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 Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov)

Title: NIBIB Biomedical Technology Resource Centers (P41)

Announcement Type
New

Update: The following update relating to this announcement has been issued:

• March 19, 2013 - This PAR has been reissued as PAR-13-144.
• March 16, 2012 - See Notice NOT-OD-12-072. The purpose of this Notice is to inform potential applicants of changes in the participation of NIH Institutes, Centers, and Offices (ICOs) in PAR-10-225.
• February 21, 2012 - See Notice NOT-EB-12-003 Notice of Clarification for the NIBIB Biomedical Technology Resource Center (P41) Program.
• July 2, 2010 - See Notice NOT-EB-10-003 This Notice modifies Section IV.6 in this PAR and includes the instructions to applicants requesting $500K or more in direct costs for any year..

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. For more information and an initial timeline, seehttp://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-035.html. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html).

Program Announcement (PA) Number: PAR-10-153

Catalog of Federal Domestic Assistance Number(s)
93.286

Key Dates
Release Date: March 25, 2010
Letters of Intent Receipt Date(s): 30 days before each receipt date
Application Submission Dates(s): Standard dates apply; please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
AIDS Application Submission Dates(s): Standard dates apply; please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
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: 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: May 8, 2013

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

• Purpose. This FOA issued by the National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Institutes of Health (NIH), encourages grant applications for Biomedical Technology Resource Centers (BTRC s) that are funded using the P41 mechanism. BTRC’s conduct research and development on new technologies that are driven by the needs of basic, translational, and clinical researchers. BTRC’s also make their technologies available, train members of the research community in the use of the technologies, and disseminate these technologies broadly.
• Mechanism of Support. This FOA will utilize the P41 grant mechanism.
• Funds Available and Anticipated Number of Awards. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the number, quality, duration and costs of the applications received.
• Budget and Project Period. Direct costs (excluding equipment) are limited to $700,000 per year. Direct costs for equipment are limited to $500,000 for the duration of the project. Support may be requested for up to five years. Two renewals may be requested, for a total of fifteen years.
• Application Research Strategy Length: The P41 Specific Aims/Research Strategy section may not exceed the page limits listed in Item 6. Other Submission Requirements, Table of Page Limits including tables, graphs, figures, diagrams, and charts.
• Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.
• Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/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.
• Number of PDs/PIs. Only one PD/PI may be designated on the application.
• Number of Applications. Applicants may not submit more than one BTRC application.
• Resubmissions. Applicants may submit a Resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).
• Renewals. Applicants may submit a Renewal application.
• Application Materials. See Section IV.1 for application materials.
• Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY (301) 451-5936

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. 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
3. Anticipated Announcement and Award Dates

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) uses the P41 mechanism to support Biomedical Technology Resource Centers (BTRCs) in a variety of areas of biomedical science. BTRCs create critical, often unique, technologies that are at the forefront of their respective fields, and apply these technologies to a broad range of basic, translational, and clinical research. Details concerning current NIBIB BTRCs can be found at http://www.nibib.nih.gov/Research/ResourceCenters.

BTRCs may be developed in a specific, narrow technological area, or they may utilize an integrated approach to the development of tools and methods across a broader line of inquiry. In either case, a BTRC assembles a critical mass of both technological and intellectual resources with the intent of exploiting advances in instrumentation and methodology for biomedical research. This intense synergy between technology development and biomedical problem-solving defines the BTCR’s as fundamentally different in character from laboratories engaged in investigator-initiated research that may have more narrowly defined goals.

A BTRC also must provide Service and Training to outside investigators and must disseminate the technology and methods it has developed. These efforts require the commitment of far greater financial and personnel resources to non-science activities than is expected for other types of research efforts. The goal of these efforts is to export the technology and expertise of the BTRC into the broader community, achieving a wider impact on biomedical research than would be possible through the projects in which the BTCR can participate directly. Industrial partnerships are not required, but they are welcome when appropriate.

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

Section II. Award Information

1. Mechanism of Support

This funding opportunity announcement (FOA) will use the P41 award mechanism. The applicant will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

2. Funds Available

Direct costs (excluding equipment) are limited to $700,000 per year. Direct costs for equipment are limited to $500,000 for the duration of the project. Support may be requested for up to five years. Two renewals may be requested, for a total of fifteen years.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

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

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.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

• Public/State Controlled Institutions of Higher Education
• 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 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)
• Small Businesses
• For-Profit Organizations (Other than Small Businesses)
• State Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribally Designated Organizations
• County Governments
• City or Township Governments
• Special District Governments
• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• U.S. Territory or Possession
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Regional Organizations
• Other(s):
  • Eligible Agencies of the Federal Government
  • Faith-based or Community-based Organizations

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 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

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

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may not submit more than one BTRC application.

Resubmissions. Applicants may submit a Resubmission application, but such application must include an Introduction addressing the previous peer review critics (Summary Statement) including comments on the TR&D Projects, Collaborative Projects Component, and Service, Training, Dissemination, and Administrative Components. See Table of Page Limits given in Item 6. Other Submission Requirements, .. Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications are permitted only a single amendment (A1). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Original new and competing renewal applications that were submitted prior to January 25, 2009 are permitted two amendments (A1 and A2). For these grandfathered applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.

Renewals. Applicants may submit a Renewal application. However, NIBIB BTRC Awards will be restricted to a total of fifteen years. Applicants for the final five-year Renewal application should be aware that BTRC funding will not be extended past the end of the final five years, and should propose a research plan for the final five-year period that takes this into account. However, no formal transition plan is required.

Section IV. Application and Submission Information

1. Address to Request Application Information

The current 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) 710-0267, Email: [email protected].

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

2. Content and Form of Application Submission

Prepare all applications using the PHS 398 application forms in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html).

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 in item (box) 2 only of the face page of the application form and the YES box must be checked.

Additional information is available in the PHS 398 grant application instructions.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review and Anticipated Start Dates
Letter of Intent Receipt Date(s): 30 days before receipt date
Application Receipt Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission 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://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm

3.A.1. Letter of Intent

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

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

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

The letter of intent is to be sent by the date listed in Section IV.3.A.

Alan McLaughlin, Ph.D.
Director, Division of Applied Science and Technology
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Boulevard, Suite 200
Bethesda, MD 20892 (20817 for courier service)
Telephone: (301) 496-9321
Fax: (301) 480-1614
Email: [email protected]

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application forms 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 materials must be sent to:

David T. George, Ph.D.
Director, Office of Scientific Review
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Boulevard
Suite 920, Room 956
Bethesda, MD 20892-5469 (20817 for courier service)
Telephone: (301) 496-8633
FAX: (301) 480-0675
Email: [email protected]

3.C. Application Processing

Applications must be submitted on or before the application receipt/submission dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.

Upon receipt applications will be evaluated for completeness by CSR. Incomplete 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 merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

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.

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 renewal award if such costs: 1) are necessary to conduct the project, and 2) 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 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 NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

6. Other Submission Requirements

July 2, 2010 - See Notice NOT-EB-10-003 This Notice modifies Section IV.6 in this PAR and includes the instructions to applicants requesting $500K or more in direct costs for any year.

PHS398 Research Plan Sections

All application instructions outlined in the PHS 398 Application Guide are to be followed, with the following additional requirements:

• Introduction (required for a resubmission or revision application) is limited to 1 page as specified in the Table of Page Limits.
• The Specific Aims secion is included in the page limitations.
• Research Strategy, including tables, graphs, figures, diagrams, and charts, is limited to the number of pages given in the Table of Page Limits.

The current version of PHS 398 form should be used for P41 grant applications.

Instead of the Research Plan outlined in Section 5.5 of the restructured PHS 398 form, the P41 Research Plan should take the following structure:

(1) Overview of the proposed BTRC

(2) Technology Research and Development (TR&D) Projects

(3) Collaborative Projects

(4) Service Projects

(5) Training

(6) Dissemination

(7) Administration

Individual TR&D Projects, Collaborative Projects and Service Projects should be described using the Research Plan format outlined in Section 5.5 of the restructured PHS 398 form (see below).

Detailed instructions (and page limits) for each of the seven Sections mentioned above are given below.

Neither a site visit nor an applicant interview is guaranteed as part of the review of the BTRC application. The written application must be complete and able to stand on its own.

Overview of the Proposed BTRC

Applicants should describe the long-term goals and overall objectives of the BTRC, point out what makes this particular BTCR unique in terms of its intellectual and technological capabilities, and give a projected timetable for technology development. For New applications, include information on factors and events contributing to the decision to create the BTRC. For Renewal applications, include a brief summary of the BTRC’s progress.

Technology Research and Development (TR&D)

The central activity of a BTRC is the group of TR&D Projects that serves as the foundation for all other BTRC activities. The mission of a BTRC may range from the narrowly-focused advancement of a single technology area to the development of a general class of technologies.

A BTRC is an inherently multidisciplinary enterprise that requires the integration of multiple approaches to complex technical and biomedical challenges.

TR&D Projects are most effective when they respond to the emerging needs of the biomedical research community. To encourage synergistic interaction, the application must include Collaborative Projects that serve as test-beds for TR&D Projects (see below). The relationship between TR&D Projects and Collaborative Projects should be clearly delineated.

The description of each TR&D Project should include the Specific Aims and the Research Strategy (Significance, Innovation and Approach) using the Restructured Research Plan (see NOT-OD-09-149). For New applications, each TR&D Project should include information on Preliminary Studies as part of the Approach section. Also, for Renewal applications each TR&D Project should include a Progress Report as part of the Approach section, and new activities should be identified. List the investigator(s) who will be primarily responsible for each project, and describe the relationship between the TR&D Projects and the overall goals of the BTRC.

An element of high risk (and potentially high payoff) may be present in one or more of the TR&D Projects.

A BTRC is expected to propose at least three TR&D Projects. Since it is expected that these projects will involve multi-disciplinary science and engineering, the projects are not required to be physically located at a single site. If more than one site is involved, provide evidence of strong communication and collaboration among distant sites.

Only scientific and technological proposals that are directly related to the NIBIB mission will be considered.

For Resubmission applications, each TR&D project must include a one-page Introduction addressing the previous peer review critique (Summary Statement).

Collaborative Projects

The development of new biomedical research tools is most effective when pursued in the context of challenging problems that drive the technology forward. A Collaborative Project is an interaction between BTRC personnel and investigators from outside the BTRC, and should be selected on the basis of their appropriateness as test-beds for new technology and their potential for significant biomedical impact. Collaborative Projects should present substantial technical challenges that make the problem difficult to solve with current approaches. There should be an iterative push-pull relationship between TR&D Projects and Collaborative Projects, advancing both the technology and the biomedical projects. Such efforts are expected to lead to joint publications and, in some cases, patents.

Collaborative Projects served by the new technology should be broad in scope and involve a variety of biomedical research areas. The BTRC is expected to be responsive to a national user community whose members are primarily grantees and contractors funded by other NIH programs.

The description of each Collaborative Project should begin with the following information:

(1) the collaborating Investigator’s name and Institution

(2) the funding status of the project, including:

• Grant number
• Project period dates
• Source of funds
• Principal Investigator s name, if different from the collaborating Investigator.

The description of each Collaborative Project should include the Specific Aims and Research Strategy (Significance, Innovation and Approach) using the Restructured Research Plan (see NOT-OD-09-149). Also, for Renewal applications, each Collaborative Project should include a Progress Report, and new activities should be identified.

In addition, the impact of the expertise of the BTRC technology on the project should be discussed.

New applications should have at least one Collaborative Project for each TR&D Project. It is possible that one Collaborative Project could drive more than one TR&D Project.

Collaborative Projects that have already been peer-reviewed will be evaluated on how they advance and stimulate BTRC technological development. Projects that have not been peer-reviewed should include more detail and will be evaluated on the scientific merit of the research proposed, as well as on their impact on a TR&D Project. It is expected that most of the Collaborative Projects will have been peer reviewed.

Purely technical collaborations focused on advancing some aspect of TR&D should be included within the relevant TR&D Project, not in the Collaborative projects.

Collaborations with biomedical researchers that make use of the technology and expertise of the BTRC, but are not intended to serve as a primary driver for technology development, should be included in the Service section (see below).

No more than ten Collaborative Projects can be presented in detail.

At the end of the Collaborative Projects section, a table of all the Collaborative Projects should be attached. For Renewal applications, Collaborative Projects from the previous funding period (including those that are not part of the Renewal application), should be listed following the new Collaborative Projects. This table will not count against the page limits. Each entry in the table should include:

(1) the Collaborative Project PI and Institution

(2) the title of the project

(3) the name(s) of BTRC personnel involved with the project

(4) the TR&D Project(s) that interact with the Collaborative Project

(5) the start and finish dates for the Collaborative Project

(6) the external funding status of the project

(8) the number of publications that have resulted from the Collaborative Project (for Renewal applications only).

For Resubmission applications, the entire Collaborative Project Component must include a one-page Introduction addressing the previous peer review critique (Summary Statement).

Service Projects

The primary purpose of the Service Projects is to provide access to the advanced technologies created in the BTRC, which are presumably not available elsewhere. The concentration of instrumentation, software, methods, and expertise developed in a BTRC represents an important resource for biomedical and clinical researchers. A BTRC is expected to actively engage this research community to provide broad access to BTRC capabilities.

Service Projects may include access to expertise in the BTRC for consultation and data interpretation, access to software and associated technical support, and access to instrumentation for routine work. Service Projects may also provide assistance to other laboratories or institutions as they build their own independent capabilities. It is expected that BTRC support will be acknowledged in papers resulting from Service Projects, regardless of whether BTRC staff are listed as authors. That acknowledgement should use the NIBIB grant number.

Service Projects differ from Collaborative Projects in that they do not drive the development of new technologies or devices. Service Projects generally exploit the more mature capabilities of the BTRC.

Service Projects are a key element of the BTRC, but the P41 mechanism is not intended to support a BTRC that is predominately focused on routine service. The BTRC should strive to conduct the major portion of its Service Projects with researchers who are outside the applicant institution.

A representative sampling of no more than 10 Service Projects should be presented. Each Service Project should include a description of the Specific Aims and the Research Strategy. Also for Renewal applications, each Service Project should include a Progress Report, and new activities should be identified.

Each project should be described in sufficient detail to allow the evaluation of the need for the BTRC technologies in the proposed project. The description of each Service Project should begin with the following information:

(1) the Service Project PI and Institution

(2) the funding status of the project including

• the grant number
• the project period dates
• the source of funds
• the Principal Investigator’s name (if different from the Service Project PI).

At the end of the Service Projects Section, a table of all the Service activities should be attached. This table will not count against the page limits. Each entry in the table should include:

(1) the Service Project PI and Institution

(2) the title of the project

(3) the name(s) of BTRC personnel involved with the project

(4) the start and finish dates for the project

(5) the external funding status of the project

(6) the number of publications that have resulted from the project (for Renewal applications only)

Service Projects from the previous funding period, including those that are not part of the Renewal application, should be included in the table, following the listing of new Service Projects.

As an administrative issue, if a charge-back system that results in program income is planned, a description of how costs are to be shared by the users should be included. Additionally, special administrative requirements that apply to program income must be observed. Program income means gross income earned by the recipient that is directly generated by a supported activity or earned as a result of the award (additional information is available in 45 CSR 74.2 and 74.24, which can be obtained by searching the Code of Federal Regulations at http://www.access.gpo.gov/nara/cfr/cfr-table-search.html. An estimate of the amount and source of program income expected to be generated as a result of the BTRC must be included on the Checklist Page of all renewal and non-competing continuation applications. Net program income earned during a budget period must be reported on the long-form Financial Status Report (except for program income earned as a result of inventions, to which special rules apply). Costs incident to the generation of program income may be deducted from gross income to determine program income, provided these costs have not been charged to the award.

For Resubmission applications, the entire Service Project Component must include a one-page Introduction addressing the previous peer review critique (Summary Statement)

Training

Training is generally necessary to facilitate use of the new technology and software by scientists outside the BTRC. A BTRC must allocate sufficient resources for training both specialists and non-specialists to make the best possible use of the new tools.

The overall goal of the training component of a BTRC is expected to be twofold: to improve the general understanding of the BTRC s technologies in the appropriate population, and to create a cadre of biomedical researchers trained in the technology so that they can effectively apply it in their own research.

Plans for training should be presented in the application, but no specific methods or activities are prescribed. The choice of approaches should be informed by the special constraints and opportunities presented by the individual BTRC. A defining feature of Training activities is the direct interaction between BTRC personnel and the trainee. Note that activities such as web-based self-service tutorials would fall under Dissemination, since there is no direct interaction between BTRC personnel and the researcher.

Examples of successful approaches include hands-on laboratory experience such as residencies in the BTRC laboratories, seminars and lectures, and short courses or symposia offered independently or in conjunction with society meetings attended by the user community. Another example would be workshops that bring together researchers from academic institutions, hospitals and industry for discussions on the BTRC’s technology. Because of the increasing importance of translational and clinical research, plans for training researchers involved in those efforts are strongly encouraged.

Funds to support courses given for academic or other types of credit may not be requested. Individuals benefiting from the training experiences may not be paid a stipend nor may the training experience be a requirement for receipt of an academic degree.

The boundary between Training and Dissemination activities may not be well defined. Approaches that incorporate elements of both components should be presented only within one section of the application, whichever is deemed more appropriate.

For Renewal applications, a progress report on Training activities should be included, and new activities should be identified.

For Resubmission applications, the Training Component must include a one-page Introduction addressing the previous peer review critique (Summary Statement)

Dissemination

A fundamental motivation for the BTRC program is to apply cutting edge technology to important biomedical research problems. A critical step in meeting this objective is to share the new technologies and methods. The Collaborative Projects, Service Projects, and Training components of a BTRC all build toward this overall goal of broad dissemination.

Dissemination activities should have two overall objectives: informing the scientific community about the technical capabilities and accomplishments of the BTRC, and promoting and enabling a broader use of the technologies. A variety of approaches can be proposed to meet these goals. These approaches include, but are not limited to: publishing articles, books, patents, newsletters, annual reports, or special issues of technical journals; issuing press releases; presenting research results at meetings; conducting workshops and conferences; distributing software products; transferring technologies to other laboratories; licensing technologies to industry; and web-based training modules and tutorials. All BTRC dissemination activities must acknowledge NIBIB grant support. That acknowledgement should use the NIBIB grant number.

BTRC’s are expected to have a robust web presence that acknowledges support from the NIBIB. The web site should provide information about:

(1) the BTRC’s research focus and capabilities

(2) contact information

(3) how to establish Collaborative and Service Projects

(4) a section on current newsworthy items directed to the general public

(5) links to online tutorials

(6) the availability of software, reagents, and other resources (as applicable)

(7) links to other related NIH funded P41 Centers and links to the NIBIB BTRC program web page.

In Centers that are developing software, emphasis should be placed on producing portable, well-documented, user-friendly software, that is readily available and has user support. NIBIB encourages sharing of source codes, consistent with the NIH data-sharing policy. Although software is not required to be open source, if a restrictive license will be used to distribute the software, written justification is required in the application.

The boundary between Training and Dissemination activities may not be well defined. Approaches that incorporate elements of both components should be presented only within one section of the application, whichever is deemed more appropriate.

For Renewal applications, a progress report on Dissemination should be included, and new activities should be identified.

Resubmission applications, the Dissemination Component must include a one-page Introduction addressing the previous peer review critique (Summary Statment).

Administration

Following the Research Plan, the administrative structure of the BTRC should be described. This section should be broken down into: Organizational Structure and Staff Responsibilities, BTRC Operating Procedures, and the External Advisory Committee.

(1) Organizational Structure and Staff Responsibilities

Describe the Organizational Structure of the BTRC. Indicate the relationship of the Center to the administrative structure of the grantee institution. Describe how the Principal Investigator and the BTRC staff will be organized with respect to the BTRC components: Technology R&D, Collaborative Projects, Service Projects, Training, Dissemination, and general BTRC administration. Describe the scientific and technical expertise of the staff that will operate, maintain, and develop the BTRC capabilities, and specify the distribution of each staff member’s effort across the different components.

(2) BTRC Operating Procedure

Describe BTRC Operating Procedures. Include criteria and mechanisms to review requests for the use of the equipment and facilities in the BTRC, and to schedule use once it has been approved. Describe criteria and methods for prioritizing and selecting Collaborative Projects as well as Service Projects. Include samples of the forms to be filled out by collaborators and users. Include instructions on how users are to acknowledge support provided by the BTRC in any resulting publications.

(3) External Advisory Committee

The External Advisory Committee (EAC) is appointed by the principal investigator (PI) and advises the PI on future directions for the Center, particularly in planning additional grant applications and in setting priorities for allocation of BTRC facilities. Each BTRC must have an EAC. The committee chair should be knowledgeable about the BTRC's technology and the science it serves, but should not be a member of the BTRC staff or a major user of the BTRC. Other committee members should be balanced among: (1) scientists knowledgeable about the BTRC technologies, (2) experts in its application of the BTRC technologies to biomedical research problems, and (3) users of the technology.

EAC members and the chair should be from outside the host institution. NIBIB encourages the inclusion of scientists who are not affiliated with the BTRC; however, inclusion of collaborators on the EAC is not prohibited. Membership should be rotated periodically. The EAC should meet at least annually and prepare a written report of its recommendations, addressed to the PI. This report must be supplied as part of the BTRC Annual Progress Report.

The role of the EAC should be described. The committee's role in advising on instrument purchases, reviewing Collaborative and Service Projects for merit and appropriateness, and allocating instrument time should be presented. For Renewal and Resubmission applications, names of current committee members and a brief description of their qualifications should be included. For New applications, potential EAC members should not be contacted or appointed prior to submission of the application; however, the scientific disciplines of anticipated committee members should be described. The application should not list the names of potential members of the EAC.

Funds should be requested in the Consultant Costs category of the budget for support of EAC member travel expenses for the annual meeting. The funds will be restricted for this purpose, and may not be re-budgeted without prior approval by program staff.

A local executive committee, or other local committees, may be proposed as an adjunct to the EAC. The function and meeting schedule for these committees should be described in this section.

For Renewal applications, include copies of the BTRC s most recent External Advisory Committee Report in the Appendix.

For resubmission applications, the Adminstrative Component must include a one-page Introduction addressing the previous peer review critique (Summary Statement).

The following Table gives page limitations for individual Sections.

Table of Page Limits

1. BTRC Overview 6 pages (total)

2. TR&D Projects (three or more)

Introduction (Resubmissions only) 1 page (each project)

Specific Aims and Research Strategy 12 pages (each project)

3. Collaborative Projects (ten or less)

Introduction (Resubmissions only) 1 page (total)

Specific Aims and Research Strategy 3 pages (each project)

4. Service Projects (ten or less)

Introduction (Resubmissions only) 1 page (total)

Specific Aims and Research Strategy 3 pages (each project)

5. Training

Introduction (Resubmissions only) 1 page (total)

Training Plan 6 pages (total)

6. Dissemination

Introduction (Resubmissions only) 1 page (total)

Dissemindation Plan 6 pages (total)

7. Administration

Introduction (Resubmissions only) 1 page (total)

Administrative Plan 6 pages (total)

References

References can be collected either into a single section as described in the revised PHS 398 instructions, or they can be presented at the end of each of the sections described above. The instructions for the format of these citations in the revised PHS 398 instructions must be followed. References are not included in the page limitations.

Renewal applications must include complete references to all appropriate publications, patents and manuscripts accepted for publication from the BTRC since it was last reviewed competitively. This section is not included in the page limitations.

Publications from the BTRC should be submitted to PubMedCentral in compliance with NIH Public Access Policy.

Animals and Human Subjects

The instructions in PHS 398 must be followed when describing experiments involving animal and human subjects. The BTRC is responsible for obtaining relevant IRB and IUCAC approvals, regardless of whether Collaborative and Service Projects have separate approvals.

Budget

This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

The detailed budget should be completed as described in the instruction sheet for Application for a PHS 398 Form (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-149.html). Funds may be requested for Technology R&D, Training, Dissemination, External Advisory Committee meetings (under Consultant Costs) and the BTRC's expenses associated with Collaborative Projects and Service Projects. Support for the development and maintenance of a web site should be included. Support for graduate students and postdoctoral fellows can be requested only if they are active participants in a TR&D research project. The outside investigators of Collaborative and Service projects must derive support for their projects from sources outside the BTRC.

There is an annual meeting of BTRC PIs, usually in the Washington, DC area. It is expected that the PI and one other senior member of the BTRC attend this meeting. Funds to support travel to this meeting should be requested in the budget.

The budget should include a detailed justification for key personnel. The NIBIB requires the PI to devote at least 25% effort to the Center. The percent effort for each member of the BTRC staff should be broken down by component (TR&D projects, Collaborative Projects, Service Projects, Training, and Dissemination).

A justification should be supplied for the equipment requested for the Center. Price quotes should be included for major items of equipment costing more than $25,000. The budget justification section should include an evaluation of alternative instruments or manufacturers along with a discussion of the proposed procurement plan.

A budget ceiling of $700,000 per year in direct cost, excluding equipment cost, and a budget ceiling of $500,000 in equipment for the duration of the requested project are placed on BTRC grants. Waivers to these ceilings may be requested. Applicants should direct such requests to program staff. Waivers require written approval by the Associate Director for Extramural Science Programs (NIBIB). Applicants must include this approval letter in their application, following the budget justification. In applications where the budget request exceeds the ceilings, scientific reasons for exceeding the ceiling must be provided in the application. A waiver must be requested at least six weeks in advance of submission of the application. Applications exceeding these ceilings will be returned without review if written approval has not been granted prior to submission.

Major equipment purchases (more than $500,000 over the course of the project period) often require support from other sources when the BTRC Program is unable to fund the entire request. Plans for such shared funding should be detailed in the application

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the additional application copies sent directly to the NIBIB. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

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 or not reviewed.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance, research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

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 that are complete will be evaluated for scientific and technical merit by (an) appropriate scientific review group (s) convened by the NIBIB and 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:

• Undergo a selection process in which only those applications deemed to have the highest scientific and technical merit, generally the top half of applications under review, will be discussed and assigned an impact/priority score.
• Receive a written critique.
• Receive a second level of review by the National Advisory Council of the NIBIB.

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 scored review criteria, and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

For the Technological Research and Development Projects, 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?

Is the technology dynamically evolving, state-of-the-art, an important area for research and development in its own right, and likely to advance the frontiers of biomedical research? Is there synergy between the TR&D project and the Collaborative Projects in advancing the technology? How is this project unique? Is the technology already broadly available?

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, 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) protection of human subjects from research risks, 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?

For Renewal applications, is there significant progress during the past grant period?

In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the overall impact/priority score for the P41.

Component scoring

Each TR&D project receives a separate overall impact/priority score.

The following components are scored as a whole regardless of the number of activities subsumed within the component: Collaborative Projects, Service Projects, Training, Dissemination.

The Administration section does not receive a separate score, but is factored into the determination of the overall impact/priority score for the BTRC application.

A single, overall impact/priority score for the BTRC application will be assigned at the end of the discussion of the components. The overall score should not simply be the average of the individual scores, but rather should take into account the synergy of the individual components. In determining this final score, the goals of the BTRC, the stage of development of the BTRC technology, and community engagement should be taken into account.

Collaborative Projects Review Criteria

Do the Collaborative Projects provide significant applications of the BTRC technologies? Do the Collaborative Projects motivate further technological research and development in the BTRC?

For Collaborative Projects that have not been peer-reviewed, what is the level of scientific merit of the research proposed?

For Renewal applications, does the BTRC have an appropriate balance between time and effort spent on Collaborative Projects and Service Projects, and is there significant progress during the previous grant period?

Service Projects Review Criteria

Is the BTRC available to outside users? Are the equipment and technology utilized for Service Projects state-of-the-art? Do the equipment and technology meet significant biomedical research needs? Do the Service Projects have a national geographical distribution? For BTRCs that do a substantial amount of service, are the plans for sharing costs by the users, including fee-for-service systems, appropriate?

For Renewal applications, is there significant progress during the previous grant period?

Training Review Criteria

Are plans to provide training opportunities appropriate? Is there a direct and meaningful interaction between BTRC personnel and the trainee? Are sufficient resources allocated for Training, so that non-specialists can make the best possible use of the new technologies?

For Renewal applications, have there been reasonable results to date?

Dissemination Review Criteria

Are the proposed Dissemination plans adequate and appropriate?

For BTRCs that are developing software, is the software portable when appropriate, well-documented, user-friendly, and readily available to the user community?

Have there been efforts to make both non-expert and expert communities aware of the new technology?

For Renewal applications, is the web site easy to find? Does the material on the web site provide useful information to the biomedical research community? Has there been reasonable and timely progress in this area?

Administration Review Criteria

Are the administrative aspects presented in the written proposal appropriate and adequate? Is the space set aside for the BTRC and the laboratory facilities, including those available to visiting scientists, appropriate and adequate? In the case of a Renewal application, is the usage of the instruments developed and supported by the BTRC appropriate and adequate? Are instruments in place and operational, and are staff members currently on site?

Is the institution's commitment to the BTRC appropriate and adequate?

Are the scientific and managerial credentials of the Principal Investigator and the credentials of other key professional and technical staff appropriate?

For New applications, are the plans for the External Advisory Committee appropriate?

For Renewal applications, is the role of the External Advisory Committee appropriate? Do the members of the External Advisory Committee have sufficient breadth and ability to take an effective role in the review and guidance of BTRC operations? Is there evidence that the External Advisory Committee is active? Are there plans for rotation of the members of this committee?

If other committees such as a local Executive Committee are proposed, are the composition and organizational plans for these committees adequately described? How they will benefit the BTRC?

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.

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. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

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.

Transition Plan. For final five-year Renewal applications, reviewers will consider the appropriateness of the research plan given that the BTRC will not be renewed at the end of the final five-year period.

Applications from Foreign Organizations. Applications from Foreign Organizations are not allowed.

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 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 applications. The following will be considered in making funding decisions:

• Scientific merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Compliance with resource sharing policies

NIH considers the following in evaluating Center grant applications:

• The scientific and technical merit of the proposed program
• The qualifications and experience of the center director and other key personnel;
• The statutory and program purposes to be accomplished;
• The extent to which the various components of the proposed program would be coordinated into one multi-disciplinary effort within the center;
• The extent to which the center's activities would be coordinated with similar efforts by other organizations;
• The administrative and managerial capability of the applicant; and
• Other factors which the awarding IC considers appropriate in light of its particular statutory mission

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his 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.

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.

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.

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

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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. Applicants are strongly encrouaged to discuss New, Resubmission or Renewal applications with the NIBIB Program staff well in advance of the application deadline.

1. Scientific/Research Contacts:

Christine Kelley, Ph.D.
Director, Division of Discovery Science and Technology
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Boulevard, Suite 200
Bethesda, MD 20892
Telephone: (301) 451-4778
Fax: (301) 480-1614
Email: [email protected]

Alan McLaughlin, Ph.D.
Director, Division of Applied Science and Technology
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Boulevard, Suite 200
Bethesda, MD 20892
Telephone: (301) 496-9321
Fax: (301) 480-1614
Email: [email protected]

2. Peer Review Contacts:

David T. George, Ph.D.
Director, Office of Scientific Review
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Boulevard
Suite 920, Room 956
Bethesda, MD 20892-5469 (20817 for courier service)
Telephone: (301) 496-8633
FAX: (301) 480-0675
Email: [email protected]

3. Financial or Grants Management Contacts:

Angela Eldridge
Office of Grants Management
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Boulevard, Suite 900
Bethesda, MD 20892
Telephone: (301) 451-4793
FAX: (301) 480-4974
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

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

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, 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.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.

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.

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.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (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 Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html), investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award. For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

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

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

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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

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

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

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/.