Part I Overview Information


Department of Health and Human Services

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

Components of Participating Organizations
National Center for Complementary and Alternative Medicine (NCCAM) (http://nccam.nih.gov)

Title: Partnerships for Complementary Alternative Medicine (CAM) Clinical Translational Research (PCCTR) (U19)

Announcement Type
This FOA is a reissue of RFA-AT 07-002 and PAR-07-248.

Update: The following updates relating to this announcement have 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, see http://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-09-066

Catalog of Federal Domestic Assistance Number(s)
93.213

Key Dates - New Dates
Release Date:  February 3, 2010
Letters of Intent Receipt Date(s): April 28, 2010; April 27, 2011
Application Receipt Date(s): May 28, 2010; May 27, 2011 (Changed to October 19, 2011 per NOT-AT-11-001)
Peer Review Date(s): July 2010, July 2011
Council Review Date(s): August 2010, August 2011
Earliest Anticipated Start Date: October 2010, October 2011
Expiration Date: (New Date October 20, 2011 per NOT-AT-11-001), Original Exp Date May 28, 2011

Key Dates - Old Dates
Release Date: December 29, 2008
Letters of Intent Receipt Date(s): May 26, 2009; May 28, 2010; May 28, 2011
Application Receipt Date(s): June 26, 2009; June 28, 2010; June 28, 2011
Peer Review Date(s): October 2009, October 2010, October 2011
Council Review Date(s): January 2010, January 2011, January 2012
Earliest Anticipated Start Date: April 2010; April 2011, April 2012
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: June 29, 2011

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism 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 and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Arbitration Process
3. Reporting

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

The National Center for Complementary and Alternative Medicine (NCCAM) invites applications for Partnerships for CAM Clinical Translational Research (PCCTR). PCCTR awards will use the U19 Cooperative Agreement mechanism.

Background: Reliable methods, metrics, protocols, and outcome measures are prerequisites for successful clinical research. These translational research tools help ensure that clinical research design and implementation yield authoritative and maximally informative results, and they facilitate cross-study comparisons of outcome, the conduct of systematic evidence-based assessments, and the translation of promising research results into practice, policy, and guidelines. Assessment of the evidence base for CAM interventions is currently often hampered by the lack of such methodology, highlighting the need for ongoing refinement of translational research tools for CAM research. CAM clinical trial design is often hampered by lack of validated markers of adherence, of fidelity of therapy delivery, and of validated, relevant, and well-characterized outcome measures.

Development of effective translational research tools for CAM research requires in-depth understanding of the interventions, the health conditions under study, and the relevant basic and clinical scientific disciplines, making multidisciplinary collaborations essential. This will best be achieved through partnerships between institutions and practitioners with particular expertise in CAM, and institutions and individuals with particular expertise in clinical trials and in the biomedical or behavioral research relevant to the area of investigation.

Although the proposed projects are NOT required to synergize, NCCAM strongly encourages applicants to structure the proposed research projects around an appropriate, but clearly defined focus. This focus may be a disease or class of diseases treated using CAM, a specific group of related CAM interventions, or the mechanisms of action of specific CAM modalities. Centers may also be organized around a CAM-relevant theme, e.g., pain. The proposed research projects should be as highly integrated as is possible, and an appropriate structure for coordinating the activities and budget of the proposed PCCTR should be described in the Overview section of the application. The research and intellectual productivity of the proposed projects should be substantially enhanced by the proposed collaborative partnership between the CAM and conventional, research-intensive institutions.

PCCTR funding may not be used to support meetings of general interest (beyond the PCCTR research team). PCCTR funding may not be used to support curriculum development.

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 U19 cooperative agreement 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).

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

At this time it is not known if this FOA will be re-issued.

2. Funds Available

NCCAM intends to commit up to $2.25 million in total direct costs annually to this initiative. The maximum allowable cost for each PCCTR in a given year is $750,000 in direct costs. For multi-institutional applications, when determining whether the direct costs are within the $750,000 direct cost budget limit, F&A costs for subcontracts are not included towards the total. Use of existing core facilities (e.g., CTSA or other Clinical research facilities, statistical and data management support) at participating research-intensive institutions is strongly encouraged.

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 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.

Each PD/PI must be able to commit an appropriate level of effort to the PCCTR. PCCTR applications with more than one PD/PI must include at least one PD/PI each from a CAM institution and from a research-intensive institution, as defined in section III.I.A, above.

Multiple PD/PI applications must include a Multiple PD/PI Leadership Plan, which should be included the Overview section of the PCCTR application.

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

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 will be permitted only a single amendment (A1). See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and NOT-OD-09-016 Original new and competing renewal applications that were submitted prior to January 25, 2009 will be 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.

Applicants may not submit more than one application. No institution may receive NCCAM funding simultaneously for more than one PCCTR award. No institution may receive NCCAM funding simultaneously for a PCCTR and a DCRC award. Only one PCCTR application per applicant institution may be submitted at any given time.

Section IV. Application and Submission Information


1. Address to Request Application Information

The 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) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5939.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. 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.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates

Letters of Intent Receipt Date(s): May 26, 2009, May 28, 2010, May 28, 2011
Application Receipt Date(s): June 26, 2009, June 28, 2010, June 28, 2011
Peer Review Date(s): October 2009, October 2010, October 2011
Council Review Date(s): January 2010, January 2011, January 2012
Earliest Anticipated Start Date(s): April 2010, 2011, 2012

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. All applicants are strongly urged to discuss potential PCCTR applications with NCCAM staff early in the planning phase of an application.

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

Partap S. Khalsa, DC, PhD, DABCO
Program Officer, Division of Extramural Research and Training
National Center for Complementary and Alternative Medicine (NCCAM)
National Institutes of Health
6707 Democracy Boulevard, Suite 401
Bethesda, MD  20892-5475
Office:  (301) 594-3462 
Fax: (301) 480-1587
Web:  nccam.nih.gov

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 ten additional copies (CDs) of the appendix materials must be sent to:

Martin Goldrosen, Ph.D.
Director of Extramural Activities
National Center for Complementary and Alternative Medicine (NCCAM)
6707 Democracy Blvd. Suite 401
Bethesda, MD 20892-5475 (use 20817 for private courier services)
Telephone: (301) 594-2014
FAX: (301) 480-2419
Email: goldrosm@mail.nih.gov

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/archive/grants/policy/nihgps_2003/index.htm.)

6. Other Submission Requirements and Information

Each PCCTR application must comply with the following special requirements and provisions:

Include documentation of national or regional accreditation of a participating, domestic CAM institution;

Attach letters of support from an appropriate, high-ranking official at the applicant institution and from each collaborating institution, documenting significant institutional commitment to the Partnership and to long-term support of research capacity development at the participating CAM institution(s);

Plan to participate, with collaborators, including all key staff, in an annual two-day meeting in the Baltimore-Washington area with other NCCAM-funded Center investigators. Travel costs for this purpose (including costs of lodging) should be included in the proposed budget for the PCCTR;

Plan to participate in an annual meeting of the PCCTR External Advisory Committee (EAC). The EAC will be established by the NCCAM Program Official for each PCCTR, and coordinated by the NCCAM Program Official and the PCCTR PD/PI(s), and will meet annually three months before the anniversary of the PCCTR award date until the final year of the award (see Section VI.2A2, below).

Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information."

SPECIAL INSTRUCTIONS

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 team beyond those mentioned above. The contact PD/PI may be changed during the program 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, a section of the research plan, entitled Multiple PD/PI Leadership Plan must be included as part of the overview section of the application. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research program 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 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 program 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. For PCCTR awards, at least 50% of the direct costs budget must be allocated at domestic CAM institutions, as defined in Section III.1.A of this announcement.

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

PCCTR Application Format, Content and Page Limitations

This multi-component grant application should be assembled and paginated as a single, complete document divided into the following sections, with a cover page for each section: 1) Overview section, and 2) One section for each proposed research project. Because the PHS 398 application form has no specific instructions for multi-component applications such as the PCCTR, the following instructions are provided. For all other items in the application, follow the standard instructions.

The instructions below are divided as follows:

Specific instructions for PCCTR application overview section

Specific instructions for individual research projects

PCCTR application overview section

Specific instructions for PCCTR application overview section

Form page 2. Using form page 2, provide a succinct but accurate description (abstract) of the overall PCCTR application addressing the overall proposed research program, the ways in which the award would enhance CAM research capacity at the participating organizations, and make significant contributions to the development of CAM clinical translational research tools, and of the ways in which the various PCCTR institutions and research projects will coordinate to interact productively. Do not exceed the space provided.

Under "key personnel," list the Principal Investigator or contact PI, followed by all other key personnel in alphabetical order. Indicate the role (e.g., Project Leader, etc.) and institution of primary appointment of each of the key personnel.

Form page 3 - Table of contents. Do not use Form page 3; a more comprehensive table of contents is needed for a multi-component application. Bearing in mind that the application will be reviewed for scientific and technical merit both as a whole and project by project, prepare a detailed table of contents that will enable reviewers to locate specific information pertinent to the overall application and each component research project. A page reference should be included for the budget for each project. Each research project should be identified by number (e.g. project 1), title, and responsible Project Co-Leaders.

Form page 4 - Detailed budget for initial budget period. Use Form page 4 of PHS Form 398 as a composite budget for the entire PCCTR application. Indicate the page location of the composite budget in the "Table of Contents." Note: An additional Form page 4 must be used to provide a separate, detailed budget for each individual project within the PCCTR application. Narrative justification for individual budget categories should be presented for each of the projects. Budget pages and justifications for individual research projects should be placed within the respective sections of the PCCTR application, and their page numbers should be noted in the overall table of contents.

When multiple institutions are involved in a multiple PD/PI application, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. Include a separate budget for each participating institution. Subcontracts must be included in the subcontract section of Form page 4 for the prime institution.

Form page 5 - Budget for entire proposed PCCTR period. Complete the total direct cost line entries for all requested budget periods (years) and include a breakdown of the total direct cost for entire period of support for each proposed project.

Subcontracts must be included in the subcontract section of Form page 5 for the prime institution.

Biographical sketch form pages. Biographical sketches of all professional personnel for all components of the PCCTR should be included at the end of the Overview section of the application. They should not be included again in the individual research project sections. Place the biographical sketch of the Center PD/PI(s) first, followed by the biosketches of all other key PCCTR personnel in alphabetical order of last names.

Resources form page. Include documentation of national or regional accreditation of participating CAM institution(s) in this section. Information on resources relevant to individual research projects is to be presented in the individual research project sections of the application.

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

Other support page. Do not complete. Any required information will be requested from successful applicants prior to grant award.

The Program Overview section of the PCCTR application is limited to 12 pages.

Foreword: Include a foreword in which you describe relevant previous collaborations. The starting points (research resources and capabilities, including personnel and equipment engaged in CAM research) of the participating institutions should be described.

In describing the research and research capacity development goals applicants should discuss their prior experiences, as well as the current state of their CAM research, and CAM research expertise, infrastructure, and collaborations.

This section should be aligned in order and structure with the PCCTR review criteria for Partnership enumerated in Section V.2. of this FOA.

The overview section must also summarize the overall plan for the multi-component application. It provides the group of investigators an opportunity to give conceptual wholeness to the overall application. Include a section that specifically addresses the integration between the participating institutions and personnel, and between the proposed research projects. Summarize special features in the environment and/or resources of each of the participating institutions that make this application strong or unique.

Describe in detail the administrative structure of the PCCTR (including the Internal Steering Committee) that will be responsible for coordination between institutions, PCCTR personnel and projects, and for coordinating External Advisory Committee, budget and reporting functions for the PCCTR cooperative agreement.

The overview section of the application must also describe in detail the proposed planning year, including the specific goals for the planning year and their contribution to the Specific Aims of the proposed research projects and of the PCCTR as a whole, and provide a timeline for achievement of those goals. Continuation of the award beyond the planning year will be dependent on programmatic review of progress of the PCCTR towards the funded planning year goals. For applications submitted by prior NCCAM DCRC awardees, the planning year may be omitted. In such cases, strong support for the ability of the proposed PCCTR to proceed immediately to the Specific Aims of the proposed research projects must be provided in the Overview section of the PCCTR application.

This section of the application should be structured to optimally present the above information, and is limited to 12 pages.

Items 4-15 of this section are not included towards the 12-page limit. They should be completed as appropriate following the standard instructions for each item.

Following Item 13 of the research plan, include letters (on institutional letterhead) from each proposed Project Leader confirming their role in the proposed PCCTR, as well as from institutional officials confirming their commitment to the PCCTR (see Special Eligibility Criteria in Section III.3, above).

Specific instructions for individual research projects

A cover page is required for each research project and should include the number and title of the project. Use numbers (1,2,3, etc.) to designate individual research projects, give each a title, and provide the names and titles of the Project Leader(s) and of other participating personnel. NCCAM strongly encourages co-leadership of each research project by faculty members from both a participating CAM institution and a participating conventional, research-intensive institution. Indicate whether the project will include human subjects research (if yes, include human subjects assurance number).

Form page 2. For each proposed project, provide a description (abstract) of the proposed research according to the instructions for form page 2. In addition, the abstract should contain a brief description of how the research project will contribute to attainment of the PCCTR program objectives. Under "key personnel," beginning with the Project Leader and Co-Leader, follow the standard instructions, listing all key personnel participating in the project, their role on the project, and their institution of primary appointment.

Form page 3. Prepare a table of contents for each research project using form page 3. Because the biographical sketches of all participating investigators will be located at the end of the Overview section of the application they should not be repeated, but the biosketches should be referenced in the table of contents.

A resources page detailing the resources that will support that specific project should be included for each research project.

Research strategy. The Research strategy for each research project may not exceed a total of 12 pages. Tables, charts, graphs, diagrams and figures must be included within the page limit. Applications that exceed the appropriate page limit or NIH requirements for type size and margins (refer to the standard instructions for details) will be returned to the applicant without further consideration. The research strategy page limits do not include Items 4-15 (Human Subjects, Vertebrate Animals, Literature Cited, Consortia and Consultants/Collaborators, etc).

Specific aims (one page, in addition to Research Strategy): List in priority order the broad, long-range objectives of the proposed project and describe concisely and realistically the more immediate goals.

Research Strategy

Significance: Use this section to address the overall biological and health significance of the proposed research project. This item should also describe how the proposed research will contribute to meeting the goals and objectives for this research project, to the development of clinical translational CAM research capacity at the participating institutions, as well as more generally. Explain the rationale for the selection of the general methods and approaches proposed to accomplish the specific aims.

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: The conceptualization and planning of each project must be sufficient to allow for an assessment of the project's potential. The proposed research must be presented in sufficient detail to allow evaluation of the proposed methods. Appropriate expertise to conduct the proposed research must be included among the key personnel, e.g., for research involving human subjects, statistical and/or clinical trial design expertise (as appropriate) is essential during the design and conduct of research.

Preliminary studies: Provide a strong rationale for the choice of problem and approach; relevant data should be cited when available. Studies demonstrating the feasibility of the proposed methods and the relevant technical experience of the personnel should be included in this section.

Projects proposing research on biologically-active agents should consult NCCAMs Policy on Biologically Active Agents Used in CAM (http://nccam.nih.gov/research/policies/index.htm).

Projects proposing clinical research should consult the Guidance for NCCAM-supported Clinical Trials (http://nccam.nih.gov/research/policies/index.htm).

Items 4-11 of the PHS 398 Research Plan should be addressed, as appropriate, according to the standard instructions. Items 12-15 should be addressed, as appropriate, for the entire PCCTR in the Overview section of the PCCTR application.

Resubmission applications should include introductions to each section of the application. The introductions may not exceed 1 (one) page per introduction.

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.

Only a single appendix may be provided for the entire PCCTR. Order of materials in the appendix should follow that of the application, i.e., starting with materials relevant to the overall program, continuing with materials relevant to the individual research projects.

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

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

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

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications that are complete 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:

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:

The major goals of the Partnerships for CAM Clinical Translational Research (PCCTR) Program are to support the development of CAM clinical translational research tools and to develop CAM research capacity. The following aspects of each PCCTR application will be evaluated:

1) Individual research projects

2) Program Director(s)/Principal Investigator(s)

3) Partnership

4) Overall Program

1) Individual research projects

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 for each research project 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 core review criteria, and additional review criteria (as applicable for the program proposed).

Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit of a research project, 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? Does the project have strong potential to contribute to the development of translational tools that will enhance and/or facilitate rigorous, clinical CAM research, as well as comparability and generalizability between CAM intervention studies?

Investigator(s): Are the Project Leader(s) and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the Project Leader(s) and other researchers? Do the Project Leader(s) and investigative team bring complementary and integrated expertise to the project? If Early Stage Investigators or New Investigators, 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 has more than one project leader, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Are CAM practitioners included as appropriate?

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) Protections for Human Subjects, 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? Is there a clear description of interventions, of primary and secondary endpoints, of ethical considerations, including monitoring? Is the proposed research supported by the literature and by a convincing rationale? Where preliminary data are provided, do they support the feasibility and significance of the proposed research? Where applicable, are there specific and adequate descriptions to address the points listed in the policy and guidelines on biologically active agents (http://grants.nih.gov/grants/guide/notice-files/NOT-AT-05-004.html)?

Environment. Will the scientific environment for the project 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 there evidence of institutional support at all institutions participating in the project?

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.

Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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.


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.

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.

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).

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.

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).

Based on the evaluation described above, each research project will receive a numerical score from 1 (exceptional) to 9(poor).

Program Director(s)/Principal Investigator(s)

The PD/PI(s), who will be the leader(s) of the entire Center, will be evaluated with respect to:

Partnership

Based on the evaluation described below, the Partnership aspect for each PCCTR application will receive a numerical score from 1 to 9

Collaborative Environment

Institutional Commitment:

Resources:

Overall Program

A single, numerical overall impact/priority score (1 to 9) will be assigned to each PCCTR application as a whole, based on the scientific merit of the research projects and the evaluation of the PD/PI (s) and the partnership.

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 ofAward (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.htm).

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

2.A. Cooperative Agreement Terms and Conditions of Award

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

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

2.A.1. Project Director/Principal Investigator (PD/PI) Rights and Responsibilities

The Principal Investigator will have the primary responsibility for:

The awardee institution and the PD/PI(s) will be responsible for the collaborative research and mentoring activities in the PCCTR. The awardee institution will be legally and financially responsible and accountable for the use and disposition of funds awarded, and will attest to the availability of personnel and facilities capable of performing and supporting the functions of the PCCTR.

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

2.A.2. NIH Responsibilities

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

The NCCAM Project Scientist will:

Additionally, an agency program official or NCCAM program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The assigned program director may also serve as an NIH Project Scientist.

2.A.3. Collaborative Responsibilities

The Program Official, in consultation with the PCCTR PD/PI(s), is responsible for establishing a PCCTR External Advisory Committee (EAC), and working with the PD/PI(s) to coordinate regular EAC meetings. The EAC will be composed of the Program Official, who will serve ex officio and up to five external advisors with appropriate expertise to provide advice relative to the objectives of the program. EAC members should be from institutions that are not participants in the PCCTR. The EAC will serve as the primary advisory body of the PCCTR, and the Program Official will rely on the EAC for objective evaluation of the Program.

The EAC will:

The EAC's evaluations and recommendations, in the form of a written annual report, are to be submitted to the Program Official and the PCCTR PD/PI(s), and will be used by the Program Official and the PCCTR PD/PI(s), to guide and direct the program. Subcommittees with additional ad hoc advisors may be established by the EAC as necessary in order to meet its planning, priority setting and evaluation responsibilities. Awardees generally will be expected to accept and implement the recommendations of the EAC; in those situations where implementation of the recommendations is not feasible, the PCCTR PD/PI(s) must provide a thorough explanation and rationale to NCCAM. The first EAC meeting will be convened by the Awardee approximately nine months after the award date. The EAC will meet annually three months before the anniversary of the PCCTR award date, until the final year of the award.

2.A.4. Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

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:

Partap S. Khalsa, DC, PhD, DABCO
Program Officer, Division of Extramural Research
National Center for Complementary and Alternative Medicine (NCCAM)
National Institutes of Health (NIH)
6707 Democracy Boulevard, Suite 401
Bethesda, MD 20892-5475
Office: (301) 594-3462; Fax: (301) 480-1587
Web: nccam.nih.gov
partap.khalsa@nih.gov

2. Peer Review Contacts:

Dale L. Birkle Dreer, PhD
Chief, Office of Scientific Review
Division of Extramural Activities
National Center for Complementary and Alternative Medicine
6707 Democracy Boulevard, Suite 401
Bethesda, MD 20892 (20817 for express mail)
Telephone: 301-451-6570
Email: birkled@mail.nih.gov

3. Financial or Grants Management Contacts:

George Tucker, MBA
Office of Grants Management
National Center for Complementary and Alternative Medicine (NCCAM)
6707 Democracy Boulevard, Suite 401
Bethesda, MD 20892-5475
Telephone: (301) 594-9102
Fax: (301) 480-3504
Email: tuckerg@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

Vertebrate Animals:
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. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the impact/priority score.

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/archive/archive/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, Minorities, and Children:
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 investigators 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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