Investigation of Potential Long-Term Effects of Stimulant ADHD Treatments in Non-Human Primates

PA Number: PAR-04-160  

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: September 29, 2004
Letters Of Intent Receipt Date(s): November 21, 2004
Application Receipt Dates(s): December 21, 2004
Peer Review Date(s): March 2005
Council Review Date(s) : May 2005
Earliest Anticipated Start Date: April 2005
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: December 22, 2004


Due Dates for E.O. 12372
Not Applicable

Executive Summary
The National Institute of Mental Health (NIMH) requests research grant applications to examine the possible long-term effects of therapeutic doses of orally administered Methylphenidate (MPH) and amphetamine (AMPH) on the brain when administered to juvenile non-human primates.There are no funds specifically dedicated to this initiative. One to two awards to responsive applications are anticipated. This PAR will use the NIH U01 Cooperative agreement award mechanism. Applications are allowed from single institutions with or without consortium agreements 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 PAR 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 PAR. 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 .

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 and Instructions
    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 and National Policy Requirements
     A. Cooperative Agreement Terms and Conditions of Award
        1. Principal Investigator Rights and Responsibilities
        2. NIH Responsibilities
        3. Collaborative Responsibilites
        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


The National Institute of Mental Health (NIMH) requests research grant applications to examine the possible long-term effects of therapeutic doses of orally administered Methylphenidate (MPH) and amphetamine (AMPH) on the brain when administered to juvenile non-human primates. The main goal is to generate data that are relevant to the clinical use of psychostimulant medications in children and adolescents within dose ranges, schedules, and routes of administration that are usually employed therapeutically. The ultimate purpose is to increase our knowledge of the safety and effectiveness of these psychopharmacological treatments administered to children and adolescents.

1. Research Objectives

Background

Stimulants including MPH and AMPH are commonly prescribed to children for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). While clinical trials to date have clearly demonstrated safety and efficacy of MPH and AMPH for the treatment of ADHD, concerns have remained regarding the potential long-term behavioral and neurobiological consequences of chronic stimulant treatment during childhood and adolescence. For example, both clinical and animal studies have suggested that stimulant treatment during development may affect reward processes relevant to mood regulation and the development of risk for drug abuse in adolescence and adulthood. Preclinical studies are useful for identifying any such potential long-term effects of chronic drug exposure. However, the majority of preclinical studies conducted so far have involved the administration of large, non-therapeutic doses of MPH and AMPH to rats, given by routes that do not emulate the therapeutic plasma concentrations seen in children given oral doses. Attempts to model human therapeutic plasma concentrations and pharmacodynamics in rats have been further hampered by large differences in their rate of MPH and AMPH metabolism. Results of rodent studies using treatment regimens attempting to approximate human therapeutic drug concentrations have suggested that chronic exposure to stimulant medication during development may result in long-term changes in dopamine function with effects on cognition and behavior. Thus, the results of studies in rodents support the possibility of persistent CNS effect of therapeutic doses of stimulant medications given during development. While these results are suggestive, it is difficult to extrapolate their potential clinical significance without verification of results in species more closely associated to humans in terms of brain development, cognitive capabilities, and drug metabolism.

Research Scope

The goal of this PA is to obtain preclinical data on possible long-term effects of chronic oral MPH and AMPH in juvenile nonhuman primates. It is anticipated that PA will encourage research designs and procedures that will lessen the gap between rodent data examining effects of stimulants and clinical literature.

Applications responsive to this PA should include the following in study designs (these are not inclusive):

These studies are expected to provide a model with the best possible approximation of clinical dosing in children. Knowledge obtained from these studies will provide much-needed preclinical data on potential long-term effects of stimulants in children. Positive results of these studies will suggest additional clinical studies to test predictions based on the results of this preclinical work.

Section II. Award Information

1. Mechanism(s) of Support

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

The NIH (U 01 ) is a cooperative agreement award mechanism. 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".

Applications are allowed from single institutions with or without consortium agreements with other institutions for the performance of specified study components. The applicant may request a project period of up to four years.

2. Funds Available
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of 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.

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:

Foreign institutions are not eligible to apply for this PA but can participate as a subcontract within a U01.  

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 as outlined in http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

N/A

Section IV. Application Submission Instructions


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 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 and National Policy 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

Letters Of Intent Receipt Date(s): November 21, 2004
Application Receipt Dates(s): December 21, 2004
Peer Review Date(s): March 2005
Council Review Date(s) : May 2005
Earliest Anticipated Start Date: April 2005


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:


Lois Winsky, 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)
Phone: (301) 443-5288
FAX: (301) 402-4740
Email: lwinsky@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 and all copies of the apendix material must be sent to:

Jean Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive boulevard, Room 6154, MSC 9609
Bethesda, MD 20892-9663
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 must be received on or before the application receipt date listed in the heading of this funding opportunity. If an application is received after that date, it will be returned to the applicant without review. Applications will be evaluated for completeness by CSR.

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


1. SPECIFIC INSTRUCTIONS FOR PREPARING THE AWARD U01 APPLICATION

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

Applications must be complete at the time of submission. There is a 25-page limit for the research plan, Sections A-D (i.e., specific aims, background and significance, preliminary studies/progress report, and research design and methods), as indicated in the form PHS 398. Appendix material limits apply as specified in the form PHS 398.

The research plan needs to address:

o The major goals and objectives of the project.

o The status of current research efforts, the limitations of existing approaches, and how the research questions posed relate to the objectives of the PA.

The feasibility of the proposed experiments, the advantages of new methodologies (if any), the potential pitfalls, alternative approaches, the means of assessing success of the research to meet the objectives of the project.

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.

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 $500,000 or more 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 the 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

Not applicable

2. Review and Selection Process

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

Appropriate scientific review groups convened by NIMH in accordance with the standard NIH peer review procedures ( http://www.csr.nih.gov/refrev.htm ) 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 : Does this study address 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? Degree to which the proposed studies address the goals of this PA as listed in the research scope section.

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?

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

Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? Expertise and knowledge of stimulant pharmacology, including clinical and preclinical pharmacokinetics, neurochemistry, and behavioral pharmacology. Expertise in neuroimaging and behavioral analyses of non-human primates. Expertise in working with juvenile primates.

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support?


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:

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 398 research grant application instructions (rev. 5/2001) 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.

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 .
2. Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will 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 presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

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 award 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 (Notice of Grant Award) are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

The 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 and National Policy Requirements

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

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 will be the cooperative agreement (U 01 ), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.


2.A.1. Principal Investigator Rights and Responsibilities
The PI will coordinate project activities scientifically and administratively at the awardee institution. The PI will have primary responsibility for defining the details for the projects within the guidelines of this PA , and for performing all scientific activities. The PI will agree to accept the close coordination, cooperation, and participation of the NIH Science Officer(s), the Steering Committee, and the Coordinating Committee, if applicable, in those aspects of scientific and technical management of the project as described below.

Specifically, the PI will:

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

An NIH Science Officer will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

NIH Science Officer

The NIH Science Officer will be NIH program staff who will have substantial scientific involvement during the conduct of this activity, through technical assistance, advice, and coordination above and beyond normal program stewardship for grants. This includes functioning as a peer with the PIs, facilitating the partnership relationship between NIH and the facilities funded under this PA, and helping to maintain the overall scientific balance in the program commensurate with new research and emerging research opportunities. Each grant funded will have a designated NIH Science Officer, and a given individual may be the NIH Science Officer for more than one project.

The NIH Science Officer will:

NIH Program Officer:

The awarding Institute(s) will appoint a Program Officer who will have responsibility for normal program oversight and stewardship of the grant. The Program Officer may also serve as the designated Science Officer.

The NIH Program Officer will:

2.A.3. Collaborative Responsibilities

Collaborative Responsibilities: Steering Committee Functions

For each awarded grant, a Steering Committee will serve as the main decision-making body. The Steering Committee will have the overall responsibility for developing and finalizing standard definitions and protocols. Members will include the PI, 1 or 2 key personnel on the grant, subcontract PIs, and NIH Science Officer assigned to the project. Outside consultants/experts may be asked to participate in Steering Committee meetings and discussions. Membership on the Steering Committee becomes effective upon issuance of the Notice of Grant Award.

The Steering Committee will:

The Steering Committee can convene meetings through telephone conference but must meet in person at least once yearly.

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

Collaborative Responsibilities: Coordinating Committee Functions

If more than one cooperative agreement is funded, a Coordinating Committee will convene annual meetings to describe and compare research approaches and results. Members of the Coordinating Committee will include all Principal Investigators and Science Officer(s) assigned to the grants funded in response to this PA. Outside consultants/experts may be asked to participate in Coordinating Committee meetings and discussions NIH Science Officer(s) will have one combined vote.

The Coordinating Committee will:


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:

Lois Winsky, Ph.D.
Division of Neuroscience and Basic Behavioral Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7184
Bethesda, MD 20892-9641
Telephone: (301) 443-5288
FAX: (301) 402-4740
Email: lwinsky@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
Division of Extramural Activities
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: rc253d@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.

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://grants1.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.

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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