ORAL MUCOSAL INNATE IMMUNE FACTORS IN THE INHIBITION OF HIV AND 
OPPORTUNISTIC INFECTIONS
 
Release Date:  September 13, 2002
 
RFA:  DE-03-002
 
National Institute of Dental and Craniofacial Research (NIDCR) 
 (http://www.nidcr.nih.gov)

LETTER OF INTENT RECEIPT DATE:  November 13, 2002

APPLICATION RECEIPT DATE:  December 11, 2002 
 
THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations:

PURPOSE OF THIS RFA 

The National Institute of Dental and Craniofacial Research (NIDCR) 
invites investigator-initiated grant applications for support of 
research on the innate factors of the oral mucosal immune system 
involved in host resistance to the acquisition and spread of HIV and 
associated opportunistic infections.   

RESEARCH OBJECTIVES

Background

HIV has infected more than 50 million people and AIDS has killed more 
than 21 million people worldwide.  Approximately 40,000 new cases of 
HIV infection are reported in the United States each year, and the 
rates of infection are climbing in certain subpopulations of 
individuals such as women, racial and ethnic minorities, young 
homosexual men, individuals with addictive disorders, and people over 
50 years of age.   

In response to this pandemic, the NIDCR plans to support research that 
will 1) increase our understanding of HIV infection in the oral cavity 
with regards to transmission; 2) develop improved therapy for the 
opportunistic infections associated with HIV immunosuppression; 3) 
reduce the incidence of oral tumors associated with AIDS ; 4) address 
the disproportionate impact of AIDS on global health, particularly in 
the developing countries, with regards to HIV infection and lesions in 
the oral cavity; and 5) reduce disparities in the incidence of oral HIV 
infection in the minority populations in the United States.  

HIV can enter the oral tissues from two directions: exogenously from 
the oral cavity or endogenously from infected cells or virions in the 
blood homing to the oral cavity.  Endogenous spread is assumed to be 
controlled by reducing the levels of circulating infected cells or free 
virions in the blood.  Control of such infection is focused on the 
reduction of HIV in the blood.  Exogenous infection, which is possible 
during receptive oral sex, is controlled by the flow of salivary, 
hypotonic destruction of infected leukocytes, and inhibition of HIV 
attachment or entry into oral tissues.  Recent evidence indicates that 
the number of confirmed reports of exogenous oral infection with HIV is 
extremely low in previously unexposed, seronegative subjects, 
suggesting that resistance to infection is largely due to antiviral 
innate factors in the oral tissues and fluids.  Similarly, the control 
of opportunistic infections in the oral cavity in the immunosuppressed 
AIDS patient is greatly influenced by the innate immune system.   
Research is sought to explain, at cellular and molecular levels, the 
relative innate resistance of the oral region to HIV infection and the 
role of innate factors in the control of opportunistic infections in 
the immunosuppressed AIDS patients.  For example, research is needed on 
the innate factors in the oropharyngeal region that inhibit HIV 
interactions with oral epithelial cells, leukocytes, and dendritic 
cells.  In addition the role of mucins, thrombospondin, salivary 
soluble proteins, histatins, interferon, beta-defensins, secretory 
leukocyte protease inhibitor (SLPI) and other anti-microbial factors in 
control of HIV and opportunistic infections is needed.   A better 
understanding of innate factors that control HIV and opportunistic 
pathogens can suggest novel microbicides and targets for enhanced 
resistance to infection as well as define underlying differences in 
susceptibility to HIV infection at other mucosal sites.  

Applications from both individuals and groups interested in oral AIDS 
research are encouraged.  However, team approaches to these efforts are 
especially encouraged in the belief that a synergistic blend of 
expertise and resources could  advance the science more quickly.  

Scope

Examples of research that may be supported by this initiative include:

o Delineate the macromolecular assemblies that augment the protective 
barrier of the oral mucosa, and determine how HIV and HIV-associated 
opportunistic infections compromise this protective barrier. 
o Determine the unique features of the architectural and cellular 
composition of the oral mucosa that contribute to resistance to 
infection.
o Determine whether and how innate host defense molecules produced by 
mucosal epithelial cells contribute to resistance to HIV.
o Explore the use of innate factors for their therapeutic potential.
o Determine the underlying innate differences in susceptibility to HIV 
infection and AIDS-related opportunistic infections among oral, 
gastrointestinal, rectal, and vaginal mucocutaneous tissues.
o Determine the influence of HAART (and other anti-HIV therapies) on 
oral mucosal protection against HIV, and determine whether oral and 
tonsillar tissues have differential HAART susceptibilities.
o Design of synthetic molecules based on innate immune factors that 
have antiviral activity.  
o Study therapeutic enhancement of host production of innate factors 
that have inhibitory effects on HIV and opportunistic pathogens.  
o Study the role of mucosal innate factors in the prevention of AIDS 
related oral tumors

This list is illustrative and not meant to be inclusive.  Investigators 
are encouraged to propose other studies related to innate immunity to 
HIV and opportunistic infections in the oral cavity, and to contact the 
research/science staff listed below to determine whether the project 
would be responsive to this RFA.  

MECHANISM OF SUPPORT
 
This RFA will use the NIH individual research project grant (R01) and 
the exploratory/developmental research grant (R21) award mechanisms.  
As an applicant you will be solely responsible for the planning, 
direction, and execution of the proposed project. 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. 

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

R21 Applications. R21 proposals should have the potential for truly 
groundbreaking impact. Use of this mechanism by investigators 
experienced in innate immunity who wish to explore new approaches to 
address basic and applied research questions related to host immunity 
to HIV or opportunistic pathogens is encouraged.  Investigators with 
expertise in fields other than innate immunity 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.

The objective of the R21 mechanism is to support innovative, high 
risk/high impact research requiring preliminary testing or development; 
exploration of the use of approaches and concepts new to AIDS/HIV 
infection; research and development of new technologies, techniques or 
methods; or initial research and development of data upon which 
significant future research may be built.  Applications will be 
considered as high impact if they demonstrate the potential for ground-
breaking, precedent-setting significance, and high risk because they 
either lack sufficient preliminary data to ensure their feasibility, or 
involve using a new model system or technique. While this RFA is 
intended to encourage innovation and high impact research, and while 
minimal preliminary data are expected to be described in the 
application, 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.  

FUNDS AVAILABLE 
 
The NIDCR intends to commit approximately $2,000,000 in FY 2003 to fund 
six to ten new and/or competitive continuation grants in response to 
this RFA.  An R01 applicant may request a project period of up to four 
years.   An R21 applicant may request a project period of up to 2 years 
and a budget for direct costs of up to $150,000 per year.  This R21 cap 
may be exceeded by $25,000 to accommodate the facilities and 
administrative (indirect) costs associated with collaborative research 
at another institution. Because the nature and scope of the proposed 
research will vary from application to application, it is anticipated 
that the size and duration of each award will also vary.  Although the 
financial plans of the NIDCR provide support for this program, awards 
pursuant to this RFA are contingent upon the availability of funds and 
the receipt of a sufficient number of meritorious applications. At this 
time, it is not known if this RFA will be reissued.

ELIGIBLE INSTITUTIONS
 
You may submit (an) application(s) if your institution has any of the 
following characteristics:

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, 
hospitals, and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic or foreign

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS   

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

SPECIAL REQUIREMENTS 
 
Grantees will meet annually at or near NIH, Bethesda, MD, to share 
results, to ensure that the NIDCR has a coherent view of the advances 
in the field, and to have an opportunity for collective problem solving 
among investigators.  Applicants should budget for travel in their 
requested budget for the principal investigator and one additional 
young investigator to attend this annual meeting. 
 
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:

Dennis F. Mangan, Ph.D. 
Division of Basic and Translational Sciences
National Institute of Dental and Craniofacial Research
Building 45, Suite 4AN-18
Bethesda, MD  20892-6402
Telephone:  (301) 594-2421
Fax:  (301) 480-8318
Email: Dennis.Mangan@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
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:

Anne Welkener
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
Building 45, Room 4AN-55
Bethesda, MD  20892-6402
Telephone:  (301) 594-4800
FAX:  (301) 480-8303
Email: nidcrgmb@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 IC staff to estimate the potential review 
workload and plan the review.
 
The letter of intent is to be sent by the date listed at the beginning 
of this document.  The letter of intent should be sent to Dr. Hausch at 
the address listed above. 

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 two years of support may be 
requested.

2. Items a-d of the Research Plan for the R21 application may not 
exceed ten (10) 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.

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.

R21 Applications:  Applicants may request direct costs in $25,000 
modules up to a total of six modules ($150,000).  This cap may be 
exceeded by one module ($25,000) to accommodate the facilities and 
administrative (indirect) costs associated with collaborative research 
at another institution.

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 original copy of the 
application, including the Checklist, and three signed, photocopies, in 
one package to:
 
Center For Scientific Review
National Institutes Of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)
 
At the time of submission, two additional copies of the application 
must be sent to:

H. George Hausch, Ph.D.
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health
Building 45, Room 4AN-44F, MSC 6402
Bethesda, MD  20892-6402
  
APPLICATION PROCESSING: Applications must be received by the 
application receipt date listed in the heading of this RFA.  If an 
application is received after that date, it will be returned to the 
applicant without review.
 
The Center for Scientific Review (CSR) will not accept any application 
in response to this RFA that is essentially the same as one currently 
pending initial review, unless the applicant withdraws the pending 
application.  The CSR will not accept any application that is 
essentially the same as one already reviewed.  This does not preclude 
the submission of substantial revisions of applications already 
reviewed, but such applications must include an Introduction addressing 
the previous critique.

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the NIDCR.  Incomplete and/or non-responsive 
applications will be returned to the applicant without further 
consideration.  Applications that are complete and responsive to the 
RFA will be evaluated for scientific and technical merit by an 
appropriate peer review group convened by the NIDCR in accordance with 
the review criteria stated below.  As part of the initial merit review, 
all applications will:

o Receive a written critique
o Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications 
under review, will be discussed and assigned a priority score
o Receive a second level review by the NIDCR National Advisory Council. 
 
REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  
In the written comments, reviewers will be asked to discuss the 
following aspects of 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 human and 
animals subjects, 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 BUDGET:  The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research.

o R21 APPLICATIONS:  The potential for ground-breaking, precedent-
setting research, with particular emphasis on novel and innovative 
approaches; and the potential to stimulate new concepts or approaches 
regarding important biomedical/behavioral problems, or provide a 
technique/system of wide applicability.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:   November 13, 2002
Application Receipt Date:   December 11, 2002
Peer Review Date:  March 2003
Council Review:  June 16, 2003 
Earliest Anticipated Start Date:  July 2003

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
 
REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD:   Research 
components involving Phase I and II clinical trials must include 
provisions for assessment of patient eligibility and status, rigorous 
data management, quality assurance, and auditing procedures.  In 
addition, it is NIH policy that all clinical trials require data and 
safety monitoring, with the method and degree of monitoring being 
commensurate with the risks (NIH Policy for Data Safety and 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 AMENDMENT 
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research - Amended, October, 2001," published in the NIH Guide 
for Grants and Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a 
complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition 
of clinical research; updated racial and ethnic categories in 
compliance with the new OMB standards; clarification of language 
governing NIH-defined Phase III clinical trials consistent with the new 
PHS Form 398; and updated roles and responsibilities of NIH staff and 
the extramural community.  The policy continues to require for all NIH-
defined Phase III clinical trials that: a) all applications or 
proposals and/or protocols must provide a description of plans to 
conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethnic groups, including subgroups if applicable; and b) 
investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN 
SUBJECTS:  The NIH maintains a policy that children (i.e., individuals 
under the age of 21) must be included in all human subjects research, 
conducted or supported by the NIH, unless there are scientific and 
ethical reasons not to include them. This policy applies to all initial 
(Type 1) applications submitted for receipt dates after October 1, 
1998.

All investigators proposing research involving human subjects should 
read the "NIH Policy and Guidelines" on the inclusion of children as 
participants in research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm. 

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH 
policy requires education on the protection of human subject 
participants for all investigators submitting NIH proposals for research 
involving human subjects.  You will find this policy announcement in the 
NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

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

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

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

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and 
proposals for NIH funding must be self-contained within specified page 
limitations. Unless otherwise specified in an NIH solicitation, Internet 
addresses (URLs) should not be used to provide information necessary to 
the review because reviewers are under no obligation to view the 
Internet sites.   Furthermore, we caution reviewers that their anonymity 
may be compromised when they directly access an Internet site.

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of 
"Healthy People 2010," a PHS-led national activity for setting priority 
areas. This RFA is related to one or more of the priority areas. 
Potential applicants may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance No. 93.121, Oral Diseases and Disorders 
Research 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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