Cooperative Drug Development Group (CDDG) for the Treatment of Mental Illness

PA Number: PAR-05-010

Part I Overview Information


Department of Health and Human Services

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

Component of Participating Organization
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov/)

Announcement Type

New

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

Catalog of Federal Domestic Assistance Number(s)
93.242

Key Dates
Release Date: October 29, 2004
Letters Of Intent Receipt Date(s): March 15 , 2005, 2006, 2007
Application Receipt Dates(s): April 15 , 2005, 2006, 2007
Peer Review Date(s): June
Council Review Date(s) : September
Earliest Anticipated Start Date: December
Additional Information To Be Available Date (URL Activation Date): N/A
Expiration Date: April 16, 2007

Due Dates for E.O. 12372
Not Applicable

Executive Summary

The National Institute of Mental Health (NIMH) requests research grant applications from academic and pharmaceutical/biotechnology industry investigators interested in participating with the National Institute of Mental Health (NIMH) in a Cooperative Drug Development Group (CDDG) program. The goal of the CDDG is to support proof-of-concept studies of novel mechanism drug candidates and promising investigational new drugs (IND) for the treatment of mental disorders. Approximately 1.5 million dollars will be set-aside for this initiative in this first year. One to 3 awards to responsive applications are anticipated on an annual basis. This PA will use the NIH U01 or U19 Cooperative agreement award mechanism. The CDDG is most appropriate for applications that include collaborations, Research Projects or core components from academia and the private sector (e.g., pharmaceutical, chemical, or biotechnological companies). Applications are allowed from single institutions with agreements for collaboration with other institutions for the performance of specified study components. For-profit or non-profit organizations, public or private institutions are eligible to apply. Foreign institutions are not eligible to apply for this PA but can participate as a subcontract. 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. Applicants may submit only one application in response to this PA. However, subcontract or consortium partners may be listed as collaborators on more than one application. Application materials are available at http://grants.nih.gov/grants/funding/phs398/phs398.html. Applicants are encouraged to contact program staff listed on the PA prior to submitting an application.

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

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
    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
      A. Receipt and Review and Anticipated Start Dates
        1. Letter of Intent
      B. Sending an Application to the NIH
      C. Application Processing
    4. Intergovernmental Review
    5. Funding Restrictions
    6. Other Submission Requirements

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

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

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

  Section VIII. Other Information - Required Federal Citations


Part II - Full Text of Announcement



Section I. Funding Opportunity Description

1. Research Objectives

The intent of this solicitation is to invite applications from academic and pharmaceutical/ biotechnology industry investigators interested in participating with the National Institute of Mental Health (NIMH) in a Cooperative Drug Development Group (CDDG) program. The goal of the CDDG is to support proof-of-concept studies of novel mechanism drug candidates and promising investigational new drugs (IND) for the treatment of mental disorders. The CDDG will specifically focus on testing drugs directed at novel targets for mood disorders, schizophrenia, eating disorders, obsessive-compulsive disorder, fragile x, autism, and other mental disorders. The CDDG will support studies to rapidly assess safety and tolerability in normal human subjects and preliminary efficacy studies in the target patient population. The proof-of-concept, early phase II or other studies such as clinical dose optimization, pharmacokinetics, and pharmacodynamics studies, should determine with reasonable certainty whether or not a drug candidate is sufficiently safe and effective to warrant further clinical and commercial development.

These data will be essential for fostering partnerships between academic investigators and the private sector (small businesses, pharmaceutical, and biotechnology companies) to further test the drug candidate in future larger-scale, longer-term studies in the target population. The goal of the CDDG is to foster these long-term partnerships between NIMH, academia, and industry that will advance the development and testing of fundamentally new, rationally designed medications and treatments for serious mental disorders.

Academic and/or pharmaceutical industry components of each CDDG should contribute unique scientific expertise towards the common goal of translating basic science findings into innovative pharmacological treatments for mental disorders. Each partnership or group must consist of a multi-disciplinary team of scientists with appropriate expertise to address the development and evaluation of novel IND-ready compounds for testing in humans. Scientists from both academia and pharmaceutical industry are encouraged to participate within a CDDG. Scientists from foreign institutions and NIH Intramural laboratories may participate in some aspects, as noted in other sections of this application.

The CDDG is most appropriate for applications that include collaborations, Research Projects or core components from academia and the private sector (e.g., pharmaceutical, chemical, or biotechnological companies). It is anticipated that the interaction of academic and non-profit research institutions with industry and NIMH via the CDDG model will: 1) accelerate the development of new therapeutics for mood disorders, schizophrenia, eating disorders, obsessive-compulsive disorder, fragile x, autism, and other mental disorders; 2) increase the availability of new IND-ready compounds suitable for testing in humans; and 3) facilitate the development and validation of new clinical measures or biomarkers suitable for use in human proof-of-concept trials of novel therapeutics for mood disorders, schizophrenia, eating disorders, obsessive-compulsive disorder, fragile x, autism, and other mental disorders.

Small businesses without academic and/or industry partners are encouraged to respond to related Program Announcements: Pharmacologic Agents and Drugs for Mental Disorders (SBIR Award) [http://grants.nih.gov/grants/guide/pa-files/PA-02-027.html] and Development of PET and SPECT Ligands for Brain Imaging (SBIR Award) [http://grants.nih.gov/grants/guide/pa-files/PA-02-028.html].

Background

Significant advances in neuroscience, genetics, and basic behavioral science, together with technological developments, have provided a rich knowledge base for understanding pathophysiology, identifying new molecular targets for drug discovery, and developing rational pharmacotherapies for the treatment of serious mental illness. With the wealth of potential new drug targets, the opportunity exists to accelerate the process of drug discovery and development to make quantum leaps toward novel and effective treatments for mood disorders, schizophrenia, eating disorders, obsessive-compulsive disorder, fragile x, autism, and other mental illnesses.

Limited support for early human studies of novel drug candidates is one rate-limiting step in the development of novel therapeutics for mental illness. The CDDG will complement the National Cooperative Drug Discovery Groups for the Treatment of Mood Disorders and Nicotine Addiction (NCDDG-MD/NA) program (http://grants.nih.gov/grants/guide/pa-files/PAR-04-009.html) which supports innovative drug discovery, research tool and model development, but does not include support for early phase human clinical testing.

The CDDG is envisioned as a NIMH cross-divisional program to rapidly assess the safety and efficacy of promising drug candidates and new indications for IND-ready drugs. The CDDG program will fill the gap that currently exists between NIMH's Division of Neuroscience and Basic Behavioral Science (DNBBS) preclinical drug discovery efforts, and the Division of Services and Intervention Research's (DSIR) clinical effectiveness trials networks.

The following priorities identified in the area of pharmacologic treatment development for mental illness are relevant to this PA: 1) human proof-of-concept studies of novel-mechanism IND-ready pharmacological agents targeting mood disorders, schizophrenia, eating disorders, obsessive-compulsive disorder, fragile x, autism, and other mental disorders; 2) exploration, development, and evaluation of novel clinical endpoints and/or biomarkers of potential value in establishing proof-of-concept in humans; and 3) facilitation of partnerships between NIMH, academia, and industry to support innovative approaches for drug development and the development of novel behavioral assays; and 4) studies to clarify the viability of further development of novel therapeutic approaches.

The CDDG will support broad, innovative, multidisciplinary, multi-project approaches to the development of new, rationally based treatments for mental illness. Since the full range of creative talents in the required scientific disciplines are rarely available in a single institution, a multi-institutional, group approach involving academic, nonprofit, commercial, and/or industrial institutions is envisioned. Academic and pharmaceutical scientists are strongly encouraged to form partnerships that take full advantage of their combined intellectual and material resources for drug discovery, lead optimization, and model development. Further, the interaction of academic and non-profit research institutions with pharmaceutical industry and NIMH is expected to facilitate subsequent development and marketing of new pharmacologic treatments, although these latter activities are not within the scope of this PA. Molecular targets for novel therapeutic approaches, and the sources and types of IND-ready pharmacological agents to be investigated, will be selected by the applying group.

Research Scope

The objective of this PA is to establish CDDGs to conduct innovative, high impact clinical research focused on the clinical development of IND-ready pharmacological agents targeting novel molecular targets implicated in the pathophysiology of mental illness. The CDDG serves as a vehicle for pharmaceutical and academic scientists to pool intellectual and material resources for the translation of basic science findings into the evaluation of new mechanism-of-action drug candidates. Groups are encouraged to select molecular targets and IND-ready agents for drug development based on recent findings in basic and clinical neuroscience, pre-clinical research, and animal model research relevant to the understanding of mental illness. Research projects directed towards ameliorating clinical dimensions of psychopathology embedded in DSM diagnostic entities, but not typically identified as the primary target of current clinical therapeutics, are encouraged.

Potential pharmacological agents of interest to NIMH might be identified by their receptor properties (e.g., partial agonists, agonists, or antagonists), solubility, pharmacokinetics, oral or CNS bioavailability, pre-clinical profiles, or other characteristics to support their use as potential therapeutics for mental illness.

The testing in humans of novel mechanism therapeutics is the principal aim of this initiative. Priority will be given to first-time or early trials of IND-ready agents with pre-clinical profiles suggesting the possibility of therapeutic effect in human disease. Testing of novel indications for already approved agents might be considered, based on strong theoretical rationale and/or public health importance.

Responsive applicants may outline plans for the evaluation of compounds as candidates for drug development as new therapeutic agents for mental illness. The application should demonstrate how the proposed studies will generate critical data sufficient to determine whether further development of the putative therapeutic agent is warranted. The testing of new IND-ready pharmacological agents or approved agents in clinical populations is a mandatory element. If proof of concept is already available for the agent selected for testing, the proposed phase II trial should be sufficiently powered to clarify the viability of further development.

It is anticipated that the interaction of academic and non-profit research institutions with NIMH and pharmaceutical industry will facilitate timely evaluation and development of clinical research tools, models, and novel therapeutics.

Note: The development of analogs of established or well-studied agents for the treatment of mental disorders is not responsive to this PA.

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the cooperative agreement (U01, U19) award mechanism(s). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

The NIH U01 and U19 are cooperative agreement award mechanisms. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the section VI. 2. Administrative and National Policy Requirements, "Cooperative Agreement Terms and Conditions of Award".


2. Funds Available

The NIMH intends to commit approximately $1,500,000 in FY 2005 to fund up to 3 new and/or competing continuation awards. 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 NIMH provide support for this program, awards pursuant to this PA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. Fiscal and administrative costs on subcontracts/consortia are not included in the direct cost limitation, see NOT-OD-04-040

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:

Scientists from foreign institutions and NIH Intramural laboratories may participate as Project Leaders or as collaborators in Research Project or scientific cores  

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
Cost Sharing is not required

3. Other-Special Eligibility Criteria
N/A

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. 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 PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and 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/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

See Section VI.2 Administrative Requirements for additional information.

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.


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

Letter of Intent Receipt Date: March 15, 2005, 2006, 2007
Application Receipt Date(s): April 15, 2005, 2006, 2007
Peer Review Date: June
Council Review Date: September
Earliest Anticipated Start Date: December

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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

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

The letter of intent should be sent to:


Wayne S. Fenton, M.D.
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6216, MSC 9621
Bethesda, MD 20892-9621
Telephone: (301) 443-9700
Email: wfenton@mail.nih.gov


3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. 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 must be sent to:

Jean G. Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-3367
FAX: (301) 443-4720
Email: jnoronha@mail.nih.gov


3.C. Application Processing

Applications in response to this PA must be received by the date listed on the first page of the announcement. Applications will be evaluated for completeness by CSR and responsiveness by NIMH.

The NIH will not accept any application in response to this PA that is essentially the same as one currently pending initial 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 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 (See also Section VI.3. Award Criteria)

6. Other Submission Requirements

Special Requirements

A. The CDDG objectives and goals should be relevant to and compatible with the NIMH priorities for innovative drug discovery and development for mental illness as specified in this PA. Applicants should describe their plans to accommodate the stated CDDG requirements, criteria, and NIMH involvement.

B. A proposed Group can consist of scientific collaborators focused on one or two Research Projects without Cores (U01 mechanism) or at least three Research Projects and Scientific and Administrative Core components (U19 mechanism). It is anticipated that the Groups will include outstanding scientists from some or all of the diverse scientific disciplines within clinical neuroscience, neuropharmacology, psychopathology research, brain imaging, radioligand development, and pharmacokinetics, and will form into synergistic research teams without regard to institutional affiliation.

C. Pharmaceutical partners should include key personnel who have authority within the company to allocate resources to ensure successful completion of the proposed clinical development efforts.

D. Intellectual Property and Research Resource Sharing Plans

Since the development of new pharmacological treatments for mental illness is a major objective of this effort and active involvement by pharmaceutical laboratories is encouraged and facilitated by the existence of adequate patent coverage, it is essential that applicants provide plans to assure the protection of intellectual property for new pharmacological agents for the treatment of mental illness under this PA.

Successful applicants are required to supply the following confidential materials to the NIMH Program Officials listed under INQUIRIES.

1. Each applicant Group must provide a detailed description of the approach used for obtaining patent coverage and for licensing where appropriate, in particular where the invention may involve investigators from more than one institution. Procedures must be described for resolution of legal problems should they arise. Your attention is drawn to the NIH Extramural Technology Transfer Policies and Documents and related sites [http://ott.od.nih.gov/NewPages/602-rev2.htm].

2. A formal statement of Patent Agreement among all Group members and their institutions as well as a detailed description of procedures to be followed for resolution of legal problems which may develop, must be signed and dated by the organizational official authorized to enter into patent arrangements for each Group member and member institution. The signed agreement must be submitted prior to award to either Dr. Wayne Fenton (DMDBA) or Dr. Linda Brady (DNBBS) at the addresses provided under INQUIRIES.

3. Prior to the award, the Principal Investigator and each Project Leader must provide a signed statement of acceptance of the participation of NIMH staff during performance of the award as outlined under "NIMH Staff Responsibilities" below.

Note: Do NOT submit documents 1-3 above with the application. However, awards will not be made until these documents are received and approved by NIMH

E. INTELLECTUAL PROPERTY AND RESEARCH RESOURCE SHARING PLANS

Restricted availability of unique research resources upon which further studies are dependent, can impede the advancement of research. The NIH is interested in ensuring that research resources (e.g., biomarkers, clinical endpoints, testing batteries, IND filing information for pharmacological agents) developed using funds through this PA become available to the broader research community in a timely manner for further research, development, and application, in the expectation that this will lead to products and knowledge of benefit to the public health. To address this interest in assuring such research resources are accessible, NIH requires applicants who respond to this PA to submit a plan: (1) for sharing research resources generated through the grant; and (2) addressing how applicant(s) will exercise intellectual property rights, should any be generated through this grant, while making such research resources available to the broader scientific community consistent with the programmatic goals and objectives of this PA.

The sharing of research resources plan and intellectual property plan must make unique research resources readily available for research purposes to qualified individuals within the scientific community in accordance with the NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps/) and the Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources: Final Notice, December 1999 ((http://www.ott.nih.gov/policy/rt_guide_final.html) and (http://ott.od.nih.gov/NewPages/64FR72090.pdf) ("NIH Research Tools Policy")). These documents further: (i) define terms, parties, and responsibilities; (ii) prescribe the order of disposition of rights; (iii) prescribe a chronology of reporting requirements, and (iv) delineate the basis for and extent of government actions to retain rights. Also, patent rights clauses may be found at 37 CFR Part 401.14 and are accessible from the Interagency Edison web page, http://www.iedison.gov/ or https://s-edison.info.nih.gov/iEdison/.

There should NOT be separate sharing plans for each research component, but rather a single plan for the Group as a whole.

In the development of the research resource sharing and intellectual property plans, applicants should confer with their own institution's office(s) responsible for handling technology transfer related matters and/or their sponsored research office(s). If applicants or their representatives require additional guidance in preparing these plans, they are encouraged to make further inquiries to the appropriate contacts listed below. Further, applicants may wish to independently research and review examples of possible approaches considered by other institutions.

F. An NIH intramural scientist may not serve as the Principal Investigator of a CDDG but may participate in a Group as a Research Project Leader, Scientific Core Leader, collaborator, or consultant. However, an Intramural scientist may not receive salary, equipment, supplies, or other remuneration from this PA. The Intramural scientist must obtain written approval of his/her NIH Institute Scientific Director for the amount of resources that may be allocated to the project; this amount must be specified in the letter, and can not exceed $200,000 in direct costs of intramural resources. The approval must also specify that the conduct of the project will comply with the DHHS regulations for research involving human subjects and, if applicable, with the PHS policy on vertebrate animal research. The participation of an intramural scientist is independent of and unrelated to the role of the NIMH Coordinator as described below in TERMS AND CONDITIONS OF AWARD. For CDDG applications that include NIH intramural components, the intramural resource level will be included in the total cost of the overall application. The involvement of Intramural scientists needs to be consistent with NIH Policy. http://www1.od.nih.gov/oir/sourcebook/ethic-conduct/ethical-conduct-toc.htm

1. SPECIFIC INSTRUCTIONS FOR PREPARING THE CDDG AWARD U01 APPLICATION

In addition to the details described here for U01 applications, applicants also need to be aware of information described under the SPECIAL REQUIREMENTS above.

Applicants should follow the PHS 398 instructions, including: face page (form page 1); description, performance sites, and key personnel (form page 2); research grant table of contents (appropriate to the application's content); detailed budget of overall application for the initial budget period (form page 4); and budget of overall application for entire proposed period of support (form page 5). This should be followed by an introductory section of no more than ten pages that provides a General Description of the CDDG. The content requirements of this General Description section are described in #3 below.

Following the General Description(s), each component (the Research Projects) should be presented individually. Each project should have the following: a cover page stating the Project number, the Project title, and Project PI; a form page 2 which includes the description, performance site, and key personnel; individual project budget pages (for the initial budget period and for the entire budget period), followed by the budget justification; biographical sketches; resources; and research plan.

For each Research Project component, there is a 25-page limit for sections a-d of the research plan (i.e., specific aims, background and significance, preliminary studies/progress report, and research design and methods), as indicated in the form PHS 398; there is no page limit for sections e-i. Appendix material limits apply to each component separately, and appendices are limited to the contents specified in the form PHS 398. They should be bundled separately, component by component.

For each individual Research Project, the research plan needs to address:

2. SPECIFIC INSTRUCTIONS FOR PREPARING THE CDDG AWARD U19 APPLICATION

In addition to the details described here for U19 applications, applicants also need to be aware of information described under the SPECIAL REQUIREMENTS above.

Applicants should follow the PHS 398 instructions, including: face page (form page 1); description, performance sites, and key personnel (form page 2); research grant table of contents (appropriate to the application's content); detailed budget of overall application for the initial budget period (form page 4); and budget of overall application for entire proposed period of support (form page 5). This should be followed by an introductory section of no more than ten pages that provides a General Description of the CDDG. The content requirements of this General Description section are described in #3 below.

Following the General Description(s), each component (the Research Projects and Cores) should be presented individually. Each project and core should have the following: a cover page stating the Project number or Core letter, the Project or Core title, and Project or Core PI; a form page 2 which includes a description, performance site, and key personnel; individual project or core budget pages (for the initial budget period and for the entire budget period), followed by the budget justification; biographical sketches; resources; and research plan.

For each Research Project there is a 25-page limit for sections a-d of the research plan (i.e., specific aims, background and significance, preliminary studies/ progress report, and research design and methods), as indicated in the form PHS 398; there is no page limit on sections e-i. Appendix material limits apply to each component separately, and appendices are limited to the contents specified in the form PHS 398. They should be bundled separately, component by component.

For each individual Research Project, the research plan needs to address:

For each Core component, there is a 10-page limit. If cores are required, the applicant must describe how each Core will contribute to the goals of the overall CDDG as well as how each individual Research Project will draw upon a particular Core. The description of each Core should clearly indicate the facilities, resources, services and professional skills that the facility will provide. Moreover, clearly described information must be provided about how the collective operation of the Cores will be effected in a coherent manner.

3. SPECIFIC INSTRUCTIONS FOR PREPARING THE GENERAL DESCRIPTION OF THE CDDG

This section is to accompany both U01 and U19 applications. The section must not exceed 10 pages, and should provided the following details:

4. SUPPLEMENTARY INSTRUCTIONS FOR NIH INTRAMURAL RESEARCHERS

NIH intramural researchers submitting an Individual Research Project as a part of a CDDG, must follow the procedures for Individual Research Projects as described above, with the following additional modifications.

Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year.

Applicants requesting $500,000 or more in direct costs for any year must carry out the following steps:
  1. Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study;
  2. Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and,
  3. Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application.

This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.

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.

Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing

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

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. NIH Grants Policy Statement http://grants.nih.gov/archive/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). See Section VI.3. Award Criteria.

Section V. Application Review Information


1. Criteria

2. Review and Selection Process


Applications submitted for this funding opportunity will be assigned to the NIMH on the basis of established PHS referral guidelines.

Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures will evaluate applications for scientific and technical merit.

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

3. Merit Review Criteria

Applications submitted in response to a funding opportunity will compete for available funds with all other recommended applications.

The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application.

The 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: Is the Group addressing an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? If the aims of the application are achieved, what is the likelihood that it will produce a new pharmacological agent with significant potential to reduce the burden of mental illness? To what degree does the proposed plan for development of novel drugs and research tools support the needs for the targeted disease?

Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Are the scientific disciplines represented in Research Projects and Scientific Cores adequate to achieve the CDDG objectives? Are preclinical models relevant to serious mental illness? If pharmaceutical partnerships are proposed, how will they facilitate the development and evaluation of candidate drugs and model validation for testing therapeutics?

Innovation: Does the CDDG employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? Are the aims original and innovative? Does the CDDG challenge existing paradigms, develop new research tools, methodologies, or technologies? Is the target under investigation for drug development novel? Will new paradigms for drug development emerge?

Investigator: Are the Principal Investigator, Research Project Leaders, and Core Leaders appropriately trained and well suited to direct or carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? Are the time commitments for each sufficient to achieve the goals? To what extent do these investigators have complementary skills? Will the Research Project Leaders and their key personnel contribute unique skills to the CDDG? Has the Principal Investigator demonstrated leadership in development, implementation, and management of comprehensive research programs?

Environment: Does the technical and scientific environment in which the Research Projects will be done contribute to the probability of success? Does the proposed work take advantage of unique features of the technical and scientific expertise and employ effective collaborations? Is there evidence of institutional support and competence of the applying Institution to serve as the Administrative Core for the Group? Is the research environment adequate for the safe and ethical conduct of clinical research ?

Interaction. Are there adequate plans for ensuring effective intra-Group communication, interaction, cohesiveness, and coordination among the PI, Research Project Leaders, and NIMH Coordinators? Do the investigators state their willingness to collaborate extensively and share information fully? Do the investigators state their willingness to abide by the policies stated in the Terms and Conditions of the Cooperative Agreement?

Review Criteria for Research Projects

Significance. Does this study address an important problem? If the aims of the application are achieved, how will development of the therapeutic approach be advanced? What will be the effect of these studies on the future development of putative therapeutic agent or agents with comparable mechanisms.

Approach. Are the conceptual framework, design, and methods adequately developed, well integrated, and appropriate to the aims of the project? Are the scientific disciplines represented in Research Projects adequate to achieve the objectives? Does the applicant acknowledge potential problem areas and consider alternative tactics? Is the plan to establish preliminary evidence of efficacy in human disease adequate ? If pharmaceutical partnerships are proposed, how will they facilitate the further development of drugs and evaluation of research tools or models?

Innovation. Does the Research Project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new tools, methodologies, or technologies?

Investigators. Are the Research Project Leader and key personnel appropriately trained and well suited to direct or carry out this work? Is the Project Leader's time commitment sufficient to achieve the goals? Is the work proposed appropriate to the experience level of the key personnel and other researchers? Have collaborations been established or consultants identified to provide the appropriate depth and breadth of expertise required for the project?

Environment. Does the technical and scientific environment in which the work will be done contribute to the probability of success? Does the proposed work take advantage of unique features of the technical and scientific expertise and employ effective collaborations? Does the clinical research team demonstrate a track record in successfully recruiting human subjects into clinical trials and research studies and completing proposed studies within projected timelines?

Management of the Group. Especially for the U19 mechanism, does the PI have previous experience of the ability to manage an integrated scientific enterprise? Do other members of the Group have experience that will facilitate achieving the desired research outcomes.

Review Criteria for Cores

1. The utility of the Core to the CDDG. Each Core must provide essential facilities or services to two or more Research Projects judged to have scientific merit.

3.A. Additional Review Criteria:

In addition to the above criteria, the following items will 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.

3.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.

3.C. Sharing Research Data


1. Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing.

3.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. NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps 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

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 Principal Investigator 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. Award Criteria.

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 Grant Award (NGA) will be provided to the applicant organization. The notice of award signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

T he notice of grant award will be sent via email to the administrative official whose name is listed in Block 12 on the Face Page of the Form PHS 398.


2. Administrative Requirements

A DEFINITIONS

AWARDEE. The institution to which the CDDG award (U19 or U01) is issued.

CORE (ADMINISTRATIVE). An administrative unit located at the Principal Investigator's institution that coordinates all CDDG activities. It is separately budgeted from the PI's Research Project (if any) and oversees support for activities pertinent to the CDDG, such as travel for intra-group meetings.

CORE (SCIENTIFIC). A separately budgeted scientific service component that provides essential facilities or services to two or more of the proposed Research Projects. Core components typically use established procedures or protocols rather than generating new research. An NIH intramural laboratory may participate as a Scientific Core.

CORE LEADER. The director of a scientific core component who is responsible for the conduct of that core.

COOPERATIVE DRUG DEVELOPMENT GROUP (CDDG). A CDDG must include a Research Project to evaluate the efficacy of a new pharmacological agent for the treatment of mental illness. The Groups may also include Research Projects to: 1) conduct clinical dose optimization; 2) pharmacokinetics, and 3) pharmacodynamics studies as part of a research program that aims to determine with reasonable certainty whether a drug candidate is sufficiently safe and effective to warrant further clinical development.

A CDDG can apply using either the U01 or U19 mechanisms. A Group of collaborators focused on one or two Research Projects without Cores should use the U01 mechanism. Groups with three-to-five Research Projects as well as Core components should use the U19 mechanism.

The development and strengthening of partnerships between scientists from academia and the pharmaceutical industry is a highly desirable outcome of this PA and is strongly encouraged. Pharmaceutical scientists are encouraged to actively participate as Principal Investigator, Project Leader, and/or key personnel/collaborators in one or more Research Projects within a CDDG.

NIMH COORDINATOR. A scientist(s) from the NIMH extramural program staff who has substantial involvement in the Group above and beyond normal program stewardship. The NIMH Coordinator(s) interacts scientifically with the Group and facilitates the role of NIMH as partner in the Group. The Coordinator(s) will be appointed after award by NIMH.

NIMH PROGRAM OFFICIAL. A staff member of NIMH who provides normal stewardship and guidance for the overall CDDG within the NIMH and ensures that the CDDG maintains its relevance to the NIMH mission for drug discovery and treatment development research. The Program Official also may serve as an NIMH Coordinator for a Group.

PRINCIPAL INVESTIGATOR. The scientist who is designated by the applicant institution to direct the CDDG. The PI will assume responsibility and accountability to the applicant institution and to the NIMH for the performance and proper conduct of the CDDG in accordance with the terms and conditions specified in this PA. It is expected that the PI will contribute at least a 20% effort to the Group. Foreign scientists and NIH intramural scientists may not be a Principal Investigator.

RESEARCH PROJECT. A research component headed by a Project Leader within an CDDG with a separate, detailed research plan and budget. Foreign institutions and NIH intramural laboratories may participate in a Research Project.

RESEARCH PROJECT LEADER. A senior scientist with proven independent research capabilities who serves as director of one of the scientific Research Projects of the Group and is responsible for the scientific conduct of that program. The Principal Investigator of the Group may be a Project Leader. Foreign scientists and NIH intramural scientists may be Project Leaders.

STEERING COMMITTEE. A governing Steering Committee composed of the PI, Research Project Leaders, Core Directors, external scientific advisors, and NIMH Coordinator(s) will be established in each CDDG to assist in monitoring and development of the scientific content and direction of the program. The Steering Committee will meet at least twice a year. The frequency of meetings, not fewer than two per year, will be determined by the PI who will be responsible for scheduling the time and place (generally at one of the performance sites) and for preparing concise proceedings or minutes (two or three pages) which will be delivered to the members of the Group within 30 days of the meeting. Plans for organizing a Steering Committee should be described in the application, but potential members should not be contacted until after an award has been made, and the names of potential members should not be listed in the application.

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.

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

2.A. Cooperative Agreement Terms and Conditions of Award

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

The administrative and funding instrument used for this program is a cooperative agreement (U01 or U19), an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the Principal Investigator for the Group, although specific tasks and activities in carrying out these studies may be shared between the awardee and the NIMH Coordinator(s) assigned to the CDDG. The tasks and activities are described more fully below.

Integration into an on-going program of the Cooperative Drug Development Groups (CDDG) is anticipated. Principal Investigators and Research Project Leaders will be expected to attend an annual meeting to review progress and share information among awardees.

2.A.1. Principal Investigator Rights and Responsibilities

a. The Principal Investigator will have primary authority and responsibility to define objectives and approaches and to plan and conduct the proposed research. She/he will assume responsibility and accountability to the applicant organization and to the NIMH for performance and proper conduct of all research supported in the CDDG, including the NIH intramural component, if applicable, in accordance with the Terms and Conditions of Award.

b. The Principal Investigator will establish a Steering Committee consisting of the PI, Research Project Leaders, Core Directors, external scientific advisors, and the NIMH Coordinator(s). The Steering Committee members will meet to review progress, plan and design research activities, and establish priorities. Intramural research scientists participating as Research Project Leaders or collaborators have the same rights and responsibilities as other members of the Steering Committee. The NIMH Program Official may attend Steering Committee meetings as a non-voting participant. The frequency of meetings, not fewer than two per year, will be determined by the PI who will be responsible for scheduling the time and place (generally at one of the performance sites) and for preparing concise proceedings or minutes (two or three pages) which will be delivered to the members of the Group within 30 days of the meeting.

c. The Awardee Institution and/or Research Project Leader's Institution will retain custody of the data, subject to the Government's right to obtain and use the data under 45 CFR 74.36. The NIMH Coordinator will have access to data generated under this cooperative agreement and may periodically review the data consistent with current DHHS, PHS, and NIH policies. Timely publication of major findings by the Group members is encouraged. Publication or oral presentation of work done under this agreement will require appropriate acknowledgment of NIMH support, including the assigned cooperative agreement award number.

d. It is the intention that new chemical entities be fully evaluated as potential candidate drugs for mental disorders, after the Group has concluded its evaluation and before the compounds are transferred to other parties for evaluation in other therapeutic areas. The Groups must submit to the NIMH for review INTELLECTUAL PROPERTY AND PATENT RIGHTS FOR NEW CHEMICAL ENTITIES or the INTELLECTUAL PROPERTY AND RESEARCH RESOURCE SHARING PLANS to ensure consistency with NIH policy.

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

2.A.2. NIH Responsibilities

During performance of the award, the role of the NIMH Coordinator(s) is one of substantial involvement above and beyond the normal program stewardship role of a Program Officer. The NIMH Coordinator interacts scientifically with the Group and may provide appropriate assistance, including assisting in research planning, suggesting studies within the scope of the Group's objectives and research activities, presenting experimental findings to the Group from published sources or from relevant contract projects, participating in the design of experiments agreed to by the Group, participating in the analysis of results, and advising in management and technical performance. The NIMH Coordinator(s) will be a voting member(s) of the Steering Committee, sharing a single vote. The NIMH Program Official may attend Steering Committee meetings as a non-voting participant. In all cases, the role of NIMH will be to assist and facilitate and not to direct activities.

The NIMH Coordinator(s) can recommend to their institute to utilize their drug development resources (e.g., CNS receptor screening, chemical synthesis, and toxicology services) in support of the CDDG research activities if such resources are required on an occasional basis. The following is a list of resources that are readily available and may be supplied if they become desirable during performance. It is not anticipated that requests of services will be considered as a continuing need.

a. Reference compounds for standardization of test systems, as analytical standards, and for related purposes.

b. Data from testing conducted in resource contract laboratories.

c. Laboratory testing capacity, whenever appropriate and possible, in NIMH's current contract-based preclinical testing programs. The Group is expected to provide sufficient test material for such testing.

d. Additional needed resources such as test materials and information that may not otherwise be available to the Group.

Additionally, an NIMH program official will be responsible for the normal scientific and programmatic stewardship and guidance for the overall CDDG award within the NIMH and will ensure that the CDDG maintains its relevance to the NIMH mission for drug discovery and treatment development research. , The NIMH Program Official is responsible for monitoring implementation of the Data Sharing Plan for Research Tools and Models for Evaluating Therapeutics. The NIMH Program Official will be named in the award notice. The Program Official also may serve as an NIMH Coordinator for a Group.

2.A.3. Collaborative Responsibilities

A governing Steering Committee composed of the PI, Research Project Leaders, Core Directors, external scientific advisors, and NIMH Coordinator(s) will be established in each CDDG to assist in monitoring and development of the scientific content and direction of the program. The Steering Committee members will meet periodically to review progress, plan and design research activities, and establish priorities. The frequency of meetings, not fewer than two per year, will be determined by the Principal Investigator who will be responsible for scheduling the time and place (generally at one of the performance sites) and for preparing concise proceedings or minutes (two or three pages) which will be delivered to the members of the Group within 30 days of the meeting.

a. The principal end products of CDDG activities are expected to include: 1) Human proof-of-concept, early phase II, or other studies such as clinical dose optimization, pharmacokinetics, and pharmacodynamics studies to determine with reasonable certainty whether a drug candidate is sufficiently safe and effective to warrant further clinical and commercial development; 2) research tools, instruments, and methods; and 3) pharmacokinetic, pharmacodynamic, and dose optimization data related to novel therapeutic candidates.

b. NIMH will retain the option to cross-file or independently file an application for an investigational clinical trial (e.g., an IND application to the United States Food and Drug Administration) of any clinical research tool or invention resulting from these NIMH supported cooperative agreements. Reports of data generated by the Group or any of its members required for inclusion in IND applications and for cross-filing purposes shall be submitted promptly by the Principal Investigator to the NIMH Coordinator upon request. Such reports shall include background information, methods, results, and conclusions.

Each full member will have one vote, however, the NIMH will have one vote on the Steering Committee Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

2.A.4. Arbitration Process

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

3. Award Criteria

The following will be considered in making funding decisions:

4. 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:

Questions about scientific/research issues related to proof-of-concept studies primarily utilizing clinical endpoints should be directed to:

Mi Hillefors, M.D., Ph.D.
Division of Adult Translational Research and Treatment Development
National Institute of Mental Health
6001 Executive Boulevard , Room 7125, MSC 9632
Bethesda , MD 20892-9632
Rockville, MD 20852 (express/courier service)
Telephone: (301) 443-2738
FAX:  (301) 443-1425
Email: mi.hillefors@nih.gov

Direct your questions about scientific/research issues related to studies primarily focused on pharmacokinetics, pharmacodynamics, dose finding, in-vivo receptor occupancy, and those that primarily use putative biomarkers (e.g., psychophysiology, imaging) as endpoints, to:

Linda Brady, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7185, MSC 9641
Bethesda, MD 20892-9641
Rockville, MD 20852-9641 (for express/courier service)
Telephone: (301) 443-5288
FAX: (301) 402-4740
Email: lbrady@mail.nih.gov

2. Peer Review Contacts:

Michael Kozak, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6138, MSC-9608
Bethesda, MD 20892-9608
Rockville, MD 20852-9608 (for express/courier service)
Telephone: (301) 443-1340
FAX: (301) 443-4720
Email: kozakm@mail.nih.gov

3. Financial or Grants Management Contacts:

Rebecca Claycamp, CRA
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6122, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2811
FAX: (301) 443-6885
Email: rclaycam@mail.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, June 12, 1998: 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, 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/guide/notice-files/NOT-OD-04-042.html). 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 that is available at 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 (see 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.

Public 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 public 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 PA 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.


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