HUMAN TEMPORAL BONE RESEARCH RESOURCE ENHANCEMENT CONSORTIUM
 
RELEASE DATE:  July 7, 2004
 
RFA Number:  RFA-DC-04-002 (This RFA has been modified, see RFA-DC-06-001)

EXPIRATION DATE:  November 16, 2004

Department of Health and Human Services (DHHS)
 
PARTICIPATING ORGANIZATION:  
National Institutes of Health (NIH)
 (http://www.nih.gov)

COMPONENT OF PARTICIPATING ORGANIZATION:  
National Institute on Deafness and Other Communication Disorders (NIDCD)
 (http://www.nidcd.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.173

LETTER OF INTENT RECEIPT DATES: October 15, 2004
APPLICATION RECEIPT DATES:  November 15, 2004  
 
THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA 

The purpose of this initiative is to solicit applications that will 
enhance the utility of human temporal bones (HTBs) for auditory and 
vestibular research. The research projects proposed in response to this 
RFA must address the collaborative development of a uniform protocol 
for HTB (and related brain tissue) acquisition and processing, and for 
the application of modern molecular-biologic assays to HTB research.

RESEARCH OBJECTIVES
 
A. Background

Clinicopathologic correlation informs our understanding of normal and 
disordered human processes, including those underlying hearing, balance 
and facial nerve function. Housed in the temporal bone, the inner ear 
structures subserving hearing and balance are inaccessible during life, 
rendering infeasible the conventional techniques of pathologic 
examination, such as biopsy/surgical excision. Consequently, the 
assessment of auditory and vestibular structures necessitates the post 
mortem study of temporal bones. 

The acquisition, processing, and evaluation of HTBs are expensive and 
time-consuming endeavors that require specialized equipment and 
personnel, which lie outside the expertise of conventional human 
pathology laboratories. Accordingly, these research endeavors have been 
relegated to specialized HTB laboratories.  

In 1992 NIDCD established the NIDCD National Temporal Bone, Hearing and 
Balance Pathology Resource Registry (“the Registry”) to promote HTB 
research by serving as a national resource for researchers and the 
public. Despite the success of the Registry in accomplishing its tasks, 
the number of active HTB laboratories and the population of researchers 
engaged in HTB research have dwindled to near extinction.  

In order to assess the needs of HTB research, both in terms of 
maintaining active laboratories and encouraging new researchers into 
the field, the NIDCD sponsored a September 2003 workshop entitled 
“Temporal Bone Histopathologic Research: Laboratories and Research 
Training”. The Workshop participants concluded that: there is a need 
for funds to support the basic acquisition and processing of HTBs; 
there is a need for a unified protocol for processing HTBs; and, there 
is a need for a concerted effort to “modernize” HTB research. 

This Human Temporal Bone Research Resource Enhancement Consortium 
(“Consortium”) RFA aims to encourage, through a multidisciplinary, 
collaborative effort, the development of a unified protocol (or 
protocols) for HTB acquisition (and related brain tissue) and 
processing that facilitates modern molecular biologic assessment. 

B. Objective

The objective of this RFA is to solicit applications that will enhance 
the utility of HTBs to modern auditory/vestibular research. Funding 
through this RFA will provide resources for investigators to work 
collaboratively (governed by a Steering Committee, described below) to 
develop, implement and assess a standardized protocol (or protocols) 
for HTB (and related brain tissue) acquisition and processing that 
renders the HTB specimens appropriate for modern molecular biologic 
study, as well as an initial assessment of the HTBs acquired. 

It is expected that applicants funded though this RFA will cooperate 
with the Registry. The data arising from the HTBs collected, processed, 
and assessed will be transmitted to the Registry for inclusion in its 
HTB database. Digitized images of salient features of each HTB will be 
created and made available to researchers in the greater scientific 
community. 

Applicants in response to this RFA must describe in detail a process 
for:

1. defining and completing an initial HTB assessment protocol (or 
protocols);
2. participating in Consortium collaborative protocols;
3. developing, implementing and testing acquisition and processing 
protocols that allow for the application of advanced molecular biologic 
assays; 
4. developing and implementing HTB protocols that inform Consortium 
collaborative protocols; 
5. obtaining a clinical history, especially as relevant to 
auditory/vestibular function;
6. obtaining regularly conducted clinical assessments, especially 
auditory and vestibular function;
7. acquiring, processing, cataloging and storing HTB specimens;
8. cooperating with the Registry;
9. transmitting the findings from the initial assessment protocol to 
the Registry;
10. cooperating with the Consortium Consulting Committee (defined 
below)(do not name potential Consortium Consulting Committee members); 
and,
11. digitizing and distributing salient images from processed HTBs. 

In addition:

12. Applications for this RFA must provide detailed documentation 
describing the ability of the Principal Investigator to assemble a 
multidisciplinary team capable of carrying out the proposed processes. 
Similarly, applicants must demonstrate the willingness, the ability and 
a plan for conducting collaborative research endeavors with applicants 
funded through this RFA. 
13. Applicants interested in serving as Chair of the Steering Committee 
(see below for definition) should provide detailed documentation of the 
ability to provide executive leadership and scientific coordination and 
should include a plan for implementing the scientific, operational, and 
organizational policies of the Consortium, for managing the logistics 
of the SC meetings and Consortium workshops/symposia, and for 
information dissemination among the Consortium members, the Consortium 
Consulting Committee (defined below), the Registry, and the NIDCD.

C. Consortium Administrative Structure

Organization: The Consortium comprises the PI and personnel of each HTB 
laboratory funded under this RFA. 

The HTB laboratory personnel should comprise not only those individuals 
traditionally involved in temporal bone processing but also individuals 
(e.g., pathologists, molecular biologists) whose expertise will be 
important to the “modernization” of HTB research.

Steering Committee (SC): The SC is responsible for scientific 
management and oversight, including monitoring the activities of the 
Consortium. For the administrative structure, and responsibilities of 
the SC, see “Collaborative Responsibilities.”

Consortium Consulting Committee (CCC): Established by the NIDCD after 
the funding of all Consortium PIs, the CCC advises the SC on relevant 
scientific issues, including study design, prioritization of technique 
development, and the development of collaborative study protocols. For 
further details, see “Collaborative Responsibilities.”

Headquarters: The institution of the SC Chair serves as the 
Headquarters of the Consortium. The SC Chair can be any Principal 
Investigator (PI) involved in the Consortium. The Chair serves as the 
PI of the Headquarters and implements the scientific, operational, and 
organizational policies of the Consortium. The Headquarters provides 
the executive leadership and scientific coordination for the 
Consortium. It serves as a center for information dissemination among 
the Consortium PIs, the CCC, the Registry and the NIDCD. The 
Headquarters manages the logistics of the SC meetings and Consortium 
workshops/symposia.

Funds: Funds will reside with the individually funded awardees of the 
Consortium.

The PIs of the awards will have funds available to support the 
development, implementation, and assessment of the common HTB 
acquisition and processing protocol, and to cover applicable 
administrative costs and travel to Consortium SC meetings and 
workshops. 

MECHANISM OF SUPPORT
 
This RFA will use the NIH Cooperative Agreement (U24) award mechanism.  
The NIH U24 is a cooperative agreement award mechanism. In the 
cooperative agreement mechanism, the PI 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 PI as described under the section "Cooperative 
Agreement Terms and Conditions of Award". 

As an applicant you will be primarily responsible for planning, 
directing, and executing Consortium collaborative studies.  This RFA 
will have one submission date: November 15, 2004. The anticipated award 
date is July 2005. Investigators may not submit more than one 
application for this RFA. NIDCD program intentions beyond the current 
RFA are indefinite.

This RFA uses just-in-time concepts. U24 is not a modular mechanism.   
This program does not require cost sharing as defined in the current 
NIH Grants Policy Statement at:    
http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm.

FUNDS AVAILABLE
 
NIDCD intends to commit approximately $1 million in FY 2005 to fund two 
to three new grants in response to this RFA. An applicant may request a 
project period of up to five years.  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 NIDCD provide support for this 
program, awards pursuant to this RFA are contingent upon the 
availability of funds and the receipt of a sufficient number of 
meritorious applications.  
 
ELIGIBLE INSTITUTIONS
 
You may submit (an) application(s) if your institution has any of the 
following characteristics: 
   
o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, 
hospitals, and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic institutions/organizations
o Foreign institutions are not eligible to apply  
o Faith-based or community-based organizations
 
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS   

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

The PIs funded under this RFA will establish a Steering Committee 
(detailed below) to provide oversight for the development of a common 
protocol (or protocols) for HTB acquisition and processing that allows 
for advanced molecular biologic assessment. Each PI will be a voting 
member of the SC and will attend two SC meetings each year. The PIs 
will organize and attend 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 collaboration. Attendance at these 
meetings is required as part of this cooperative agreement.

Cooperative Agreement Terms and Conditions of Award

These 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, and other HHS, 
PHS, and NIH Grant Administration policy statements. [Part 92 applies 
when state and local governments are eligible to apply as a "domestic 
organization."]

Under the cooperative agreement, the NIDCD purpose is to support and/or 
stimulate the recipient's activity by involvement in and otherwise 
working jointly with the award recipient in a partner role, but it is 
not to assume direction, prime responsibility, or a dominant role in 
the activity. Consistent with this concept, the dominant role and prime 
responsibility for the activity resides with the awardee(s) for the 
project as a whole, although specific tasks and activities in carrying 
out the studies will be shared among the awardees and the NIDCD Program 
Coordinator.

A.  Rights and Responsibilities of Human Temporal Bone Research 
Resource Enhancement Consortium PIs 

Collaborative Studies:

Each PI will collaborate with other Consortium awardees to develop a 
common protocol for HTB (and related brain tissue) acquisition and 
processing that enables modern molecular biologic evaluation.

Each PI will be responsible for accepting and implementing the goals, 
priorities, common protocols, procedures, and policies agreed upon by 
the Steering Committee (SC – see C.1. below for details) for the 
collaborative studies.

Each PI will be responsible for collaborating on common research 
designs or protocols, including methods and requirements for joint 
participation and collaboration as recommended by the SC, and handling 
of data, including appropriate sharing of methods and data among 
collaborating organizations. 

Each PI will be responsible for acquiring, processing and performing 
the initial evaluation of HTB specimens for studies approved by the SC.

Each PI will develop procedures for study monitoring to assure 
compliance with protocol designs and protection of patients from 
research risk.  

Each PI will assume responsibility for managing their laboratory’s 
participation in collaborative projects approved by the SC. 

Each PI will monitor and maintain appropriate records for protocols, 
informed consents, assurances, and annual certifications of 
Institutional Review Board (IRB) review and approval (OMB No. 0990-
0263, "Protection of Human Subjects, Assurance Identification/IRB 
Certification/Declaration of Exemption, (Common Rule) 
"http://www.hhs.gov/ohrp/humansubjects/assurance/OF310.rtf”). 

Each PI will assume responsibility and accountability to the applicant 
organization officials and to the NIDCD for the performance and proper 
conduct of the research supported by the U24 in accordance with the 
terms and conditions of the award. 

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

B.  NIDCD Extramural Staff Responsibilities 

The NIDCD Program Coordinator will have 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 Program Coordinator will convene the initial meeting of the SC, 
have voting membership on the SC, and, as determined by that committee, 
its subcommittees. 

Although the PI will have lead responsibilities in all collaborative 
tasks and activities, it is anticipated that the NIDCD Program 
Coordinator will have lead responsibilities in managing and sharing the 
broad programmatic issues among awardees.

An NIDCD Program Official will also be responsible for normal 
programmatic stewardship and monitoring of the awards.  The NIDCD 
Program Official may serve as 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; a 
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.
 
C. Collaborative Responsibilities

1. 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. 

The SC will be composed of the PI from each awardee institution and the 
NIDCD Program Coordinator. Each member will have one vote.  The Chair 
(non-NIH person) will be selected by the SC. The institution of the SC 
Chair serves as the Headquarters of the Consortium. The SC Chair can be 
any Principal Investigator (PI) involved in the Consortium. The SC 
Chair serves as the PI of the Headquarters and implements the 
scientific, operational, and organizational policies of the Consortium. 
The Headquarters provides the executive leadership and scientific 
coordination for the Consortium. It serves as a center for information 
dissemination among the Consortium PIs, the CCC, the Registry and the 
NIDCD. The Headquarters manages the logistics of the SC meetings and 
Consortium workshops/symposia.

1. After all the Consortium awardees have been funded, the SC will 
convene.  Thereafter, the SC will meet twice yearly. Responsibilities 
of the SC include but are not limited to:

o developing and refining a common protocol (or protocols) for HTB 
acquisition, processing and initial evaluation;

o developing collaborative policies and procedures, including 
publication policies;

o developing policies and procedures for maintaining liaison and 
sharing data with the Registry;

o developing policies and procedures for reviewing changes in projects 
not showing promise; and,

o developing standards or “decision criteria” for pursuing techniques 
for further study.

2. The SC will review HTB accrual, protocol compliance, results of 
audits, and regulatory requirements at the participating laboratories 
and formally report the results of its reviews to the NIDCD. 

3. The SC will promote and foster the inclusion of women and ethnic 
minorities in clinical studies and assure the completeness of informed 
consent. 

4. The SC will track collaborative research progress and assure that 
the results are published in peer-reviewed journals in a timely manner 
and in accordance with established publication policies.  

5. The SC will discuss, develop and implement collaborative projects to 
be pursued jointly.

6. Collaborative studies/protocols will be approved by the SC. Data 
will be submitted to the Headquarters. The SC will define the rules 
regarding access to data and publications consistent with NIDCD 
policies. 

8. The SC will plan 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 collaboration. The Consortium 
Consulting Committee and the NIDCD Program Coordinator will provide the 
SC with advice on participants for the workshops and symposia. The 
Headquarters will manage the logistics for these meetings. 

2. Consortium Consulting Committee (CCC):

1. Established by the NIDCD, the CCC advises the SC on relevant 
scientific issues, including study design, prioritization of technique 
development, and the development of collaborative study protocols. 

2. The membership of the CCC and duration of service will be 
established by the NIDCD in consultation with the SC.  The membership 
includes researchers/institutions not participating in the Consortium.  
The CCC will include molecular biologists, pathologists, and temporal 
bone researchers.  

3. The Chair of the CCC is elected by its members.  The Chair of the SC 
also serves as an ad hoc member of this advisory committee.  The NIDCD 
is represented by relevant program staff, which will be responsible for 
meeting logistics. 

4. The CCC advises the NIDCD on the progress and success of the 
Consortium against the criteria developed by the SC.

5. The CCC helps the NIDCD in site visits to the participating 
institutions, as necessary. 

6. The CCC collaborates with the SC to suggest participants for and to 
assist in the implementation of workshops and symposia and to provide 
liaison between the human temporal bone research community and the 
Consortium.

7. The CCC will meet at least once yearly in the Bethesda, MD area.

D. Arbitration
 
A panel will be formed to review any scientific or programmatic 
disagreement (within the scope of the U24 award) between the award 
recipients and the NIDCD.  The panel will be composed of three members: 
one selected by the SC (with the NIDCD Program Coordinator not voting); 
a second member selected by the NIDCD; and, the third member selected 
by the two prior selected members.  Any disagreement that may arise on 
scientific/programmatic matters (within the scope of the award) between 
award recipients and the NIDCD may be brought to arbitration. 

This special arbitration procedure in no way affects the awardee's 
right to appeal an adverse action that is otherwise appealable in 
accordance with the PHS regulations at 42 CFR Part 50, Subpart D and 
HHS regulation at 45 CFR Part 16.

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA 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:

o Direct your questions about scientific/research issues to:

A. Julianna Gulya, MD
Division of Scientific Programs
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400D-7
MSC 7180
Bethesda, MD  20892-7180
Telephone:  (301) 435-4085
FAX: (301) 402-6251
Email: julie_gulya@nih.gov

o Direct your questions about peer review issues to:

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: s8k@cu.nih.gov 

o Direct your questions about financial or grants management matters 
to:

Chief, Grants Management Branch
Division of Extramural Research
National Institute on Deafness and Other Communication Disorders 
6120 Executive Boulevard, Room 400B
MSC-7180
Bethesda, MD  20892-7180
Telephone:  (301) 402-0909
FAX:  (301) 402-1758
Email: stones@nidcd.nih.gov

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

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this RFA 

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 NIDCD 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:

A. Julianna Gulya, MD
Division of Scientific Programs
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400D-7
MSC 7180
Bethesda, MD  20892-7180
Telephone:  (301) 435-4085
FAX: (301) 402-6251
Email: julie_gulya@nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001). Applications must 
have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) 
number as the Universal Identifier when applying for Federal grants or 
cooperative agreements. The DUNS number can be obtained by calling 
(866) 705-5711 or through the web site at 
http://www.dunandbradstreet.com/. The DUNS number should be entered on 
line 11 of the face page of the PHS 398 form. The PHS 398 document is 
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in 
an interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

SUPPLEMENTARY INSTRUCTIONS (please also refer to “SPECIAL REQUIREMENTS” 
listed above)

Special Instructions for Preparation of the Application

1. COMPLIANCE WITH TERMS OF THE CONSORTIUM COOPERATIVE AGREEMENT

In a separate, labeled section, specific issues related to the 
cooperative agreement must be addressed. 

Applicants must include their specific plans for responding to the 
“Cooperative Agreement Terms and Conditions of Award” section. 
Applicants should 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 SC and be bound 
by its decisions, and to share data and research resources with each 
other and the NIDCD. Successful applicants will be expected to submit 
information on specimen collections to the Registry (through the 
Headquarters).

At the end of this section, applicants must append a letter from the 
applicant institution describing how that institution intends to meet 
the NIH policies for sharing of data or why data sharing is not 
possible. In this regard, attention is drawn to the NIH Final Statement 
on Sharing Research Data 
(http://grants.nih.gov/grants/policy/data_sharing/index.htm and 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html), 
which was published in the NIH Guide on February 26, 2003. This is an 
extension of NIH policy on sharing research resources, and reaffirms 
NIH support for the concept of data sharing. The new policy became 
effective with the October 1, 2003 receipt date for applications or 
proposals to NIH.  

Applicants to this RFA must also include a research tools and resources 
sharing plan in the letter to be appended to this section.  
Investigators conducting biomedical research frequently develop unique 
research resources.  The policy of the NIH is to make available to the 
public the results and accomplishments of the activities that it funds. 
NIH recognizes that certain research activities may result in 
inventions and that grantees are entitled to protect such inventions 
through patenting and licensing activities in accordance with the Bayh-
Dole Act, 35 USC § 200 et seq. and the implementing regulations, 37 CFR 
Part 401 (“Bayh-Dole Act”). However, the Consortium’s mission of 
collaboration among Consortium members and between Consortium members 
and the larger community of researchers necessarily anticipates the 
sharing of intellectual property arising out of research resources 
developed in Consortium-related activities.  To address the interest in 
assuring that research resources are accessible, NIH expects applicants 
who respond to this RFA to submit plans (1) for sharing the unique 
research resources generated through the grant; and (2) for addressing 
how they will exercise intellectual property rights, should any be 
generated through this grant, while making such research resources 
available to the broader scientific community.

The sharing of research resources and intellectual property plans must 
make unique research resources readily available for research purposes 
to qualified individuals within the scientific community in accordance 
with the NIH Grants Policy Statement 
(http://grants.nih.gov/grants/policy/nihgps/) and the Principles and 
Guidelines for Recipients of NIH Research Grants and Contracts on 
Obtaining and Disseminating Biomedical Research Resources: Final 
Notice, December 1999 
(http://www.ott.nih.gov/policy/rt_guide_final.html and 
http://ott.od.nih.gov/NewPages/64FR72090.pdf)(“NIH Research Tools 
Guidelines”).  
These documents define terms, parties, and responsibilities.  The 
documents also prescribe the order of disposition of rights, and a 
chronology of reporting requirements and delineate the basis for and 
extent of government actions to retain rights.  Patent rights clauses 
may be found at 37 CFR Part 401.14 and are accessible from the 
Interagency Edison web page, (http://www.iedison.gov); see also, 35 USC 
§ 210(c); Executive Order 12591, 52 FR 13414 (Apr. 10, 1987); and 
Memorandum on Government Patent Policy (Feb. 18, 1983). 

2. APPLICANTS FOR STUDY CHAIR

Applicants interested in serving as Chair of the Steering Committee 
should provide detailed documentation of their ability to provide 
executive leadership and scientific coordination. They should 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 CCC, the Registry, and the NIDCD.
 
3. BUDGET

1. Applicants must budget for travel and per diem expenses for 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 Steering Committee 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. 

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 CCC; only the applicant elected Chair will 
be awarded such budgeted funds. The use of these set aside 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”.

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 
5/2001) application form 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.
 
SENDING AN APPLICATION TO THE NIH: 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
Bethesda, MD  20817 (for express/courier service)
 
At the time of submission, two additional copies of the application and 
all copies of the appendix material must be sent to:

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
 
APPLICATION PROCESSING: Applications must be received on or before the 
application receipt date listed in the heading of this RFA.  If an 
application is received after that date, it will be returned to the 
applicant without review. 

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and 
funding assignment within 8 weeks.
 
The Center for Scientific Review (CSR) will not accept any application 
in response to this RFA 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 an RFA, it is to be prepared as a NEW 
application.  That is, the application for the RFA 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.  

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the NIDCD. Incomplete applications will not be 
reviewed. If the application is not responsive to the RFA it will be 
returned without review.

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 the NIDCD, in accordance with the review 
criteria stated below.  As part of the initial merit review, all 
applications will:

o Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications 
under review, may be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the National Deafness and Other 
Communication Disorders Advisory Council.   
 
REVIEW CRITERIA

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

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The application does not need to be strong in all categories to be 
judged likely to have major scientific impact and thus deserve a high 
priority score.  For example, an investigator may propose to carry out 
important work that by its nature is not innovative but is essential to 
move a field forward.

SIGNIFICANCE: Does the proposed work enhance research resources for 
HTBs?
 
APPROACH: Are the plans for developing, assessing and implementing a 
standardized protocol (or protocols) for HTB acquisition and processing 
adequately developed and appropriate to the aims of the Consortium? 
Does the applicant acknowledge potential problem areas and consider 
alternative tactics? Is the timeline for the proposed work reasonable?

Are organizational and administrative plans likely to lead to a well 
functioning, cohesive research group?

Are there adequate plans for effective interaction and collaboration 
with the Consortium components, the Steering Committee, the Consortium 
Consulting Committee, the Registry, and the NIDCD?

For applicants interested in serving as Steering Committee Chair: are 
there adequate plans for accomplishing the tasks of the SC Chair? Are 
the plans for information dissemination among the components of the 
Consortium, the Registry, the Consortium Consulting Committee and the 
NIDCD adequate? Are the plans for managing meeting logistics adequate?

INNOVATION: Will the project provide improved utility, methodologies, 
or knowledge to facilitate researcher use of HTBs?
 
INVESTIGATOR: Are the investigator and key personnel sufficiently 
knowledgeable, experienced and 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 
investigator propose the establishment of an appropriate 
multidisciplinary team?

For applicants interested in serving as Steering Committee Chair: Does 
the investigator demonstrate the requisite scientific, operational and 
organizational skills? 
 
ENVIRONMENT: Does the scientific environment in which the work will be 
done contribute to the probability of success? Does the proposed work 
take advantage of unique features of the scientific environment or 
employ useful collaborative arrangements? Is there evidence of 
institutional support?  

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 criteria 
included in the section on Federal Citations, below).
 
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.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria in the 
sections on Federal Citations, below).

ADDITIONAL REVIEW CONSIDERATIONS

PLAN FOR SHARING RESEARCH RESOURCES

The reviewers will provide an administrative comment evaluating the 
adequacy and feasibility of the resource sharing plan. Recommendations 
regarding such plans are at 
http://www.ott.nih.gov/policy/rt_guide_final.html. This comment will 
not affect the priority score of the proposal.  NIH staff will consider 
the adequacy of the plan in determining whether to recommend an 
application for award.  The sharing plan as approved, after negotiation 
with the applicant as necessary, will become a condition of the grant 
award.

BUDGET:  The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date: October 15, 2004
Application Receipt Date: November 15, 2004 
Peer Review Date: Feb/Mar 2005 
Council Review: May 2005
Earliest Anticipated Start Date: July 2005 

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
 
REQUIRED FEDERAL CITATIONS 

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 

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.

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 - Amended, October, 2001," published in the NIH Guide 
for Grants and Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines are 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 RESEARCH INVOLVING HUMAN 
SUBJECTS: The NIH maintains a policy that children (i.e., individuals 
under the age of 21) must be included in all human subjects 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 proposals for 
research involving human subjects.  You will find this policy 
announcement in the NIH Guide for Grants and Contracts Announcement, 
dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

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 RFA 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 RFA is related to one or more of the priority areas. 
Potential applicants may obtain a copy of "Healthy People 2010" at 
http://www.healthypeople.gov/.

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

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

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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