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) 710-0267, 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
|
|
|
|
Department of Health and Human Services (HHS)
|
|
|
|
NIH... Turning Discovery Into Health®
|