SPECIALIZED CENTERS FOR ORAL, DENTAL and CRANIOFACIAL RESEARCH

RELEASE DATE:  April 21, 2003
 
RFA Number:  DE-04-006  
 
National Institute of Dental and Craniofacial Research (NIDCR)
 (http://www.nidcr.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER:  93.121
 
LETTER OF INTENT RECEIPT DATE:  November 15, 2003

APPLICATION RECEIPT DATE:  December 16, 2003  
 
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 of Dental and Craniofacial Research (NIDCR) 
invites applications for Specialized Centers for Oral, Dental and 
Craniofacial Research.  These Specialized Centers will replace the 
currently existing Comprehensive Oral Health Research Centers of 
Discovery (COHRCDs) supported by the NIDCR. While the COHRCDs have 
been, and continue to be, effective, the required scope of activities 
has somewhat restricted in depth exploration of certain aspects of the 
selected themes.  With the completion of the Human Genome Project and 
the rapidly escalating development of new sensitive high-throughput 
technologies, it is timely for the NIDCR to concentrate on contemporary 
approaches to areas critical to its mission.  Through the establishment 
of Specialized Centers, emphasis will be placed on four areas: 
craniofacial biology, orofacial pain, oral infectious diseases (with 
the exclusion of HIV infections and the systemic consequences of oral 
infection), and salivary gland biology including Sjögren's syndrome.  
The Centers will focus on basic research associated with any aspect 
(except as noted) of these four areas and must be comprised of highly 
integrated multidisciplinary projects.
 
RESEARCH OBJECTIVES

It is becoming increasingly apparent that novel solutions to biomedical 
problems may best be met by the combined efforts of individuals with 
diverse scientific backgrounds.  The Specialized Center mechanism 
provides an opportunity to apply this concept to the in depth 
exploration of various aspects of craniofacial biology, orofacial pain, 
oral infectious diseases and salivary gland biology including Sjögren's 
syndrome.  Regardless of the selected topic, each Center must be 
composed of a minimum of three tightly integrated basic science 
projects and any appropriate cores.  Although clinical samples may be 
used for the basic research projects, Phase I, Phase II or Phase III 
clinical trials are excluded.  Each project in each multidisciplinary 
Center will be expected to utilize state of the art approaches such as 
genomics, proteomics, biomimetics, tissue engineering, utilization of 
stem cells, systems/computational biology, bioimaging to interrogate 
biological events in real time, etc.  It is anticipated that the 
establishment of these centers will provide new insights into the 
identification of targets for the prevention, diagnosis and 
intervention of the diseases and disorders related to the four selected 
areas.  In addition, each Center is expected to provide an excellent 
environment for training of graduate students, postdoctoral fellows and 
other health professionals. 

Craniofacial Biology 

Craniofacial and dental defects account for the majority of birth 
defects in infants born in the United States and result in an 
overwhelming financial and social burden. Cleft lip, cleft palate, 
ectodermal dysplasia, craniosynostosis, tooth agenesis, dentinogenesis 
imperfecta, amelogenesis imperfecta, dentin dysplasia, 
hypophosphatasia, holoproencephaly and hemifacial microsomia are some 
of the consequences of abnormal craniofacial and/or tooth development.  
While significant advances have been made in identifying the genetic 
aberrations that result in a number of these defects, there is a major 
need for further studies that clearly define their genetic basis. This 
is particularly true of disorders attributable to multiple 
susceptibility genes.  In addition, investigations are also essential 
to elucidate the mechanisms by which relevant gene products function in 
normal craniofacial and tooth development.  Centers in this scientific 
area could include topics such as:

o Identification of genes, gene function and protein networks involved 
in normal craniofacial and tooth development;

o Identification of aberrations in primary and regulatory genes and 
networks involved in the induction of craniofacial and tooth 
abnormalities;

o Development of novel animal models of craniofacial and tooth 
disorders; and

o Application of biomimetics, tissue engineering and/or the use of stem 
cells for the restoration/regeneration of craniofacial and tooth 
anomalies.

Orofacial Pain

The amelioration of both acute and chronic orofacial pain remains a 
major public health issue.  Chronic pain is a disorder of the nervous 
system that persists for months or years and cannot be fully relieved 
by standard pain medications.  This neuropathic pain can be initiated 
by nerve injury or by persistent inflammation in the target tissue or 
along the nerve.  Orofacial pain can be sufficiently severe to restrict 
not only such vital functions as talking, chewing, and swallowing but 
may force affected individuals to sacrifice their professions and 
social interactions.  Among the more common of these conditions are 
trigeminal neuralgia and pain associated with temporomandibular muscle 
and joint disorders.  The pathophysiology of these disorders is poorly 
defined.  As a result, the development of rational therapeutic 
modalities has been significantly hindered. Centers focusing on 
orofacial pain might incorporate such topics as:

o Transduction and processing of nociceptive stimuli by peripheral 
nerves and the central nervous system;

o Identification of novel nociceptors and their modulation;

o Identification and functional studies of neurotransmitters, 
neuromodulators and intracellular messengers involved in orofacial 
pain;
 
o Identification of gene and protein networks implicated in the 
initiation and persistence of orofacial pain;

o Modulation of neurogenic inflammation;

o Application of pharmacogenomic approaches to determine responsiveness 
to therapeutic agents;

o Utilization of bioimaging for real-time interrogation of biological 
events; and

o Development of improved model systems for investigation of orofacial 
pain processing mechanisms and phenotypic characteristics of pain. 

Oral Infectious Diseases

Infectious diseases of the oral cavity (caries and periodontal 
diseases) continue to be significant public health burdens.  Dental 
caries is the most common chronic infectious disease in the United 
States and is most prevalent in certain populations including children, 
the economically disadvantaged and the elderly.  Periodontal diseases 
result in the destruction of the tissues that surround and support the 
teeth and the severity of these diseases increases with age. While oral 
microorganisms are the etiologic agents for periodontal diseases, the 
deleterious inflammation of the oral tissues that ultimately leads to 
tooth loss is largely attributable to responses of the host to these 
microbes.  In both caries and periodontal diseases, highly organized 
biofilms serve as reservoirs for the causative microorganisms.  Not 
only are complex interactions involved in the adhesion of microbes to 
other microbes in these biofilms, but also in the adhesion of oral 
microbes to host tissues.  Although periodontitis has been implicated 
in such systemic disorders as stroke, atherosclerosis, diabetes and the 
birth of pre-term low birth weight infants, it is not the intent of 
these Centers to explore these associations.  Rather, the emphasis is 
to be placed on the oral complications of these infectious processes.  
However, oral tissues, cells, etc. from individuals with these 
disorders could be utilized to investigate the influence of these 
disorders on oral manifestations of microbial infections.  Centers in 
this scientific area could address topics such as:

o Determination of genetic diversity among members of different oral 
microbial species;  
 
o Genomic and proteomic approaches to identify the mechanisms 
implicated in colonization and production of virulence factors;

o Development of state of the art technologies for the early detection 
of caries, evaluation of dental erosion in caries, and determination of 
remineralization of teeth;

o Development of genetic based markers for caries activity and 
susceptibility;

o Elucidation of the microbial initiated mechanisms involved in soft 
tissue and bone destruction (microbe-host cell communication, cell 
signaling, production of mediators, apoptosis, etc.);

o Delineation of the mechanisms by which oral microbes evade the host 
innate and acquired immune responses;

o Studies on transmission of genetic information between oral microbes 
and the relationship of this event to pathogenesis; 

o Development of genetic based markers for early and progressive 
periodontal disease;

o Identification of novel therapeutic targets in caries and periodontal 
disease; and

o Development of novel approaches to dysregulate plaque formation and 
maturation.

Salivary Gland Biology and Sjögren's Syndrome

Saliva provides primary protection of the mouth and upper 
gastrointestinal tract. Perturbations of salivary secretory mechanisms 
can consequently lead to a number of detrimental sequelae including 
difficulty speaking, chewing and swallowing; rampant tooth decay; 
mucosal candida infections; loss of taste and oral discomfort.  "Dry 
mouth" (xerostomia) can be induced by radiation of the head and neck 
for treatment of cancer or certain medications and is the primary 
symptom of Sjögren's syndrome, an autoimmune disorder characterized by 
secretory dysfunction of the salivary and lacrimal glands. In the early 
stages of Sjögren's syndrome, both the acini and ducts are infiltrated 
by lymphocytes and subsequently undergo degenerative changes.  Studies 
related to the etiology of this syndrome have revealed the 
specificities of some of the autoantibodies involved.  However, a 
comprehensive understanding of the multiple factors contributing to the 
initiation and progression of Sjögren's syndrome is lacking. Centers in 
this scientific area could include topics such as:

o Elucidation of the genetic (including modulatory genes) and molecular 
basis for normal development and function of salivary glands;

o Elucidation of the genetic and molecular basis for loss of salivary 
gland function;

o Application of bioimaging to real time monitoring of biological 
events occurring in normal and pathologically affected salivary glands;  

o Development of novel technologies for the early diagnosis of 
Sjögren's syndrome;

o Identification and functional analysis of immunological and antigenic 
components implicated in the etiology of Sjögren's syndrome;

o Identification of molecular targets for intervention of Sjögren's 
syndrome;

o Utilization of stem cell based technologies for salivary gland 
regeneration;

o Restoration of salivary gland function including restoration of the 
biologically active molecules present in saliva; and

o Development of an artificial salivary gland.

MECHANISM OF SUPPORT
 
This RFA will use NIH P50 (Specialized Center Grant) award mechanism.  
As an applicant you will be solely responsible for planning, directing, 
and executing the proposed project.  This RFA is a one-time 
solicitation.  The anticipated award date is August 2004. 

This RFA uses just-in-time concepts.  This program does not require 
cost sharing as defined in the current NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.  

FUNDS AVAILABLE
 
The NIDCR intends to commit approximately $10.0 million total costs in 
FY 2004 to fund up to six new grants in response to this RFA. An 
applicant may request a project period of up to five years and a budget 
for total costs (direct plus facilities and administrative (F&A) costs) 
of up to $1.5 million per year.  This amount may be exceeded by a 
request of up to $200,000 for F&A costs associated with subcontracts.  
Funds may not be utilized for training but each Center is expected to 
provide an environment for the training of graduate students, post 
doctoral fellows and health professionals.  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 NIDCR 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 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 
o Faith-based or community-based organizations 
 
Foreign institutions are not eligible to apply.

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 

Applicants should request funds for one trip per year by the PI and one 
project leader for an annual meeting to be held at NIH in Bethesda, MD.  
The purpose of these meetings is to discuss scientific advances and the 
potential for collaborations.  All applications will be expected to 
address data sharing as indicated at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html
  
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:

Ann L. Sandberg, Ph.D.
Acting Director, Division of Basic and Translational Sciences
National Institute of Dental and Craniofacial Research
Building 45, Room 4AN-12B
Bethesda, MD  20892
Telephone:  (301) 594-2419
FAX:  (301) 480-8319
Email:  ann.sandberg@nih.gov

o Direct your questions about peer review issues to:

H. George Hausch, Ph.D.
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
Building 45, Room 4AN-44F
Bethesda, MD  20892
Telephone:  (301) 594-2904
FAX:  (301) 480-8303
Email: George.Hausch@nih.gov

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

Mary Daley
Chief Grants Management Officer
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
Building 45, Room 4AN-44B
Bethesda, MD  20892
Telephone:  (301) 594-4808
FAX:  (301) 480-3562
Email: md74u@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 IC staff to estimate the potential review 
workload and plan the review.
 
The letter of intent is to be sent by the date listed at the beginning 
of this document.  The letter of intent should be sent to:

Ann L. Sandberg, Ph.D.
Acting Director, Division of Basic and Translational Sciences
National Institute of Dental and Craniofacial Research
Building 45, Room 4AN-12B
Bethesda, MD  20892
Telephone:  (301) 594-2419
FAX:  (301) 480-8319
Email: ann.sandberg@nih.gov

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.

SUPPLEMENTAL INSTRUCTIONS

The following page limitations will apply:
Overview describing the Center as an entity-5 pages
Individual projects-25 pages
Cores-10 pages
The applicants should include, in the Overview, a discussion of the 
synergistic interactions that will be achieved through the 
establishment of multi-disciplinary teams, the utilization of novel 
approaches and the integration of the various projects. No appendices, 
with the exception of color figures, and no journal reprints will be 
accepted.  All essential information must be in the submitted 
application.  No corrections or updated information will be accepted 
after the application has been submitted.  
 
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 
must be sent to:

H. George Hausch, Ph.D.
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health
Building 45, Room 4AN-44F, MSC 6402
Bethesda, MD  20892-6402
 
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.  While the investigator may 
still benefit from the previous review, the RFA application is not to 
state explicitly how.

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the NIDCR. Incomplete and/or non-responsive 
applications will be returned to the applicant 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 NIDCR 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 NIDCR National 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 the 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 the application's overall score, weighting them 
as appropriate for each application.  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 this study address an important problem? If the aims 
of the application are achieved, how will scientific knowledge be 
advanced? What will be the effect of these studies on the concepts or 
methods that drive this field?

APPROACH: Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of 
the project? Does the applicant acknowledge potential problem areas and 
consider alternative tactics?

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

INVESTIGATOR: Is the investigator 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)?

ENVIRONMENT: Does the scientific environment in which the 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:

ADMINISTRATION:  Are the quality control of the research, managerial 
oversight, internal communication, cooperation between the 
investigators and contractual agreements adequately addressed?

MULTIDISCIPLINARY APPROACH:  Is the Center comprised of collaborative 
efforts between individuals from different scientific disciplines?

INTEGRATION OF PROJECTS:  Are the proposed projects and cores well 
integrated in addressing the selected Center theme?

UTILIZATION OF CONTEMPORARY TECHNOLOGIES:  Are state of the art 
technologies applied to the exploration of the selected topic?

TRAINING ENVIRONMENT:  Does the Center provide an environment conducive 
to the training of graduate students, postdoctoral fellows and other 
health professionals?    

Each project will be reviewed according to the criteria indicated 
above.  The review of the Cores will be based on the justification for 
and usefulness of the core facilities to the various research projects 
(each core should provide essential facilities or services for two or 
more individual projects). The review of all submitted projects will be 
included in the overall review and final score. Weak components will 
not be recommended for deletion prior to scoring.

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).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals 
are to be used in the project, the five items described under Section f 
of the PHS 398 research grant application instructions (rev. 5/2001) 
will be assessed.  

ADDITIONAL CONSIDERATIONS 

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

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:  November 15, 2003 
Application Receipt Date:  December 16, 2003
Peer Review Date:  May 2004
Council Review:  August 2004
Earliest Anticipated Start Date:  August 2004

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

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. 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.

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). 
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 
(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.health.gov/healthypeople.

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

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

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