ANDROGEN RECEPTOR IN PROSTATE GROWTH AND CANCER
 
RELEASE DATE:  April 1, 2002
 
RFA:  DK-02-031
 
National Institute of Diabetes and Digestive and Kidney Diseases
National Institute on Aging

LETTER OF INTENT RECEIPT DATE:  October 16, 2002
APPLICATION RECEIPT DATE:  November 14, 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 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 RFA seeks applications that will foster greater understanding of 
the role of the androgen receptor (AR) in carrying out the signaling 
program that reflects androgen action in the prostate gland.  The long-
term goal is to better our knowledge of the role of androgens, and the 
AR, in growth and development of the prostate, and/or development and 
progression of prostate cancer.

RESEARCH OBJECTIVES
  
Background

In a recent NIDDK RFA (DK-01-008 "Role of Hormones and Growth Factors 
in Prostate Cancer") grant applications were solicited to explore the 
underlying mechanism(s) of action of hormones and growth factors in the 
regulation of prostate development, growth and tumorigenesis. While 
this initiative resulted in the funding of major new projects, 
significant scientific opportunities remain to be exploited.

Advances in the nuclear hormone receptor (NR) superfamily, of which the 
androgen receptor is a member, have revealed a complex pattern of 
hormone action in target tissues and cells in response to hormone 
(ligand).  NRs are ligand-dependent and –independent transcription 
factors, with roles in development, reproduction, metabolism, and 
disease.  For many of the known NRs, including the steroid receptor 
subfamily (ER, PR, GR, and AR), evidence now points to formation of 
large, multicomponent complexes in the nucleus, at the 
promoter/enhancer region of target genes, to effect regulation of 
expression.  The complexes may include coactivators (SRC-1, -2, -3), 
corepressors (NCoR, SMRT), RNA transcripts (SRA), histone acetylases 
(HAT), or deacetylases (HDAC), methylases (CARM1), components of the 
RNA polymerase machinery, and chromatin remodeling factors (ACTR).  
Various combinatorial groupings of these factors appear to be essential 
for expression of genes in a regulated and specific manner.  Examples 
include HDACs that depend on the presence of a specific co-repressor 
(Fishcle et al., Mol. Cell 9:45-57, 2002), or enhancers (e.g. the POU 
domain transcription factor, Oct-1) that recruit specific coactivators 
(Gonzalez and Robins, JBC 276: 6420-6428, 2001).  Importantly, some 
factors when present at inappropriate levels have been implicated in 
malignant transformation, including overexpression of the SRC-2 family 
member AIB(amplified in breast cancer)1 coactivator in some tumors of 
breast, and the fusion protein ETO (eight:to:twentyone), a 
hematopoietic transcription factor fused to a NR (RAR) creating an 
aberrant transcription factor that recruits high levels of corepressor 
in some leukemias.  Exciting use of this basic knowledge has led to 
development of an RAR ligand that relieves repression and leads to 
differentiation of the tumor cells, resulting in remission.  In these 
examples alterations in the combinatorial complex subverts the normal 
program of regulation leading or contributing to tumor formation.

For the AR, new evidence suggests that receptor interaction with other 
structural and signaling molecules in prostate, including caveolin (Lu 
et al. JBC 276: 13442-51, 2001) or Smads (Kang et al. PNAS 98:30181-23, 
2001), affects the ability of AR to regulate gene expression.  
Signaling cross-talk involving novel protein kinases (Yang et al. JBC 
276:15345-53, 2001), such as PAK6, or interaction with elements of the 
cytoskeleton important for nuclear localization (Tyagi et al. Mol. 
Endocrinol. 14:1162-74, 2000), may also be important for hormone 
action.  The net result has been to sharpen our focus on the AR and how 
it functions to carry out a program of gene regulation in prostate in 
response to androgens.  Research is needed to better understand how 
this program functions to regulate normal growth of the prostate and 
how it may be subverted in prostate cancer.  

The revolution in genomics and proteomics has fostered a multitude of 
new approaches, such as array technology, and high throughput mass 
spectroscopy, to identify genes that are up or down regulated at key 
times in the lifecycle of a cell or tissue.  Understanding the 
composition and function(s) of higher order regulatory complexes in 
normal physiology and disease development/progression represents an 
important scientific opportunity.  By utilizing functional genomics it 
may be possible to use computational approaches to dissect known 
regulatory pathways and uncover unknown components (Michelson et al. 
PNAS 99:546-548, 2002) in a way that allows greater integration of 
information and reveal hitherto unrecognized relevance to disease.  The 
NIDDK has attempted to foster the application of these technologies to 
problems in its core mission through a Technology Center initiative 
(DK-01-019 "NIDDK Biotechnology Centers Initiative") in which resources 
were provided to develop technology cores to assist funded 
investigators apply new approaches to their research.  This seed money 
has fostered development of operational technology centers, including 
microarray cores, to subsequently operate on an independent basis. The 
opportunity now exists to integrate new technologies with emerging 
concepts of hormone action to explore the underlying mechanism(s) of 
prostate growth, tumor formation and progression.  

Scope

In order to achieve the objectives of this RFA it may be necessary to 
foster collaborative projects with expertise in molecular 
endocrinology, genomics, proteomics, array technology, developmental 
biology, cancer biology, pharmacology, or physiology.  Specific 
questions that require further research include:

Regulation of gene expression in prostate in response to androgens

Modulation of the androgen signaling program by other signals (cross-
talk) and potential role in growth and tumorigenesis

Determination of the components of AR-nuclear accessory protein 
complexes responsible for determination of specificity and regulation 
of gene expression

Role of aberrant signaling in tumor progression and possible role(s) in 
development of androgen-independent tumor growth 

Identification of AR target genes up- and/or down regulated by hormone 
in normal and transformed prostate through use of DNA arrays, high 
throughput proteomics, in silico computational, or other means  

Development of systems to identify and/or utilize model androgen-
sensitive genes for studies into the mechanism of action of the AR

Determination of key AR-cofactor interaction sites as potential targets 
for development of therapeutic intervention

Elucidation of the mechanism(s) of action of selective receptor 
modulators (SRMs) with potential AR antagonist or selective partial 
agonist activity

In addition, the National Institute on Aging (NIA) is interested in 
funding applications focused on age-related changes in androgen action, 
androgen receptor signaling pathway and interactions with other 
signaling pathways, AR-dependent gene expression, and other androgen- 
and AR-dependent processes that may impact prostate growth in middle-
aged and older men leading to their high risk for prostate- and 
urinary-associated health problems.  This research is very important 
for understanding potentially negative health consequences of 
testosterone replacement in elderly men.  The NIA is also interested in 
funding research relevant to age-related changes in androgen- and AR-
associated actions in minority populations for which substantial health 
disparities exist in the incidence and prevalence of prostate cancer, 
and for which studies have suggested that genetic differences in AR 
structure may exist.

These examples do not preclude other important questions relevant to 
the AR that can be posed by investigators responding to this 
initiative.  In order to accomplish several of the above objectives, 
use of existing NIDDK Biotechnology Centers is encouraged.

MECHANISM OF SUPPORT
 
This RFA will use the NIH R01 and R21 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 1, 2003.

This RFA uses just-in-time concepts.  It also uses the modular and 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.

FUNDS AVAILABLE 
 
NIDDK intends to commit $3M (Total costs) in FY 03 to fund 12 to 15 new 
grants in response to this RFA. The NIA will commit an additional 
$250,000 (Total costs) to fund 1-2 applications. An applicant may 
request a project period of up to 4 years (2 for the R21) per year.  
While the budgets for the R01 are not capped, for the R21 a limit of 
$100,000/year is in place. 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 R01 award will also vary. Although 
the financial plans of the IC(s) 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 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 encouraged to apply to NIH programs.   
 
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 relevant to 
NIDDK to:

Ronald Margolis, Ph.D.
Senior Advisor, Molecular Endocrinology
Division of Diabetes, Endocrinology, and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Democracy II, Room 6107
Bethesda, MD  20892-5460
Telephone:  (301) 594-8819
FAX:  (301) 435-6047
Email: rm76f@nih.gov

o Direct your questions about scientific/research issues relevant to 
NIA to:

Frank Bellino, Ph.D.
Biology of Aging Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 2C231 MSC 9205
Bethesda, MD  20892-9205
Telephone:  (301) 496-6402
FAX:  (301) 402-0010
Email:  fb12a@nih.gov

o Direct your questions about peer review issues to:

Dr. Francisco Calvo
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases 2 
Democracy, Room 752
Bethesda, MD  20892
Telephone:  (301) 594-8897
FAX:  (301) 480-3505
Email: CalvoF@extra.niddk.nih.gov

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

Florence Danshes
Senior Grants Management Specialist
Grants Management Branch, DEA
NIDDK
Democracy II, Room 734
Bethesda, MD  20892
Telephone:  (301) 594-8861
FAX:  (301) 480-3504
Email: fd39j@nih.gov 

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

Jeff Ball
Grants Management Specialist
National Institute on Aging
7201 Wisconsin Ave., Suite 2N212
Bethesda, MD  20892-9205
Telephone:  (301) 496-1472
FAX:  (301) 492-3672
Email: ballj@nia.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. Francisco Calvo
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases  
Democracy II, Room 752
Bethesda, MD  20892
Telephone:  (301) 594-8897
FAX:  (301) 480-3505
Email: fc15y@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.

SPECIFIC INSTRUCTIONS FOR R21 GRANT APPLICATIONS:  Use of the R21 grant 
mechanism for this RFA is intended for pilot and feasibility studies 
related to the scope of this solicitation. Applicants should use the 
PHS398 application (as above), but should not exceed 15 pages for Items 
a-d. All tables, graphs, figures, diagrams, and charts must be included 
within the 25-page limit. Applicants are encouraged to be succinct and 
are reminded that there is no necessity to use all 15-pages allotted to 
Items a-d of the Research Plan. All other instructions listed for the 
PHS398 application should apply.

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 
plus any appendix material must be sent to:

Dr. Francisco Calvo
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases  
Democracy II, Room 752
Bethesda, MD  20892
Telephone:  (301) 594-8897
FAX:  (301) 480-3505
Email: fc15y@nih.gov
 
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 (IC). Incomplete applications will be 
returned to the applicant without further consideration.  If the 
application is not responsive to the RFA as determined by NIDDK program 
staff, CSR staff may contact the applicant to determine whether to 
return the application to the applicant or submit it for review in 
competition with unsolicited applications at the next appropriate NIH 
review cycle.

Applications that are complete and responsive to the RFA will be 
evaluated for scientific and technical merit by an appropriate peer 
review group convened by the NIDDK 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 Diabetes and Digestive 
and Kidney Diseases 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?

SPECIFIC CRITERIA FOR REVIEW OF R21 APPLICATIONS:  R21 applications 
submitted to this RFA should reflect pilot and feasibility studies with 
a high degree of potential significance and innovation, and for which 
there may be more risk and less preliminary data than for a full R01 
submission.

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 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:    October 16, 2002 
Application Receipt Date:         November 14, 2002
Peer Review Date:                 March/April 2003
Council Review:                   May 2003
Earliest Anticipated Start Date:  July 1, 2003

AWARD CRITERIA

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

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

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the 
policy of the NIH that women and members of minority groups and their 
sub-populations must be included in all NIH-supported clinical research 
projects unless a clear and compelling justification is provided 
indicating that inclusion is inappropriate with respect to the health 
of the subjects or the purpose of the research. This policy results 
from the NIH Revitalization Act of 1993 (Section 492B of Public Law 
103-43).

All investigators proposing clinical research should read the AMENDMENT 
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research - Amended, October, 2001," published in the NIH Guide 
for Grants and Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a 
complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_20
01.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. 93.847 for NIDDK, and 93.866 for NIA, 
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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