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) (www.cancer.gov)
National Heart, Lung, and Blood Institute (NHLBI) (
www.nhlbi.nih.gov)

Title:Improved Measures of Diet and Physical Activity for the Genes and Environment Initiative (GEI) (U01)

Announcement Type
New

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

Request For Applications (RFA) Number: RFA-CA-07-032

Catalog of Federal Domestic Assistance Number(s)
93.399

Key Dates

Release Date:  October 4, 2006
Letters of Intent Receipt Date(s): December 11, 2006
Application Receipt Date(s): January 11, 2007
Peer Review Date(s): March/April 2007
Council Review Date(s): May 2007
Earliest Anticipated Start Date(s): July 2007
Additional Information To Be Available Date (URL Activation Date): Not applicable
Expiration Date: January 12, 2007

Due Dates for E.O. 12372

Not Applicable.

Additional Overview Content

Executive Summary

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 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. 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. Submitting an Application Electronically 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
    A. Cooperative Agreement Terms and Conditions of Award
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

Nature of the Research Opportunity

The NIH invites applications to support the development of new sensor devices and systems that provide quantitative, reliable, field-deployable measurement of personal-level exposure to dietary intake and physical activity that can be used in free-living populations. This Funding Opportunity Announcement (FOA) is a part of for the NIH-wide Genes and Environment Initiative (GEI) (http://www.gei.nih.gov/).

The GEI is a 4-year, NIH-wide program proposed in the President’s FY2007 budget and currently awaiting Congressional approval.  If approved, the program will support efforts to identify major genetic susceptibility factors for diseases of public health significance and to develop technologies for reliable and reproducible measurement of potentially causative environmental exposures.  The GEI is being developed and implemented by an NIH-wide Coordinating Committee, and administered via two complementary programs, the Exposure Biology Program led by the National Institute of Environmental Health Sciences (NIEHS) and the Genetics Program led by the National Human Genome Research Institute (NHGRI).

The Exposure Biology Program of the GEI is intended to be a multi-component program involving several solicitations.  A major component will support the development of technology to make precise, quantitative measurements of personal exposure to environmental chemical/biological agents, diet, physical activity, and psychosocial stress.  The other exposure biology component includes development of biological response indicators for a variety of environmental stressors.  These activities will generate new exposure assessment tools that can be applied in future population-based and whole genome association studies supported by the GEI to better inform about the role of gene-environment interactions in human disease.

The GEI will also consider factors related to disparities in health outcomes, including, but not limited to environmental exposures, genetic variations and/or other underlying biological, race/ethnic, social, and familial factors. Health disparities research provides an important opportunity to integrate biological with social/behavioral knowledge in better identification and understanding of the determinants of disease, reducing disease risks, and providing better treatment.  How genetic variation contributes to health disparities remains largely unclear, since most genetic studies do not have adequate measures of behavioral, physical, social, and environmental factors.  The GEI will provide a valuable scientific contribution to health disparities research by its collection and analyses of genotype, phenotype, and exposure data, while simultaneously measuring other factors within disease subgroups (e.g., race, ethnicity, behaviors, geography, genetic backgrounds, exposures and social environments) that may lead to differential health outcomes.

There are five Requests for Application (RFAs) being announced concurrently that define the scope of the Exposure Biology Program.  The RFA numbers and titles are as follows: RFA-ES-06-011, Environmental Sensors for Personal Exposure Assessment (U01); RFA-DA-07-005, Field-deployable Tools for Quantifying Exposures to Psychosocial Stress and to Addictive Substances for Studies of Health and Disease (U01); RFA-ES-06-012, Biological Response Indicators to Environmental Stressors Centers (U54); RFA-ES-06-013, Biological Response Indicators to Environmental Stressors (U01); and this RFA, RFA-CA-07-032, Improved Measures of Diet and Physical Activity for the Genes and Environment Initiative (GEI) (U01).

The Overall Purpose of This Funding Opportunity Announcement

As part of the GEI Exposure Biology Program, RFA-CA-07-032 is designed to promote substantive work to refine or improve the assessment of usual diet and physical activity. Specifically, applications are solicited for projects to develop new or adapt existing technologies (such as sensors; scanning and/or measurement devices; imaging techniques; wireless technologies; and bioinformatics tools and solutions) for dietary intake and physical activity assessment. Development of objective recovery biomarkers that measure absolute intake of dietary constituents is also encouraged.  The FOA centers on projects that can be completed in four years and technologies that are suitable for large-scale studies.  It is anticipated that any devices or measures to be developed under this FOA will have reached the prototype stage and be available for application in large-scale population studies by the end of the funding period.

Background

Diet and physical activity are lifestyle and behavioral factors that play an important role in the etiology, prevention, and treatment of many chronic diseases, including heart disease, vascular disease, chronic lung disease, metabolic disorders, cancer, and psychiatric conditions.  Accurate data on diet and physical activity are critical in understanding how these factors may impact health and functional status over the human lifespan.  On an individual level, interactions between genetic factors and diet or physical activity may influence disease risk.  An improved understanding of how these genes and environment interactions affect disease risk may lead to better prevention or treatment approaches.

The measurement of usual dietary intake (considered the long-run average intake over the past year) or physical activity over varying recent time periods or in the past, by necessity, has relied on self-reported instruments.  A variety of self-reported instruments exist but they may be cognitively difficult for respondents, and are prone to measurement error depending on the time period considered, the instrument’s ease of use, and the ethnic and demographic characteristics of the respondents.  For these reasons, this FOA supports the development of more objective methods to assess dietary intake and physical activity that will overcome these limitations.

Dietary Assessment

A variety of self-report methods have been developed to assess intake of foods, nutrients, dietary constituents, and dietary supplements.  These methods include food records, 24-hour dietary recalls, and food frequency questionnaires (FFQs).

Both food records and 24-hour dietary recalls are self-report methods designed to collect detailed data on foods, beverages, and dietary supplements consumed.  Subjects completing a food record are instructed to record food as it is consumed in real time, whereas for recalls, subjects are interviewed by a trained interviewer about intake over the previous 24-hours.  Both methods require more than a few days of data to represent usual intakes and are subject to varying degrees of reporting bias.  Strengths of the food record and 24-hour recall are that both instruments provide specific details on the amounts and kinds of foods and supplements consumed.  However, there is considerable research showing that when individuals are asked to record what they eat or drink, they tend to modify their eating habits to make the task easier, represent their diets in a more positive way, underreport their energy intake, and/or undereat on recording days.  In addition, records require motivated subjects and have high respondent burden, as evidenced by data showing that quality declines over time.  The strength of the 24-hour recall is that it is not subject to reactivity and is less prone to biased reporting.  The limitations include expense (because of the need for trained interviewers) and reliance on respondents’ ability to remember the previous day’s intake.

It is possible that newer technologies could lessen the limitations of both methods.  Over time, food recording methods have increasingly incorporated technological advances, initially including the use of electronic scales or computerized data entry, and more recently, including cell phones and personal digital assistants (PDAs) to capture both visual and recorded detail that is electronically submitted to the researcher.  Methods to collect recalls have advanced to computerized systems (e.g., the Nutrition Data System for Research and the United States Department of Agriculture’s [USDA’s] Automated Multiple Pass Method) that lead trained interviewers through standardized probes and multiple passes, techniques that have led to improvements in prompting recall and estimating intakes.  There have been some recent advances in creating automated self-administered 24-hour recalls for which there is limited but promising validation research.  The goal of such software is to replace the interviewer with a user-friendly interface for querying intake and food/beverage photography to aid in reporting portion size.  There is potential for technological advances such as the use of digital data (pictures possibly annotated with descriptive information) to address some of the limitations and improve methods for both records and recalls.  The challenge is to design affordable technological devices, software, and/or sensors for population-based research that will ease respondent burden while providing accurate estimates of nutrient, food, and supplement intakes.

Food frequency questionnaires (FFQs) are self-administered instruments in which respondents report usual frequency of consumption for a list of foods over a specific time period (usually 1 year).  Extensive development and validation research has produced many widely available FFQs, such as the NCI Diet History Questionnaire, and the Block, Willett, and Fred Hutchinson FFQs.  Although the FFQ is designed to obtain usual intakes and is currently much less costly to administer and code than recalls or records, it lacks the detail and specificity of records or recalls, is cognitively difficult to complete, and is more prone to measurement error than records or recalls.  Given the extent of previous work and the inherent limitations of FFQs, it is unlikely that significant improvements of this method are possible in the future.

The limitations of self-reported dietary assessment instruments have led to interest in biomarkers of intakes that would accurately reflect the absolute amount of nutrient or foods consumed; for example, recovery biomarkers, such as doubly labeled water, which can be used as a measure of energy intake under conditions of energy balance, and 24-hour urinary nitrogen, which reflects nitrogen intake under steady-state conditions.  There is a critical need for additional objective recovery biomarkers that reflect intakes accurately and that are practical for use in population-based studies.

Physical Activity Assessment

Assessment of physical activity is complex because the measurement encompasses several important elements:  type of activity, intensity, frequency, and duration of individual bouts.  Particular aspects of physical activity may affect different health outcomes.  For example, the metabolically integrated aspect of energy expenditure is related to obesity, whereas subcomponents, such as frequency and intensity are more relevant to modulation of insulin levels and function or lipid utilization.  Physical activity may also affect immune function and inflammation markers.  Physical activity includes exercise (i.e., the purposeful behavior performed with the intention to improve health and/or for recreation, such as jogging, swimming, resistance training, or sports participation) that may be moderate-intensity or vigorous and activity that may occur as part of routine daily functions in varying contexts, such as transportation, occupation, and household chores.

Direct measurement of physical activity by physiologic monitoring, such as heart rate monitoring or motion sensors, has been favored for physical activity assessment.  Objective monitoring is preferred to self-report data because it reduces the bias introduced by poor memory and over- or under-reporting, and can require minimal respondent burden.  Great strides have been made in physical activity sensor technologies over the past 2 decades.  Initially, motion sensors only gave an indication of activity through “counts.” Devices using more recent integrated computer technology have been able to link motion with physiologic responses. Other enhancements include spatial orientation, allowing distinctions between, e.g., walking on the flat versus on stairs or lying versus sitting.  Innovative technologies, novel sensors and devices, including wireless technology, that can link the occurrence of motion with activity context, and technology integration that can supersede self-report methods would greatly improve the current state of assessment methodology.

Overarching Scientific Goals of the Genes and Environment Initiative

The overarching goal of GEI is to determine the etiology of common diseases by focusing on the interaction of genetic and environmental factors that increase the risk of these diseases.  The Exposure Biology component of the GEI will develop, confirm, and apply new methods to assess personal exposure to stressors in the environment and the response to these stressors in key biological pathways that are also involved the pathogenesis of common diseases.

Specific Objectives of this Research Program

To be regarded responsive to this FOA, the research project(s) proposed in an application must center on the development of new or refining of existing technologies that are of clear importance for the measurement of usual dietary intake (including contributions from supplements and alcohol) or physical activity or both.  Small scale validation of new technologies/methodologies as a component of a technology development project is expected (but stand-alone technology validation projects are not eligible). 

Proposed research should be aimed at developing devices or biological measures of exposures and responses that are reliable and valid, have low respondent burden, and are economically feasible for use in population studies.  Devices or biological measures should be applicable within general populations, and subgroups based on gender, cultural, and socio-economical diversity, low-literacy respondents, and/or across the lifespan.  These devices must reach the prototype stage and ready for application in large-scale population studies at the end of the funding period. Appropriate performance/completion milestones for each research project must be proposed (see below).

Research projects resulting from this FOA are expected to bring about substantive technological improvements. In the area of physical activity assessment, such improvements are sought in objective methods using motion or physiologic sensors, monitors, imaging methods, cellular telephony and wireless technologies, as well as bioinformatics tools and database solutions.  Approaches to assess usual dietary intake could take advantage of existing technologies, such as: sensors, scanning, and/or other measurement devices; imaging techniques; wireless technologies; and software and database applications.  In addition, the development of objective recovery biomarkers that would enable measurement of absolute intake of a wide array of short- or long-term nutrient or food intakes is also encouraged. 

The focus of this FOA is on assessments of the behaviors, and not on the determinants of these behaviors.  Much effort has already been devoted to the development of dietary intake and physical activity assessment instruments.  Therefore, it is not the intent of this FOA to fund minor adjustments to existing instruments (such as simply adding culturally specific foods or activities to an instrument).

Possible topics to address in applications include, but are not limited to:

•       Developing new or adapting existing technologies to measure dietary and supplement intake, such as: sensors, scanners, and/or other devices; imaging detection software; or wireless technologies.  Examples include: automating the analysis of photos to identify foods and estimate portions consumed; combining digital cameras, audio recording, and bar code scanner technologies in one device; or using wireless technology to transmit data in real-time.

•       Refining existing computer, web-based, or personal digital assistant (PDA) technologies to assess dietary and supplement intake.  Improvements could include faster processing time to reduce participant burden, addition of voice-recognition software for low-literate users, or faster searching algorithms to speed selection of foods consumed or probing questions (via the web or wireless transmission).

•       Developing new or adapting existing technologies that measure physical activity to capture intensity, duration, and type.  Examples include integration of sensors to detect motion, location, and physiologic markers such as heart rate, respiration, and temperature.

•       Exploring the potential of ecological momentary assessment (EMA) techniques using cell phones or PDA hardware in the assessment of the complex, episodic occasions of physical activity.

•       Developing valid recovery biomarkers that reflect absolute intake of a wide array of short- or long-term nutrient or food/beverage intakes.

Proposed projects should focus on the coupling of promising technologies with needs and opportunities for diet and physical activity assessment.  The development of devices and/or biological measures is an interdisciplinary process involving engineers, chemists, nutritionists, exercise physiologist, and information specialists.  It is expected that individual research projects will encourage collaborations among experts in these disciplines to support the full spectrum of research activities needed for conceptualization, development, pilot testing, and validation.  Applicants should describe the partnerships that will be established to facilitate the identification and adaptation of emerging technologies, their integration into approaches suitable for population research settings, and the potential for transitioning prototypes to use in future research studies.

Alternative funding opportunities:

The scope of this FOA using the U01 mechanism is similar to the scope of PAR-06-104 and PAR-06-103, which utilize the R01 and R21 mechanisms, respectively. All three FOAs support research on assessment of dietary intake and physical activity. There are however, significant differences in emphasis.

This RFA-CA-07-032 focuses chiefly on developing and/or improving technology, while underscoring multidisciplinary efforts to reach the product prototype stage by the end of non-renewable awards. Research projects on statistical methodologies, validation only studies, modification of existing questionnaires, or development of survey instruments are NOT responsive to RFA-CA-07-032.

Such studies, however, may be appropriate for PAR-06-104 and PAR-06-103.  Both PARs emphasize research 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. Projects involving technology improvements in this context may be submitted in response to either of these two PARs. Awards made under PAR-06-104 are renewable.

Application Information Meeting

NIH staff will conduct an Application Information Meeting for the entire GEI Exposure Biology Program and videoconference in Research Triangle Park, NC, on October 20, 2006.  This meeting will allow potential applicants to discuss and clarify any issues related to this FOA with NIH staff.  Detailed information about the meeting (e.g., time, location, videoconference information, etc.) will be available on the Exposure Biology website (http://www.gei.nih.gov/exposurebiology/index.asp).  Whether you plan to attend or videoconference into the meeting, please register online at this website. Potential applicants are encouraged to submit their questions about this FOA via e-mail to Dr. Amy Subar (subara@mail.nih.gov) in advance of the meeting.

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 Announcement (FOA) will use the U01 Research Project Cooperative Agreement award mechanism.

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

The NIH U01 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award."

2. Funds Available

The total amount of funding committed to this program is $16 million (total costs) over a 4-year period. NIH intends to commit approximately $4 million in FY2007 to fund six to eight new grants in response to this FOA. An applicant may request a project period of up to 4 years and a budget for direct costs up to $425,000 dollars per year.

The anticipated start date is July 2007 and the program period will be from July 1, 2007 to June 30, 2011.

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 IC(s) 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 (F&A) 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

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 support.

2. Cost Sharing or Matching

Cost sharing is not required.

The most current NIH Grants Policy Statement can be found at http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria

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 most 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 http://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 special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Receipt, Review, and Anticipated Start Dates
Letter of Intent Receipt Date(s): December 11, 2006
Application Receipt Date(s): January 11, 2007
Peer Review Date(s): March/April 2007
Council Review Date(s): May 2007
Earliest Anticipated Start Date: July 2007

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 IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Amy F. Subar, Ph.D., M.P.H., R.D.
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Boulevard, EPN Room 4005, MSC 7344
Bethesda, MD 20892-7344 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 594-0831
Fax: (301) 435-3710
Email: subara@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (for 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).

At the time of submission, two additional copies of the application and all of the appendix material in pdf format must be sent to:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery; non-USPS service)
Telephone:  (301) 496-3428
Fax:  ( 301) 402-0275
Email: ncirefof@dea.nci.nih.gov

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

3.C. Application Processing

Applications may be submitted on or after the opening date and must be Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by NIH. Incomplete and non-responsive applications will not be reviewed. If the application is not responsive to the RFA, NIH staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle.

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

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at https://commons.era.nih.gov/commons/.

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 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 award.

The incurrence of pre-award costs in anticipation of a 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/archive/grants/policy/nihgps_2003/index.htm.

6. Other Submission Requirements

Applicants should follow instructions for PHS 398 Research Plan with additional requirements specified below. Items A–D in the application (Specific Aims, Background and Significance, Preliminary Studies, and Research Design and Methods) should not exceed 25 pages.

Partnerships

All applications must include in Section D. Research Design and Methods of PHS 398 Research Plan a short sub-section labeled “Partnerships”. This sub-section should identification critical partnerships needed to conduct the research and development activities that are specific to the facets of technology conceptualization, prototype device development, small-scale field testing, and functional validation.

Milestones

All applications must include in Section D. Research Design and Methods of PHS 398 Research Plan a specific sub-section labeled “Milestones”. For each year of the proposed project, applicants must provide well-described, quantitative, and scientifically justified milestones that would NOT be simply a restatement of the specific aims. Rather, the milestones must define specific quantitative benchmark parameters and offer a timeline for the development of the proposed technology. These milestones will be used to judge the success of the proposed research on an individual-project basis. It is expected that the milestones will be adjusted annually at the award anniversary dates to incorporate the group's scientific accomplishments and progress and to reflect any recommendations of the Steering and Advisory Committees.

Plan for Sharing Research Data

Applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity must include in Section D of the PHS398 Research Plan (within the specified page limits) a description of how final research data will be shared, or explain why data sharing is not possible.

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 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.

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 presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

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 (NIH Grants Policy Statement at http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm and at http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.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.

The goals of the FOA program are to support the development of technologies and/or biological measures of exposures and responses that are reliable and valid, have low respondent burden, and are economically feasible for use in studies of free-living, diverse populations. Examples of these technologies for diet and physical activity assessments include: motion or physiologic sensors; scanning or other measurement devices; imaging techniques; wireless technologies; software and database applications; and to accelerate commercialization of such systems.

The NIH will support the research and technology needed to accelerate the development commercialization of diet and physical activity technologies that will be readily available for use at the end of the funding period.

Applicants are expected to include a plan addressing how they will exercise their intellectual property rights, while making such research resources available within and across the NIH Gene Environment Initiative (GEI) programs, and to the broader scientific community for research purposes consistent with the goals of the GEI.  A reasonable time frame for release of materials should be specified in the data sharing plan and will be considered by program staff members. Furthermore, transfers of research resources must be made consistent with the NIH Research Tools Policy (http://www.ott.nih.gov/policy/rt_guide_final.html) and other NIH sharing policies. In the development of any sharing and intellectual property plans, applicants should confer with their own institution's office(s) responsible for handling technology transfer related matters and/or their sponsored research office. If applicants or their representatives require additional guidance in preparing these plans, they are encouraged to make further inquiries to the appropriate contacts listed below for such matters.

Program staff, in determining whether the application shall be awarded, will consider the adequacy of the proposed plans. The plans as approved after negotiation with the applicant when necessary will be part of the terms and conditions of the award. Evaluation of progress reports (PHS 2590) will include assessment of the awardee's adherence to the proposed plans, and will be a criterion for continued funding of the award.

Applicants also are reminded that the grantee institution is required to disclose each subject invention within 2 months after the inventor discloses it in writing to grantee institutional personnel responsible for patent matters. The lead institute reserves the right to monitor awardee activity in this area to ascertain if patents or patent applications are adversely affecting the goals of this FOA.

Public Domain of Data

All awards made under this FOA are subject to the Final NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html) and the Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources (http://www.ott.nih.gov/policy/rt_guide_final.html). This document also defines terms, parties, responsibilities, prescribes the order of disposition of rights, prescribes a chronology of reporting requirements, and delineates the basis for and extent of government actions to retain rights. Patent rights clauses may be found at 37 CFR Part 401.14 and are accessible from the Interagency Edison web page (http://www.iedison.gov). It is expected that research resources generated through the award will be shared by awardees according to these guidelines. The plans for the development of resources for use by the biomedical community will have the appropriate timelines and milestones. Program staff will evaluate the compliance with the sharing plan and scientific progress in the non-competing progress report (Form 2590); such compliance will be a criterion for continued funding of the award.

Appendix Materials:

As described in NIH Guide Notice NOT-OD-06-051 and clarified in Notice NOT-OD-06-053, effective for applications for submission/receipt dates of May 10, 2006, and beyond, the instructions for including appendix material have changed. The Appendix may not include manuscripts submitted for publication. Also, according to the new process, journal articles that are publicly available on line should not be submitted as Appendix materials. Only a link to such articles should be provided.

The following materials may be included in the Appendix (a combined total of up to 10 items):

Applicants are cautioned not to use the Appendix to circumvent the page limitations of the Research Plan.  An application that does not observe the relevant policies and procedures may be delayed in the review process.

Note on Budget:

The Exposure Biology Program investigators will be expected to attend Steering Committee meetings two times per year. Funds for travel and per diem expenses for the key investigators to attend these meetings should be included in the application budget.

Section V. Application Review Information


1. Criteria 

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

The following will be considered in making funding decisions:

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NCI and NHLBI in accordance with the review criteria stated below.

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

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.

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

The reasonableness of the data sharing plan or the rationale for not sharing research data will 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 presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

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/archive/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.

Model Organism Sharing Plan:  Reviewers are asked to assess the sharing plan in an administrative note. The sharing plan itself should be discussed after the application is scored. Whether a sharing plan is reasonable can be determined by the reviewers on a case-by-case basis, taking into consideration the organism, the timeline, the applicant's decision to distribute the resource or deposit it in a repository, and other relevant considerations.

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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/archive/grants/policy/nihgps_2003/index.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 12 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/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable Office of Management and Budget (OMB) administrative guidelines, Department of Health and Human Services (HHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement (U01), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility reside with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The following Terms of Award apply to cooperative agreements that will be funded under RFA-CA-07-032 “Improved Measures of Diet and Physical Activity for the Genes and Environment Initiative (GEI) (U01),” which is one of five RFAs that define the scope of the Exposure Biology Program of the NIH-wide Genes and Environment Initiative (GEI); the Exposure Biology Program is led by the National Institute of Environmental Health Sciences (NIEHS).

2.A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their studies. The Principal Investigator will agree to accept close coordination, cooperation and management of the project as described under “NIH Responsibilities.” Specifically, the Principal Investigator will:

2.A.2. NIH Responsibilities

An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

An NIH Project Scientist will be assigned to administer each of the awarded U01 projects.  This staff member will be a scientist from the staff of any of the participating NIH institutes selected because of relevant scientific content-area expertise and experience with regard to the scientific goals and objectives of a given U01 award. Project Scientists will have substantial scientific and programmatic involvement during the conduct of this activity through technical assistance, advice, and coordination. 

The role of these Project scientists and other NIH staff members will be to facilitate and not to direct the activities of the Steering Committee.  It is anticipated that decisions in all matters will be reached by consensus of the GEI Diet and Physical Activity Steering Committee and that NIH will be given the opportunity to offer input into this process.  There will be no more than four NIH Project Scientists participating as members of the Steering Committee, who will collectively have only one NIH vote, reached by consensus.  The Project Scientists will have the following substantial involvement:

Additionally, an NIH Program Director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the NoA. The Program Director will closely monitor progress of assigned grants and recommend the withholding or reduction of support from any project that fails to achieve its goals or comply with the Terms and Conditions of award. The Program Director may also serve as one of the Project Scientists.

2.A.3. Collaborative Responsibilities

All involved investigators will meet two times a year in order to share information.  Key co-investigators and pre- and post-doctoral trainees, in addition to the Principal Investigators, are eligible to attend these meetings. Close interaction among the participating investigators will be required, as well as significant involvement from the NIH to develop and monitor GEI Diet and Physical Activity Assessment Program milestones and timelines for product development, field testing, and validation in order to meet the overall goals of the Genes and Environment Initiative. 

The GEI Diet and Physical Activity Assessment Steering Committee will serve as the governing board for the Cooperative Agreements made in response to this FOA.  Membership of the Steering Committee will consist of the Principal Investigator of each U01 award and not more that four NIH Project Scientists.  Each Principal Investigator will have one vote, whereas the NIH Projects Scientists will collectively have one NIH vote, reached by consensus. The chair of the Steering Committee will be selected from among the members by vote.  If more than four NIH Project Scientists are assigned to the grants, their Steering Committee membership will be rotated so as not to exceed the limit of four NIH members.

The GEI Diet and Physical Activity Assessment Steering Committee will meet physically two times a year and monthly by means of conference calls. The roles and responsibilities of the Steering Committee include:

2.A.4. Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

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 F. Subar, Ph.D., M.P.H., R.D.  
Applied Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Plaza Boulevard, EPN Room 4012, MSC 7344
Bethesda, MD 20892-7344
Telephone: (301) 594-0831
Fax: (301) 435-3710
Email: subara@mail.nih.gov

Catherine (Cay) Loria, Ph.D.
Clinical Applications and Prevention Branch

Division of Prevention and Population Sciences
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

2. Peer Review Contacts:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery; non-USPS service)
Telephone:  (301) 496-3428
Fax:  ( 301) 402-0275
Email:  ncirefof@dea.nci.nih.gov

3. Financial or Grants Management Contacts:

Crystal Wolfrey
Office of Grants Administration
National Cancer Institute
6120 Executive Boulevard, EPS Suite 243, MSC 7150
Bethesda, MD 20892-7150 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery; non-USPS service)

Telephone: (301) 496-8634
Fax: (301) 496-8601
Email: crystal.wolfrey@nih.gov

Section VIII. Other Information


Required Federal Citations

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

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

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); and efficacy, effectiveness, and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application in response to this FOA regardless of cost, 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 institutional review board (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.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time, the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh-Dole Act (see the NIH Grants Policy Statement at http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004, receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

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.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

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://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/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. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for 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 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.

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% 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.


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