RELEASE DATE:  July 9, 2003

PA NUMBER:  PA-03-151

March 2, 2006 (NOT-OD-06-046) – Effective with the June 1, 2006 submission date, 
all R03, R21, R33 and R34 applications must be submitted through using 
the electronic SF424 (R&R) application. This announcement will stay active for 
only the May 1, 2006 AIDS and AIDS-related application submission date for these 
mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms 
expires on the date indicated below. Other mechanisms relating to this announcement 
will continue to be accepted using paper PHS 398 applications until the stated 
expiration date below, or transition to electronic application submission. 
A replacement R21 (PA-06-366) funding opportunity announcement has been issued 
for the submission date of June 1, 2006 and submission dates for AIDS and 
non-AIDS applications thereafter.

EXPIRATION DATE for R21 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R21 AIDS and AIDS-Related Applications: May 2, 2006
EXPIRATION DATE for All R01 Applications: June 13, 2006 
National Institute on Deafness and Other Communication Disorders (NIDCD)


o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support 
o Eligible Institutions
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations


This serves as an initial program announcement of the National Institute on 
Deafness and Other Communication Disorders (NIDCD) to expand support of 
proteomic research in the auditory system.  This announcement seeks to 
promote the use of proteomic technologies to investigate the molecular and 
cellular mechanisms of normal/abnormal auditory development, and maintenance, 
as well as specific disease states of hearing tissues and sensory organs.  
The utilization, development and improvement of innovative proteomic 
technologies to address these issues are encouraged through applications 
relevant to these biological areas.  


High throughput technologies with the singular goal of acquiring the most 
inclusive collection of representative genomic sequence, transcript, and/or 
protein, is the current view of biomedical research. Data sets of transcript 
and protein expression provide investigators a comprehensive cellular 
snapshot of existing proteins of a given protein complex, cell type, tissue 
and environmental condition.  While both sequence and transcript profiling 
have made significant advances in their technologies and utilization, there 
remains a need to comprehensively catalog protein content within many 
important cell types and tissues of the auditory sensory system.

The molecular exploration of hearing has identified an exquisite array of 
developing sensory organs and tissues.  The identification of genes and the 
regulation of their corresponding proteins are important to normal and 
abnormal developmental processes, genetic disorders and environmental noise 
trauma.  Numerous cell types, and their substructures, unique to the inner 
ear, such as hair cells, Deiters, Hensen, Claudius', interdental, and 
marginal/dark cells, have been virtually unexplored from a proteomic 
perspective.  Additionally, middle ear infections (otitis media) and other 
diseases of the auditory system such as otosclerosis and cholesteatoma, pose 
important clinical challenges involving the identification of causative 
extrinsic factors, infectious organisms and the complexity of host response.  
Microarrays and other transcript sensing technologies have been used 
successfully to increase the number of candidate genes, but clearly there 
remain interpretive limitations to the correlative protein function. These 
assays bypass and/or inadequately address such substantial issues of post-
translational modifications, turnover, and alternately spliced transcripts.  

Proteomic approaches have become increasingly successful and gaining utility 
for studying complex biological problems relevant to the auditory system.  
Technologies using tandemly coupled two-dimensional (2-DE) gel 
electrophoresis and mass spectrometry (MS) for protein peptide identification 
(PMF-peptide mass fingerprinting) combined with the differentially isotopic 
labeling of protein allows profile comparisons between two different cellular 
states (e.g. disease versus non-disease).  There are numerous variations of 
protein separation matrices as well as dispersion and analysis, e.g. ESI/HPLC, 
ESI-TOF/ ESI-MS/MS, MALDI-TOF, etc., and the designation of use is often 
preferenced by the biological parameters of the sample.  Other types of high 
throughput assays, such as cell biochips encompassing both antigen and 
antibody based arrays, yeast two-hybrid systems, co-immunoprecipitations, 
used in combination with 2-DE/MS/PMF (or other) followed by bioinformatical 
analysis allow even further specialized approaches of biopolymer 
identification for both proteomic and subproteomic data.  The attempt to 
generate a comprehensive proteome atlas has limitations with regard to 
sensitivity and detection, as well as, sufficient material acquisition; 
improvements have increased measurements from picomoles, to femtomoles, with 
some reports of attomole measurements allowing smaller sample sizes to be 
accurately measured. 

Proteomic roadmaps display the complex interactiveness of signal transduction 
pathways and the interconnectedness of protein associations.  They will 
provide the working protein profiles that identify the numerous interolog 
relationships of a given interactome, and allow comparison of protein species 
in a comprehensive manner.  There will continue to be the need for improved 
technologies and novel proteomic approaches that enhance sensitivity and 
increase comprehensiveness. These technological developments would be of 
particular interest when accomplished through projects directed at 
understanding or solving problems related to cells, organs and/or diseases of 
the auditory system.

The following examples are not meant to be comprehensive or restrictive, but 
rather represent projects relevant to the NIDCD hearing mission. Examples of 
projects responsive to this PA include but are not limited to:

o Proteomic analysis of specific cell types of the inner ear and/or their 
subcellular structures

o Proteomic analysis of specific otocyst cell/tissue types through a variety 
of developing stages

o Comparative analysis between proteome and transcriptome of a defined 
auditory cell and/or tissue type; comparative determination between proteomic 
and transcriptome results

o Comparative analysis of infection state in middle ear tissue, cell type, in 
response to invasion with otitis media pathogens; comparative proteomic 
analysis of infectious pathogens involved in middle ear infections upon 
biofilm or infection stimulus

o Proteomic analysis of auditory genetic disorders, environmental noise or 
drug trauma; biological and/or clinical in design

o Proteomic analysis of purified and/or in vitro propagated cultures of 
putative auditory progenitor cells

o Use of proteomic approaches to study the signal transduction networks 
related to transcription factors, cell surface receptors, growth factors, and 
other biomarkers relevant to auditory development

o Proteomic identification of novel signaling molecules and pathways involved 
in cell development, differentiation, communication, function and destruction, 
as applied to auditory signaling processes

o Development of novel proteomic bioinformatics as related to annotating 
genomic and protein sequence information for auditory function


This PA will use the NIH R01 and R21 
( award 
mechanisms. As an applicant, you will be solely responsible for 
planning, directing, and executing the proposed project.

This PA uses just-in-time concepts.  It also uses the modular as well 
as the non-modular budgeting formats (see Specifically, 
if you are submitting an application with direct costs in each year of 
$250,000 or less, use the modular format.  Otherwise follow the 
instructions for non-modular research grant applications.  This program 
does not require cost sharing as defined in the current NIH Grants 
Policy Statement at


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 or foreign
o Faith-based or community-based organizations  


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.


Inquiries concerning this PA are strongly recommended to discuss scientific 
issues with potential applicants.  Inquiries may fall into two areas:  
scientific/research, and financial/grants management issues:

o Direct your questions about scientific/research issues to:

Nancy L. Freeman, Ph.D.  
Scientific Program Director  
National Institutes of Health  
National Institute on Deafness and Other Communication Disorders  
Executive Plaza South-400C  
6120 Executive Blvd. MSC-7180  
Bethesda, MD 20892-7180  
Tel: (301) 402-3458  
Fax: (301) 402-6251

o Direct your questions about financial/grants management matters relevant 

Ms. Sara Stone 
Chief, Grants Management Branch 
Division of Extramural Research
National Institutes of Health
National Institute on Deafness and Other Communication Disorders
Executive Plaza South-400C
6120 Executive Blvd.  MSC-7180
Bethesda, MD  20892-7180 
Telephone:  (301) 402-0909 
Fax:  (301) 402-1758 


Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001).  The PHS 398 is 
available at in 
an interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 710-0267, Email:

APPLICATION RECEIPT DATES: Applications submitted in response to this 
program announcement will be accepted at the standard application 
deadlines, which are available at  Application deadlines are also 
indicated in the PHS 398 application kit.

instructions outlined in the PHS 398 application kit are to be followed, 
with the following requirements for R21 applications

1.  R21 applications will use the "MODULAR GRANT" and "JUST-IN-TIME" 
concepts, with direct costs of up $275,000 for the two year period.  
For example, the applicant may request $100,000 in the first year and 
$175,000 in the second year.  The request should be tailored to the 
needs of the project.  Normally, no more than $200,000 may be requested 
in any single year.  

2.  Although preliminary data are not required for an R21 application, 
they may be included.

3.  Sections a-d of the Research Plan of the R21 application may not 
exceed 15 pages, including tables and figures.  

4.  R21 appendix materials should be limited, as is consistent with the 
exploratory nature of the R21 mechanism, and should not be used to 
circumvent the page limit for the research plan.   Copies of appendix 
material will only be provided to the primary reviewers of the 
application and will not be reproduced for wider distribution.  The 
following materials may be included in the appendix:

o Up to five publications, including manuscripts (submitted or accepted 
for publication), abstracts, patents, or other printed materials 
directly relevant to the project.  These may be stapled as sets.

o Surveys, questionnaires, data collection instruments, and clinical 
protocols.  These may be stapled as sets.

o Original glossy photographs or color images of gels, micrographs, 
etc., provided that a photocopy (may be reduced in size) is also 
included within the 15 page limit of items a-d of the research plan

requesting up to $250,000 per year in direct costs must be submitted in 
a modular grant format.  The modular grant format simplifies the 
preparation of the budget in these applications by limiting the level 
of budgetary detail.  Applicants request direct costs in $25,000 
modules.  Section C of the research grant application instructions for 
the PHS 398 (rev. 5/2001) at includes step-
by-step guidance for preparing modular grants.  Additional information 
on modular grants is available at

YEAR: Applications requesting $500,000 or more in direct costs for any 
year must include a cover letter identifying the NIH staff member 
within one of NIH institutes or centers who has agreed to accept 
assignment of the application.   

Applicants requesting more than $500,000 must carry out the following 

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

2) Obtain agreement from the IC staff that the IC will accept your 
application for consideration for award; and,
3) Identify, in a cover letter sent with the application, the staff 
member and IC who agreed to accept assignment of the application.  

This policy applies to all investigator-initiated new (type 1), 
competing continuation (type 2), competing supplement, or any amended 
or revised version of these grant application types. Additional 
information on this policy is available in the NIH Guide for Grants and 
Contracts, October 19, 2001 at


Submit a signed, typewritten original of the application, including the 
checklist, and five 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)

the number of this announcement, PA-03-151, must be typed on line 2 of the 
face page of the application form and the YES box must be marked.

APPLICATION PROCESSING: Applications must be mailed on or before the 
receipt dates described at  
The CSR will not accept any application in response to this PA that is 
essentially the same as one currently pending initial review unless the 
applicant withdraws the pending application.  The CSR will not accept 
any application that is essentially the same as one already reviewed.  
This does not preclude the submission of a substantial revision of an 
application already reviewed, but such application must include an 
Introduction addressing the previous critique.  

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


Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review 
group convened in accordance with the standard NIH peer review 
procedures ( will evaluate 
applications for scientific and technical merit.  

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

o Receive a written critique

o Undergo a selection process in which only those applications deemed 
to have the highest scientific merit, generally the top half of 
applications under review, will be discussed and assigned a priority 

o Receive a second level review by the National Deafness and 
Communication Disorders Advisory Council.


The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  
In the written comments, reviewers will be asked to discuss the 
following aspects of your application in order to judge the likelihood 
that the proposed research will have a substantial impact on the 
pursuit of these goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these 
criteria in assigning your application's overall score, weighting them 
as appropriate for each application.  Your 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, 
you may propose to carry out important work that by its nature is not 
innovative but is essential to move a field forward.

(1) SIGNIFICANCE:  Does your study address an important problem? If the 
aims of your application are achieved, how do they advance scientific 
knowledge?  What will be the effect of these studies on the concepts or 
methods that drive this field?

(2) APPROACH:  Are the conceptual framework, design, methods, and 
analyses adequately developed, well integrated, and appropriate to the 
aims of the project?  Do you acknowledge potential problem areas and 
consider alternative tactics?

(3) INNOVATION:  Does your project employ novel concepts, approaches or 
methods? Are the aims original and innovative?  Does your project 
challenge existing paradigms or develop new methodologies or 

(4) INVESTIGATOR: Are you appropriately trained and well suited to 
carry out this work?  Is the work proposed appropriate to your 
experience level as the principal investigator and to that of other 
researchers (if any)?

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

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

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).
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 Inclusion Criteria 
in the sections on Federal Citations, below).

are to be used in the project, the five items described under Section f 
of the PHS 398 research grant application instructions (rev. 5/2001) 
will be assessed.  

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


Applications submitted in response to a PA will compete for available 
funds with all other recommended applications.  The following will be 
considered in making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities


components involving Phase I and II clinical trials must include 
provisions for assessment of patient eligibility and status, rigorous 
data management, quality assurance, and auditing procedures.  In 
addition, it is NIH policy that all clinical trials require data and 
safety monitoring, with the method and degree of monitoring being 
commensurate with the risks (NIH Policy for Data Safety and Monitoring, 
NIH Guide for Grants and Contracts, June 12, 1998:  

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 

All investigators proposing clinical research should read the AMENDMENT 
"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 
a complete copy of the updated Guidelines are available at
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.

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. This policy applies to all initial 
(Type 1) applications submitted for receipt dates after October 1, 1998.

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 

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

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of 
research on hESCs can be found at and at  
Only research using hESC lines that are registered in the NIH Human 
Embryonic Stem Cell Registry will be eligible for Federal funding (see  It is the responsibility of the applicant to 
provide the official NIH identifier(s) for the hESC line(s) to be used 
in the proposed research.  Applications that do not provide this 
information will be returned without review. 

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

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application 
should include a description of the archiving plan in the study design 
and include information about this in the budget justification section 
of the application. In addition, applicants should think about how to 
structure informed consent statements and other human subjects 
procedures given the potential for wider use of data collected under 
this award.

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). 
Those who must comply with the Privacy Rule (classified under the Rule 
as "covered entities") must do so by April 14, 2003  (with the 
exception of small health plans which have an extra year to comply).  

Decisions about applicability and implementation of the Privacy Rule 
reside with the researcher and his/her institution. The OCR website 
( 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

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

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance No. 93.173 and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or 
Health Systems Agency review. Awards are made under authorization of 
Sections 301 and 405 of the Public Health Service Act as amended (42 
USC 241 and 284) and administered under NIH grants policies described 
at under Federal 
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.

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) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
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