IMPROVING DIET AND PHYSICAL ACTIVITY ASSESSMENT

RELEASE DATE:  October 10, 2002

PA NUMBER:  PAR-03-009  (The R01 portion of this PAR has been reissued, 
                         see PAR-06-104)

March 2, 2006 (NOT-OD-06-046) – Effective with the June 1, 2006 submission date, 
all R03, R21, R33 and R34 applications must be submitted through Grants.gov using 
the electronic SF424 (R&R) application. Replacement R21 (PAR-06-103 funding 
opportunity announcements have been issued for the submission date of June 1, 2006 
and submission dates thereafter. 

EXPIRATION DATE:  November 02, 2005

National Cancer Institute (NCI)
 (http://www.nci.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)  
 (http://www.niddk.nih.gov)
National Institute on Aging (NIA)
 (http://www.nia.nih.gov)
National Institute of Nursing Research (NINR) 
 (http://www.ninr.nih.gov/)

Letter of Intent dates:     January 1, 2003, September 1, 2003, May 1, 2004, 
January 1, 2005, September 1, 2005
Application receipt dates:  February 1, 2003, October 1, 2003, June 1, 2004, 
February 1, 2005, October 1, 2005
Revised application dates:  November 1, 2003, July 1, 2004, March 1, 2005
November 1, 2005 

THIS PA CONTAINS THE FOLLOWING INFORMATION

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

PURPOSE OF THIS PA 

The objective of this Program Announcement is to support research to improve 
diet and physical activity measurement through improved instruments, 
technologies, or statistical/analytic techniques. Proposals should be aimed 
at exploring the optimal combination of objective and self-report measures of 
physical activity or dietary intake that can capture these behaviors in both 
general and diverse populations.

RESEARCH OBJECTIVES

I.  Overview

Diet and physical activity are lifestyle and behavioral factors that play a 
role in the etiology and prevention of many chronic diseases such as cancer 
and coronary heart disease.  Both also play a role in prevention of 
overweight/obesity and maintaining weight loss.  Moreover, longitudinal data 
on physical activity and dietary intake would be especially helpful in 
understanding how the physical activity and dietary intake patterns over the 
lifespan may impact on health and functional status in later years and old 
age.  Therefore, diet and physical activity are assessed for both 
surveillance and epidemiological/clinical research purposes.  The measurement 
of usual dietary intake or physical activity over varying time periods or in 
the past, by necessity, has relied on self-reported instruments.  Such 
reports are cognitively difficult for respondents, and are prone to varying 
degrees of measurement error depending on the time period considered, the 
ease of the instrument, and the characteristics of the respondents.  
Understanding and interpretation of instruments and the concepts they address 
may differ among population subgroups.  The NCI, NIDDK, NIA, and NINR are 
interested in promoting research to:  1) improve existing instruments that 
seek to measure dietary intake and physical activity within diverse 
populations over time, 2) develop or refine new technologies for the 
measurement of dietary intake or physical activity, and 3) improve the 
statistical and analytical techniques to correct for measurement error in 
diet and physical activity assessment instruments.

II.  Background and Rationale

A.  Dietary Assessment

Dietary assessment instruments are used in a variety of research settings in 
which intake of individual foods or nutrients are of interest, as well as 
overall energy intake.  Such instruments run the gamut from food records in 
which respondents record all foods as they are consumed, to detailed and 
standardized 24-hour recalls of all food or drink ingested in the past day, 
to food frequency questionnaires in which individuals are asked to report 
usual frequency of intake of a long list of foods over a specified time 
period, to short screeners which ask about usual frequency of intake of a 
group of foods targeting a specific food group or nutrient.  Each of these 
self-reported dietary assessment instruments is successfully used in various 
research or public health settings, however, each has flaws and limitations 
both in the amount of information obtained, the quality of the data, and the 
analytic techniques used to provide nutrient or food group estimates (1).  

Food records are used in a number of nutrition research settings to measure 
dietary intake over a single time period, usually three to seven days.  
Records require motivated, trained, and literate respondents.  The strength 
of the food record approach is that it provides specific details on the 
amount and kind of food consumed.  Methods for food recording have improved 
over time and include such innovations as electronic scales or computer entry 
programs.  However, records have important limitations.  First, there is 
consistent research showing that when individuals are asked to record what 
they eat, they modify their eating habits to make the task easier and/or to 
represent their diet in a more positive way.  In addition, the quality of 
diet recording is known to decline with increasing number of days.  Among 
many respondents there is a tendency for energy estimates from records to be 
lower than that required for energy balance.  This indicates that such 
respondents are either under-eating and/or underreporting their intake.  Even 
with accurate reporting, a diet record is not thought to represent usual 
intake unless it is repeated over different time periods and seasons.

Twenty-four hour dietary recalls, in which a trained interviewer asks and 
probes respondents to report the kind and amount of all food and drink 
consumed the previous day, are currently used to monitor group mean intakes 
in the population.  It is generally accepted that a single 24-hour recall 
does not represent usual individual intake and cannot be used to estimate 
population intake distributions of nutrients or food groups.  Multiple 
recalls are required to represent usual intake of all nutrients and foods, 
and for nutrients and food groups that are infrequently consumed, many days 
are required.  Methods to collect recalls vary from paper-and-pencil to 
computerized systems.  The more highly sophisticated systems have 
standardized probes, multiple passes of intake over the day to prompt recall, 
and "forgotten foods lists."  Such innovations in the recall methods have led 
to improvements in prompting recall and, therefore improved estimates of 
nutrient intake among respondents.  However, recalls, like records, are prone 
to underreporting, although the extent of underreporting may vary by quality 
of the recall.  Underreporting is likely due to problems involving memory, 
difficulty in reporting portion size, and biases of the respondents.

Food frequency questionnaires (FFQs) are self-administered instruments in 
which respondents are presented with a long list of items and asked to report 
usual frequency of consumption over a specific time period (usually one 
year).  The strengths of the FFQ method are that it is designed to obtain 
data regarding usual intake and is much less costly to administer and code 
than recalls or records.  Therefore, the FFQ has been the method of choice 
for large-scale epidemiological studies.  However, FFQs lack the detail and 
specificity of records or recalls.  The food list found on FFQs is, by 
design, largely composed of frequently consumed foods.  The nutrient database 
lacks specificity and relies on nutrient content of the most common form in 
which foods are consumed rather than on specific forms.  Usual portion sizes 
are either assumed or queried in a general fashion.  In addition, completing 
FFQs is cognitively difficult, requiring good memory and estimation skills.  
There are many well-developed FFQs available for use by investigators; 
therefore, development from scratch is not generally necessary for most 
research efforts.  Many FFQs available today can be adapted to meet 
particular research needs.  There have been limited efforts to adapt FFQs for 
culturally specific populations and there is a continuing need to adapt 
instruments as research in diverse and distinct socio-cultural populations 
expands.

Extensive research has led to the general acceptance that FFQs are prone to 
more and/or different kinds of error than records or recalls.  FFQs have 
commonly been calibrated with recalls or records, which are considered to be 
more precise.  However, given that there is measurement error in all dietary 
assessment methods, various methods employing measurement error models and 
energy adjustment are used to assess validity or to adjust relative risks for 
disease outcomes.  More recently, intake biomarkers such as doubly labeled 
water for energy expenditure or urinary nitrogen for protein intake have been 
used to better understand the structure of measurement error and to devise 
methods to correct for this error in epidemiological studies.  

The limitations of self-administered dietary assessment instruments also pose 
a significant challenge for dietary intervention and/or metabolic studies, 
especially where stringent monitoring of overall dietary composition and 
energy intake is required.  Such studies have often opted to provide meals to 
the study subjects or include doubly labeled water assessments in addition to 
the self-report dietary measures.  However these approaches are not 
necessarily feasible (e.g., limited availability of doubly labeled water), 
often entail substantial time commitment on part of the study subjects and 
study personnel (e.g., preparation and distribution of meals from the 
metabolic kitchen, travel time of the study participants to collect or eat 
their meals at the metabolic kitchen), and may run the risk of increasing 
study subject burden, thereby affecting retention and future recruitment of 
study subjects.  In this regard, there is a critical need for objective and 
accurate dietary assessment instruments and methodology (e.g., new nutrient 
biomarkers, improved doubly labeled water protocols, and alternatives to 
doubly labeled water) for dietary intervention and/or metabolic studies. 

B.  Physical Activity Assessment

Until fairly recently, the primary focus of research and recommendations 
regarding physical activity was on sustained vigorous exercise.  Such 
activity is usually obtained through purposeful, programmed behavior such as 
jogging, swimming, or sports participation.  With these characteristics, 
vigorous exercise is relatively easy for respondents to report, although 
validation studies generally find a bias toward over-reporting (2).  Recent 
physical activity guidelines (3,4) have emphasized the accumulation of 
shorter episodes of moderate intensity physical activity.  Moderate intensity 
activity can occur in many routine daily activities.  Interventions to 
increase physical activity obtained through moderate intensity daily 
activities have achieved comparable physiologic outcomes to those that used 
more vigorous programmed activities.  However, monitoring behavior to assess 
moderate intensity activities is a challenge because of the need to assess 
many activities of short duration that may occur as part of routine daily 
functions in varying contexts – transportation, occupation, household chores, 
as well as recreation and sport (5).  Current guidelines also note the 
importance of engaging in activities to promote strength and flexibility.  
Maintaining strength and flexibility are important for an aging population, 
and may have beneficial effects for disease prevention.  Little attention has 
been given to assessment of these types of activities.  

Physical activity records have been shown to be quite accurate for capturing 
total activity.  Records can provide desired details regarding activity 
context, the type of activity (e.g., aerobic, strengthening, or for 
flexibility), as well as frequency, intensity, and duration.  However, like 
diet records, they are burdensome to respondents, requiring responses each 
time there is a change in activity throughout the day.  An advantage for 
physical activity, in contrast to diet, is that recent technological advances 
allow physical activity frequency, duration, and intensity to be objectively 
measured by wearable monitors that can record movement and/or heart rate.  A 
challenge with the use of monitors is capturing total activity.  This is 
because activity monitors selectively record movement of the part of the body 
to which they are attached.  Activity monitors worn on the hip primarily 
capture locomotion, but not upper body movement; if worn on the wrist, 
locomotion is not accurately recorded.  Without supplemental data collection, 
activity monitors do not capture activity context (e.g., occupation, 
transportation, household, recreation).    

Most evaluations of physical activity in surveillance or risk factor 
epidemiology rely upon retrospective questionnaire assessment.  Many 
instruments have been developed and some have been validated.  A major 
improvement in questionnaire assessment of physical activity was the 
inclusion of household sources of activity, which can be the primary context 
for physical activity among women.  Efforts have also been made to adapt 
questionnaires to include sources of physical activity common among certain 
racial/ethnic groups.  However, efforts to understand constructs implicit in 
physical activity questionnaires, such as leisure time activity or moderate 
physical activity, across various population subgroups are limited. 

C. Parallels Between Diet and Physical Activity Assessment

There are many parallels in diet and physical activity assessment research 
(6).  For example, assessing total physical activity is analogous to 
assessing total energy intake; assessing subcomponents of physical activity, 
such as occupational or leisure time activity, or cardiovascular or 
strengthening activities is analogous to assessing dietary fat or fruit and 
vegetable intake.  Reference periods for either diet or physical activity 
behaviors can vary from a week to a lifetime, and may focus on recent 
behavior, a specific previous period, or may be recorded contemporaneously.  
Ideally, physical activity assessment includes type of activity and context 
(specified by question content or respondent), frequency of behavior, 
duration of behavior, and performance intensity.  Estimating performance 
intensity or duration is similar in many ways to estimating portion size in 
dietary questionnaires.  Respondents may not have internal reference criteria 
that agree with the external criteria of the investigator, and the estimates 
can be influenced by cultural norms or public health messages.

As with diet and other self-reported behaviors, physical activity assessment 
is prone to measurement error.  This error is related to the same challenges 
of memory, estimation, and bias found in dietary assessment instruments.  
Perhaps even more than for diet, many aspects of physical activity, 
especially moderate physical activity, are routine and therefore not salient 
enough to be recalled well by a respondent.  Measurement error can obscure 
relationships between physical activity and disease risk, and also distorts 
values used for surveillance.  Recent applications of measurement error 
theory to dietary assessment have shown that reporting error can obscure 
potentially important relationships.  Furthermore, the demonstration of 
correlated errors between FFQs and 24-hour recalls have called into question 
the common calibration study approach.  Physical activity assessment research 
has lagged behind diet in addressing methods to evaluate and address 
measurement error through statistical models and analytic procedures.  It may 
be possible to use recent advances in addressing dietary measurement error as 
a basis for exploring means to characterize and handle measurement error in 
physical activity.

III.  Objectives

The objective of this Program Announcement is to support research to improve 
diet and physical activity measurement through improved instruments, 
innovative technologies, or application of statistical/analytic techniques.  
Proposals should be aimed at exploring the optimal combination of objective 
and self-report measures of physical activity or dietary intake that can 
capture these behaviors in both general and diverse populations.

Specifically, this PA is intended to support research and innovation in 
dietary and physical activity assessment.  The focus is on the assessment of 
the behaviors, and not on the determinants of these behaviors.  Much effort 
has already been put forth in the development of dietary and physical 
activity instruments.  For example, there are highly developed standardized 
methods for collecting 24-hour recall data (e.g., Nutrition Data System for 
Research (7), USDA 5 Pass Method (8)), food frequency questionnaire data 
(e.g., NCI Diet History Questionnaire (9), Block FFQ (10), Willet FFQ (11)), 
and physical activity questionnaires (e.g., Seven-Day Physical Activity 
Recall, International Physical Assessment Questionnaire (12)).  Given this 
history, it is not the primary intent of this PA to make minor adjustments to 
existing instruments (such as simply adding culturally specific foods or 
activities to an instrument).  The purpose is to promote substantive work to 
refine or improve the assessment of diet and physical activity.  Applications 
could include development of:  novel assessment approaches, better methods to 
evaluate instruments, assessment tools for culturally diverse populations, 
across various age-groups including older adults, improved technology or 
applications of existing technology, or statistical methods to assess or 
correct for measurement error.  

Research topics to be supported by this PA will be those falling within areas 
of clear importance for assessing the administration, utility, and/or 
validity of collecting data to measure dietary intake or physical activity.  
Possible topics include:

o Refine, and test methods of dietary or physical activity assessment for use 
in population surveillance, epidemiological studies, and/or behavioral 
interventions within general populations, socio-culturally diverse 
populations, low-literacy respondents, or specific age groups.

o Develop or refine innovative methods to improve respondent self-report of 
diet or physical activity behavior.  Potential areas include non-
standardized questionnaire administration, or use of life event history 
calendars or other recall cues to enhance retrieval of relevant information.

o Develop or refine innovative methods to improve underreporting of energy 
intake among obese and overweight individuals.

o Develop, refine and test analytic or statistical methods to address 
measurement error in the collection of dietary intake or physical activity 
assessment instruments.

o Improve methods for measuring the type (resistance vs. aerobic) and amount 
(frequency, intensity, duration) of physical activity behavior, the energy 
cost associated with physical activity, energy intake, and energy balance.

o Improve methods for assessing intake of particular types of food 
constituents, such as fat subtypes and phytochemicals.

o Validate methods for measuring dietary intake or physical activity using 
appropriate reference instruments, including biomarkers, objective measures, 
or physiologic outcomes such as strength and fitness.

o Develop or refine new technologies for the measurement of dietary intake or 
physical activity.

o Conduct cognitive testing of self-reported dietary or physical activity 
instruments to assess respondents' abilities to answer questions, 
particularly in population subgroups.

o Conduct validation or testing of existing instruments to assess utility in 
diverse populations.

o Identify factors leading to misreporting on dietary or physical activity 
assessment instruments.

o Explore psychometric properties of instruments so that questionnaire items 
can be developed for various groups, compared using the same metric, or be 
administered with innovative approaches such as computer adaptive testing 
methodologies.

o Explore the potential of ecological momentary analysis (EMA) techniques in 
the assessment of the complex, periodic behaviors of dietary intake and 
physical activity. 

o Develop and test new methods for accurate assessment in normal elderly and 
elderly with cognitive impairment or dementing diseases, which might result 
in difficulty remembering details of dietary intake and physical activity

MECHANISM OF SUPPORT 

Support of this program will be through the National Institutes of Heath 
(NIH) research project grant (R01) or an exploratory/developmental grant 
(R21).  Applicants will be responsible for planning, direction, and execution 
of the proposed project.  Awards will be administered under NIH grants policy 
as stated in the NIH Grants Policy Statement.  The total project period for 
an application submitted in response to this PA may not exceed 5 years for an 
R01 application and 2 years for an R21 application.  For R21 submissions, you 
may request up to $100,000 direct costs (four budget modules) per year unless 
your application includes consortium costs, in which case the limit is 
$125,000 direct costs (five budget modules) per year.  The R21 grants are 
non-renewable and continuation of projects developed under this PA will be 
through the traditional unsolicited investigator initiated grant program.

Applicants without extensive preliminary data or who wish to explore the 
utility of new dietary or physical activity assessment methods are urged to 
submit applications for this PA using the exploratory/developmental grant 
(R21) mechanism.  Investigators are encouraged to seek continued support 
after completing an exploratory/developmental grant project through a 
research project grant (R01).  Applicants may wish to coordinate efforts in 
developing their applications.  Furthermore, applicants proposing to develop 
new instruments for measuring dietary intake or physical activity are 
strongly encouraged to build upon existing measures and instruments and to 
collaborate with other investigators undertaking work in these areas as a 
means of promoting improved methods or analytic techniques that can be shared 
among multiple investigators and have utility in a number of research 
settings.

This PA uses just-in-time concepts.  It also uses the modular as well as the 
non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  Specifically, if 
you are submitting an application with direct costs in each year of $250,000 
or less, use the modular format.  Otherwise follow the instructions for non-
modular research grant applications.

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 or foreign
o Faith-based or community-based organizations 

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with 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 

NCI intends to convene one or more workshops involving grantees funded under 
this program announcement to facilitate future planning and program 
direction.  Grantees should provide budgets that include two two-day trips to 
the Washington, DC area.

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this PA and welcome the opportunity answer 
questions from potential applicants.  We strongly encourage investigators to 
go to http://riskfactor.cancer.gov/ to learn more about this PA.  Inquiries 
may fall into two areas:  scientific/research and financial or grants 
management issues:

o Direct your questions about scientific/research issues to:

Amy Subar, PhD or Richard Troiano, PhD
Division of Cancer Control and Population Sciences
National Cancer Institute 
Building EPN Room 4005
Bethesda, MD  20892
Telephone:  (301) 594-0831 or 301-435-6822
FAX:  301-435-3710
Email: subara@mail.nih.gov or troianor@mail.nih.gov

Susan Yanovski, MD
Director Obesity and Eating Disorders Program
National Institute of Diabetes & Digestive & Kidney Diseases
2 Democracy Plaza, Rm 665
Bethesda, MD 20892-5450
Telephone:  (301) 594-8882
FAX: (301) 480-8300
Email: YanovskiS@extra.niddk.nih.gov

Chhanda Dutta, PhD
Geriatrics and Clinical Gerontology Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 3E-327, MSC 9205
Bethesda, MD  20892-9205
Telephone:  (301) 435-3048
FAX:  (301) 402-1784
Email: mcd23z@nih.gov

Dr. Janice Phillips
Office of Extramural Programs
National Institute of Nursing Research
6701 Democracy Blvd, Room 710, MSC 4870
Bethesda, MD  20892-4870
Telephone:  (301) 594-6152
FAX:  (301) 480-8260
Email:  Janice_Phillips@nih.gov

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

Crystal Wolfrey
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Suite 243
Bethesda, MD  20892
Telephone:  (301) 496-8634
FAX:  (301) 496-8601
Email: crystal.wolfrey@nih.gov

Ms. Sharon Bourque
Grants Management Specialist
Division of Extramural Affairs, NIDDK
6707 Democracy Blvd.
Room 612, MSC 5456
Bethesda, MD  20892-5456
Telephone:  (301) 594-8846
FAX:  (301) 480-3504
Email:  bourques@extra.niddk.nih.gov

Ms. Linda Whipp
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2N212, MSC 9205
Bethesda, MD  20892-9205
Telephone:  (301) 496-1472
FAX:  (301) 402-3672
Email:  WhippL@nia.nih.gov

Ms. Tara Mowery
Office of Grants and Contracts Management
National Institute of Nursing Research
6701 Democracy Blvd, Room 710, MSC 4870
Bethesda, MD  20892-4870
Telephone:  (301) 594-5979
FAX:  (301) 451-5650
Email:  tara_mowery@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 PA 

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 NCI staff to estimate the potential review workload and plan 
the review.
 
The Letter of Intent is to be sent to Dr. Richard Troiano, at the address 
listed under WHERE TO SEND INQUIRIES.

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 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.

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted on February 1, 2003, October 1, 2003, June 1, 
2004, February 1, 2005, and October 1, 2005.  Revised applications will be 
accepted on November 1, 2003, July 1, 2004, March 1, 2005, and November 1, 
2005.

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.

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR:  
Applications requesting $500,000 or more in direct costs for any year must 
include a cover letter identifying the NIH staff member within one of NIH 
institutes or centers who has agreed to accept assignment of the application.   

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

1)  Contact the NIH program staff at least 6 weeks before submitting the 
application, i.e., as you are developing plans for the study; 

2)  Obtain agreement from the relevant institute staff that the institute 
will accept your application for consideration for award; and,
  
3)  Identify, in a cover letter sent with the application, the staff member 
at the relevant institute who agreed to accept assignment of the application.  

This policy applies to all investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended or revised 
version of these grant application types. Additional information on this 
policy is available in the NIH Guide for Grants and Contracts, October 19, 
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. 

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the checklist, and five signed photocopies in one 
package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

APPLICATION PROCESSING: Applications must be received by or mailed on or 
before the receipt dates of February 1, 2003, October 1, 2003, June 1, 2004, 
February 1, 2005, or October 1, 2005.  Revised applications must be received 
or mailed by November 1, 2003, July 1, 2004, March 1, 2005, or November 1, 
2005.  The CSR will not accept any application in response to this PA that is 
essentially the same as one currently pending initial review unless the 
applicant withdraws the pending application.  The CSR will not accept any 
application that is essentially the same as one already reviewed.  This does 
not preclude the submission of a substantial revision of an application 
already reviewed, but such application must include an Introduction 
addressing the previous critique.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review group 
convened in accordance with the standard NIH peer review procedures 
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific 
and technical merit.  

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

o  Receive a written critique
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  Those that receive a priority score will undergo a second level review by 
an appropriate Advisory Board.

REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to discuss the following 
aspects of your application in order to judge the likelihood that the 
proposed research will have a substantial impact on the pursuit of these 
goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The scientific review group will address and consider each of these criteria 
in assigning your application's overall score, weighting them as appropriate 
for each application.  Your 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, you may propose to carry out 
important work that by its nature is not innovative but is essential to move 
a field forward.

(1) SIGNIFICANCE:  Does your study address an important problem? If the aims 
of your application are achieved, how do they advance scientific knowledge?  
What will be the effect of these studies on the concepts or methods that 
drive this field?

(2) APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project?  Do you acknowledge potential problem areas and consider alternative 
tactics?

(3) INNOVATION:  Does your project employ novel concepts, approaches or 
methods? Are the aims original and innovative?  Does your project challenge 
existing paradigms or develop new methodologies or technologies?

(4) INVESTIGATOR: Are you appropriately trained and well suited to carry out 
this work?  Is the work proposed appropriate to your experience level as the 
principal investigator and to that of other researchers (if any)?

(5) ENVIRONMENT:  Does the scientific environment in which your 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, your 
application will also be reviewed with respect to the following:

PROTECTIONS:  The adequacy of the proposed protection for humans, animals, or 
the environment, to the extent they may be adversely affected by the project 
proposed in the application.

INCLUSION:  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 included in the 
section on Federal Citations, below)

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

AWARD CRITERIA

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

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

REQUIRED FEDERAL CITATIONS 

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 AMENDMENT "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 require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable; 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:  
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them. This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 
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.  A 
continuing education program in the protection of human participants in 
research in now available online at:  http://cme.nci.nih.gov/

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

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

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of "Healthy 
People 2010," a PHS-led national activity for setting priority areas. This PA 
is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople/

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance No. 93.393 and 93.866, and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under authorization of Sections 301 
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and 
administered under NIH grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92. 

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. 

REFERENCES

1.  Thompson FE, Subar AF.  Chapter 1:  Dietary Assessment Methodology. In:  
Nutrition in the Prevention and Treatment of Disease, Coulston AM, Rock CL, 
Monsen ER (eds), Academic Press, San Diego, 2001.

2.  Sallis JF, Saelens BE. Assessment of physical activity by self-report: 
Status, limitations, and future directions. Res Q Exerc Sport 2000; 71:1-
14.

3.  US Department of Health and Human Services. Physical Activity and Health: 
A Report of the Surgeon General. 1996. US Department of Health and Human 
Services, Centers for Disease Control and Prevention, National Center for 
Chronic Disease Prevention and Health Promotion, Atlanta, GA.

4.  Pate RR, Pratt M, Blair SN, Haskell WL, Macera CA, Bouchard C, Buchner D, 
Ettinger W, Heath GW, & King AC. Physical activity and public health. A 
recommendation from the Centers for Disease Control and Prevention and the 
American College of Sports Medicine. 1995; J Amer Med Assoc 273:402-407.

5.  Troiano RP, Macera CA, Ballard-Barbash R. Be physically active each day. 
How can we know? 2001; J Nutr 131:451S-460S.

6.  Friedenreich CM. Physical activity and cancer: Lessons learned from 
nutritional epidemiology. 2001; Nutr Rev 59:349-357.

7.  http://www.ncc.umn.edu/index.htm

8.  AJ Moshfegh, N Raper, I Ingwersen, L Cleveland, J Anand, J Goldman, R 
LaComb.  An improved approach to 24-hour dietary recall methodology.  Ann 
Nutr Metab 2001; 45(suppl 1): 156.

9.  http://riskfactor.cancer.gov/DHQ/

10. http://www.nutritionquest.com/

11. Rimm EB, Giovannucci EL, Stampfer MJ, et al.  Reproducibility and 
validity of an expanded self-administered semiquantitative food frequency 
questionnaire among male health professionals.  Am J Epidemiol 
1992;135:1114-1126.
12. A collection of physical activity questionnaires for health-related 
research. Med Sci Sport Exerc 1997;29(6, Suppl), 205 pp.

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NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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