GENE DISCOVERY FOR CRANIOFACIAL DISORDERS
 
RELEASE DATE:  May 9, 2002
 
RFA: DE-03-001
 
PARTICIPATING INSTITUTES AND CENTERS (ICs):

National Institute of Dental and Craniofacial Research (NIDCR) 
 (http://www.nidr.nih.gov/)
National Eye Institute (NEI)
 (http://www.nei.nih.gov/)

LETTER OF INTENT RECEIPT DATE:  June 30, 2002

APPLICATION RECEIPT DATE:       July 30, 2002
 
THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanisms of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to become Principal Investigators
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) and 
the National Eye Institute (NEI) invite applications aimed at fostering 
creative approaches for the discovery of genes that cause or modify 
susceptibility to craniofacial, dental, oral, and ocular disorders.  
The applications may be for individual research projects (R01) or for 
exploratory/developmental grants (R21).  This Request for Applications 
(RFA) encourages research projects focused on identifying genes that 
cause craniofacial disorders, modifier genes that influence risk, and 
environmental conditions that alter gene expression and modify 
susceptibility in diverse genetic backgrounds.  Advances in genetic 
studies will reveal the molecular networks that regulate the formation 
of craniofacial, dental, and ocular tissues and thus, shed light on 
pathogenic mechanisms leading to structural defects and disorders.  
These advances will provide a basis for gene-based diagnostic criteria, 
improved genetic counseling, and they will provide insights for 
developing novel prevention and therapeutic strategies. Collaborative 
projects involving interdisciplinary teams of investigators are strongly 
encouraged.  
 
RESEARCH OBJECTIVES
  
Background

Birth defects affect 5% of all infants born in the United States, and 
three-quarters of these involve the head, face and oral tissues.  This 
means that in the United States there is a child born every 5 minutes 
with a craniofacial defect.  While there are several hundred disorders 
affecting the face, skull, jaw, eyes and teeth, by far the most common 
craniofacial defect is isolated, or non-syndromic cleft lip with or 
without cleft palate (CL/P) that affects more than one child per 1000 
births.  Other hereditary syndromes such as ectodermal dysplasias are 
marked by the absence of all or most teeth in children and adults, 
while Rieger"s syndrome is associated with  significant ocular and 
tooth anomalies.  The social and economic costs of craniofacial 
disorders are enormous and they place a disproportionately high burden 
on particular population subgroups. 

During the past decade, there has been significant progress in 
identifying the genetic basis of many rare craniofacial and 
ophthalmologic disorders that are strongly influenced by single genes 
(i.e., hypohidrotic ectodermal dysplasia, dentinogenesis imperfecta II, 
Papillon-Lefevre syndrome, Apert syndrome, aniredia, and congenital 
fibrosis of the extraocular muscles).  Progress has been substantially 
slower for the more common craniofacial disorders that are complex 
disorders influenced by multiple genes interacting with each other and 
with environmental factors.  The search for susceptibility loci for 
complex craniofacial disorders such as non-syndromic cleft lip with or 
without cleft palate (CL/P) has often yielded weak linkages and 
inconsistent results.  This may be due in part, to the limitations of 
current linkage strategies as well as our lack of understanding of the 
role of genetic polymorphisms in response to environmental factors.  
Genetic analysis may also be hampered by the use of disease categories 
that combine phenotypes of different severity that may represent 
genetically heterogeneous defects.  Identification of susceptibility 
genes for craniofacial disorders will permit studies of the molecular 
pathways leading to these disorders and will enhance our understanding 
of individual risk, clinical phenotype, and variation in response to 
environmental factors.  

The current initiative is the result of recommendations from several 
prior NIDCR-supported conferences focused on craniofacial disorders and 
genetics.  These meetings highlighted the major scientific 
opportunities created by the wealth of genomic information from the 
Human, Mouse and other Genome Projects for the discovery of genes 
involved in craniofacial disorders.  These meetings include the 
Workshop on the Prevention of Craniofacial Anomalies, held in September 
1999, the NIDCR Genetics Workgroup held in November 1999, and a series 
of three NIDCR-sponsored World Health Organization meetings 
"International Collaborative Research on Craniofacial Anomalies" held 
in 2000-2001.  

Scope

Applications submitted in response to this announcement should focus on 
discovery of genes causing or contributing to craniofacial, oral, 
dental, and ocular disorders. A partial list of disorders of interest 
to NIDCR is available in Appendix 5 of the Report of the NIDCR Genetics 
Workgroup http://www.nidr.nih.gov/about/strat-plan/Genetics_Rpt.pdf).  
These include common disorders such as orofacial clefting and 
hypodontia/tooth agenesis as well as a broad spectrum of less common 
disorders such as amelogenesis and dentinogenesis imperfecta, Sj gren"s 
syndrome, Treacher-Collins syndrome, Papillon-Lefevre syndrome, and 
many others. 

The types of research that would be encouraged by the proposed 
initiative include:

o  Discovery of genes involved in single-gene or polygenic disorders 
that affect dental, oral, ocular and craniofacial tissues throughout 
the lifespan. 

o  Genotype-phenotype analysis including correlations of specific 
allelic variants in primary or modifier genes and their clinical 
phenotype.

o  Studies focused on distinguishing heterogeneous genetic subgroups 
that show similar clinical presentations.
 
o  Research strategies for gene discovery for craniofacial disorders 
may include traditional linkage analysis, case-control association 
studies, linkage disequilibrium mapping, candidate gene analyses, 
positional cloning techniques, SNP variant analyses, gene expression 
profiling and proteomics using microarray and other high-throughput 
technologies.

o  Studies in model organisms(e.g., mouse, rat, zebrafish, chick, 
and fruit fly) for identifying and validating candidate and modifier 
genes, and for analyzing molecular mechanisms that underlie genetic 
disorders are encouraged as research indicates that key molecules 
involved in facial specification and assembly are evolutionarily 
conserved. 

o  Backcross strategies such as speed congenics for mapping 
susceptibility loci and evaluating modifier genes that influence 
penetrance and expressivity. 

High-throughput human and mouse genotyping services are available to 
applicants through the Center for Inherited Disease Research (CIDR).  
Since NIDCR and NEI are NIH Institutes that participate in the support 
of CIDR, research projects funded under this initiative are eligible to 
apply for no-cost genotyping services at CIDR through a competitive 
peer review process by a chartered CIDR Access Committee (CAC). 
Detailed information and deadlines for applications to CIDR are 
available at http://www.cidr.jhmi.edu.   

Applicants are also advised of the availability of global gene 
expression profiles during early stages of human craniofacial, oral and 
dental development.  These resource tools are available through the 
Craniofacial and Oral Gene Expression Network (COGENE) a NIDCR-
supported consortium, and can be accessed at the web site 
http://hg.wustl.edu/COGENE.

This initiative encourages multidisciplinary approaches involving 
geneticists, molecular biologists, dental and medical clinicians, 
epidemiologists, ophthalmologists, optometrists, bioinformaticians, and 
researchers in other disciplines in order to enhance gene discovery 
research.  

Applicants are strongly encouraged to develop comprehensive operational 
diagnostic criteria that include state-of-the-art diagnostic 
methodologies such as imaging techniques in order to refine diagnostic 
classifications. Diagnostic criteria for many rare craniofacial 
disorders are highly variable and this hampers attempts to combine data 
across samples and to replicate findings. Analysis of genetic and 
environmental etiologies for complex traits such as orofacial clefting, 
will benefit from the application of sophisticated methodologies that 
permit phenotypic subgroups to be distinguished and classification 
schema to be developed.

MECHANISMS OF SUPPORT
 
This RFA will use NIH R01 (investigator-initiated research project 
grant) and the R21 (exploratory/developmental research grant) award 
mechanisms. As an applicant you will be solely responsible for 
planning, directing, and executing the proposed project.  This RFA is a 
one-time solicitation.  Future unsolicited, competing-continuation 
applications based on this project will compete with all investigator-
initiated applications and will be reviewed according to the customary 
peer review procedures.  The anticipated award date is February 01, 
2003.

This RFA uses just-in-time concepts.  It also uses the modular 
budgeting format. (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.

R21 Applications. R21 proposals should have the potential for truly 
groundbreaking impact. Use of this mechanism by investigators 
experienced in orofacial disorders who wish to explore new genetic 
approaches to address basic and applied research questions is 
encouraged. Investigators with expertise in fields other than orofacial 
disorders who wish to establish new research programs on the genetics 
of these disorders is also encouraged.  Applicants are encouraged to 
contact program staff for advice about choosing the appropriate grant 
mechanism.

FUNDS AVAILABLE 
 
The NIDCR intends to commit approximately $2,500,000 and the NEI 
intends to commit approximately $1,500,000 in FY 2003 to fund 10 to 16 
new grants in response to this RFA.  An R01 applicant may request a 
project period of up to 4 years and a budget for direct costs of up to 
$250,000 per year. An R21 applicant may request a project period of up 
to 2 years and a budget for direct costs of up to $125,000 per year. 
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 ICs 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 
under-represented racial and ethnic groups as well as individuals with 
disabilities are always encouraged to apply for NIH programs.  

 
SPECIAL REQUIREMENTS
 
Plan for Dissemination of Data and Biomaterials

Rapid sharing of data and biomaterials is strongly encouraged.  
Applications are required to contain a detailed plan for the timely 
dissemination of data and biomaterials generated through the grant, in 
agreement with PHS policy (NIH Grants Policy Statement at 
http://grants.nih.gov/grants/guide/notice-files/not96-184.html.  
Sharing of data and biomaterials is essential to foster rapid progress 
in genetic studies of craniofacial disorders.  The information to be 
shared is expected to include pedigree structures and all clinical and 
diagnostic data, which should be stripped of personal identifiers and 
placed in publicly accessible databases.  Applicants may also propose 
to share biomaterials such as DNA samples and cell lines.  The Initial 
Review Group will evaluate the proposed sharing plan and comment on its 
adequacy as an administrative note in the summary statement.  The 
adequacy of the sharing plan will be considered by NIH staff in 
determining whether the grant shall be awarded.  The sharing plan as 
approved, after negotiation with the applicant when necessary, will be 
a condition of the award.  Evaluation of renewal applications will 
include an assessment of the effectiveness of data and biomaterial 
release. 
 
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:

Rochelle K. Small, Ph.D.
Director, Developmental Biology and Mammalian Genetics 
Division of Basic and Translational Sciences
National Institute of Dental and Craniofacial Research
National Institutes of Health 
45 Center Drive, Room 4AN-44F 
Bethesda, MD 20892-6402 
Telephone: (301) 594-9898
FAX:  (301) 480-8318
Email:  Rochelle.Small@nih.gov

Ellen Liberman, Ph.D.
National Eye Institute
Executive Plaza South, Suite 350
6120 Executive Blvd., MSC 7164
Bethesda, MD 20892-7164
Phone: (301) 451-2020
Fax:     (301) 502-0528
Email: ellenliberman@nei.nih.gov

o Direct your questions about peer review issues to:

H. George Hausch, Ph.D. 
Acting Director, Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health 
45 Center Drive, Room 4AN-44F 
Bethesda, MD 20892-6402 
Telephone: (301) 594-2904 
FAX: (301) 480-8303 
Email: George.Hausch@nih.gov 

Direct your questions about financial or grants management matters to: 
Mr. Kevin Crist
Grants Management Branch 
Division of Extramural Activities 
National Institute of Dental and Craniofacial Research 
45 Center Drive, Room 4AN-44F 
Bethesda, MD 20892-6402 
Telephone: (301) 594-4800 
Fax: (301) 402-1517 
Email: Kevin.Crist@nih.gov 

Mr. William W. Darby
Grants Management Branch 
Division of Extramural Research 
National Eye Institute 
6120 Executive Blvd., Suite 350
Bethesda, MD 20892-7164 
Telephone: (301) 451-2020 
Fax: (301) 496-9997 
Email: wwd@nei.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 NIDCR 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: 

H. George Hausch, Ph.D. 
Acting Director, Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health 
45 Center Drive, Room 4AN-44F 
Bethesda, MD 20892-6402 
Telephone: (301) 594-2904 
FAX: (301) 480-8303 
Email: George.Hausch@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) 710-0267, Email: GrantsInfo@nih.gov.
 
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 
must be sent to:

Dr. H. George Hausch 
Division of Extramural Activities 
National Institute of Dental and Craniofacial Research 
45 Center Drive, Room 4AN-44F 
Bethesda, MD 20892-6402 
 
APPLICATION PROCESSING: Applications must be received by July 30, 2002. 
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 NIDCR and NEI.  Incomplete applications will be 
returned to the applicant without further consideration.  And, if the 
application is not responsive to the RFA, CSR staff may contact the 
applicant to determine whether to return the application to the 
applicant or submit it for review in competition with unsolicited 
applications at the next appropriate NIH review cycle.

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 National Advisory Councils of 
either NIDCR or NEI.

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 SHARING PLAN:  The adequacy of the proposed plan to make all data and 
biological materials collected and produced as a result of the proposed 
research accessible in a timely manner to the biomedical research 
community. 

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

o OTHER REVIEW CRITERIA: R21 applications only: Does this project have 
the potential for groundbreaking impact?   If successful, will this 
project achieve at least one of the following goals: 1) generate pilot 
data to assess the feasibility of a novel avenue of investigation,  2) 
involve high risk experiments that could lead to a breakthrough in a 
particular field,  or 3) demonstrate the feasibility of new 
technologies that could have major impact in a specific area.

 
RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date: June 30, 2002
Application Receipt Date: July 30, 2002
Peer Review Date:  Fall 2003
Council Review:  January 2003
Earliest Anticipated Start Date:  February 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
o Adequacy of proposed sharing plan
 
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 RFA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application 
should include a description of the archiving plan in the study design 
and include information about this in the budget justification section 
of the application. In addition, applicants should think about how to 
structure informed consent statements and other human subjects 
procedures given the potential for wider use of data collected under 
this award.

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 (NIDCR) and No. 93.867 (NEI) 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.

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