RFA Number: RFA-HL-04-022

Part I Overview Information

Department of Health and Human Services

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

Announcement Type: New

Updates: The following updates relating to this announcement have been issued:

• August 22, 2006 - This RFA has been reissued as RFA-HL-07-007.

Catalog of Federal Domestic Assistance Number(s): 93.837, 93.866, 93.286, 93.847, 93.848, 93.393, 93.399

Key Dates
Release Date: September 20, 2004
Letters Of Intent Receipt Date: January 17, 2005
Application Receipt Dates: February 16, 2005
Peer Review Date: June/July 2005
Council Review Date: September, 2005
Earliest Anticipated Start Date: September 30, 2005
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: February 17, 2005

Due Dates for E.O. 12372 Not Applicable

Executive Summary

The purpose of this RFA is to solicit applications to develop and validate new and innovative bioengineering technology to address clinical problems related to energy balance, intake, and expenditure. Novel sensors, devices, imaging, and other approaches are expected to be developed and evaluated by collaborating engineers, physical scientists, and scientists from other relevant disciplines with expertise in obesity and nutrition. Basic and applied research applications with rigorous hypothesis-testing designs 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.

This funding opportunity will use the NIH R01 and R21 award mechanisms

It is anticipated that approximately $4.75 million dollars will be committed in FY 05 to fund 8-12 new and/or competitive continuation grants in response to this RFA.

Applications may be submitted by any individual with the skills, knowledge, and resources necessary to carry out the proposed research. Eligible domestic and foreign institutions/organizations include for-profit or non-profit; public or private; Units of State and local governments; eligible agencies of the Federal government; and faith-based or community-based organizations Application materials are available at http://grants.nih.gov/grants/funding/phs398/phs398.html.

Telecommunications for the hearing impaired: TTY 301-435-0088.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

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

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

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Arbitration Process
3. Award Criteria
4. 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

The purpose of this RFA is to solicit applications to develop and validate new and innovative bioengineering technology to address clinical problems related to energy balance, intake, and expenditure. Novel sensors, devices, imaging, and other approaches are expected to be developed and evaluated by collaborating engineers, physical scientists, and scientists from other relevant disciplines with expertise in obesity and nutrition. Basic and applied research applications with rigorous hypothesis-testing designs 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, 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.

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 is difficult.

To overcome the limitations of current methods to assess energy balance and control weight, innovative approaches are needed. The problems associated with measuring and monitoring components of human energy balance present unique opportunities for engineers with expertise in the disciplines of thermodynamics, mechanics, heat transfer, instrumentation, imaging, and design. By collaborating with obesity researchers, such engineers, especially those with biomedical backgrounds, 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 RFA is to encourage and enable bioengineering teams 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, human and animal nutrition, aging, exercise sciences, behavioral sciences, medicine, biochemistry, and biotechnology.

Basic and applied research applications with rigorous hypothesis-testing designs are encouraged.

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

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

• Diagnostic and therapeutic systems to monitor energy balance and appropriate biomarkers. Such systems may be used to provide appropriate feedback to stimulate behavior change or to administer appropriate agents.
• Biosensors, including intra- and extra-cellular systems, for measuring calorie consumption and energy expenditure. Sensors that are non-invasive, minimally invasive, miniature, stable, and durable.
• Mathematical and computational models for predicting interrelationships between energy balance and weight control or obesity.
• Implantable devices for monitoring and treating obesity and overweight.
• Bioengineering tools that integrate self-reported information with biologic and/or sensor measures of physical activity, diet/nutrition, and energy balance/obesity. This would include tools that measure this integrated information in real-time.
• Methodologies for imaging structure and function, blood flow, perfusion, and metabolism from the molecular/cellular to whole organs for the purpose of measuring and studying energy balance, intake and expenditure, and weight control.
• Miniaturized non-invasive sensors to detect motion, thermal output, pressure/other mechanical forces, body position, geophysical location.
• Energy balance indicators, such as smart clothing, household or office furnishings, that incorporate sensors, bar codes or other identifying technologies to calculate energy expenditure, detect motion, identify food characteristics, and assess portion sizes.
• Development of sensors to continuously measure physiological parameters/biomarkers which regulate or reflect appetite and metabolism (e.g. insulin, leptin, vagus nerve activity).
• Identification of new and accurate biomarkers that correlate with energy expenditure, calorie intake, physical activity, or total energy balance, and sensors to detect levels of these biomarkers, inasmuch as output from such sensors would provide needed feedback measures.

Special Requirements

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 RFA:

• Devices and technologies related to the performance of bariatric surgery;
• Basic investigations of cellular biochemistry and physiology of obesity;
• Development of medical devices to deliver agents to suppress appetite and/or increase metabolism, as needed, based on sensor input;
• Epidemiological studies to evaluate the efficacy of existing devices;
• Studies whose primary focus is efficacy of behavioral, surgical, or pharmacologic treatment of obesity.

This funding opportunity will use the NIH R01 and R21 award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format described in the PHS 398 application instructions. Otherwise follow the instructions for non-modular research grant applications.

This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is September 30, 2005. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated applications using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application.

The participating ICs, NHLBI, NIA, NIBIB, NIDDK and NCI, intend to commit approximately $4.75 million dollars in FY 05 to fund 8-12 new and/or competitive continuation grants in response to this RFA. An applicant for an R01 grant may request a project period of up to 4 years and a budget for direct costs of up to $500,000 per year. An applicant for an R21 grant may request a project period of up to 2 years with a combined budget for direct costs of up $275,000 for the two-year period. For example, the applicant may request $100,000 in the first year and $175,000 in the second year. The request should be tailored to the needs of the project. Normally, no more than $200,000 in direct costs may be requested in any single year.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the ICs 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. Fiscal and administrative costs are not included in the direct cost limitation, see NOT-OD-04-040.

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

• For-profit or non-profit
• Public or private institutions, such as universities, colleges, hospitals, and laboratories
• Units of State government
• Units of local government
• Eligible agencies of the Federal government
• Domestic and foreign institutions/organizations
• Faith-based or community-based organizations

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants2.nih.gov/grants/policy/nihgps_2001/part_i_1.htm

3. Other-Special Eligibility Criteria

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].

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

Applications must be received on or before the receipt date listed below.

3.A. Receipt, Review and Anticipated Start Dates

Letters Of Intent Receipt Date: January 17, 2005
Application Receipt Dates: February 16, 2005
Peer Review Date: June/July 2005
Council Review Date : September, 2005
Earliest Anticipated Start Date: September 30, 2005

3.A.1. Letter of Intent

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

• Descriptive title of proposed research
• Name, address, and telephone number of the Principal Investigator
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Valerie Prenger, Ph.D.
Chief, Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Two Rockledge Center
Bethesda, MD 20892-7924 (Express 20817)
Telephone: (301) 435-0270
Fax: (301) 480-0730
Email: [email protected]

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

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

Valerie Prenger, Ph.D.
Chief, Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Two Rockledge Center
Bethesda, MD 20892-7924 (Express 20817)
Telephone: (301) 435-0270
Fax: (301) 480-0730
Email: [email protected]

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/label-bk.pdf.

6. Other Submission Requirements

Grantees Meetings

The sponsoring ICs will hold annual meetings to encourage exchange of information among the investigators who have received grant awards under the aegis of this RFA. In their budgets, applicants should include funds for annual one-day grantees meetings, which most likely will be held in Bethesda, Maryland. Applicants should also include a statement in their applications indicating their willingness to participate in these meetings. The first such meeting likely will take place approximately 6 months after award.

General Clinical Research Center (GCRC)

Applicants from institutions that have a GCRC funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or the GCRC principal investigator should be included with the application.

Specific Instructions for Modular Grant applications.

Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

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

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

• Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.
• Receive a written critique
• Receive a second level of review by the NHLBI, NIA, NIBIB, NIDDK, or NCI Advisory Councils.

3. Merit Review Criteria

The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application.

• Significance
• Approach
• Innovation
• Investigator
• Environment
• Additional Review Criteria

The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field?

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

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed.

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.

There is no requirement to share research resources

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

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

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The notice of award signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Notification will be made electronically to the designated administrative/ institutional official.

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

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

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.

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:

Abby G. Ershow, Sc.D.
Nutrition Program Officer
Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute
Two Rockledge Center, Suite 10-193, MSC 7956
6701 Rockledge Drive
Bethesda, MD 20892-7956 (Express 20817)
Phone (301) 435-0550
Fax (301) 480-2858
Email: [email protected]

Tim Baldwin, Ph.D.
Biomedical Engineer
Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute
Two Rockledge Center, Room 9051, MSC 7956
6701 Rockledge Drive
Bethesda, MD 20892-7956 (Express 20817)
Phone (301) 435-0513
Fax (301) 480-1335
Email: [email protected]

NIBIB

Peter Moy, Ph.D.
Division of Discovery Science and Technology
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Boulevard, Suite 200, MSC 5469
Bethesda, MD 20892-5469 (Express 20817)
Phone: 301-451-4772
Fax: 301-480-1614
Email: [email protected]

NIDDK

Maren R. Laughlin, Ph.D.
Senior Advisor for Integrative Metabolism
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd, Room 6101
Bethesda, Maryland 20895 (Express 20817)
301-594-8802
FAX 301-480-3503
Email: [email protected]

NCI

Sharon Ross, Ph.D.
Program Director
Nutritional Sciences Research Program
Division of Cancer Prevention
National Cancer Institute
6130 Executive Boulevard, Room EPN-3157
Bethesda, MD 20892-7328
301-594-7547
FAX 301-480-3925
Email: [email protected]

Audie A. Atienza, Ph.D.
Division of Cancer Control & Population Sciences
National Cancer Institute
6130 Executive Boulevard, Room EPN-4074A
Bethesda, MD 20892-7335
Phone: 301-402-8426
Fax: 301-480-2087
Email: [email protected]

NIA

Winifred K. Rossi, M.A.
Special Assistant for Planning
Geriatrics and Clinical Gerontology Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 3C307
Bethesda, MD 20892-9205 (Express: 20814)
Telephone: 301-496-3836
Fax: 301-402-1784
Email: [email protected] or [email protected]

Valerie Prenger, Ph.D.
Chief, Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Two Rockledge Center
6701 Rockledge Drive
Bethesda, MD 20892-7924 (Express: 20817)
Telephone: (301) 435-0270
Fax: (301) 480-0730
Email: [email protected]

Mr. Edward (Gene) McGeehan
Grants Operations Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Two Rockledge Center
6701 Rockledge Drive, Suite 7142, MSC 7926
Bethesda, MD 20892-7926 (Express 20817)
Telephone: (301) 435-0177
FAX: (301) 480-0422
Email: [email protected]

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) 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, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

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 that is available at http://grants.nih.gov/grants/funding/children/children.htm.

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH 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.

Public Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

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

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.

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

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

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.

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