INNOVATIONS IN TRANSLATIONAL EPILEPSY RESEARCH FOR JUNIOR INVESTIGATORS
Release Date: March 27, 2000
RFA: NS-01-006
National Institute of Neurological Disorders and Stroke
http://www.ninds.nih.gov
Letter of Intent Receipt Date: October 1, 2000
Application Receipt Date: November 15, 2000
THIS RFA USES THE MODULAR GRANT AND JUST-IN-TIME CONCEPTS. IT
INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS
THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA.
PURPOSE
The National Institute of Neurological Disorders and Stroke (NINDS) is
interested in promoting collaborations among junior investigators
(Postdoctoral Fellows through Assistant Professors, or equivalent) to
stimulate translational research in the field of epilepsy. This
exploratory grants program is being issued in conjunction with the
White House-initiated, NIH-sponsored conference, "Curing Epilepsy:
Focus on the Future." To this end the NINDS invites
exploratory/developmental research grant applications (R21) in patient-
oriented research, developmental neurobiology, genetics, advanced
technology, imaging, pharmacotherapeutics, or other research areas,
which are likely to lead to the cure of epilepsy (defined as "the
prevention of epilepsy before it occurs in people at risk, and the
cessation of seizures without therapy-associated side effects in those
who develop the disease"). Emphasis will be placed on cross-
disciplinary collaborations, novel hypotheses, and unique approaches in
applying fundamental neurobiological concepts to epilepsy research.
Special consideration will be given to proposals that enhance the
application of scientific knowledge to the understanding and treatment
of the disorder. This initiative requires collaborations of two or
more junior investigators at different institutions, or in different
laboratories within the same institution. Investigators already
working together at the same department are not eligible.
RESEARCH OBJECTIVES
The purpose of this initiative is to 1) focus attention of young
investigators on translational research in epilepsy; 2) promote the
interaction of basic researchers and clinical scientists; and 3)
provide preliminary information leading to the prevention and cure of
epilepsy. The ultimate goal is to effect meaningful advances in
understanding the factors that contribute to epileptogenesis, and to
develop interventions and effective treatments that improve the quality
of life of people with the disorder.
Background
Epilepsy, characterized by the repeated occurrence of uncontrolled
seizures, is one of the most common neurological disorders in our
country. It currently afflicts approximately 15 million Americans of
all ages and backgrounds. Epilepsy exacts an enormous toll on patients
and their families, and has a huge impact on society related to loss of
employment potential and the cost of medical care. Despite many
decades of research, new anticonvulsant drugs, and advances in
surgical therapy, a large number of people with epilepsy suffer from
incompletely controlled seizures or the side effects of drugs or
surgical treatment. For these patients, current approaches to
treatment will, at best, lessen but not prevent the occurrence of
seizures. At worst, current therapies cause debilitating side effects
and have little or no effect on seizures. In addition, there has been
complacency on the part of the medical establishment to accept partial
control of seizures, or therapy-associated side effects, as an
acceptable, long-term outcome for patients with epilepsy.
Research in neuroscience has escalated rapidly in the past decade,
especially in the areas of molecular biology, genetics, neuroimaging,
and clinical diagnosis. The purpose of this initiative is to apply
this knowledge to curing epilepsy. The initiative requires
collaborations among two or more junior investigators at different
institutions or at different laboratories within the same institution.
The intent is to develop innovative proposals in translational epilepsy
research. Potential topic areas for proposals may include, but are not
limited to: mechanisms for interrupting or modifying the process of
epileptogenesis (i.e., approaches aimed at preventing the formation of
a seizure focus in patients at risk for epilepsy); identification and
characterization of genetic mutations that are the basis of inherited
forms of epilepsy and which can provide a means of understanding the
causes of seizures and determining treatment strategies; studies of the
basic biology of neural development that might contribute to
identification of the molecular basis for abnormalities observed in
some patients; visualization of structural and functional changes in
the brains of patients using advanced imaging technologies such as
magnetic resonance spectroscopy, functional magnetic resonance imaging
and magnetoencephalography; development of new classes of
pharmacological agents and other effective therapeutic strategies such
as focal brain stimulation and brain irradiation; and, innovative
clinical trial methodologies to quickly identify effective
antiepileptogenic interventions. A brief description of the areas of
emphasis follows:
Interrupting epileptogenesis -- Epilepsy may develop after common brain
"insults" including stroke, trauma, prolonged febrile convulsions,
meningitis and encephalitis, or in the course of chronic
neurodegenerative diseases such as Alzheimer's disease. Being able to
identify whether the epilepsy develops when the lesion first occurs, or
later when the first seizure appears, will have a major impact on the
ability to prevent, or "cure", epilepsy. Animal models of brain injury
have shown the progression of anatomic, physiologic and molecular
changes that occur; however, there has been little success in
preventing the development of epilepsy after injury in these models.
Treatment with antiepileptic drugs has failed to prevent epilepsy in
patients after head trauma in controlled clinical trials. Grant
applications are encouraged that address topics such as brain
development, cell loss, neurogenesis, cell migration, axonal or
dendritic reorganization, seizure- or injury-induced changes in gene
expression, modulation of receptor functions, and other mechanisms that
may contribute to altered network function in the CNS. The
applications should address how this knowledge can be applied to the
formation of better hypotheses about mechanisms of epileptogenesis and
better models to test new approaches to prevention.
Monitoring epileptogenesis -- Structural brain imaging has been used to
identify epileptogenic lesions in patients with seizures and has
revolutionized our understanding of the basic mechanisms of epilepsy.
The ability to monitor the process of epileptogenesis is an essential
component of any approach aimed at preventing epilepsy or treating
individuals known to be at high risk for developing epilepsy. Studies
are encouraged that address the monitoring of changes in lesions (e.g.,
tumor growth), anatomy (mesial temporal sclerosis), and electrical
activity. Studies that characterize receptors and explain biochemical
changes may be able to provide insights into focal and regional
pathology that lead to predicting responsiveness to antiepileptic
medications. An emerging area of research involves the concept of
network synchrony. Neuronal network synchrony increases prior to a
seizure and remains elevated for hours following the event. The
ability to assess these dynamic changes and apply measurements of
neuronal network synchrony to interictal periods and ictal events may
help predict, and prevent, seizure occurrence.
Genetic strategies -- The epilepsies are a heterogeneous group of
disorders with many underlying causes. Recent advances in molecular
biology have provided insight into the genetic basis of inherited
epilepsies in humans and in model organisms such as the mouse.
Epilepsy genes have been found to fall into several distinct
categories. Mutations have been identified in genes that encode
voltage-gated or ligand-gated ion channels associated with human
idiopathic epilepsies. They are predicted to directly or indirectly
increase neuronal excitability, which lead to seizures. Mouse mutants,
including phenotypes with generalized spike-wave discharges, also
provide evidence of epilepsy as an ion channel disease. Mutations in a
gene encoding an actin-binding protein that initiates neuronal
migration, and two genes that encode possible cell signaling proteins
that direct neuronal migration, have been identified in neuronal
migration disorders. Other genes involve progressive neurodegeneration
and disturbances of cerebral energy metabolism. The exact function of
these various genes, and the pathways of which they are a part, remain
to be discovered. However, it is expected that further discoveries of
genes associated with epilepsy, as well as studies of the mechanisms by
which genes cause epilepsy, will substantially advance our
understanding of the biological basis of many forms of seizure
disorders. This will, in turn, lead to progress in the treatment and
cure of patients with epilepsy.
Therapeutic strategies -- The goal of curing epilepsy is to identify
individuals who are at risk for developing the disorder and to provide
effective treatment without therapeutic side effects to those who have
the disease. Topics to address may include, but are not limited to:
the effectiveness of early pharmacologic interventions in patients
presenting with seizures; whether medications may exacerbate long-term
problems such as seizure severity and associated cognitive problems;
studies to better analyze changes in the CNS of high-risk individuals;
evaluation of surgical approaches, including early intervention;
alternative therapies such as gene therapy or cell therapy; surrogate
markers that can be used to monitor new therapies; and, new designs for
intervention studies. Exploratory research studies in this area will
hopefully provide the necessary information for determining effective
preventative strategies and rational therapeutic designs.
Scope and objectives
Applications submitted in response to this RFA may address any of the
above areas of emphasis. Examples of approaches responsive to this RFA
include:
o Adaptation of models of neuronal development, injury or degeneration
to the study of epilepsy and epileptogenesis.
o Novel strategies and hypotheses that enhance understanding of the
mechanisms of pathogenesis.
o Proposals to identify genes involved in the epilepsies.
o Studies directed at the development of therapeutic regimens. This
could include identification of appropriate clinical markers
(neuroimaging, neurophysiologic, neurochemical), or preliminary
information for developing clinical protocols, methodologies, and/or
pharmacological agents.
o Development of new technologies relevant to the areas of emphasis in
this initiative.
SPECIAL REQUIREMENTS
The research plan should include a section entitled, "Role of
Collaborators" (not to exceed three pages) that discusses the
contribution of each of the collaborators to the overall effort and how
the different parts of the project interact to achieve the proposed
goals. The Research Plan must be soundly developed with well-defined
and clear objectives. The Approach should make use of appropriate
concepts and methodologies. Applicants should elaborate on innovative
aspects of the proposed research, novel collaborations, and special
attributes of the resources and environment. In addition, applicants
must identify how the exploratory studies could result in new insights
or capabilities for translational research in epilepsy.
MECHANISM OF SUPPORT
This RFA will use the National Institutes of Health (NIH)
exploratory/developmental research grant award mechanism (R21). The
R21 awards are used for support of creative, novel, and/or high
risk/high payoff approaches that could produce innovative advances in
this field. This includes feasibility studies, protocol planning, and
the incorporation of new disciplines and technologies. This mechanism
provides the means to acquire the necessary pilot information, to
attract talented new investigators from related disciplines, and to
foster the development of interdisciplinary, inter-institutional
collaborative efforts among investigators with diverse training and
expertise. Responsibility for the planning, direction, and execution
of the proposed project will be solely that of the applicant. This RFA
is a one-time solicitation. Future unsolicited competing continuation
applications will compete with all investigator-initiated applications
and be reviewed according to the customary peer review procedures. The
earliest anticipated award date is July 1, 2001.
Specific application instructions have been modified to reflect
MODULAR GRANT and JUST-IN-TIME streamlining efforts being examined
by the NIH. Complete and detailed instructions and information on
Modular Grant applications can be found at
http://grants.nih.gov/grants/funding/modular/modular.htm.
FUNDS AVAILABLE
NINDS intends to commit up to $1 million total costs, in FY 2001, to
fund new research grants in response to this RFA. An applicant may
request a project period of up to three years and a budget for direct
costs of up to $150,000 per year. Because the nature and scope of the
research proposed may vary, it is anticipated that the size of each
award will also vary. Although the financial plans of the NINDS
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.
ELIGIBILTY REQUIREMENTS
Applications may be submitted by foreign or domestic, for-profit and
nonprofit organizations, public and private, such as universities,
colleges, hospitals, laboratories, units of State and local
governments, and eligible agencies of the Federal government.
Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as principal investigators.
INQUIRIES
Inquiries concerning this RFA are encouraged. The opportunity to
clarify any issues or questions from the potential applicants is
welcomed.
Direct inquiries regarding programmatic issues to:
Margaret P. Jacobs
Program Director, Epilepsy Research
National Institute of Neurological Disorders
and Stroke, NIH
Neuroscience Center, Room 2110-
6001 Executive Boulevard
Bethesda, MD 20892-9523
Phone: 301/496-1917
Fax: 301/480-2424
Email: mj22o@nih.gov
Direct inquiries regarding fiscal matters to:
Jerome Lofton
Grants Management Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 3248
Bethesda, MD 20892-9537
Telephone: (301) 496-9231
FAX: (301) 402-0219
Email: mj34w@nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that
includes a descriptive title of the proposed research, the names,
addresses and telephone numbers of the collaborating investigators, the
identities of other key personnel, and the number and title of the RFA
in response to which the application may be submitted. 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
avoid conflict of interest in the review.
The letter of intent is to be sent by October 1, 2000, (fax and e-mail
encouraged) to:
Margaret P. Jacobs
Program Director, Epilepsy Research
National Institute of Neurological Disorders
and Stroke, NIH
Neuroscience Center, Room 2110
6001 Executive Boulevard
Bethesda, MD 20892-9523
Phone: 301/496-1917
Fax: 301/480-2424
Rockville, MD 20852 (for express/courier service)
Email: mj22o@nih.gov
SCHEDULE SUMMARY
Letter of Intent Receipt Date: October 1, 2000
Application Receipt Date: November 15, 2000
Peer Review Date: March 2001
Council Review: May 2001
Earliest Anticipated Start Date: July 1, 2001
APPLICATION PROCEDURES
The research grant application form PHS 398 (rev. 4/98) is to be used
in applying for these grants. These forms 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 301/710-0267, email: GrantsInfo@nih.gov.
The RFA label available in the PHS 398 (rev. 4/98) application form
must be affixed to the bottom of the face page of the application.
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 sample RFA label available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been
modified to allow for this change. Please note this is in pdf format.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS
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 in response to this RFA will request direct
costs in $25,000 modules, up to a total direct cost of $150,000 per
year for up to three years. 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 $150,000 per year) 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, which is not to exceed 3 years.
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 of 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 RESEARCH PLAN: Applications in response to this RFA should include
an Introduction, not to exceed 3 pages, as explained above under
Research Objectives. This is not included as part of the 25 page
limit.
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.
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 time of submission, two additional copies of the application must be
sent to:
Dr. Lillian Pubols
Chief, Scientific Review Branch
Division of Extramural Activities, NINDS
Neuroscience Center, Room 3208
6001 Executive Blvd.
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)
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.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed for completeness by the CSR
and responsiveness by the NINDS. Incomplete and/or non-responsive
applications will be returned to the applicant without further
consideration.
Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by the NINDS in accordance with the review
criteria stated below. 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 NINDS National Advisory Council.
Review Criteria
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.
In the written comments reviewers will be asked to discuss the
following aspects of 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 important work that by its nature
is not innovative but is essential to move a field forward.
Given that the purpose of this R21 initiative is to encourage
collaborations in translational research in epilepsy, the focus of
review will be on innovation in the development of novel concepts, new
methodologies, and cross-collaborations. Since the developmental
research projects proposed under this RFA may contain preliminary tests
of feasibility, substantial risks, and challenges to current concepts,
and may lack the amount of preliminary data and background experience
normally found in an R01 application, reviewers will weigh the
following review criteria accordingly:
(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? In the context of the R21
mechanism, a strong rationale and conceptual framework are normally
sufficient for establishing the feasibility of the project, in lieu of
preliminary data.
(3) Innovation: Does the project employ novel concepts, approaches or
method? Are the aims original and innovative? Does the project
challenge existing paradigms or develop new methodologies or
technologies? If the project is not innovative but is essential to
move the field forward, the applicant should mention and discuss this
aspect in the proposal.
(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?
(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
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.
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 was published in the Federal Register of March 28, 1994 (FR
59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23,
Number 11, March 18, 1994, and are available on the web at:
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 the 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 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.
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 Request for
Application (RFA), Innovations in Translational Epilepsy Research, is
related to the priority area of chronic disabling conditions. 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.93.853. Awards are made Federal Domestic Assistance No. Awards are made
under authorization of Sections 301 and 405 of the of the Public Health
Service Act as amended (42 USC 241 and 284) and administered under NIH grants
policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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, 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 America.
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