CLINICAL GENETICS OF CRANIOFACIAL AND ORAL DISORDERS
 
RELEASE DATE:  May 8, 2003
 
RFA Number:  DE-04-004
 
National Institute of Dental and Craniofacial Research (NIDCR) 
 (http://www.nidr.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER:  93.121

LETTER OF INTENT RECEIPT DATE:  October 20, 2003

APPLICATION RECEIPT DATE:  November 18, 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 goal of this Request for Applications (RFA) is to promote research 
that will enhance clinical genetics studies of the genes and 
environmental factors that cause or modify susceptibility to 
craniofacial, oral and dental disorders and diseases.  Currently, a 
major hindrance to progress in clinical genetics research has been the 
variation that exists between individuals with the same craniofacial 
disorder and the lack of consensus in the clinical community regarding 
phenotypic definitions.  Specifically, this initiative is focused on  
developing well-characterized patient populations with distinct 
craniofacial disorders by fostering unique partnerships between 
clinicians and basic scientists to develop rigorous diagnostic 
criteria. Research studies are encouraged to refine clinical 
characterization, to identify diagnostic biomarkers, to establish 
reliable subphenotypes, and to develop standardized and comprehensive 
phenotypic definitions that extend to associated anomalies beyond the 
head and neck. Because of the interdisciplinary nature of this 
research, collaborative projects are encouraged among clinicians, 
geneticists, epidemiologists, molecular and developmental biologists, 
and other researchers. 

RESEARCH OBJECTIVES

Background:

There are more than 300 genetic syndromes that have an associated 
craniofacial, oral or dental component.  In addition there are many 
isolated, or non-syndromic, craniofacial defects that are not part of a 
genetic syndrome.  Craniofacial disorders require surgical, dental, 
speech, medical and behavioral interventions and they impose a 
substantial burden on patients and their families.  Clefts of the lip 
and palate affect about 1/700 births and show a wide variability 
related to geographic regions.  Craniofacial disorders are often rare 
disorders and many have complex etiologies involving the interaction of 
both genetic and environmental factors. Increased risk for craniofacial 
disorders has been associated with variables such as maternal use of 
prescription drugs, alcohol, and tobacco, maternal nutritional status, 
and occupational exposures during pregnancy.  

A major barrier to progress in clinical genetics studies of 
craniofacial disorders has been the process of accruing well-defined 
patient populations with a rigorous phenotypic characterization. 
Diagnostic criteria for many rare craniofacial disorders are often 
imprecise or poorly defined.  In addition, the variation that currently 
exists in the phenotypic characteristics or clinical manifestations 
among individuals with the same craniofacial disorder and the lack of 
consensus in the clinical community regarding phenotypic definitions 
hampers efforts to combine data from different patient samples and 
efforts to replicate research findings. The completion of the Human 
Genome Project and the development of genome wide high-throughput 
technologies provide important new tools for facilitating progress in 
clinical genetics studies of craniofacial disorders.  In order to take 
advantage of these new approaches and accelerate the rate of research 
progress, there are several obstacles that must be overcome.  
Development of rigorous and comprehensive diagnostic criteria and 
accrual of well-defined patient populations are essential for 
implementing high-throughput technologies to identify genetic and 
environmental factors that contribute to oral and craniofacial 
disorders. The ability to distinguish reliable subphenotypes within a 
broader phenotype will greatly increase the power of gene mapping 
studies by permitting subsets of cases to be analyzed from within 
larger data sets.

Scope:

Applications submitted in response to this announcement should focus on 
methodologies to standardize diagnostic criteria and to enhance the 
accrual of well-defined patient populations with specific oral and 
craniofacial disorders. Applications may focus on either single gene or 
multigenic disorders relevant to the research mission of NIDCR.  A 
partial listing of dental, oral and craniofacial genetic diseases and 
disorders of interest to NIDCR is provided in Appendix 4 of the NIDCR 
Genetics Workgroup Report (http://www.nidr.nih.gov/about/strat-
plan/Genetics_Rpt.pdf).  Definitive diagnostic criteria are currently 
lacking for many of these target disorders and diseases. Research 
supported by this RFA will promote the collection of pedigrees, the 
detailed characterization of clinical phenotypes, the generation of 
reliable subphenotypes, and the standardization of comprehensive 
diagnostic criteria for craniofacial disorders. It is anticipated that 
research proposed in response to this initiative will involve the 
formation of multidisciplinary collaborations between clinicians, 
geneticists, epidemiologists, molecular biologists, developmental 
biologists and other researchers.  Studies focused on gene discovery 
are not considered responsive to the RFA.  The following is a non-
inclusive list of research topics considered appropriate for response 
to this initiative: 

o Accrual of well-characterized patient populations, including the 
collection of biomaterials (e.g. DNA, cell lines, and affected tissue 
samples), clinical information, and laboratory tests;
o Development of comprehensive diagnostic criteria based on a synthesis 
of patient information including history, laboratory procedures, 
medical records and clinical interviews;
o Phenotypic assessment utilizing state of the art methodologies such 
as morphometry, MRI and other imaging techniques; assessment may 
include associated anomalies beyond the head and neck as well as 
behavioral, psychological, cognitive and other characteristics;
o Generation of reliable subphenotypes within broader diagnostic 
classifications;
o Analyses of genotype/phenotype correlation;
o Association of dental anomalies with orofacial clefts and other 
craniofacial disorders;
o Standardization of protocols for patient data records and for sample 
collection and storage; 
o Longitudinal studies describing the natural history and clinical 
course of craniofacial disorders;
o Identification of diagnostic biomarkers and biomarkers that predict 
severity, progression and response to clinical interventions;  studies 
to develop biomarkers may include the application of cDNA and protein 
microarray technologies;
o Development of a controlled vocabulary to describe phenotypes and 
subphenotypes;
o Identification of phenotypic features that distinguish heterogeneous 
genetic subgroups;
o Studies to identify factors that account for phenotypic variability 
that is associated with a mutation in a specific gene; 
o Studies to determine the range of phenotypes associated with a 
particular genetic mutation.  

MECHANISMS OF SUPPORT
 
This RFA will use the NIH R01 Individual Research Project Grant and the 
R21 Exploratory/Developmental 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 July 2004.  Applications that are not funded 
in the competition described in this RFA may be resubmitted as NEW 
investigator-initiated applications using the standard receipt dates 
for NEW applications described in the instructions to the PHS 398 
application. 

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.  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.

R21 Applications: Objectives of the R21 Exploratory/Developmental Grant 
award mechanism include: the support of innovative, high risk/high 
impact research requiring preliminary testing or development; 
exploration and development of new approaches and concepts; research 
and development of new technologies, techniques or methods; or initial 
research and development of data upon which significant future research 
may be built. While minimal preliminary data are expected to be 
described in the R21 proposal, applications should clearly indicate 
that the proposed research and/or development is scientifically sound, 
that the qualifications of the investigators are appropriate, and that 
resources available to the investigators are adequate. Investigators 
with expertise in fields other than craniofacial clinical genetics who 
wish to establish new research programs in this area are also 
encouraged to apply. 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 total cost in FY 
2004 or FY2005 to fund 3 to 4 new R01 grants and 5 to 7 new R21 grants 
in response to this RFA. An R01 applicant may request a project period 
of up to 3 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 3 years 
and a budget for direct costs of up to $125,000 per year. Funding caps 
may be exceeded by a request for one additional module for indirect 
costs associated with subcontracts on R21 applications or two 
additional modules for indirect costs associated with subcontracts on 
R01 applications.  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. 
 
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
o Faith-based or community-based organizations 
 
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS   

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

SPECIAL REQUIREMENTS  

In order to enhance investigator progress and to promote the process of 
achieving agreement on comprehensive standardized diagnostic criteria 
for craniofacial disorders, principal investigators are expected to 
attend an annual conference that will be held at or near the NIH, 
Bethesda MD.   Applicants are advised to include funds to support 
travel of the PI and one other investigator in each year's budget.  

The sharing of biomaterials, data, and software in a timely manner has 
been an essential element in the rapid progress that has been made in 
the genetic analysis of human diseases.  NIH policy requires that 
investigators make unique research resources produced with DHHS funding 
available for research purposes to qualified individuals within the 
scientific community.  A draft NIH Statement on sharing research data 
that describes these policies is available at: 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-035.html.  
Applicants who respond to this RFA must develop and propose detailed 
plans for sharing and disseminating the data and biomaterials generated 
through the grant.   It is expected that the information to be shared 
will include clinical, diagnostic, and pedigree structure information, 
in addition to cell lines and DNA.  When possible, it is preferable 
that data and biomaterials generated through grants funded through this 
RFA be placed in common, public access databases or repositories that 
are widely accessible to investigators throughout the scientific 
community. Rapid sharing of data and biomaterials is strongly 
encouraged. The scientific review group will evaluate the adequacy of 
the proposed plans for sharing data. Comments on the plan and any 
concerns will be presented in an administrative note in the Summary 
Statement. The adequacy of the plan will be considered by NIDCR program 
staff and will be important 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 non- competing continuation applications will include assessment of 
the effectiveness and timeliness of research resource 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 Small, PhD 
Division of Basic and Translational Sciences
National Institute of Dental and Craniofacial Research
National Institutes of Health
Natcher Bldg. 45, Room 4AN-18D
Bethesda, MD  20892
Telephone: 301) 594-9898  
FAX: (301) 480-8318
Email: rochelle.small@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
National Institutes of Health
Natcher Bldg. 45, Room 4AN-44F 
Bethesda, MD 20892-6402
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
Division of Grants Management
National Institute of Dental and Craniofacial Research
National Institutes of Health
Natcher Bldg. 45, Room 4AN-44B
Bethesda, MD  20892
Telephone: (301) 594-4808
FAX: (301) 480-8303
Email: daleym@mail.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:

Rochelle Small, PhD 
Division of Basic and Translational Sciences
National Institute of Dental and Craniofacial Research 
Natcher Bldg. 45, Room 4AN-18D
Bethesda, MD  20892
Telephone: 301) 594-9898  
FAX: (301) 480-8318
Email: rochelle.small@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:
 
R21 Applications: All application instructions outlined in the PHS 398 
application kit are to be followed with the following modifications for 
R21 applications: 

1. FACE PAGE, Item 6: Up to a total of three years of support may be 
requested. 

2. Items a-d of the Research Plan for the R21 application may not 
exceed fifteen (15) pages, including tables and figures. The following 
information should be taken into account for items a, b and c: 

o Item a, SPECIFIC AIMS--The instructions for this section suggest that 
the applicant state "the hypotheses to be tested". Since some 
applications submitted in response to this RFA may also be design- or 
problem-driven (e.g., development of novel technologies), or need- 
driven (initial research to develop a body of data upon which future 
research will build), hypothesis testing per se may not be the driving 
force in developing such a proposal and, therefore, may not be 
applicable. The application should state the hypotheses, design, 
problem and/or need which will drive the proposed research. 

o Item b, BACKGROUND AND SIGNIFICANCE--In this section, it is important 
to identify clearly how the application addresses the specific 
objectives of this RFA and the purpose of the R21 mechanism.

o Item c, PRELIMINARY STUDIES/PROGRESS REPORT—Minimal preliminary data 
are required for an R21 application. 

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: R01 applications 
requesting up to $250,000 per year in direct costs and all R21 
applications 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:
H. George Hausch, Ph.D.
Division of Extramural Activities 
National Institute of Dental and Craniofacial Research 
National Institutes of Health 
Natcher Bldg. 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 applications will be 
returned to the applicant without further consideration.  And, if the 
application is not responsive to the RFA, NIH 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 Dental and 
Craniofacial Research 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 
(if any)?

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?  

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 scientific review group will evaluate the adequacy of the proposed 
plans for sharing data. Comments on the plan and any concerns will be 
presented in an administrative note in the Summary Statement. 
 
BUDGET:  
The reasonableness of the proposed budget and the requested period of 
support will be evaluated in relation to the proposed research.  Budget 
requests should include funds to support travel of the PI and one other 
investigator to attend an annual conference to be held at or near the 
NIH, Bethesda MD. 

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  October 20, 2003
Application Receipt Date:  November 18, 2003
Peer Review Date:  February/March 2004
Council Review:  June 2004
Earliest Anticipated Start Date:  July 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 

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.

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 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. 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.


Return to Volume Index

Return to NIH Guide Main Index


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.