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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 on Drug Abuse (NIDA), (http://www.nida.nih.gov)

Title: NIDA Core Center of Excellence Grant Program (P30)

Announcement Type
This is a reissue of PAR-08-073.

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

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-10-220

Catalog of Federal Domestic Assistance Number(s)
93.279

Key Dates
Release Date: June 22, 2010
Letters of Intent Receipt Date(s): September 27, 2010, August 25, 2011, August 25, 2012
Application Submission Dates(s): October 27, 2010, September 25, 2011, September 25, 2012
AIDS Application Submission Dates(s): January 7, 2011, January 7, 2012, January 7, 2013
Peer Review Date(s): February 2011, February 2012, February 2013
Council Review Date(s): May 2011, May 2012, May 2013
Earliest Anticipated Start Date: July 2011, July 2012, July 2013
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: (Extended to January 8, 2014 per NOT-DA-13-010), Originally January 8, 2013

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Purpose. NIDA Core Center of Excellence Grants (P30) are intended to bring together investigators currently funded by NIH or other Federal or non-Federal sources, to enhance the effectiveness of existing research and also to extend the focus of research to drug abuse and addiction. It is expected that a Center will transform knowledge in the sciences it is studying. Incremental work should not be the focus of Center activities; rather, new and creative directions are required. A P30 should integrate and promote research in existing funded projects, to achieve new and creative directions. It is expected that individual core activities reflect a relationship to the integrating theme of the Center and the Center is expected to support the education, training, and mentoring of new investigators, and share findings, data and their resources.

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

Core Center of Excellence Grants (P30) are intended to bring together investigators currently funded by NIH or other Federal or non-Federal sources to enhance the effectiveness of existing research and also extend the focus of research to drug abuse and addiction. A Core Center of Excellence should support innovation and be on the cutting edge of science. Incremental work should not be the focus of Center Activities. It is expected that research activities will cross a variety of disciplines to bring multiple perspectives and approaches to bear on significant problems. The Center should reflect thematic integration so that the Center does not appear to support a collection of independent research projects. Multidisciplinary interactions in the Center are expected to have a synergistic effect that results in greater depth, breadth, quality of research and productivity beyond what is possible among individual research projects.

The applicant may propose pooling of existing core resources and request additional support for developing a shared research infrastructure. The research infrastructure support may include, for example, administrative coordination, subject recruitment, equipment, laboratories, statistical analysis, quality control, training in methodology, and database management. It should be made clear how this Center support would enhance a minimum of 3 funded constituent research projects with at least 2 distinct principal investigators and result in programmatic coherence, synergy and integration. Applicants must demonstrate the potential for the continuation of funding of participating projects, and there must be at least two years of funding left for each project identified at the time of submission. Funds may be requested for pilot research projects.

A NIDA P30 Core Center of Excellence grant contains an administrative core and one or more research support cores, providing centralized resources and facilities for funded research projects that will be directed to new research in drug abuse and addiction. These may include, but are not limited to, genetics, proteomics, molecular, cellular, organ, system, developmental, behavioral, clinical, treatment, social, epidemiology, prevention, health services and AIDS. Training and mentoring to enhance junior researchers or other researchers skills should be conducted consistent to the Center’s goal, but funds may not be used for training stipends or training not required to conduct the research. A Core Center may also contain a core to support pilot projects.

In addition, NIDA P30 research Centers are expected to serve as national research resources in the drug abuse research field. They are expected to attract established and promising investigators into drug abuse research, provide opportunities for research training, career development, and mentoring, as well as for community outreach to enhance effective dissemination of research findings.

Special Considerations

HIV/AIDS Counseling and Testing Policy for the National Institute on Drug Abuse: In light of recent significant advances in rapid testing for HIV and in effective treatments for HIV, NIDA has revised its 2001 policy on HIV counseling and testing. NIDA-funded researchers are strongly encouraged to provide and/or refer research subjects to HIV risk reduction education and education about the benefits of HIV treatment, counseling and testing, referral to treatment, and other appropriate interventions to prevent acquisition and transmission of HIV. This policy applies to all NIDA funded research conducted domestically or internationally. For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-07-013.html.

National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects: The National Advisory Council on Drug Abuse (NACDA) recognizes the importance of research involving the administration of drugs with abuse potential, and dependence or addiction liability, to human subjects. Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Web site at http://www.nida.nih.gov/about/organization/nacda/CouncilStatement.html.

Networking Website for Consultation and Collaboration

NIDA has established a web-based Networking Project (NNP) to encourage investigators to collaborate with other scientists to gain access to specialized expertise, unique research resources, diverse populations, or geographic locations not otherwise available. For applicants interested in identifying potential collaborators, the NNP website is available at http://nnp.drugabuse.gov, as a source of information on the mission, focus, and leadership of NIDA s research networks. The website features an interactive map with more than 300 local network sites, a directory of close to 400 addiction researchers and practitioners, and the extensive resources of 14 NIDA-supported research networks located across the country. If appropriate for the proposed research, NIDA encourages grant applicants to use the resources of the NNP and make reference in the grant application when they are utilized.

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 P30 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

Applicants may apply for up to five years of support whether as new or competing renewal applications.

A Pilot Research Project Support Core may not have an annual budget exceeding 25% of the annual budget for the NIDA Core Center.

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:

Because of the role of the Centers as national resources, foreign applicants are not eligible to apply, but investigators at foreign institutions may serve as project or core directors and otherwise participate in Center programs.

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.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://grants.nih.gov/grants/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

Multiple PDs/PIs may be designated only for the NIDA Core Center, but not for individual cores.

A single individual may not concurrently be the Center director on more than one NIDA center grant.

The Core Center director(s) should be the PD/PI for the Administrative Core.

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

The P30 must propose to support a research base of at least 3 ongoing research projects supporting at least 2 distinct principal investigators that are funded by NIH, and/or NSF, or other PHS agencies and have at least 2 years left in the award period at the time of submission.

Each Research Support Core should interact with 2 or more funded research projects.

A principal investigator of a NIDA P30 Core Center of Excellence cannot simultaneously serve as a principal investigator of another NIDA center grant.

Number of Applications. Applicants may submit more than one application, provided that each application is scientifically distinct.

Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). 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.

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.

Applications with Multiple PDs/PIs

When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a 3h for all PD/PIs. NIH requires one PD/PI be designated as the contact PD/PI for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the Contact PD/PI, et. al. The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the section of the Research Plan entitled Multiple PD/PI Leadership Plan , must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

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): September 27, 2010, August 25, 2011, August 25, 2012
Application Receipt Date(s): October 27, 2010, September 25, 2011, September 25, 2012
AIDS Application Submission Date(s): January 7, 2011, January 7, 2012, January 7, 2013
Peer Review Date(s): February 2011, February 2012, February 2013
Council Review Date(s): May 2011, May 2012, May 2013
Earliest Anticipated Start Date(s): July 2011, July 2012, July 2013

3.A.1. Letter of Intent

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

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

Email: [email protected]

Applicants are encouraged to send the letter of intent by email to the email address above but as an alternative the letter may also be sent to:

Center Grant Applications

Director
Office of Extramural Affairs
National Institute on Drug Abuse, NIH, DHHS
6001 Executive Boulevard, Room 4245, MSC 9550
Bethesda, MD 20892-8401

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:

Center Grant Applications

Director
Office of Extramural Affairs, NIDA
6001 Executive Blvd, Room 4245, MSC 9550
Bethesda, Maryland 20892-9550
Telephone: (301) 443-2755
FAX: (301) 443-0538

3.C. Application Processing

Applications must be received on or before the application receipt/ date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review.

Upon receipt applications will be evaluated for completeness by 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

The following paragraphs describe the Special Requirements for a NIDA Core Center of Excellence (P30) application. This paper submission uses the most current PHS 398 instructions cited above (Section IV.1). Applicants may consult with NIDA staff concerning the technical aspects of preparing the application.

BUDGET:

BIOSKETCHES: Provide a biosketch for the PD/PI(s) as Core Center Director, for each Research Support Core Director and for each PI holding a qualifying grant listed in the research base. Place individual biosketches in alphabetical order and do not duplicate these pages in the individual research support cores.

PAGE LIMITS: -The Overall Center, Research Support Cores, and the Pilot Research Project Support Core are limited to 1 page for Specific Aims and 12 pages for the Research Strategy. The Administrative Core is limited to 1 page for Specific Aims and 6 pages for the Research Strategy.

OVERALL CENTER (Specific Aims: 1 page; Research Strategy: 12 pages)

Use this section to describe how this NIDA Core Center will serve its biomedical research base. Describe existing environment and facilities briefly in the context of how the Core Center will use or change existing access, space and usage.

Specific Aims (1 page): Concisely state how the goals and objectives of the NIDA Core Center of Excellence will enhance the research base; include potential impact, any areas of special interest, and any research ideas, disease entities, and target populations to be studied.

Research Strategy (12 page limit): Describe how the NIDA Core Center of Excellence will serve its research base, including the required significance, innovation, and approach. Include an overview of the scientific focus of the ongoing research projects in the research base of the Core in sufficient detail to allow reviewers to judge the extent and the interrelationships of ongoing research. How Center members interact, the quality and productivity of the research programs, demonstrated or potential interdisciplinary collaborations, and how establishment of a Core Center will further extend, stimulate and provide added dimensions to the current research activities are all important considerations. The qualifying research projects have been through peer review, establishing the quality of the individual funded projects, so important aspects will be: (1) interactions and interrelationships of the research efforts; (2) uses and benefits of core services; and (3) plans to continue/develop productive collaboration among Core investigators. Documentation of a collaborative environment may be included (listing co-authored publications from PIs). In addition, use this section to describe how the Core Center will provide opportunities for training, mentoring and career development of researchers; provide outreach to drug abuse research communities, educational organizations, the general public, and policy makers; and to further scientific collaborations and dissemination of research results and act as a national resource. It is suggested that each of these activities be presented under separate subheadings in the Research Strategy.

Provide a table (within the 12 page limit) of the ongoing research projects that will interact with the Center. The required minimum number of qualifying research projects in the research base of a Core Center is three, and each must have at least two years of support remaining at the submission date of the P30 application. Use columns for the PI’s last name, the PI’s % effort on the project, the funding source e.g., R01 DA999999, the project end date (not just the current year of support), the annual direct cost, and the project title. Use one row for each project (a PI holding more than one grant will appear on more than one row), and wrapping text within columns is allowed. For listed qualifying projects that are not funded by NIDA, add a justification sentence at the bottom of the table for each, stating how it relates to NIDA’s mission areas. If relevant, a second table may be included for Additional Funded Projects planning some use of Core facilities.

Preliminary Studies/Progress Report (within the 12 page limit): This part of the Research Strategy is especially important for competing renewals or competitive revisions; for new applications, this section may be shorter and may include examples of previous/ongoing services/techniques that have provided increased productivity within the research environment. Renewal applications use this section to document the impact the NIDA Core Center of Excellence has had on research accomplishments, shared resources, new collaborations, and other outcomes enabled by the core as well as providing services as a national resource. Provide information on core usage and other benefits to the scientific research enterprise, and note any specific problems in core administration and management.

ADMINISTRATIVE CORE (Specific Aims: 1 page; Research Strategy: 6 pages)

Use regular PHS 398 form pages to describe the Administrative Core that will manage the NIDA Core Center. Start this section of the application with a cover page with the title Administrative Core. On the cover page list the key personnel, administrators and staff for the Administrative Core (not individual Research Support Cores). The Center Director(s) should be the PD/PI for the Administrative Core. Do not duplicate Biosketches provided earlier in the application. If Research Support Core Directors also help administer the NIDA Core Center, list them as well.

Resources: Describe any particular administrative facilities and environment features not covered earlier for the Overall Center section.

Specific Aims (1 page): Describe briefly how the Administrative Core administration will coordinate and manage activities across the Research Support Cores, and have an impact on the research infrastructure.

Research Strategy (6 page limit): Describe how the administration of the NIDA Core Center will enhance the research base activities, including the required significance, innovation, and approach. The PDPI(s) provides scientific and administrative leadership for the Center and must have demonstrated ability to coordinate, integrate, and provide guidance in establishing multi-faceted research programs. Describe the administrative framework to manage the NIDA Core Center and each core, including the roles of the Center Director(s) and Research Support Core Directors, the lines of authority and relationship to appropriate institutional officials, how access and utilization of services will be prioritized, how potential disputes will be resolved, and how periodic evaluations will be used to improve the services. Describe how the proposed Administrative Core will foster developing close interactions among the Administrative Core Center Director(s), Research Support Core Directors, the PIs of the funded projects utilizing the core, and appropriate institutional administrative personnel.

If the NIDA Core Center will have multiple PDs/PIs, the multiple PD/PI Leadership Plan should be included in this section.

Vertebrate Animals and/or Human Subjects: Separate sections must be included as required (see Section VIII and PHS 398). If not applicable, mark them N/A.

Literature Cited, Consortium/Contractual Arrangements: Include as appropriate; if not applicable, mark them N/A.

RESEARCH SUPPORT CORES (Specific Aims: 1 page; Research Strategy: 12 pages)

Each Research Support Core should interact with 2 or more funded research projects.

Present each proposed Research Support Core separately in the regular form 398 format. Give each Core a cover page with a descriptive title (e.g., Research Support Core 1: Imaging , Research Support Core A: Subject Recruitment ). The cover page should also provide a list of personnel for the core, starting with the core director and other key personnel. Do not repeat the Biosketches already presented earlier.

Resources: Include any particular equipment or spaces particular to the Research Support Core not covered earlier in the facilities and environment for the Overall Center, and describe the convenience, accessibility and distance of Core resource locations from the various core users.

Specific Aims (1 page): Concisely describe how this Research Support Core will provide new services to the individual ongoing grants beyond what is currently available, and/or increase effectiveness by sharing expertise or centralizing labor-intensive tasks, how it will encourage and facilitate collaborative work, or promote public health advances. Include impact beyond the qualifying users, if applicable to other users of the core.

Research Strategy (12 page limit): Describe how the Research Support Core facilities or services will enhance research activities of the projects using this core, and add benefits to the research accomplishments; include the required significance, innovation and approach. Include how the Research Support Core will provide increased or innovative capabilities; facilitate increased productivity or effectiveness through sharing expertise or centralizing labor-intensive tasks; and/or foster collaborative or new research directions, including bridging basic and clinical goals or attracting new investigators into an area. Each proposed technique or service in the Research Support Core, and its current status of staffing, space and equipment, should be described in enough detail to allow a comprehensive evaluation. Existing methodologies already in use may be described briefly; methodologies new to the institution need to be described in greater detail and strategies delineated for successful implementation. Include any developmental methods for research or training, if proposed. If applicable, include sections on quality control. It is critical to document benefits of the core’s activities to the existing research base.

Table of the Projected Use: Within the 12 page limit, provide a table listing the projects in the research base, by PI name and grant number/funding source, with a column showing for each project an estimate of the proportion of Core resource time used by each funded investigator. In general, no single core should be used more than 50% of the time by a single PI. If a proposed research core is not to be used 100% of the time, explain why.

Include plans for administration, organization and proposed management of the Research Support Core. Administrative organization is a critical part of the application. Include plans to implement core services, prioritize investigator use among projects competing for core use, and how potential disputes will be resolved. If the core is used to train investigators in special techniques, describe the nature and extent of this training and the qualifications of core personnel to provide and oversee this training. Specifically address the strategies for integrating the resources of the Research Support Cores with resources already provided to the research base. Describe how this integration of resources expands the capability of the research base.

Resources: Include any particular equipment or spaces particular to the Research Support Core not covered earlier in the facilities and environment for the Center, and describe the convenience, accessibility and distance of Core resource locations from the various core users

Vertebrate Animals and/or Human Subjects: Separate sections must be included as required (see Section VIII and PHS 398). If not applicable, mark them N/A.

Literature Cited, Consortium/Contractual Arrangements: Include as appropriate; if not applicable, mark them N/A.

PILOT RESEARCH PROJECT SUPPORT CORE (Specific Aims: 1 page; Research Strategy: 12 pages)

A Pilot Research Project Support Core provides short term support for new initiatives or feasibility research studies which lead to collection of sufficient data to pursue support through other funding mechanisms. This program should be directed at new investigators, at investigators established in other research disciplines with expertise that may be applied to substance abuse research and at investigators who wish to take new and innovative approaches to their research, for example to assess the feasibility of an innovative research question or approach, or the unique and innovative use of an existing methodology to explore a new scientific area. A pilot research project could be used to encourage clinical projects or translational research. By establishing ties with the institution's ongoing clinical activities, the pilot research project resources could be leveraged effectively to pursue such projects. Pilot project support need not be limited to investigators based at the Center institution (or institutions), but may be used to promote participation of investigators outside the Center through effective collaborations with Center-based investigators. Within the 12 page limit for this section, use no more than 3 pages to describe each pilot project proposed for the initial year of support.

A Pilot Research Project Support Core must include a description of a plan to solicit, review, and evaluate progress of pilot projects. Up to 25% of the direct cost budget for each year may be allocated to the Pilot Research Project Support Core. Investigators are encouraged to consult with NIDA program staff for submission of new NIH applications based on pilot project-supported data.

Resources: Include any particular equipment or spaces particular to the Research Support Core not covered earlier in the facilities and environment for the Overall Center, and describe the convenience, accessibility and distance of Core resource locations from the various core users

Vertebrate Animals and/or Human Subjects: Separate sections must be included as required (see Section VIII and PHS 398). If not applicable, mark them N/A.

Literature Cited, Consortium/Contractual Arrangements: Include as appropriate; if not applicable, mark them N/A.

Renewal

Renewal (formerly Competing Continuation ) applications must document progress in the Approach part of the Research Strategy section (within the 12 page limit). A Progress Report should describe the impact of the Center, including evidence of PI interactions with each other and recruitment of additional investigators to the substance abuse field. A Renewal application should also include: a summary of major accomplishments that can be attributed to the Core Center program, clearly emphasizing accomplishments beyond those possible from the existing support to the individual grants in the research base. Include the significance of the resources contributed by the Research Support Cores to the projects in the research base; provide evidence that the Core Center shared resources effectively and efficiently and of the extent of core use by individual PIs in the research base; describe the effectiveness of the Core Center in facilitating collaborations or helping to attract investigators to substance abuse research. Any data-sharing activities undertaken as part of the Core activities should be described and any other information that is considered directly attributable to the use and conduct of the Core Center. Provide a list of the publications (do not list manuscripts in preparation or under review) that have resulted specifically from using resources of the Core Center grant (this list is not within the Research Strategy page limit).

Renewal applications should describe the impact of the existing pilot projects program, including the processes for review, providing support and the measures of success, such as publications, subsequent funding, and career advancement of the sponsored individuals. A renewal application should include: historical overview of the Pilot Project Program during the last program period; a description of the management of the program; and a listing of all pilot projects which were supported during the last project period.

Resubmission

Resubmission (formerly Revised ) applications must have an introduction that addresses the criticisms from the previous review and notes changes made in the application. One page is allowed for introduction in the Overall Center section of the application to describe all the changes made, and one page for introduction is allowed for each component of the Core Center that has been revised. All changes in the research plan must be clearly marked following PHS 398 Instructions.

Revision

Applications for revisions to Center grants will be supported only under the most exceptional circumstances.

Revision (formerly Supplemental ) applications requesting the addition of a research core(s) to an existing P30 are allowed, but they may not exceed the term of award of the parent P30. A Revision requires a one page Introduction. In the Research Strategy section, include a brief overview of the administrative structure and research base of the parent Core Center (this could include passages from the original application), as well as a brief overview of the currently funded individual research cores. Then describe research plans for the new core and how it will be integrated into existing Center activities. Reviewers will evaluate the supplemental core in the context of the overall P30 and the appropriateness of administrative oversight.

PHS398 Research Plan Sections

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

Research Strategy, including tables, graphs, figures, diagrams, and charts, is limited to 6 pages for the Administrative Core and 12 pages for the Overall section, 12 pages for each Research Support Core and 12 pages for the Pilot Research Project Support Core.

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).

Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year

Applicants requesting $500,000 or more in direct costs for any year (excluding consortium F&A costs) must carry out the following steps:

1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as plans are being developed for the study;

2) Obtain agreement from the IC staff that the IC will accept the application for consideration for award; and,

3) Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application.

This policy applies to all new, renewal, revision, or resubmission applications. See NOT-OD-02-004.

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 submitted for this funding opportunity will be assigned on the basis of established PHS referral guidelines to the ICs for funding consideration.

Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIDA 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? How will each core support and enhance ongoing research projects beyond currently available resources, promote collaborative research and/or attract new investigators to the field, provide enhanced or increased efficiency of services, and/or offer services that are new, unique or otherwise unavailable on individual grants? If present, are translational components well designed to enhance potential collaborations leading to public health advances? How well does each individual core fit in and contribute to the overall Core Center? How relevant and interrelated are the separately funded ongoing research projects to the central theme of the Core Center of Excellence? How likely is it that meaningful collaborations are going to be established between the Core Center and the greater substance abuse research community? How likely are the Pilot projects to bring in Early-Stage Investigators, bring in established investigators new to substance abuse research or permit established investigators to change research directions? How do the proposed Enrichment Program activities, such as use of seminars, visiting scientists, workshops and use of consultants, contribute to the objectives of the NIDA Core Center of Excellence?

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? Do the Core Center Director and leaders of the individual cores have the training, leadership, commitment and ability to devote the required time and effort to the core?

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? Does the Core Center use innovative ways to communicate, to allocate resources, to promote new cross-departmental or multi-disciplinary collaborations, or to integrate activity among the research cores or across basic and clinical fields? How will each individual core contribute to the innovation of the overall Core Center?

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? Are the research support cores well integrated into the Core Center? Are there plans to establish and maintain communication and cooperation among the Center investigators? Are there adequate administrative management plans for the Core Center and the research support cores, including implementation, allocation, user prioritization, quality control and utilization of services? How well do the management plans address accountability, flow of authority, dispute resolution, evaluation and integration with the home institution fiscal and academic administration? Will at least two federally funded research investigators use each core and how significant will their use be? Will each core provide opportunities not otherwise available to the investigators; represent an appropriate cost savings/cost sharing advantage; and stimulate the development of new approaches? Is appropriate administrative organization proposed for the following:(a) coordination of ongoing research between the separately funded projects and the Center, including mechanisms for internal monitoring; (b) establishment and maintenance of internal communication and cooperation among the Center investigators; (c) mechanism for selecting and replacing professional or technical personnel within the cores; (d) mechanism for reviewing the use of, and administering funds for, the pilot project program; and (e) management capabilities, including fiscal administration, procurement, property and personnel management, planning, budgeting, and other appropriate capabilities?

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? Is the institutional commitment appropriate?

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.

If the Resubmission 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.

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.

To what degree has the research base expanded or been strengthened over the last project period? To what degree have new projects arisen from effective collaborations fostered by the existing Center? How well have the Center’s activities provided support for the substance abuse research as a national resource?

,To what extent did the Pilot Research projects support investigators previously listed? To what extent have previously supported projects been successful?

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.

Additional Review Considerations

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

Budget and Period 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:

NIH considers the following in evaluating Center grant applications:

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 Notice of Award will be generated via email notification from the awarding component to the grantee business official.

2. Administrative and National Policy Requirements

Awards to P30s involving Human Subjects activities beyond those done in the research of participating R01s (see Section IV.2) must follow instructions for Human Subjects reporting, including Human Recruitment tables and Human Enrollment tables. See also Section VIII on Federal Citations.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Notice of Award. 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:

1. Scientific/Research Contacts:

Jamie Biswas, Ph.D.
Chief, Medications Research Grants Branch
Division of Pharmacotherapies and Medical
Consequences of Drug Abuse
National Institute on Drug Abuse, NIH, DHHS
6001 Executive Boulevard, Room 4123, MSC 9551
Bethesda, MD 20892-9551
Telephone: 301-443-8096
FAX 301-443-9649
Email: [email protected]

Meyer D. Glantz, Ph.D.
Assoc. Director for Science
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse, NIH, DHHS
Suite 5185, MSC 9589
Bethesda, Maryland 20892-9589
Telephone: (301) 443-6504
Email: [email protected]

Paul Schnur, Ph.D.
Deputy Director
Division of Basic Neuroscience and Behavioral Research
National Institute on Drug Abuse, NIH, DHHS
6001 Executive Blvd., Rm 4273, MSC 9555
Bethesda, MD 20892-9555
Telephone: 301-435-1316
FAX: 301-594-6043
Email: [email protected]

Laurence R. Stanford, Ph.D.
Deputy Director
Division of Clinical Neuroscience and Behavioral Research
National Institute on Drug Abuse, NIH, DHHS
National Institutes of Health
6001 Executive Boulevard, Room 3165, MSC 9593
Bethesda, MD 20892-9593
Telephone: (301) 402-3869
FAX: (301) 443-6814
Email: [email protected]

2. Peer Review Contacts:

Mark Swieter, Ph.D.
Chief
Extramural Affairs Branch
Office of Extramural Affairs
National Institute on Drug Abuse, NIH, DHHS
6001 Executive Boulevard, Room 4235, MSC 9550
Bethesda, Maryland 20892-9550
Telephone: (301) 435-1389
FAX: (301) 443-0538
Email: m[email protected]

3. Financial or Grants Management Contacts:

Pam Fleming
Chief, Grants Management Branch
Office of Planning and Resource Management
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 4000
Bethesda, MD 20892-9560
Phone: 301-253-8729
FAX: 301-594-6849
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/.

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