Part I Overview Information


Department of Health and Human Services

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

Components of Participating Organizations
National Heart, Lung, and Blood Institute (NHLBI/NIH), (http://www.nhlbi.nih.gov)

Title: Computational Modeling for Heart, Lung, Blood, and Sleep Biologists: Introductory Courses (T15)

Announcement Type
New

Request For Applications (RFA) Number: RFA-HL-07-002

Catalog of Federal Domestic Assistance Number(s)
93.837, 93.838, 93.839, 93.233

Key Dates
Release Date: April 28, 2006
Letters of Intent Receipt Date(s): May 25, 2006
Application Receipt Dates(s): June 21, 2006
Peer Review Date(s): October - November 2006
Council Review Date(s): January - February 2007
Earliest Anticipated Start Date(s): April 2007
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: June 22, 2006

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(s) of Support
  2. Funds Available

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

Section IV. Application and Submission Information
  1. Address to Request Application Information
  2. Content and Form of Application Submission
  3. Submission Dates and Times
      A. 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
      A. Additional Review Criteria
      B. Additional Review Considerations
      C. Sharing Research Data
      D. Sharing Research Resources
  3. Anticipated Announcement and Award Dates

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

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

The function of complex three-dimensional tissues and organs, such as the heart, the lung, or the blood vessel wall, cannot be modeled reliably in isolated systems, such as a cell culture system.  Simple linear and intuitive approaches cannot capture the complex behaviors and responses of these systems to perturbations, because complex systems often have emergent properties that cannot be predicted simply from knowledge of their component parts.  Instead, a quantitative framework for computational modeling that can integrate experimental data and predict experimental outcomes is necessary to understand function in health and disease. 

Multi-disciplinary systems biology research relies on expertise in both the biology of the systems under study and ability to build accurate and effective in silico models of the system.  These models are built using biological expertise and generate specific predictions that can be validated experimentally.  This type of approach can make scientific research much more effective and rapid, as experiments that may take weeks or months in the laboratory may be performed in silico by altering parameters in computational models in a few hours or days.  Thus, experimental laboratory work can be more focused on answering key questions.

Although many research areas supported by the NHLBI are well suited to these new computational modeling approaches, the lack of cross-disciplinary training has limited the use of these approaches in cardiovascular, lung, and blood biology.  This initiative seeks to overcome this barrier by introducing computational approaches and tools to biomedical researchers and clinician-scientists.  The resulting combination of experimental and computational approaches may improve our understanding of normal physiology and aid in the design of effective prevention, intervention, and therapeutic strategies for HLBS disorders. 

Each course may target a specific type of modeling approach (i.e., cellular models or multi-scale models) and/or research area (cardiac, vascular, lung, blood, or sleep research). Courses may alternate their modeling and/or research area foci in different sessions or different years, thereby serving a wider range of the HLBS research community.

The goal of these courses is to introduce HLBS researchers and clinician-researchers to modeling and computational biology approaches.  These short courses should include:

o Introduction to different types of computational modeling approaches, including strengths and shortcomings of different approaches and how to choose between them.

o Hands-on experience in application of a computational model to a specific research area, including discussion of how to measure and/or estimate crucial parameters, and how these impact model results.

o Understanding of how experimental and computational approaches complement and strengthen each other.

o How to validate model predictions experimentally.

By the end of the course, participants should understand:

o Different classes of models (e.g., stochastic, partial differential equations, ordinary differential equations, multi-scale versus single scale, etc.).

o Which types of models might be best applied to their research questions of interest.

Basic principles of how to build, test, and validate models.

These courses should enable networking of participants to allow for future collaborative opportunities. Courses will be required to evaluate the effectiveness of their outreach and training program to ensure they are reaching their target audience and introducing them to computational approaches suitable to their field of research.

Courses should introduce participants to the tools, software, and resources for computational modeling and the application of computational approaches to specific NHLBI-related research issues. Topic areas may include but are not limited to:

o Predictive computational models of disease risk and response that may highlight relationships between disease phenotypes (e.g., stroke, cystic fibrosis, thalassemias, or sickle cell disease), using computational approaches such as Bayesian networks, Monte Carlo methods, or Hidden Markov models.

Integrated, multi-scale models of the role of altered cardiac protein expression and post-translational modifications on action potential prolongation during heart failure.

o Three-dimensional models of lung structure and function that incorporate effects of protein expression, alveolar structure, and vascularization.

o Quantitative cellular scale models of signaling pathways in vascular cells to determine how molecular interactions respond to diverse stimuli and affect cellular function.

o Mathematical, cellular scale models quantifying factors that influence blood cell differentiation and determination.

o Models of ventricular myocytes that integrate mathematical models of multiple subsystems, such as cellular metabolism, ion currents, spatial heterogeneity, Ca2+ compartmentalization, and excitation-contraction coupling.

o Multi-scale models of mechanical-molecular interactions and perturbations of blood constituents and interactions with the vessel wall.

Quantification of the role of alveolar, cellular, and protein structure and modifications on the lung’s fragile anatomical barriers to infectious agents.

The applicants should develop an appropriate and innovative education program to be conducted during an intensive short course (one-week or longer) to be offered once or twice a year. The course should not merely cover the necessary techniques to execute a particular protocol. Rather it should provide an understanding of the strengths and weaknesses of particular technologies and approaches. Each topic area of the application should be addressed in sufficient depth to show how it significantly enhances the ability of scientist to integrate computational approaches to their on-going studies. A combination of lectures, laboratories, demonstrations, and seminars may be employed. The development of novel educational tools and approaches is encouraged.

Applicants may offer an optional second phase focusing on applying computational modeling to the participant’s own research.  This second phase would reinforce and put into practical use the training received in the first phase, as participants in short courses sometimes face additional hurdles in application of techniques learned during short courses.  During this phase, select participants could return for a brief, intensive training session to obtain expert assistance in applying these modeling techniques to their own research problem, beyond assistance available in the main section of the course.  Applicants may choose to have this secondary tutoring phase of the program as a continuation of the first introductory short course or they may choose to have select participants return for supplemental tutoring within four months of completing the short course.  Applicants should specify how they will select the participants for the secondary phase of the program.  

Applicants will be required to disseminate educational materials. They should describe the specific mechanisms for dissemination and should indicate what resources will be available for continuing education when participants return to their home institutions. In the case of Internet-based materials used in the training, applicants are encouraged to submit plans on how these materials will be advertised and made available to appropriate research communities and evaluated for effectiveness. Provision of handout materials via websites and access to lecture via streaming video or other technologies is highly encouraged. Access to archival video material is desirable.

Applications for courses must develop plans for recruiting and selecting students, the number of students expected per class, and must include plans to evaluate the effectiveness of the course in terms of attendees' perceptions of the material and conduct of the course. Importantly, there must be plans in place to assess the long-term impact, as measured by attendees' subsequent activities or responsibilities in their institutions in applying computational modeling approaches into their ongoing studies.

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the NIH Continuing Education Training Grant (T15) award mechanism, which funds institutions to establish, expand, or improve programs of continuing professional education. These awards are not a part of the National Research Service Awards Program (NRSA) of the Public Health Service.

Applicants may request up to four years of support.  Courses are expected to be offered once or twice per year for four years.  The duration of a course may be 7 days or longer as long as they are consistent with the goals of the proposed plan.  Participants may be recruited locally (at the grantee institution), regionally, or nationally.

NHLBI T15 awards are not renewable.

As an applicant, you will be solely responsible for planning, directing, executing, and evaluating the proposed continuing education program.

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

2. Funds Available

The NHLBI intends to commit approximately $700,000 dollars in FY 2007 to fund up to three new grants in response to this RFA.  An applicant may request a project period of up to four years and a budget for direct costs up to $215,000 dollars per year. The facilities and administration rate for T15 awards is eight percent of modified total direct costs.  Although the financial plans of the NHLBI 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. The NHLBI intends to commit $2.8 M for FY 2007-2010 pending availability of funds.

Allowable Costs

Allowable costs include personnel; rental of laboratory facilities and equipment for period of the course offering; supplies; travel and per diem for faculty; and other costs such as printing, telephone, audio/visuals, postage, recruitment materials, and computer software. The purchase of equipment is not an allowable cost. In addition, travel and per diem funds for participants attending courses developed by applicants are appropriate when necessary.  However, it is expected that courses will be partially funded through registration fees paid for by the participants and their home institutions.


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

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

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

Foreign institutions are not eligible to apply; however, foreign scientists may participate as instructors.

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

2. Cost Sharing or Matching

Not applicable

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

Participants:  Individuals who are biomedical researchers and clinician-scientists active in cardiovascular, lung, blood, or sleep research are the intended recipients of support for the short courses in this continuing education program.  Participants must be citizens or non-citizen nationals of the United States, or must have been lawfully admitted to the United States for Permanent Residence. Non-citizen nationals are generally persons born in outlying possessions of the United States, i.e. American Samoa and Swains Island. Individuals on temporary or student visas are not eligible.

Sponsoring Institution:  The sponsoring institution must ensure the availability and willingness to provide the necessary institutional facilities, such as adequate classroom and computer resources.

Section IV. Application and Submission Information


1. Address to Request Application Information

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

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

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

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

Applications should follow the format for Ruth L. Kirschstein National Research Service Award (NRSA) applications, as detailed in Section IV of the Instructions for Form PHS 398 (http://grants1.nih.gov/grants/funding/phs398/phs398.pdf). Certain elaborations on and modifications to the instructions in the NSRA application form, specific to this RFA, supersede the instructions in the NRSA application where applicable. These elaborations and modifications are detailed below. Applicants must therefore refer to both the NRSA application instructions and the instructions below when completing their applications. Where no superseding instructions appear below, applications should follow the NRSA instructions. The numbered sections and sub-sections below refer specifically to their counterparts in Section IV of the Instructions for Form PHS 398, beginning on Page 58.

Table of Contents: Applicants should use the Substitute Table of Contents for Institutional NRSA (Kirschstein-NRSA Substitute Form 3, http://grants1.nih.gov/grants/funding/phs398/phs398.html). Items A – D (Background, Program Plan, Minority Recruitment and Retention Plan, and Plan for instruction in the Responsible Conduct of Research) should not exceed 25 pages.

Budget: Applicants should use the standard PHS 398 Form Page 4 (detailed budget for initial budget period) and Form Page 5 (Budget for the entire proposed period of support) from the PHS 398 Form set.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date(s): May 25, 2006
Application Receipt Dates(s): June 21, 2006
Peer Review Date(s): October - November 2006
Council Review Date(s): January - February 2007
Earliest Anticipated Start Date(s): April 2007

3.A.1. Letter of Intent

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

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NHLBI 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:

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

3.B. Sending an Application to the NIH

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

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

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

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

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

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

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NHLBI. Incomplete and non-responsive applications will not be reviewed.

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

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

6. Other Submission Requirements

Responsible Conduct of Research:

Applications must include a description of a program to provide formal or informal instruction in the responsible conduct of research. Applications without plans for instructions in the responsible conduct of research will be considered incomplete and may be returned to the applicant without review.  Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, and policies for handling misconduct policies regarding the use of human and animal subjects and data management. Applicants must follow the application instructions found on page 49 of the PHD-398 application package and refer to the NIH web site (http://www.nih.gov/sigs/bioethics/researchethics.html) for additional guidance.

Diversity Recruitment Plan:

The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation’s capacity to address and eliminate health disparities.

Accordingly the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as:  individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research.  Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis.  The NIH is particularly interested in encouraging the recruitment and retention of the following classes of candidates:

A.Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see http://www.nsf.gov/sbe/srs/women/start.htm)  In addition, it is recognized that underrepresentation can vary from setting to setting and individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should  be e encouraged to participate in this program.

B.Individuals with disabilities, who  are defined as those with a physical or mental impairment that substantially limits one or more major life activities.

C.Individuals from disadvantaged backgrounds  who  are defined as:

1.Individuals who come from a family with an annual income below established low-income  thresholds.  These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs.  The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml.  For individuals from low income backgrounds, the institution must be able to demonstrate that such candidates have qualified for Federal disadvantaged assistance or they have received any of the following student loans:  Health Professional Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

2.Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.  Recruitment and retention plans related to a disadvantaged background are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement.

Dissemination Plan:

Applicants to this program will be required to disseminate their educational materials widely.  Applicants should describe what specific mechanisms they will employ for dissemination.  In the case of internet-based materials, applicants are encouraged to submit plans on how these materials will be advertised and made available to the appropriate communities and evaluated for effectiveness.

Evaluation Plan:

Proposals for courses should include clear plans for evaluating the effectiveness of the short courses) in terms of attendees’ perceptions of the material and conduct of the course.  Importantly, there must be plans for assessing the longer-term impact, as measured by attendees’ subsequent activities or responsibilities in their institutions in computational modeling.  For example, assessments might address whether course participants are promoting interdisciplinary research and training by increasing the number of researchers with knowledge and skills to apply both experimental and computational approaches to heart, lung, blood, and sleep research.

Sharing Research Resources

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

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

Section V. Application Review Information


1. Criteria

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

The following will be considered in making funding decisions:

2. Review and Selection Process

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:

The goal of this short course training program is to develop skills and knowledge in computational biology that enable its application in basic research. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score.  

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

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

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

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

2.B. Additional Review Considerations

The priority score should not be affected by the evaluation of the following elements:

Responsible Conduct of Research: The reasonableness of proposed formal or informal instruction in the responsible conduct of research.

Diversity Recruitment Plan: The adequacy of plans to recruit participants currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research.

Evaluation Plan: Adequacy of plans to evaluate the effectiveness of the short courses.

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed continuing education training program.

2.C. Sharing Research Data  

N/A

2.D. Sharing Research Resources

NIH policy expects that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/pdfs/64FR72090.pdf). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

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

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

3. Anticipated Announcement and Award Dates

N/A

Section VI. Award Administration Information


1. Award Notices

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

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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

2. Administrative and National Policy Requirements

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

3. Reporting

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

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Jennie E. Larkin, Ph.D.
Division of Heart and Vascular Disease
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive
Room 9142, MSC 7940
Bethesda, MD 20892-7934
Telephone: (301) 435-0513
FAX: (301) 480-1335
Email: Larkinj2@mail.nih.gov

Or

Pothur Srinivas, Ph.D., MPH
Division of Heart and Vascular Disease
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive
Room 10188, MSC 10193
Bethesda, MD 20892- 7956
Telephone: (301) 435-0550
FAX: (301) 480-2858
Email: srinivap@nhlbi.nih.gov

2. Peer Review Contacts:

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

3. Financial or Grants Management Contacts:

Marsha Mathis
Grants Operations Branch
National Heart, Lung, and Blood Institute
Rockledge II, Room 7158
6701 Rockledge Drive
Bethesda, MD 20892
Telephone: (301) 435-0170
FAX: (301) 480-3310
Email: mathismd@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

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

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, state and federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with federal funds and (2) cited publicly and officially by a federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

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 http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004, receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

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

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

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

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

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information," the "Privacy Rule," on August 14, 2002 . The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

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

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

Authority and Regulations:

This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 , 42 CFR Part 63a,  and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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