PILOT CLINICAL TRIALS IN THE EPIDEMIOLOGY, PREVENTION AND TREATMENT OF
RESPIRATORY FAILURE IN CHILDREN
RELEASE DATE: July 26, 2002
RFA: HD-02-027
National Institute of Child Health and Human Development (NICHD)
(http://www.nichd.nih.gov/)
National Institute of Nursing Research (NINR)
(http://www.ninr.nih.gov)
LETTER OF INTENT RECEIPT DATE: October 31, 2002
APPLICATION RECEIPT DATE: November 26, 2002
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The National Institute of Child Health and Human Development (NICHD) and the
National Institute of Nursing Research (NINR) solicit applications for
clinical studies designed to enhance understanding and prevention and
treatment of respiratory failure in children. The present clinical
literature documents the efficacy of various treatment modalities, including
mechanical ventilation strategies employing conventional and innovative
techniques, over a wide range of parameters, manipulated with both invasive
and non-invasive maneuvers. Survival of children mechanically ventilated for
a wide variety of indications is now the rule.
This RFA solicits clinical studies to 1) define and characterize acute and
chronic respiratory failure of various etiologies in children, 2) develop new
approaches to prevent the development of chronic functional disability in
children who have been mechanically ventilated for any cause, and 3)
ameliorate the effects of mechanical ventilation on child development
(cognitive and interpersonal), cardiovascular stability, pulmonary function,
and integration into school and home care.
A separate RFA solicits basic and clinical research specifically addressing
the problem of improving outcomes after childhood cardiopulmonary arrest,
specifically, the effects of choice, timing and duration and intensity of
therapies on functional outcomes.
RESEARCH OBJECTIVES
Background
The ARDSnet trial, in adults, and other smaller, more descriptive studies in
children, have underscored with empiric data the importance of carefully
chosen mechanical ventilation strategies in order to minimize, prevent, and
control the devastating complications that result from acute respiratory
failure. However, innovative ventilatory modalities (equipment and
strategies), are evolving rapidly. As more children survive mechanical
ventilation in the pediatric intensive care unit, data that evaluate the
incidence of long-term complications are needed. Whether the incidence of
such complications is related to mechanical ventilatory (equipment and
strategy) modalities remains unknown. Long term oxygen and diuretic
dependence, sleep hypoventilation, the need for persistent tracheostomy, and
the emerging use of less invasive technologies have not been linked to child
health outcomes in the literature in sufficiently powered studies.
Similarly, children with special needs and complex medical disorders
represent an increasing proportion of the pediatric critical care patient
population. Special needs children may need pediatric surgical intervention
to correct congenital anomalies, or ameliorate the course of disabilities
that are traumatically sustained. The effects of such intervention on child
health parameters remain understudied. This contributes to the increase in
the number of children with suboptimal respiratory function at the time of
discharge from the critical care unit, and into the chronic care and
outpatient setting.
Acute and chronic ventilatory modalities (strategies and equipment) that
produce optimal outcomes for special needs children are reported only
anecdotally in the literature. Exercise tolerance, vital capacity, chronic
fibrotic or reactive airway disease, as sequelae of mechanical ventilation
outside the neonatal age group remain understudied. To achieve and maintain
independence from invasive mechanical ventilation, patients and their
caregivers (physicians, nurses, respiratory therapists) must walk a tight
rope, balancing reduction of support against the danger of hypoxia.
Another facet of this balance is evident when the effect of increased
respiratory work is considered in the disabled child, however, these
considerations also apply to children who were physically and functionally
normal before critical illness, but are left with decreased pulmonary
reserve. Integration into educational programs, and the ability to live in
the family unit must be balanced with the need to provide oxygenation and
mechanical support which will optimize growth and development, cognition,
emotional health, normal sleep patterns. Indeed, for many children with
respiratory compromise and their families, the need for prolonged ventilatory
support is the major obstacle to maximizing child health outcomes in this
setting.
The potential of failure of mechanical ventilation and oxygenation systems is
frightening to children, their families, and schools. In fact, for some
children and families, fear of abrupt respiratory failure may outweigh
motivation to maximize developmental outcome. Children are then deprived of
their full potential for development, maturation and successful integration
into adult society.
Fear of hypoxia and ventilatory failure is well founded, as both confer
significant morbidity and mortality acutely. Acutely, diminished brain
function during a hypoxemic episode poses potential dangers to children with
already diminished functional abilities and reserves. In addition, recurrent
hypoxemia may impose long-lasting damaging effects on the brain, resulting in
impairment of memory or other cognitive functions. This is especially a
concern in the early childhood years when the nervous system is still
developing, and children are adapting to their disability.
Recurrent hypoxemia and hypercarbia may eventually also impair the body"s
defense mechanisms against hypoventilation and hypoxia, creating a vicious
cycle for the patient. The progressive decline in effective physiologic
responses to hypoventilation and hypoxia may precipitate or substantially
worsen chronic disability. Young children cannot reliably report or interpret
symptoms of hypoxemia and hypoventilation. Chronic use of inhaled beta
agonists is common in such children and complicates assessment by children
and their parents and clinicians. Unrecognized decline in respiratory
sufficiency over time may contribute to catastrophic outcomes in otherwise
treatable respiratory infections, a too-frequent outcome in special needs
children.
To address this critical problem for children, the National Center for
Medical Rehabilitation Research (NCMRR), NICHD, and National Institute of
Nursing Research (NINR), cosponsored a workshop on mechanical ventilation in
the disabled, prior to founding the new program in pediatric critical care
and rehabilitation research. Most recently, a planning conference of
subspecialists (May 3-4, 2002) identified the need to study critical care
interventions and long-term outcomes in children.
Basic research is needed to enhance understanding of the central and
peripheral control mechanisms that counteract acute and chronic respiratory
failure, and the pathogenic mechanisms involved in loss of counter-regulatory
control. In addition, clinical studies are needed to better define the scope
of the problem and develop new prevention and therapeutic approaches to
maximize outcomes for childhood survivors of mechanical ventilation. As a
first step toward addressing the problem of respiratory failure in children,
the NICHD has issued this RFA as part of the new program at the NCMRR in
pediatric critical care and rehabilitation research. The National Heart,
Lung, and Blood Institute (NHLBI) has interest in research related to acute
lung injury and critical care. Therefore, applications that are of mutual
interest may be given a secondary assignment to NHLBI in accordance with the
NIH referral guidelines.
Scope and Objectives
This RFA solicits clinical studies to 1) define the scope and nature of
respiratory failure in children, especially those with special needs, and 2)
develop and evaluate acute and chronic management strategies to prevent or
minimize the development of chronic respiratory failure in children or to
ameliorate its effects. Recent scientific and engineering advances,
including the availability of innovative approaches and techniques that
potentially open up new avenues of exploration, might be utilized to enhance
management and quality of life for children with respiratory failure.
While this RFA focuses on clinical studies of respiratory failure, basic
research to evaluate cellular and tissue mechanisms of respiratory
insufficiency in children is also of interest, particularly as it relates to
long term adaptation in survival from critical illness in young animals.
Appropriate topics for investigation under this RFA would include, but are
not limited to:
o Studies to determine the prevalence of respiratory insufficiency in
children with special needs, with a focus on delineating differences among
various age groups (e.g., infants, children and adolescents).
o Studies to delineate the role of age, gender, race/ethnicity, socioeconomic
status and other factors in the risk of respiratory insufficiency, and the
adaptation to home ventilatory support.
o Studies to identify factors, including acute and chronic modes and
strategies of ventilatory support, which optimize child health outcomes.
o Studies to establish normative data for respiratory parameters (pulmonary
function, oxygen saturation levels and indices of ventilation)particularly in
special needs children requiring ventilatory support, throughout a 24-hour
period.
o Studies to determine whether there are changes in respiratory regulatory
mechanisms with age.
o Studies to determine whether novel strategies that minimize the need for
obtrusive and invasive mechanical ventilatory support result in more optimal
short and long-term outcomes in children.
o Studies to assess the reliability and utility of continuous
oximeters/sensors in detecting hypoxia during sleep, or in situations where
it may be less apparent in children, particularly those with special needs.
o Studies to determine whether the occurrence of hypoxemia and
hypoventilation, as well as the need for ongoing ventilatory support, can be
minimized by altering the choice of drugs, or timing of drug administration,
or drugs with altered kinetics.
o Studies to determine whether different therapeutic modalities (strategies
and equipment) regimens for respiratory failure in childhood affect central
and peripheral regulatory mechanisms.
o Studies to develop and test strategies for minimizing the risk of
impairment due to subtle alterations in oxygenation and ventilation in
survivors of critical illness in childhood.
MECHANISM OF SUPPORT
This RFA will use the NIH Exploratory/Developmental Research Grant (R21)
award mechanism. As an applicant you will be solely responsible for
planning, directing, and executing the proposed project. This RFA is a one-
time solicitation. The anticipated award date is July 1, 2003.
The R21 awards are intended to demonstrate feasibility and to obtain
preliminary data testing innovative ideas that represent clear departure from
ongoing research interests. These grants are intended to 1) provide initial
support for new investigators, 2) allow exploration of possible new
directions for established investigators, and 3) stimulate investigators from
other areas to lend their expertise to research within the scope of this
solicitation. These R21 grants will not be renewable, continuation of
projects developed under this program will be through the regular research
grant (R01) program.
Applicants from institutions which 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. In
such a case, a letter of agreement from either the GCRC program director or
Principal Investigator should be included with the application.
This RFA uses just-in-time concepts. It also uses the modular budgeting
format (see https://grants.nih.gov/grants/funding/modular/modular.htm).
Specifically, if you are submitting an application with direct costs in each
year of $250,000 or less, use the modular format.
FUNDS AVAILABLE
The NICHD and NINR intend to commit approximately $1.15 million in total
costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2003 to
fund four to six new grants in response to this RFA. NINR intends to commit
funds for one project by a nurse researcher. An applicant may request a
project period of up to two years and a budget for direct costs of up to
$125,000 per year. Because the nature and scope of the proposed research
will vary from application to application, it is anticipated that the size
and duration of each award will also vary. Although the financial plans of
the NICHD and NINR provide support for this program, awards pursuant to this
RFA are contingent upon the availability of funds and the receipt of a
sufficient number of meritorious applications.
ELIGIBLE INSTITUTIONS
You may submit an application if your institution has any of the following
characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges,
hospitals, and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic or foreign
o Faith-based organizations
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with their institution to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH programs.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants management
issues:
o Direct your questions about scientific/research issues to:
Carol Nicholson, M.S., M.D.
Program Director, Pediatric Critical Care and Rehabilitation Research
National Institute of Child Health and Human Development
National Center for Medical Rehabilitation Research
6100 Executive Boulevard, Room 2A03, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301)435-6843
Email: nicholca@mail.nih.gov
Hilary D. Sigmon Ph.D., R.N.
Program Director
National Institute of Nursing Research
6701 Democracy Boulevard, Room 710, MSC 4870
Bethesda, MD 20892-4870
Telephone: (301) 480-8260
FAX: (301) 480-8260
Email: hilary.sigmon@nih.gov
o Direct your questions about peer review issues to:
Robert H. Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
Building 6100 Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-1485
FAX: (301) 402-4104
Email: STRETCH@NIH.GOV
o Direct your questions about financial or grants management matters to:
Christopher Myers
Grants Management Branch
National Institute of Child Health and Human Development
Building 6100 Room 8A14H, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 435-6996
FAX: (301) 480-4783
Email: cm143g@nih.gov
Tara Mowery
Grants Management Specialist
National Institute of Nursing Research
45 Center Drive MSC 6300
Bethesda, MD 20892-6300
Telephone: (301) 594-5979
FAX: (301) 480-8260
Email: tara-mowery@nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does not
enter into the review of a subsequent application, the information that it
contains allows NICHD staff to estimate the potential review workload and
plan the review.
The letter of intent is to be sent by the date listed at the beginning of
this document. The letter of intent should be sent to:
Carol Nicholson, M.S., M.D.
Program Director, Pediatric Critical Care and Rehabilitation Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 2A03, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301)435-6843
Email: nicholca@mail.nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
Email: GrantsInfo@nih.gov.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications
requesting up to $250,000 per year in direct costs must be submitted in a
modular grant format. The modular grant format simplifies the preparation of
the budget in these applications by limiting the level of budgetary detail.
Applicants request direct costs in $25,000 modules. Section C of the
research grant application instructions for the PHS 398 (rev. 5/2001) at
https://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step
guidance for preparing modular grants. Additional information on modular
grants is available at
https://grants.nih.gov/grants/funding/modular/modular.htm.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001)
application form must be affixed to the bottom of the face page of the
application. Type the RFA number on the label. Failure to use this label
could result in delayed processing of the application such that it may not
reach the review committee in time for review. In addition, the RFA title
and number must be typed on line 2 of the face page of the application form
and the YES box must be marked. The RFA label is also available at:
https://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application, including the Checklist, and three signed, photocopies, in
one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application must be
sent to:
Robert H. Stretch, Ph.D.
Director, Division of Scientific Review (DSR)
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for courier/express service)
APPLICATION PROCESSING: Applications must be received by the application
receipt date listed in the heading of this RFA. If an application is
received after that date, it will be returned to the applicant without
review.
The Center for Scientific Review (CSR) will not accept any application in
response to this RFA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application. The
CSR will not accept any application that is essentially the same as one
already reviewed. This does not preclude the submission of substantial
revisions of applications already reviewed, but such applications must
include an Introduction addressing the previous critique.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NICHD and NINR. 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 NICHD in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
o Receive a written critique
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications under
review, will be discussed and assigned a priority score
o Receive a second level review by the National Advisory Child Health and
Human Development Council.
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In
the written comments, reviewers will be asked to discuss the following
aspects of your application in order to judge the likelihood that the
proposed research will have a substantial impact on the pursuit of these
goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these criteria
in assigning your application"s overall score, weighting them as appropriate
for each application. Your application does not need to be strong in all
categories to be judged likely to have major scientific impact and thus
deserve a high priority score. For example, you may propose to carry out
important work that by its nature is not innovative but is essential to move
a field forward.
(1) SIGNIFICANCE: Does your study address an important problem? If the aims
of your application are achieved, how do they advance scientific knowledge?
What will be the effect of these studies on the concepts or methods that
drive this field?
(2) APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the aims of the
project? Do you acknowledge potential problem areas and consider alternative
tactics?
(3) INNOVATION: Does your project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does your project challenge
existing paradigms or develop new methodologies or technologies?
(4) INVESTIGATOR: Are you appropriately trained and well suited to carry out
this work? Is the work proposed appropriate to your experience level as the
principal investigator and to that of other researchers (if any)?
(5) ENVIRONMENT: Does the scientific environment in which your work will be
done contribute to the probability of success? Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements? Is there evidence of institutional
support?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your
application will also be reviewed with respect to the following:
o PROTECTIONS: The adequacy of the proposed protection for humans, animals,
or the environment, to the extent they may be adversely affected by the
project proposed in the application.
o INCLUSION: The adequacy of plans to include subjects from both genders,
all racial and ethnic groups (and subgroups), and children as appropriate for
the scientific goals of the research. Plans for the recruitment and
retention of subjects will also be evaluated. (See Inclusion Criteria
included in the section on Federal Citations, below)
o BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: October 31, 2002
Application Receipt Date: November 26, 2002
Peer Review Date: February/March 2003
Council Review: June 2003
Earliest Anticipated Start Date: July 1, 2003
AWARD CRITERIA
Criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
REQUIRED FEDERAL CITATIONS
MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components
involving Phase I and II clinical trials must include provisions for
assessment of patient eligibility and status, rigorous data management,
quality assurance, and auditing procedures. In addition, it is NIH policy
that all clinical trials require data and safety monitoring, with the method
and degree of monitoring being commensurate with the risks (NIH Policy for
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12,
1998: https://grants.nih.gov/grants/guide/notice-files/not98-084.html).
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of
the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a
clear and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of
the research. This policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43).
All investigators proposing clinical research should read the AMENDMENT "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research - Amended, October, 2001," published in the NIH Guide for Grants and
Contracts on October 9, 2001
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete
copy of the updated Guidelines is available at
https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research, updated racial and ethnic categories in compliance with the new OMB
standards, clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398, and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable,
and b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all human subjects research, conducted or supported
by the NIH, unless there are scientific and ethical reasons not to include
them. This policy applies to all initial (Type 1) applications submitted for
receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as participants in
research involving human subjects that is available at
https://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH proposals for research involving human
subjects. You will find this policy announcement in the NIH Guide for Grants
and Contracts Announcement, dated June 5, 2000, at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2)
cited publicly and officially by a Federal agency in support of an action
that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this RFA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the
application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Furthermore,
we caution reviewers that their anonymity may be compromised when they
directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of "Healthy
People 2010," a PHS-led national activity for setting priority areas. This
RFA is related to one or more of the priority areas. Potential applicants
may obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance No. 93.929 (NICHD) and 93.361 (NINR), and is not
subject to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency review. Awards are made under authorization of
Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241
and 284) and administered under NIH grants policies described at
https://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations
42 CFR 52 and 45 CFR Parts 74 and 92.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.