Part I Overview Information

Department of Health and Human Services

Participating Organizations
 National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
National Cancer Institute (NCI), (http://www.nci.nih.gov/)
National Heart, Lung, and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov/index.htm)
National Institute on Aging (NIA), (http://www.nia.nih.gov)
National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), (http://www.niddk.nih.gov)
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov/)
National Institute of Nursing Research (NINR), (http://www.ninr.nih.gov/)
National Institutes of Health, Office of the Director, Office of Dietary Supplements (NIH OD ODS), (http://dietary-supplements.info.nih.gov/)

Title: Improving Diet and Physical Activity Assessment (R01)

Announcement Type

Update: The following update relating to this announcement has been issued:

This program announcement is a reissuance of PAR-03-009, which was released on October 10, 2002.

Looking Ahead: As part of the Department of Health and Human Services' implementation of e-Government, during FY 2006 the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications electronically using Grants.gov. For more information and an initial timeline, see http://era.nih.gov/ElectronicReceipt/. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html). Specific funding opportunity announcements will also clearly indicate if Grants.gov submission and the use of the SF424 (R&R) is required. Investigators should consult the NIH Forms and Applications Web site (http://grants.nih.gov/grants/forms.htm) for the most current information when preparing a grant application.

Program Announcement (PA) Number: PAR-06-104

Catalog of Federal Domestic Assistance Number(s)
93.242, 93.361, 93.399, 93.837, 93.838, 93.848, 93.865, 93.866

Key Dates
Release Date: December 23, 2005
Letters of Intent Receipt Dates (new applications and competing renewal applications): May 1, 2006; January 1, 2007; September 1, 2007; May 1, 2008; January 1, 2009
Letters of Intent Receipt Dates (amended/revised applications): June 1, 2006; February 1, 2007; October 1, 2007; June 1, 2008; February 1, 2009
Application Submission Dates (new applications): June 1, 2006; February 1, 2007; October 1, 2007; June 1, 2008; February 1, 2009 (alternating standard receipt dates).
Application Submission Dates (amended/revised; competing renewal applications): July 1, 2006; March 1, 2007; November 1, 2007; July 1, 2008; March 1, 2009
Peer Review Date(s): October-November 2006, June-July 2007, February-March 2008, October-November 2008; June-July 2009
Council Review Date(s): January 2007; October 2007, May 2008; January 2009; October 2009
Earliest Anticipated Start Date: April 2007; December 2007; July 2008; April 2009; December 2009
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date for R01 Non-AIDS Applications: November 2, 2006
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007

Due Dates for E.O. 12372
Not Applicable.

Additional Overview Content

Executive Summary

Alternative funding opportunity: Applicants who do not yet have sufficiently extensive preliminary data pertinent to diet and physical activity or those who wish to explore the utility of untested new dietary intake or physical activity assessment methods in pilot studies should not respond to this funding opportunity. Instead, they are advised to consider submitting applications in response to the partner funding opportunity using the exploratory/developmental (R21) grant mechanism which will be activated on Grants.gov on 2/2/2006.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
  1. Research Objectives

Section II. Award Information
  1. Mechanism(s) of Support
  2. Funds Available

Section III. Eligibility Information
  1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
  2. Cost Sharing or Matching
  3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
  1. Address to Request Application Information
  2. Content and Form of Application Submission
  3. Submission Dates and Times
    A. Submission, Review and Anticipated Start Dates
      1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
  4. Intergovernmental Review
  5. Funding Restrictions
  6. Other Submission Requirements

Section V. Application Review Information
  1. Criteria
  2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
  3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
  1. Award Notices
  2. Administrative and National Policy Requirements
  3. Reporting

Section VII. Agency Contact(s)
  1. Scientific/Research Contact(s)
  2. Peer Review Contact(s)
  3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

PURPOSE

This funding opportunity is aimed at advancing the quality of measurements of dietary intake and physical activity pertinent to cancer and/or other pathologies through support of research on improved instruments, technologies, and/or statistical/analytical techniques. Studies proposed in the grant applications should be aimed at optimizing the combined use of objective and self-report measures of physical activity and/or dietary intake for testing in both general and diverse populations.

Applicants responding to this funding opportunity, which uses the R01 grant mechanism, should have already tested and validated new approaches and have obtained feasibility data in the context of cancer or other relevant diseases. Applicants without sufficiently extensive preliminary data or those who wish to explore the utility of new untested dietary or physical activity assessment methods in pilot studies are advised to consider submitting applications for the partner funding opportunity using the exploratory/developmental grant (R21) mechanism that will be activated on Grants.gov on 2/2/2006.

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, coronary heart disease, and overweight/obesity as well as in maintaining weight loss. Accurate longitudinal data on physical activity and dietary intake patterns would be especially helpful in understanding how these factors may impact on health and functional status over the human lifespan. 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 intervals or in the past, by necessity, has relied on self-report 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, NHLBI, NIA, NICHD, NIDDK, NIMH, NINR, and NIH OD ODS are interested in promoting innovative research to enhance the quality of measurements of dietary intake and physical activity. Applications may 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 errors or biases.

II.  Background and Rationale

A.  Dietary Assessment

Dietary assessment instruments are used in a variety of research settings to estimate the consumption of individual foods or nutrients 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, to food frequency questionnaires (sometimes called screeners) which ask about usual frequency of intake of a group of foods targeting a specific food group or nutrient.  Each of these self-report dietary assessment instruments is successfully used in various research or public health settings. However, each has flaws and limitations as to the amount of information obtained, the quality of the data, and the analytic techniques used to provide nutrient or food group estimates.

Food records are used in a number of nutrition research settings to measure dietary intake over a single time period, usually 3 to 7 days.  For such records to be reasonably accurate, respondents need to be motivated, trained, and literate.  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 numbers of days.  Moreover, energy estimates based on self-report records for some respondents tend to be lower than those required for energy balance.  This pattern 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 consistently observed over different time intervals 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 1 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 significant challenges for dietary intervention and/or metabolic studies, especially in situations when stringent monitoring of overall dietary composition and energy intake is required.  Such studies have often been designed 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 always 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 methodologies (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.  Recent physical activity guidelines 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, e.g., transportation, occupation, household chores, as well as recreation and sport.  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 flexibility exercise), 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.  Also, some types of questionnaires include sources of physical activity common among certain racial/ethnic groups.  However, efforts to understand how certain constructs used in physical activity questionnaires, such as leisure time activity or moderate physical activity, are understood across various population subgroups, are limited.

C. Parallels between Diet and Physical Activity Assessment

There are many parallels between diet and physical activity assessments.  For example, assessing total physical activity is analogous to assessing total energy intake, while 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.  Many aspects of physical activity, especially those that are associated with low to moderate intensity, 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 may distort data used for surveillance.  Recent applications of measurement error theory to dietary assessment have shown that reporting error may mask potentially important relationships with other variables.  Furthermore, the demonstration of correlated errors between FFQs and 24-hour recalls have called into question the common calibration study approach.  Research pertinent to the assessment of physical activity has lagged behind the improvements in estimates of dietary intake. In particular, methods to evaluate measurement errors and algorithms to compensate for such errors through the use of statistical models and analytic procedures remain underdeveloped.  It may be possible, however, to capitalize on recent advances in addressing dietary measurement errors as a basis for exploring means to characterize and handle measurement errors in estimates of physical activity as well.

III.  Objectives

This funding opportunity will support research pertinent to improving the measurements of diet and physical activity through the development of better instruments, innovative technologies, and/or applications of advanced statistical/ analytic techniques. Research proposed in the applications should be aimed at exploring and optimizing innovative combinations of objective and self-report measures of physical activity or dietary intake in both the general population and its diverse subgroups.

Specifically, this funding opportunity is intended to support innovative research focused on assessments of dietary and physical activity patterns, not on the determinants of these behaviors.   Moreover, it is not the primary intent of this program announcement to make minor adjustments to existing instruments (such as simply adding specific foods or activities to the already established standardized methods and questionnaires (e.g., Nutrition Data System for Research, USDA 5 Pass Method, NCI Diet History Questionnaire, Block FFQ, Seven-Day Physical Activity Recall, International Physical Assessment Questionnaire).  Rather, the purpose is to promote substantive improvements in the assessment of diet and physical activity as related to cancer or other pathologies.

Potential topics include, but are not limited to:

See Section VIII, Other Information - Required Federal Citations for policies related to this announcement.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the National Institutes of Heath (NIH) research project R01 grant mechanism. 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 funding opportunity announcement may not exceed 5 years.
 
As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget 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 described in the PHS 398 application instructions. Otherwise, follow the instructions for non-modular research grant applications.

2. Funds Available

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NIH institutes and centers provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

1.B. Eligible Individuals

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.

2. Cost Sharing or Matching
Not Applicable

3. Other-Special Eligibility Criteria
Not Applicable

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance, contact GrantsInfo, Telephone: (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the current PHS 398 research grant application instructions and forms. Applications must have a 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 GrantsInfo@nih.govhttp://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

Proposed research should provide a unique research opportunity not available in the U.S.

3. Submission Dates and Times
See Section IV.3.A. below for details.

3.A. Submission, Review, and Anticipated Start Dates

Letters of Intent Receipt Dates (new applications and competing renewal applications): May 1, 2006; January 1, 2007; September 1, 2007; May 1, 2008; January 1, 2009
Letters of Intent Receipt Dates (amended/revised applications): June 1, 2006; February 1, 2007; October 1, 2007; June 1, 2008; February 1, 2009
Application Submission Dates (new applications): June 1, 2006; February 1, 2007; October 1, 2007; June 1, 2008; February 1, 2009 (alternating standard receipt dates)
Application Submission Dates (amended/revised; competing renewal applications): July 1, 2006; March 1, 2007; November 1, 2007; July 1, 2008; March 1, 2009
Peer Review Dates: October-November 2006, June-July 2007, February-March 2008, October-November 2008; June-July 2009
Council Review Date(s): January 2007; October 2007, May 2008; January 2009; October 2009
Earliest Anticipated Start Date: April 2007; December 2007; July 2008; April 2009; December 2009

3.A.1. Letter of Intent

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

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 NIH Institute or Center (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:

Richard Troiano, Ph.D.
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Plaza, EPN Room 4018, MSC 7344
Bethesda, MD 20892-7344
Telephone: (301) 435-6822
FAX: (301) 435-3710
Email: troianor@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application. 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 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

3.C. Application Processing

Applications must be submitted on or before the application receipt/submission dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.

Upon receipt applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This rule does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks.

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

Specific Instructions for Modular Grant applications.

Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget 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 at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm

Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year.

Applicants requesting $500,000 or more in direct costs for any year must carry out the following steps:

1) Contact the IC 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 IC staff that the IC will accept your application for consideration for award; and,

3) Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application.

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

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (see the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria
Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to the NIH ICs on the basis of established PHS referral guidelines.

Appropriate scientific review groups 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:

The following will be considered in making funding decisions:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an 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 or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators 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? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria

In addition to the above criteria, the following items will continue to 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 the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities, and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

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 Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy (see http://grants.nih.gov/grants/policy/data_sharing).
 
2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (see the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and at http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates
Not applicable

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590, annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity 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.

1. Scientific/Research Contacts:

Amy Subar, Ph.D. or Richard Troiano, Ph.D.
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Boulevard, EPN Room 4005, MSC 7344
Bethesda, MD  20892-7344
Telephone:  (301) 594-0831 or (301) 435-6822
FAX:  (301) 435-3710
Email: subara@mail.nih.gov or troianor@mail.nih.gov

Catherine Loria, Ph.D.
Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 8112, MSC 7936
Bethesda, MD 20892-7936
Telephone: (301) 435-0702
FAX: (301) 480-1773
Email: loriac@mail.nih.gov

Chhanda Dutta, Ph.D.
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

Terry Huang, Ph.D., M.P.H
Endocrinology, Nutrition, and Growth Branch
National Institute of Child Health & Human Development
6100 Executive Boulevard, Room 4B11, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 594-1846
FAX: (301) 480-9791
Email: huangter@mail.nih.gov

Michael Spittel, Ph.D.
Demographic and Behavioral Sciences Branch
National Institute of Child Health & Human Development
6100 Executive Boulevard, Room 8B07, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-1174
FAX: (301) 496-0962
Email: spittelm@mail.nih.gov

Carolyn Miles, Ph.D.
National Institute of Diabetes & Digestive & Kidney Diseases
2 Democracy Plaza, Room 665, MSC 9205
Bethesda, MD 20892-5450
Telephone:  (301) 451-3759
FAX: (301) 480-8300
Email: milesc@mail.nih.gov

William Riley, Ph.D.
National Institute of Mental Health
6001 Executive Boulevard, Room 6226, MSC 9615
Bethesda, MD  20892-9615
Telephone:  (301) 435-0301
FAX:  (301) 480-2920
Email: wiriley@mail.nih.gov

Martha L. Hare, Ph.D., R.N
National Institute of Nursing Research
6701 Democracy Boulevard
One Democracy Plaza, Room 710, MSC 4870
Bethesda, MD  20892-4870
Telephone: (301) 451-3874
FAX: (301) 480-8260
Email: martha.hare@nih.gov

Rebecca B. Costello, Ph.D., F.A.C.N.
Deputy Director
Office of Dietary Supplements
National Institutes of Health
6100 Executive Boulevard, Room 3B01, MSC 7517
Bethesda, Maryland 20892-7517
Telephone: (301) 435-2920
FAX: (301) 480-1845
Email: CostellB@od.nih.gov

2. Peer Review Contacts:
Not applicable

3. Financial or Grants Management Contacts:

Crystal Wolfrey
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, EPS Suite 243, MSC 7150
Bethesda, MD  20892-7150
Telephone:  (301) 496-8634
FAX:  (301) 496-8601
Email: crystal.wolfrey@nih.gov

Craig E. Bagdon, M.P.A.
Grants Operations Branch
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7129, MSC 7926
Bethesda, MD 20892-7926
Telephone (301) 435-0480
Fax (301) 480-3310
Email: bagdonc@mail.nih.gov

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

Lisa Moeller
Grants Management Team Leader
National Institute of Child Health & Human Development
6100 Executive Boulevard, Room 8A01, MSC 7510
Bethesda, MD  20892-7510
Telephone: (301) 435-6995
FAX: (301) 451-5510
Email: moellerl@mail.nih.gov

Sharon Bourque
Grants Management Specialist
National Institute of Diabetes & Digestive & Kidney Diseases
6707 Democracy Boulevard, Room 612, MSC 5456
Bethesda, MD  20892-5456
Telephone:  (301) 594-8846
FAX:  (301) 480-3504
Email: bourques@extra.niddk.nih.gov

Rita Sisco
Grants Management
National Institute of Mental Health
6001 Executive Boulevard, Room 6120, MSC 9537
Bethesda, MD  20892-9537
Telephone:  (301) 443-2805
FAX:  (301) 443-6885
Email: rr46w@nih.gov

Brian Albertini
Office of Grants and Contracts Management
National Institute of Nursing Research
6701 Democracy Boulevard, Room 710, MSC 4870
Bethesda, MD 20892-4870
Telephone: (301) 594-6869
FAX: (301) 451-5651
Email: albertib2@mail.nih.gov

Section VIII. Other Information

Required Federal Citations

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

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 and 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.

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 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 funding opportunity 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.

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

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical 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 (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 applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov/) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from: 1) currently funded NIH research projects; or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://www.nih.gov/about/publicaccess/ and view the Policy or other Resources and Tools including the Authors' Manual (http://www.nih.gov/about/publicaccess/publicaccess_Manual.htm).

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 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 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 discourages 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.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50 percent of their time (at least 20 hours per week based on a 40-hour week) for 2 years to the research. For further information, please see http://www.lrp.nih.gov/.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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