OBESITY AND THE BUILT ENVIRONMENT

RELEASE DATE: August 20, 2004
 
RFA Number:  RFA-ES-04-003 

EXPIRATION DATE:  December 18, 2004

Department of Health and Human Services (DHHS)
 
PARTICIPATING ORGANIZATIONS: 
National Institutes of Health (NIH)
(http://www.nih.gov) 
Centers for Disease Control and Prevention (CDC)
(http://www.cdc.gov)

COMPONENTS OF PARTICIPATING ORGANIZATIONS:  
National Institute of Environmental Health Sciences (NIEHS)
(http://www.niehs.nih.gov/) 
National Cancer Institute (NCI)
(http://www.nci.nih.gov/)
National Institute of Child Health and Human Development (NICHD)
(http://www.nichd.nih.gov) 
Office of Behavioral and Social Sciences Research (OBSSR)
(http://obssr.od.nih.gov/)
National Center for Chronic Disease Prevention and Health Promotion 
(NCCDPHP)
(http://www.cdc.gov/nccdphp/)
National Center for Environmental Health (NCEH)
(http://www.cdc.gov/nceh/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.113, 93.114, 93.115 
(NIEHS); 93.864, 93.865, 93.929 (NICHD); 93.399 (NCI)

LETTER OF INTENT RECEIPT DATE:  November 17, 2004
APPLICATION RECEIPT DATE:  December 17, 2004  

THIS RFA CONTAINS THE FOLLOWING INFORMATION

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

PURPOSE OF THIS RFA 

This initiative will support R01 and R21 studies in two specific areas 
related to the built environment and obesity: First, understanding the 
role of the built environment in causing/exacerbating obesity and 
related co-morbidities; and second, developing, implementing, and 
evaluating prevention/intervention strategies that influence parameters 
of the built environment in order to reduce the prevalence of 
overweight, obesity and co-morbidities.  

This RFA will support projects that delineate the significance and 
impact of the built environment on overweight and obesity by enhancing 
our understanding of the roles played by city and regional planning, 
housing, transportation, media, access to healthy foods and availability 
of public and green spaces (such as playgrounds, walking paths, etc.) as 
determinants of physical activity and nutritious dietary practices.  
Currently, there is insufficient research that delineates the influence 
of the built environment on nutritional factors and physical activity. 
One intended outcome of this program is the development of models of 
health-promoting communities that provide access to a wide variety of 
foods that are consistent with current dietary guidelines, physical 
activity patterns that are consistent with current recommendations, and 
how this impacts overweight and obesity. These community-based 
environmental interventions would serve as models for management and 
prevention of overweight, obesity, and co-morbidities across other 
communities in need of change. Of particular interest are studies 
conducted in vulnerable populations (such as children, the aging 
population, low socioeconomic status (SES) communities, racial/ethic 
minorities, persons with disabilities that require use of assistive 
mobility devices such as wheelchairs and prostheses).

Definition of the Built Environment: It encompasses all buildings, 
spaces and products that are created, or modified, by people.  It 
includes homes, schools, workplaces, parks/recreation areas, greenways, 
business areas and transportation systems.  It extends overhead in the 
form of electric transmission lines, underground in the form of waste 
disposal sites and subway trains, and across the country in the form of 
highways.  It includes land-use planning and policies that impact our 
communities in urban, rural and suburban areas.

Definition of overweight and obese: Body Mass Index (BMI) is a common 
measure expressing the relationship (or ratio) of weight-to-height.  It 
is a mathematical formula in which a person's body weight in kilograms 
is divided by the square of his or her height in meters (i.e., wt/ht). 
The BMI is highly correlated with body fat.  Adults with a BMI of 25 to 
29.9 are considered overweight, while individuals with a BMI of 30 or 
higher are considered obese.  According to the CDC Growth Charts: United 
States 2000, children and adolescents with a Body Mass Index (BMI) 
between the 85th and 95th percentile are currently defined as at risk 
for overweight.  Those with a BMI above the 95th percentile are 
overweight 
(http://www.cdc.gov/nccdphp/dnpa/bmi/00binaries/bmi-checkbook.pdf).

It is important to note that, because of the wide range of built 
environmental issues to be addressed and the diversity of communities, 
this RFA requires interdisciplinary partnerships.  These teams must 
consist, at a minimum, of a scientist with expertise in health research 
(e.g., an epidemiologist, behavioral or social scientist), a clinical 
specialist (e.g., a nutritionist, pediatrician, cardiovascular 
specialist, healthcare provider, occupational therapist, nurse) and an 
expert on planning, design, or transportation (e.g., representative of a 
local or state planning, transportation agency, zoning departments).  
Other scientists and experts (e.g., in economics, health policy, 
community health, housing, education, recreation, psychology, universal 
design) as well as those with scientific expertise in diseases and 
conditions that are co-morbidities of obesity should be considered to 
complement, but will not substitute for, those mentioned above. 
Partnerships with state and local health departments working in the area 
of obesity, prevention and control through promotion of improved 
physical activity and nutrition may also be considered.  

These personnel must be listed on Page 2 of the PHS 398 application, and 
a biographical sketch must be provided for each.  The role of each 
member of the team in carrying out the project should be well described.  
The inclusion of one or more subcontract arrangements may be helpful in 
defining all parties' programmatic and budgetary roles.  

RESEARCH OBJECTIVES
 
Background

Obesity is an important area of health and disease that is related to 
the built environment.  In the United States, obesity and overweight 
have risen to an epidemic rate during the past 20 years and are among 
the most important health challenges of our time.  Obesity in adults, 
particularly abdominal or upper-body obesity, is associated with 
increased risk of a number of diseases and metabolic abnormalities 
including coronary heart disease, hyperinsulinemia, insulin resistance, 
type 2 diabetes, certain cancers and osteoarthritis.  It has also been 
observed that most of the conditions associated with obesity are also 
associated with increasing age.  In the US, there is a general increase 
in body weight and body mass index with age, until approximately 60 
years of age.  In addition, the proportion of intra-abdominal fat, which 
is related to increased morbidity and mortality, progressively increases 
with age. Weight loss in the elderly can reduce morbidity from 
arthritis, and also cardiovascular risk factors.  Overweight among 
children (6-19 years of age) currently stands at 15 percent.  Risk 
factors for heart disease, such as high cholesterol and high blood 
pressure, occur with increased frequency in overweight children and 
adolescents compared to children with a healthy weight.  Type 2 
diabetes, previously considered an adult disease, is increasingly 
observed in overweight children and adolescents.  Other diseases in 
children and adults that are associated with unhealthy diet include 
dental diseases.  Preliminary studies on weight loss in children have 
resulted in better overall school performance.

Research indicates that rates of obesity and overweight are increasing. 
One of the national health objectives for the year 2010 is to reduce the 
prevalence of obesity among adults to less than 15 percent.  Obesity-
associated health care costs currently account for approximately 7 
percent of national expenditures, approximately $75 billion.  Obesity is 
an enormous public health challenge for Americans of all ages, 
especially for children and minorities.  Many educational programs 
targeted to individuals to affect changes in obesity and weight gain 
have not been successful.  However, environmental changes that reinforce 
factors supporting healthy lifestyles and reduce barriers to healthy 
lifestyles may serve to diminish health disparities.  Access to healthy 
foods and opportunities to impact physical activity are factors that 
have been considered both at the community and individual levels. 
Approaches that modify the environment to promote healthful eating 
practices (such as increases in fruits and vegetable intake, lower 
caloric intake, and increases breast feeding practices), increase 
physical activity, and decrease sedentary behaviors offer the potential 
for safe and effective programs for obesity prevention that could be 
widely disseminated.  Investigators applying to this RFA may propose 
collaborations with organizations/institutions such as schools, 
supermarkets, restaurants, religious organizations, recreation 
facilities, industry, governmental, public health, or community groups, 
worksites, and so forth, to develop approaches that, if successful, 
could potentially be translated into larger-scale 
prevention/intervention programs.

Persons who have physical disabilities and require the use of assistive 
devices such as wheelchairs and lower limb prostheses are especially 
vulnerable to inaccessible or inadequately designed home, school and 
work environments, transportation systems and equipment.  They 
frequently encounter unavailable or inadequate access to fitness 
options.  At the same time they face serious health challenges that are 
greatly exacerbated by the prevalence of obesity. Obesity coupled with 
impaired mobility can easily lead to an increase in functional 
limitations and a decrease in the quality of life. For example, elevated 
obesity can result in the inability to use lower limb prosthesis, the 
need for a wider wheelchair that cannot pass through a standard doorway 
or greater difficulty in transferring to and from the wheelchair.  In 
addition there is a limited understanding of energy metabolism and 
nutritional needs of persons with impaired mobility due to neurological 
conditions such as spinal cord injury. Obesity in persons with these 
types of disabilities is frequently associated with a more rapid onset 
of medical conditions such cardiovascular disease, dyslipidemia and 
diabetes.   

Research on the connections between the built environment and health has 
shown that the burden of illness has been greater on lower socioeconomic 
strata and minority/vulnerable populations (including persons who have 
impaired mobility and use assistive devices such as wheelchairs and 
lower limb prostheses). Understanding linkages between socioeconomic 
inequity and health is essential to reducing exposures to environmental 
hazards as well as disparities in health. Increased environmental 
pollutants have resulted in lifestyle changes especially with regard to 
diet and physical activity. For example, the increased pollution in 
Alaskan waters has led to some Native American communities substituting 
their traditional diets with more foods bought at the grocery stores. 
This also has had a negative impact on their traditional fishing and 
hunting activities. Lower socioeconomic status communities usually have 
limited access to quality housing stock and live in neighborhoods that 
do not facilitate outdoor activities and provide an uneven mix of 
healthy and unhealthy food outlet choices such as few supermarkets but 
many low-cost restaurants. Inequities in construction and maintenance of 
low income housing, especially for racial and ethnic minorities, older 
persons, and immigrants have resulted in insufficient housing, poor 
quality housing, overcrowding, and higher levels of population density 
and health problems. Also, studies have consistently shown an 
association between a deteriorated physical environment and higher rates 
of crime, making neighborhoods less safe for walking and in some cases 
resulting in greater social isolation. 

Most studies to date have solely focused their efforts in urban 
environment, while there are several unattended issues in the rural 
areas.  While the connections between the built environment and health 
are more clearly delineated in urban areas, these issues are obscured in 
rural areas.  For example, greater pesticide use in rural areas has 
resulted in people remaining indoors for longer periods of time and 
decreasing non-motorized travel.  One of the consequences of motorized 
ways of living in rural areas has been decreased levels of physical 
activity and concomitant increases in obesity. 

Though the built environment is one of our most important habitats, 
current research in the area has focused mainly on the challenges of 
balanced transportation (e.g., roads, highways, infrastructure, public 
transportation), urban sprawl, air pollution due to increased traffic, 
and the diminishing natural environment.  However, more concerted 
research is needed to identify mechanisms by which the built environment 
adversely and positively impacts health and to develop appropriate 
interventions to reduce or eliminate harmful health effects.  Such 
research efforts are required because of the growing health burden and 
attendant economic costs associated with growing incidence of complex 
disease (e.g., cardiovascular disease, diabetes, cancer).  While many of 
these complex diseases are attributable to an interaction of genetic, 
behavioral, and environmental influences over time, it may, at this 
point be more effective to modify the built environment to impact 
overweight, obesity and co-morbidities.

Some recent research explores the effect of improved built environments 
or sustainable communities (where long-term benefits outweigh potential 
negative impacts) on physical activity, asthma, obesity, cardiovascular 
disease, lung cancer mortality, and mental health.  The President’s 
Council on Sustainable Development in 1993 (Executive Order 12852) 
offered a working definition for sustainable communities as "healthy 
communities where natural and historic resources are preserved, jobs are 
available, sprawl is contained, neighborhoods are secure, education is 
life-long, transportation and health care are accessible, and all 
citizens have opportunities to improve the quality of their lives."  
While much research indicates the negative health impact of a poor built 
environment, there is very limited research on the health benefits of 
promoting sustainable communities to reduce overweight, obesity and 
related co-morbidities. The sparse research on sustainable communities 
suggests that diligent planning is needed to create an environment that 
is conducive to the mental and physical well being of humans as well as 
the natural environment. Most of the research in this area is based on 
cross-sectional studies, while studies that establish the associations 
between built environment and overweight, obesity and related co-
morbidities that can used to develop concrete interventions are limited.

Scope

This RFA will support both R21 and R01 mechanisms. To understand the 
wide variety of issues relating to the built environment and obesity, 
studies that combine qualitative and quantitative methodologies are 
strongly encouraged.  This combination of methodologies will allow for 
diverse perspectives to be incorporated in the studies.  Studies can be 
conducted at the micro (individual/familial), meso (interpersonal and 
community), and macro (societal, policy) levels. Intervention projects 
must incorporate multilevel approaches.  The Community Guide developed 
by the Community Preventive Services (Task Force), appointed by the 
Director of the Centers for Disease Control and Prevention (CDC) 
provides recommendations regarding population-based interventions for 
physical activity (see http://www.thecommunityguide.org/pa/default.htm).  
Intervention projects supported by this RFA must build upon and advance 
these recommendations and should not duplicate the Task Force efforts. 
For the purposes of this RFA to develop and include new and improved 
objective measures that link the built environment to biology wherever 
appropriate, such as endothelium dependent dilation, serum glucose, 
cholesterol, insulin, energy balance, oxidative stress, body 
composition, lipid profile. 

Few successful models exist for treatment and prevention of obesity.  
The Surgeon General’s Report on overweight and obesity 
(http://www.surgeongeneral.gov/topics/obesity/calltoaction/CalltoAction.pdf.
) indicates that environmental modifications offer the best 
opportunity for the treatment and prevention of obesity.  Given this, 
multisite and multilevel environmental interventions including schools, 
worksites, communities and a variety of larger social settings would be 
appropriate.  Single site based interventions have been shown to be 
effective in improving diet and physical activity levels of children for 
a short period of time through changes in school lunch and vending 
machine contents and levels of physical activity.  Thus, the most 
effective strategy would be studies that address both energy intake and 
expenditure and combine different levels and settings.  Across all 
settings, interventions submitted in response to this RFA may address 
food access and availability (e.g., at schools, worksites; ala carte 
foods, community restaurants, convenience stores, grocery stores), 
opportunities for physical activity (e.g., organized school, worksite, 
community activities; recreational facilities; enhancing physical 
activity in daily routines and lifestyles), and the policies that 
connect energy intake and expenditure to the built environment (e.g., 
land use planning; social marketing; financial incentives at multiple 
levels). So for the purposes of this RFA, multisite and multilevel 
proposals are encouraged.

Evaluation is an essential component for all intervention studies and 
proposed studies should include both process and outcome measures.  The 
latter could also include appropriate biological measures.  While it is 
important that both quantitative and qualitative measures are included, 
wherever possible the adoption of objective measures is encouraged.  

The R21 mechanism (see 
http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html) is limited to 
two years of funding and is intended to encourage new exploratory/developmental 
research projects by providing support for the early stages of their 
development.  For example, such pilot/exploratory projects could assess 
the feasibility of a novel area of investigation or a new experimental 
system that has the potential to enhance health-related research.  Applications 
for R21 awards should describe projects distinct from those supported through 
the traditional R01 mechanism.  For example, long-term projects, or projects 
designed to increase knowledge in a well-established area will not be considered 
for R21 awards.  Applications submitted under the R21 mechanism should be 
exploratory and novel and may include development of new methods and 
measurements. Under these provisions these R21 proposals should evaluate 
the validity and reliability of the measures and when appropriate also 
ensure that they are linguistically and culturally relevant.  Some areas 
of interest for R21 submissions include but are not limited to the 
following: 

o At the macro-level, the development and validation of reliable 
measures/indicators for assessing the means by which the built 
environment impacts food availability/access and physical activity to 
promote healthy behaviors and lifestyles and reduce obesity and related 
co-morbidities. 
o At the meso-level the development of measures of neighborhood 
characteristics that promote healthy lifestyles and mediate the effect 
of built environment on overweight, obesity and related co-morbidities.
o At the micro-level, the development of valid and reliable measures for 
behaviors that moderate obesity such as physical activity, nutrient 
intake, etc.  It is also important that these measures are 
linguistically and culturally validated. 
o Feasibility studies that identify and quantify built environment 
related risk factors and variables that mediate and moderate built 
environment health effects for public health interventions and outcomes 
to reduce overweight, obesity and related comorbidities. 
o Pilot studies that assess the impact of state, local and institutional 
policy changes in the built environment on overweight, obesity and 
related co-morbidities.  These could be an evaluation of natural 
experiments such as comparing differently designed communities; 
examining before and after events (such as physical activity and driving 
levels before and after new transit system is opened and nutritional 
changes with the removal of unhealthy foods from schools or the 
opening/closing of a grocery in a community).  
o Studies to identify environmental and social conditions of people’s 
work and living choices that may influence physical activity and dietary 
intake. For example, do healthy people choose to live in healthy 
environments or do healthy environments differentially attract healthy 
people?

o Evaluate the health impact assessment instrument as an appropriate and 
useful tool for local and state health officials to provide information 
to decision makers about the health consequences of proposed built 
environment projects and policies. 

o Studies, such as the above examples, that include or focus on obesity 
concerns and needs of persons who have impaired mobility and use 
assistive devices such as wheelchairs and lower limb prostheses.

R01 applications have to be well-developed, known to be feasible and 
hypothesis driven based on preliminary data and may request a project 
period of up to five years.  Some areas of interest for R01 submissions 
include, but are not limited to the following:
o Assess the means by which the built environment and/or sustainable 
communities influences overweight, obesity and related co-morbidities. 
These studies should be multilevel and simultaneously account for 
individual, community, and systemic factors including biological, 
socioeconomic, neighborhood, and physical environment factors.  These 
studies must be designed to establish concrete patterns of association 
among various factors so that they can be used in developing tangible 
interventions.
  
o Intervention studies that implement and evaluate the efficacy of 
establishing environments that are supportive of both physically active 
and healthful dietary lifestyles to prevent or reduce overweight, 
obesity and related comorbidities. These interventions can include 
evidence-based strategies.  Multilevel and multisite (e.g., school, 
home, work, community, state) interventions should be emphasized to have 
environmental changes.  

o Examine differences in response among vulnerable populations to the 
built environment changes designed to reduce obesity and related co-
morbidities. 

o Assess how existing models enhance our ability to understand how and 
when a combination of environmental factors (such as use of sidewalks, 
accessibility to grocery stores and nutritious foods, green spaces, land 
zoning, media, etc.) affect overweight, obesity and related co-
morbidities. 

o Identify and quantify risk factors that mediate and moderate built 
environment health effects for public health interventions and outcomes, 
e.g., nutrition and dietary intake, physical activity, genetic factors.  
These studies could also include individual level factors such as 
lifestyle choices and behaviors as well as both energy intake and 
expenditure that can prevent or reduce obesity.

o Intervention studies that examine the role of the social environment 
(including but not limited to, social capital, challenges of living in 
isolated communities) in connection with the physical/chemical 
environment in determining access to nutritional foods and also 
improving physical activity to reduce morbidity.

o Studies that assess the impact of state, local and institutional 
policy changes in the built environment on overweight, obesity and 
related co-morbidities.  These could be an evaluation of natural 
experiments such as comparing differently designed communities; 
examining before and after events (such as physical activity and driving 
levels before and after new transit system is opened and nutritional 
changes with the removal of unhealthy foods from schools or the 
opening/closing of a grocery in a community).

MECHANISM OF SUPPORT

This RFA will use the NIH research project grant (R01) and the 
exploratory/developmental research 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 June 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. 

This RFA uses just-in-time concepts.  It also uses the modular budgeting 
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 budget format.  Otherwise follow the 
instructions for non-modular budget research grant applications.  If you 
are submitting a R21 application, use the modular budget format.  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 participating institutes intend to commit approximately $5M in FY 
2005 to fund 10 to 12 new grants in response to this RFA.  An applicant 
using the R01 mechanism may request a project period of up to five years 
and a budget for direct costs of up to $400,000 per year, excluding 
Fiscal and Administrative costs 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html).  
R21 applications 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, requests can be $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.  R21 applications must adhere to 
the page and budgetary limitations described in the trans-NIH R21 
program announcement (PA-03-107) available at: 
http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html.  Although 
the financial plans of the participating institutes 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(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
o Faith-based or community based organizations 

Although a single institution or organization must be the applicant, a 
multi-institutional arrangement (consortium) is possible.  Such 
consortia, entailing active participation by more than one organization, 
are encouraged if there is clear evidence of close interaction and 
responsible partnership among the participants.  

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 their 
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.   

SPECIAL REQUIREMENTS

This RFA requires interdisciplinary partnerships: These teams must 
consist, at a minimum, of a scientist with expertise in health research 
(e.g., an epidemiologist, behavioral or social scientist), a clinical 
specialist (e.g., a nutritionist, pediatrician, cardiovascular 
specialist, healthcare provider, occupational therapist, nurse) and an 
expert on planning, design, or transportation (e.g., representative of a 
local or state planning, transportation agency, zoning departments).  
Other scientists and experts (e.g., in economics, health policy, 
community health, housing, education, recreation, psychology, universal 
design) as well as those with scientific expertise in diseases and 
conditions that are co-morbidities of obesity should be considered to 
complement, but will not substitute for, those mentioned above. 
Partnerships with state and local health departments working in the area 
of obesity, prevention and control through promotion of improved 
physical activity and nutrition may also be considered.  These personnel 
must be listed on Page 2 of the PHS 398 application, and a biographical 
sketch must be provided for each.  The role of each member of the team 
in carrying out the project should be well described.  The inclusion of 
one or more subcontract arrangements may be helpful in defining all 
parties' programmatic and budgetary roles. Applications without these 
required personnel will be returned without review.

To encourage applicants to share information gained via these grants, 
the research teams as stated above, i.e., the scientist with expertise 
in health research, the clinical specialist and the expert on planning, 
design, or transportation, for each project will be asked to attend at 
least annual meetings over the course of the grant in the Research 
Triangle Park, North Carolina area.  R21 applicants and their 
collaborators will be required to attend a maximum of two meetings and 
R01 applicants and collaborators will be required to attend at least 
four meetings over the entire granting period.  Applicants should 
include such travel in their budget requests.

The NIEHS may provide supplemental funds for logistical arrangement for 
the meeting.  This meeting will convene all the grantees and will serve 
to inform other grantees and the research community of the progress to-
date. NIEHS may provide supplemental funds to the selected host 
institution, after the receipt of an appropriate application and review 
by Program Staff.  Applicants are still expected to provide travel for 
the required personnel on each project in their grant budget.

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:

Shobha Srinivasan, Ph.D.
Scientific Program Administrator
Susceptibility and Population Health Branch
National Institute of Environmental Health Sciences (NIEHS)
P.O. Box 12233, MD EC-21 
111 T.W. Alexander Drive 
Research Triangle Park, NC  27709 
Telephone: (919) 541-2506 
Fax: (919) 316-4606 
Email: sriniva2@niehs.nih.gov

Deborah H. Olster, Ph.D.  
Senior Advisor  
Office of Behavioral and Social Sciences Research (OBSSR)  
National Institutes of Health (NIH)
Bldg. 1, Room 256  
One Center Drive
Bethesda, MD 20892-0183 
Telephone: (301) 451-4286  
Fax: (301) 402-1150  
Email: olsterd@od.nih.gov

Harold W. (Bill) Kohl, III, Ph.D.  
Lead Epidemiologist/Team Leader  
Centers for Disease Control and Prevention (CDC) 
Physical Activity and Health Branch  
National Center for Chronic Disease Prevention and Health Promotion  
Division of Nutrition and Physical Activity  
4770 Buford Highway, NE,  MS K-46  
Atlanta, Georgia 30341-3717   
Telephone: (770)488-5481  
Fax: (770) 488-5473
Email: hkohl@cdc.gov

Dr. Andrew Dannenberg
Centers for Disease Control and Prevention (CDC)
Division of Emergency Environmental Health Services
National Center for Environmental Health
4770 Buford Highway, NE, MS F-30
Atlanta, Georgia  30341
Telephone:  (770) 488-7108
Email:  acd7@cdc.gov

Gilman D. Grave, M.D.
Chief, Endocrinology, Nutrition and Growth Branch
Center for Research for Mothers and Children
National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard; Suite 4B-11
Bethesda, MD 20892-7510
Telephone: 301-496-5593
Fax: 301-480-9791
E-mail: gg37v@nih.gov

Louise C. Masse, Ph.D.
Health Promotion Research Branch
Behavioral Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute (NCI)
6130 Executive Blvd., MSC 7335
Executive Plaza North, Room 4076
Bethesda, MD 20892-7335
Telephone: (301) 435-3961 
Fax:(301) 480-2087 
Email: massel@mail.nih.gov

o Direct your questions about peer review issues to:

Leroy Worth, Jr., Ph.D.
Scientific Review Administrator
National Institute of Environmental Health Sciences (NIEHS)
P.O. Box 12233, MD EC-30
111 T.W. Alexander Drive
Research Triangle Park, NC  27709
Telephone:  (919) 541-0670
Fax:  (919) 541-2503
Email: worth@niehs.nih.gov

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

Ms. Pam Evans
Grants Management Specialist
National Institute of Environmental Health Sciences (NIEHS)
P.O. Box 12233, MD EC-22
111 T.W. Alexander Drive
Research Triangle Park, NC  27709
Telephone:  (919) 541-7269
Fax:  (919) 541-2860
Email: evans3@niehs.nih.gov

Sharron P. Orum  
Grants Management/Contracting Officer  
Centers for Disease Control & Prevention (CDC) 
Procurement & Grants Office, AABB  
2920 Brandywine Road  
Atlanta, Georgia 30341 
Telephone: (770) 488-2716
Fax:  (770) 488-2777  
Email: spo2@cdc.gov

Angelos Bacas
Grants Management Branch
National Institute of Child Health and Human Development (NICHD)
6100 Executive Blvd., 8A17, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 435-7010 
Fax: (301) 402-7827
E-mail: ab329n@nih.gov

Crystal Wolfrey 
Team Leader, DCCPS Team  
Grants Administration Branch  
National Cancer Institute (NCI) 
6120 Executive Blvd., Suite 243  
Bethesda, MD 20892 (for regular mail)  
Rockville, MD 20852 (for hand delivered mail)  
Telephone: (301) 496-8634  
Fax: (301) 496-8601 
Email: crystal.wolfrey@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 IC 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:

Leroy Worth, Jr., Ph.D.
Scientific Review Administrator
Division of Extramural Research and Training
National Institute of Environmental Health Sciences (NIEHS)
P.O. Box 12233, MD EC-30
111 T.W. Alexander Drive
Research Triangle Park, NC  27709
Telephone:  (919) 541-0670
Fax:  (919) 541-2503
Email: worth@niehs.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.

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/labels.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:

Leroy Worth, Jr., Ph.D.
Scientific Review Administrator
Division of Extramural Research and Training
National Institute of Environmental Health Sciences (NIEHS)
P.O. Box 12233, MD EC-30
79 T.W. Alexander Drive, 4401 Building, 3rd Floor (courier/express)
Research Triangle Park, NC  27709
Telephone:  (919) 541-0670
Fax:  (919) 541-2503
Email: worth@niehs.nih.gov
 
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 8 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 NIH and CDC.  Incomplete and/or nonresponsive 
applications will not be reviewed.  
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 NIEHS 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 the National Advisory Environmental 
Health Sciences Council.
 
REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  
In the written comments, reviewers will be asked to evaluate 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 the following 
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.

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:

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

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals 
are to 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.  

ADDITIONAL REVIEW CONSIDERATIONS

EVALUATION:  Plans for evaluation of factors contributing to the 
effectiveness of interventions should be included.  These should include 
both process and outcome measures.  The latter could also include 
appropriate biological measures.  While it is important that both 
quantitative and qualitative measures are included, wherever possible 
the adoption of objective measures is encouraged.  Applications 
proposing intervention studies should include an evaluation component. 

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: November 17, 2004
Application Receipt Date: December 17, 2004
Peer Review Date: February 2005
Council Review: May 2005
Earliest Anticipated Start Date: July 2005

AWARD CRITERIA

Award 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 

ANIMAL WELFARE PROTECTION:  Recipients of PHS support for activities 
involving live, vertebrate animals must comply with PHS Policy on Humane 
Care and Use of Laboratory Animals 
(http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), 
as mandated by the Health Research Extension Act of 1985 
(http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the 
USDA Animal Welfare Regulations 
(http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable.

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

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 
http://grants.nih.gov/grants/policy/data_sharing/. 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.

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 are 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 or 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.healthypeople.gov/

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.

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