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 Allergy and Infectious Diseases (NIAID), (www.niaid.nih.gov)

Title: National Biocontainment Laboratories (NBLs) Operations Support Limited Competition (UC7)

Announcement Type
New

Related Notices

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

Request For Applications (RFA) Number: RFA-AI-10-018

Catalog of Federal Domestic Assistance Number(s)
93.856

Key Dates
Release Date: June 10, 2010
Letters of Intent Receipt Date(s): Not Applicable
Application Receipt Date(s): July 13, 2010 (Extended to August 16, 2010 per NOT-AI-10-037)
Peer Review Date(s): October, 2010 (Now December 2010 per NOT-AI-10-037)
Council Review Date(s): January, 2011
Earliest Anticipated Start Date: May, 2011
Additional Information To Be Available Date (Url Activation Date): http://www.niaid.nih.gov/ncn/qa/revniaid.htm
Expiration Date: (Now Expired August 17, 2010 per NOT-AI-10-037), July 14, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
D. Application Assignment
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
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Dispute Resolution Process
3. Reporting

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

The purpose of this limited competition FOA, issued by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, is to continue operations support for Biosafety Level 4 (BSL4) facilities at the National Biocontainment Laboratories (NBLs) at the University of Texas Medical Branch (UTMB) in Galveston, Texas and Boston University in Boston, Massachusetts. Operations support is provided in the following areas: facility maintenance and operations; biosecurity (including biosurety) environmental health and biosafety regulations and requirements; regulatory compliance; and specialized research support services.

The overall goal of the NBL Operations Support Program is to enable the NBLs to develop and maintain the research resources infrastructure and facilities required to conduct research that will facilitate the development of next generation therapeutics, diagnostics and vaccines for infectious diseases. As part of the NIAID Biodefense Network, NBLs are expected to be a national resource and to provide maximum containment research facilities for NIAID funded investigators and other research, as appropriate. Additionally, the NBLs must be prepared and available to provide facilities and support to first-line responders in the event of a public health emergency.

Background

NIAID awarded construction grants to the University of Texas Medical Branch and Boston University in 2003 to construct state-of-the-art BSL2/3/4 facilities to provide critical research resources, as recommended in 2002 by the NIAID Blue Ribbon Panel on Bioterrorism and Its Implications for Biomedical Research. As noted in the Broad Agency Announcement issued by NIAID for the construction (https://www.fbo.gov/index?s=opportunity&mode=form&id=6935f85a868e77e823d2426c8def0657&tab=core&_cview=1), recipients of NBL awards may compete for anticipated operations funding to support on-going costs. To that end, NIAID funded operations support grants in 2006 (http://www.grants.nih.gov/grants/guide/notice-files/NOT-AI-05-044.html) while construction of the facilities was ongoing to support the development and establishment of the NBLs organizational structure and operations support cores; this FOA is intended to continue this operations support. Even though the NBLs are at different levels of functionality, the costs of operating maximum containment laboratories are considered extraordinary for a typical university research laboratory. In order to conduct the critical research on biodefense and emerging and re-emerging infectious diseases in an environment that is safe and secure, continuing NBL operations funding support is essential.

Goals and Objectives

The objective of this FOA is to support the continuation of the National Biocontainment Laboratories (NBLs) Operations Support Program for the purpose of developing and maintaining the research facilities, resources and infrastructure needed to conduct research that will facilitate the development of next generation therapeutics, diagnostics and vaccines for infectious diseases.

To accomplish this, applicants must propose Operation Support Cores that address the following five areas:

Facility Maintenance and Operation Provides high containment operational management monitoring and oversight; routine facilities maintenance and upkeep of the physical plant that supports the high containment space including a preventative maintenance plan for all BSL 4 equipment and systems; non-routine emergency repairs of BSL4 equipment and systems; specialized training for facilities personnel working in and around BSL4 space and associated building systems; and community outreach and communications.

BioSecurity Ensures compliance with all evolving legislation and regulations related to control of select agents and other highly pathogenic agents; devises and directs relevant staff training activities; develops and implements prospective BSL 4 staff screenings and background checks; assists in planning for required biosecurity drills; and manages inventory and access to select agent inventories. Components of a laboratory biosecurity program include physical security, personnel security, material control & accountability, transport security, and information security.

Environmental Health and Biosafety Regulations and Requirements -- Provides critical health, safety, and training services; maintains consistency in biosafety and biocontainment practices; provides biosafety theory education and hands-on training; and leads registration, record keeping and administrative activities of the Select Agent program. Continuously maintains and monitors the integrity of the BSL4 containment areas; provides expertise in areas of primary containment operations, maintenance and certification; leads decontamination, retesting, and certification of BSL4 containment facilities; maintains the capability to respond to potential emergency events; and establishes a plan for the orderly shutdown and decontamination of containment due to weather or other events.

Regulatory Compliance - Provides oversight and coordination of all research functions that require compliance with regulatory statutes and guidelines for the purpose of supporting product licensure, promoting accuracy and integrity of any data generated in such studies; conducts relevant GLP compliance training for core directors and key staff; develops and maintains policies and procedures pertaining to GLP research; and provides advice and oversight for equipment procurement and facility commissioning activities.

Integrated Support Services Provides specialized services essential to support BSL 4 activities in such cores as veterinary, imaging, insectary, and aerobiology services. These services are to provide only partial costs of specialized support resources and therefore the NBLs are required to develop and implement cost reimbursement business models that will generate grant or contract support for the direct costs of the research.

The NBL Core directors and support services staff are encouraged to collaborate with other NIH-funded investigators. In addition, the NBLs organize and promote relationships with pharmaceutical and biotechnology companies; with federal, state, and local agencies; and with other qualified investigators to foster translational research and promote maximal use of the Core facilities and NBL expertise by a broad range of qualified scientists. In times of a national biodefense or EID emergency, the NBLs will be expected to rapidly realign their activities to assist response efforts within the US. This includes making their core facilities, scientific expertise, and other resources available to assist in the implementation of national emergency plans.

Examples of anticipated research areas using the NBLs as a resource include, but are not limited to, the following:

To ensure that the NBLs Operations Support Program contributes maximally and effectively to the NIAID biodefense and emerging infectious diseases effort, the overall direction and scope of activities of the Program will be coordinated and monitored by the NIAID Biodefense Facilities Program Office, in collaboration with the NBL Principal Investigators. The NBLs will be members of the NIAID Biodefense Network, a group consisting of the principal investigators (PIs) of the National and Regional Biocontainment Laboratories, Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases (RCE), and the NIAID Biodefense Facilities and RCE Program Office staff. The Network will meet at least annually to discuss matters of mutual interest and to coordinate activities.

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 will use the UC7 award mechanism(s). The Project Director/Principal Investigator (PD/PI) 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).

This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

2. Funds Available

The estimated amount of funds available for support of the two NBL projects awarded as a result of this announcement is $30 million in total costs for fiscal year 2011. Future year amounts will depend on annual appropriations.

Because the nature and scope of the proposed activities 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 and the receipt of a sufficient number of meritorious applications. Moreover, the operation support provided to each site will be limited to a level commensurate with the site’s scientific capacity and capability for research activities. Final determination of funding will be based on institutional need at the time of annual, incremental award as determined by NIAID.

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:

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed activities as the PD/PI 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 program support.

Commons prior to the submission of the application (see http://grants.nih.gov/grants/ElectronicReceipt/preparing.htm for instructions).

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 submit only one application.

Resubmissions. Resubmission applications are not permitted in response to this FOA.

Renewals. Renewal applications are not permitted in response to this FOA.

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: GrantsInfo@nih.gov.

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 and 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.

The exceptions from the PHS 398 instructions and detailed information on the application structure and components are provided in Section IV.6 Other Submission Requirements . All applicants must follow the specific instructions in that section.

Applications with Multiple PDs/PIs

Not applicable to this FOA. In addition, multiple PIs on individual Cores are not allowed.

3. Submission Dates and Times

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

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): Not Applicable.
Application Receipt Date(s): July 13, 2010
Peer Review Date(s): October, 2010
Council Review Date(s): January, 2011
Earliest Anticipated Start Date: May, 2011

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

3.B. Sending an Application to the NIH

Applications must be prepared using the 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 material must be sent to:

Peter R. Jackson, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3133, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
FedEx Zip 20817-7616
Telephone: (301) 496-8426
Fax: (301) 480-2310
E-mail: pjackson@mail.nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute. Incomplete and/or non-responsive applications will not be reviewed.

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at 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 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 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

Supplemental Instruction for the Preparation of Multi-Core Applications

The following section supplements the instructions found in Form PHS 398 for preparing a multi-Core grant application (UC7). Additional instructions are required because the Form PHS 398 is designed primarily for individual, free-standing research project grant applications, and has no specific instructions for multi-Core applications consisting of Cores interrelated by a common theme.

The supplemental instructions for multi-Core applications below are divided as follows:

A. General Instructions addresses collaborative efforts among cores, the administrative and organizational structure as well as the overall facilities and environment, and the overall budget.

B. Specific Instructions for Cores Describes modifications to PHS Form 398 instructions on selected items to address the collaborative or interactive role of the Core.

A. General Instructions

All applications must be submitted on Form PHS 398. The multi-Core grant application should be assembled and paginated as one complete document.

1. Form Page 1 - Face Page

Items 1 - 14: complete these items as instructed. This should be the first page of the entire application and all succeeding pages should be numbered consecutively.

2. Form Page 2

Using Page 2 of Form 398, provide a succinct but accurate description (abstract) of the OVERALL multi-Core application addressing the major, common theme of the program. Do not exceed the space provided.

List the performance sites where the core activities will be conducted.

Under "Key Personnel", list the PD(s)/PI(s) of the multi-Core application, followed by the Core Leaders of the component cores, and other key personnel and then other significant contributors.

3. Form Page 3 - Table of Contents

Do not use Form Page 3 of the PHS 398; a more comprehensive table of contents is needed for a multi-Core application.

Bearing in mind that the application will be scientifically reviewed by core components , prepare a detailed Table of Contents that will enable reviewers to readily locate specific information pertinent to the overall application as well as to each component Core. A page reference should be included for the budget for each Core. Further, each Core should be identified by letter (e.g. Core A), title, and responsible Core Leader. The page location of a COMPOSITE BUDGET should be indicated in the "Table of Contents."

4. Composite Budget

Do not use Form Page 4 of PHS Form 398. Instead, using the suggested format presented below, prepare a Composite Budget For All Proposed Years of Support. (Justification for budget elements should not be presented here but in the individual budgets of the Cores.)

SAMPLE: Consolidated Direct Cost Budget for All Proposed Years of Support

Component

Year 1

Year 2

Year 3

Year 4

Year 5

All Years

Area 1 - Core A

125,000

130,000

135,200

140,608

146,232

677,040

Core B

125,000

130,000

135,200

140,608

146,232

677,040

Area 2 - Core C

100,000

104,000

108,160

112,486

116,985

541,631

Core D

50,000

52,000

54,080

56,243

58,493

270,816

Core E

25,000

50,000

52,000

54,080

56,243

237,323

Totals

425,000

466,000

484,640

504,025

524,185

2,403,850

5. Form Page 5

Complete the Total Direct Cost line entries for all requested budget periods (years) and the Total Direct Cost for Entire Period of Support entry. Detailed budgets are required within the descriptions of each Core (see below). If the FOA allows for budget requests beyond 5 years, use a second Form Page 5 to reflect the additional budget years requested.

6. Biographical Sketch Format Page

Biographical sketches of all professional personnel for all components should be placed at the end of the application with the PI(s)/PD(s) first, followed by those of other key personnel in alphabetical order.

7. Resources Format Page

Do not complete. Essential information is to be presented in the individual core sections of the application.

8. Program Overview (Objectives and Strategic Plan)

This narrative section provides a Program Overview of the NBL that summarizes the overall objectives and strategic plan for the operation and use of the NBL and its Cores and is limited to 30 pages. Include the facility plans, the status of construction and schedule for completion, the proposed Cores and the proposed timetable for their establishment and development to full operation. Describe the NBL organization and management plans and the processes to be used to establish operations support priorities. Describe the NBL and Core leadership in terms of training, experience and qualifications for their proposed roles and responsibilities. Describe the purpose, structure, and functions of any advisors or advisory groups to the NBL. Address how the NBL and the proposed cores will interface with, support, and be supported by, the parent institution environment including the existing management and operations systems, processes and facilities. Address plans for maintenance of the facility including the portions of the work that will be subcontracted, anticipated maintenance schedules, quality control and performance standards. Address how the NBL will interface with the NIAID Biodefense Network, a group that includes the Principal Investigators of the NBLs, the Regional Biocontainment Laboratories (RBLs), the Regional Centers of Excellence in Biodefense and Emerging Infectious Diseases Research (RCEs), and NIAID RCE/NBL/RBL Program Officers. Address how the NBL will be prepared to and respond in the event of a national public health emergency. Address proposed methods for recovering costs of support for research projects conducted, in whole or in part, at the NBL. Address plans for staff training and development. Training that can be supported by the NBL is limited to targeted instruction in the conduct of research in biocontainment facilities, including the specialized training for maintenance of high containment facilities and the essential training needed for personnel of the proposed cores.

9. Checklist

One Checklist, placed at the end of the application, is to be submitted for the entire application.

10. Appendix Materials

Refer to Section IV.6. Appendix Materials below, for instructions on submitting appendix materials.

For each core in the application, 3 publications plus other approved material are allowed. A single appendix for the application may be submitted in pdf format. Appendix material is limited to 100 pages. Include supporting material such as architectural renderings. Provide a Table of Contents for the Appendix and label each appendix item so that it is linked to the appropriate section of the application (e.g., overview or specific core).

B. Specific Instructions for Core(s)

Except for the requirements below, follow the PHS 398 Specific Instructions found at http://grants1.nih.gov/grants/funding/phs398/phs398.doc#_Toc130797900 in preparing each proposed core.

For each individual Core, include:

Cover page (see special instructions, below)

Description & Key personnel (PHS 398 Form Page 2)

Table of Contents (PHS 398 Form Page 3)

Budget Pages (PHS 398 Form Pages 4 and 5); with budget justifications

Operations Support Core Plan

Resources Format Page

NOTE: Multiple PIs on individual Cores are not allowed.

1. Cover Page.

The Face Page of the 398 Form should not be used as a cover page for Cores within the application. Instead, use the 398 continuation page to create a "Cover Page" containing selected data about each individual core. This Cover Page will demarcate each core and should contain the following information items (which are a subset of the information provided on a Face Page - see PHS 398):

Core Letter and Core Title: (e.g., A. Monoclonal Antibody Production Core)

Name of Core Leader: (e.g., Smith, Robert A.)

Human Subjects (Yes or No)

If Yes,

Exemption Number, -or-

IRB Approval Date (e.g., 5/14/06, or Pending), and Federalwide Assurance (FWA) number

Vertebrate Animals (Yes or No)

If Yes,

IACUC Approval Date (e.g., 4/15/07, or Pending), and Animal welfare assurance number

Proposed Period of Support

From: (mmddyy, e.g., 07/01/2007)

To: (mmddyy, e.g., 06/30/2012)

Costs Requested for Initial Budget Period

Direct Costs (e.g. $50,000)

Total Costs (e.g. $70,000)

Costs Requested for the Entire Budget Period

Direct Costs (e.g. $212,323)

Total Costs (e.g. $297,252)

Applicant Organization (ABC University; 111 Main Street; Anywhere, Else 99999)

The following are specific instructions for sections of the PHS 398 application form that are to be completed differently than usual. For all other items in the core application, follow the usual PHS 398 instructions.

2. Form Page 2.

Provide a Description (abstract) of the core activities and services according to the instructions on Form Page 2 of the PHS 398. In addition, the abstract should contain a brief description of how the core services will contribute towards attainment of the program objectives.

List the performance sites where the core activities and services will be conducted.

Under "Key Personnel", list the Core Leader, followed by other key core personnel, and then other significant contributors.

3. Form Page 3. Prepare a Table of Contents for the core using page 3 of Form PHS 398.

4. Budget Pages (PHS 398 Form Pages 4 and 5)

Prepare a detailed budget and justification for the core using Form Pages 4 and 5 of the PHS 398.

5. Operations Support Core Plan

Specific Aims (Limited to 1 page.)

List in priority order, the broad, long-range objectives and goals of the proposed Core. State the core’s relationship to the NBL’s goals and how it relates to the other cores in the application.

Core Strategy (Limited to (12) pages.)

Organize the Core Strategy in the specified order as stated in the PHS 398 Instructions, Section 5.5. Make sure to start each section with the appropriate section heading in order, Significance, Innovation, Approach, and include the appropriate information. Experimental details should be cited using the Bibliography and Reference Cited section and need not be detailed in the Research Strategy. Preliminary Studies for new Cores and progress reports for renewal Cores in a renewal application must be included as part of the approach section.

A Core is a shared component that enables the NBL to function as a resource to investigators who require these facilities in which to conduct their independently funded individual research projects. Cores should be designed to furnish a group of investigators some service, technique, assay, or instrumentation in a manner that will enhance the research in progress, consolidate manpower effort, and contribute to cost effectiveness. Cores may be proposed in relation to any acceptable research activity of the NBL. The reasons and justifications for proposing a core are important; NBL Cores are to be justified on the basis of need for NBL management and operation and use by independently funded NBL or NBL-linked investigators. The justification should describe how the Core will contribute to the management and operation of the NBL, increase the efficiency of the research programs and enhance the research productivity of the investigators. In addition, indicate how these activities will interface with parallel, existing programs or processes at the institution and describe how the Core is supported by, and provides support to, the institutional environment. The Operations Support Core plan should address the following:

6. Resources

Provide information on resources available for the core. Describe how the environment in which the work will be done contributes to the probability of success (e.g., institutional support, physical resources, and intellectual rapport.) Describe any special facilities used for working with biohazards or other potentially dangerous substances.

7. Biographical Sketches

Do not repeat the biographical sketches of participating investigators since this information will be included at the end of the overall application (and therefore will be referenced in the Overall Table of Contents).

See Section IV.2, Content and Form of Application Submission and additional text above for page limitations associated with multi-Core applications.

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).

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 application. 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.

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: Investigators seeking $500,000 or more in direct costs in any year 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 and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIAID 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:

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

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? Are the management and operation plans for the NBL to function as a regional and national resource for Biodefense research adequate and feasible? Are the overall goals effectively focused on the objectives of the FOA and the mission of the NIAID in biodefense and emerging infectious diseases?

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, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do the proposed Core leaders have the appropriate qualifications, training, experience, availability and level of effort for the work described?

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 core? Are potential problems, alternative strategies, and benchmarks for success presented? If the core is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Is there sufficient coordination and synergy of the individual cores towards the achievement of the central objectives of the proposed NBL?

If the core 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? Will the proposed cores adequately support NBL operations and enhance the NBL research base? Are the plans and procedures for quality control, cost effectiveness and cost reimbursement clear and reasonable? Is the plan for the core to promote NBL interdisciplinary research and to provide unique research opportunities well documented and meritorious?

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? Are the facilities and equipment appropriate for the proposed level of work?

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. Resubmission applications are not applicable to this FOA.

Renewal Applications. Renewal applications are not applicable to this FOA.

Revision Applications. Revision applications are not applicable to this FOA.

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.

Applications from Foreign Organizations. Not applicable to this FOA.

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

The following will be considered in making funding decisions:

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.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (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).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

2. A.1. Principal Investigator Rights and Responsibilities

a. Awardees will have primary responsibility for the project as a whole, including all phases of the management, operation and maintenance of the NBL. Such activities include research design and conduct, data collection, data quality control, data analysis and interpretation and preparation of publications, as well as collaborations with other awardees. Awardees will retain primary custody of and have primary rights to the data developed under these awards, subject to government rights of access consistent with current HHS, PHS, and NIH policies. However, awardees must be committed to making the therapeutic, vaccine and diagnostic products and other research tools and research materials they develop available to the biodefense and emerging infectious disease research community through the NIAID Biodefense and Emerging Infectious Diseases Research Resources Program or other appropriate vehicles.

b. Awardees agree to establish and maintain appropriate committees or other oversight groups for the NBL that include external scientific advisors as well as appropriate community members. Awardees also agree to maintain community outreach and education efforts throughout the period of support.

c. Awardees agree to participate in projects identified by the NIAID Biodefense Network that include common research interests that address specific biodefense problems or emerging infectious diseases.

d. The Principal Investigator must attend and participate as a voting member in regular meetings of the NIAID Biodefense Network to discuss progress and directions of research and to ensure that overall NIAID Biodefense Agenda goals are being met. The Principal Investigator must participate, as needed, in regular, local meetings of the associated NBL, RBL and RCEs to discuss progress and directions of research and to ensure that the necessary interdisciplinary interactions are taking place. Additionally the Principal investigator must ensure that the facilities of the NBL are utilized to the fullest extent possible and that procedures remain in place to make facilities available to qualified users in the region /country.

e. Each NBL will submit annual progress reports to the NIAID that describe activities and accomplishments during the previous funding/reporting period and attend an annual program meeting. NIAID may also schedule site visits or reverse site visits with awardees periodically.

f. Awardees agree to operate the facility in a manner consistent with biosafety guidelines in the BMBL, the Select Agent Rule, and all other applicable federal, state, and local laws, regulations, and guidelines.

g. Awardees will be responsible for operating and maintaining the physical plant (facilities) in such a way that deterioration of the facility is prevented and that its ability to serve its intended purpose of providing an environment where biological research may be conduced in a safe, secure and efficient manner is preserved.

h. Awardees agree that the facilities must be used in support of the NIAID Biodefense Agenda or other NIAID approved biomedical research activities for which is was constructed for twenty years after occupancy unless prior written approval has been obtained from the NIAID. In addition, the facility must be available and prepared to assist national, state, and local public health effort in the event of a bioterrorism emergency.

i. All awardees must adhere to the Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources (64 Federal Register 72090).The Principles and Guidelines can be accessed electronically at: (http://ott.od.nih.gov/).

j. Monitoring Clinical Studies. When clinical studies or trials are a component of the research proposed for conduct in whole or in part in the federally-supported NBL, NIAID policy requires that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. The full policy, including terms and conditions of award, is available at: http://funding.niaid.nih.gov/ncn/clinical/clinterm.htm.

k. Select Agents. All U.S. awardees must be in compliance with the U.S. Select Agent Regulations (http://www.cdc.gov/od/sap/) and NIH Guidelines for Research Involving Recombinant DNA Molecules (http://oba.od.nih.gov/rdna/nih_guidelines_oba.html). Award to a U.S. Institution: Before using NIH funds, the awardee must complete registration with CDC (or USDA, depending on the agent). No funds can be used for research involving Select Agents if the final registration certificate is denied. Award to U.S. Institution with Foreign Institution Participation: Before using NIH funds for any work directly involving the Select Agent at the US institution, the awardee must complete registration with CDC (or USDA, depending on the agent). No funds can be used for research involving Select Agents if the final registration certificate is denied. Before using NIH funds for any work directly involving the Select Agents at the foreign institution, the US awardee must provide information from the foreign institution to the NIAID that a process equivalent to that described in 42 CFR 73 for US institutions is in place and will be administered on behalf of all Select Agent work sponsored by these funds. All foreign laboratories are inspected to determine if the site has minimum biosafety and biosecurity procedures in place for working with Select Agents. During inspections the awardee must be willing to address the following key elements appropriate for the foreign institution: safety, security, training, procedures for ensuring that only approved/appropriate individuals have access to the Select Agents, If available, the awardee will be asked to provide copies of any applicable laws, regulations and policies equivalent to 42 CFR 73.

l. Consortium Plan. In order to promote discussion and early consensus among the participants regarding intellectual property (IP) and management matters that may arise during NBL supported projects, the applicants are required to submit a consortium plan within six (6) months of the receipt of an award, and this requirement will be a term of award. While the specific terms of such a plan are left to the parties involved, NIAID recommends that the applicants consider the following points in the plan:

m. Protection of Proprietary Data. Raw and primary data may be provided exclusively to the NIAID, industrial collaborators, and the FDA, as appropriate. This provision shall not affect the investigators' right to disseminate their research findings through publications or presentations.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

2. A.2. NIH Responsibilities

An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

a. The role of NIH staff in the cooperative agreement arrangement is to support and stimulate the recipient's activities by substantial involvement as facilitators in the process without assuming responsibilities that remain with the PI. The NIAID Program Officers assigned to each NBL will work closely with the PI and other RCE/RBL/NBL member scientists to facilitate collaborations with other NIAID-funded research groups and to leverage the resources available in the NBL. They will assist and facilitate this process and not direct it. Other NIAID staff will be responsible for normal program stewardship and monitoring of award. NIAID Program Officers will monitor the progress of the NBL as well as other participants in the RCE/RBL/NBL programs, helping coordinate activities between them, and contributing to the adjustment of research projects or approaches as warranted. The NIAID Program Officers will assist and facilitate this process and not direct it.

b. The Program Officers will also monitor activities to assure consistency with the overall goals of the RCE/RBL/NBL Program and the NIAID biodefense and emerging infectious diseases mission. When appropriate, issues may be brought to the NIAID Biodefense Network for advice.

c. NIAID RCE/RBL/NBL Program Officers will help organize an annual meeting of The NIAID Biodefense Network.

d. The NIAID Program Officers will keep the NBL informed about other ongoing studies supported by NIAID to avoid duplication of effort and to encourage sharing and collaboration in the development of new clinically useful reagents and methodologies for biodefense and emerging infectious diseases research. The NIAID Program Officers will coordinate access for the NBL to other resources from NIAID, including NIAID sponsored contracts for preclinical and clinical testing, drug screening, preclinical toxicology testing, and assistance in IND filing, etc. NIAID Program Officers assist the research efforts of the NBL by facilitating access to fiscal and intellectual resources provided by industry, private foundations, NIH intramural scientists and other federal government agencies.

2.A.3. Collaborative Responsibilities

a. The NIAID Biodefense Network will provide overall scientific coordination of the RCE /RBL/NBL Program; RCE Principal Investigators,, PIs of the RBL/NBLs (BSL3/4 facilities), and the NIAID RCE/NBL/RBL Program Officers will be members. Additional NIAID Program Staff and scientists other than PIs may attend when additional expertise is required.

b. The NIAID Biodefense Network will meet yearly or as needed. The purpose of these meetings is to share scientific information, to assess scientific progress, to identify new research and development opportunities and potential avenues of collaborations such as with industry, private foundations, NIH intramural scientists, and other federal government agencies and to establish priorities that will accelerate the translation of preclinical findings into clinical applications, reallocate resources and conduct other business of the RCE/RBL/NBL Programs.

c. The Network may recommend redirection of certain efforts in RCE/RBL/NBLs when results and data suggest that ongoing activities are no longer feasible or progressing toward desired goals. The Network will be called upon to make recommendations regarding approaches to specific threat agents and emerging diseases that require attention as the need arises. The Network will also seek input from the scientific research communities, and help the NIAID determine initiatives that will have an impact on the health and safety of the nation. The Network will also provide a forum for coordinating RCE/RBL/NBL activities that require a liaison function with other federal agencies such as FDA, USDA, and CDC.

Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

2.A.4. Dispute Resolution Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

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:

1. Scientific/Research Contacts:

Nancy Boyd
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room 3606, MSC-6603
6610 Rockledge Drive
Bethesda, MD 20892-6603
Telephone: (301) 402-8585
FAX: (301) 480-1263
Email: nboyd@niaid.nih.gov

2. Peer Review Contacts:

Peter R. Jackson, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3133, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
FedEx Zip 20817-7616
Telephone: (301) 496-8426
Fax: (301) 480-2310
E-mail: pjackson@mail.nih.gov

3. Financial or Grants Management Contacts:

Michael Fato
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2123, MSC-7614
6700-B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: (301) 402-6581
FAX: 493-0597
Email: mf59e@nih.gov

Section VIII. Other Information

Required Federal Citations

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

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/.

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

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

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.

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