CELLULAR REPAIR STUDIES OF THE AUDITORY AND VESTIBULAR SYSTEMS
 
RELEASE DATE:  June 6, 2002
 
RFA:  DC-02-003
 
National Institute on Deafness and Other Communication Disorders
 (http://www.nidcd.nih.gov/)
 
LETTER OF INTENT RECEIPT DATE:  July 10, 2002

APPLICATION RECEIPT DATE:  August 15, 2002
 
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 Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations:

PURPOSE OF THIS RFA 

The National Institute on Deafness and Other Communication Disorders is 
committed to the treatment and elucidation of molecular mechanisms 
involved in human deafness and balance disorders. The primary cause of 
sensorineural hearing loss and impaired vestibular function results 
from damage and loss of auditory and vestibular sensory hair cells of 
the inner ear.  Current clinical treatments are limited to the use of 
devices, hearing aids and cochlear implants, not the repair of the  
sensory cells.

Irreparable loss of sensory hair cells can result from numerous factors 
including disease, aminoglycoside antibiotics, noise, and aging. In 
lower vertebrates hair cells are capable of regeneration following 
damage, but in mammals this capacity is absent.  Recent advances in 
stem cell biology research, especially as related to tissue and 
cellular repair, hold great promise for the eventual treatment of 
hearing and balance disorders.  The purpose of this RFA is to support 
fundamental stem cell biology research for repair, regeneration, and 
cell lineage delineation, as applied to the auditory and vestibular 
systems.
 
RESEARCH OBJECTIVES
 
The auditory and vestibular neuroepithelia are critical to the 
functional processes of hearing and balance.  The hair cells residing 
in the cochlea are responsible for sound transduction, and the hair 
cells of the semicircular canals and otholithic organs are responsible 
for sensing rotational and linear acceleration forces of the head.  The 
loss of these hair cells in mammals leads to the irreparable loss of 
hearing and vestibular mediated balance function.  

Two contributing research avenues that could impact cellular 
restoration of hearing and balance function are hair cell regeneration 
and development.  Regenerative studies have consisted primarily of 
comparative analyses between the regenerative ability of avian systems 
versus the lack of regenerative ability in mammals.  Avian hair cell 
regeneration involves the up-regulation of cell proliferation and 
differentiation of postmitotic cells, whereas mammalian auditory and 
vestibular organs show little evidence of terminal hair cell 
differentiation from postmitotic cells.  These renewing processes in 
the avian system result in repopulation of hair cells and full 
restoration of hearing and balance function.  While understanding the 
biological processes of avian renewal is important, there is 
insufficient data to determine the clinical value to humans.  

Auditory and vestibular developmental studies have revealed an 
exceptionally elegant and complex system.  The eventual formation of 
the inner ear involves the convergence and contribution of the 
epithelium, mesenchymal, mesodermal and neural crest cell layers.  
Specifically, the invagination of the placodal ectoderm leads to the 
formation of the otic placode, eventually giving rise to a defined base 
of auditory and vestibular sensory hair cells and non-sensory support 
cells.  This process occurs early in embryonic development and once a 
full complement of hair and support cells is established, division of 
the precursor cells cease.  Elucidation of the putative progenitors and 
the molecular factors that impact these differentiation and 
regenerative events will be crucial to defining cell lineage in the 
auditory and vestibular organs.  

The self-renewal and plasticity characteristics intrinsic to the stem 
cell hold the promise of significant clinical application, and stem 
cell research in regenerative and reparative therapy provides new 
avenues of auditory and vestibular research exploration.  To date, stem 
cell populations have been identified from almost all normal tissues 
including mesenchymal, peripheral and cord blood, neuronal and muscle, 
and offer numerous possibilities for putative regenerative 
capabilities.  Knowledge acquired from these other systems may be 
biologically relevant to the auditory and vestibular systems.  
Similarly, research information acquired from the auditory and 
vestibular environment may have reparative relevance for other tissue 
and organ systems.  At the core, many fundamental questions exist:  
factors determining a cell's multipotency that allow replenishing 
capabilities;  mechanisms and factors regulating de-differentiation and 
trans-differentiation into a multipotent cell;  factors and molecules 
involved in the interaction and integration of a newly transplanted 
cell and the microenvironment.  Eventually, these questions should be 
addressed for every tissue type and organ system to realize the full 
potential of stem cell biology therapy.

Objectives and Scope

The potential translational application of stem cell biology research 
to the auditory and vestibular systems is the focus of this initiative.  
Research efforts on the cellular, molecular and genetic mechanisms that 
influence the lineage choices of stem cells relevant to the auditory 
and vestibular systems are of high importance.  Research areas of great 
interest include, but are not limited to: 

o  Identification of auditory and vestibular progenitor cells.  It is 
unclear if stem cells exist in the auditory and vestibular systems, and 
if hair cell generation involves "reserve" stem cells or 
dedifferentiation of other cells. The putative replenishing involvement 
of support cells in the generation of hair cells is also unknown.  
Identification studies of true stem cell progenitors versus products of 
trans-amplification are needed.  

o  Identification of auditory and vestibular cell specific markers.  In 
vivo and in vitro integration studies will require input cell 
validation, and should assess clonality. Identification of cell 
specific receptors, surface antigens etc., are needed.

o  Development and validation of physiological assays. Cells delivered 
to a test environment will have to demonstrate function that is 
critical for experimental validation.  Development of assays that 
permit accurate and reliable characterization of integrated stem or 
precursor cells in the auditory and vestibular systems is needed.

o Development of cell purification and expansion technologies.  
Ultimate use and therapeutic efficacy will be dependent upon the 
validation of cell source.  The auditory and vestibular organs, due to 
small size and limited accessibility, pose a difficult challenge to 
cell harvest and purification.  Development of novel technologies and 
methodologies to isolate and expand pure lines of putative progenitors 
are needed.

o  Cellular and molecular commonalities.  It is unknown if stem cells 
from other sources can be stimulated to differentiate into auditory 
and/or vestibular cells.  Stem cells harvested from various sources are 
currently being used successfully in other reparative systems and their 
use to replenish the auditory or vestibular systems should be 
investigated.

o Auditory and vestibular microenvironment.  There is a need to 
elucidate developmental and signaling pathways to identify 
combinatorial effects between putative progenitor cell markers and the 
surrounding cellular environment.  There is a need to identify agents, 
such as morphogens, feeder lines, and growth conditions that would 
allow propagation of auditory and vestibular progenitors in vivo or in 
vitro specifically for reparative assays.  

o  Vector and delivery systems.  Synthetically fabricated or 
biologically based support platforms are needed to allow propagation, 
delivery and integration of cell populations within the auditory and 
vestibular systems. The development of new and novel surgical 
approaches to deliver these systems into auditory and vestibular target 
environments is needed.      

o  Transplantation studies.  Feasibility studies are needed to explore 
cellular replacement within the auditory and vestibular systems.  
Identification and characterization of putative target areas for both 
hair cell regeneration and neural restoration is needed.

MECHANISM OF SUPPORT
 
This RFA will use the National Institutes of Health (NIH) R21 
EXPLORATORY/DEVELOPMENTAL GRANT) and R01 (INVESTIGATOR INITIATED 
RESEARCH GRANT) award mechanisms. Responsibility for the planning, 
direction, and execution of the proposed project will be solely that of 
the applicant. This RFA will have one submission date: August 15, 2002. 
Beyond this date, future unsolicited competing continuation applications 
will compete with all investigator-initiated applications and be 
reviewed according to the customary peer review procedures. The 
anticipated award date is April, 2003.  Investigators may submit more 
than one application for this RFA. 

Generally, applications proposing exploratory/feasibility studies with 
limited preliminary data should use the R21 mechanism, while applicants 
proposing more extensive projects based on significant published and 
preliminary results should use the RO1 mechanism.  In addition, 
applicants are strongly encouraged to contact the scientific Program 
Officer listed below under INQUIRIES to discuss which mechanisms (R21 
or RO1) would be most suitable for the proposed research project.

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

FUNDS AVAILABLE

The NIDCD intends to commit approximately $1,500,000 in FY 2003 to fund 
up to 3 to 5 new R21 and 3 to 5 new R01 grants in response to this RFA. 
Because of the exploratory nature of the R21, applicants submitting an 
R21 may only request a budget for direct costs of up to $100,000 per 
year for a maximum of two (2) years. R01 applicants may request a 
project period of up to five (5) 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. At this time, it is not known if this RFA will 
be reissued.
  
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 or foreign

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.   
 
SPECIAL REQUIREMENTS

Applications in response to this RFA with the intent to use human 
embryonic stem cells (hESC) must comply with federal guidelines.  A 
cover letter signed by the principal investigator, appropriate 
institutional official and business office, acknowledging review and 
approval of the grant application proposing human embryonic stem cell 
research must be included.  All applications must indicate the official 
identifier(s) for the appropriate hESC line(s) as found in the NIH 
Registry (http://escr.nih.gov/).  In addition, compliance to all of the 
federal guidelines must be satisfied.  These NIH guidelines are listed 
at, http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-049.html.  
Applications not including this information will be returned 
without further consideration.  Answers to frequently asked questions 
about hESC may be found at: 
http://grants.nih.gov/grants/stem_cell_faqs.htm

This announcement highly encourages collaboration between stem cell 
biologists and auditory/vestibular investigators.
 
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:

Dr. Nancy L. Freeman
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 
nancy_freeman@nih.gov
Tel:  (301) 402-3458
Fax: (301) 402-6251

o Direct your questions about peer REVIEW issues to:

Dr. Craig Jordan
Chief, Scientific Review 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: 301-402-8683
Fax:  301-402-6250
Email:  jordanc@nih.gov

o Direct inquires of FINANCIAL or grants management matters to:

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 
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 institute staff to estimate the potential 
review workload and plan the review.
 
The letter of intent is to be sent by July 10, 2002.  The letter of 
intent should be sent to:

Dr. Nancy L. Freeman
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 
nancy_freeman@nih.gov
Tel:  (301) 402-3458
Fax: (301) 402-6251

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001).  The PHS 398 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.
 
ADDITIONAL R21 APPLICATION PROCEDURES

All application instructions in the PHS 398 research grant application 
instructions and forms (rev. 5/2001) apply to the R21 with the exception 
of the following modifications: 

1. R21 applications may request up to four (4) $25,000 modules for a 
maximum direct cost of $100,000 per year for up to a maximum of two (2) 
years.

2. The Research Plan for the R21 application may not exceed 10 pages. 
Tables and Figures (color and black and white) must be included within 
the 10-page limit. However, to aid reviewers, additional original color 
figures should be included in the appendices if the data cannot be 
adequately evaluated when copied in black and white (see APPLICATION 
SUBMISSION.)
 
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS:

Applications 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 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-
by-step guidance for preparing modular grants.  Additional information 
on modular grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

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/label-bk.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 
appendix material must be sent to:

CHIEF, SCIENTIFIC REVIEW BRANCH 
DIVISION OF EXTRAMURAL RESEARCH 
NATIONAL INSTITUTE ON DEAFNESS AND 
OTHER COMMUNICATION DISORDERS 
6120 EXECUTIVE BOULEVARD, ROOM 400-C, MSC 7180 
BETHESDA, MD  20892-7180 
ROCKVILLE, MD  20852 (for express/courier service) 
 
APPLICATION PROCESSING: Applications must be received by 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.
 
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.  The CSR will not accept any application that is 
essentially the same as one already reviewed. This does not preclude 
the submission of substantial revisions of applications already 
reviewed, but such applications must include an Introduction addressing 
the previous critique.

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the NIDCD. Incomplete and non-responsive 
applications will be returned without further consideration.  

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 Receive a written critique
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, will be discussed and assigned a priority score
o Receive a second level review by the NDCD 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 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 
technologies?

(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, your 
application will also be reviewed with respect to the following:

o PROTECTIONS:  The adequacy of the proposed protection for humans, 
animals, or the environment, to the extent they may be adversely 
affected by the project proposed in the application.

o INCLUSION:  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 included in the section on Federal Citations, below)

o DATA SHARING:  The adequacy of the proposed plan to share data. 

o OTHER REVIEW CRITERIA:  RO1/R21 applications proposing the use of 
human embryonic stem cells will not be required to contain the same 
amount of pilot data as judged for a typical RO1/R21.  It is 
appreciated that this area of investigation is in the early stages of 
research development and assessment of pilot data will be reviewed 
accordingly, however, the application still must demonstrate the 
feasibility of the approach.

o 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:    July 10, 2002	
Application Receipt Date:         August 15, 2002	
Peer Review Date:                 November, 2002	
Council Review:                   January 2003	
Earliest Anticipated Start Date:  April 1, 2003		

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 

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 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 
(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. 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 
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.

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

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: 
The Office of Management and Budget (OMB) Circular A-110 has been 
revised to provide public access to research data through the Freedom of 
Information Act (FOIA) under some circumstances.  Data that are (1) 
first produced in a project that is supported in whole or in part with 
Federal funds and (2) cited publicly and officially by a Federal agency 
in support of an action that has the force and effect of law (i.e., a 
regulation) may be accessed through FOIA.  It is important for 
applicants to understand the basic scope of this amendment.  NIH has 
provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

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

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.health.gov/healthypeople.

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 http://grants.nih.gov/grants/policy/policy.htm and 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.

Return to Volume Index

Return to NIH Guide Main Index

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, RealPlayer, Video or Flash files, see Help Downloading Files.