LEIOMYOMATA UTERI: BASIC SCIENCE AND TRANSLATIONAL RESEARCH
 
RELEASE DATE:  November 18, 2002 
 
RFA:  HD-03-005

National Institute of Child Health and Human Development (NICHD)
 (http://www.nichd.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS)
 (http://www.niehs.nih.gov/)
Office of Research on Women's Health (ORWH)
 (http://www4.od.nih.gov/orwh/)

LETTER OF INTENT RECEIPT DATE:  March 14, 2003

APPLICATION RECEIPT DATE:  April 14, 2003
 
THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism 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 Child Health and Human Development (NICHD), the 
National Institute of Environmental Health Sciences (NIEHS), and the NIH 
Office of Research on Women's Health (ORWH) invite new and experienced 
investigators to submit research grant applications in basic science, 
environmental health science, and translational research with the goal of 
translating advances in our understanding of the molecular basis of 
leiomyomata uteri (uterine fibroids) into new therapies for prevention, 
treatment, and cure of this common benign gynecologic disorder.  This 
solicitation focuses on basic science and translational research studies that 
are innovative in their approach to determine the complex molecular basis of 
this disorder.  Results from this research are expected to have important 
applications for moving advances in basic science research from the 
laboratory to clinical practice.
 
RESEARCH OBJECTIVES

Background

This initiative addresses the need to increase our knowledge and 
understanding about leiomyomata uteri and the biological processes that lead 
to their development and long-term sequelae.  The objective is to strengthen 
research in this critical area of women's health, contribute to reducing the 
burden of this disease, and improve the quality of life for women affected 
with this disorder.  Uterine leiomyomata constitute a significant public 
health concern.  While uterine leiomyomata represent the most common 
gynecologic tumor in women, the mechanisms that initiate uterine leiomyoma 
growth and pathogenesis are not completely understood.  Several studies 
estimate that 20 to 40 percent of reproductive age women have uterine 
leiomyomata and, according to some reports, they are diagnosed in African 
American women two to three times more frequently than in Caucasian women.  
This disorder is clinically important because it is a significant source of 
abnormal uterine bleeding, anemia, and pelvic pain.  In addition to pain, 
uterine leiomyomata may press on adjacent structures, leading to difficulty 
with urination or defecation or dyspareunia.  These symptoms frequently lead 
to various medical and/or surgical interventions.  Surgical procedures are of 
primary concern, because uterine leiomyomata remain the leading indication 
for a hysterectomy in the United States.  Thus, both the economic costs and 
effect on quality of life can be substantial.  Increased emphasis on a 
condition that poses a serious reproductive threat for many women and 
represents a disproportionate burden for African American women can enhance 
our ability to preserve the fertility and reproductive health of all women. 

To address the need for increased attention in this area, NICHD collaborated 
with the ORWH in sponsoring a workshop in 1992 on "Abnormal Uterine Bleeding, 
Myomas and Infertility."  At the workshop, experts defined and prioritized 
research needs.  The presentations and discussions stimulated the development 
of ideas for new projects and, because of this meeting, the research 
community was made aware of the interest of NICHD in these areas.  This 
workshop was followed by a Request for Applications on the Pathophysiology of 
Endometriosis and Leiomyomata Uteri (RFA-HD-93-04), resulting in the award of 
several new grants.  In a subsequent workshop, convened in 1994, on 
"Alternatives to Hysterectomy--Bench to Bedside," funded investigators, along 
with outside experts, were brought together to discuss how evolving basic 
science could now provide a framework for more applied or clinical research.  
Topics included medical regimens, such as utilization of gonadotropin-
releasing hormone (GnRH) analogs, antiprogestins, prostaglandin inhibitors, 
and conservative surgical approaches.  This meeting demonstrated that while 
researchers have gained some insight into the mechanisms that mediate uterine 
leiomyoma development and growth, and some progress has been made, many 
challenges remain.  On October 7-8, 1999, the NICHD in collaboration with 
NIEHS, ORWH, and the Public Health Service, Office of Women's Health, 
convened another conference, entitled "Women's Health and the Environment: 
The Next Century--Advances in Uterine Leiomyoma Research," to explore the 
state-of-the-science.  The distinguished panel of speakers provided a review 
of the current approaches to the pathophysiology, mechanisms of tumor 
development, epidemiology, environmental influences, and clinical 
therapeutics related to uterine leiomyomata.  A summary of the conference was 
published in Environmental Health Perspectives, 2000, 108 (S5) 769-773.  In 
response to recommendations made at the conclusion of this conference, 
priority was placed on stimulating relevant research strategies focusing on 
promising and innovative studies that would continue to enhance our knowledge 
of uterine leiomyomata.  These activities have formed the groundwork for 
assessing future research opportunities and complementing the ongoing 
commitment of NICHD, NIEHS, and ORWH to support research important to women's 
reproductive health.  

Research Scope

The general scope of proposed studies could encompass determining the 
etiology, diagnostic criteria, and underlying pathophysiology deemed 
important for building a substantive knowledge base.  Critical variables for 
uterine leiomyoma growth, such as hormonal stimulation, molecular and 
cytogenetic changes, differences in cell regulation, and the influence of 
exposures to environmental agents are areas for further assessment.  
Moreover, aspects of research such as preclinical studies, animal models, 
basic biological processes, genetic factors, and translational research are 
all potential avenues for further examination.  This initiative is expected 
to increase our knowledge about the underlying mechanisms that will build a 
framework for strengthening the science base, improving clinical 
applications, and providing clues for more effective conservative management 
of this clinically relevant disorder.

Examples of the scope of research topics considered responsive to this 
announcement include, but are not limited to, the following:

o Initiation of a genome-wide screen to characterize the genetic liability 
for developing uterine leiomyomata, with particular emphasis on racial 
overexpression in African American women, twin-pair correlation, and familial 
predisposition; 

o Elucidation of the role of genetic alterations in the process of tumor 
transformation, correlating the cytogenetic and/or genomic abnormalities with 
phenotypic expression; 

o Development of surrogate animal models to assess the mechanism of leiomyoma 
formation and to screen for candidate therapeutic agents and prevention 
strategies; 

o Identification of the basic molecular and cellular processes and 
examination of the mechanisms by which estrogen and progesterone induce cell 
transformation and promote tumor growth or suppression.  Clarification of the 
interaction between estrogen and progesterone and related growth factors;

o Study of the potential role of selective estrogen receptor modulators 
(SERMs) on uterine leiomyoma development and growth.  Further 
characterization of endocrine disrupters and their influence on the risk of 
uterine leiomyoma formation, including the effect of time of exposure (fetal, 
neonatal, pubertal or adult) and dose relationships on the initiation or 
exacerbation of uterine leiomyoma development; 

o Assessment of whether growth factor expression is the framework through 
which abnormal myometrial cellular and extracellular growth can be explored 
to clarify the interaction between estrogen/progesterone and growth factors 
and/or environmental exposures on uterine leiomyoma initiation and 
development; 

o Identification of noninvasive biomarkers to delineate molecular alterations 
at specific stages of tumor development and definition of molecular markers 
for uterine leiomyoma progression and recurrence;

o Facilitation of collaborative molecular studies through the establishment 
of a tissue bank; 

o Development of new avenues for diagnostic and conservative treatment 
modalities that target relevant hormonal pathways for uterine leiomyoma 
formation, including the design of novel pharmaceutical agents directed at 
these pathways;

o Examination of gene-environment relationships including an examination of 
genetic polymorphisms in key pathways and the effects of various 
environmental insults, such as the exposures to solvents, pesticides, water 
disinfection byproducts, and metals singly or in mixtures in the initiation 
or exacerbation of uterine leiomyoma.  These studies may include 
transgenerational effects as well as developmental vulnerability. 

MECHANISM OF SUPPORT
 
This RFA will use the NIH individual research project grant (R01) award 
mechanism.  As an applicant you will be solely responsible for planning, 
directing, and executing the proposed project.  This RFA is a one-time 
solicitation.  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 September 30, 2003.

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

FUNDS AVAILABLE 
 
The NICHD intends to commit approximately $2 million [Direct plus Facilities 
and Administrative (F & A) costs] in FY 2003 to fund five to six new grants 
in response to this RFA.  The NIEHS intends to commit up to $600,000 [Direct 
plus Facilities and Administrative (F&A) costs] in FY 2003 to fund up to two 
grants with an emphasis on the role of environmental exposures on the 
initiation or exacerbation of uterine leiomyoma.  An applicant may request a 
project period of up to five years and a budget for direct costs of up to 
$250,000 per year.  Because the nature and scope of the proposed research 
will vary from application to application, it is anticipated that the size 
and duration of each award will also vary.  Although the financial plans of 
the NICHD and NIEHS 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 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 

Annual Investigator Meeting  

After initiation of the program, the NICHD will sponsor a meeting to 
encourage the exchange of information among investigators who participate in 
this program.  In the preparation of the budget for the grant application, 
applicants should include travel funds for the meeting to be held in 
Bethesda, Maryland.  Applicants should also include a statement in the 
applications indicating their willingness to participate in such a 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 two 
areas:  scientific/research and financial or grants management issues:

o Direct your questions about basic science and translational 
scientific/research issues or general RFA matters to:

Estella Parrott, M.D., M.P.H.
Center for Population Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B01, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-6515
FAX:  (301) 496-0962
Email:  ep61h@nih.gov

o Direct your questions about the role of environmental agents or 
environmental scientific/research issues to:

Jerrold Heindel, Ph.D.
Organs and Systems Toxicology Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
79 T.W. Alexander Drive
4401 Building
Research Triangle Park, NC 27709
Telephone:  (919) 541-0781
FAX:  (919) 541-0781
Email:  heindelj@niehs.nih.gov 

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

Ms. Kathy Hancock
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17, MSC 7510 
Bethesda, MD  20892-7510
Telephone:  (301) 496-5482
FAX:  (301) 480-4782
Email:  kh47d@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 NIH 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:

Estella Parrott, M.D., M.P.H.
Center for Population Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B01, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-6515
FAX:  (301) 496-0962
Email:  ep61h@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.
 
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS:  Applications 
requesting up to $250,000 per year in direct costs must be submitted in a 
modular grant format.  The modular grant format simplifies the preparation of 
the budget in these applications by limiting the level of budgetary detail.  
Applicants request direct costs in $25,000 modules.  Section C of the 
research grant application instructions for the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step 
guidance for preparing modular grants.  Additional information on modular 
grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

USING THE RFA LABEL:  The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  Failure to use this label 
could result in delayed processing of the application such that it may not 
reach the review committee in time for review.  In addition, the RFA title 
and number must be typed on line 2 of the face page of the application form 
and the YES box must be marked. The RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
 
SENDING AN APPLICATION TO THE NIH:  Submit a signed, typewritten original of 
the application, including the Checklist, and five 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)
 
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 NICHD and NIEHS.  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 NIH 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 Child Health and 
Human Development Council and the National Advisory Environmental Health 
Sciences 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 humans, animals, 
or the environment, to the extent they may be adversely affected by the 
project proposed in the application.

o INCLUSION:  The adequacy of plans to include subjects from both genders, 
all racial and ethnic groups (and subgroups), and children as appropriate for 
the scientific goals of the research.  Plans for the recruitment and 
retention of subjects will also be evaluated.  (See Inclusion Criteria 
included in the section on Federal Citations, below.)

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

o 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:  March 14, 2003
Application Receipt Date:  April 14, 2003
Peer Review Date:  June 2003
Council Review:  September 2003
Earliest Anticipated Start Date:  September 30, 2003

AWARD CRITERIA

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 is available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable; 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them. This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.  All investigators proposing research 
involving human subjects should read the "NIH Policy and Guidelines" on the 
inclusion of children as participants in research involving human subjects 
that is available at 
http://grants.nih.gov/grants/funding/children/children.htm. 

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

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

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

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

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

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

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of 
Federal Domestic Assistance Nos. 93.864 and 93.113 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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