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

Announcement Type

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

Program Announcement (PA) Number: PAR-05-152

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

Key Dates
Release Date: August 10, 2005
Letters of Intent Receipt Dates: October 14, 2005; October 16, 2006; October 15, 2007
Application Receipt Dates: November 14, 2005, 2006, and 2007
Peer Review Dates: February – March 2006, 2007, and 2008
Council Review Dates: May – June 2006, 2007 and 2008
Earliest Anticipated Start Dates: July 2006, 2007, and 2008
Additional Information To Be Available on: August 14, 2005
http://nccam.nih.gov/announcements/disparitiesPAR.htm
EXPIRATION DATE for R21 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R21 AIDS and AIDS-Related Applications: May 2, 2006

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(s) of Support
   2. Funds Available

 Section III. Eligibility Information
   1. Eligible Applicants
     A. Eligible Institutions
     B. Eligible Individuals
   2. Cost Sharing or Matching
   3. Other - Special Eligibility Criteria

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

 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
   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 PAR

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, in reducing and eliminating health disparities. 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 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) which is also listed in Part I above under “Key Dates.”

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. 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 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 by soliciting applications from those centers funded by NIH or AHRQ for research on minority health or health disparities. By s timulating 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 NIH- or AHRQ-funded minority health centers or health disparities centers to submit applications on research topics addressed by the center at the applicant institution. Because NCCAM previously announced the initiative, Secondary Analysis of Data on CAM Use in Minority Populations (PAR-03-102, http://grants.nih.gov/grants/guide/pa-files/PAR-03-102.html), applications proposing epidemiologic studies of CAM use will not be considered responsive to this initiative.

Objectives

The objective of this PAR 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 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 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 health disparity conditions relevant to the focus of the minority health research center or health disparity research center at the applicant institution. This program announcement seeks to stimulate research that will increase the understanding of CAM in relation to identified health disparities conditions and diseases and identify possible roles for traditional or CAM practices in reducing and ultimately eliminating health disparities. Clinical studies of 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. As indicated previously, all projects must relate to health disparity diseases or conditions being studied by the applicant institution's center. 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(s) of Support

This program announcement will use the NCCAM R21 award mechanism. For pre-clinical R21 projects, applicants may request a project period of up to two years with a combined budget for direct costs of up to $275,000 for the two-year period.  For example, an applicant may request $100,000 in the first year and $175,000 in the second year.  The request should be tailored to the needs of the project.  Normally, no more than $200,000 may be requested in any single year.

For clinical R21 projects, applicants may request a project period of up to three years with a combined budget for direct costs of up to $400,000 for the three-year period. The budget request should be tailored to the needs of the project. For example, an applicant may request $100,000 in the first year, $200,000 in the second year and $100,000 in the third year. However, no more than $250,000 direct costs may be requested in any single year.

The R21 grant is not renewable. Further information on the guidelines for NCCAM R21 applications may be obtained from the NCCAM website at: http://nccam.nih.gov/research/instructions/r21/index.htm.

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This funding opportunity uses just-in-time concepts. It also uses the modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/modular/modular.htm).

2. Funds Available

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

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

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 is invited to work with their 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 programs.

2. Cost Sharing or Matching

This program does not require cost sharing, matching or cost participation as defined in the current NIH Grants Policy statement.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#matching_or_cost_sharing.

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 PAR, interested potential applicants should check the list of the NIH RFAs and PAs from which an institution needs to have received center grant funding at the URL (http://nccam.nih.gov/announcements/disparitiesPAR.htm) which is also listed above in Part I Overview Information. The application must include a letter from the Minority Health Center Director or Health Disparities Center Director assuring the availability of the Center's resources for collaboration on the project. To be appropriate for this PAR, applications must propose research projects that relate to a health disparity disease or condition and are consistent with the research focus of the applicant center. 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.  

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a Dun & Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

NCCAM offers two types of R21 grants through this Program Announcement: 1) basic or pre-clinical R21 applications, and 2) clinical R21 applications. Each type of R21 application differs in its requirements as indicated below.

Page Limitations and Appendix Requirements:

For basic or pre-clinical R21 applications, all instructions for the PHS 398 must be followed except:

1. Items a-d of the Research Plan (Specific Aims , Background and Significance, Preliminary Studies, and Research Design and Methods) may not exceed a total of 15 pages. No preliminary data are required but may be included if available. Competing continuation applications will not be accepted.

2. Appendix: Color photos and no more than 5 manuscripts, previously accepted for publication, may be included.

For clinical R21 applications, all instructions for the PHS 398 application kit must be followed, along with the following requirements for clinical R21 applications: 1. Although preliminary data are not required for an R21 application, they may be included. 2. Sections a-d of the Research Plan of the clinical R21 application may not exceed 20 pages, including tables and figures.

3. Applicants should document the research team's ability to access relevant populations and accrue from them sufficient numbers of participants for the proposed projects.

4. R21 appendix materials should be limited, as is consistent with the exploratory nature of the R21 mechanism, and should not be used to circumvent the page limit for the research plan. Copies of appendix material will only be provided to the primary reviewers of the application and will not be reproduced for wider distribution among reviewers. The following materials may be included in the appendix:

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. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Dates: October 14, 2005; October 16, 2006; October 15, 2007
Application Receipt Dates: November 14, 2005, 2006, 2007
Peer Review Dates: February – March 2006, 2007, 2008
Council Review Dates: May – June 2006, 2007, 2008
Earliest Anticipated Start Dates: July 2006, 2007, 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 NCCAM 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 Meeting

In order to give potential applicants the opportunity to clarify any issues or questions concerning this PA, NCCAM expects to coordinate annual Application Information Meetings (AIMs). At the AIMs, potential applicants will have the opportunity to discuss application concepts and outlines of proposed applications with NIH staff. The AIMs will be held at or in close proximity to NIH on dates to be determined that may be found at the URL listed above in Part I Overview Information. Although a fee is not associated with this meeting, pre-registration is encouraged. NCCAM, NCI, and NCMHD have not allocated funds to pay for attendee travel to the AIM; all travel costs are the responsibility of the attendee. Additional information on the meeting can be obtained from the URL listed in Part I Overview Information above. A summary of the presentations and issues discussed at the meeting will be made available through the NCCAM Web-site about one week after the AIM. Hard copies will be made available for those applicants without Web access.

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

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

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

3.C. Application Processing

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

Upon receipt, applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation 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 or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

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/.

Specific Instructions for Modular Grant applications.

Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

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.

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/archive/grants/policy/nihgps_2003/index.htm and 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, http://grants.nih.gov/grants/funding/2590/2590.htm). 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 the National Center for Complementary and Alternative Medicine in accordance with the review criteria stated below.

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

The following will be considered in making funding decisions:

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.

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 a knowledgeable 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 the Research Plan, Section E on Human Subjects in the PHS Form 398).

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 the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions 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: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

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/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan 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 will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. 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 Principal Investigator will also receive a written critique called a Summary Statement.

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 (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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

2. Administrative and National Policy Requirements

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

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) 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

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 the scientific merit or the priority score.

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 new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-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.

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.

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


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