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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
Office of Dietary Supplements (ODS/NIH), (http://ods.od.nih.gov)
National Center for Complementary and Alternative Medicine (NCCAM), (http://nccam.nih.gov)
National Cancer Institute NCI, (http://nci.nih.gov)

Title: Dietary Supplement Research Centers: Botanicals (P50)

Announcement Type
This is a reissue of RFA-OD-04-002 and RFA-OD-06-001.

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

Request For Applications (RFA) Number: RFA-OD-09-001

Catalog of Federal Domestic Assistance Number(s)
93.213

Key Dates
Release Date: January 29, 2009
Letters of Intent Receipt Date: Not applicable
Application Receipt Date: December 3, 2009
Peer Review Date: March 2010
Council Review Date: May 2010
Earliest Anticipated Start Date: July 1, 2010
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: December 4, 2009

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
D. Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

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

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
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

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

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Background

Dietary supplements containing botanical ingredients are readily available to U.S. consumers who use these products to promote health and wellness as well as prevent and treat disease. However, the quality, safety and efficacy of many widely used botanical ingredients have not been adequately evaluated. Before these issues can be addressed in human studies, high quality basic and mechanistic research that will inform clinical trials is needed.

Botanicals as test materials present unique research challenges. Plants are extraordinary repositories of diverse metabolites. In contrast to prescription drugs, botanical dietary supplements expose consumers to complex chemical mixtures and the active constituents may not be known. In addition, the pharmacognosy and natural products literature documents biologically relevant synergistic and antagonistic effects of chemicals within botanicals. These factors suggest that the scientific study of botanicals requires consideration of multiple actives and their potential interactions and use of the increasingly sophisticated analytical methods and advances in natural products chemistry for examination of components of complex mixtures.

Botanical research requires expertise in many disciplines usually bringing together researchers with proficiency in biological and physical sciences. More than just assembling researchers from multiple disciplines is required to address the challenging and complex problems of botanical research. Like multidisciplinary research, interdisciplinary research involves many areas of expertise but goes a step further and takes the relevant parts from the contributing disciplines and integrates them in ways intended to produce a new conceptual framework. An important emphasis should be placed on contemporary technologies used to explore the chemical components of plants. For example, there have been significant advances in the area of spectroscopy (e.g. NMR and MS), separation chemistry (e.g. counter current chromatography) as well as plant genomics that can be exploited. Integrating different disciplines in this way also holds the promise of identifying and understanding the biological effects of botanicals and revealing their mechanism(s) of action.

Botanicals of Interest

Botanicals of particular interest include plants commonly referred to as traditional herbal medicines or phytomedicines (e.g., ginkgo, echinacea, valerian), many of which are widely available in the U.S. as dietary supplements. This RFA also supports research on foods of plant origin (e.g., cranberry, broccoli, garlic) which by virtue of biologically active components may provide health benefits beyond basic nutrition; these bioactive constituents are appearing with increasing frequency as ingredients in dietary supplements. Botanicals as dietary supplements are intended to be orally ingested. Other intended routes of administration (e.g., topical) are not within the scope of this FOA.

Botanical test materials ranging from whole fresh plants to isolated bioactive constituents are appropriate test materials for the proposed research. There are potential differences in biological effects of and clinical response to a relatively complex preparation (e.g. powder, extract, tincture) compared to an isolated bioactive constituent from plants. Thus, applicants proposing to study isolated constituents from plants should remain aware of the potential effects of removing bioactive constituents from their original matrix, and perhaps more importantly the potential change in physiological response as one moves from a relatively complex preparation to an isolated bioactive constituent.

Definition of Botanicals

For the purpose of this RFA, botanical is defined as plants, plant parts (e.g., bark, leaves, stems, roots, flowers, fruits, seeds, berries), plant exudates, algae, and macroscopic fungus. Bacterial or yeast fermentation products are not included. The definition of botanical is further extended to include botanical preparations and isolated bioactive constituents other than essential nutrients. Synthetic compounds derived from botanical sources are not encouraged as test materials for research conducted under this initiative. If the applicant proposes to study synthetic compounds, their use must be scientifically justified. This FOA is not supportive of applications aimed at new drug discovery.

BRC Themes

Each BRC will be structured around a central theme. Themes provide a focal point for research activities and should promote synergy (i.e., when individual components of a center work in concert and result in a research outcome that is greater than the sum of the individual parts). An overarching research theme can be developed in a number of ways. Examples include but are not limited to: biological effects of a class of bioactive compounds (e.g., flavonoids, sterols,) derived from botanicals with purported health promoting properties; an experimentalapproach; a biological process (e.g., inflammation) with multiple clinical endpoints; potential beneficial effects on an organ system (e.g., digestive); or research conducted under the umbrella of a traditional medical system (e.g., Traditional Chinese Medicine or Ayurveda).

Selection of a theme and associated research projects may be guided by a number of additional considerations, including but not limited to: (1) the potential to translate the proposed research to human health benefits, (2) state of the science related to the theme and proposed research topics, and (3) potential for integrating research activities and simultaneously maintaining thematic focus.

Requirements

1. Build collaborative interdisciplinary research teams that will advance basic science to inform clinical studies. To do this, the following activities should be emphasized:

2. Cultivate the use of contemporary technologies and innovative approaches (e.g., NMR, mass spectrometry, bioimaging, genomics, proteomics, metabolomics, bioinformatics, systems biology) in botanical research

3. (OPTIONAL) Conduct an early phase clinical study such as a human metabolic study, Phase I or Phase II clinical trials.

Experimental Approaches

The increased need for collaborative integrated interdisciplinary research approaches stems, in large part, from the rapid progress in developing new research tools for understanding chemistry and biology both at a molecular and at a systems level. Research on diatary supplements and botanicals may encompass any form of structural, biochemical, genetic, cellular, molecular, or other appropriate experimental approach.

Potential research directions might include but are not limited to the following:

This list should not be considered to be comprehensive, restrictive, or in priority order.

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 P50 award mechanism.
The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

2. Funds Available

The ODS and NCCAM intend to commit up to $9 million in total costs in FY 2010 to fund up to six new and/or renewal applications in response to this FOA. Future year amounts will depend on annual appropriations. An applicant may request a project period of up to five years and a budget in direct costs up to $1.0 million per year. NCI will provide $350K to support one R01 level project within one center. The earliest anticipated start date is July 1, 2010.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

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

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

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

Applications from foreign institutions are not allowed.

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. Women and individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

Only investigators who submitted a pre-application in response to PAR-09-091 and were notified are eligible to submit full applications under this FOA.

The PD/PI must be Center Director, Director of the Administrative Core, and a Project Leader of one R01 level Research Project.

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

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) 710-0267, Email: [email protected].

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 D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

Face Page (Page 1):

The face page is the same as the face page (form page 1) in the PHS 398 kit. In item 1, enter the title of the Center. The title should be descriptive and reflect the thematic focus of the Center. In item 2, insert the RFA number, and enter the title Dietary Supplement Research Centers: Botanicals . In item 3, indicate the name, degree, and position (or equivalent) title of the BRC Principal Investigator.

Description, Performance Sites, and Key Personnel (Page 2):

Page 2 is the same as form page 2 in the PHS 398 application kit. Provide a brief description of the BRC in the space provided, specifically addressing each project and proposed resource core. Fill in all the performance sites and all key professional personnel including all Research Project and Core Leaders and key personnel of the Pilot Research Program and Career Development effort, using continuation pages as required.

Table of Contents:

Instead of using form page 3 in the PHS 398 application kit, prepare a Table of Contents that identifies by page number all major parts of the BRC application so that each can be readily located. When listing individual projects and core components, identify each by a project or

core number, title and responsible investigator (i.e., Research Project or Core Leader) in the order in which they appear in the application.

Budget:

Budgets for each component (Cores and Research Projects) of the Center application and a composite overall budget should be included in the application. Use PHS 398 form page 4 to present the summary budget for the first year for the entire center. Applicants may request up to $1.0 million in the direct costs for the first year.

Use additional PHS 398 form pages 4 to show the budgets requested for each research project and core.

If the grant application includes research activities that involve institutions other than the applicant organization, the proposed program represents a consortium effort. It is essential to explain the

programmatic, fiscal, and administrative arrangements for such activities. These matters also should be discussed in general terms in the Program Overview section of this application and more specifically within descriptions of pertinent projects. Include in the designated blocks on form page 4 the total cost (direct plus F & A cost) associated with such third party participation.

Use PHS 398 form page 5 to show the total BRC budget requested for each of the five years.

Use additional PHS398 form pages 5 to show the yearly budgets for each research project and core.

Justifications for increases in succeeding years or substantial changes in budget categories should be included here.

Biographical Sketches:

Prepare biographical sketches as described in the PHS 398 application kit. Begin with the Principal Investigator/BRC Director and then proceed in alphabetical order. Biographical sketches are required for all key personnel participating in the individual BRC projects and

cores, including consultants.

Letters of Support:

A letter of institutional commitment from the Dean or another person of similar rank should be included. If the application is a consortium effort, similar letters of support from participating institutions should be included.

BRC Research Plan:

A BRC should be an identifiable organizational unit formed by a single institution or a consortium of cooperating institutions. A BRC must minimally consist of: (1) an Administrative Core; (2) three to four R01 level Research Projects; (3) at least two Research Resource Cores, one of which must provide expertise in botanicals or a closely related discipline; (4) a Pilot Research Program and (5) opportunities for training and career development.

Research projects, BRC administration, research cores and the pilot research program are the main components of the BRC Program. It is up to the applicants to decide how best to organize their Center to achieve its goals. Because of the complexity of a Center program, the importance of a clear and efficient management plan can not be overstated.

The Center application should be presented as a whole and include the following components in this order:

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

3. Submission Dates and Times

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

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: Not applicable
Application Receipt Date: December 3, 2009
Peer Review Date: March 2010
Council Review Date: May 2010

3.A.1. Letter of Intent

Not applicable

3.B. Sending an Application to the NIH

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

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

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

At the time of submission, two additional copies of the application and ALL copies of the appendix material (see below) must be sent to:

Martin Goldrosen, Ph.D.
Director, Division of Extramural Activities
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892 (for express/courier service use 20817)
Telephone: (301) 594 2014
Fax: (301) 480 2419
Email: [email protected]

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by NCCAM. Incomplete and/or non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.).

6. Other Submission Requirements and Information

A. Research Plan Page Limitations

The Research Plan section of the application is limited to 100 pages, excluding literature citations and lists of publications. Eligible renewal applicants are allowed an additional 6 pages for their Summary of Past Progress of the Center as a whole, excluding literature citations. Please note that there is no requirement to submit the maximum number of pages; instead, concise applications are desired. Applicants may divide the 100 allowable pages between components as they wish.

Appendix Materials

All paper PHS 398 applications must provide appendix material on CDs only, and include (5 identical CDs in the package sent to Dr. Goldrosen, see section 3B. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html).

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

Organize the single Appendix in sub-appendices that correspond to the relevant research project or core.

Materials permitted in the Appendix are:

Special Requirements

This section includes detailed descriptions of required components of the application and provides post-award conditions. If notified to submit a full BRC application, applicants may not make significant changes in the full application from what is proposed in the X02 application

Applications that do not include required components of the application will be considered non-responsive to the RFA and will not be reviewed. Applicants with concerns about being responsive are encouraged to contact NIH Program Officers early in the application preparation process.

Botanical Test Materials

The rationale for selection of specific botanicals for study should be clearly described and could include but is not limited to the following: history of use, prevalence of use, indications for use, the preclinical science base, and results of clinical studies.

Eligible applicants are strongly encouraged to consult NCCAM s policy and guidance: Biologically Active Agents Used in Complementary and Alternative Medicine (CAM) and Placebo Materials (http://grants.nih.gov/grants/guide/notice-files/NOT-AT-05-003.html;).http://grants.nih.gov/grants/guide/notice-files/NOT-AT-05-004.html The Just-in-Time information of product integrity will be reviewed by NCCAM s Product Integrity Working Group (PIWG), and a satisfactory rating must be obtained before an application can be funded.

To assure proper identification of botanical materials and better assure replication of preclinical and clinical studies, botanical test materials must be adequately characterized and documented. This requirement applies to new and renewal applications. Centers submitting renewals will be required to submit documentation to NCCAM PIWG for evaluation of new botanical test materials.

Foreign Collaborations

Foreign institutions are not permitted as the applicant organization. Foreign collaborations are appropriate if they are required to achieve the research objectives of the applicant institution. Applicants must address potential problems associated with long distance collaborations. Applicants should describe the nature of the collaboration, plans to formalize a relationship, obtain necessary permits, and establish contract elements. At a minimum, applicants are advised to consider the following issues: intellectual property rights, particularly as they pertain to traditional healing practices; regulations for collection of botanical material from foreign countries; and rights and responsibilities of both parties if any patents are developed from the proposed research. Relevant host country, governmental, non-governmental and community organizations should be consulted early in the grant planning stage to ensure that research plans are compatible with national and local policies and to identify potential barriers to collaboration.

This RFA is not intended to support international studies or build research infrastructure in foreign institutions. Funding support for such activities may be available from other initiatives at the NIH.

1. Center Organization and Structure

Program Overview

The application should contain an overview section that clearly states the theme, mission, overall aims and goals of the BRC. This section should include a timeline with milestones to gauge progress. The timeline should indicate how the center goals can be met within the time frame of the grant. The timeline also will assist the investigators and NIH program staff in evaluating progress toward the goals of the center. The Overview should explain the organizational structure of the BRC and include a core utilization table, indicating how the Research Cores will be used by the Research Projects. This section should specifically address synergy within the Center.

Center Director (PD/PI)

Each applicant institution shall name a PD/PI. The PD/PI will be the key figure in the administration and management of the center grant. The PD/PI must have relevant scientific expertise, leadership and administrative skills commensurate with those required for a P50 or similar award mechanism. Applications that do not meet this requirement will be non-responsive to the RFA. The PD/PI will be responsible for the organization and operation of the Center and for communications with NIH. The PD/PI is also required to be a Project Leader of one of the research projects within the Center, and Director of the Administrative Core. The PD/PI is required to commit at least 25% effort.

Research Project and Core Leaders

The research projects will be headed by Research Project Leaders. A Research Project Leader is essentially equivalent to a PI on a standard NIH R01 grant application. Research cores will be headed by Research Core Leaders.

Summary of Past Progress of the Center as a whole (for renewal applications)

Provide a summary of progress made in the current funding period, including a list of all publications that cite support from the current BRC. Include the beginning and ending dates of the current award. Summarize the overall theme and goals of the existing Center and explain changes in direction. Explain any changes in key personnel. Explain and justify which projects and cores will be continued in the renewal. Provide an explanation and rationale for changing or eliminating projects and/or cores. Describe the institutional support and the development/acquisition of additional resources. The list of publications is not included in the page limit. Experimental details about progress relevant to specific research projects and/or cores should be provided within the appropriate research project or core component (see below).

Administrative Core

Leadership: The Project Director (PD/PI) is the Center Director and head of the Administrative Core. The Director is responsible for the organization, scientific and administrative leadership of the BRC and expected to devote substantial effort (25 percent) to the Center.

The organization of the Administrative Core should encompass a support structure sufficient to ensure accomplishment of the following: develop a research mission, establish research milestones, and a timeline for achieving milestones; coordinate and integrate Center activities; develop a plan for regular evaluation of scientific progress; form and interact with two advisory groups; oversee the solicitation, review and selection of pilot research studies; oversee training and career development efforts; work with the applicant institute to enhance the visibility and effectiveness of the center as a focus for botanical research. The Administrative Core may include limited funds for program enrichment activities such as seminars and research workshops. Funds from the center grant cannot be allocated for web site development or maintenance, news letters, consumer information or outreach activities.

The Administrative Core includes two advisory groups. An External Advisory Committee (EAC) will provide oversight and assist the Center Director in making scientific and administrative decisions. An Internal Steering Committee (ISC) composed of the Research Project and Core Leaders will meet regularly with the Center Director to assess research progress and determine if research goals are being met.

While the final administrative structure of the Center will be left to the discretion of the Center Director, experience demonstrates that effective development of a Center program requires interaction among the director, research project and core leaders, advisory groups, appropriate institutional administrative personnel, and NIH program staff. The Center Director may include a Project Manager/Specialist in the Administrative Core.

Administrative Core Progress (renewal applications only): A progress report must be provided for the administrative core in renewal applications. Provide the beginning and ending dates of the most recent award period. Summarize the specific aims of the core during this period and the importance of the accomplished activities. Provide justifications for major changes in the core.

Career Development and Training: This RFA supports the enhancement of existing research infrastructure to increase interactions among scientists from a variety of disciplines and to provide outstanding training and research environments for future leaders in botanical research relevant to dietary supplements. The core should include plans for obtaining funds to provide training and career development opportunities. Supplemental funding for training and career development could be sought from NIH Ruth L. Kirschstein National Research Service Awards, institutional training grants (T32), individual fellowships (F31, F32), mentored career development awards (K01, K08) and other sources including, but not limited to, the parent institution and private foundations.

Centers are encouraged to provide interdisciplinary research training and career development opportunities to graduate students and postdoctoral fellows. These activities should be integrated into the research of the BRC.

Pilot Research Project Program: Pilot awards are intended to attract promising investigators to centers and give them the opportunity to generate sufficient preliminary data to facilitate the submission of new applications for peer-reviewed research. Clinical studies are excluded from the pilot program. The Center must request funds to support pilot projects. Pilot projects are intended to attract promising investigators to centers and give them the opportunity to generate sufficient preliminary data to facilitate the submission of new applications for peer reviewed research. The application must include a description of the process for soliciting, reviewing, selecting, and monitoring pilot projects. The External Advisory Committee (EAC) must be involved in the review process for selection of pilot awards (e.g., directly as reviewers or indirectly as part of EAC oversight responsibilities). Potential projects to be included in this program should NOT BE LISTED OR DESCRIBED in the application and will not be considered in the review of scientific merit.

Pilot research studies are typically limited to a period of one to two years. No more than $100,000 (direct costs) per year may be devoted to all pilot research projects. The first pilot studies should be awarded during the first budget year.

Pilot project funds cannot be awarded to the Center Director, Research Project Leaders, Core Leaders, or other scientists listed in the initial grant application as key personnel. Otherwise, both new and established investigators from the applicant institution and/or a consortium are eligible to apply for funding. The research must be related to the Center theme and research aims. Clinical research is excluded from pilot funding. Pilot funds cannot be used to assess the variability of botanical ingredients in botanical dietary supplement products available to consumers, because this activity is unlikely to advance the research of the center or to lead to applications for independent funding.

NIH program staff must be notified before funds can be expended to initiate pilot projects, to verify (1) EAC approval and (2) approval of animal care and use and human subject assurances. The notification should include the proposal and specific research aims, the pilot research budget, and a biosketch of the pilot study investigator.

For renewal applications, this section should include a summary documenting success in attracting promising new investigators to the BRC and their contribution to the center and success in generating preliminary data to submit new applications for peer-reviewed research.

External Advisory Committee (EAC): The Administrative Core will establish a scientific advisory board to review and provide guidance on Center activities. In addition to evaluating scientific progress of the Center, the EAC should periodically comment and report on Center operations to ensure that resources, especially core resources are devoted to the most scientifically worthy projects. The EAC is expected to participate in the review of pilot project applications and may perform other duties deemed appropriate by the applicant. For example, termination or change in scope of a research project or core must be discussed with the EAC.

EAC members and the committee chair will be appointed by the Center Director; members may serve on a rotating basis. The Center Director will serve on the EAC in an ex-officio capacity only. The EAC should consist of at least six members in addition to the Center Director. Experts might include a pharmacognosist or ethnobotanist, molecular biologist, nutritionist, pharmacologist, toxicologist, research clinician, biostatistician, and other individuals with scientific expertise specific to the BRC (e.g., health outcome(s) under investigation, relevant technologies). EAC members may be employees of the grantee institution, participating institutions, or from outside institutions, but they cannot participate directly in the research of the BRC. If an EAC member becomes directly involved in the research of the Center, the resulting committee vacancy must be reported to NIH program staff and a replacement sought in a timely manner.

APPLICANTS SHOULD NOT IDENTIFY POTENTIAL EAC MEMBERS IN THEIR APPLICATION. While description of EAC activities should be included in the application, potential members of the Board should NOT be contacted, named, or selected until an award has been made. This stipulation will allow a wider pool of potential reviewers of the applications.

In addition to specifying the type of expertise needed, the applicant should also describe the process by which EAC members will be selected. The EAC should be established within six months of the start of the first budget period and meet once before the end of that period. Thereafter, the EAC shall meet at least twice a year. Minutes of all (i.e., scheduled and ad hoc) EAC meetings must be kept. Minutes of the two regularly scheduled meetings shall be sent to NIH staff within 30 days and also be included in the annual progress report. At least one of the semi-annual meetings must take place in person; other meetings may be conducted by video- or teleconference. Support for the EAC must be explicitly budgeted in the Administrative Core. If it is anticipated that the EAC committee will include individuals who require travel expenses, these costs should be reflected in the administrative budget.

Internal Steering Committee (ISC): The ISC will meet regularly to assess research progress, resolve problems, evaluate utilization of core resources, and consider new research opportunities. Regular meetings of the ISC are intended to facilitate internal communication, cooperation, and interdisciplinary collaboration among BRC investigators. The applicant should provide a plan for ISC meetings. In the planning phase of the grant application, the ISC should work with the Center Director in developing the Program mission statement, developing specific aims and setting milestones.

Travel: The Center Directors and at least two selected Research Project Leaders shall participate in one meeting per year, alternating between the Washington DC metropolitan area or another site agreed to by the Center Directors and the NIH. Funds should be included in the proposed budgets to support attendance at this annual meeting. Plans for these meetings should be presented as part of the Administrative Core section of the application

Resource Sharing Plan(s): NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

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

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

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

Intellectual Property Rights. The institution should provide written assurance that it will protect the intellectual property rights of the BRC investigators and their collaborators and under no circumstances engage in formal/legal agreements with commercial sources (e.g., pharmaceutical companies, dietary supplement ingredient suppliers or manufacturers) that would compromise the ability of BRC investigators to have unhampered access to institutional resources in BRC-related research or participate fully in collaborations with any other researchers. The statement of commitment should also include a written assurance that in its interactions with commercial entities under sponsored research agreements, the BRC will comply with the requirements of the Bayh-Dole Act and NIH funding agreements while upholding basic principles of academic freedom. Sponsored research agreements with commercial entities should be entered into by a BRC only upon due consideration of the points outlined in "Developing Sponsored Research Agreements: Considerations for Recipients of NIH Research Grants and Contracts (Federal Register, Vol. 59, No. 215, Tuesday, November 8, 1994, pp. 55674-55679)", a copy of which can be viewed at: http://grants.nih.gov/grants/guide/notice-files/not94-213.html. The statement of commitment should also include a written assurance that the BRC will manage its interactions with third parties so that they do not restrict the ability of a BRC to receive and disseminate biomedical research materials from and to the scientific community. Likewise, letters should be supplied by any relevant third parties confirming their adherence to these policies. Third party agreements should be identified at the time of grant submission. If third party agreements with commercial sources are established after application submission: (1) but prior to review, contact NCCAM (Dr. Goldrosen); (2) and after review but prior to award, contact ODS (Dr. Swanson).

Research Projects

The research projects are equivalent to NIH R01 research grants in size and complexity. All research projects must be hypothesis driven and supported by preliminary data (new and renewal applications) and progress reports (renewal applications only). The collection of research projects must be interdisciplinary, synergistic and consistent with the thematic focus of the center.

Center applications composed solely of basic/preclinical research projects should describe the relevance of the proposed research to human health and the potential for translation to clinical practices.

Only applicants with demonstrated expertise should propose clinical research (e.g., a metabolic study, Phase I or II clinical trial); only one clinical research study is allowed per application. Phase I/II clinical studies to assess feasibility, dose range effects, pharmacology, safety, and biological efficacy are acceptable. Phase III studies will be considered non-responsive to this RFA. The PI should contact NIH program officers if s/he has questions about suitability, number, or definition of clinical studies.

Research projects should follow the standard R01 format as described in PHS 398. Start with a cover page that lists the title of the project and the project leader. Follow this with form page 2, description and list of key personnel. Follow this with continuation pages listing performance sites, a description of resources for the specific project, and justification for the roles and duties of each of the key personnel. Do not include budget pages, biographical sketches or other support Follow this with applicable Research Plan sections 2 (specific aims), 3 (background and significance), 4 (preliminary studies/progress report), 5 (research design and methods), 6 (bibliography), 7 (publication list for renewal applications), 8 (protection of human subjects), 9 (inclusion of women and minorities), 10 (planned enrollment table), 11 (inclusion of children), 12 (vertebrate animals), 13 (select agent research), 15 (consortium/contractual arrangements), 16 (letters of support specific to the research project), and 17 (resource sharing plans).

For renewal applications, a progress report must be provided for each research project that is a continuation or extension of a currently funded project. Include the beginning and ending dates of the current award period. Summarize the specific aims of the original project and the importance of the research results. Provide complete references to appropriate publications and manuscripts accepted for publication. The list of publications is not part of the page limitations.

Applications must include at least three, but no more than four, R01 level research projects. Collectively, the research projects must show evidence of interdisciplinary collaboration among scientists across the Center. At least three of the submitted projects must be judged meritorious by the peer-review panel for the application to meet the minimal requirements of a P50 Center. Failure to meet this requirement will remove the application from funding consideration.

At least three R01 level research projects must be active throughout the period of grant support. If this requirement is not met, the grant mechanism may be changed.

Only one of the proposed R01 level research projects can include a clinical study; either a metabolic study, Phase I or early Phase II clinical trial can be proposed. Epidemiologic and behavioral studies, population surveys and health services research are not permissible as clinical studies and cannot be proposed either as primary research projects or submitted for consideration for pilot funding.

NCCAM requires all clinical projects to undergo review by the Office of Clinical and Regulatory Affairs (OCRA). Those grants supported by NCCAM and which contain a clinical component will be required to obtain NCCAM approval. Applicants are directed to the NCCAM guidance document for clinical studies http://nccam.nih.gov/research/policies/clinical-considerations.htm .

It is the sole responsibility of the applicant to obtain all necessary clearances from the Food and Drug Administration (FDA) as required. Questions regarding IND applications should be addressed to the FDA.

Applicants are strongly encouraged to consult their local Institutional Review Boards (IRB) regarding IND applications. If applicable, the applicant should present a plan for IND submission, provide evidence that an IND application is in process or that the FDA has allowed an exemption.

Investigators are cautioned against relying solely on label information or certificates of analysis of botanical materials for research projects. Careful sourcing and verification of named botanical constituents are essential. Botanical test materials used to generate preliminary data for the R01 level projects must be sufficiently characterized and tested for stability to assure that preliminary findings can be replicated.

Research projects in the application may be simultaneously submitted to the CSR as investigator-initiated applications (e.g., NIH R01). The dual submission must be clearly documented in the Center application under pending support. If, following review, both the Center application and the R01 application are found to be in the fundable range, the research project investigator must relinquish the R01 and will not have the option to withdraw from the Center grant. This is an NIH policy intended to preserve the scientific integrity of a multi-project grant, which may be seriously compromised if a strong component project is removed from the program. Investigators wishing to participate in a multi-project grant must be aware of this policy before making commitments to the Center Director and applicant institution.

Research Resource Core(s)

The research cores provide infrastructure and result in increased productivity contributing to synergy of the research effort as a whole. A Center must establish at least two Research Cores. One of the Research Cores must provide significant expertise in botanicals or a closely related discipline and the analysis of chemical components of plants. Examples of other Research Cores include but are not limited to groups that provide expertise in the following areas: analytical chemistry, proteomics, physiology, pharmacology, clinical research and biostatistics. It is expected that leaders of the research cores will participate in developing the conceptual framework for the research conducted by the center.

A. Research cores must be utilized by a minimum of two research projects. Applicants must provide a core utilization table showing an estimate of percent effort of each core devoted to each proposed research project. This table should be presented as part of the Project Overview.

While the research core(s) may function primarily as a service entity, core scientists are often involved in conducting original and developmental research. Proteomics and mass spectrometry cores, for example, often develop new methods and innovative procedures essential to advancing the research of the center.

Core resources should not duplicate resources already available to Center investigators. However, fee-for-service core components (i.e., Center use of existing facilities) are acceptable with adequate justification.

Use standard form PHS 398 to present each Research Core. Start with a cover page that lists the title of the core and the core leader. Follow this with form page 2, description and list of key personnel. Follow this with continuation pages listing performance sites, a description of resources for the specific core, and justification for the roles and duties of each of the key personnel. Do not include budget pages, biographical sketches or other support Follow this with applicable Research Plan sections 2 (specific aims), 3 (background and significance), 4 (preliminary studies/progress report), 5 (research design and methods), 6 (bibliography), 7 (publication list for renewal applications), 8 (protection of human subjects), 9 (inclusion of women and minorities), 10 (planned enrollment table), 11 (inclusion of children), 12 (vertebrate animals), 13 (select agent research), 15 (consortium/contractual arrangements), 16 (letters of support specific to the research core), and 17 (resource sharing plans).

A progress report must be provided for each research core. Include the beginning and ending dates of the current award period. Summarize the activities of each core, importance of findings, and major contributions of each core to the research projects. Provide complete references to appropriate publications and manuscripts accepted for publication. The list of publications is not part of the page limitations.

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

An appropriate scientific review group convened by NCCAM will evaluate applications for scientific and technical merit.

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

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

The following components of the BRC application will be evaluated:

1) Individual Research Projects

2) Research Cores

3) Administrative Core

4) Principal Investigator

5) Resources and Environment

6) Program Synergy

7) Progress Report (renewals only)

8) Overall Program

1) INDIVIDUAL RESEARCH PROJECTS

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

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

Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit.

Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is the research project consistent with the thematic focus of the BRC?

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? Do the investigators have complementary and integrated expertise?

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

Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Do the preliminary data support the feasibility and significance of the proposed research? Are there specific and adequate descriptions to address NCCAM policy and guidelines on biologically active agents (http://www.nccam.nih.gov/research/policies/bioactive.htm)? If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? For clinical studies, does the research project include a trial design and sample size that adequately address the objectives? Does the research project contain a clear description of interventions, of primary and secondary endpoints, and ethical considerations including monitoring of data integrity, privacy, and safety?

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

Additional Review Criteria. As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit.

Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.

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

Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

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

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

Select Agent Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

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

Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

(2) RESEARCH CORES

Each research core will receive a merit descriptor (i.e., outstanding, acceptable, unacceptable) based on the following criteria:

(3) ADMINISTRATIVE CORE

The administrative core will receive a merit descriptor (i.e., outstanding, acceptable, unacceptable) based on the following criteria:

(4) PRINCIPAL INVESTIGATOR (Center Director)

The Center Director (PD/PI) will be evaluated on the following criteria:

(5) RESOURCES and ENVIRONMENT

Each application will receive a merit descriptor for Resources and Environment (i.e., outstanding, acceptable, unacceptable) based on the following criteria

(6) PROGRAM SYNERGY

Each application will receive a merit descriptor (i.e., highly synergistic, synergistic, not synergistic) that reflects the degree of synergy and interaction of the projects and cores within the proposed BRC. In particular, program synergy will be evaluated on:

(7) PAST PROGRESS (Renewal applications only)

Each renewal application will receive a merit descriptor (outstanding, acceptable, unacceptable) that reflects the progress of the Center as a whole during the current funding period, evaluated on:

(9) OVERALL PROGRAM

A single numerical impact/priority score (1: exceptional to 9: poor) will be assigned to the BRC application as a whole. Primary emphasis will be placed on scientific merit of the research projects, as reflected by the numerical average of the scores for each project. Significant consideration will also be given to the qualitative assessment of cores, leadership ability of the Center Director, institutional commitment, resources and environment, past progress (renewals) and program synergy. In addition, reviewers will consider the following:

3. Anticipated Announcement and Award Dates

The earliest anticipated award date will be July 1, 2010

Section VI. Award Administration Information

1. Award Notices

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

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

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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

3. Reporting

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

The Annual Progress Report is due two months prior to the grant anniversary date. It should be sent to:

Division of Extramural Activities Support, OER
National Institutes of Health
6705 Rockledge Drive, Room 2207, MSC 7987
Bethesda MD 20892-7987 (for regular or US Postal Service Express mail)
Bethesda, MD 20817 (for other courier/express mail delivery only)
Phone Number: (301) 594-6584

There is no specific page limit on the progress report. It should include the following information: an overview of the major changes, research progress, education and training activities, outreach activities, data and resource sharing, and intellectual property issues.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Direct general questions and questions about research interests specific to ODS to:

Marguerite Klein, M.S.
Director, Botanical Research Centers Program
Office of Dietary Supplements, NIH
6100 Executive Blvd., Room 3B01, MSC 7517
Bethesda, MD 20892-7517
phone: (301) 496-0168
Fax: (301) 480-1845
Email: [email protected]

Direct questions about specific scientific research interests of NCCAM to:

D. Craig Hopp, Ph.D.
Program Officer
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892 (20817 for express mail)
Ph: 301-496-5825
Fax: 301-480-1587
Email: [email protected]

Direct questions about specific scientific research interests of NCI to:

Harold E. Seifried, Ph.D.
Program Director
Nutritional Sciences Research Group
Division of Cancer Prevention
National Cancer Institute, NIH
6130 Executive Blvd., Suite 3160
Rockville MD 20852
phone: 301-496-8573
Email: [email protected]

Direct questions about Investigational New Drug Applications for clinical studies to:

Jinhui Dou, Ph.D.
Pharmacologist, Botanical Review Team
ODE-I, CDER, FDA
Bldg. 22, Room 4205
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Ph: 301-796-1062
Fax: 301-796-9840
Email: [email protected]

2. Peer Review Contacts:

Dale L. Birkle Dreer, Ph.D.
Chief, Office of Scientific Review
Division of Extramural Activities
National Center for Complementary and Alternative Medicine , NIH
6707 Democracy Blvd, Suite 401
Bethesda, MD 20892 (20817 for express mail)
Ph: 301-451-6570
Fax: 301-480-2419.
Email: [email protected]

3. Financial or Grants Management Contacts:

George Tucker, MBA
Director, Office of Grants Management
National Center for Complementary and Alternative Medicine, NIH
6707 Democracy Boulevard, Suite 401
Bethesda, MD 20892 (20817 for express mail)
Ph: (301) 594-9102
Fax: (301) 480-1552
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

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

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

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

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

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

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

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

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

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

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

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-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 Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award. For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.

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