Part I Overview Information

Department of Health and Human Services

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

Components of Participating Organizations
National Human Genome Research Institute (NHGRI), (http://www.genome.gov/)
Office of Rare Diseases (ORD), (http://rarediseases.info.nih.gov/)
National Institute of Drug Abuse (NIDA), (http://www.nida.nih.gov)

Title: K 23 with Emphasis on Therapeutic Interventions Employing Genomic or Proteomic Technologies

Announcement Type
This is a modification of RFA-HG-03-006 which was previously released on July 1, 2003.

Request For Applications (RFA) Number: RFA-HG-05-013

Catalog of Federal Domestic Assistance Number(s)
93.172, 93.279

Key Dates
Release Date: January 10, 2005
Letters of Intent Receipt Date(s): May 16, 2005
Application Receipt Dates(s): June 15, 2005
Peer Review Date(s): O ctober/November 2005
Council Review Date(s): January/February 2006
Earliest Anticipated Start Date: M arch 2006
Additional Information To Be Available Date (Url Activation Date):
Expiration Date: June 16, 2005

Due Dates for E.O. 12372
Not applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

  Section I. Funding Opportunity Description
    1. Research Objectives

  Section II. Award Information
    1. Mechanism(s) of Support
    2. Funds Available

  Section III. Eligibility Information
    1. Eligible Applicants
      A. Eligible Institutions
      B. Eligible Individuals
    2.Cost Sharing
    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. 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 purpose of the Mentored Patient-Oriented Research Career Development Award (K23) is to support the career development of translational researchers in genomics. The program will support clinicians who propose an integrated clinical research and bench research project that applies genomics and proteomics tools to the study of human patients whose disease has a genetic component. For the purpose of this award, genomics and proteomics are being broadly interpreted to include the application of increasing knowledge of the genome and the proteome to the development and implementation of novel therapeutic strategies as applied to genetic diseases and complex diseases with a genetic component. Priority will be given to projects that have a near-term objective that will lead to the development of effective therapeutic interventions. This award will provide support for three to five years of supervised study and research for clinically trained professionals who plan to become independent, productive clinical investigators focusing on patient-oriented research.

This K23 award has several important features: (1) it requires an integrated clinical-laboratory research project that directly involves patients affected by the disease being studied so that awardees can develop skills in both clinical research and basic science, i.e. bench-to-bedside research; (2) it emphasizes career development and a research program that focuses on developing effective therapeutic interventions; and (3) it requires significant utilization of genomic and proteomic tools and technologies in the research project.

NHGRI: This initiative is consistent with the NHGRI's new vision for the future of genomics research (http://www.genome.gov/11006873) which includes translating the information and resources generated by the Human Genome Project into medical value and is responsive to the recommendations of the NIH Director's panel on Clinical Research http://www.nih.gov/news/crp/97report/) and the Institute of Medicine's Committee on Addressing Career paths for Clinical Research (http://www.nap.edu/books/0309048907/html/).

ORD: Under the Rare Diseases Act of 2002, the office has a legislative mandate to support training in clinical research in rare diseases.

NIDA: The institute is interested in the application of genomic and proteomic tools and technologies in pursuit of therapeutic interventions in drug addiction and drug abuse.

The NHGRI's Division of Intramural Research in Bethesda, MD, has a companion program, Physician Scientist Development Program, for clinicians who wish to conduct their research at the National Institutes of Health. To learn more about this program, please visit this website: http://www.genome.gov/10002061.

Research Objectives

There are several events that make this an opportune time for clinically trained investigators who are interested in incorporating genomic and proteomic approaches to develop new therapeutic approaches to disease problems. As of April 2003, the finished sequence of the human genome is available. Draft sequences of the mouse and rat genomes are also available, as are finished genome sequences of several other important model organisms (yeast, fly and roundworm). Genomics has emerged as a new approach to conducting research, and has already provided a variety of powerful tools and methods to assist in the elucidation of genomic information and the application of such information to address important health problems. The ultimate goal of biomedical research is to improve our overall ability to prevent, diagnose, treat and cure diseases. Thus, the effective and efficient translation of the basic research findings coming out of the Human Genome Project into understanding and treating diseases is now a major challenge. An important way to facilitate the translation of the findings into improved medical care is through the training of clinicians interested in patient-oriented research. Therefore, the objectives of the Mentored Patient-Oriented Research Career Development Award (K23) are to: (1) develop clinician researchers who are able to utilize genomic and proteomic knowledge, approaches, tools and technologies to develop therapeutic interventions for human diseases; and (2) increase the pool of independent clinical researchers who can conduct patient-oriented studies that capitalize on the discoveries of genomics and proteomics and effectively translate them into clinical settings.

In order to develop skills necessary to apply genomic tools, methods, technologies and approaches to understanding disease and to develop new therapeutic interventions, the candidate should propose a plan that includes the following:

Training:

A didactic training program that provides a thorough understanding of the basic knowledge underlying the research problem. Such a program may include courses in the biological, quantitative and informational sciences.

Research:

NHGRI and ORD are interested in research that focuses on the application of modern genomic and proteomic tools and technologies to the development of effective interventions based on an understanding of the disease process. There are, generally speaking, two ways to approach therapeutic intervention. One approach to therapeutic intervention, gene therapy, defined here as the replacement, manipulation, or supplementation of genes that are not fully functional with ones that are more functional, will not be supported. This area already receives significant research and training support from other sources. Another approach is gene-based therapy, meaning an intervention that is based on knowledge about how the gene or encoded protein functions normally and malfunctions in the case of disease. These approaches will be the focus of this K23 program, i.e., using genomic and proteomic tools and information about the properties of genes, gene functions, and gene products to develop new therapeutic approaches or using small molecules to stimulate or replace missing functions or to inhibit abnormal functions. The types of diseases that might lend themselves to this type of approach are: (a) diseases associated with variations in a single known gene; (b) diseases that are designated as rare diseases (http://ord.aspensys.com/asp/diseases/diseases.asp); (c) common diseases that have a genetic component and for which at least some of the genes have been identified; and (d) metabolic diseases that require knowledge of the function, expression and regulation of genes.

NIDA is interested in research that focuses on: (a) the application of modern genomic and proteomic tools and technologies to identify target molecules, pathways or profiles that will identify target genes/proteins or diagnostic/prognostic indicators involved in the mechanisms of drug addiction and treatment of drug addiction including, but not limited to, addiction to nicotine (tobacco), benzodiazepines, cocaine, marijuana, and methamphetamine. Research in which the proteomic or genomic data will be integrated with epidemiological data are of particular interest. (b) proteomic or genomic studies looking at the effects of drugs of abuse on the progression and/or treatment of human immunodeficiency virus (HIV) or Hepatitis C virus (HCV) are also of interest.

It is expected that the research program proposed by the applicant will involve a tight integration with clinical investigation directly involving patients affected by the disease or condition being studied.

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

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the K23 award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available

The participating ICs have allotted approximately one million dollars for these awards.

Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

1.B. Eligible Individuals

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

The candidate must have a clinical doctoral degree or its equivalent. Illustrative examples include, but are not limited to: M.D., D.D.S., D.M.D., D.O or Ph.Ds in clinical genetics, nursing, or clinical psychology.

The candidate also must have completed clinical training, including specialty and, if applicable, subspecialty training prior to receiving an award. However, the candidate may submit an application prior to the completion of clinical training. The candidate must identify a mentor with extensive research experience in clinical research and genomics or proteomics. If the mentor does not have the expertise or experience in genomics or proteomics, this aspect of the training may be provided by others (individuals or committee) who will work collaboratively with the candidate and the mentor.

During the award period, the candidate must be willing and able to spend a minimum of 90% of full-time professional effort in support of this award. This 90% effort is meant to encompass: (1) didactic training; (2) laboratory research activities; and (3) clinical research activities related to the project. It is anticipated that the primary activity of the awardee will be spent on the laboratory research activities; in no case should the awardee plan to spend more than half of the supported time on the clinical research activities. Such a time commitment in the initial two years of the program is considered essential. After completion of the didactic training period, it may be possible, upon approval from the awarding unit, to reduce the minimum effort devoted to the award from 90% to 75% of full-time professional effort.

At the time of the award, a candidate must be a citizen or non-citizen national of the United States, or have been lawfully admitted to the United States for permanent residence (i.e., in possession of a currently valid Alien Registration Receipt Card I-551, or other legal verification of such status). Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the United States. They are usually born in lands that are not states but are under US sovereignty, jurisdiction or administration. Individuals on temporary or student visas are not eligible for this award. Minorities, women and individuals with disabilities are encouraged to apply.

Ineligible individuals include current and former principal investigators on NIH research projects (R01), FIRST Awards (R29), comparable career development awards (K01, K07, or K08), sub-projects of program project (P01) or center grants (P50), and the equivalent. Former principal investigators of NIH Small Grants (R03) or Exploratory/Developmental Grants (R21) remain eligible.

2. Cost Sharing or Matching

Not applicable.

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

3. Other-Special Eligibility Criteria

A. Mentor: The mentor must be a clinician-researcher and have expertise in genomics or proteomics tools and technologies. The mentor must ensure that the candidate will obtain the didactic training and clinical research expertise necessary to become an independent investigator. The applicant must name a mentor who, together with the applicant, is responsible for the planning, direction, and execution of the program. The mentor should be recognized as an accomplished investigator in the proposed research area and have a record of success in training independent investigators. The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award. If the mentor is not the appropriate researcher experienced in genomics or proteomics, the candidate may get access to this expertise from another faculty member or small committee. Where feasible, women, minority individuals and individuals with disabilities should be involved as mentors to serve as role models.

B. Program: The award provides up to five consecutive 12-month awards. At least 90% of the recipient's full-time professional effort must be devoted to the goals of this award. The remainder may be devoted to clinical duties, teaching, or other research pursuits consistent with the objectives of the award. Both the didactic and the research phases of an award period must be designed to develop the necessary knowledge and research skills in scientific areas relevant to the career goals of the candidate. The candidate must demonstrate that s/he has taken or will take during the award period, (a) relevant courses in genetics and genomics that provide a basic understanding of these areas and (b) courses that provide a basic understanding of experimental design and interpretation, such as: statistics, data management, epidemiology, study design, hypothesis development, etc., as well as the legal and ethical issues associated with research on human subjects.

Because of the focus on progression to independence as a researcher, a candidate for the K23 should propose a period of study and career development consistent with her or his previous academic background and research and clinical experiences. For example, a candidate with limited experience in a given field of research may find a phased developmental program that includes a designated period of didactic training followed by a period of closely supervised research experience to be the most efficient means of attaining independence. On the other hand, a candidate with previous research experience and training may not require extensive additional didactic preparation, and a program that focuses on an intensive, supervised patient-oriented research experience may be appropriate. The proposed program must be tailored to meet the individual needs of the candidate to ensure that s/he will gain the skills and knowledge necessary to carry out high quality patient-oriented research. The candidate and the mentor are jointly responsible for the preparation of the plan for this program. The mentor may form an advisory committee to assist with the development of the genomics or proteomics component of the research program or to monitor the candidate's progress through the career development program. The didactic and research components of both phases must develop new knowledge and research skills in scientific areas relevant to the career goals of the candidate. It is critical that there is a laboratory research component directly related to the patient-oriented research proposed in the application.

C. Environment: The institution must have both a well-established clinical and genomics or proteomics research programs. It must also have faculty qualified in clinical research with an emphasis on patient-oriented research to serve as mentors. The institution must be able to demonstrate a commitment to the development of the candidate as a productive, independent investigator. The candidate, mentor, and institution must be able to describe an in-depth, multi-disciplinary career development program that will utilize the relevant research, genomics, proteomics, and educational resources.

D. Research Grant Application: The purpose of this award is to provide the training and research experiences that will facilitate the awardee becoming an independent investigator. Therefore, awardees will be strongly encouraged to submit a grant application to the National Institutes of Health 12 to 18 months before the termination of the K23 award. The purpose of this will be to give the awardee experience in writing a research grant application, an opportunity to become familiar with the NIH peer review process, and the opportunity to obtain guidance from the mentor and other experts in the institution regarding grantmanship.

E. Salary: The NIH will provide 100% of the Principal Investigator's institutional base annual salary in any given year, as long as the salary is not in excess of Executive Level I of the Federal Executive Pay Scale (for FY 2004, $174,500/year; (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-025.html).

The total salary requested must be based on a full-time, 12-month staff appointment and must be consistent both with the established salary structure at the grantee institution and with salaries actually provided by the institution from its own or other non-federal funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure.

The grantee institution may supplement the NIH contribution up to a level consistent with the institution's salary scale. Supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. Because the salary amount provided by this award is based on the full-time institutional salary, no other NIH funds may be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with or detract from the purpose of the award.

F. Research Support: The NIH will provide up to $50,000 per year for the following expenses: (a) tuition, fees, and books related to career development; (b) research expenses, such as supplies and technical personnel; c) travel to research meetings or training; (d) travel to annual meetings of K23 awardees in Bethesda, MD; and (e) research support services including personnel and computer time. It is expected that the mentor will have sufficient resources to support the remainder of the awardee's research program.

G. Ancillary Personnel Support: Salary for the mentor, secretarial and administrative assistance, etc., is not allowed.

H. Facilities and Administrative Costs: These costs will be reimbursed at 8% of modified total direct costs.

I. Loan Repayment Program: Awardees under this program may be eligible to apply to the NIH Extramural Loan Repayment Program (LRP) for Clinical Researchers. The purpose of the LRP is to recruit and retain highly qualified health professionals as clinical investigators by providing for repayment of the educational loan debt of qualified health professionals who agree to conduct clinical research. The program provides for the repayment of up to $35,000 of the principal and interest of the educational loans of extramural grantees or awardees for each year of obligated service. NIH also covers the Federal taxes on the loan repayments, which are considered taxable income to program participants. Information regarding the eligibility requirements and benefits for the program may be obtained via the LRP website: http://www.lrp.nih.gov.

J. Other Income: Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, honoraria from other institutions for lectures or seminars, fees resulting from clinical practice, professional consultation or other comparable activities, provided these activities remain

incidental, are not required by the research and research-related activities of this award, and provided that the retention of such pay is consistent with the policies and practices of the grantee institution.

All other income and fees, not included in the preceding paragraph as retainable, may not be retained by the career award recipient. Such fees must be assigned to the grantee institution for disposition by any of the following methods:

K. Special Leave: Leave to another institution, including a foreign laboratory, may be permitted if directly related to the purpose of the award. Only local, institutional approval is required if such leave does not exceed three months. For longer periods, prior written approval of the NIH funding component is required.

To obtain prior approval, an awardee must submit a letter to the NIH describing the plan, countersigned by the department head and the appropriate institutional official. A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the career award will continue during such leave.

Leave without award support may not exceed 12 months. Such leave requires the prior written approval of the NIH funding component and will be granted only in unusual situations. Support from other sources is permissible during the period of leave. Such leave does not reduce the total number of months of program support for which an individual is eligible. Parental leave will be granted consistent with the policies of the NIH and the grantee institution.

L. Termination or Change of Institution: When a grantee institution plans to terminate an award, the NIH funding component must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination.

If the awardee plans to relocate, s/he must submit to the NIH funding component, in advance of the move, a written request for transfer, countersigned by the appropriate institutional business official, describing the reasons for the change and including the new sponsor's name and biosketch. The request must establish that the specific aims of the research program to be conducted at the new institution are within the scope of the original peer reviewed research program. Additionally, the new mentor must have the appropriate research expertise to supervise your program and sufficient research support to ensure continuation of the research program to the end of the award. Staff within the NIH funding component will review this request and may require a review by an initial review group and/or the appropriate National Advisory Council or Board. Upon approval of the request, the new institution, on the awardee's behalf, must submit a new career award application far enough in advance of the requested effective date to permit review. The period of support requested in the new application must be no more than the time remaining within the existing award period.

If the awardee plans to change mentor, the institution must submit a letter from the proposed mentor and awardee documenting the need for substitution, the new mentor's qualifications for supervising the program, and the level of support for your continued career development. The letter must also document that the specific aims of the research program will remain within the scope of the original peer reviewed research program. The NIH must also receive a letter from the original mentor relinquishing sponsorship of the awardee. Staff within the NIH funding component will review the request and will notify your institution of the results of the evaluation.

A final progress report, invention statement, and financial status report are required upon either termination of an award or relinquishment of an award in a change of institution situation.

Applicants may submit only one application in response to this RFA.

Section IV. Application and Submission Information

1. Address to Request Application Information

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

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

2. Content and Form of Application Submission

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

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

K 23 with Emphasis on Therapeutic Interventions Employing Genomic or Proteomic Technologies; RFA-HG-05-013.

3. Submission Dates and Times
Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times not applicable.

3.A. Receipt, Review and Anticipated Start Dates

Letters of Intent Receipt Date(s): May 16, 2005
Application Receipt Dates(s): June 15, 2005
Peer Review Date(s): O ctober/November 2005
Council Review Date(s): January/February 2006
Earliest Anticipated Start Date: M arch 2006

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 May 16, 2005, which is the date listed at the beginning of this document. The letter of intent should be sent to:

Bettie J. Graham, Ph.D.
Division of Extramural Research
National Human Genome Research Institute
Twinbrook Building; Room 4706
5635 Fishers Lane
Rockville, MD 20852
Telephone: (301) 496-7531
Email: bettie_graham@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 appendix material must be sent to:

Ken Nakamura, Ph.D.
Division of Extramural Research
National Human Genome Research Institute
5635 Fishers Lane
Twinbrook Building; Room 4706
Rockville, MD 20852
Telephone: (301) 402-0838
Email: ken_nakamura@nih.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf. Personal deliveries of applications are no longer permitted.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NHGRI. Incomplete and non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

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

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

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm (see also Section VI.3. Reporting).

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

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

6. Other Submission Requirements

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.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

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.

Sharing Research Resources

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

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

The following will be considered in making funding decisions:

2. Review and Selection Process

Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NHGRI. Incomplete and/or non-responsive applications will not be reviewed.

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NHGRI in accordance with the review criteria stated below.

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

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

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

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

Career Development Plan

Research Plan

Reviewers should recognize that clinicians are likely to have variable degrees of research experience. Those with more limited experience are less likely to prepare a plan with the breadth and depth of that submitted by more experienced investigators unless the mentor plays a significant role. All plans must include fundamentally sound research approaches but reviewers should consider the applicant's research experience and the mentor's commitment to and involvement in the career development of the candidate (See Mentor section below).

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

4. Investigators. Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Qualifications of the Candidate

Qualifications and Appropriateness of the Mentor/Co-Mentor

The application must include a signed statement from the mentor including information on research qualifications and previous experience as a research supervisor. The applications must also include information to describe the mentor's research support related to the candidate's research plan and nature

of the supervision that will occur during the mentored phase of the proposed award period. The application will also be assessed for the following:

5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria:

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

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Training in the Responsible Conduct of Research. Quality of the proposed training in the responsible conduct of research.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

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.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates
The anticipated award date is March 2006.

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 NGA 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. See Also Section IV.5. Funding Restrictions.

Applicant institutions will be notified if an award will be made through the receipt of the Notice of Grant Award. If the institution is e-mailed enabled, the Notice of Grant Award will be e-mailed to the institution. If the institution is not e-mailed enabled, the Notice of Grant Award will be mailed.

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).

2.A. Cooperative Agreement Terms and Conditions of Award
Not applicable

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts

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

1. Scientific/Research Contacts:

For scientific/program issues related to NHGRI:

Bettie J. Graham, Ph.D.
Division of Extramural Research
National Human Genome Research Institute
Twinbrook Building; Room 4706
5635 Fishers Lane
Rockville, MD 20852
Telephone: (301) 496-7531
Email: bettie_graham@nih.gov

For scientific /programmatic issues related to ORD's interest:

Giovanna M. Spinella, M.D.
CDR, US Public Health Service
Director, Extramural Research Program
Office of Rare Diseases, OD, NIH
6100 Executive Blvd. Rm. 3B01-MSC 7518
Bethesda, MD 20892-7518
Telephone: 301 402-4336
E-mail: spinellg@od.nih.gov

For scientific/programmatic issues related to NIDA's interest:

Christine Colvis, Ph.D.
Program Director
Genetics and Molecular Neurobiology Research Branch
Division of Neuroscience & Behavioral Research
National Institute on Drug Abuse/NIH
6001 Executive Blvd.
Room 4260, MSC 9555
Bethesda, MD 20892-9555
Telephone: 301-435-1323
FAX: 301-594-6043 fax
Email: ccolvis@nida.nih.gov

2. Peer Review Contacts:

For initial scientific review issues related to NHGRI and ORD:

Ken Nakamura, Ph.D.
Division of Extramural Research
National Human Genome Research Institute
5635 Fishers Lane
Twinbrook Building; Room 4706
Rockville, MD 20852
Telephone: (301) 402-0838
Email: ken_nakamura@nih.gov

For initial scientific review issues related to NIDA:

Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD 20892-9547
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: tl25u@nih.gov

3. Financial or Grants Management Contacts:

For financial or grants management matters related to NHGRI or ORD:

Ms. Cheryl Chick
Division of Extramural Research
National Human Genome Research Institute
5635 Fishers Lane
Twinbrook Building; Room 4706
Rockville, MD 20852
Telephone: (301) 402-0733
Email: cheryl_chick@nih.gov

For financial or grants management matters related to NIDA:

Gary Fleming, J.D., M.A.
Chief Grants Management Officer
National Institute on Drug Abuse
National Institutes of Health
6001 Executive Blvd.
NSC Building, Suite 3131, MSC 9541
Bethesda, MD 20892-9541
Telephone: (301) 443-6710
FAX: (301) 594-6849
E-mail: gf6s@nih.gov

Overnight Delivery Address:

6001 Executive Blvd., Suite 3131
Rockville, MD 20852

Section VIII. Other Information

Required Federal Citations

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

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

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

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

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

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

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

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

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

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.

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.healthypeople.gov.

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

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

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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