Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Center for Complementary and Alternative Medicine (NCCAM)

Funding Opportunity Title

Centers of Excellence for Research on CAM (P01)

Activity Code

P01 Research Program Projects

Announcement Type

New

Related Notices

  • May 2, 2013 - This PAR has been expired and reissued as PAR-13-220.

Funding Opportunity Announcement (FOA) Number

PAR-12-151

Companion FOA

None

Number of Applications

Only one application per instituion is allowed, as defined Section III.3 Additional Information on Eligibility Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.213

FOA Purpose

This funding opportunity announcement (FOA) is issued by the National Center for Complementary and Alternative Medicine (NCCAM) to enable submission of applications that propose to conduct research that is of high-priority to NCCAM that requires synergistic collaboration between outstanding scientists, and the synthesis of multiple research approaches by multi-disciplinary research teams. The CERC mechanism is designed to support research in which the funding of three or four synergistic, highly meritorious projects as a group offers significant scientific advantages over support of the same projects as individual research grants.  Each CERC must consist, throughout the duration of the award, of three or four research projects, focused on basic, mechanistic, and/or translational research questions relevant to the research priorities described in the current NCCAM Strategic Plan.

Key Dates
Posted Date

March 30, 2012

Letter of Intent Due Date

Not Applicable.

Application Due Date(s)

September 25, 2012, 2013, 2014  

AIDS Application Due Date(s)

January 7, 2013, 2014,2015

Scientific Merit Review

February/March 2013, 2014, 2015

Advisory Council Review

May 2013, 2014, 2015

Earliest Start Date(s)

July 2013, 2014, 2015

Expiration Date

(Now Expired May 2, 2013 per issuance of PAR-13-220), Originally January 8, 2015

Due Dates for E.O. 12372

Not Applicable.

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

PURPOSE

The purpose of NCCAM's Centers of Excellence for Research on CAM (CERC; P01) program is to support multidisciplinary, synergistic, multi-project research programs that have strong potential to advance the mission of NCCAM and to increase understanding of the mechanisms of action, optimal application, safety, efficacy and/or effectiveness of complementary/alternative medicine (CAM).  Each proposed CERC should have a well-defined, central research focus or objective that is of high priority to NCCAM,  For a successful CERC application, the relevant research area(s) must be sufficiently mature to be able to effectively leverage this multi-project mechanism.

NCCAM currently supports collaborative research through several other mechanisms:

A central theme or well-defined major objective is the foundation of the CERC (P01) program. Compared to the more narrow thrust of a traditional R01 research project, a CERC is directed toward a range of scientific questions that elucidate various aspects of the central theme. Each CERC must comprise three or four interrelated research projects, each capable of standing on its own scientific merit but synergizing with one another. Each of the proposed projects should be highly meritorious, distinct from the other proposed projects, directly relevant to the research priorities described in NCCAM's current Strategic Plan (http://nccam.nih.gov/about/plans/2011), and should contribute to the program objective, such that research ideas, efforts, and outcomes of the program as a whole will offer a distinct advantage over pursuing the individual projects separately. If needed for the proposed research, applicants may propose one or more shared resource cores. Each shared resource core must provide support, and enhance the productivity, cost-effectiveness, and/or research outcome of at least two of the proposed research projects.

The collaborating scientists should be established investigators with strong records of innovative research and independent funding support. Thus, support of one senior investigator as program director, and postdoctoral or research associate-level scientists as project leaders is not appropriate. In addition, the program project grant may not be used as a vehicle for departmental research support. The PD/PI should be an investigator with a strong track record (which includes peer-reviewed research publications) in one or more research areas directly relevant to the focus of the proposed CERC as well as in the successful leadership of large research enterprises.  The PD/PI is required to exercise leadership in maintaining the momentum and focus of the CERC as a whole, as well as the quality and integrity of the research. The specific anticipated duties and responsibilities of the CERC PD/PI should be clearly defined in the application and an appropriate level of effort proposed.

The research of the CERC should advance the mission of NCCAM to rigorously investigate the usefulness and safety of integrative/complementary health practices and their roles in improving health and health care.

Investigators who are considering pursuing a collaborative approach to a high priority research problem are strongly encouraged to contact NCCAM program staff early in the process to discuss a potential application. The discussion could include the choice of funding mechanism, relevance of the topic to NCCAM's strategic plan and research priorities, and the scope and approach of the project. Further information on the NCCAM CERC mechanism is available on the NCCAM website (http://www.nccam.nih.gov/grants/P01guidelines).

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal
Resubmission
Revision

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications. However, NCCAM anticipates making approximately 2 - 3 awards yearly for the duration of this FOA.

Award Budget

It is strongly recommended that applicants not request a budget of more than $1,250,000 in direct costs per year. These costs are exclusive of subcontract facilities and administrative costs.

Award Project Period

The maximum project period for these awards is 5 years. Starting with new and renewal P01 grants reviewed and funded in fiscal year 2013, only one more renewal will be allowed.

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

Eligible Organizations

Higher Education Institutions

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her 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.

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.  See also http://grants.nih.gov/grants/multi_pi/      

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

 Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the PHS398 Application Guide.

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and 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)

At the time of submission, two additional paper copies of the application and five copies of the Appendix on CDs must be sent to:

Dale Birkle Dreer, Ph.D.
Chief, Office of Scientific Review
National Center for Complementary and Alternative Medicine
6707 Democracy Boulevard, Suite 401, MSC 5475
Bethesda, MD 20892-5474
Telephone: 301-451-6570
Email: birkled@mail.nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following additional requirements:

More detail is provided in the NCCAM guidelines for preparing CERC (P01) applications, see http://www.nccam.nih.gov/grants/types/P01guidelines.

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the PHS398 Application Guide, with the following modification:

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide. Provide a single appendix for the entire CERC application, with materials relevant to the overview section, to individual research projects, and/or to cores organized in the same order as in the body of the application.  Do NOT include separate appendices for each individual section of the application.  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.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

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 only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 8 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the PHS398 Application Guide.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Review Criteria for the Overall Program Project

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the Center as a whole to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the Center proposed).

In assigning the impact 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. 

For a P01 to receive an impact score, it must consist of at least three scored individual projects for the duration of the project period. Each core must provide essential functions or services for at least two of these projects.

Specific factors to be evaluated in the consideration of the overall program project are as follows:

1. The potential impact on the field, scientific merit of the program as a whole, and that of individual projects;

2. 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, or greater than achievable if each project were supported separately) should contribute significantly to the overall score.;

3. The evaluation of the leadership and scientific ability of the PD(s)/PI(s), their commitment and their track record of ability to effectively drive and manage a highly productive, multi-disciplinary research team, the presence of a well-defined central research focus, innovation, approach, and environment.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the Center proposed).

Scored Review Criteria - Overall

Reviewers will consider each of the review criteria below in the determination of scientific 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 Center that by its nature is not innovative may be essential to advance a field.

Significance

Does the Center address an important problem or a critical barrier to progress in the field? If the aims of the Center 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(s)/PI(s), collaborators, and other researchers well suited to the Center? 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(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do(es) the Center PD(s)/PI(s) have (a) track record(s) of consistently producing highly significant research publications in one or more of the research areas proposed for the Center?  Do(es) the Center PD(s)/PI(s) have (a) track record(s) demonstrating the ability to effectively and productively manage a large, interdisciplinary project in the proposed research area(s)?  Do the proposed Project and Research Core Leaders have track records demonstrating their ability to independently complete their proposed research projects?  Is there a clear, detailed plan for managing the Center's research and administration, ensuring appropriate prioritization of research, needed course corrections and problem identification and resolution, and effective sharing of resources, that conveys a high likelihood of effective, productive management of the Center as whole?

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 Center? 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 Center 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? Is there adequate data in support of feasibility of recruiting sufficient participants from the proposed population to achieve the stated objectives?  

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is there evidence of substantial institutional commitment on the part of each participating institution?  Is there evidence of prior productive collaboration of the research team (including in the P01 application)?  Are the application and investigator track records indicative of the establishment of a strong collaborative environment for the program project?  

Additional Review Criteria - Overall

As applicable for the Center proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Synergy

In assigning the impact 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. 

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 are likely to advance this research area to a greater extent than could be achieved without Center support.

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. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed Center 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. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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 on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Resubmissions

For Resubmissions, 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 Center.

Renewals

For renewals, the committee will consider the progress and achievements specific to Center since the previous review.  Were the goals and objectives of the prior grant period achieved?  Have the results from the prior funding period advanced the science related to CAM?   Are new research goals a logical extension of ongoing work?  Is there justification for deleting components?  The extent of collaboration will be assessed by publications and resource sharing, including the performance and use of the cores.  

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the Center..

Additional Review Considerations

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

Applications from Foreign Organizations

Applications from foreign organizations are not permitted..

Select Agent 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; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Review Criteria for Individual Research Projects

Reviewers will consider each of the review criteria below in the determination of scientific merit of each proposed research project, and give a separate numerical (1 to 9) score for each criterion, as well as an overall impact score for the project. A project 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 Project leader and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative, do the investigators have complementary and integrated expertise; are their leadership and research track records appropriate for the project?

Innovation

Does the proposed project 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 human subjects 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? Is there adequate data in support of feasibility of recruiting sufficient participants from the proposed population to achieve the stated objectives?

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?

Review Criteria for Research Cores

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

Additional Review Criteria

As applicable for the project or Core proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, 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. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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 on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Resubmissions

For Resubmissions, 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.

Renewals

For Renewals, the committee will consider the progress made in the last funding period. Were the the goals and objectives of the prior project or core achieved? How many papers directly related to the prior project or core were published in high impact journals? How have the results from the prior funding advanced the science related to CAM?

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project or core..

Additional Review Considerations

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

Applications from Foreign Organizations

Applications from foreign organizations are not permitted..

Select Agent 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; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.   

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NCCAM in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned to NCCAM and will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council for the Center for Complementary and Alternative Medicine (NACCAM). The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD(s)/PI(s) will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

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 the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

 Investigators, who are considering pursuing this funding mechanism are strongly encouraged to contact NCCAM program staff at least 9 months prior to the projected receipt date to discuss a potential application.  The discussion could include the choice of funding mechanism, relevance of the topic to the NCCAM mission and the scope and approach of the project.  Further information on the NCCAM CERC (P01) award is available at:  http://www.nccam.nih.gov/grants/types/P01guidelines

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Partap S. Khalsa, DC, PhD, DABCO
Program Director, Division of Extramural Research
National Center for Complementary and Alternative Medicine (NCCAM)
6707 Democracy Boulevard, Suite 401
Bethesda, MD 20867
Telephone: 301-594-3462
Email: partap.khalsa@nih.gov

Peer Review Contact(s)

Dale Birkle Dreer, Ph.D.
Chief, Office of Scientific Review
National Center for Complementary and Alternative Medicine
6707 Democracy Boulevard, Suite 401
Bethesda, MD 20867
Telephone: (301)451-6570
Email: birkled@mail.nih.gov

Financial/Grants Management Contact(s)

George Tucker, M.B.A.
Chief Grants Management Officer
National Center for Complementary and Alternative Medicine (NCCAM)
6707 Democracy Boulevard, Suite 401
Bethesda, MD 20867
Telephone: 301-594-9102
Email: gt35v@nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

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 Part 52 and 45 CFR Parts 74 and 92.


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