Full Text DE-95-001

ORAL HEALTH RESEARCH CLINICAL CORE CENTERS

NIH GUIDE, Volume 23, Number 40, November 18, 1994

RFA:  DE-95-001

P.T. 04

Keywords: 
  Oral Diseases 
  Etiology 
  Pathogenesis 
  Epidemiology 
  Disease Prevention+ 


National Institute of Dental Research

Letter of Intent Receipt Date:  January 13, 1995
Application Receipt Date:  June 13, 1995

PURPOSE

The National Institute of Dental Research (NIDR) invites grant
applications for the support of Oral Health Research Clinical Core
Centers (OHRCCCs).  The primary goal of these centers is to enhance
the nation's oral health clinical research capability and, thereby,
facilitate the transfer from the laboratory to the clinic of
fundamental knowledge of the etiology, pathogenesis, epidemiology,
prevention, diagnosis and treatment of oral diseases and
dysfunctions.  This Request for Applications (RFA) consolidates under
one umbrella and announces the first recompetition of all the NIDR
clinical core center programs.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This RFA,
Oral Health Research Clinical Core Centers, is related to the
priority area of oral health.  Potential applicants may obtain a copy
of "Healthy People 2000" (Full Report:  Stock No. 017-001-00474-0) or
"Healthy People 2000" (Summary Report:  Stock No. 017-001-00473-1)
through the Superintendent of Documents, Government Printing Office,
Washington, DC 20402-9325 (telephone 202-783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic for-profit and non-profit
organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State or local governments, and
eligible agencies of the Federal government.  Foreign organizations
are not eligible to apply.  However, domestic applications may
include international components.  Applications with key personnel
such as center directors or principal investigators who are minority
individuals and/or women are encouraged.  Although an application
must be submitted from a single institution, it may include consortia
arrangements with other institutions.

Applicant institutions must provide clear evidence of having a
suitable clinical research base to ensure appropriate utilization of
the added resources that the NIDR would provide through the OHRCCC.
This must include meritorious ongoing clinical research projects
and/or the capability to develop such clinical research.

MECHANISM OF SUPPORT

Support of this program will be through the National Institutes of
Health (NIH) center core grant (P30).  Responsibility for the
planning, direction, and execution of the proposed center will be
solely that of the applicant.

This RFA is a one-time solicitation.  Subsequent support will be
contingent upon program needs and availability of funds.  The total
project period for applications submitted in response to the present
RFA must be five years.  The earliest possible award date will be
December 1, 1995.  In addition to support for pilot and feasibility
studies, support will be provided for shared resources and facilities
(core units), the sharing of which will facilitate the total research
effort.  Each core unit must be utilized by at least two projects.
Applicants must limit their requests to not more than $300,000 direct
costs for the initial budget period.  Where indirect costs are
assigned to a subcontract and counted as direct costs, the direct
cost maximum of $300,000 may be exceeded by the amount of the
indirect costs assigned to the subcontract.  Budget increases of no
more than four percent per year for recurring costs may be requested
for each of the subsequent four years.  Included in the direct cost
maximum of $300,000 are funds with a limit of $45,000 for the support
of specified pilot and feasibility studies, each of which must not
exceed $20,000 in direct costs per year and may last for a maximum
period of two years.  Applications that exceed these limits will be
returned without review.

Pilot and feasibility studies are the only research projects that
will be directly supported by this mechanism.  The OHRCCC will not
provide direct funding for ongoing research projects.  These must be
funded through other sources or support mechanisms.

FUNDS AVAILABLE

It is anticipated that up to four to five awards will be made and up
to $2,250,000 in total costs will be committed for the first year of
support for the entire program, if a sufficient number of
applications of high scientific merit are received.  The receipt of
three competing continuation applications is anticipated.  These
applications will compete for the awards along with other
applications received in response to this RFA.  Although this program
is provided for in the financial plans of the NIDR, the award of
grants pursuant to this RFA is also contingent upon the availability
of funds for this purpose.

Applicants are encouraged to seek additional support from other
public sources and private sector sources, including foundations and
industrial concerns, for activities, including information transfer
and outreach programs, that will complement and expand the OHRCCCs.
A summary of the objectives and financial support for such activities
must be included in the application.

RESEARCH OBJECTIVES

Background

Establishment of the NIDR's Clinical Research Core Centers program
was recommended by an expert panel and highlighted in a 1985 report,
requested by Congress, on NIDR's use of the center and other large
grant mechanisms.  A number of additional advisory groups, including
the National Advisory Dental Research Council, have reaffirmed the
need for expansion in clinical research and the use of core centers
to expedite the translation of new knowledge from the laboratory to
the clinic.

The NIDR initiated this program on October 20, 1989 by issuing an RFA
on Clinical Dental Research Core Centers (CDRCCs).  The primary goal
of these centers was to facilitate clinical research relevant to the
pathogenesis, diagnosis, early detection, prevention, control and
treatment of oral diseases and dysfunctions.  The intent of this
program was to provide the resources and facilities necessary to
develop and to conduct clinical research at the level of
sophistication necessary to expedite the translation of basic
scientific knowledge into new and better methods for improving the
oral health of the nation.  Two CDRCCs were funded on September 30,
1990.

A second RFA on Clinical Core Centers for Oral Health Research
(CCCOHR) was issued by NIDR on January 4, 1991.  This type of center
was intended to facilitate and stimulate clinical research to improve
oral health in adults, senior citizens, and other groups at high risk
for oral diseases.  Such groups include individuals with systemic
diseases (e.g., diabetes), undergoing medical treatments (e.g.,
chemotherapy or radiation), or having oral conditions (e.g.,
xerostomia) that increase the risk for oral diseases or tooth loss,
and rural residents and members of minority groups who have not
shared the gains in oral health seen in many segments of the U.S.
population.  One CCCOHR was funded on September 15, 1991.

Another major objective of the clinical research core center programs
was to encourage expanded funding from other public and private
sector sources (e.g., industry, foundations, or other government
agencies) for both ongoing and new clinical research projects
utilizing the center core units, thereby contributing to the cost-
effectiveness of these centers.  In addition to support for core
units, funds were available for pilot and feasibility studies.
Moreover, it was expected that the applicant institution would have
ongoing clinical research projects and/or the potential to develop,
through complementary non-NIDR funding, clinical research projects
which would utilize the core units.

Preliminary data suggest that considerable progress already has been
made toward the original goals of the existing centers.  Highlights
of progress include success in attracting substantial funds and in-
kind contributions from other public and private sector sources,
establishment of one or more training courses in clinical research
methodology, and contributions to several significant research
advances.

The present RFA on OHRCCCs consolidates under one umbrella and
announces the first recompetition of the original clinical research
core center programs.

Center Goals and Scope

The primary goal of the OHRCCCs is to provide the shared resources
and facilities necessary to develop and to conduct clinical research
at the level of sophistication necessary to expedite the translation
of basic scientific knowledge into new and better methods for
improving the oral health of individuals of all ages and of all
segments of the U.S. population irrespective of the afflicting oral
disease or dysfunction.  The centers, thereby, are intended to:
provide nuclei around which additional clinical studies, funded
through government or private sources, can be conducted; encourage
increased collaboration among the various disciplines of oral health
clinical research and among basic and clinical scientists with
expertise relevant to this initiative; and serve as magnet
organizations to foster productive research-related relationships
with other institutions.  The secondary goal of the OHRCCCs is to
foster the development of clinical research scientists at all levels
of career development by providing improved opportunities for
collaboration and expanded environments for clinical research.

The clinical research supported by these centers must be relevant to
the attainment of the NIDR's objectives.  Research areas of interest
include, but are not limited to:  the epidemiology, etiology,
pathogenesis, diagnosis, prevention and treatment of dental caries,
periodontal and soft tissue diseases, oral cancer and manifestations
of AIDS, salivary gland disorders, craniofacial anomalies and
orofacial pain; trigeminal neurobiology; the relationship of
behavioral, social, economic and cultural factors to oral diseases;
biomaterials, pulp biology and implants; the role of fluoride and
nutrition in oral health and disease; and clinical research to
improve oral health in the elderly, women, minorities, and other
groups at high risk for oral diseases.

Center Characteristics

Each OHRCCC must be a clearly defined organizational entity within a
dental school or dental research institution with a director
responsible for management of the center.  Strong and effective
scientific leadership must be provided.  The application should
specify provisions that will be made for replacement of the director
with a suitably qualified alternative should circumstances require.
OHRCCC directors will be responsible for the organization and
operation of the centers and for communication with the OHRCCC
advisory panels and with the NIDR on scientific and administrative
matters.  Directors will be responsible for maintaining high-quality
research efforts and for ensuring effective collaboration among
OHRCCC scientists.  It is essential that the various elements of the
OHRCCC be interrelated and that their utilization facilitates an
enhanced quality and quantity of clinical oral health research.

Funding of an OHRCCC is intended to support shared resources and
facilities (core units) that will enhance and extend the
effectiveness of clinical research related to improving the oral
health of the nation.  Each center must include a minimum of three
core units.  One unit must be an administrative core.  A
biostatistics core unit also is mandatory.  The biostatistics
component may be incorporated into the administrative core.  Other
cores proposed must directly relate to ongoing and planned oral
health clinical research activity of the center.

Descriptions of core units include:

o  Administrative Core:  Funds for the center director and
administrative staff will be provided.  This core unit should ensure
that OHRCCC participants are provided with shared support services
that enhance their research.  The director will be responsible for
monitoring the overall quality and the scope of center activities.
The administrative core may provide limited funds to facilitate
improved accrual of patient populations for pilot studies for
subsequent studies supported through collateral funding.

The director will convene an advisory panel of experts from outside
the applicant institution at least once a year to review center
activities and provide a written report on the progress of the
center.  This report may be included in the center's annual progress
report to the NIDR.  The center director will be expected to utilize
panel recommendations in guiding and strengthening OHRCCC activities.
Pilot and feasibility studies also will be administered through the
administrative core and will remain under the purview of the center
director.

o  Biostatistics, Experimental Design, Data Management and Analysis
Core:  This core will provide the staff and other resources needed to
enhance programs of clinical research through the application of
epidemiology, sampling, biostatistics, and related support
methodologies.  Specifically, it should foster and strengthen
biostatistician-clinical investigator interaction in the design and
conduct of clinical research.

o  Diagnostics Core:  May provide and develop methods and/or
instrumentation to detect early signs or markers of oral disease or
dysfunction and to monitor the efficacy of treatments.

o  Laboratory Core:  May provide resources and scientific expertise
to carry out adjunct studies on clinical trial patients or general
population samples.  Animal resources may be included where
appropriate.  Laboratory cores could include, for example:
behavioral/social sciences, biomaterial sciences, pharmacology,
microbiology, immunology, nutrition, or molecular biology.  The
composition of the laboratory core(s) should reflect the resource
needs and added research opportunities arising from ongoing clinical
research activities.

o  Unique Clinical Facilities Core:  May provide resources to
facilitate research that cannot be carried out in conventional
health-care settings, such as the use of mobile units for clinical
studies involving elderly or physically disabled individuals or
worksite-based dental operatories for preventive interventions with
employed adults.

The above descriptions are not intended to include the full range of
possible activities.  Inclusion of core units of all these types in a
single proposed center is not required nor even necessarily
advisable.  In structuring OHRCCC proposals, applicants should
consider their institution's areas of special clinical research
potential, its profile of currently funded clinical research
projects, and determine which areas present the greatest need for
shared resources.  Cores may provide support for personnel, including
the necessary expertise to direct cores, equipment, supplies,
services, facilities, and limited travel.  In addition, they may
provide funds for the integration of activities with other research
centers in the same or related biomedical or behavioral/social
science areas for purposes of program enrichment.

Applicants from institutions that have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research
Resources may wish to identify the GCRC as a resource for conducting
the proposed research.

This award also will provide up to $45,000 (i.e., no more than 15
percent of direct center costs) for pilot and feasibility studies.
These are the only research projects that will be directly supported
by this mechanism.  The OHRCCC will not provide direct funding for
ongoing research projects.  These must be funded through other
sources or support mechanisms.  Each pilot or feasibility study must
not exceed $20,000 in direct costs per year and must not extend for a
period of more than two years.  The goals of the pilot and
feasibility studies are to provide start-up funds for new projects,
to develop young investigators under the direction of experienced
clinical scientists and to encourage established investigators to
utilize recent research techniques in addressing areas of oral health
concerns.  Research plans for pilot and feasibility projects to be
carried out during the first and second years of the award and
detailed procedures for the review and selection of future such
projects by advisory panels and the center director must be included
in the application.

SPECIAL REQUIREMENTS

Each OHRCCC will be expected to establish, as an integral component
of its mandatory biostatistics core unit, a plan that includes
offering a regularly scheduled workshop and/or intensive minicourse.
This plan should foster training in clinical oral health research
methodology for basic scientists and clinicians, either with or
without prior postdoctoral research experience.  This may be
accomplished through utilization of OHRCCC resources and/or
associated projects and training grants supported by the NIH or by
other public or private sources.  Applicants should provide details
of this plan in their applications and include pertinent funds, if
any, in their budget requests.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS

It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion  of Minorities in Study Populations) which
have been in effect since 1990.  The new policy contains some new
provisions that are substantially different from the 1990 policies.

All investigators proposing research involving human subjects should
read the "NIH Guidelines For Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted
in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18,
1994.

Investigators may obtain copies from these sources or from the
program staff listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.

LETTER OF INTENT

Prospective applicants are asked to submit, by January 13, 1995, a
letter of intent.  This must include a descriptive title for the
OHRCCC and each pilot and feasibility project and core, give the
name, address, and telephone number of the center director and the
identities of other key personnel and participating institutions and
departments, and identify this RFA by number and title.

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 is helpful in planning for the timely
review of applications.  It allows NIDR staff to estimate the
potential review workload and to avoid possible conflicts of interest
in the review.

The letter of intent is to be addressed to Dr. G.G. Roussos at the
address listed under INQUIRIES.

APPLICATION PROCEDURES

Prospective applicants are encouraged to communicate with program and
grants management staff of the NIDR's Extramural Program as early as
possible in the planning phase of application preparation.  Advice
and suggestions by staff may materially assist applicants to ensure
that the OHRCCC's objectives and structure and the budget format are
acceptable.

Applications are to be prepared on form PHS 398 (rev. 9/91),
available at most institutional offices of sponsored research and
from the Office of Grants Information, Division of Research Grants
(DRG), National Institutes of Health, 5333 Westbard Avenue, Room 449,
Bethesda, MD 20892, telephone 301-435-0714.  The RFA label available
in the PHS 398 application form kit must be affixed to the bottom of
the face page of the original and the original must be placed on top
of the entire package.  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, in order to
identify the application as a response to this RFA, the RFA title
"Oral Health Research Clinical Core Centers" and number "DE-95-001"
must be typed in item 2a of the face page of the application form and
the YES box must be checked.

The instructions accompanying form PHS 398 must be followed as far as
possible, but some modification will be necessary.  For example, a
new Table of Contents must be prepared giving page numbers for all
items in the application.  Pagination must be consecutive throughout
the application.  Each pilot or feasibility project and core unit
must be identified by number and investigator.  A consolidated budget
for the complete OHRCCC for the entire project period must be
presented (use page 5, form PHS 398).  Separate detailed, annual and
total budgets for the entire project period for each project and core
must be presented (use pages 4-5, form PHS 398).  In addition, a
summary table must be included providing budget totals for each
project and core and for the entire program, for all years of
support.  Direct and indirect costs are to be given.  Funds may be
requested for professional, technical, and administrative personnel,
consultant services, equipment, supplies, travel, patient costs
directly related to the research, minor renovations and other costs.
Detailed justification of the budget requests will be required.

Specific attention should be given to efforts to contain costs and
ensure cost-competitive implementation of center goals.  Accordingly,
provide a summary of additional financial support from non-NIDR
sources for activities that will complement and expand the program
proposed for support by the NIDR.  Explain how these activities will
further the goals of the OHRCCC and make it more cost-effective.
Awardees will be expected to update this information on an annual
basis.

Under Research Plan, describe the goals of the center and explain how
each proposed core and pilot/feasibility project will contribute
toward achieving those goals.  Describe the administrative structure,
the responsibilities of the center director, individual
investigators, advisory groups, and the proposed mechanisms for
monitoring scientific progress.  Describe the relationship of all
existing and pending institutional research projects that may be
relevant to the OHRCCC regardless of funding source.

Each core unit must be presented as in a research grant application,
that is, the instruction pages 19-24 of form PHS 398 should be
followed.  The 25-page limitation will apply to each core unit.  Each
pilot/feasibility study must be presented as in a small grant
application, that is, the Research Plan may not exceed ten pages.
Additional instructions and guidelines, in this connection, are to be
found in the NIDR Small Grant Program announcement PA-91-36:  NIH
GUIDE, Vol. 20, No. 12, March 22, 1991, and in its modification by
the notice that appeared in the NIH GUIDE, Vol. 22, No. 1, January 8,
1993.  Abstracts (page 2, form PHS 398) must be completed for the
entire application, each core unit, and for each pilot and
feasibility study proposed for initiation during the first two years
of the award.

Whenever appropriate, the application must: (a) delineate all
consortia arrangements and formally and officially confirm them by
signed statements from the responsible official(s) of each
institution; (b) be accompanied by firm funding commitments that
ensure that appropriate clinical research projects will be active at
the time of an OHRCCC award; and (c) include a letter of agreement
from either the GCRC program director or principal investigator
should the applicant identify a GCRC as a resource for conducting the
proposed research.

Submit a signed, typewritten original of the application, including
the Checklist, and three signed photocopies, in one package to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

At the time of submission, two additional copies of the application
must also be sent to:

Dr. H. George Hausch
Extramural Program
National Institute of Dental Research
Natcher Building, Room 4AN-44F
45 Center Drive MSC 6402
Bethesda, MD  20892-6402

Applications must be received by June 13, 1995.  If an application is
received after that date, it will be returned to the applicant
without review.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the
Division of Research Grants (DRG) and responsiveness by the NIDR.
Incomplete applications will be returned to the applicant without
further consideration.  If NIDR staff find that the application is
not responsive to the RFA, it will be returned 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 NIDR in accordance with the review
criteria stated below.  As part of the initial merit review, a
process (triage) may be used by the initial review group in which
applications will be determined to be competitive or non-competitive
based on their scientific merit relative to other applications
received in response to the RFA.  Applications judged to be
competitive will be discussed and be assigned a priority score.
Applications determined to be non-competitive will be withdrawn from
further consideration and the principal investigator/program director
and the official signing for the applicant organization will be
promptly notified.  Secondary review of the applications will be
conducted by the National Advisory Dental Research Council.

Major factors to be considered in the evaluation of the applications
include:

o  The scientific merit of cores and pilot projects.  This element
involves, but is not limited to:

(a) the availability of a base of meritorious ongoing clinical
research projects or proposed projects with firm funding commitments
permitting optimal utilization of OHRCCC resources;

(b) the extent to which the center will expedite the translation of
basic scientific knowledge into new and better methods for improving
oral health;

(c) the feasibility and relevance of plans for fostering training in
clinical research methodology;

(d) the scientific/technical merit and justification for requested
core resources;

(e) the scientific merit, appropriateness and relevance of pilot and
feasibility projects proposed to be conducted during the first two
years of the award; and

(f) the ability to recruit individuals from appropriate study
populations (i.e., women, subpopulations of minorities and disabled
individuals) as defined by the NIH guidelines along with provisions
for their protection from research risks and the humane treatment of
any animal research subjects that may be used.

o  The experience of the director and key staff.  This element
involves, but is not limited to:

(a) the scientific, clinical and administrative qualifications,
experience and commitment of the center director and his/her ability
to provide effective leadership as well as the provisions for
selection of his/her replacement should it be necessary; and

(b) the competence and commitment of the key center staff
participating in core units and pilot/feasibility studies.

o  The scientific and administrative structure of the center.  This
element involves, but is not limited to:

(a) the provisions for quality control during the development of the
application and establishment of the center;

(b) the procedures for monitoring the research;

(c) the mechanisms for reviewing changes in research direction;

(d) the composition and use of internal and external advisory
committees;

(e) the commitment of the institution to the proposed center; and;

(f) the combination of the various projects and core units into an
effective and cohesive program, and the adequacy of plans to ensure
efficient collaboration, interaction, and dissemination of
information among investigators.

o  The budget and period of support for the center.  This element
involves, but is not limited to:

(a) the adequacy of the budget justification for each pilot and
feasibility project and core resource as well as for the entire
center; and

(b) the extent to which complementary projects, supported from non-
NIDR funds, will contribute to the cost-effectiveness of the proposed
OHRCCC.

o  In the case of a competing continuation application, the progress
made toward the original goals of the existing center in terms of:

(a) success in attracting funds and in-kind contributions from other
public and private sector sources;

(b) establishment of one or more courses in clinical research
methodology; and

(c) contribution to significant research advances.

The inclusion of pilot projects or cores deemed to have limited
scientific merit or that are considered peripheral to the OHRCCC's
objectives may be considered a reflection of the center director's
judgement and may adversely affect the rating of the application.
Component pilot projects or cores lacking significant and substantial
merit will not be recommended for further consideration.  Pilot
projects or cores with only adequate merit that are not deemed
essential to success of the OHRCCC may be recommended for deletion.

AWARD CRITERIA

The earliest anticipated date of award is December 1, 1995.
Applicants should be aware that, in addition to scientific merit,
program priorities and program balance, the total cost of the OHRCCC
to the NIDR will be considered by NIDR staff and the National
Advisory Dental Research Council in making funding recommendations.
One consideration will be the extent to which complementary projects,
supported from non-NIDR funds, will contribute to the
cost-effectiveness of the proposed OHRCCC.  In circumstances in which
applications have similar scientific merit, but vary in cost-
competitiveness, the NIDR is likely to select the more cost-
competitive application for funding.

Once funded, an OHRCCC may undergo an interim peer review by NIDR to
evaluate progress.  Funding for subsequent years may be contingent on
successful outcome of this review.

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.

Direct inquiries regarding programmatic issues to:

Dr. G.G. Roussos
Extramural Program
National Institute of Dental Research
Natcher Building, Room 4AN 18A
45 Center Drive MSC 6402
Bethesda, MD  20892-6402
Telephone:  (301) 594-5500
FAX:  (301) 480-8318
Email:  roussosg@de45.nidr.nih.gov

Direct inquiries regarding grants management issues to:

Ms. Theresa Ringler
Extramural Program
National Institute of Dental Research
Natcher Building, Room 4AS-55
45 Center Drive  MSC 6402
Bethesda, MD  20892-6402
Telephone:  (301) 594-4800
Email:  rubinstein@de45.nidr.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.121. Awards are made under authorization of the
Public Health Service Act, Title IV, Part A (Public Law 78-410, as
amended by Public Law 99-158, 42 USC 241 and 285) and administered
under PHS grants policies and Federal Regulations 42 CFR 52 and 45
CFR Part 74.  This program is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency
review.

The Public Health Service strongly encourages all grant recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.

.

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