ANCILLARY STUDIES TO NIMH MULTI-SITE CLINICAL TRIALS
Release Date: May 17, 2000 (see addenda NOT-MH-01-005, NOT-MH-00-009, NOT-MH-00-012)
PA NUMBER: PAR-00-095
National Institute of Mental Health
THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. THIS PA INCLUDES
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED
WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS PA.
PURPOSE
The National Institute of Mental Health (NIMH) recently issued four contracts
to support multi-site clinical trials in schizophrenia, Alzheimer’s disease,
bipolar disorder, treatment resistant depression, and adolescent depression.
Information about these trials is available on the NIMH website at
http://www.nimh.nih.gov/studies/index.cfm. NIMH invites investigator-
initiated research project applications for ancillary studies that extend the
utility of the national resource created in these trials. The purpose of
ancillary studies is to promote innovative lines of scientific inquiry
regarding the understanding and treatment of mental disorders. Ancillary
studies may use subjects recruited in a trial; may be an expansion into a new
(related) population at some or all of the clinical sites participating in
the trial; or may simply share methods and measures with the trial.
Ancillary studies must not interfere with the objectives of a trial, and each
trial has an Ancillary Study Committee to review the appropriateness of
proposed projects. The website for each trial contains ancillary study
policies and procedures. Current participation in a trial as a principal
investigator, co-investigator, consultant, or clinical site investigator is
not a prerequisite for submission of an ancillary study application.
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 Program Announcement
(PA), Ancillary Studies to NIMH Multi-Site Clinical Trials, is related to the
priority areas of Mental Health and Mental Disorders. Potential applicants
may obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople/
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic and foreign, for-profit and non-
profit organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State and local governments, and eligible
agencies of the Federal government. Foreign institutions are not eligible
for the Small Grant (R03) mechanism. Racial/ethnic minority individuals,
women, and persons with disabilities are encouraged to apply as principal
investigators.
MECHANISM OF SUPPORT
This PA will use the following research grant mechanisms: Small Grants
(R03), Exploratory/Developmental Grants (R21), Research Project Grants (R01),
and Collaborative R01s for Clinical Studies of Mental Disorders. The Small
Grant (R03) provides two years of funding with a maximum of $50,000 direct
costs for each year. The Exploratory/Developmental Grant (R21) provides up
to three years of funding with up to $125,000 in total direct costs annually,
and is intended for pilot testing of interventions and other aspects of
intervention development. The Research Project Grant (R01) provides up to
five years of funding that is commensurate with the science proposed.
Collaborative R01s for Clinical Studies of Mental Disorders (CSMD) support
research that requires multiple sites and Principal Investigators.
For all competing R03 and R21 applications, and R01 applications requesting
up to $250,000 direct costs per year, specific application instructions have
been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining
efforts being undertaken at NIH. More detailed information about modular
grant applications, including a sample budget narrative justification pages
and a sample biographical sketch, is available via the Internet at:
http://grants.nih.gov/grants/funding/modular/modular.htm. R01 applications
that request more than $250,000 in any year must use the standard PHS 398
(rev. 4/98) application instructions.
Small Grants (RO3s), Exploratory/Developmental Grants (R21), and
Collaborative R01s for Clinical Studies of Mental Disorders, have special
eligibility requirements, application formats, and review criteria.
Applicants are strongly encouraged to consult with program staff (listed
under INQUIRIES) and to obtain the appropriate additional announcements for
those grant mechanisms. These can be found at:
http://grants.nih.gov/grants/guide/pa-files/PAR-99-140.html (R03);
http://grants.nih.gov/grants/guide/pa-files/PA-99-134.html (R21);
http://grants.nih.gov/grants/guide/pa-files/PAR-98-017.html (Collaborative
R01s).
RESEARCH OBJECTIVES
BACKGROUND
The National Institute of Mental Health (NIMH) has made a major commitment to
support treatment research that directly affects and improves public health.
This effectiveness model is a relatively new approach for mental health
treatment researchers, whose studies in the past have either been clinical
trials focused on short term efficacy and regulatory issues, or studies of
systems of care and service utilization. NIMH has issued contracts for four
large-scale multi-site clinical trials: (1) Systematic Treatment Enhancement
Program for Bipolar Disorder (STEP-BD) to investigate strategies for managing
bipolar disorder, (2) Clinical Antipsychotic Trials of Intervention
Effectiveness (CATIE) to study the effectiveness of the new atypical
antipsychotics in schizophrenia and Alzheimer’s disease, (3) Sequenced
Treatment Alternatives to Relieve Depression (STAR*D) to develop algorithms
for managing resistant depression, and (4) Treatment of Adolescents with
Depression Study (TADS). Information about the objectives of each of these
trials, detailed study protocols, and participating investigators and sites
can be found at http://www.nimh.nih.gov/studies/index.cfm.
The trials supported by these contracts address fundamental questions about
the day-to-day care of people with mental illness. However, despite their
size and the level of NIMH’s commitment, they will not be able to answer all
relevant issues. They are only a beginning, and one of NIMH’s goals in
funding these contracts is to develop an infrastructure to facilitate and
foster investigator-initiated research grants that focus on understanding the
nature and course of illness and on improving treatment in the community.
This Program Announcement invites research project applications that make use
of the infrastructures developed in the NIMH clinical trial contracts. The
scope of these projects could range from small pilot studies to multi-site,
multi-principal investigator collaborative research projects. NIMH is
particularly interested in fostering projects by new investigators, as well
as translational research studies that apply basic science findings in a
clinical setting. Ancillary studies might use subjects recruited in the
trials, or might be an expansion into a new (related) population at the
clinical sites participating in the trial, or might simply share data,
methods and resources with the trials. The distinguishing feature of an
ancillary study is that it either requires the resources of a trial to
achieve its goals, or that this involvement and interaction with a trial
significantly enhances the ancillary study’s efficiency or scientific value.
Current participation in a trial as a principal investigator, co-
investigator, consultant, or clinical site investigator is not a prerequisite
for submission of an ancillary study application (although these
investigators can also propose ancillary studies). Since ancillary studies
may involve close interaction with trial participants or personnel, it is
important that the projects be coordinated. In particular, ancillary studies
must not interfere with the objectives of the trial, and an ancillary study
must be approved by the trial before NIMH will consider funding an
application. Each trial has established an Ancillary Study Committee (ASC)
to review proposed projects for appropriateness prior to submitting an
application to NIMH or other potential funding sources. The ASC will also
serve as a point of initial contact for investigators interested in an
ancillary study, and will help formulate methods and develop budgets. Each
Trial ASC has established its own policies and procedures, which can be
obtained via http://www.nimh.nih.gov/studies/index.cfm.
There are currently four multi-site NIMH clinical trials for which ancillary
studies may be considered:
(1) Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD):
The overall goal of this project is to improve treatment of bipolar disorder
by identifying optimal treatments for normalizing mood and preventing
recurrence, as well as providing answers to a host of important questions
confronting clinicians who treat bipolar disorder. The primary objectives
are 1) developing a registry of bipolar patients treated in diverse settings
by a network of clinicians following common clinical practice guidelines; 2)
determining the most effective strategies for treatment of the depressed
phase of bipolar illness; and 3) determining which maintenance strategies
most effectively prevent recurrence of affective episodes.
(2) Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE): The
projects includes two separate trials with a common administrative and
operational core, studying the new atypical antipsychotics in people with
schizophrenia and people with Alzheimer’s disease. The primary objectives of
the schizophrenia trial are to determine the cost effectiveness of the new
atypical antipsychotics compared to conventional agents and to determine the
differential effectiveness of the new atypical antipsychotics compared to one
another. The primary objective of the Alzheimer’s disease trial is to study
the effectiveness of the new atypical antipsychotics in managing psychosis
and severe agitation in people with Alzheimer’s disease.
(3) Sequenced Treatment Alternatives to Relieve Depression (STAR*D): The
overall goal of this project is to develop and evaluate clinical strategies
for improving outcomes for outpatients with treatment resistant depression in
both primary care and specialty settings. The primary objectives are (a) to
determine which "next step" treatments are acceptable to depressed patients
who have failed previous treatments, and provide maximal clinical benefit
with minimal side effects; (b) studying how well these next step treatments
prevent subsequent relapses; and (c) providing estimates of the relative
costs effectiveness and benefits of these treatments.
(4) Treatment of Adolescents with Depression Study (TADS): This project
compares the effectiveness of different treatment modalities in 12-17 year
old patients with major depressive disorder. In this multi-site trial, a
total of 432 teens will be randomized to either pharmacotherapy with
fluoxetine, cognitive-behavioral therapy, combined cognitive-behavioral
therapy plus fluoxetine, or clinical management with placebo medication.
Treatment continues for up to 9 months, depending on clinical response, with
a post-treatment follow-up of 12 months.
EXAMPLES
Examples of appropriate ancillary studies include (but are not limited to)
the following (please note that NIMH’s interest in these topics does not
guarantee approval by a trial’s ASC):
o Developing and testing specific treatment interventions for patients who
are screened for a trial but do not meet the entry criteria, or who reach a
study end-point.
o Studying treatment effects on additional outcome variables not included in
the initial trial protocol.
o Investigating potential moderators and mediators of treatment effects
(including side effects) not already included in the trial protocol
o Follow-up assessments of patients who have completed a trial.
o Population pharmacokinetics of drugs used in a trial.
o Development of pharmacogenetic databases using samples and data from trial
subjects.
o Coordination with existing or new brain banks by characterizing patients
ante-mortem, securing patient and family permission, and collecting post-
mortem brain tissue.
o Investigations with neuroimaging measures of brain function (PET, SPECT,
MRI, MRS) to identify, characterize, and validate biomarkers that predict
treatment response, non-response, or placebo response.
o Investigations with neuroimaging measures of brain function (PET, SPECT,
MRI, MRS) to identify the sites and therapeutic mechanisms of action of
different psychotropic drugs.
o Investigation of illness state, treatment, service use, and outcomes in
persons excluded from a trial because of risk of suicide.
o Development of interventions to manage suicidality in persons excluded
from a trial due to risk for suicide.
o Determining patient, provider and encounter factors that may enhance or
detract from the effective delivery of interventions.
o Assessing and testing methods to more quickly and effectively synthesize
and incorporate results from a trial into clinical practice.
o Characterizing system and organizational factors/processes that interfere
with clinical care of subjects in a trial.
o Investigating and optimizing procedures for assessing capacity and
obtaining informed consent in trial participants.
o Examining stigma and its effects in trial subjects.
o Examining ethnicity, cultural, and socioeconomic factors that influence
outcome in trial participants, including their effects on help-seeking
behavior, formation of therapeutic alliances, and adherence to treatment.
o Investigations of basic behavioral processes (e.g., cognition, emotion,
motivation, personality, social cognition) to identify how these processes
are altered in disorder and/or predict treatment response, non-response, or
placebo response.
o Investigations of the effects of atypical antipsychotics on metabolism and
endocrine function.
o Investigations of the effects of the new atypical antipsychotics on
cardiovascular physiology.
o Investigations of the effects of sex hormones on antidepressant treatment
response in patients demonstrating treatment resistant depression.
o Development and refinement of psychosocial interventions to enhance
adherence to antidepressant medication or psychotherapy regimens in patients
demonstrating treatment resistant depression.
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 policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43).
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 in the NIH Guide for Grants and Contracts, Vol.
23, No. 11, March 18, 1994 available on the web at the following URL address:
http://grants.nih.gov/grants/guide/notice-files/not94-100.html
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of NIH 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 was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html
Investigators also may obtain copies of these policies from the program staff
listed under INQUIRIES. Program staff may also provide additional relevant
information concerning the policy.
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. Reviewers are cautioned that their anonymity may
be compromised when they directly access an Internet site.
APPLICATION PROCEDURES
An ancillary study application must provide written proof of approval from a
trial’s Principal Investigator and its Ancillary Study Committee (ASC) or
Executive Committee both before NIMH accepts it for scientific review, and
again before an award is made.
Applicants are strongly encouraged to contact the program contacts listed
under INQUIRIES with any questions regarding their proposed project and the
goals of this PA and other programmatic priorities.
Applications are to be submitted on the grant application form PHS 398 (rev.
4/98) and will be accepted at the standard application deadlines as indicated
in the application kit. Application kits are available at most institutional
offices of sponsored research and from the Division of Extramural Outreach
and Information Resources, National Institutes of Health, 6701 Rockledge
Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, Email:
GrantsInfo@nih.gov. Applications are also available on the World Wide Web
at: http://grants.nih.gov/grants/forms.htm.
For all competing R03, R21 and R01 applications requesting up to $250,000
direct costs per year, specific application instructions have been modified
to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being
undertaken at NIH. Applications that request more than $250,000 in any year
must use the standard PHS 398 (rev. 4/98) application instructions.
SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS
The modular grant concept establishes specific modules in which direct costs
may be requested as well as a maximum level for requested budgets. Only
limited budgetary information is required under this approach. The
just-in-time concept allows applicants to submit certain information only
when there is a possibility for an award. It is anticipated that these
changes will reduce the administrative burden for the applicants, reviewers
and Institute staff. The research grant application form PHS 398 (rev. 4/98)
is to be used in applying for these grants, with the modifications noted
below.
BUDGET INSTRUCTIONS
Modular Grant applications will request direct costs in $25,000 modules, up
to a total direct cost request of $250,000 per year. (Applications that
request more than $250,000 direct costs in any year must follow the
traditional PHS 398 application instructions.) The total direct costs must
be requested in accordance with the program guidelines and the modifications
made to the standard PHS 398 application instructions described below:
PHS 398
o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs
(in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular
Total Direct plus Facilities and Administrative (F&A) costs] for the initial
budget period. Items 8a and 8b should be completed indicating the Direct and
Total Costs for the entire proposed period of support.
o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page
4 of the PHS 398. It is not required and will not be accepted with the
application.
o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the
categorical budget table on Form Page 5 of the PHS 398. It is not required
and will not be accepted with the application.
o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative
page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for
sample pages.) At the top of the page, enter the total direct costs
requested for each year. This is not a Form page.
o Under Personnel, list key project personnel, including their names,
percent of effort, and roles on the project. No individual salary
information should be provided. However, the applicant should use the NIH
appropriation language salary cap and the NIH policy for graduate student
compensation in developing the budget request.
For Consortium/Contractual costs, provide an estimate of total costs (direct
plus facilities and administrative) for each year, each rounded to the
nearest $1,000. List the individuals/organizations with whom consortium or
contractual arrangements have been made, the percent effort of key personnel,
and the role on the project. Indicate whether the collaborating institution
is foreign or domestic. The total cost for a consortium/contractual
arrangement is included in the overall requested modular direct cost amount.
Include the Letter of Intent to establish a consortium.
Provide an additional narrative budget justification for any variation in the
number of modules requested.
o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by
reviewers in the assessment of each individual's qualifications for a
specific role in the proposed project, as well as to evaluate the overall
qualifications of the research team. A biographical sketch is required for
all key personnel, following the instructions below. No more than three
pages may be used for each person. A sample biographical sketch may be
viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm
- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on
research projects ongoing or completed during the last three years.
- List selected peer-reviewed publications, with full citations;
o CHECKLIST - This page should be completed and submitted with the
application. If the F&A rate agreement has been established, indicate the
type of agreement and the date. All appropriate exclusions must be applied
in the calculation of the F&A costs for the initial budget period and all
future budget years.
o The applicant should provide the name and phone number of the individual
to contact concerning fiscal and administrative issues if additional
information is necessary following the initial review.
Applicants planning to submit an investigator-initiated new (type 1),
competing continuation (type 2), competing supplement, or any amended/revised
version of the preceding grant application types requesting $500,000 or more
in direct costs for any year are advised that he or she must contact
Institute program staff before submitting the application, i.e., as plans for
the study are being developed. Furthermore, the application must obtain
agreement from Institute staff that the Institute will accept the application
for consideration for award. Finally, the applicant must identify, in a
cover letter sent with the application, the staff member and Institute who
agreed to accept assignment of the application.
This policy requires an applicant to obtain agreement for acceptance of both
any such application and any such subsequent amendment. Refer to the NIH
Guide for Grants and Contracts, March 20, 1998 at
http://grants.nih.gov/grants/guide/notice-files/not98-030.html
Any application subject to this policy that does not contain the required
information in a cover letter sent with the application will be returned to
the applicant without review.
The title and number of the program announcement must be typed on line 2 of
the face page of the application form and the YES box must be marked.
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 must be
sent to:
Henry Haigler, Ph.D.
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD 20892-9609
REVIEW CONSIDERATIONS
Applications will be assigned on the basis of established PHS referral
guidelines. Applications will be evaluated for scientific and technical
merit by an appropriate scientific review group convened by NIMH. As
part of the initial merit review, all applications will receive a written
critique and undergo a process in which only those applications deemed
to have the highest scientific merit, generally the top half of applications
under review, will be discussed, assigned a priority score, and receive a
second level review by the appropriate national advisory council or board.
Review Criteria
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In
the written comments reviewers will be asked to discuss the following aspects
of the application in order to judge the likelihood that the proposed
research will have a substantial impact on the pursuit of these goals. Each
of these criteria will be addressed and considered in assigning the overall
score, weighting them as appropriate for each application. Note that the
application does not need to be strong in all categories to be judged likely
to have major scientific impact and thus deserve a high priority score. For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.
(1) Significance: Does this study address an important problem? If the aims
of the application are achieved, how will scientific knowledge be advanced?
What will be the effect of these studies on the concepts or methods that
drive this field?
(2) Approach: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics?
(3) Innovation: Does the project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does the project challenge
existing paradigms or develop new methodologies or technologies?
(4) Investigator: Is the investigator appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to the experience
level of the principal investigator and other researchers (if any)?
(5) Environment: Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements? Is there evidence of institutional
support?
In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:
o The adequacy of plans to include both genders, minorities and their
subgroups, and children as appropriate for the scientific goals of the
research. Plans for the recruitment and retention of subjects will also be
evaluated.
o The reasonableness of the proposed budget and duration in relation to the
proposed research
o 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.
AWARD CRITERIA
Applications will compete for available funds with all other recommended
applications assigned to the Institute. The following will be considered in
making funding decisions: Quality of the proposed project as determined by
peer review, availability of funds, and program priority.
INQUIRIES
Inquiries are encouraged. The opportunity to clarify any issues or questions
from potential applicants is welcome.
Direct inquiries regarding issues related to the trials as well as scientific
issues related to programs in the Division of Services and Interventions
Research to:
John K. Hsiao, M.D.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7160, MSC 9635
Bethesda, MD 20892-9635
Telephone: (301) 443-1185
FAX: (301) 594-6784
Email: jhsiao@helix.nih.gov
Direct inquiries regarding scientific issues related to programs in the
Division of Mental Disorders, Behavior, and AIDS to:
Bruce Cuthbert, Ph.D.
Division of Mental Disorders, Behavior, and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6184, MSC 9625
Bethesda, MD 20892-9651
Telephone: (301) 443-3728
FAX: (301) 443-4611
Email: bcuthbert@mail.nih.gov
Direct inquiries regarding scientific issues related to programs in the
Division of Neuroscience and Basic Behavioral Sciences to:
Steven Zalcman, M.D.
Division of Neuroscience and Basic Behavioral Sciences
National Institute of Mental Health
6001 Executive Boulevard, Room 7177, MSC 9639
Bethesda, MD 20892-9639
Telephone: (301) 443-1692
FAX: (301) 443-4822
Email: szalcman@mail.nih.gov
Direct inquiries regarding fiscal matters to:
Diana S. Trunnell
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2805
FAX: (301) 443-6885
Email: Diana_Trunnell@nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance Nos.
93.242. 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, 45 CFR 66 and 45 CFR 74. This program is not subject
to the intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review.
The PHS strongly encourages all grant and contract recipients to provide a
smoke-free workplace and promote the non-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, and 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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