH Research Project Grant (R01) and 
Exploratory/Developmental Grant (R21) award mechanisms. As an applicant you 
will be solely responsible for planning, directing, and executing the proposed 
project.  This RFA is a one-time solicitation.  Future unsolicited, competing 
continuation applications based on this project will compete with all 
investigator-initiated applications and will be reviewed according to the 
customary peer review procedures. The anticipated award date is August 1, 
2005.  Applications that are not funded in the competition described in this 
RFA may be resubmitted as NEW investigator-initiated applications using the 
standard receipt dates for NEW applications described in the instructions to 
the PHS 398 application.

The Exploratory/Developmental (R21) grant mechanism is used to support 
exploratory and developmental research projects by providing support for the 
early and conceptual stages of these projects. Applications submitted under 
this mechanism should be exploratory and novel. More information about the R21 
mechanism can be obtained at 
http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html. 

The Research Project Grant (R01) mechanism is used to support larger scale 
studies that require more than two years of support.  Investigators applying 
for an R01 grant in response to this RFA may request support of up to $500,000 
per year in direct costs for a period of up to five years.  

This RFA uses just-in-time concepts.  It also uses the modular as well as the 
non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  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
http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm.

FUNDS AVAILABLE

The NICHD intends to commit approximately $3 million, the National Center for 
Complementary and Alternative Medicine intends to commit approximately 
$250,000, the National Center on Minority Health and Health Disparities 
intends to commit approximately $250,000, the National Heart, Lung, and Blood 
Institute intends to commit approximately $1 million, the National Institute 
of Dental and Craniofacial Research intends to commit approximately $500,000, 
the National Institute of Nursing Research intends to commit approximately 
$500,000, the Office of Behavioral and Social Sciences Research intends to 
commit approximately $250,000, and the NIH Office of Disease Prevention, 
Office of the Director, intends to commit approximately $10,000 in total costs 
[Direct plus Facilities and Administrative (F & A) costs] in FY 2005 to 
support five to 12 new and/or competing continuation grants in response to 
this RFA.  An applicant for an R01 may request a project period of up to five 
years and budget for direct cost of up to $500,000 per year. An applicant for 
an R21 may request a project period of up to two years with a combined budget 
for direct costs of up $275,000 for the two-year period.  For example, the 
applicant may request $100,000 in the first year and $175,000 in the second 
year.  The request should be tailored to the needs of the project.  Normally, 
no more than $200,000 may be requested in any single year.  Because the nature 
and scope of the proposed research will vary from application to application, 
it is anticipated that the size and duration of each award will also vary.  
Although the financial plans of the ICs provide support for this program, 
awards pursuant to this RFA are contingent upon the availability of funds and 
the receipt of a sufficient number of meritorious applications. 

ELIGIBLE INSTITUTIONS

You may submit an application 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 or foreign institutions/organizations 
o Faith-based or community-based organizations 

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

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.   

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into three 
areas:  scientific/research, peer review, and financial or grants management 
issues:  

o Direct your questions about scientific/research issues to:  

Gilman Grave, M.D.
Endocrinology, Nutrition and Growth Branch
National Institute of Child Health and Human Development  
6100 Executive Boulevard, 4B11, MSC 7510
Bethesda, MD  20892-7510
Telephone: (301) 496-5593
FAX: (301) 480-9791
Email:  graveg@mail.nih.gov 

Marguerite Klein 
National Center for Complementary and Alternative Medicine
6707 Democracy Boulevard, Suite 401, MSC 5475
Bethesda, MD 20892-5475 
Telephone: (301) 402-5860
FAX:  (301) 480-3621
Email: me16o@nih.gov or kleinm@mail.nih.gov

Mireille Kanda, Ph.D.
National Center for Minority Health and Health Disparities
6707 Democracy Boulevard, Suite 800, MSC 7565
Bethesda, MD 20892-7565
Telephone: (301) 402-1366
FAX: (301) 402-7040
Email: kandam@mail.nih.gov

Denise Simons-Morton, M.D., Ph.D.
Director, Clinical Applications and Prevention Program 
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, MSC 7936
Bethesda, MD 20892-7936
Telephone:  (301) 435-0384
FAX:  (301) 480-1669
Email: simonsd@nhlbi.nih.gov

Maria Teresa Canto, D.D.S., M.P.H.
National Institute of Dental and Craniofacial Research
Natcher Building, Room 4AS43B, MSC 6402
Bethesda, MD 20892-6402
Telephone:  (301) 594-5497
FAX:  (301) 480-8322
Email: cantom@mail.nih.gov 

Robert Kuczmarski
National Institute of Diabetes and Digestive and Kidney Diseases 
2 Democracy Plaza, Room 673
Bethesda, MD 20892
Telephone:  (301) 451-8354
FAX:  (301) 480-8300
Email: rk191r@nih.gov

Yvonne Bryan, Ph.D., R.N.
Office of Extramural Programs 
National Institute of Nursing Research 
6701 Democracy Blvd, Room 710, MSC 870
Bethesda, MD 20892-4870
Telephone: (301) 594-6908
FAX: (301) 480-8260
Email: Bryany@mail.nih.gov

Deborah H. Olster, Ph.D.
Senior Advisor 
Office of Behavioral and Social Sciences Research 
Office of the Director
National Institutes of Health 
Building 1 Center Drive, Room 256, MSC 0210
Bethesda, MD 20892-0210
Telephone:  (301) 451-4286
FAX:  (301) 402-1150
Email: olsterd@od.nih.gov

Martina Vogel-Taylor, Ph.D.
Office of Disease Prevention
Office of the Director
National Institutes of Health
6100 Executive Boulevard, Room 2B-03B, MSC 7510
Bethesda, MD 20892-7510
Telephone:  (301) 496-6614
Email:  vogelm@mail.nih.gov

o Direct your questions about peer review issues to:  

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, 5B01, MSC 7510
Bethesda, MD  20892-7510
Telephone: (301) 496-1485
FAX: (301) 402-4104
Email:  stretchr@mail.nih.gov 

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

Angelos Bacas
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 8A17, MSC 7510
Bethesda, MD  20892-7510
Telephone: (301) 435-7010
FAX: (301) 402-7827
Email:  ab329b@nih.gov 

George A. Tucker, M.B.A.
Acting Chief Grants Management Officer
Grants Administration Branch
National Center for Complementary and Alternative Medicine 
6707 Democracy Boulevard, Room 401, MSC 5475
Bethesda, MD 20892-5475
Telephone: (301) 594-9102
FAX: (301) 480-1552
Email:  tucker@nih.hhs.gov

Bryan S. Clark, M.B.A. 
Chief Grants Management Officer 
National Center on Minority Health and Health Disparities
6707 Democracy Boulevard, Suite 800, Room 835
Bethesda, MD 20892
Telephone: (301) 594-8412
FAX: (301) 480-4049
Email: clarkb1@mail.nih.gov

Holly Atherton 
Senior Grants Management Specialist 
National Heart, Lung and Blood Institute 
6701 Rockledge Drive, Rockledge 2, MSC 7926 
Bethesda, MD 20892-7926 
Telephone: (301) 435-0177 
FAX: (301) 480-3310 
Email: athertoh@nhlbi.nih.gov

Robert L. Tarwater
Grants Management Branch
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
Building 45, Room 4AS51, MSC 6402
Bethesda, MD 20892-6402
Telephone: (301) 594-4836
FAX: (301) 480-3562
Email: tarwater@nih.gov

Sharon Bourque 
Grants Management Specialist
National Institute of Diabetes, Digestive, and Kidney Disease 
2 Democracy Plaza, Room 719 
Bethesda, MD 20892 
Telephone: (301) 594-8846 
FAX: (301) 480-3504 
Email: bourques@ep.niddk.nih.gov

Lawrence Haller
Grants Management Specialist 
Office of Grants/Contract Management 
National Institute of Nursing Research
6701 Democracy Boulevard, Room 710, MSC 4870 
Bethesda, MD 20892-4870 
Telephone: (301) 402-1878 
FAX: (301) 451-5652 
Email: HALLERL@mail.nih.gov

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes 
the following information:  

o Descriptive title of the proposed research 
o Name, address, and telephone number of the Principal Investigator 
o Names of other key personnel 
o Participating institutions 
o Number and title of this RFA 

Although a letter of intent is not required, is not binding, and does not 
enter into the review of a subsequent application, the information that it 
contains allows NICHD staff to estimate the potential review workload and plan 
the review.

The letter of intent is to be sent by the date listed at the beginning of this 
document.  The letter of intent should be sent to:  

Gilman Grave, M.D.
Endocrinology, Nutrition and Growth Branch
National Institute of Child Health and Human Development  
6100 Executive Boulevard, 4B11, MSC 7510
Bethesda, MD  20892-7510
Telephone: (301) 496-5593
FAX: (301) 480-9791
Email:  graveg@mail.nih.gov 
 
SUBMITTING AN APPLICATION

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 http://www.dunandbradstreet.com/. The D&B number 
should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 
document is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.
 
SUPPLEMENTARY INSTRUCTIONS:  All instructions for the PHS 398 (rev. 5/2001) 
must be followed, with these exceptions:

Exploratory/Developmental Grant (R21) Applications:

o Research Plan

Items a - d of the Research Plan (Specific Aims, Background and Significance, 
Preliminary Studies, and Research Design and Methods) may not exceed a total 
of 15 pages. No preliminary data is required, but may be included if it is 
available. Please note that a Progress Report is not needed; competing 
continuation applications for an exploratory/developmental grant will not be 
accepted.

o Appendix:  Use the instructions for the appendix detailed in the PHS 398 
except that no more than five manuscripts, previously accepted for 
publication, may be included.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS:  Applications requesting 
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 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step 
guidance for preparing modular grants.  Additional information on modular 
grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

USING THE RFA LABEL:  The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  Failure to use this label 
could result in delayed processing of the application such that it may not 
reach the review committee in time for review.  In addition, the RFA title and 
number must be typed on line 2 of the face page of the application form and 
the YES box must be marked.  The RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.

SENDING AN APPLICATION TO THE NIH:  Submit a signed, typewritten original of 
the application, including 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 and all 
copies of the appendix material must be sent to:  

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, 5B01, MSC 7510
Bethesda, MD  20892-7510
Rockville, MD  20852 (for express/courier service)

APPLICATION PROCESSING:  Applications must be received on or before the 
application receipt date listed in the heading of this RFA.  If an application 
is received after that date, it will be returned to the applicant without 
review.

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.

The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application.  
However, when a previously unfunded application, originally submitted as an 
investigator-initiated application, is to be submitted in response to an RFA, 
it is to be prepared as a NEW application.  That is, the application for the 
RFA must not include an Introduction describing the changes and improvements 
made, and the text must not be marked to indicate the changes from the 
previous unfunded version of the application.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NICHD.  Incomplete and/or non-responsive applications 
will be returned to the applicant without further consideration.  

Applications that are complete and responsive to the RFA will be evaluated for 
scientific and technical merit by an appropriate peer review group convened by 
the NICHD in accordance with the review criteria stated below.  As part of the 
initial merit review, all applications will: 

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
o Receive a written critique 
o Receive a second level review by an appropriate National Advisory Council or 
Board.

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 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 
application.  

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.

The NIH R21 exploratory/developmental grant is a mechanism for supporting 
novel scientific ideas or new model systems, tools or technologies that have 
the potential to significantly advance our knowledge or the status of health-
related research. Because the research plan is limited to 15 pages, an 
exploratory/developmental grant application need not have extensive background 
material or preliminary information as one might normally expect in an R01 
application. Accordingly, reviewers will focus their evaluation on the 
conceptual framework, the level of innovation, and the potential to 
significantly advance our knowledge or understanding. Reviewers will place 
less emphasis on methodological details and certain indicators traditionally 
used in evaluating the scientific merit of R01 applications including 
supportive preliminary data. Appropriate justification for the proposed work 
can be provided through literature citations, data from other sources, or, 
when available, from investigator-generated data. Preliminary data are not 
required for R21 applications.

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 Evidence of intent and ability to evaluate the cost-effectiveness of 
interventions under study.

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK:  The involvement of human 
subjects and protections from research risk relating to their participation in 
the proposed research will be assessed.  (See criteria included in the section 
on Federal Citations, below.)

INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH:  The adequacy of 
plans to include subjects from both genders, all racial and ethnic groups (and 
subgroups), and children as appropriate for the scientific goals of the 
research will be assessed.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria in the sections on 
Federal Citations, below.)

ADDITIONAL CONSIDERATIONS  

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

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  October 25, 2004
Application Receipt Date:  November 23, 2004
Peer Review Date:  March/April 2005
Council Review:  June 2005
Earliest Anticipated Start Date:  August 01, 2005

AWARD CRITERIA

Criteria that will be used to make award decisions include: 

o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities

REQUIRED FEDERAL CITATIONS

HUMAN SUBJECTS PROTECTION:  Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and 
others, and the importance of the knowledge gained or to be gained 
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

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: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH:  It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of the 
research.  This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43).

All investigators proposing clinical research should read the "NIH Guidelines 
for Inclusion of Women and Minorities as Subjects in Clinical Research - 
Amended, October, 2001," published in the NIH Guide for Grants and Contracts 
on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.  
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that:  a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable; and 
b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:  
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported by 
the NIH, unless there are scientific and ethical reasons not to include them.  

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS:  NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:  The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) cited 
publicly and officially by a Federal agency in support of an action that has 
the force and effect of law (i.e., a regulation) may be accessed through FOIA.  
It is important for applicants to understand the basic scope of this 
amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this RFA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the application.  
In addition, applicants should think about how to structure informed consent 
statements and other human subjects procedures given the potential for wider 
use of data collected under this award.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  The 
Department of Health and Human Services (DHHS) issued final modification to 
the "Standards for Privacy of Individually Identifiable Health Information", 
the "Privacy Rule," on August 14, 2002.  The Privacy Rule is a federal 
regulation under the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996 that governs the protection of individually identifiable 
health information, and is administered and enforced by the DHHS Office for 
Civil Rights (OCR). 

Decisions about applicability and implementation of the Privacy Rule reside 
with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including 
a complete Regulation Text and a set of decision tools on "Am I a covered 
entity?"  Information on the impact of the HIPAA Privacy Rule on NIH processes 
involving the review, funding, and progress monitoring of grants, cooperative 
agreements, and research contracts can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

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

HEALTHY PEOPLE 2010:  The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of "Healthy 
People 2010," a PHS-led national activity for setting priority areas.  This 
RFA 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 at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under 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 
http://grants.nih.gov/grants/policy/policy.htm.  

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)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, RealPlayer, Video or Flash files, see Help Downloading Files.