Part I Overview Information

Department of Health and Human Services (DHHS)

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)

Title: Human Temporal Bone Consortium for Research Resource Enhancement

Announcement Type
This is a modification of RFA-DC-04-002, which was previously released July 7, 2004

Request For Applications (RFA) Number: RFA-DC-06-001

Catalog of Federal Domestic Assistance Number(s)
93.173

Key Dates

Release Date: September 16, 2005
Letters of Intent Receipt Date(s): January 20, 2006
Application Receipt Dates(s): February 21, 2006
Peer Review Date(s): March/April 2006
Council Review Date(s): September 2006
Earliest Anticipated Start Date: September 2006
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: February 22, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
  1. Research Objectives

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

Section III. Eligibility Information
  1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
  2.Cost Sharing or Matching
  3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
  1. Address to Request Application Information
  2. Content and Form of Application Submission
  3. Submission Dates and Times
    A. Receipt 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
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
  3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
  1. Award Notices
  2. Administrative and National Policy Requirements
    A. Cooperative Agreement Terms and Conditions of Award
      1. Principal Investigator Rights and Responsibilities
      2. NIH Responsibilities
      3. Collaborative 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

Opportunity

Incorporating modern approaches of molecular biology, biochemistry, imaging technology, and data management to human temporal bone (HTB) research provides an opportunity to enhance the value of these tissues for auditory and vestibular research. The combination of a new pool of HTB specimens along with better utilization of the existing pool also provides an opportunity to link patient history and pathology with genetics and modern biology. Clinical diagnoses and treatments are expected to be improved significantly by modernizing scientific research results to correlate pathological findings with patient histories.

Background

Clinical understanding of disorders and disease is informed by correlating structure with function, comparing pathological with normal tissues, and interpreting data from individual specimens in the context of their relevant medical history and genetics. Studying human disorders of hearing and balance is made difficult because the sensory organs of the ear, its auditory and vestibular nerves all lie within the hard temporal bone. In living humans these tissues are inaccessible to conventional pathologic examination techniques such as biopsy or surgical excision, so they must be studied post mortem, using lengthy and expensive special methods for human temporal bone removal, dissection and tissue processing. As a result, research has been mainly confined to specialized laboratories that have equipment and personnel expertise outside that of conventional human pathology laboratories. There has been little change in the classical anatomical methods for studying HTBs, despite recent dramatic advances in techniques for molecular biological and biochemical approaches, for microscopic analysis, and for computational handling of digitized images and other data.

In 1992 the NIDCD National Temporal Bone, Hearing and Balance Pathology Resource Registry (“the Registry”) was established to promote HTB utilization for research on human hearing and balance disorders, and to serve as an information resource for researchers and the public. Despite the success of the Registry, the numbers of laboratories and investigators engaged in HTB research have declined to levels causing serious concern. In September 2003 the NIDCD sponsored a workshop entitled “Temporal Bone Histopathologic Research: Laboratories and Research Training" to assess the need to maintain active laboratories and encourage new researchers in the field. The Workshop participants concluded that it is important to support basic acquisition and processing of HTBs, unified protocols for processing HTBs, and a concerted effort to modernize HTB research.

Knowledge to achieve

Knowledge remains inadequate about disorders and diseases of the ear, and clinical progress depends on research on post-mortem human temporal bones. Inner ear pathology includes the vestibular system, the endolymphatic system, and the eighth nerve as well as the cochlear apparatus. Procurement and processing of human temporal bones has to allow these different tissues to be approached in different ways to answer relevant questions based on the medical history for the particular specimen. Conflicting needs are recognized because using one approach may eliminate getting some information by a different approach. It is crucial to have good anatomical, molecular and biochemical data from humans to relate to pathological changes such as loss of sensory hair cells, changes of innervation patterns, or changes in structures or fluids of the cochlea or vestibular apparatus. Equally crucial is having relevant clinical information, including behavioral, physiological and genetic data, from patient histories of HTB donors in a manner that allows correlations and interpretations across laboratories. Knowledge also can be gained from earlier classically fixed and imbedded tissues, enriching the results from the newer methods.

Objectives

This initiative is to support projects that will enhance how human temporal bone specimens are used for modern auditory and vestibular research. Applications must delineate important research questions requiring human temporal bone specimens, provide protocols for tissue processing that are robust within the constraints of sample acquisition and varying user needs, and describe mechanisms for access to and sharing of HTB materials including archived and new specimens. Applications must incorporate techniques of modern molecular biology, imaging technology and data management. There must be explicit plans for participating in a consortium to promote collaborative work among HTB resource centers. These plans must include ways to promote methodological improvements, to encourage data sharing, and to recruit and train future researchers to work on these tissues of fundamental importance for auditory and vestibular biomedical advances.

Application of modern research techniques is needed to improve information gained from new material and the extensive material already available. New HTB tissue specimens can be targeted for investigating gene expression, protein interactions, or cellular repair mechanisms, using molecular, biochemical and imaging approaches. It is a great advantage if any relevant clinical behavioral and physiological information (e.g., audiograms, blood and tissue samples for DNA or other markers) came from the same donor. Existing HTB specimens include a vast number of microscopic sections of high quality, allowing digitized images, often linked with medical data, which together could provide a database of very useful reference material for the whole field.

A system is needed to optimize using a set of alternative standard processing protocols for new specimens, with some standard criteria for choosing when to use each alternative. No single processing protocol is likely to be uniformly adequate because post-mortem acquisition of HTBs has such variability, including the time since death, the clinical pathology of each individual case, and the varying needs of the research plans (e.g., fixation method, or plane of sectioning). New imaging technologies allow non-invasive, non-destructive initial morphological views that can guide the choices for further analysis. These issues make it important to have strategies for multiple approaches incorporated into a decision tree that guides how samples from an individual HTB should be procured, processed, analyzed and its data distributed.

The consortium structure is intended to coordinate and optimize the utilization of HTB specimens. Each individual laboratory obtaining and studying HTBs is likely to have particular strengths for one approach more than another. This RFA envisions a consortium as a national resource to promote formation of multi-disciplinary laboratories, and collaborations between laboratories and with the Registry. This resource also will enable addressing some research questions too multifaceted for single laboratories to solve with specimens that are hard to obtain.

Successful applicants will form the Human Temporal Bone Consortium for Research Resource Enhancement, in consultation with NIDCD officials as a Cooperative Agreement (See ‘Award Information' below) with an internal Steering Committee and an external Advisory Committee. The Consortium will consist of the Principal Investigator (PI) and personnel of each HTB laboratory funded under this RFA. A Steering Committee formed by the successful applicant PIs and the Program Coordinator from NIDCD will be responsible for scientific management and oversight of Consortium activities. A Headquarters will be established at the home institution of the PI who is elected by the Steering Committee to serve as its Chair. The Headquarters implements the executive leadership and scientific coordination for the Consortium, and provides a center for disseminating information to the Consortium PIs, the Registry, and NIDCD. An Advisory Committee of 'external' researchers will be established by NIDCD after the Consortium is formed, to provide expert scientific advice to the Consortium and NIDCD.

Awards will be made as Cooperative Agreements using the U24 mechanism, and funds will be held by the individual awardees of the Consortium. The PIs will have funds available to support development, implementation and assessment of the protocols for acquisition and processing of HTB material, and to cover applicable administrative costs and travel to Consortium meetings and workshops. Applicants funded though this RFA also will cooperate with the Registry; the data arising from the HTBs collected, processed, and assessed must be transmitted to the Registry for inclusion in its HTB database. Using modern imaging and informatics tools, data on salient features of each HTB also will be created and made available to researchers in the greater scientific community.

In response to this RFA applications explicitly must address:

a) ways to optimize specimen preparation protocols, including the application of advanced molecular biological and biochemical assays, and a decision tree for when to choose the best protocol for the particular research question,

b) ways to optimize getting relevant clinical histories and regular assessments from potential donors, including linking to functional or genetic medical information (i.e., audiograms, blood and tissue samples) relevant to auditory and vestibular function of patients;

c) ways to obtain and archive specimens and images for auditory and vestibular researchers and clinicians;

d) plans outlining a mechanism for collaboration and cooperation of the participating laboratory with the Consortium, including transmitting relevant findings from clinical assessments, molecular and anatomical data to the Registry;

e) ways to facilitate wider access to HTB specimens, new as well as existing, including digitized data and cooperation with the Registry;

f) ways to incorporate and/or train investigators who may not have prior experience with HTBs but who bring expertise important for the 'modernization' of HTB research (e.g. molecular biologists, pathologists, forensics experts, imaging experts, etc.);

g) documentation of the Principal Investigator's (PI's) willingness and experience as a collaborator and a team leader.

In addition, applicants interested in serving as Chair of the Steering Committee (see below for definition) must provide:

h) detailed documentation of the ability to provide executive leadership and scientific coordination, and

i) a plan for implementing the scientific, operational, and organizational policies of the Consortium, for managing the logistics of the meetings and Consortium workshops/symposia, and for information dissemination among the Consortium members, the Steering Committee (defined below), the Registry, and the NIDCD.

Research and approaches

Research and experimental work for this RFA are expected to deal with the handling of human temporal bone tissues. Animal studies are generally not appropriate for the goals intended, but if animal tissue is used for any experimental work it must be tightly linked to a specific need in this RFA. Research can include a range of approaches that will obtain useful data for molecular and biochemical analyses to correlate with analyses from pathophysiology and anatomy. Appropriate research topics include developing protocols for patient assessment, post-mortem tissue acquisition, image capture and analysis, and data distribution. Research plans will be strengthened by potential uses of existing HTB tissues while emphasizing the use of modern approaches for new material. Collaborations are expected among researchers representing multiple disciplines and multiple approaches; there must be some description of strategies to coordinate such efforts, and to couple such efforts with the proposed Consortium.

Examples of research topics. N/A.

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 U24 award mechanism(s).

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.

The NIH U24 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award". This Program intends to continue these projects beyond the initially awarded period, subject to available funding and progress in the field.

2. Funds Available

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the 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 subcontract participants are not included in the direct cost limitation, see NOT-OD-05-004.


Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

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

Foreign institutions are not eligible to apply.

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 or Matching

Cost-sharing is allowed but not required.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

Only one application may come from an individual institution.

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.

Applications must be new. Applications will not be accepted as “revised” amended applications from the prior RFA-DC-04-002.

3. Submission Dates and Times

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

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: January 20, 2006
Application Receipt Date(s): February 21, 2006
Peer Review Date: March/April 2006
Council Review Date: September 2006
Earliest Anticipated Start Date: September 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 the date listed at the beginning of this document.

The letter of intent should be sent to:

Christopher Platt, Ph.D.
Division of Scientific Programs
National Institute on Deafness and Other Communication Disorders
6120 Executive Blvd, Suite 400
Bethesda, MD 20892-7180
Telephone: (301) 496-1804
FAX: (301) 402-6251
Email: plattc@nidcd.nih.gov


3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. 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)

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

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:


Melissa Stick, Ph.D., M.P.H.
Chief, Scientific Review Branch
National Institute on Deafness and Other Communication Disorders
6120 Executive Blvd., Suite 400
Bethesda , MD 20892-7180
Telephone: (301) 496-8683
FAX: (301) 402-6250
Email: stickm@nidcd.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.


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 NIDCD. 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.

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/grants/policy/nihgps_2003/NIHGPS_Part6.htm.


6. Other Submission Requirements

Applications must be new. Applications will not be accepted as “revised” amended applications from the prior RFA-DC-04-002.

A wardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2 "Award Administration Information" (below).

A. Compliance with terms of the Consortium Cooperative Agreement. In a separate, labeled section, applicants must include their specific plans for responding to the “Cooperative Agreement Terms and Conditions of Award” section. Applicants must state their willingness to collaborate and share data freely with the other Consortium members, to participate in planning and attending workshops and symposia, to serve on the Steering Committee (SC; see below) and be bound by its decisions, and to share data and research resources with each other and the NIDCD (see below on Sharing Research Data and Sharing Research Resources). Successful applicants will be expected to submit information on specimen collections to the Registry (through the Headquarters).

B. Applicants for Steering Committee (SC) Chair. Applicants interested in serving as Chair of the SC must provide detailed documentation of their ability to provide executive leadership and scientific coordination. They must include a plan for implementing the scientific, operational, and organizational policies of the Consortium, for managing the logistics of SC meetings and Consortium workshops/symposia, and for information dissemination among the Consortium members, the Advisory Committee (AC; see below), the Registry, and the NIDCD.

C. Budget.

1. Applicants must budget for travel and per diem expenses for Steering Committee (SC) meetings. In the first year, applicants should plan for the Principal Investigator and an additional senior investigator to attend a Planning Meeting and two SC meetings. In the second and subsequent years, applicants should plan for the Principal Investigator and an additional senior investigator to attend two SC meetings per year.

2. Applicants must budget for travel and per diem expenses for participation in Consortium workshops and symposia. Applicants should plan that at least two investigators will attend at least two Consortium workshops/symposia during the total project period.

3. Applicants interested in serving as SC Chair must budget for expenses solely related to the headquarters function (see above) and the yearly meetings of the Advisory Committee (AC); only the applicant elected Chair will be awarded such budgeted funds. The use of these funds will be restricted and be released from the U24 by NIDCD. Indicate this amount in the “Other Expenses” category under the heading “Headquarters Funds”.

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.

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/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.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:

In addition to the points above, the plans for protocols, utilization and sharing of specimen data, infrastructure development, and collaborations also will be considered in the funding decisions (see below).

2. Review and Selection Process

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 NIDCD 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.

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? Will the project enhance the relevance of HTB research for modern biological and clinical advances? Are links established between the medical and the biological data to make correlations clinically relevant? Are collaborative projects likely to incorporate new investigators from fields not represented in current HTB research?

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? Will the proposed protocols be sufficient for the diverse specimen needs, and likely to provide comparable results across different laboratories? Have problems of post-mortem tissue acquisition been addressed? Does the project include ways to enhance the information available from archival HTBs as well as new tissues? Are plans and expertise adequate for recording and storing data in digital form to enable broad sharing?

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? Do the proposed approaches bring modern approaches and techniques into the field? Does the proposed project go significantly beyond current research in this area?

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)? Will the investigators bring new skills or new combinations of expertise to HTB research? For a proposal where the PI has an interest in being Chair of the Steering Committee, what is the evidence of his/her leadership skills and experience? (This last feature is not applicable to all proposals so it is not to be considered in scoring the project.)

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? Does the project address the larger environment of national infrastructure for HTB acquisition and data sharing, including the Registry? For a proposal where the PI has an interest in to be Chair of the Steering Committee, how reasonable are the plans for coordination? (This last feature is not applicable to all proposals so it is not to be considered in scoring the project.)

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.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

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

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/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.

Reviewers will be asked to assess the adequacy of the plan for sharing resources. Does the plan provide adequate access to archival and new HTB specimens? Does the plan adequately consider sharing with the community beyond the Consortium? Does the plan include adequate components of informatics for sharing the various forms of data including digitized databases and images?

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
N/A.

Section VI. Award Administration Information


1. Award Notices

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 (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.


2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Notice of 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.


2.A. Cooperative Agreement Terms and Conditions of Award

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

The administrative and funding instrument used for this program will be the cooperative agreement (U24), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined above.


2.A.1. Principal Investigator Rights and Responsibilities
The Principal Investigator will have the primary responsibility for managing their laboratory's participation in collaborative projects approved by the Steering Committee (SC; see 2.A.3. below for details). Each award is part of a consortium of several awards made under RFA DC-06-001 “Human Temporal Bone Consortium for Research Resource Enhancement.”

Each PI is responsible for accepting and implementing the collaborative goals, priorities, protocols, procedures, and policies agreed upon, including methods and requirements for joint participation as recommended by the SC, and handling of data, including appropriate sharing of methods and data among collaborating organizations

Each PI:

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

2.A.2. NIH Responsibilities

An NIH Program Official within NIDCD will be designated the Program Coordinator for the Consortium, and will have substantial programmatic involvement above and beyond the normal stewardship role in awards, as described below.

The NIDCD Program Coordinator for the Consortium has substantial scientific programmatic involvement during conduct of this activity, through technical assistance, data sharing and analysis, composition of reports, and advice and coordination above and beyond normal program stewardship for grants as described below

The NIDCD Program Coordinator:

The NIDCD reserves the right to adjust funding, withhold support, suspend, terminate or curtail a study or an individual award in the event of: a failure to comply with the Terms and Conditions of Award; substantial shortfall in HTB specimen acquisition, processing, or evaluation; lack of data reporting or quality control; other major breach of scientific conduct; or human subject ethical issues, whenever applicable.

Additionally, the same NIDCD Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

2.A.3. Collaborative Responsibilities

Collaborative responsibilities will be handled by two groups, a Steering Committee (SC) of Consortium PIs, working with an Advisory Committee (AC) of 'external' advisors.

a) Steering Committee (SC)

The SC will have major scientific management oversight and responsibility for developing collaborative research projects, facilitating the conduct and monitoring of studies, and reporting study results.

i. The SC members are the PI from each awardee institution, with the NIDCD Program Coordinator as a non-voting member; each other member has one vote. The Chair is selected by the SC, and may be any PI involved in the Consortium, not an official from NIH. Members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

ii. The Headquarters of the Consortium is the home institution of the SC Chair, who serves as the PI of the Headquarters and implements the scientific, operational, and organizational policies of the Consortium. The Headquarters provides executive leadership for the Consortium; it also disseminates information among the Consortium PIs, the Advisory Committee (AC; see below), the Registry and the NIDCD. The Headquarters manages the logistics for the SC meetings and for Consortium workshops/symposia.

iii. After all the Consortium awardees have been funded, the SC will convene to select a Chair and begin work. Thereafter, the SC will meet twice yearly; one of those meetings may be in conjunction with the Advisory Committee. Responsibilities of the SC include but are not limited to:

iv. The SC reviews HTB accrual, protocol compliance, results of audits, and regulatory requirements at the participating laboratories and formally reports the results of its reviews annually to the NIDCD. Such review includes:

v. The SC plans at least two workshops/symposia during the project period to inform the scientific community of the progress made toward development and application of HTB acquisition and processing techniques developed through awardee collaborations. The Advisory Committee and the NIDCD Program Coordinator provide the SC with advice on participants for the workshops and symposia. The Headquarters manages the logistics for these meetings.

b) Advisory Committee (AC):

The AC provides external advice to the NIDCD and the SC on the progress and success of the Consortium against the criteria developed by the SC, and on relevant scientific issues, including study design, prioritization of technique development, and the development of collaborative study protocols.

i. The membership of the AC and duration of service are established by the NIDCD in consultation with the SC. The members are:

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

ii. The AC collaborates with the SC to suggest participants and to assist in the implementing workshops and symposia, and to provide liaison between the human temporal bone research community and the Consortium. The AC helps the NIDCD in site visits to the participating institutions, as necessary.

iii. The AC will meet at least once yearly in the Bethesda , MD area. This meeting may be in conjunction with a Steering Committee regular meeting.

2.A.4. Arbitration Process

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


3. 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:

Christopher Platt, Ph.D.
Division of Scientific Programs
National Institute on Deafness and Other Communication Disorders
6120 Executive Blvd., Suite 400
Bethesda , MD 20892-7180
Telephone: (301) 496-1804
FAX: (301) 402-6251
Email: plattc@nidcd.nih.gov


2. Peer Review Contacts:

Melissa Stick, Ph.D., M.P.H.
Chief, Scientific Review Branch
National Institute on Deafness and Other Communication Disorders
6120 Executive Blvd., Suite 400
Bethesda , MD 20892-7180
Telephone: (301) 496-8683
FAX: (301) 402-6250
Email: stickm@nidcd.nih.gov


3. Financial or Grants Management Contacts:

Christopher Myers
Chief, Grants Management Branch
National Institute on Deafness and Other Communication Disorders
6120 Executive Blvd., Suite 400
Bethesda , MD 20892-7180
Telephone: (301) 402-0909
FAX: (301) 402-1758
Email: myersc@nidcd.nih.gov

Section VIII. Other Information


Required Federal Citations

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

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

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

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

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

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

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

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

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

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005 . The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://www.nih.gov/about/publicaccess/ and view the Policy or other Resources and Tools including the Authors' Manual (http://www.nih.gov/about/publicaccess/publicaccess_Manual.htm).

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.

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


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NIH Funding Opportunities and Notices


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