and Human Services (HHS)
EXPIRED
Department of Health and Human
Services
Participating Organizations
National Institutes of Health
(NIH), ( http://www.nih.gov)
Components of Participating
Organizations
National
Heart, Lung, and Blood Institute (NHLBI), ( http://www.nhlbi.nih.gov)
National Institute of Biomedical Imaging and Bioengineering (NIBIB), (http://www.nibib.nih.gov)
National Institute of Diabetes and Digestive and Kidney Disorders (NIDDK) (http://www.niddk.nih.gov)
National Cancer Institute (NCI), (http://www.nci.nih.gov)
National Institute on Aging (NIA), (http://www.nia.nih.gov)
Title: Bioengineering Approaches to Energy Balance and Obesity (SBIR [R43/R44])
Announcement
Type
This is a reissue of PA-06-055 which was previously released November 25, 2005.
Updates: The following updates relating to this announcement have been issued:
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) SBIR/STTR 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.
Program Announcement (PA) Number: PA-07-435
Catalog of Federal Domestic Assistance Number(s)
93.837,
93.286, 93.393, 93.399, 93.866
Key Dates
Release/Posted Date: August
20, 2007
Opening Date: November 5, 2007 (Earliest date an application may be submitted
to Grants.gov)
Letters of Intent Receipt Date(s): Not applicable
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): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): Standard dates
apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply,
please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (URL
Activation Date): Not Applicable
Expiration Date: August 6, 2010
Due
Dates for E.O. 12372
Not Applicable
Additional Overview
Content
Executive
Summary
Table of Contents
Part
I Overview Information
Part
II Full Text of Announcement
Section
I. Funding Opportunity Description
1. Research Objectives
Section
II. Award Information
1. Mechanism of Support
2. Funds Available
Section
III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section
IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and
Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application
Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section
V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review
Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section
VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy
Requirements
A. Cooperative Agreement Terms and
Conditions of Award
1. Project
Director/Principal Investigator (PD/PI) Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative
Responsibilities
4. Arbitration Process
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
Applications are encouraged that represent scientific and technical expertise and collaborations from fields such as biomedical, mechanical, and electrical engineering, computer sciences, physics, human and animal nutrition, aging, exercise sciences, behavioral sciences, medicine, biochemistry, and biotechnology.
The purpose of this FOA 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. The goal is to increase the number of useful technologies and tools available to scientists to facilitate their research in energy balance and health and/or which can be used to improve weight control in the general population. Eventually these novel tools should facilitate therapeutic advances and behavioral changes to address such problems as weight control and obesity.
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 (greater than or equal to 25 kg/m2) or obese (greater than or equal to 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.
Challenged 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.
Research Topics
Research topics are intended to provide a perspective on the scope of research that would meet the objectives of this program. It is not required that all or any of these topics be included. Applicants are encouraged to consider other topics that are relevant to the goals of this FOA. Examples of research topics include:
See Section
VIII, Other Information - Required Federal Citations, for policies related
to this announcement.
Section
II. Award Information
1. Mechanism(s) of Support
This funding opportunity
will use the Small Business Innovation Research (SBIR [R43/R44] grant
mechanisms. Applications may be submitted for support as Phase I,
Phase II, or Fast-Track grants as described in the SF424 (R&R) SBIR/STTR
Application Guide.
Small
business concerns that have received a Phase I SBIR grant may apply for Phase
II funding of that project. The Phase II must be a
logical extension of the Phase I research but not necessarily as a Phase I
project supported in response to this funding opportunity. Phase II applications will
compete with all SBIR applications and will be reviewed according to the
customary peer review procedures.
The
applicant small business concern (SBC) will be solely responsible for planning,
directing, and executing the proposed project.
This
funding opportunity uses Just-in-Time information concepts. The modular
budget format is not accepted for SBIR grant applications. Applicants must
complete and submit budget requests using the SF424 Research and Related
(R&R) Budget component found in the application package attached to this
FOA in Grants.gov/Apply.
2. Funds Available
The SF424 (R&R) SBIR/STTR Application
Guide indicates the statutory guidelines of funding
support and project duration periods for Phase I and Phase II SBIR awards.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
Only United States small
business concerns (SBCs) are eligible to submit SBIR applications. A small
business concern is one that, at the time of award for both Phase I and Phase
II SBIR awards, meets all of the following criteria:
1. Is independently owned and operated, is not dominant in the field of operation in which it is proposing, has a place of business in the United States and operates primarily within the United States or makes a significant contribution to the US economy, and is organized for profit.
2. Is (a) at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, or (b) for SBIR only, it must be a for-profit business concern that is at least 51% owned and controlled by another for-profit business concern that is at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States.
3. Has, including its affiliates, an average number of employees for the preceding 12 months not exceeding
500, and meets the other regulatory requirements found in Title 13 Code of Federal Regulations (CFR) Part 121. Business concerns are generally considered to be affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both.
Control can be exercised through common ownership, common management, and contractual relationships. The term "affiliates" is defined in greater detail in 13 CFR 121.103. The term "number of employees" is defined in 13 CFR 121.106.
A business concern may be in the form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust, or cooperative. Further information may be obtained at http://sba.gov/size, or by contacting the Small Business Administration's (SBA) Government Contracting Area Office or Office of Size Standards.
One of the circumstances that would lead to a finding that an organization is controlling or has the power to control another organization involves sharing common office space and/or employees and/or other facilities (e.g., laboratory space). Access to special facilities or equipment in another organization is permitted (as in cases where the awardee organization has entered into a subcontractual agreement with another organization for a specific, limited portion of the research project). However, research space occupied by an SBIR awardee organization must be space that is available to and under the control of the SBIR awardee for the conduct of its portion of the proposed project.
Title 13 CFR 121.3 also states that control or the power to control exists when key employees of one concern organize a new concern... and serve as its officers, directors, principal stockholders, and/or key employees, and one concern is furnishing or will furnish the other concern with subcontracts, financial or technical assistance, and/or other facilities, whether for a fee or otherwise. Where there is indication of sharing of common employees, a determination will be made on a case-by-case basis of whether such sharing constitutes control or the power to control.
For purposes of the SBIR program, personnel obtained through a Professional Employer Organization or other similar personnel leasing company may be considered employees of the awardee. This is consistent with SBAs size regulations, 13 CFR 121.106 Small Business Size Regulations.
All SBIR grant applications will be examined with the above eligibility considerations in mind. If it appears that an applicant organization does not meet the eligibility requirements, NIH will request a size determination by the SBA. If eligibility is unclear, NIH will not make an SBIR award until the SBA provides a determination.
Note: An applicant organization that has been determined previously by SBA to be other than small for a size standard of not more than 500 employees or for purposes of the SBIR/STTR program, the organization must be recertified by the SBA prior to any future SBIR/STTR awards.
1.B. Eligible Individuals
Any
individual with the skills, knowledge, and resources necessary to carry out the
proposed research 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.
More than one PD/PI, or multiple PDs/PIs, may be designated on the application
for projects that require a team science approach that clearly does not fit
the single-PD/PI model. Additional information on the implementation plans and
policies and procedures to formally allow more than one PD/PI on individual
research projects is available at http://grants.nih.gov/grants/multi_pi . All PDs/PIs must be registered in the NIH eRA Commons prior to the submission
of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a single PD/PI or multiple PD/PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for multiple PD/PI grants will require additional information, as outlined in the instructions below. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PD/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
Under the SBIR program, for both Phase I and Phase II, the primary employment of the PD/PI must be with the small business concern at the time of award and during the conduct of the proposed project. For projects with multiple PD/PIs, at least one must meet the primary employment requirement. That individual will serve as the Contact PD/PI. Primary employment means that more than one half of the PD/PIs time is spent in the employ of the small business concern. Primary employment with a small business concern precludes full-time employment at another organization. Occasionally, deviations from this requirement may occur. Such deviations must be approved in writing by the grants management officer after consultation with the NIH SBIR/STTR Program Coordinator.
When the proposed PD/PI clearly does not have sufficient qualifications to assume this role, the application is not likely to receive a favorable evaluation.
If the application has the likelihood for funding, the awarding component will require documentation to verify the eligibility of the Contact PD/PI, if at the time of submission of the application, the Contact PD/PI is a less-than-full-time employee of the small business concern, is concurrently employed by another organization, or gives the appearance of being concurrently employed by another organization, whether for a paid or unpaid position.
If the Contact PD/PI is employed or appears to be employed by an organization other than the applicant organization in a capacity such as Research Fellow, Consultant, Adjunct Professor, Clinical Professor, Clinical Research Professor, or Associate, a letter must be provided by each employing organization confirming that, if an SBIR grant is awarded to the applicant small business concern, the Contact PD/PI is or will become a less-than-half-time employee of such organization and will remain so for the duration of the SBIR project. If the Contact PD/PI is employed by a university, such a letter must be provided by the Dean's office or equivalent; for other organizations, the letter must be signed by a corporate official.
All current employment and all other appointments of the Contact PD/PI must be identified in his or her Biographical Sketch required as part of the application. Be certain that correct beginning and ending dates are indicated for each employment record listed.
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 not simultaneously submit identical or essentially
identical applications under this funding opportunity and any other HHS FOA,
including the current SBIR and STTR Parent FOAs. The NIH will accept as many
"different" applications as the applicant organization chooses.
However, the NIH will not accept similar grant applications with essentially
the same research focus from the same applicant organization. This includes
derivative or multiple applications that propose to develop a single product,
process or service that, with non-substantive modifications, can be applied to
a variety of purposes. Likewise, identical or essentially identical grant
applications submitted by different organizations will not be accepted. Applicant
organizations should ascertain and assure that the materials they are
submitting on behalf of the principal investigator are the original work of the
principal investigator and have not been used elsewhere in the preparation and
submission of a similar grant application. Applications to the NIH are grouped
by scientific discipline for review by individual Scientific Review Groups and
not by disease or disease state. The reviewers can thus easily identify multiple
grant applications for essentially the same project. In these cases,
application processing may be delayed or the application(s) may be returned to
the applicant without review.
It is unlawful to enter into contracts or grants requiring essentially equivalent work or effort. Essentially equivalent work or effort occurs when (1) substantially the same research is proposed for funding in more than one contract proposal or grant application submitted to the same Federal agency; (2) substantially the same research is submitted to two or more different Federal agencies for review and funding consideration; or (3) a specific research objective and the research design for accomplishing an objective are the same or closely related in two or more proposals or awards, regardless of the funding source. If there is any question concerning essentially equivalent work or effort, it must be disclosed to the soliciting agency or agencies before award.
Only one Phase II award may be made for a single SBIR/STTR project.
You may submit a Phase II application either before or after expiration of the Phase I budget period, unless you elect to submit a Phase I and Phase II application concurrently under the Fast-Track procedure. To maintain eligibility to seek Phase II support, a Phase I grantee organization should submit a Phase II application within the first six receipt dates following the expiration of the Phase I budget period.
Section IV. Application and Submission Information
To download a SF424 (R&R)
Application Package and SF424 (R&R) SBIR/STTR Application Guide for
completing the SF424 (R&R) forms for this FOA, use the Apply for Grant
Electronically button in this FOA or 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:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.
Several additional separate actions are required before an applicant SBC 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.
To affiliate the PD/PI with the applicant small business concern:
Both the PD/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
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.
Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and the eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.
1. Request Application Information
Applicants must download
the SF424 (R&R) application forms and SF424 (R&R) SBIR/STTR Application
Guide for this FOA using the Apply for Grant Electronically button in this
FOA or 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: [email protected].
Telecommunications for the hearing impaired: TTY
301-451-5936.
2. Content and Form of Application Submission
Prepare all SBIR applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) SBIR/STTR Application Guide.
The SF424 (R&R) SBIR/STTR 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/PIs assigned eRA Commons User ID). Failure to include this data field will cause the application to be rejected.
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
SBIR/STTR
Information
Optional
Components:
PHS398
Cover Letter File
Research & Related Subaward Budget Attachment(s) Form
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs (see Section III.1.B), but has no other special roles or responsibilities within the project team beyond those mentioned above. For SBIR, the contact PI must be employed by the small business. All funding for SBIR projects goes to the small business awardee, so funding for PD/PIs from other organizations must be requested via a subcontract with the small business using the Research & Related Subaward Budget Attachment(s) Form.
Information for the Contact PD/PI should be entered in Item 13 of the SF424 (R&R) Cover component.All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI.Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission.The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component.Failure to include this data field will cause the application to be rejected.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan, must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts.The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
3. Submission Dates and Times
See Section
IV.3.A. for details.
3.A.
Submission, Review, and Anticipated Start Dates
Opening Date:November 5, 2007 (Earliest
date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not Applicable
Application
Submission/Receipt Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): Standard dates apply, please
see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s):
Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates
apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
3.A.1.
Letter of Intent
A letter of intent is
not required for the funding opportunity.
3.B. Submitting an
Application Electronically to the NIH
To submit an application in
response to this FOA, applicants may use the Apply
for Grant Electronically button in this FOA or link to http://www.grants.gov/applicants/apply_for_grants.jsp
and follow steps 1-4. Note: Applications must only be submitted
electronically.PAPER APPLICATIONS WILL
NOT BE ACCEPTED.
3.C.
Application Processing
Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.
Submission to Grants.gov is not the last step - applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!
3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings
IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.
Once an application package has been successfully submitted through Grants.gov NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.
Note that the following caveats apply:
3.C.3 Viewing an Application in the eRA Commons
Once any eRA identified 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 weekdays (Monday Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review (CSR). Incomplete applications will not be reviewed.
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 or competing renewal award if such costs: are
necessary to conduct the project, and would be allowable under the grant, if
awarded, without NIH prior approval. If specific expenditures would otherwise
require prior approval, the grantee must obtain NIH approval before incurring
the cost. NIH prior approval is required for any costs to be incurred more than
90 days before the beginning date of the initial budget period of a new or
competing renewal 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
Annual Investigator
Meetings: Upon initiation of the program, all participating ICs will sponsor
joint annual meetings to encourage the exchange of information among
investigators who participate in this program, perhaps in conjunction with
other Institute sponsored programs. In the preparation of the budget for the
grant application, applicants should include travel funds for the one meeting
each year to be held in Bethesda, Maryland. Applicants should also include a
statement in the applications indicating their willingness to participate in
such meetings.
PD/PI Credential (e.g., Agency Login)
The NIH requires each 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.
Organizational DUNS
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 Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
PHS398 Research Plan Component Sections
All application instructions outlined in the SF424 (R&R) SBIR/STTR Application Guide are to be followed, with the following requirements.
SBIR Phase I applications:
SBIR Phase II applications:
SBIR Fast-Track applications:
Resubmissions:
Warning: Please be sure that you observe the total 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.
Appendix Materials
NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html
Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).
Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process. Phase I SBIR/STTR Appendix materials are not permitted unless specifically requested by NIH.
Plan
for Sharing Research Data
Applicants
requesting $500,000 or more in direct costs in any year must include a brief
one paragraph description of how final research data will be shared, or explain
why data sharing is not possible. The specific nature of the data to be
collected will determine whether or not the final data set may be shared. If
the final data are not amenable to sharing (for example human subject concerns,
the Small Business Act provisions, etc.) this must be explained in the
application. Applicants are encouraged to discuss their data-sharing plan with
the institute/center (IC) staff likely to accept assignment of their
application.
The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the impact/priority score. For more information on data sharing see http://grants.nih.gov/grants/policy/data_sharing. and http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm. (See FAQ #13.)
Sharing
Research Resources
NIH policy expects that grant recipients make
unique research resources readily available for research purposes to qualified
individuals within the scientific community after publication (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 plan for
sharing research resources addressing how unique research resources will be
shared or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The effectiveness
of the resource sharing will be evaluated as part of the administrative review
of each Non-Competing
Grant Progress Report (PHS 2590), 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
Review Process
Applications
submitted for this funding opportunity will be assigned to the ICs for funding
consideration on the basis of established PHS referral guidelines.
Applications that are complete will be evaluated for scientific and technical merit by (an) appropriate scientific review group(s) in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below.
As part of the scientific peer review, all applications will:
The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).
Scored Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the proposed project have commercial potential to lead to a marketable product, process or service? (In the case of Phase II, Fast-Track, and Phase II Competing Renewals, does the Commercialization Plan demonstrate a high probability of commercialization?
Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for (1) Protections for Human Subjects, and (2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
Environment. Will the scientific environment
in which the work will be done contribute to the probability of success?
Are the institutional support, equipment and other physical resources available
to the investigators adequate for the project proposed? Will the project
benefit from unique features of the scientific environment, subject
populations, or collaborative arrangements?
Additional Review
Criteria
As
applicable for the project proposed, reviewers will consider
the
following additional items in the determination of scientific and technical
merit, but will not give separate scores for these items.
For Phase II Applications Only. When reviewing Phase II applications, how well did the applicant demonstrate progress toward meeting the Phase I objectives, demonstrating feasibility, and providing a solid foundation for the proposed Phase II activity?
For Phase I/Phase II Fast-Track Applications Only. When reviewing Phase I/Phase II Fast-Track applications, reviewers will consider the following:
1.
Does the Phase I application specify clear, appropriate, measurable goals
(milestones) that should be achieved prior to initiating Phase II?
2. To what extent was the applicant able to
obtain letters of interest, additional funding commitments, and/or resources
from the private sector or non-SBIR/STTR funding sources that would enhance the
likelihood for commercialization?
Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: (1) risk to subjects, (2) adequacy of protection against risks, (3) potential benefits to the subjects and others, (4) importance of the knowledge to be gained, and (5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: (1) the justification for the exemption, (2) human subjects involvement and characteristics, and (3) sources of materials.
Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.
Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: (1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; (2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; (3) adequacy of veterinary care; (4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and (5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.
Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.
Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
Additional Review Considerations
As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.
Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans.
Reviewers will comment on whether the following Resource Sharing Plans, or the
rationale for not sharing the following types of resources, are reasonable: 1)
Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm);
2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html);
and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
Budget and Period of Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Selection Process
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended SBIR or STTR applications. The following will be considered in making funding decisions:
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 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 also Section
IV.5., Funding Restrictions.
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include
the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and
Conditions of NIH Grant Awards, Subpart A: General and Part
II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions
for Specific Types of Grants, Grantees, and Activities.
3. Reporting
NIH requires that
SBIR/STTR grantees submit the following
reports within 90 days of the end of the grant budget period unless
the grantee is under an extension.
Financial Status Report (OMB 269, http://www.whitehouse.gov/omb/grants/grants_forms.html)
Final Progress Report
Final Invention Statement and Certification (HHS 568)
Annual Invention Utilization Reports
Final Cash Transaction Report (PSC 272, http://www.dpm.psc.gov/Reports.aspx)
Phase II Data Collection Requirement for Government Tech-Net Database (http://technet.sba.gov)
Failure to submit timely final reports may affect future funding to the organization or awards with the same principal investigator.
For details about each specific required report, see the section on Award Guidelines, Reporting Requirements, and Other Considerations, in the SF 424 (R&R) SBIR/STTR Application Guide.
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.
Division of Cardiovascular Diseases
National Heart, Lung, and Blood Institute
Two Rockledge Center, Suite 9152, MSC 7956
6701 Rockledge Drive
Bethesda, MD 20892-7956
Phone (301) 435-0550
Fax: (301) 480-1338
Email: [email protected]
J. Timothy Baldwin, Ph.D.
Biomedical Engineer
Division of Cardiovascular Diseases
National Heart, Lung, and Blood Institute
Two Rockledge Center, Room 8206, MSC 7940
6701 Rockledge Drive
Bethesda, MD 20892-7956
Phone (301) 435-0513
Fax: (301) 480-1335
Email: [email protected]
NIBIB
Todd Merchak
Division of Interdisciplinary Training
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Boulevard, Suite 200
Bethesda, MD 20892-5469
Phone: (301) 496-8592
Fax: (301) 480-1614
Email: [email protected]
NCI
Sharon Ross, Ph.D.
Nutritional Sciences Research Program
Division of Cancer Prevention
National Cancer Institute
6130 Executive Blvd EPN-3157
Bethesda, MD 20892-7328
Phone: (301) 594-7547
Fax: (301) 480-3925
Email: [email protected]
Connie Dresser, RDPH, LN
Health Communication and Informatics Research Branch
Behavioral Research Program
Division of Cancer Control & Population Sciences
National Cancer Institute
6130 Executive Blvd, EPN-4072
Bethesda, MD 20892-7365
Phone: (301) 435-2846
Fax: 301-480-2087
Email: [email protected]
Audie A. Atienza, Ph.D.
Division of Cancer Control & Population Sciences
National Cancer Institute
6130 Executive Boulevard, EPN 4074A
Bethesda, MD 20892-7335
Phone: (301) 402-8426
Fax: 301-480-2087
Email: [email protected]
NIA
Winifred K. Rossi, M.A.
Geriatrics and Clinical Gerontology Program
National Institute on Aging, NIH, DHHS
7201 Wisconsin Avenue, Suite 3C307
Bethesda, Maryland 20892-9205 (Express: 20814)
Phone: (301) 496-3836
Fax: (301) 402-1784
Email: [email protected]
2. Peer Review Contacts:
Not
Applicable
3. Financial or Grants
Management Contacts:
David Reiter
Grants Operations Branch
National Heart, Lung, and Blood Institute
2 Rockledge Center, Room 7172, MSC 7926
6701 Rockledge Drive
Bethesda, MD 20892-7926 (Express 20817)
Phone: (301) 435-0177
Fax: (301) 480-3510
Email:[email protected]
Section VIII. Other Information
Required Federal Citations
Vertebrate Animals:
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 submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their
institutions on issues related to institutional policies and local IRB rules,
as well as local, state, and Federal laws and regulations, including the
Privacy Rule. Reviewers will consider the data sharing plan but will not factor
the plan into the determination of scientific merit or the impact/priority score.
Access to Research Data through the Freedom of
Information Act:
The 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 the 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, Minorities, and Children:
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); and updated roles and responsibilities
of NIH staff and the extramural community. The policy continues to require for
all NIH-defined Phase III clinical trials that: a) all applications or
proposals and/or protocols must provide a description of plans to conduct
analyses, as appropriate, to address differences by sex/gender and/or
racial/ethnic groups, including subgroups if applicable; and b) investigators
must report annual accrual and progress in conducting analyses, as appropriate,
by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical
Research:
The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical research,
conducted or supported by the NIH, unless there are scientific and ethical
reasons not to include them.
All investigators proposing research involving human
subjects should read the "NIH Policy and Guidelines on The Inclusion of
Children as Participants in Research Involving Human Subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human
Subject Participants:
NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can
be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research.
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 (HHS)
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 HHS 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) or PubMed Central (PMC) submission
identification numbers must be used for publicly accessible on-line journal
articles.Publicly accessible on-line journal articles or PMC
articles/manuscripts accepted for publication that are directly relevant to the
project may be included only as URLs or PMC submission
identification numbers accompanying the full reference in either the
Bibliography & References Cited section, the Progress Report Publication
List section, or the Biographical Sketch section of the NIH grant application.
A URL or PMC submission identification number citation may be repeated in each
of these sections as appropriate. There is no limit to the number of URLs or
PMC submission identification numbers that can be cited.
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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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