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EXPIRED

NIDCD Translational Research Grants

PA Number: PAR-05-023

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 Institute on Deafness and Other Communication Disorders (NIDCD), (http://www.nidcd.nih.gov/)

Announcement Type:
New

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

Catalog of Federal Domestic Assistance Number(s):
93.173

Key Dates
Release Date: November 24, 2004
Letters Of Intent Receipt Date(s): January 22, 2005, October 22, 2005, June 22, 2006, January 22, 2007
Application Receipt Dates(s): February 22, 2005, November 22, 2005, July 22, 2006, February 22, 2007
Peer Review Date(s): June 2005, February 2006, October 2006, June 2007
Council Review Date(s): September 2005, May 2006, January 2007, September 2007
Earliest Anticipated Start Date: December 2005, July 2006, March 2007, December 2007
Expiration Date for R21 Applications: March 2, 2006
Expiration Date for R01 Non-AIDS Applications: November 2, 2006
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007

Due Dates for E.O. 12372
Not Applicable

Executive Summary

The NIDCD is encouraging applications in translational research in the NIDCD mission areas of hearing, balance, smell, taste, voice, speech and language. This PAR (program announcement with special review) has four submission dates. Applicants may use the R01 or R21 (Developmental/Exploratory) mechanism. Although there are no funds set-aside for this initiative, applications will be reviewed by an institute special review group. It is anticipated that a total of three to six grants will be awarded each cycle in response to this solicitation.

The intent of this PAR is to provide a new avenue for basic scientists and clinicians or clinical scientists to jointly explore, initiate and conduct translational research projects. The scope of this PAR includes a range of activities to encourage translation of basic research findings to have a practical impact on the diagnosis, treatment and prevention of communication disorders. Multi-institutional, multi-disciplinary, and academic-industrial collaborations studies are encouraged. This PAR is not intended for outcome studies, the extension of ongoing clinical research studies, or the optimization of current clinical protocols.

Eligible organizations include domestic and foreign for-profit and non-profit public and private institutions. Eligible principal investigators include those with the skills, knowledge and resources necessary to carry out the proposed research. Applicants may submit multiple applications in response to this PAR.

Application materials may be obtained at URL 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 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 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

1. Research Objectives

NATURE AND BACKGROUND

The goal of NIH sponsored research is to improve human health. To improve human health, basic scientific discoveries must be translated into practical applications. As part of its mission, the NIDCD facilitates the translation of basic biomedical or behavioral research discoveries in the field of deafness and other communication disorders into new clinical tools, prostheses and assistive devices, behavioral therapies or interventions, and medications.

A bench-to-bedside approach to translational research requires collaborations and interactions between basic scientists (delivering new information and ideas) and clinical scientists (providing observations about the nature, progression and treatment of disease). These interactions, in turn, can stimulate new avenues for advances in basic and clinical investigations. Substantial advances have been made in understanding both basic biomedical (e.g., cellular, molecular, genetic, systems) and behavioral (e.g., perception, cognition, attention, motor) aspects of deafness and other communication disorders. However, this information often does not progress beyond the basic science laboratory into clinical application. Multidisciplinary efforts are often needed to use basic knowledge to develop new assessment, treatment and prevention strategies.

The purpose of this PAR is to support collaborative research between basic scientists and clinicians or clinical scientists that will hasten the translation of basic research findings into the diagnosis, treatment and prevention of deafness and other communication disorders.

This PAR is one of two coordinated programs being released by the NIDCD to promote translational research. See also NOT DC-05-001 NIDCD P30 Grants for Translational Research (http://grants.nih.gov/grants/guide/notice-files/NOT-DC-05-001.html).

DEFINITION

Translational research is the application of discoveries from basic biomedical and behavioral research toward the diagnosis, treatment or prevention of human disease, with the ultimate goal of improving public health. For the purposes of this PAR, outcomes research (understanding end results of health care practices and interventions, including monitoring and quality improvement) is not included. Further, this PAR is not intended for the extension of ongoing clinical research studies or the optimization of current clinical protocols.

OBJECTIVES

The objective of this PAR is to provide support for R21 pilot studies and R01 projects for translational research. The research must be focused on one or more of the scientific mission areas of the NIDCD: hearing, balance, smell, taste, voice, speech or language.

The intent of this PAR is to encourage the development of collaborative partnerships between scientists who study basic biological and behavioral processes and those who study the etiology, diagnosis, treatment and prevention of deafness and other communication disorders and the delivery of those services to those with these disorders. Applications are expected to have both basic scientists and clinicians or clinician scientists included as key personnel (although exceptions may be allowed and must be sufficiently justified within the application) for joint exploration, initiation and conduct of translational research projects.

The scope of this PAR includes a range of activities to encourage the translation of basic research findings to practical impact on the diagnosis, treatment and prevention of deafness and other communication disorders. Multi-institutional, multi-disciplinary, and academic-industrial collaborations studies are encouraged. Research conducted under this PAR may include laboratory studies with human subjects as well as preclinical studies in animal models.

Both R01 and R21 exploratory research grants may include, in addition to the requisite research studies, networking activities designed to initiate and explore potential research collaborations between basic and clinical scientists, such as cross-site visits and workshops.

Possible goals include, but are not limited to:

Development of assays that permit screening of candidate therapeutics or enhance diagnostic capabilities. These include biochemical, electrophysiological and behavioral assays. (High-throughput drug screening is not responsive).

Pharmacology (toxicity) and pharmacokinetic studies for candidate therapeutics that have demonstrated potential for the treatment of communication disorders.

Chemical optimization of strongly supported therapeutic leads.

Dosage studies for safety, tolerability and effectiveness. Phase I and Phase II clinical trials are responsive to this PAR.

Studies designed to determine whether an intervention produces sufficient evidence of short-term activity, justifying subsequent efficacy studies.

Studies to test the efficacy of highly promising interventions in animal disease models.

Development of animal models for evaluation of candidate therapeutics and/or toxicology studies. Animal model development is appropriate only if it will lead directly to treatment and intervention efforts, and is not appropriate for studying basic mechanisms of disease.

Development of tools and techniques for better diagnostic, therapeutic and drug delivery systems, including but not limited to drug delivery devices, neuro-electrical stimulators and recording devices. Such tools or technologies should overcome existing obstacles and facilitate the direct application of delivery of drugs or electrical stimulation, for example. Basic viral vector research is not responsive.

Development of screening tests, including biomarkers, to identify individuals at risk for a disorder to allow for early intervention.

Development and testing of new tools to better target the treatment to the individual patient and to better predict the patient response.

Development of sensitive and objective technologies and tools for clinical decision matrices.

Development and testing of innovative prevention and treatment paradigms using discoveries from biological, psychological, and social sciences.

Development and testing of delivery systems or parameter settings in prosthetic devices or surgical techniques with the goal of providing better patient performance.

Development and assessment of new data collection and measurement instruments leading to better diagnostic, evaluation and assessment paradigms.

PROJECT ORGANIZATION

Applicants should demonstrate that a research partnership between basic and clinical researchers exists or will be developed and nurtured. It is expected that applications will have both basic scientists and clinicians or clinician scientists included as key personnel and that exceptions must be justified within the application. The minimum collaborative arrangement would involve two investigators, although larger numbers of existing or potential collaborators are encouraged, as appropriate.

Research teams should be formed based on the nature of the translational research goals and should not be limited by departmental or geographical boundaries. Collaborations among different institutions are encouraged, but applications must note how communication will occur across these boundaries so that actual collaborative research partnerships can occur. Relevant expertise may include biostatistics, bioinformatics, bioengineering, health economics, epidemiology, imaging, pharmacology, pharmacogenetics, psychology, regulatory expertise, etc. Because the eventual outcome of these studies may lead to commercialization of a product, academic-industrial collaborations are also encouraged.

Applications submitted in response to the PAR may be written in a format that emphasizes a milestone-based structure for the project, rather than the hypothesis-driven format used in a traditional R01 or R21. For example, a proposal for device development might be organized around the following milestones: a. development of an initial prototype to implement essential design concepts, b. validation of surrogate endpoints to assess safe and effective device operation, c. enhancement of the prototype device through a series of refinements, and d. incorporation of the best design elements into a device to be utilized by humans outside of the research laboratory. Possible milestones for vaccine development may include: a. generate preclinical data to demonstrate efficacy in a relevant animal model, b. conduct Phase I clinical trials to demonstrate safety and immunogenicity, and c. utilize data acquired in Phase I to procure industry license or to proceed with Phase II trials. It is incumbent upon the applicant to include the criteria and contingency plans that will be utilized in determining milestone completion before proceeding to the next phase of the project.

Due to the collaborative nature of these projects, applicants should document arrangements for sharing of recognition among the investigators and for future developments ensuing from these projects.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the NIH R01 and R21 award mechanism(s). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

R01 applicants may request a project period of up to five years and there is no budgetary cap. R21 applicants may request a project period of up to two years with a combined budget for direct costs of up $275,000 for the two year period. For example, the applicant may request $100,000 in the first year and $175,000 in the second year. The request should be tailored to the needs of the project. Normally, no more than $200,000 direct costs may be requested in any single year. Applicants must clearly specify on both the face page and within the application which mechanism (i.e., R21 or R01) is being requested.

This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format described in the PHS 398 application instructions. Otherwise follow the instructions for non-modular research grant applications.

2. Funds Available

There are no funds set-aside for this PAR.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

1.B. Eligible Individuals

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

2. Cost Sharing
Cost Sharing is not required

3. Other-Special Eligibility Criteria

This PAR is a one-time solicitation with four submission dates for new and revised applications. Applications submitted for one submission date may be revised and resubmitted for later submission dates indicated for this PAR. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].

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

2. Content and Form of Application Submission

Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001; 9/2004 version after May 10). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

See also Subsection VI.2. Administrative Requirements for additional information.

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

3. Submission Dates

3.A. Receipt, Review and Anticipated Start Dates

Letters Of Intent Receipt Date(s): January 22, 2005, October 22, 2005, June 22, 2006, January 22, 2007
Application Receipt Dates(s): February 22, 2005, November 22, 2005, July 22, 2006, February 22, 2007
Peer Review Date(s): June 2005, February 2006, October 2006, June 2007
Council Review Date(s) : September 2005, May 2006, January 2007, September 2007
Earliest Anticipated Start Date: December 2005, July 2006, March 2007, December 2007

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:

Amy Donahue, Ph.D. Chief, Hearing and Balance/Vestibular Sciences Branch Acting Chief, Translational Research Branch NIDCD 6120 Executive Boulevard, EPS Room 400C MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 402-3458 FAX: (301) 402-6251 Email: [email protected]

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)

Two additional copies of the application and all sets of appendix material, if applicable, must be mailed to the NIDCD at the following address: Melissa Stick, Ph.D., MPH Chief, Scientific Review Branch Division of Extramural Activities National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400C MSC-7180 Bethesda, MD 20892-7180 Telephone: (301) 496-8683 FAX: (301) 402-6250 Email: [email protected]

3.C. Application Processing

Applications must be received on or before the application receipt dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.

The NIH will not accept any application in response to this PAR 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

This PAR requires that all applications must include an introductory paragraph describing the translational nature of the project and how these projects are distinct from the traditional R21 and R01 applications accepted on the standard NIH receipt dates.

It is expected that all applications will have both basic scientists and clinicians or clinician scientists included as key personnel. Applications should demonstrate that a research partnership between basic and clinical researchers exists or will be developed and nurtured. For the purposes of this PAR, a basic scientist is defined as one who has demonstrable expertise in one or more lines of basic research, and for whom a preponderance of his or her research effort (typically, 50% or more) has involved non-clinical populations, as measured by publications, grant support, presentations, or other scholarly work. The minimum collaborative arrangement would thus involve two investigators, although larger groups of actual and potential collaborators are encouraged, if appropriate.

Applicants must clearly specify in the application which mechanism is being requested. Since the R21 is intended to encourage exploratory, pilot and developmental research projects by providing support for the early and conceptual stages of translational research, R21 applicants must also address why their projects are appropriate for the R21 mechanism. Pilot data are not required for the R21, although demonstration of feasibility should be included, if possible.

R21 and R01 applications submitted in response to this PAR may be more milestone- driven than hypothesis-driven.

Specific Instructions for Modular Grant applications.

R01 applications should follow the instructions for the PHS 398 (rev. 5/2001). Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm. R01 applicants requesting $500,000 or more in direct costs for any year must carry out the following steps:

1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study;

2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and,

3) Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application.

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

Specific Instructions for R21 applications.
R21 applications should follow the instructions for the PHS 398 (rev. 5/2001), with the following exceptions: You may request a project period of up to two years. The combined budget for direct costs for the two year project period may not exceed $275,000. For example, you may request $100,000 in the first year and $175,000 in the second year to meet the needs of your project. Normally, no more than $200,000 may be requested in any single year. All budgets should be in modular format. Exploratory/developmental grant support is for new projects only; competing continuation applications will not be accepted. Items a - d of the Research Plan (Specific Aims, Background and Significance, Preliminary Studies, and Research Design and Methods) may not exceed a total of 15 pages. No preliminary data is required but may be included if available. However, the applicant does have the responsibility for developing a demonstrably sound research plan designed to assess the feasibility of the proposed pilot project. Use the instructions for the appendix detailed in the PHS 398 except that no more than 5 manuscripts, previously accepted for publication, may be included.

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.

Section V. Application Review Information
1. Criteria
See below.

2. Review and Selection Process

Applications submitted for this funding opportunity will be reviewed for completeness by the CSR and for responsiveness by the NIDCD. Incomplete applications will not be reviewed. If the application is not responsive to the PAR, NIH staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited application at the next appropriate NIH review cycle.

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

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

3. Merit Review Criteria

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?

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)?

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?

3.A. Additional Review Criteria:

Has the applicant described the translational nature and scope of the project and appropriateness to the intent of the PAR? Is it likely that the results produced by the application will increase the translation of research findings to the clinic?

Collaborative Research Team: Does the research team consist of both basic scientists and clinicians or clinician scientists in a collaborative arrangement (unless an exception is adequately justified)?

Quality of the TR proposed: The success of TR applications will depend upon three factors: 1) What is the quality of the basic research that is being translated; 2) what are the strengths of the clinical research team and their ability to implement the translational findings from the basic research; and 3) how appropriate are the basic science areas and paradigms to the clinical research program? Note: Approximately equal weight should be given to these three factors.

Is the application appropriate for the R21 mechanism?

R21 and R01 applications submitted in response to this PAR may be more milestone-driven and less hypothesis-driven, and thus, lack of hypothesis-driven research aims will not necessarily detract from the merit of an application. Has the applicant included the criteria and contingency plans that will be utilized in determining milestone completion before proceeding to the next phase of the project?

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

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

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

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

3.B. Additional Review Considerations

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

3.C. Sharing Research Data

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

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/grants/policy/nihgps_2003/NIHGPS_part4.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 for successful candidates will be sent to the sponsoring institution's Office of Sponsored Research via e-mail or paper copy.

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

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.

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:

Amy M. Donahue, Ph.D. Chief, Hearing and Balance/Vestibular Sciences Branch Acting Chief, Translational Research Branch NIDCD EPS Room 400C 6120 Executive Boulevard Bethesda, MD 20892-7180 Telephone: (301) 402-3458 FAX: (301) 402-6251 Email: [email protected]

2. Peer Review Contacts:

Melissa Stick, Ph.D., MPH
Chief, Scientific Review Branch
NIDCD
EPS, Rm 400C
6120 Executive Blvd
Bethesda, MD 20892-7180
Telephone: (301) 496-8683
FAX: 301-402-6250
Email: [email protected]

3. Financial or Grants Management Contacts:

Mr. Christopher Myers
Grants Management Officer
NIDCD
EPS, Rm 400B
6120 Executive Blvd
Bethesda , MD 20892-7180
Telephone: (301) 402-0909
FAX: 301-402-1758
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

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

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

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity, and dose-finding studies (phase I); efficacy studies (Phase II) efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

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

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

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

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

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

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

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

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

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

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

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

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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

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

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

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