Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov/)

Components of Participating Organizations
National Center for Complementary and Alternative Medicine (NCCAM), (http://nccam.nih.gov)
National Cancer Institute (NCI), (http://www.nci.nih.gov)
National Center for Minority Health and Health Disparities (NCMHD), (http://ncmhd.nih.gov)

Title: CAM at Minority or Health Disparities Research Centers (R21)

Announcement Type
This is a reissue of PAR-05-152 which was previously released August 10, 2005.

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

 NOTICE: Applications submitted in response to this FOA for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines provided with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least 4 weeks prior to the grant submission date. See Section IV.

Program Announcement (PA) Number: PAR-06-372

Catalog of Federal Domestic Assistance Number(s)
93.213, 93.393, 93.307

Key Dates
Release/Posted Date:  April 27, 2006
Opening Date: May 2, 2006 (earliest date an application may be submitted to Grants.gov).
NOTE:  On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of applicant institution/organization).
Letters of Intent Receipt Date(s): October 16, 2006; October 15, 2007
Application Submission/Receipt Date(s): November 14,  2006, and 2007
Peer Review Date(s): February – March  2007 and 2008
Council Review Date(s): May – June 2007 and 2008
Earliest Anticipated Start Date(s): July 2007, and 2008
Additional Information To Be Available Date (Url Activation Date): August 14, 2005
Expiration Date:  November 15, 2007  

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. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Submission, Review and Anticipated Start Dates
       1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
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

Purpose of this FOA

The purposes of this initiative are to:

Background

The purpose of this solicitation is to stimulate research that will enhance the understanding of the mechanisms of CAM interventions and increase the knowledge base regarding the potential role of complementary and alternative medicine practices (CAM), including Traditional Indigenous Medicine practices, either in reducing and eliminating health disparities, or regarding minority health. This program announcement will support exploratory/developmental (R21) research projects on CAM interventions at institutions that have received NIH or AHRQ awards for research centers on minority health or health disparities. The infrastructure and resources of these centers may be used to support basic, pre-clinical, clinical, translational, and health services research projects addressing issues relating to CAM and minority health or health disparities. For the purpose of this program announcement, an eligible institution is defined as one that has received funding from NIH or AHRQ for a single organizational entity incorporating multiple research projects and associated project cores. The list of program announcements from which eligible centers are funded may be found at the URL (http://nccam.nih.gov/announcements/disparitiesPAR.htm)

NCCAM defines CAM practices as those that are “…unproven by science and not presently considered an integral part of conventional medicine.” (http://nccam.nih.gov/about/plans/2005/index.htm) NCCAM groups the wide range of CAM modalities into four domains: 1) Mind-Body Medicine; 2) Biologically-based practices; 3) Manipulative and body-based practices; and 4) Energy Medicine.  In addition, NCCAM studies whole medical systems, such as Ayurvedic medicine, Traditional Chinese Medicine, Traditional Indigenous medicine, and homeopathy.  Mind-Body interventions use a variety of techniques designed to enhance the mind's capacity to affect body functions and symptoms.

Mind-body techniques that are considered CAM include prayer, mental healing, and therapies that use creative outlets such as art, music, or dance, and meditation for selected purposes.   Other techniques that were considered CAM in the past have become mainstream, such as patient support groups and cognitive-behavioral therapy.

Biologically-based practices for prevention and therapy use foods and their components, diets, and dietary supplements such as vitamins, herbs, and other natural products.

Manipulation and body-based methods in CAM are based on manipulation and/or movement of one or more parts of the body.  Examples include chiropractic or osteopathic manipulation, and massage therapy.

Energy therapies are of two types: 1) Biofield therapies (e.g., Qi gong, Reiki, and Therapeutic Touch), which are intended to affect energy fields that surround and penetrate the human body, and 2) Bioelectromagnetic-based therapies that involve the unconventional use of electromagnetic fields such as pulsed fields, magnetic fields, or alternating current or direct current fields for selected purposes.

Although numerous surveys document use of CAM by the general population, less information is available on CAM use by racial and ethnic minority populations. NCCAM previously published the initiative, “Secondary Analysis of Data on CAM Use in Minority Populations,” to stimulate research on this subject. Some practices now considered to be CAM have long histories of use as traditional practices in populations and cultures outside the mainstream. America's increasing cultural diversity and increasing minority populations necessitate a better understanding of their views on health, illness and healthcare.  Because of the integral role of Traditional Indigenous/CAM practices in these cultures, a better understanding of these factors can provide insight into health behaviors and beliefs of the populations, generating information that may inform the delivery of conventional health care and lead to reduced health disparities.

At the same time, statistics document significant disparities for minority populations in health outcomes, such as quality of life, as well as mortality, processes, quality and appropriateness of care, and the prevalence of certain conditions or diseases. DHHS has targeted health disparities in six conditions – HIV/AIDS, cancer, cardiovascular diseases, diabetes, adult and childhood immunizations, and infant mortality – for elimination by the year 2010, I response to which NIH has funded several research centers to address these and other health disparities. The centers funded by NIH for research on minority health and health disparities research, as well as the AHRQ centers for research on health disparities, all can contribute to the objectives of this program announcement.

Scientific Knowledge to be Gained

While many CAM therapies are in extensive use by the public, few have been thoroughly tested for safety and/or efficacy. For this reason, the potential role of traditional or CAM practices in the elimination of health disparities remains to be defined.  As part of its contribution to this effort, NCCAM seeks to fund research to determine the safety and efficacy of CAM interventions regarding minority health and the possible roles for CAM in contributing to the elimination of racial and ethnic health disparities.  Research illuminating mechanisms of action for relevant CAM interventions as well as outcomes of CAM use for health disparities conditions or diseases also are of interest.  NCCAM intends to build on research investments addressing health disparities or minority health by soliciting applications from those centers funded by NIH or AHRQ for research on minority health or health disparities.  By stimulating high quality, exploratory/developmental studies of CAM at institutions with infrastructure and research activities focusing on minority health or health disparities, NCCAM seeks to generate new knowledge regarding CAM as it relates to racial and ethnic health disparities.

Centers for research on minority health or health disparities span a broad research spectrum including basic, pre-clinical, clinical, translational, and health services research relating to minority health and health disparities. To increase the understanding of all aspects of traditional and CAM practices as they relate to health disparities, this program announcement invites institutions with NIH- or AHRQ-funded minority health centers or health disparities centers to submit applications on research topics relating to CAM and minority health or health disparities. Because NCCAM previously announced the initiative, Secondary Analysis of Data on CAM Use in Minority Populations (PAR-03-102), applications proposing epidemiologic studies of CAM use or secondary analyses of data on CAM use will not be considered responsive to this initiative.

Objectives

The objective of this FOA is to encourage the submission of high quality, exploratory/developmental studies investigating the spectrum of CAM and Traditional Indigenous Medicine interventions as they apply to racial and ethnic minority populations or health disparities.  Applications may propose research projects for basic, pre-clinical, clinical, translational, or health services research studies of CAM or Traditional Indigenous Medicine interventions as they relate to minority health or health disparities. Those applications seeking funding for clinical research grants may propose projects in any CAM domain in order to provide preliminary data that can be used as a foundation for larger clinical studies and illuminate a possible role for Traditional Indigenous or CAM practices in reducing and ultimately eliminating health disparities in cancer, diabetes, cardiovascular diseases (including stroke), HIV/AIDS, or other minority health or health disparity condition.  This FOA seeks to stimulate research that will increase the understanding of CAM in relation to minority health conditions or identified health disparities and identify possible roles for traditional or CAM practices in reducing and ultimately eliminating health disparities. Clinical studies proposing projects involving procedure-based CAM or Traditional Indigenous Medicine practices are required to include a knowledgeable practitioner as part of the research team.

Examples of Research Topics

The following list of research topics provides examples of the types of research projects being sought by this initiative. This list is illustrative, is not exhaustive, is not intended to be exclusive, and is not in priority order.  In addition, NCCAM has identified research areas of special interest as well as areas that are subject to a short “pause” in new research funding.  Please see the NCCAM Web site (http://nccam.nih.gov/research/priorities/index.htm#5) for further information.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the NCCAM R21 (Exploratory/Developmental Project) award mechanisms.

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.  Applicants are encouraged to direct inquiries regarding the appropriate mechanism to scientific/research staff listed in the Section VII.1. Scientific/Research Contacts.

The R21 awards are exploratory/developmental research grants for support of pilot and feasibility research designed to provide investigators with an opportunity to produce preliminary data in support of a larger project that may be submitted in the future as a research project (R01) grant application. Two NCCAM R21 funding mechanisms (http://nccam.nih.gov/research/instructions/r21/index.htm ) are available:  (1) Basic and Preclinical Research on Complementary and Alternative Medicine and (2) NCCAM Exploratory/Developmental Grant for Clinical Studies.  Applicants are advised to check the website above for the most current NCCAM R21 announcements, and also to abide by the application guidance, allowable project period length, and direct cost limits.

This FOA uses just-in-time concepts. It also uses the modular budget formats (see the “Modular Applications and Awards” section of the NIH Grants Policy Statement. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, “Modular Budget Component,” of the Application Guide).

Exploratory/developmental grant support is for new projects only; competing renewal (formerly “competing continuation”) applications will not be accepted. Up to two resubmissions (formerly “revisions/amendments") of a previously reviewed exploratory/developmental grant application may be submitted. See NOT-OD-03-041, May 7, 2003.

2. Funds Available

The total amount awarded and the number of awards will depend upon the number, quality, duration, and costs of the applications received.  This funding opportunity will use the NCCAM R21 award mechanisms.  The NCCAM R21 award mechanisms limit the amount of funds that can be requested. 

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 ICs provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

F&A costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, November 2, 2004.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

To be eligible for this initiative, applicants must have received an NIH- or AHRQ-funded grant for a research center on minority health or a research center on health disparities.  To assist in determining eligibility for this FOA, interested potential applicants should check the list of the NIH and AHRQ RFAs and FOAs from which an institution needs to have received center grant funding at the URL (http://nccam.nih.gov/announcements/disparitiesPAR.htm).  Questions regarding eligibility may be directed to the NCCAM Scientific/Research Contact listed below in Section VII.1.  The application must be accompanied by a letter from the Minority Health Center Director or Health Disparities Center Director which must include:  1) the grant number through which the Minority Health or Health Disparities Center is funded; 2)  the FOA or RFA number to which the previously funded Center grant application was submitted; and 3)  an assurance that the Center’s resources will be available for collaboration on the proposed project.  This letter must be attached to the SF424 application as Item 20 (“Pre-application”) of the Cover Component on the Research and Related (R&R) Form.  Although the DHHS and NIH Initiatives target six health disparity conditions (cancer, diabetes, cardiovascular diseases, HIV/AIDS, adult and child immunizations, and infant mortality), applications that address another disease or condition that is the subject of research at the applicant institution's minority health center or health disparities center are appropriate for submission. Those applicants seeking funding for basic, mechanistic, or preclinical research to elucidate the underlying mechanisms of CAM therapies and to provide a stronger foundation for ongoing and planned clinical studies may propose projects in any CAM domain. Investigators in the fields of biology, chemistry, physics, psychology, neurosciences, endocrinology, immunology, genetics, pharmacology, and other relevant fields of inquiry who are interested in applying their expertise and contemporary technologies to help advance the science of CAM are encouraged to apply.  

Applicants may submit more than one application, provided each application is scientifically distinct.

Section IV. Application and Submission Information


Registration and Instructions for Submission via Grants.gov


To download a SF424 (R&R) Application Package and SF424 (R&R) SBIR/STTR Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

PD/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Started

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take 4 weeks or more. Therefore, applicants should immediately check with their business official to determine whether their institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.


For further assistance, contact GrantsInfo; Telephone: 301-435-0714, E-mail: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R &R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”

The SF424 (R &R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information

Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget

Optional Components:
PHS398 Cover Letter File
R&R Subaward Budget Attachment (s) Form

Note: While both budget components are included in the SF424 (R&R) forms package, the NIH R21 uses ONLY the PHS398 Modular Budget. (Do not use the detailed Research & Related Budget.)

Please see the NCCAM website at: http://nccam.nih.gov/research/instructions/r21/index.htm for further information on the guidelines for pre-clinical and clinical R21 applications.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review and Anticipated Start Dates
Opening Date: May 2, 2006 (earliest date an application may be submitted to Grants.gov).
Letter of Intent Receipt Date(s):  October 16, 2006; October 15, 2007
Application Submission/Receipt Date(s): November 14, 2006 and 2007
Peer Review Date(s):  February – March 2007 and 2008
Council Review Date(s):  May – June 2007 and 2008
Earliest Anticipated Start Date(s):  July 2007 and 2008

3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:

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

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Morgan N. Jackson, M.D., M.P.H.
Division of Extramural Research and Training
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892-5475
(for courier service, use the Zip Code 20817)
Telephone: (301) 402-1278
Email: mj145m@nih.gov

Application Information Meetings

In order to give potential applicants the opportunity to clarify any issues or questions concerning this FOA, NCCAM expects to coordinate annual Application Information Meetings (AIMs).  At the AIMs, potential investigators will have the opportunity to discuss application concepts and outlines of proposed applications with NIH staff.  The AIMs will be held as telephone conference calls on dates to be determined, approximately two months prior to the application receipt date.  The dates will be listed approximately three months prior to each application receipt date on the URL http://nccam.nih.gov/announcements/disparitiesPAR.htm.  Although a fee is not associated with this meeting, pre-registration is required.  Additional information on the conference calls can be obtained from the URL http://nccam.nih.gov/announcements/disparitiesPAR.htm.  A summary of the presentations and issues discussed at the meetings will be made available through the NCCAM Web-site approximately two weeks after the AIMs. Hard copies will be made available for those applicants without Web access.

3.B. Sending an Application to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note: Applications must only be submitted electronically.
PAPER APPLICATIONS WILL NOT BE ACCEPTED.

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also in the Commons. 

The NIH will not accept any application in response to this FOA 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. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an “Introduction” addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).

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 award if such costs are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval.  If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost.  NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See the NIH Grants Policy Statement.

For NCCAM funding strategies and pay line, please see “Funding Strategy/Payline” at http://nccam.nih.gov/research.

6. Other Submission Requirements

Because of various considerations characteristic of research on CAM interventions, investigators are strongly encouraged to familiarize themselves with the range of policies that NCCAM has implemented for CAM research.  For example, NCCAM has posted to its Web site special requirements and guidance for research on biologically active agents (http://nccam.nih.gov/research/policies/bioactive.htm).

All pre-clinical as well as clinical applications should adhere to the policies and guidelines published in the NIH Guide and available on the NCCAM website at http://nccam.nih.gov/research/policies/.

The NIH requires the PD/PI to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”

Renewal (formerly “competing continuation” or “Type 2”) applications are not permitted.

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, with the following requirements for R21 applications:

Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement  http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., “Reporting.”

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 review group convened by NCCAM in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended R21 applications. The following will be considered in making funding decisions:

The NIH R21 exploratory/developmental grant is a mechanism for supporting novel scientific ideas or new model systems, tools or technologies that have the potential to significantly advance our knowledge or the status of health-related research.  Because the research plan is limited to 15 pages, an exploratory/developmental grant application need not have extensive background material or preliminary information as one might normally expect in an R01 application.  Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding.  Reviewers will place less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data.  Preliminary data are not required for R21 applications.   

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the study address an important health disparities problem?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? For clinical studies, does the investigative team include (as appropriate) a knowledgeable Traditional Medicine/CAM practitioner?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? Is the applicant taking full advantage of the resources at the associated Minority Health or Health Disparities Research Center? Does the application evidence synergy between the proposed project and the Center's activities?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See item 6 of the Research Plan component of the SF424 (R&R).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated.  See item 7 of the Research Plan component of the SF424 (R&R).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under item 11 of the Research Plan component of the SF424 (R&R) will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. Is the effort listed for the PD/PI appropriate for the work proposed? Is each budget category realistic and justified in terms of the aims and methods?

2.C. Sharing Research Data

Not applicable

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (see the NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590), See Section VI.3., “Reporting.”

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 NIH 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 (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

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

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

2. Administrative and National Policy Requirements

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

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

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:

Morgan N. Jackson, M.D., M.P.H.
Division of Extramural Research and Training
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892-5475
(for courier service, use the Zip Code 20817)
Telephone: (301) 402-1278
Email: mj145m@nih.gov

Sharon Ross, Ph.D., M.P.H.
Division of Cancer Prevention
National Cancer Institute
6130 Executive Blvd., Room 3157, MSC 7328
Bethesda, MD 20892-7328
Telephone: 301-594-7547
FAX: 301-480-3925
Email: rosssha@mail.nih.gov

Mireille Kanda, M.D., M.P.H.
Deputy Director
National Center on Minority Health and Health Disparities
National Institutes of Health
6707 Democracy Blvd., Suite 800
MSC-5465
Bethesda, Maryland 20892-5465
Phone: 301-402-1366
Fax: 301-480-4049
Email: kandam@mail.nih.gov

2. Peer Review Contacts:

Dr. Martin Goldrosen
Director, Office of Scientific Review
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892-5475
(for courier service, use the Zip Code 20817)
Tel: 301-594-2014
Fax: 301-480-2419
Email: goldrosm@mail.nih.gov

3. Financial or Grants Management Contacts:

Mr. George Tucker
Grants Management Officer
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892-5475
(for courier service, use the Zip Code 20817)
Telephone: 301-594-9102
FAX: 301-480-1552
Email: gt35v@nih.gov

Section VIII. Other Information


Required Federal Citations

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

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of scientific merit or the priority score.

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

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/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.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R); 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-02-005.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. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://PublicAccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_manual.htm).

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. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to 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 PA 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 or Health Systems Agency review. 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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.