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 Center for Complementary and Alternative Medicine, (NCCAM/NIH), (http://nccam.nih.gov)

Title: Centers of Excellence for Research on CAM (CERC) for Pain (P01)

Announcement Type
New

Request For Applications (RFA) Number: RFA-AT-10-002

Catalog of Federal Domestic Assistance Number(s)
93.213

Key Dates
Release Date: March 18, 2010
Letters of Intent Receipt Date: July 13, 2010
Application Receipt Date: August 13, 2010
Peer Review Date(s): November, 2010
Council Review Date(s): January 2011
Earliest Anticipated Start Date: April 2011
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: August 14, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

• Purpose. The purpose of this Funding Opportunity Announcement (FOA) is to support and enhance research on the application and use of promising complementary/alternative/integrative medicine (CAM/IM) modalities or approaches in the setting of chronic pain. Specifically, this FOA encourages applications for Centers comprised of three or four synergistic, R01-comparable projects by multidisciplinary research teams focused on the basic, mechanistic, and/or translational research questions that must be addressed in order to better understand the optimal application and use of CAM/IM interventions for treating or ameliorating chronic pain.
• Mechanism of Support. This FOA will utilize the P01 (Program Project) award mechanism.
• Funds Available and Anticipated Number of Awards. The total amount of funding that NCCAM expects to award through this announcement will depend upon the quality, duration, and costs of the applications received. It is anticipated that a maximum of three pain-focused CERC, each funded at approximately $1.25 million per year, will be awarded in FY 2011.
• Budget and Project Period. Budgets for direct costs of up to $1.25 million per year and a project duration of up to five years may be requested for a maximum of $6.25 million (direct costs) over a five-year project period.
• Application Research Strategy Length: The P01 Overview and individual Project Research Strategy sections may not exceed 12 pages each, including tables, graphs, figures, diagrams, and charts. The Research Strategy sections of Cores may not exceed 6 pages each, including tables, graphs, figures, diagrams, and charts.
• Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.
• Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
• Number of PDs/PIs. More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application.
• Number of Applications. Applicants may submit more than one application, provided they are scientifically distinct. However, multiple applications from the same applicant organization are strongly discouraged and expected only in special circumstances (e.g., separate campuses, components of large institutions).
• Resubmissions. Resubmission applications are not permitted in response to this FOA.
• Renewals. Renewal applications are not permitted in response to this FOA.
• Special Date(s). This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates.
• Application Materials. See Section IV.1 for application materials.
  Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: (301) 451-5936

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(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
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

In order to support and enhance high-priority research requiring the synthesis of multiple research approaches by multi-disciplinary research teams, this FOA encourages applications for Centers of Excellence for Research on Complementary/Alternative Medical (CAM) approaches for chronic pain. Each CERC must consist of three or four synergistic, R01-comparable projects focused on the basic, mechanistic, and/or translational research questions that must be addressed in order to better understand the optimal application and use of CAM/Integrative Medicine (CAM/IM) interventions for treating or ameliorating chronic pain.BACKGROUND

• Data from the 2002 and 2007 National Health Interview Surveys indicate that the most frequently cited health problem for which Americans use CAM/IM is pain. Over the last decade a body of basic, translational, and clinical research evidence has been assembled that points toward the potential promise of certain CAM interventions for amelioration or treatment of various specific pain conditions. Furthermore, the potential of such research to influence practice is indicated by the identification of selected CAM practices as having potential clinical application in practice guidelines. For example, guidelines of the American College of Physicians and the American Pain Society (R. Chou et al, Ann. Intern. Med., 2007) suggest that massage, spinal manipulation, and acupuncture be considered as options for treatment of some patients with chronic low back pain. Nonetheless, there remain numerous and important basic, mechanistic, translational, and clinical research questions that must be addressed in developing the quantity and quality of scientific evidence needed to establish whether these practices have real clinical utility, and how they should best be used in clinical practice. For instance, an understanding of mechanisms of action may be crucial in optimizing clinical interventions, or in developing appropriate and optimal outcome measures, surrogate markers, or biomarkers for use in clinical trials of efficacy or studies of clinical effectiveness. Similarly, clinical trial design requires a thorough understanding of optimal dosing, measures of fidelity and adherence, and choice of control.
• Research on some particularly promising CAM approaches to pain requires the kind of multi-disciplinary, multi-level, interactive approach facilitated by the program project grant mechanism.

SPECIFIC OBJECTIVES OF THIS FOA

• NCCAM envisions that CERC for chronic pain will provide a vehicle for accomplished researchers to apply their expertise to highly focused basic, mechanistic, and/or translational CAM/IM research questions, with an emphasis on applying synergistic, cutting-edge scientific approaches to the study of CAM/IM therapies and modalities that have substantial potential to improve management of chronic pain. Applications must contain three to four research projects structured around a central research theme that is clearly relevant to the use of CAM/IM interventions for prevention, treatment or amelioration of chronic pain.
• To be eligible for this FOA, the proposed Center must be focused on basic, mechanistic, and/or translational research that aims to build a body of evidence concerning the clinical application of CAM/IM interventions to chronic pain.
• For the purposes of this FOA, translational research is defined as the process of applying discoveries generated during research in the laboratory and in preclinical studies to the development of clinical trials and other studies in humans.
• Specific CAM/IM interventions as applied to chronic pain are appropriate areas of focus for this FOA.
• Within the overall focus on CAM/IM applied to chronic pain, related and project-relevant research employing clinical or pre-clinical models of chronic pain, as well as pain processing, pain regulation, or systems biology approaches is also encouraged, as is research on placebo and other component or context effects relevant to a full understanding of the mechanisms of action of, and translational research on the intervention.
• Each proposed CERC must have at least one project focused on human subjects research; the human subjects research focus may be observational, mechanistic, or translational.
• Responsive applications may focus on CAM interventions for a specific population of chronic pain patients, or on a specific CAM/IM intervention for chronic pain, or may focus on CAM/IM interventions proposed to have similar mechanisms.
• Each CERC may propose administrative and/or research cores as appropriate and necessary to provide the scientific and administrative leadership, oversight, support, and coordination needed to ensure optimal progress and synergy among the Center’s investigators and research projects. Applications must clearly demonstrate how each core will serve the needs of the overall research program, and how each project will use core resources. Cores should be utilized by at least two of the proposed research projects.
• An External Advisory Committee (EAC) must be proposed and assembled as part of the leadership structure of each CERC, to independently assess progress and contributions of the CERC components and the CERC as a whole and to provide guidance to the PD(s)/PI(s). The application should describe the disciplines to be represented on the EAC. Potential EAC members should NOT be named in the application except when the application derives from a prior NCCAM CERC award and EAC members from the initial award are proposed to continue to serve on the EAC.
• CERC PD(s)/PI(s) and project leaders should plan to participate in an annual, two-day meeting with other NCCAM-funded center PDs/PIs in the Washington, D.C. area. Travel costs for this purpose should be included in the budget.
• Phase III clinical trials will NOT be supported through this FOA. Investigators interested in proposing a Phase III clinical trial are urged to discuss a potential proposal and appropriate funding mechanisms with the relevant NCCAM Program contact (please see http://nccam.nih.gov/grants/resources/).
• Applicants planning to propose research involving human subjects or biologically-active agents should consult the relevant NCCAM policies at http://nccam.nih.gov/research/policies/
• Appropriate topics for research proposed for this FOA include, but are not limited to:
• Translational studies on chronic pain, for example studies that aim to:
  • develop and assess feasibility or fidelity of treatment algorithms,
  • assess and improve protocol adherence,
  • develop, assess, and validate measures of safety,
  • develop, assess and validate outcomes,
  • develop, assess and validate mediators of outcomes, including patient-reported outcomes, surrogate markers, biomarkers, or other relevant endpoints.
• Phase I or Phase II clinical trials of CAM/IM related to chronic pain, of modest size, if they satisfy the definition of translational research and are adequately powered to meet their objectives.
• Elucidation of the mechanisms of action of CAM/IM therapies for which there exists a substantial body of evidence indicating or pointing toward efficacy in preventing, treating or managing chronic pain.
• Where clearly relevant to application of CAM/IM to chronic pain and scientifically relevant to the focus of the CERC application, research on acute pain models may be included.
• Mechanistic, and/or translational studies aimed at developing a strong body of clinical evidence concerning the safety and efficacy (or lack thereof) of specific CAM/IM approaches for various painful conditions or syndromes.

Applications that do not clearly address the targeted research focus of this FOA will be considered non-responsive and will not be reviewed.

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 Program Project (P01) 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).

2. Funds Available

The direct cost budget for each CERC is limited to $1.25 million per year for a maximum of five years. Applications exceeding this budget limit will be considered non-responsive and returned without review.

The estimated amount of funds available for support of up to three CERC projects awarded as a result of this announcement is $3.75 Million for fiscal year 2011. Future year amounts will depend on annual appropriations.

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 and the receipt of a sufficient number of meritorious applications.

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

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

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education
• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Small Businesses
• For-Profit Organizations (Other than Small Businesses)
• State Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribally Designated Organizations
• County Governments
• City or Township Governments
• Special District Governments
• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• U.S. Territory or Possession
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Regional Organizations
• Other(s):
  • Eligible Agencies of the Federal Government
  • Faith-based or Community-based Organizations

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research 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.

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://era.nih.gov/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.

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 more than one application, provided they are scientifically distinct. However, multiple applications from the same applicant organization are strongly discouraged and expected only in special circumstances (e.g., separate campuses, components of large institutions).

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: [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 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.

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 such as SO or IAR 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 entitlted 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

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

3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date: July 13, 2010
Application Receipt Date: August 13, 2010
Peer Review Date: November, 2010
Council Review Date: January 2011
Earliest Anticipated Start Date: April 2011

3.A.1. Letter of Intent

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

• Descriptive title of proposed research
• Name, address, and telephone number of the PD(s)/PI(s)
• Names and institutions of other key personnel (including all project and core leaders and co-leaders)
• Participating institutions
• Number and title of this funding opportunity

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

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

The letter of intent should be sent to:

Barbara C. Sorkin, Ph.D.
Coordinator, Centers of Excellence for Research on CAM Program, Division of Extramural Research
National Center for Complementary and Alternative Medicine (NCCAM)
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892-5475
Telephone: (301) 594-8018
Email: [email protected]

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:

Dale Birkle Dreer, Ph.D.
Division Director, Office of Scientific Review
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd., Suite 401, MSC 5475
Bethesda, MD 20892-5474
Telephone: (301) 451-6570
FAX: (301)480 2419
Email: [email protected]

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

PDs/PIs and key personnel are required to attend an annual meeting of NCCAM Center investigators, usually held in the Washington, D.C. metropolitan area. Travel costs for key personnel to attend the annual NCCAM Centers meeting must be included in the budget of each CERC.

Supplemental Instructions for the Preparation of Multi-Project Applications

The following section supplements the instructions found in the PHS Form 398 for preparing multi-project grant applications that will be submitted in paper format. Additional instructions are required because the PHS Form 398 is designed primarily for individual, free-standing research project grant applications, and has no specific instructions for multi-project applications such as the CERC, that consist of research projects interrelated by a common theme. Additional guidance for submissions to this FOA may be found at http://nccam.nih.gov/grants/CERCguidance/index.htm.

The supplemental instructions below are divided as follows:

i. General Instructions this section addresses format for the application as a whole.

ii. Specific Instructions for the Overview Section - this section addresses the overall objectives and unifying theme(s) of this multi-project Center and explains how the individual components will contribute to the overall objectives of the CERC and will mutually support each other, and why and how the synergistic interactions of the individual components will strengthen the research of the Center as a whole, contributing to research to progress in ways that could not be supported through individual research project grants. This section should also describe how each component of the proposed Center will contribute to the overall budget, and address specific interactions between individual research projects and cores. If no administrative core is proposed, the planned administrative structure of the proposed CERC should be clearly described in the Overview Section.

iii. Specific Instructions for Individual Projects this section describes modifications to PHS Form 398 instructions on selected items to address the collaborative or interactive role of the project.

iv. Specific Instructions for Cores this section describes modifications to PHS Form 398 instructions on selected items to address the collaborative or interactive role of the core. Each core must provide services or resources to at least two research projects.

i. General Instructions

All applications must be submitted on PHS Form 398.

PHS398 Research Plan Sections

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

• Specific Aims is limited to 1 page.
• Each Research Strategy section, including tables, graphs, figures, diagrams, and charts is limited to 12 pages (overview and research projects) or 6 pages (cores). The following instructions describe modifications to the standard instructions on selected items to address the collaborative or interactive nature of the CERC. For all other items in the individual project application, follow the standard instructions.

The multi-project CERC grant application should be assembled and paginated as a single, 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.

When multiple PDs/PIs are proposed, use the Face Page-Continued page to provide items 3a-3h for all PDs/PIs. The Contact PI should be listed on block 3 of Form Page 1-Face Page, with additional PDs/PIs listed on the Face Page-Continued.

2. Form Page 2

Using Form Page 2 of the PHS 398, provide a succinct but accurate summary of the OVERALL multi-project application addressing the major, common theme of the program, as well as the contributions of the individual research projects and any cores. Do not exceed the space provided.

List the performance sites where the research will be conducted.

Under "Key Personnel", list the names and institutions of the PD(s)/PI(s) of the multi-project application, followed by the names and institutions of the project and core leaders of the component research projects and cores, other key personnel, and then other significant contributors. Each research project should be identified by number (e.g. Project 1), title, and responsible project leader(s), and each core should be identified by a letter (Core A, Core B, etc.), title, and responsible core leader.

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-project application.

Bearing in mind that the application will be scientifically reviewed project by project and core by core, as well as for overall impact and synergy, 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 research project and core. Further, each research project should be identified by number (e.g., Project 1), title, and responsible Project Leader, and each Core should be identified by letter (e.g., Core A), title, and responsible Core Leader. Page references should be provided for individual project and core budget justifications, and for letters from the project and core leaders, and from institutional officials, confirming their roles in the proposed Center. Page references for the biographical sketches (clustered at the end of the application) should be provided.

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

4. Composite Budget

Using the suggested format below, prepare a composite budget for all proposed years of support. Indicate the page location of the composite budget in the "Table of Contents." Immediately following the composite budget, include a Form page 4 for the initial budget period of each individual project and core.

Narrative justification for individual budget categories should be presented for each of the projects and cores in the relevant section of the application and should NOT be presented in the Overview section.

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

Component	Year 1	Year 2	Year 3	Year 4	Year 5	All Years
Project 1.	125,000	130,000	135,200	140,608	146,232	677,040
Project 2.	125,000	130,000	135,200	140,608	146,232	677,040
Project 3.	100,000	104,000	108,160	112,486	116,985	541,631
Core A. Admin. Core.	50,000	52,000	54,080	56,243	58,493	270,816
Core B. Biostat. Core	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 and budget justifications are required within the descriptions of each individual project and core (see below).

6. Biographical Sketches

Biographical sketches of all professional personnel for all components should be provided, starting with the PD(s)/PI(s), followed by those of other key personnel in alphabetical order. Please note new instructions for the biographical sketch .

7. Resources Format Page

Do not complete for the overview section of the application. Essential information is to be presented in the individual research project and core sections of the application.

8. Checklist

Complete for the entire application and place at the end of the application package.

ii. Instructions for program overview strategy

This section is limited to twelve pages.

This narrative section summarizes the overall research strategy for the multi-project application. The CERC should be viewed as a confederation of synergistic research projects and, as applicable, cores, each of which is capable of standing on its own scientific merit, but where the ability of the Center components to mutually impact each others research justifies funding the Center as a whole, rather than through individual project grants.

This important section provides the group of investigators an opportunity to give conceptual wholeness to the overall program by giving a statement of the general problem area and by laying out a broad strategy for attacking the problems.

Include a section that specifically addresses scientific and/or programmatic synergy between projects, and between projects and proposed cores. Delineate how different components of the CERC, including key personnel, will interact, why they are essential to accomplishing the overall goal of the research, and how the combined resources create capabilities that are more than the sum of the parts. Provide examples of ways in which the proposed projects/cores are anticipated to scientifically inform and enhance each other.

Indicate the contribution of each project and core to the overall scheme, keeping in mind that each proposed core must be utilized by at least two proposed projects. Include a chart showing the percentage of core activities required for support of each project throughout the requested funding period. Summarize special features of the environment and/or resources that make this application strong or unique.

Describe the collaborative process and methods of communication, including areas of potential collaboration and areas of focused collaboration. If collaborating entities are physically separated it is especially critical to describe in detail the anticipated frequency of specific modes of communication/interaction.

Show that the research projects proposed for the CERC do not overlap in purpose or intent with existing NIH-funded grants, but will constitute new activities or a natural progression of current research.

Applications that do not include an Administrative Core should describe the administrative structure for the CERC in the overview section of the application, addressing how administrative and scientific coordination of the various CERC components will be achieved, and how secretarial, budget, core, administrative services, and other resources will be administered, prioritized and apportioned, how travel to the annual NCCAM Centers meeting, expenses for publications produced by the project, communication expenses, organization of External Advisory Council meetings, and evaluation and determination of focused and overall scientific direction will be decided, coordinated, managed and supported.

For applications proposing multiple PD(s)/PI(s), the multi-PD/PI leadership plan should be included in this section of the application.

iii. Instructions for individual research projects

Cover Page

Do not use Form page 1 as a cover page. Instead, prepare a cover page for each research project that includes the number and title of the project. Use numbers (1,2,3, etc.) to designate individual research projects. Give each project a title and provide the names and titles of the project leader(s) and of participating investigators.

Form page 2

For each proposed project, provide a summary of the proposed research according to the instructions for form page 2. In addition, the description should contain a brief description of how the research project will contribute to attainment of the CERC program objectives.

Under "key personnel", follow the standard instructions, listing all key personnel participating in the project, beginning with the project leader.

Form page 3

Prepare a table of contents for each research project using form page 3. Since the biographical sketches of all participating investigators will be located at the end of the overall application and therefore should be referenced in the overall table of contents, do not repeat these pages.

Specific Aims

Specific Aims are limited to one page.

State concisely the goals of the proposed research and summarize the expected outcome(s), including the impact that the results of the proposed research will exert on the research field(s) involved.

List succinctly the specific objectives of the research proposed, e.g., to test a stated hypothesis, create a novel design, solve a specific problem, challenge an existing paradigm or clinical practice, address a critical barrier to progress in the field, or develop new technology.

Research Strategy

Do not exceed a total of 12 pages for the Research Strategy section of each individual project. Tables, charts, graphs, diagrams and figures must be included within the 12-page limit. Applications that exceed the 12-page limit or NIH requirements for type size and margins (refer to instructions for details) will be returned to the applicant without further consideration or not reviewed. The 12-page limit does not include the following sections: Human Subjects, Vertebrate Animals, Literature Cited, Consortia and Consultants/Collaborators.

Organize the Research Strategy in the specified order and using the instructions provided below. Start each section with the appropriate section heading A)Significance, B)Innovation, C)Approach.

A) Significance

Explain the importance of the problem or critical barrier to progress in the field that the proposed project addresses.

Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields.

Describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field will be changed if the proposed aims are achieved.

B) Innovation

Explain how the application challenges and seeks to shift current research or clinical practice paradigms.

Describe any novel theoretical concepts, approaches or methodologies, instrumentation or intervention(s) to be developed or used, and any advantage over existing methodologies, instrumentation or intervention(s).

Explain any refinements, improvements, or new applications of theoretical concepts, approaches or methodologies, instrumentation or interventions.

C) Approach

Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project. Include how the data will be collected, analyzed, and interpreted as well as any resource sharing plans as appropriate.

Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the aims.

If the project is in the early stages of development, describe any strategy to establish feasibility, and address the management of any high risk aspects of the proposed work.

Discuss the project leader’s preliminary studies, data, and/or experience pertinent to this application. Preliminary data can be an essential part of a research grant application and help to establish the likelihood of success of the proposed project. Early Stage Investigators should include preliminary data.

Appendix. No appendix should be provided for individual projects, as a single appendix is to be provided for the entire CERC application.

Checklist. Not required for individual projects. Submit a single checklist for the entire application.

iv. Specific instructions for Cores

Cover Page.

Do not use Form page 1 as a cover page for the Cores. Instead prepare a cover page that includes the title and letter designation of the core and provide the names and titles of the core leader and of all participating investigators.

Cores must contribute to two or more projects.

Administrative Core (optional). The applicant (awardee) institution and the PD(s)/PI(s) will be responsible for the application and for collaborative research activities in the CERC program. The awardee institution will be legally and financially responsible and be accountable for the use and disposition of funds awarded to the application, and will attest to the availability of personnel and facilities capable of performing and supporting the administrative functions of the CERC program.

Where an Administrative Core is proposed, it must include a budget for the overall administrative efforts including secretarial and other administrative services, travel to the annual NCCAM Centers meeting, expenses for publications produced by the project, and communications expenses including organization of External Advisory Council meetings.

Scientific Core(s). A scientific core is a resource to the CERC as a whole. The core section of the application must indicate which specific projects the core would serve. Each core must be utilized by two or more of the CERC research projects. Each core section should present a clear picture of the facilities, techniques, and skills that the core will provide. The role of the core leader and each of the key participants should be described. The apportionment of dollars, or percentage of dollars budgeted for each scientific core that will support each CERC research project should be presented.

Form page 2

Provide a summary of the core activities and services according to the instructions on form page 2. In addition, the summary should contain a brief description of how the core services will contribute towards attainment of the CERC program objectives.

Form page 3

Prepare a table of contents for each Core using form page 3. Since the biographical sketches of all participating investigators will be located at the end of the overall application (and therefore should be referenced in the overall Table of Contents), do not repeat these pages.

Specific aims: State the core's relationship to the CERC goals and how it relates to the research projects in the application. This is limited to one page

Core Research Strategy

Organize the core research strategy in the specified order and using the instructions provided below. Start each section with the appropriate section heading A)Significance, B)Innovation, C)Approach.

Do not exceed a total of 6 pages for each individual core. Tables, charts, graphs, diagrams and figures must be included within the 6-page limit. Applications that exceed the 6-page limit will not be reviewed. The 6-page limit does not include the following sections: Human Subjects, Vertebrate Animals, Literature Cited, Consortia and Consultants/Collaborators.

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 NCCAM and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

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

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.

A single numerical impact/priority score (10 to 90) will be assigned by the reviewers to the CERC application as a whole. An application in which the reviewers consider no more than two component research projects to be of substantial and significant scientific merit will not satisfy the requirements for this P01 award, and therefore will be recommended for "no further consideration."

In assigning the impact/priority score for the application as a whole, although primary emphasis will be placed on scientific merit of the research projects, the assessment of scientific synergy (i.e., the extent to which the potential for scientific impact of the proposed CERC as a whole is deemed likely to be greater than the sum of its component research projects and cores) may contribute significantly to the overall score. Significant consideration will also be given to:

• the strength of any core(s),
• leadership ability and commitment to the proposed Center of the PD(s)/PI(s),
• Strength of plans for coordination, problem identification and resolution, and the establishment of a strong collaborative environment for the program project,
• Extent of institutional commitment, and
• Availability of appropriate resources and environment.

The following specific aspects of the CERC will be evaluated:

A) Individual Research Projects

B) Administrative Core or structure

C) Research or Scientific Cores

D) Project Director(s)/Principal Investigator(s)

E) Resources and Environment

F) Overall Program and Program Synergy.

A) Individual research projects will be evaluated using the five standard review criteria below and will receive numerical impact scores ranging from 1 to 9.

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?

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

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. Resubmissions are not allowed for this FOA.

Renewal Applications. Renewals are not allowed for this FOA.

Revision Applications. Revisions are not allowed for 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. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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.

B) Administrative Core or Administrative Structure (as described in the Overview section, for applications not including an Administrative Core)

Each CERC Administrative Core/structure will receive a merit descriptor (outstanding, acceptable, unacceptable) that reflects:

• Strength of the plans for day-to-day administration, as well as program coordination and ongoing evaluation of the center;
• Extent to which the plans for management, communication, decision-making, allocation of resources, and monitoring of conflict of interest, intellectual property, and other compliance issues are clearly delineated and likely to support efficient and productive function of the Center as a whole and its individual components;
• Where applicable, the strength of the multi-PD/PI leadership plan.

C) Other (Research/Scientific) Cores:

Each additional Core will receive a merit descriptor (outstanding, acceptable, unacceptable) that reflects:

• Technical merit and justification of the proposed Core - Does each scientific core provide critical facilities or services for two or more funded research projects?;
• Qualifications, experience, and commitment of the personnel involved in the Core;
• Adequacy of plans for use of the Core by the research projects, including criteria for prioritization, and the benefit to the projects from Core resources.

D) Project Director(s)/Principal Investigator(s)

Project Director(s)/Principal Investigator(s) will receive a merit descriptor (outstanding, acceptable, unacceptable) that reflects:

• leadership and scientific ability to successfully coordinate and administer a program of synergistic research projects with a well-defined central research focus, and
• commitment of sufficient effort to successfully coordinate and adminster the proposed Center.

E) Resources and Environment

Resources and Environment will receive a merit descriptor (outstanding, acceptable, unacceptable) that reflects:

• The intellectual and physical resources available to the program project participants;
• Adequacy of facilities, including clinical facilities, laboratory facilities and data management systems to support the proposed research;
• Institutional commitment to the program; and
• The extent to which CAM investigators and clinicians are involved in the research where appropriate.

F) Overall Program and Program Synergy

Each application will receive a merit descriptor (highly synergistic, synergistic, not synergistic) that reflects the degree of synergy of the proposed CERC. In particular, program synergy will be evaluated on:

• The extent to which the combined approaches to the research question proposed for the CERC are synergistic, and the integration and parallel pursuit of the projects and cores is likely to advance this research area to a greater extent than could be achieved without Center support;
• The extent to which the application submitted provides evidence of strong collaborative interactions between the participating institutions and investigators.

Selection Process

The following will be considered in making funding decisions:

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

NIH considers the following in evaluating Center grant applications:

• The scientific and technical merit of the proposed program;
• The qualifications and experience of the center director and other key personnel;
• The statutory and program purposes to be accomplished;
• The extent to which the various components of the proposed program would be coordinated into one multi-disciplinary effort within the center;
• The extent to which the center's activities would be coordinated with similar efforts by other organizations;
• The administrative and managerial capability of the applicant; and
• The extent of synergy among components of the proposed Center, and the likelihood that the integration and parallel pursuit of the combined approaches to the research questions proposed for the Center will advance this research area to a greater extent than could be achieved without Center support.

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 Notice of Award 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 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

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:

Barbara C. Sorkin, Ph.D
Coordinator, Centers of Excellence for Research on CAM Program
Division of Extramural Research
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892-5475
Office: (301) 594-8018
Email: [email protected]

2. Peer Review Contacts:

Dale Birkle Dreer, Ph.D.
Chief, Office of Scientific Review
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Blvd., Suite 401, MSC 5475
Bethesda, MD 20892-5475
Telephone: (301)451-6570
FAX:(301)480-2419
Email:[email protected]

3. Financial or Grants Management Contacts:

George Tucker, M.B.A.
Chief Grants Management Officer
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Blvd., Suite 401, MSC 5475
Bethesda, MD 20892-5475
Phone: 301-594-9102
Fax: 301-480-1552
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/

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.