Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Heart, Lung, and Blood Institute (NHLBI)
Funding Opportunity Title	Summer Institute for Training in Biostatistics II (T15)
Activity Code	T15 Continuing Education Training Grants
Announcement Type	Renewal of RFA-HL-09-009
Related Notices	None
Funding Opportunity Announcement (FOA) Number	RFA-HL-13-015
Companion FOA	None
Number of Applications	Only one application per institution is allowed. See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.837, 93.838, 93.839, 93.233
FOA Purpose	The National Heart, Lung and Blood Institute (NHLBI) invites applications for training grants to develop, conduct, and evaluate summer courses in the basic principles and methods of biostatistics as employed in biomedical research. The courses will introduce advanced undergraduates, recent graduates, and beginning graduate students to the field of biostatistics for the purpose of encouraging them to pursue careers in biostatistics. The courses should cover the fundamental concepts of probability, statistical reasoning and inferential methods motivated, in part, by examples that include data collected in studies of heart, lung, blood, and sleep disorders. The courses would be taught during the summers of 2013, 2014, 2015 with appropriate modifications or refinements following each of the first two summer sessions.

Posted Date	January 19, 2012
Open Date (Earliest Submission Date)	January 28, 2012
Letter of Intent Due Date	March 11, 2012
Application Due Date(s)	April 11, 2012, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable.
Scientific Merit Review	July/August, 2012
Advisory Council Review	January, 2013
Earliest Start Date(s)	April, 2013
Expiration Date	April 12, 2012
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide especially the Supplemental Instructions to the SF424 (R&R) for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

PURPOSE

The National Heart, Lung, and Blood Institute (NHLBI) invites applications for grants to develop, conduct, and evaluate summer courses in the basic principles and methods of biostatistics as employed in biomedical research. The courses would introduce participants to the field of biostatistics for the purpose of attracting new students into the field. The course will attract students from the entire USA and will cover the fundamental concepts of probability, statistical reasoning and inferential methods motivated, in part, by examples that include data collected in studies of heart, lung, blood, and sleep disorders. The course will be taught during the summers of 2013, 2014, and 2015 with appropriate modifications or refinements following each of the first two summers sessions. Programs may choose an area of emphasis, such as clinical trials, statistical genetics, bioinformatics or epidemiology or take a general approach. Recent college graduates as well as advanced undergraduates should be eligible to participate provided they have not participated in SIBS previously.

BACKGROUND

Biostatistics is a fundamental scientific component of biomedical and public health research. Traditional and emerging methodologies are used in clinical trials, observational or epidemiologic studies, medical imaging, and genomics. The current demand for biostatisticians far exceeds the supply, and the gap continues to widen. Recommendations of two workshops (2001, 2003) held by the National Institutes of Health (NIH) were published as Training of the next generation of biostatisticians: a call to action in the U.S. (Statistics in Medicine 25(20): 3415-3429, 2006). The workshops examined the need to train more biostatisticians to meet the increasing opportunities in the biomedical research enterprise. The supply of new PhD graduates in biostatistics in the U.S. has been relatively steady for the past two decades while the demand has increased dramatically. These workshops concluded that a renewed effort must be made in the U.S., led in part by the NIH, to add to and expand the existing training programs to increase the supply. At a prior meeting of the CTSA Biostatistics/Epidemiology/Research/ Design subcommittee, investigators bemoaned their inability to hire the needed biostatistical staff both at the master’s and Ph.D. levels.

RESEARCH TRAINING OBJECTIVES, APPROACHES AND EXAMPLES

The objective of this FOA is to support up to eight awards to teach summer courses in biomedical statistics for advanced undergraduates and beginning graduate students in order to encourage them to pursue careers in biostatistics. This program provides a continuation of the Summer Institute for Training in Biostatics (SIBS) program. It is not intended to provide an in-depth basic course in the subject, nor is it intended to be a standard introductory course in statistics. It would, instead, comprise an innovative introduction to some basics of probability and elementary statistical methods motivated by a series of examples illustrating the use of probability and statistical reasoning applied to the design and analysis of data from studies including those of the heart, lung, blood, and sleep disorders. There is a wealth of data from observational cohort studies and numerous clinical trials (http://www.nhlbi.nih.gov/resources/deca/default.htm) that can be used to demonstrate the essential role biostatistics plays in medical research as well as genetics data. An essential aspect of the course will be the use of a personal computer by each student. The PC will be an indispensable learning tool for understanding and using some of the fundamental elements of data analysis. For this reason, instruction in the use of a basic programming language, such as R or S-plus, would comprise part of the early classroom instruction. Applicants are encouraged to be as creative as possible, since the primary goal of the course is to attract the interest of potential biostatistics students. Depending on the level and interest of the students, the following are examples of the concepts to be covered and the approach to be used in their assignments.

• Descriptive statistics (measures of central tendency and dispersion, histograms) are formally presented followed by a PC-based demonstration using real data. Student assignments would repeat these calculations on individually chosen samples from real data sets.
• Students learn to draw random samples from data sets and compute measures of central tendency and sample proportions. With this skill they explore the nature of the distributions of these quantities in the context of repeated sampling from a large data set. This sets the stage for introducing the normal, Student's t, and binomial probability distributions.
• Using an epidemiology cohort study data set, possibly from one of those funded by NHLBI, instructors demonstrate the concept of adjusted (for age, race, gender, etc.) rates of disease incidence and mortality. Students learn how to compute and compare these rates in different subsets of the cohort.
• A classroom exposition of some of the details underlying the results of an actual epidemiologic cohort study reported in the media.
• The principles underlying the randomized clinical trial are introduced using data from one of the clinical trials related to disorders of the heart, lung, blood, or sleep. Students learn some of the subtleties of the conduct and interpretation of data using, for example, the Cardiac Arrhythmia Suppression Trial as a case study.
• A review of several published studies where flawed analyses have produced misleading results.
• Guest lectures by one or more investigators who have recently completed studies that have attracted media attention.
• An illustration of the problems of multiple hypothesis testing that arise in genome-wide association studies.
• An illustration of how computing aids interpretation of very complex data.

The course will take a creative approach to engaging students' interest, perhaps through data associated with topics pertaining to their own particular interest. They should be expected to spend time outside of class on individual assignments involving projects that address questions related to selected data sets. Assuming a summer schedule of classes with perhaps four hours of class and laboratory each day over a five-to-six week period, the course may reasonably qualify as a one-year credit course in basic statistics that many undergraduate curricula require. Proposals for SIBS should indicate criteria for student selection and the number of students expected per class, and should include specific plans for evaluating the effectiveness of the course in terms of students' perceptions of the material and conduct of the course. In addition, there must be plans in place to assess the longer-term impact, as measured by students' subsequent choice of vocation and field of graduate study.

Funding Instrument	Grant
Application Types Allowed	New Renewal The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NHLBI intend to fund up to six awards, corresponding to a total of $2 million, for fiscal year 2013. Future year amounts will depend on annual appropriations. The following NIH component intends to commit the following amounts in FY 2013: NHLBI: $1,496,000
Award Budget	An applicant may request a project period of up to 3 years and the direct cost amount for each individual award is limited to $248,000 and 8% for facilities and administrative costs in fiscal year 2013. Future year amounts are subject to the availability of funds.
Award Project Period	The expected project period is three years.

Personnel Costs Personnel Costs	Individuals designing, directing, and implementing the program may request salary and fringe benefits appropriate for the person-months devoted to the program. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. Limited program-related administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant organization may be direct charges to the grant only when they are in accordance with applicable cost principles. When specifically identified and justified, these expenses must be itemized in Sections A and B, as appropriate, of the R&R Budget.
Participant Costs	Trainee participant support for travel and per diem while attending the continuing education program will be provided by the grant.
Other Program Related Expenses	NIH will provide funds to help defray other research training expenses, such as health insurance, staff salaries, consultant costs, equipment, research supplies, and faculty/staff travel directly related to the research training program. To coordinate among the institutions awarded, awardees under this FOA are expected to budget for a meeting at the NHLBI in Bethesda, MD, prior to the start of the recruitment for summer 2013. This meeting would provide an opportunity for the awardees to meet with the project officer and with each other, and to share the plans for recruitment, training, and evaluation.
Indirect Costs	Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees and expenditures for equipment), rather than on the basis of a negotiated rate agreement.

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

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

Governments

• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations

The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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.

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

The PD(s)/PI(s) should be an established investigator in the scientific area(s) in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD(s)/PI(s) will be expected to monitor and assess the program and submit all documents and reports as required.

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

Only one application per institution is allowed.

US citizenship or permanent residence status is required for the trainees. Each program will set a standard to assure that the most qualified candidates are admitted. Advanced undergraduates, recent graduates, and beginning graduate students will be considered.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

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

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed research training program
• Name, address, and telephone number of the PD(s)/PI(s)
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

The letter of intent should be sent to:

Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924 (Express Mail Zip: 20817)
Telephone: 301-435-0270
Fax: 301-480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.

Project Summary /Abstract

Provide an abstract of the entire application, including the long-term goals and objectives of the program. Include the rationale and design of the program, the planned duration of the program and the projected number of trainees, including their levels (i.e., predoctoral, postdoctoral).

The filename provided for each Other Attachment will be the name used for the bookmark in the electronic application in eRA Commons.

Program Administration (Component of Program Plan)

Describe the strengths, leadership and administrative skills, and scientific expertise of the Training PD(s)/PI(s). Include the planned strategy and administrative structure to be used to oversee and monitor the program. For applications with multiple PD(s)/PI(s), address the Leadership Plan and how the combined knowledge, skills and experience of the individual PD(s)/PI(s) will enhance the likelihood of success of the program.

Program Faculty (Component of Program Plan)

Describe in general terms the complementary expertise and experiences of the proposed mentors. Provide an overview of their active research and other scholarly activities, as well as track records of mentoring and training.

Proposed Training (Component of Program Plan)

Provide an overview of the proposed program: Describe the immediate and long-term objectives of the program, including activities that will be used to ensure that the objectives of the program are met. Describe the objectives and logistical arrangements for the program. Describe the curricula for the program including the objectives for each didactic and hands-on laboratory course in terms of scientific skills and knowledge. Describe the format and list the agenda, including the principal topics to be covered, problems to be addressed, and developments or contributions the course might stimulate. Describe plans for announcing the program, application and selection procedures, and criteria for selection of trainee participants. Describe any educational materials to be developed and those that are currently available. Describe any plans for continuing exchange of information after trainee participants return to their home institutions. Provide a detailed justification for the educational program, including the scientific need, timeliness, and usefulness of the program to the scientific community. Describe the composition and role of any organizing committee or advisory committee.

Institutional Environment and Commitment to the Program (Component of Program Plan)

The application must include a statement from the applicant institution describing the commitment to the planned program. The institution must assure that essential time will be allowed for the PD(s)/PI(s), other faculty and mentors.

Recruitment and Retention Plan to Enhance Diversity

Individuals are required to comply with the instructions for Recruitment and Retention Plan to Enhance Diversity as provided in Chapter 8 of the SF424 (R&R) Application Guide.

Plan for Instruction in the Responsible Conduct of Research

Individuals are required to comply with the instructions for Plan for Instruction in the Responsible Conduct of Research as provided in Chapter 8 of the SF424 (R&R) Application Guide.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

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 only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD(s)/PI(s) Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the program to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific 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.

Training Program and Environment

• What are the objectives and design of the research training program and what is the potential effectiveness of the proposed course in training researchers in biostatistics?
• Are the objectives, design, direction, and quality of the proposed educational research training program appropriate?
• Do the objectives, design and direction of the proposed research program ensure effective training?
• Are the course content and syllabus appropriate?
• Is the time allotted sufficient to cover the planned material? Is the level of individual attention for trainee participants sufficient?
• Do the courses address state-of-the-art science relevant to the aims of the program?
• Does the program provide training in state-of-the-art or novel methodologies and techniques?
• Will the course content and materials be useful to the broader community?
• Is the course evaluation plan adequate and sufficiently detailed to rate trainee participants satisfaction with the course and determine the success of the course?
• Is a significant level of institutional commitment to the program evident?

What is the institutional training environment, including the institutional commitment to training students in basic, behavioral, and clinical research, quality of the facilities, availability of appropriate courses and seminars, and availability of research support? What is the availability and willingness to provide the necessary institutional facilities, such as adequate classroom and computer resources?

• What is the institution's plan for measuring the effectiveness of the training program, including the productivity of the trainees (e.g., publications, abstracts, presentations), the impact of the program on the institution, and the impact of the program on career choices, including the trainees understanding of biostatistics, and the impact of the program on career plans, and further research activities of the trainees?
• What are the plans for conducting a formal evaluation of the course at the end of first and second summer courses and to use the evaluation results to improve overall quality of the program at its next offering?
• What is the quality of the proposed plans for advertisement and selection of trainees?
  
  

Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))

• Does the Training PD(s)/PI(s) have the scientific background, expertise, and experience to provide strong leadership, direction, management, and administration to the proposed research training program?
• Does the PD(s)/PI(s) plan to commit sufficient time to the program to ensure its success?
• Is sufficient administrative and research training support provided for the program?

For applications designating multiple PD(s)/PI(s):

• Is a strong justification provided that the multiple PD(s)/PI(s) leadership approach will benefit the training program and the trainees?
• Is a strong and compelling leadership approach evident, including the designated roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the training program and with the complementary expertise of each of the PD(s)/PI(s)?

Preceptors/Mentors

• Are sufficient numbers of experienced preceptors with appropriate expertise available to support the number and level of trainee participants proposed in the application?
• Do the preceptors have strong records as researchers and experience with the topics and technologies to be covered in the course?
• What is the track record of the preceptors in directing continuing education training programs or the potential of those preceptors who lack a track record?
• Are the commitment and availability of the faculty well-suited for the program?
• Is there sufficient interaction planned between faculty and trainee participants?
• What are the qualifications of the participating preceptors as basic and clinical researchers, including publications and successful competition for research? What are the training, experience, and competence of the faculty in biostatistics issues applicable to this program?

Trainee Candidates/Participants

• Are the quality and size of the applicant pool and plans for the selection of individuals appointed to the training program appropriate?
• Are the recruiting/advertising procedures for the course and selection criteria for trainee participants adequate and well-defined?
• Are the plans to recruit women, minorities and individuals with disabilities adequate?

Training Record

• How many individuals have participated in the program, and what disciplines have been represented?
• Is there evidence that the program has had an impact on the career choices of former trainee participants?
• Are there any other indicators of the success of the program?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Inclusion of Women, Minorities, and Children

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Vertebrate Animals

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Biohazards

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Resubmissions

Not Applicable.

Renewals

For Renewals, the committee will consider the progress made in the last funding period and the success of the program in attracting individuals from diverse populations, including populations underrepresented in biomedical and behavioral science. Does the application describe the program’s accomplishments over the past funding period(s)? Are changes proposed that would improve or strengthen the training experience?

Revisions

Not Applicable.

As applicable for the project proposed, reviewers will consider 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.

Recruitment & Retention Plan to Enhance Diversity

Peer reviewers will separately evaluate the recruitment and retention plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups. The review panel’s evaluation will be included in an administrative note in the summary statement. Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Training in the Responsible Conduct of Research

Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Select Agent 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).

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.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the NHLBI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted response to this FOA.

Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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. More information is provided at Award Conditions and Information for NIH Grants.

Not Applicable.

The Non-Competing Continuation Grant Progress Report (PHS 2590) and financial statements as described in the NIH Grants Policy Statement are required annually. Continuation support will not be provided until the required forms are submitted and accepted. Chapter 8 of the SF424 (R&R) Application Guide, Additional Instructions for Preparing a Progress Report for an Institutional Research Training Grant, Including Ruth L. Kirschstein National Research Service Awards, must be followed.

Failure by the grantee institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Dr. Song Yang
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health
6701 Rockledge Drive, Room 9210
Bethesda, MD 20892-7913
Bethesda, MD 20817 (express/courier service)
Telephone: 301-435- 0431
Email:yangso@NHLBIl.nih.gov

Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924 (Express Mail Zip: 20817)
Telephone: 301-435-0270
Fax: 301-480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

Ms Teresa Marquette
National Heart, Lung, and Blood Institute (NHLBI)
Office of Grants Management
6701 Rockledge Drive, Room 7145, MSC 7926
Bethesda, MD 20892
Telephone: 301-435-0166
Fax: 301-451-5462
Email:marquettet@nhlbi.nih.gov

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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 63A and 45 CFR Parts 74 and 92.