MULTIDISCIPLINARY APPROACH FOR RESEARCH ON ORAL COMPLICATIONS OF HIV INFECTION
 
RELEASE DATE:  December 3, 2003
 
RFA Number:  RFA-DE-05-003

Department of Health and Human Services (DHHS) 

PARTICIPATING ORGANIZATION:
National Institute of Health (NIH)
 (http://www.nih.gov)

COMPONENT OF PARTICIPATING ORGANIZATION:
National Institute of Dental and Craniofacial Research (NIDCR) 
 (http://www.nidcr.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  
No. 93.121, Oral diseases and Disorders Research
 
LETTER OF INTENT RECEIPT DATE:  August 17, 2004  
APPLICATION RECEIPT DATE:  September 14, 2004

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 

This initiative is designed to encourage multidisciplinary research on 
the oral complications of HIV infection and their prevention that 
crosses several academic disciplines (e.g., virology, immunology, cell 
biology, pathology, epidemiology, biochemistry, pharmacology, medical 
imaging, etc.)  It is anticipated that this research will increase our 
knowledge of the basic mechanisms involved in the pathogenesis of the 
oral disorders associated with AIDS and that it will identify novel 
strategies for prevention, treatment and diagnosis of the oral 
manifestations of AIDS.

RESEARCH OBJECTIVES
 
Background:

HIV infection is a major public health problem throughout the world.  
The major hallmark of this infection is a gradual depletion of CD 4+ T 
cells which eventually lead to a state of immunosuppression.  This 
immunosuppression makes patients vulnerable to several oral 
complications, including oral tumors, oral candidiasis, oral viral 
infections, HIV related salivary gland disorders, and oral ulcerations 
of diverse etiologies.

The majority of infections associated with HIV disease are initiated at 
mucosal surfaces, occurring as a result of the passage of the pathogens 
across mucosal membranes. The oral mucosa is more resistant to HIV 
infection than other mucosal sites in the body. The reasons for this 
resistance are far from understood, and the factors underlying such 
resistance may be the basis for novel rational prevention strategies 
against HIV/AIDS and HIV associated opportunistic infections. The oral 
cavity is rich in immune cells, such as CD4+ and CD8+ T cells and their 
Th1/Th2 subpopulations, Langerhans cells and dendritic cells. The 
cascade of events triggered by HIV and HIV-associated oral pathogens in 
the oral mucosa may affect local and systemic innate and adaptive host 
immune responses. Elucidating the sequence of events, and the 
immunological and virological factors involved, are likely to shed 
light on how HIV and the associated oral viral pathogens evade the host 
immune response. 

The oral mucosa is bathed with saliva, which lubricates the oral cavity 
and provides protection against many pathogens. Mucosal secretions 
contain several non specific inhibitors that target bacteria, viruses 
and fungi. Those with significant inhibitory activity to HIV, include 
lactoferrin, secretory leukocyte protease inhibitor, proline rich 
proteins, defensins, salivary agglutinin and cystatins. These innate 
immunity effectors are rapidly available and ready to kill or 
neutralize their pathogens within minutes. The role of these immune 
factors in the resistance to oral transmission of HIV is not well 
defined. Understanding the coordination of the innate and adaptive 
immunity to HIV would yield information that will lead to novel 
therapeutic strategies and protective vaccine designs.  

The immunosuppression characteristic of AIDS, predisposes the patients 
to cancers, warts and preneoplastic oral lesions.  Some of the 
neoplasms are aggressive, hard to treat and can affect the quality of 
life of the patients.  Oral malignancies and tumors affect up to 25% of 
patients with AIDS.  The most frequent oral malignancies are Kaposi’s 
sarcoma (KS) and non-Hodgkin’s lymphoma.  Oral warts and oral hairy 
leukoplakia (OHL), a benign epithelial hyperplasia of the lingual 
squamous epithelium, are also reported.
  
Interestingly, the genome of some of the viruses that are associated 
with the oral complications of HIV infection have sequence homology 
with some human cytokines and/or chemokines.  For example, a 
cytomegalovirus gene encodes vIL-10 and CXC1&2, an EBV gene encodes 
vIL-10 and a HHV-8 gene encodes vIL-6.  The role of this mimicry with 
mammalian cell cytokines in disease pathogenesis is not known.  IL-10 
and IL-6 mediate Th2 cell responses and inhibit Th1 immune responses.  
IL-6 also stimulates lymphocyte proliferation.  

Patients with HIV-related salivary gland disease present with signs and 
symptoms similar to those of patients with Sjögren’s syndrome.  This 
condition is characterized by lymphocytic infiltration of the salivary 
glands and lymphoepithelial cysts of the major salivary glands.  
Occasionally lymphomas may develop within the salivary glands.  The 
search for an etiology for these lymphomas is inconclusive.  The 
incidence of salivary gland disease among HIV infected patients appears 
to have increased following the introduction of HAART.  The cause of 
this increase is not known at the present time.

A multidisciplinary comprehensive approach for study of the oral 
complications of HIV disease will expedite and enhance our knowledge of 
the field and will provide new insights and solutions to an ever 
growing list of unanswered questions that continue to emerge.

Scope

The aim of this initiative is to encourage the submission of 
multidisciplinary proposals with at least three (3) tightly integrated 
projects and any necessary cores that address the existing gaps in our 
knowledge of the pathogenesis of the oral complications of HIV 
infection.
 
Examples of topics include, but are not limited to:

o   Determining how HIV and viruses with oncogenic potential interact 
and disrupt the cellular regulatory networks to induce neoplastic 
changes of mucosal cells;  
o   Evaluating the role of cytokine and chemokine mimicry of viruses 
associated with the pathogenesis of oral complications of HIV 
infection; 
o   Identification of anti-HIV factors in saliva.  Determine the 
usefulness of such factors for early HIV diagnosis and identify 
factors that may predict disease progression;  
o   Studies on salivary gland complications in HIV infection 
including basic research on the etiology, pathogenesis, and 
prevention as well as high throughput analyses of gene expression 
in health and disease;  
o   Genetic therapies to induce salivary glands to secrete anti-viral 
factors against HHV-8, HPV, EBV and CMV;
o   Studies on oral mycotic pathogens associated with HIV infection 
that involve their pathogenesis; strain variability and 
virulence; mechanisms of anti-fungal resistance; and 
identification of novel targets for antifungal therapy;  
o   Studies on oral mucosal immunity including research on innate and 
adaptive immunity; novel immunological approaches for interfering 
with oropharyngeal HIV transmission; novel vaccine approaches for 
HIV that make use of the buccal or the nasopharyngeal mucosa as a 
portal for inoculation;
o   Oral complications associated with the prolonged use of HAART in 
patients with HIV including etiology, host susceptibility, early 
detection and prevention; and, 
o   Development of animal and in vitro cell- based models for AIDS-
related oral complications.

This initiative is not designed to support clinical trials.  However, 
the use of clinical samples from patients is allowable and encouraged.    

MECHANISM OF SUPPORT

This RFA will use NIH Research Program Project (P01) award mechanism. 
Program Project grants support broadly based, multi-disciplinary 
research programs that have a well-defined, central research focus or 
objective.  An important feature is that the interrelationships of the 
individual scientifically meritorious projects will result in a greater 
contribution to the overall program goals than if each project were 
pursued individually.  The program project grant consists of a minimum 
of three interrelated individual research projects (four or more are 
recommended) that contribute to the program objective.  This type of 
award also can provide support for certain common resources termed 
cores.  Such resources should be utilized by two or more projects 
within the award.  The total project period may not exceed five years.  

Applicants will be solely responsible for planning, directing, and 
executing the proposed project.  This RFA is a one-time solicitation. 
The anticipated award date is March of 2005. 

This RFA uses just-in-time concepts.  It also uses the non-modular 
budgeting formats and 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 $3.3 million total cost 
(direct cost and applicable facilities and administrative F&A costs) in 
FY 2005 to fund up to 3 grants new and/or competitive continuation 
grants in response to this RFA.  An applicant may request a project 
period of up to 5 years and a budget of up to $1.1 million total cost 
(direct cost and applicable facilities and administrative F&A costs) 
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 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 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 institutions/organizations
o 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:

Mostafa Nokta, M.D., Ph.D.
Division of Basic and Translational Sciences
National Institute of Dental and Craniofacial Research,
Building 45, Room 4AN-18H
Bethesda MD, 20892-6402
Telephone: (301) 594-7985
Fax: (301) 480-8319
Email: Mostafa.Nokta@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  20892-6402
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
Grants Management Branch  
National Institute of Dental and Craniofacial Research
45 Center Drive MSC 6402
Building 45, Room 4AN-44B
Bethesda, MD  20892-6402
Phone: (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 Institute 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.
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
Building 45, 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). Applications must 
have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) 
number as the Universal Identifier when applying for Federal grants or 
cooperative agreements. The DUNS number can be obtained by calling 
(866) 705-5711 or through the web site at 
http://www.dunandbradstreet.com/. The DUNS number should be entered on 
line 11 of the face page of the PHS 398 form. The PHS 398 document 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.

SUPPLEMENTARY INSTRUCTIONS 
 
The applicants should include an Overview 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. 

The following page limitations will apply: 
 
Overview describing the Program Project synergy -5 pages
Cores - 10 pages
Individual projects - 25 pages (Research Plan sections a-d of the 
PHS398 form) 

Appendix- All essential information must be in the submitted 
application. Use the instructions for the appendix detailed in the PHS 
398 except that no more than 5 manuscripts previously accepted for 
publication may be included per individual project. All components of 
the appendix should be single sided and unbound.

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, send two additional copies of the 
application 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
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 Undergo a process in which all applications  will be reviewed, 
discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the NIDCR National Advisory Council 
or Board. 
 
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.  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.  

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
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?  

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, for example, equipment calibration and 
maintenance, personnel oversight, internal communication, and 
synergistic interactions between investigators adequately addressed?  
Will there be an external review committee?  

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

INTEGRATION OF PROJECTS:  Are the proposed projects and cores well 
integrated?

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?    

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 

Sharing Research Data 

Applicants requesting more than $500,000 in direct costs in any year of 
the proposed research are expected to include a data sharing plan in 
their application. The reasonableness of the data sharing plan or the 
rationale for not sharing research data will be assessed by the 
reviewers. However, reviewers will not factor the proposed data sharing 
plan into the determination of scientific merit or priority score.  See 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.  

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: August 17, 2004
Application Receipt Date: September 14, 2004
Peer Review Date: November 2004
Council Review: January 2005
Earliest Anticipated Start Date: March 1, 2005

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

DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required 
for all types of clinical trials, including physiologic, toxicity, and 
dose-finding studies (phase I); efficacy studies (phase II), efficacy, 
effectiveness and comparative trials (phase III). The establishment of 
data and safety monitoring boards (DSMBs) is required for multi-site 
clinical trials involving interventions that entail potential risk to 
the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide 
for Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

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://stemcells.nih.gov/index.asp 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, in the project description and elsewhere in the application as 
appropriate, 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.

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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