Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)
National Science Foundation (NSF) (http://www.nsf.gov)

Components of Participating Organizations
National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov)
National Institute on Aging (NIA) (http://www.nia.nih.gov)
National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov)
National Cancer Institute (NCI) (http://www.nci.nih.gov)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov)

Title: Bioengineering Approaches to Energy Balance and Obesity (R21)

Announcement Type
This is a reissue with modifications of RFA-HL-04-022, which was previously released September 20, 2004.

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission, and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Request For Applications (RFA) Number: RFA-HL-07-007

Catalog of Federal Domestic Assistance Number(s)
93.837, 93.286, 93.393, 93.866, 47.041, 93.848

Key Dates
Release/Posted Date: August 22, 2006
Opening Date: October 22, 2006 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): November 24, 2006
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Submission/Receipt Date(s): December 22, 2006
Peer Review Date(s): June-July, 2007
Council Review Date(s): August 2007
Earliest Anticipated Start Date(s): September 30, 2007
Additional Information: http://www.nhlbi.nih.gov/
Expiration Date: December 23, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

The purpose of this FOA is to solicit applications to develop and validate new and innovative engineering approaches to address clinical problems related to energy balance, intake, and expenditure. Novel sensors, devices, imaging, and other technologies, including technologies to detect biochemical markers of energy balance, are expected to be developed and evaluated by collaborating engineers, physical scientists, mathematicians, and scientists from other relevant disciplines with expertise in obesity and nutrition. Basic and applied scientific applications with rigorous hypothesis-testing designs or for design-directed research are encouraged. The goal is to increase the number of useful technologies and tools available to scientists to facilitate their research in energy balance and health. Eventually these research tools should facilitate therapeutic advances and behavioral changes to address such problems as weight control and obesity.

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
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

The purpose of this FOA is to solicit applications to develop and validate new and innovative engineering approaches to address clinical problems related to energy balance, intake, and expenditure. Novel sensors, devices, imaging, and other technologies, including technologies to detect biochemical markers of energy balance are expected to be developed and evaluated by collaborating engineers, physical scientists, mathematicians, and scientists from other relevant disciplines with expertise in obesity and nutrition. Basic and applied scientific applications with rigorous hypothesis-testing designs or for design-directed research are encouraged. The goal is to increase the number of useful technologies and tools available to scientists to facilitate their research in energy balance and health. Eventually these research tools should facilitate therapeutic advances and behavioral changes to address such problems as weight control and obesity.

Background

Public Health Need

Obesity is a problem of energy balance, wherein adipose tissue stores accumulate to excess levels when expenditure does not keep up with intake. At present, approximately 65% of American adults are either overweight (=25 kg/m2) or obese (=30 kg/m2), and approximately 15% of American children are similarly categorized (by age-adjusted percentiles of weight for height). This situation reflects the high-energy efficiency of American life, where little physical effort is needed for work and recreation, and where the national diet is abundant in low-cost, energy-dense food. Popular approaches to weight control have been generally unsuccessful, despite constant publicity about the problem and considerable individual efforts at weight loss.

The health consequences of obesity (e.g., diabetes, cancer, heart disease) are predicted to grow worse. Type 2 diabetes rates are rising in adults and children, and a substantial increase in morbidity and mortality from cardiovascular disease is expected. Furthermore, obesity has been linked to the development of several types of cancer. Ultimately, resolution of the obesity epidemic at the population level will depend on individual behavioral change that takes place within the larger societal environment. Such changes may be facilitated through better medical therapies. However, technologies and tools to more easily monitor behavior and achieve treatment goals are also needed.

Conversely, inadvertent weight loss (cachexia) is also of high concern, particularly in the aging population. Cachexia represents a situation of persistent negative energy balance that often is accompanied by disproportionate loss of muscle tissue, weakness, and steady deterioration of physical function. Aged individuals are less likely than younger persons to be able to restore body weight after a period of impaired intake, perhaps due to aging-related blunting of compensatory effects on appetite. Overall, little is known about how best to reverse cachexia once it develops; methods for detecting the onset of such periods would be useful. Cachectic states also are common among patients with advanced stages of chronic diseases such as heart failure, chronic obstructive pulmonary disease, and cancer.

Aging poses additional interesting questions related to energy balance and its assessment. When studying these, one must distinguish between the normal biology of aging, as opposed to age-associated ailments that are part of the health and social experience of the aged population. Even relatively healthy, high-functioning individuals will experience age-related declines in metabolic rate, muscle mass, energy intake, and energy expenditure. However, many aged individuals are characterized by existing poor function, an ever-increasing propensity to adverse unpredictable events (such as falls and sudden illness), and impaired response to such events. Prediction of the propensity to such events, and detection of early stages of impaired adaptive responses, is needed in order to preserve functional capacity.

Clearly, the ability to measure states of energy balance and its various components, such as dietary intake, resting metabolism, and physical activity, is a critical public health need. However, this is remarkably difficult to achieve in satisfactory fashion, and the inconvenience, expense, and relative inaccuracy of current methods are a persistent and serious barrier to progress. Engineering approaches have the potential to overcome these limitations, but represent a relatively untapped area of scientific expertise for tackling the research issues and practical aspects of the obesity epidemic. Emerging technologies, such as nanotechnology, also offer unique opportunities for interfacing with engineering approaches to help address some of the problems in obesity research.

The Engineering Approach

The research proposed in response to this FOA is expected to follow an engineering approach to substantially address the problems of measuring and assessing energy balance to better understand, treat, and prevent obesity. The Engineering Approach is a powerful method which involves the application of knowledge of physical and biological sciences and mathematics to address specific practical problems, in this case energy balance and obesity. The approach incorporates the following elements in a systematic way:

As illustrated by these elements, the Engineering Approach offers the capability to create physics-based mathematical models and validated physical simulations based on empirical evidence which can ultimately be applied to design useful devices and processes.

Challenges in Measuring Energy Balance

Assessment of human energy balance, the net difference between energy intake (by diet) and expenditure (by work and heat), is a key component of obesity research, prevention, and treatment. The importance of accurate measurement of states of energy balance can be appreciated by considering average weight gain in middle-aged adults (~10 lb/decade). This significant gain in weight results from very small, persistent excesses of intake over expenditure of approximately 0.3% of the daily calorie consumption. This imbalance is well below the level of perception for most individuals. Similarly, energy expenditure from physical activity must be quantified accurately in order to understand the dose effects of exercise on body weight and other aspects of health, such as blood pressure. Weight loss programs often include ~5% increments of expenditure and ~20% decrements of intake. Research on the degree of increased activity or dietary changes that include energy reduction necessary for weight loss suggests that objective measurable differences can be undetectable, even if reported behavior varies between groups. At present, apart from body weight, objective measures of achievement of behavioral goals related to weight control are difficult.

To overcome the limitations of current methods to assess energy balance and control weight, innovative effective approaches are needed. The problems associated with measuring and monitoring components of human energy balance present unique opportunities for engineers and physical scientists with expertise in the disciplines of thermodynamics, mechanics, heat transfer, instrumentation, imaging, and design. By collaborating with obesity researchers, such engineers and scientists may develop the novel approaches to successfully address the problem of obesity.

Each component of the energy balance equation presents unique challenges. For example, the difficulty of ascertaining food intake with acceptable levels of accuracy is well known to nutritionists. The standard self-report questionnaire and recall techniques can provide valuable data on dietary patterns, and have been improved by electronic information technologies and by judicious use of results from cognitive process research. Nevertheless, these techniques are time-consuming and inconvenient. Furthermore, considerable under-reporting of total energy intake is typical, with this error more severe in overweight than non-overweight individuals. At the other extreme of precision and cost is the research technique (also occasionally used in therapeutic situations) of providing a controlled diet with all food intake observed and defined by chemical analysis. Use of these techniques is severely limited by their high cost and limited applicability because of the population samples typically enrolled and the highly controlled conditions used. Therefore, new and improved methods of determining energy intake are critically needed for research as well as practical purposes.

Measuring the various modes of physical activity is difficult as well, particularly outside the laboratory. Devices must be convenient, cost-effective, suitable for short-term and habitual activity, and valid for an array of circumstances and states of health and fitness. None of the available methods (pedometers, accelerometers, electronic load transducers, foot contact time monitors, heart rate monitoring) is fully satisfactory, because they only capture a fraction of needed information. They do not yield data that are easily understood, particularly by the lay public, nor can they easily detect changes in behavior, except for the pedometer, which yields data in terms of steps and can foster behavior change (i.e., more walking). In addition, the data yielded by these devices do not readily translate into calories expended over the entire course of a day, which must be compared with energy from food intake to obtain an estimate of energy balance. Therefore, there is a problem of inter-converting measurements of energy expenditure and intake into the same units as food intake.

Assessment of states of total energy balance also is a critical research need. Recently improved research tools include small or portable indirect calorimeters for short-term expenditure measurements during physical tasks, room calorimeters with floor mounted force plates to study movement energetics, and global positioning system (GPS) transponders to track outdoor activity patterns. Doubly-labeled water is valuable for determining total expenditure but is expensive, involves stable isotopes, and only is suitable for basic research. Nevertheless, we need to be able to accurately, precisely, and directly measure whether an individual is in energy balance, deficit, or excess, and to translate the results into everyday behavior. The overall state of body energy stores also cannot be easily ascertained, particularly at the individual level, because data outputs are usually based on group-derived algorithms. However, there has been some recent progress in techniques used to estimate energy stores (e.g., bioelectric impedance for percent body fat, MRI-quantified adipose depots to define metabolically active compartments).

Such imaging and sensor technologies will also be beneficial to the elderly. In this population, such tools are needed to assess rates of change in total energy intake, balance, and expenditure, and in the size and function of multiple metabolic compartments (especially muscle mass), over relatively long intervals and in response to rare but cumulative events. These technologies need to be able to distinguish between changes related to the physiological process of aging, as opposed to age-associated ailments and other changes reflecting the health and social experience of the aged population. Any methodology used for the elderly population must accommodate a spectrum of functioning ranging from the unusually fit, to typical level, to the frail. Also, the information gathered should be translatable to research and/or practical applications related to preservation or impairment of ability to undertake activities of daily living. Assessment techniques and data analysis methods need to be able to distinguish between true capacity vs. elicited performance; these are highly variable among the aged, and are unusually susceptible to measurement biases and errors. Human factors issues are particularly important for the elderly population, and must acknowledge participant burdens related to time (including that of caregivers/assistants), transportation, cognitive capacity and effort, discomfort, and physical capabilities (such as vision, hearing, strength, mobility).

In conclusion, most techniques for measuring either side of the energy equation are costly, cumbersome, and suitable primarily for research use. They do not address the critical issue of overall energy balance, nor do they take advantage of new knowledge of biochemical markers. Moreover, the available devices are not sufficiently precise or specific for guiding individual behavior, and their measurement errors may be greater than the treatment effect. Devices designed for use by the public are particularly hampered by these problems. At present, we do not have the equivalent of a "magic wristwatch" that can readily convey whether the wearer has exceeded an intake goal or fallen short on expenditure. New approaches might provide accurate, convenient, easily understood, and inexpensive devices to foster research and improve clinical management of adults and children.

The greatest scientific need is for improved ways to achieve short- and long-term measurement of total energy intake, expenditure, exchange, and balance, and components thereof (e.g., resting and basal metabolic rate, physical activity, thermic effect of food) under various physiologic conditions and activities, including work, sleep, and leisure activity, and related body composition and metabolic compartments. The use of micro-electro-mechanical systems for biomedical applications (BioMEMs) to measure appropriate biomarkers of energy balance may be of great benefit to assessing energy balance. Since many materials exhibit novel and unique properties at the nano level, their use might represent a new approach for precise measurements of energy status and metabolic activity.

Summary of Priority Areas

In summary, the objective of this FOA is to encourage and enable teams of engineers and scientists to develop and evaluate new technologies, instrumentation, and medical devices to better assess appropriate biomedical parameters and provide feedback and/or therapy to reduce the prevalence of obesity and overweight. Development of new technologies and application of existing technologies may be proposed. Examples of relevant technologies include, but are not limited to, imaging, diagnostic and therapeutic devices, direct and remote sensors, meters, micro-transmitters, and biomaterials. Studies may include use of animal models and/or human participants, but are not required to do so. If appropriate, plans for manufacturing and clinical evaluation of developed instrumentation and medical devices should be included in the application.

Applications are encouraged that represent scientific and technical expertise and collaborations from fields such as biomedical engineering, computer sciences, physics, mathematics, statistics, human and animal nutrition, aging, exercise sciences, behavioral sciences, medicine, biochemistry, and biotechnology.

Basic and applied scientific applications with rigorous hypothesis-testing designs or for design-directed research are encouraged.

All grant applications submitted in response to this FOA should include sample size and statistical power calculations appropriate to the proposed study design.

Appropriate topics for research, development, and/or validation under this FOA include, but are not limited to, the following:

Special Requirements

All grant applications submitted in response to this FOA should include sample size and statistical power calculations appropriate to the proposed study design.

Exclusions

Certain types of investigations, although potentially of scientific interest, will not be considered for support by this program.

Applications proposing the following types of studies will be considered non-responsive to the FOA:

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

Section II. Award Information


1. Mechanism of Support

This Funding Opportunity Announcement (FOA) will use the Exploratory/Developmental Research Grant (R21) award mechanism. The applicant will be solely responsible for planning, directing, and executing the proposed project. This FOA uses Just-in-Time information concepts.

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 Institutes and Centers (ICs) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

The total project period for an application submitted in response to this funding opportunity may not exceed 3 years. Although the size of award may vary with the scope of research proposed, it is expected that applications will stay within the budgetary guidelines for an exploratory/developmental project. Direct costs are limited to $450,000 over a three-year period, with no more than $150,000 in direct costs allowed in any single year.

The participating organizations (NHLBI, NCI, NIA, NIBIB, NIDDK, and NSF) intend to commit approximately $3,050,000 dollars in FY2007 to fund 10-15 applications.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, November 2, 2004.

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 as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization 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

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Applicants may submit more than one application, provided each application is scientifically distinct.

Section IV. Application and Submission Information


To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

PD/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1. Organizational/Institutional Registration in Grants.gov/Get Started

2. Organizational/Institutional Registration in the eRA Commons

3. Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the federal government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo: Telephone 301-710-0267, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

Required Components:

SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Budget

PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist

Optional Components:

PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

Note: While both budget components are included in the SF424 (R&R) forms package, this NIH R21 uses ONLY the detailed Research & Related Budget. (Do not use the PHS 398 Modular Budget.)

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. Submission, Review, and Anticipated Start Dates

Opening Date: October 22, 2006 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): November 24, 2006
Application Submission/Receipt Date(s): December 22, 2006
Peer Review Date(s): June-July 2007
Council Review Date(s): August 2007
Earliest Anticipated Start Date(s): September 30, 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 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:

Chief, Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Two Rockledge Center, Room 7214
6701 Rockledge Drive
Bethesda, MD 20892-7924 (Express 20817)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: NHLBIchiefreviewbranch@nhlbi.nih.gov

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

In order to expedite the review, applicants are requested to notify the NHLBI Referral Office by email NHLBIchiefreviewbranch@nhlbi.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

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.

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.

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 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.

6. Other Submission Requirements

All applications are expected to include in the Background and Significance section of the Research Plan component a section specifically labeled Broader Impact and addressing the Broader Impact merit review criterion described below in Section V.2 (Application Review Information Review and Selection Process). Please see examples at: http://www.nsf.gov/publications/pub_summ.jsp?ods_key=gpg

All applications are expected to include statistical power and sample size calculations as appropriate to the study design and the research questions under investigation.

All application budgets should include funds for the Principal Investigator to attend an annual grantees meeting in the Washington DC area.

The NIH requires the PD/PI to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Registration FAQs Important Tips -- Electronic Submission of Grant Applications.

Warning: Please be sure that you observe the direct cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.

Research Plan Component Sections

While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

Application Characteristics

All application instructions outlined in the SF424 (R&R) application are to be followed, with the following requirements for R21 applications:

Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

Appendix Materials

The following additional materials may be included in the Appendix:

Do not 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.

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.

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.

All 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 should include a description of how final research data will be shared, or explain why data sharing is not possible.

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.

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 http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). 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.

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

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

Additionally, NSF staff will give careful consideration to the following in making funding decisions:

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. 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 scientific health 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 PD/PI 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?

Broader Impact: What are the broader impacts of the proposed activity? How well does the activity advance discovery and understanding while promoting teaching, training, and learning? How well does the proposed activity broaden the participation of underrepresented groups (e.g., gender, ethnicity, disability, geographic, etc.)? To what extent will it enhance the infrastructure for research and education, such as facilities, instrumentation, networks, and partnerships? Will the results be disseminated broadly to enhance scientific and technological understanding? What may be the benefits of the proposed activity to society?

http://www.nsf.gov/publications/pub_summ.jsp?ods_key=gpg

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 item 6 of the Research Plan component of the SF424 (R&R).

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 item 7 of the Research Plan component of the SF424 (R&R).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under item 11 of the Research Plan component of the SF424 (R&R) will be assessed.

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. Is the number of person months listed for the effort of the PD/PI appropriate for the work proposed? Is each budget category realistic and justified in terms of the aims and methods?

2.C. Sharing Research Data

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. 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 http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). 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 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), 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/her Summary Statement (written critique) via the NIH 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.

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.

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 Section IV.5., Funding Restrictions.

2. Administrative and National Policy Requirements

N/A

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually 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:

NHLBI

Abby G. Ershow, Sc.D.
Nutrition Program Officer
National Heart, Lung, and Blood Institute
Two Rockledge Center, Suite 10-193, MSC 7956
6701 Rockledge Drive
Bethesda, MD 20892-7956 (Express 20817)
Telephone: (301) 435-0550
Fax (301) 480-2858
Email: ErshowA@mail.nih.gov

Timothy Baldwin, Ph.D.
Biomedical Engineer
National Heart, Lung, and Blood Institute
Two Rockledge Center, Room 9051, MSC 7940
6701 Rockledge Drive
Bethesda, MD 20892-7956 (Express 20817)
Telephone: (301) 435-0513
Fax (301) 480-1335
Email: BaldwinT@mail.nih.gov

NSF

Patrick Phelan, Ph.D.
Program Director
Thermal Transport and Thermal Processing Program
Directorate for Engineering
The National Science Foundation
Telephone: (703) 292-8371
Email:
pphelan@nsf.gov

William Schultz, Ph.D.
Program Director, Fluid Dynamics and Hydraulics
Chemical and Transport Systems Division
National Science Foundation
4201 Wilson Blvd.
Arlington, VA 22230
Telephone: (703) 292-8371
Fax: (703) 292-9054

Semahat Demir, Ph.D.
Program Director
Biomedical Engineering & Research to Aid Persons with Disabilities (BME/RAPD)
Division of Bioengineering and Environmental Systems
National Science Foundation
4201 Wilson Blvd. Suite 565
Arlington, VA 22230
Telephone: (703) 292-7950
Fax: (703) 292-9098|
Email:
sdemir@nsf.gov

NIBIB

Brenda Korte, Ph.D.
Program Director
Division of Discovery Science and Technology
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Blvd., Suite 200, MSC 5469
Bethesda, MD 20892-5469 (Express 20817)
Telephone: (301) 451-4778
Fax (301) 480-0675
Email: kortebr@mail.nih.gov

NCI

Sharon Ross, Ph.D.
Program Director, Nutritional Sciences Research Program
National Cancer Institute
6130 Executive Blvd., Room EPN-3157, MSC 7328
Bethesda, MD 20892- 7328 (Express 20817)
Telephone: (301) 594-7547
Fax (301) 480-3925
Email: sr75k@nih.gov

NIDDK

Maren Laughlin, Ph.D.
Senior Advisor for Integrative Metabolism
National Institute of Diabetes and Digestive and Kidney Diseases
2 Democracy Plaza, Rm. 6101
Bethesda, MD 20892 (Express 20817)
Telephone: (301) 594-8802
Fax (301) 480-3925
Email: ml33q@nih.gov

NIA

Winnie Rossi, M.A.
Special Assistant for Planning, Geriatrics and Clinical Gerontology Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 3C307, MSC 9205
Bethesda, MD 20892- 9205 (Express 20817)
Telephone: (301) 496-3836
Fax (301) 402-1784
Email: rossiw@nia.nih.gov

2. Peer Review Contacts:

Chief, Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Two Rockledge Center, Room 7214
6701 Rockledge Drive
Bethesda, MD 20892-7924 (Express 20817)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: NHLBIchiefreviewbranch@nhlbi.nih.gov

3. Financial or Grants Management Contacts:

Ms. Mary Baylor
Grants Operations Branch
National Heart, Lung, and Blood Institute
6701 Rockledge Drive MSC 7926
Bethesda, MD 20892
Telephone: (301) 435-0177
Fax: 301-480-3310
Email: baylorm@nhlbi.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 (45 CFR 46) 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); 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 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.

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. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal 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 SF424 (R&R) application; 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: (1) 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 (2) 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://publicaccess.nih.gov/ and view the Policy or other Resources and Tools, including the Authors' Manual.

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 FOA 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 Part 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 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 two years to the research. For further information, please see: http://www.lrp.nih.gov.


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