COLLABORATIVE INITIATIVE ON FETAL ALCOHOL SPECTRUM DISORDERS
RELEASE DATE: October 31, 2002 (Reissued as RFA-AA-07-004)
(see NOT-AA-03-001)
RFA: AA-03-002
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
(http://www.niaaa.nih.gov)
Letter of Intent Receipt Date: February 11, 2003
Application Receipt Date: March 11, 2003
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Scope and Organization
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements for Cooperative Agreements
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 on Alcohol Abuse and Alcoholism (NIAAA) invites
applications for a Consortium for the "Collaborative Initiative on Fetal
Alcohol Spectrum Disorders"(CIFASD). The purpose of this Initiative is to
inform and develop effective interventions and treatment approaches for Fetal
Alcohol Spectrum Disorders (FASD) through a highly integrated multidisciplinary
research approach involving basic, behavioral, and clinical investigators and
projects. Furthermore, the objective is to integrate existing resources within
the alcohol research community and also create new resources that are crucial
for the success of the research questions to be addressed. CIFASD will also
provide opportunities for collaboration between scientists in the alcohol field
and prominent investigators from other research areas, resulting in the
application of new ideas and technology to the study of alcohol-related fetal
injury.
RESEARCH OBJECTIVES
Children with FASD exhibit an array of cognitive, behavioral, and emotional
deficits that impair daily functioning in many domains. A summary of research
findings can be found in the "10th Special Report to the U.S. Congress on
Alcohol and Health". Chapter 5: Prenatal Exposure to Alcohol can be downloaded,
in PDF format, from the NIAAA website (http://www.niaaa.nih.gov).
The term Fetal Alcohol Spectrum Disorder (FASD) is used in this RFA to reflect
the understanding that Fetal Alcohol Syndrome (FAS) and Fetal Alcohol Effects
(FAE) or Alcohol Related Neurological Disorders (ARND) are terms that represent
a spectrum of prenatal alcohol effects. These include the acknowledgement that
the characteristic facial features develop as a result of alcohol exposure
during early pregnancy and that equally devastating neurobehavioral, growth and
emotional deficits can result from drinking in other trimesters.
The goal of this Initiative is to develop definitive diagnoses of FASD and to
develop effective behavioral and pharmacological therapies for those affected.
The problems inherent in making progress toward the understanding of the
underlying mechanisms of FASD and their diagnosis, treatment and prevention are
many. Among them are the small numbers of similar age cases in any one site,
the need for close collaboration between basic and clinical research
scientists, and the need to exchange information quickly from research to
practice and to transfer experiential knowledge from practice to research.
This Initiative presents extraordinary opportunities to identify areas of
discovery that build upon important recent developments in knowledge, available
resources, and technology and that hold promise for making significant progress
in research on Fetal Alcohol Spectrum Disorders. The novelty and scope of this
Initiative should be used to narrow the enormous gap between discovery and the
application of discoveries and to address alcohol related deficits in children.
The primary focus of the Initiative should be the advancement of research
progress through the generation of new knowledge rather than mere replication
or minor modification of previous studies and theories. The RFA uses the
cooperative agreement mechanism. The Initiative will include individual
hypothesis-driven research projects, pilots or developmental research project
process, and resource cores. To be effective, the Initiative should coordinate
efforts that result in new and/or improved syntheses, theories, methods and
interventions. The cores will provide essential infrastructure to facilitate
rapid advances.
The aim of this Initiative is to accelerate these areas of research by
establishing an infrastructure to foster collaboration and coordinate basic,
clinical and translational research. The multi-site collaborative Initiative
may involve research scientists investigating prenatal neurobiological
developmental abnormalities in FASD with those studying the subsequent
postnatal behavioral deficits during early childhood and beyond. Research on
genetic influences and on molecular techniques to reverse or block specific
deleterious effects may be included. The development and testing of potential
effective behavioral and pharmacotherapies discovered in preclinical settings
needs to be tested at several clinical sites using small cohorts of same age
similarly diagnosed children and rigorous protocols. The project will include
the gathering of clinical data from studies of cohorts of FASD children in
national and international settings where the prevalence is high.
Coordinated Multi-disciplinary and Multi-site Research is needed in the
following areas:
I. Research, that directly informs pre-clinical and clinical studies, to
understand how ethanol and its metabolism interferes with normal brain
development, what are the more vulnerable regions and processes and the
structure/function relationships affected by prenatal alcohol exposure, and
what are the ensuing structure/function relationships.
II. Research to better define and characterize the description of FASD
specific core deficits in specific age and ethnic groups.
III. Basic and pre-clinical studies to determine potential pharmacotherapies
for intervening with affected children or preventing fetal alcohol injury.
IV. Prenatal diagnosis of FASD through surrogate biomarkers and new imaging
technologies in the mother-child unit.
V. Research on the genetics and metabolism of the mother-child unit in
determining susceptibility to fetal injury, and the influence of nutrition and
other environmental factors on vulnerability.
SCOPE AND ORGANIZATION OF CIFASD
NIAAA recognizes the innovation, synergy, and conceptual advances that arise
from interactions across scientific disciplines, methodologies, and levels of
analysis. It is anticipated that under this Initiative knowledge will be
generated and integrated from all levels of analysis using state-of-the-art
techniques at each level. Expertise has become so sophisticated at any given
level of analysis that integration at the level of individual investigators
becomes very difficult to accomplish, particularly to a level of analysis
outside of their domain. The CIFASD Initiative would induce such integration
and significantly speed up the translation of such critical new information to
the clinical condition.
The incorporation of groups of scientists into a research consortium focused on
the neurodevelopmental and behavioral aspects of Fetal Alcohol Spectrum
Disorders will also offer additional advantages. The rapid and detailed
exchange of information among CIFASD members will provide immediate
opportunities for applying the Consortium expertise to profitable research
arenas. The success of the proposed Initiative will thus relate to the
presence of research expertise that uses the full gamut of basic biological,
behavioral, clinical research, and psychopharmacology to study the neuroscience
of FASD. Thus, information flowing both from the most basic molecular level to
the human behavioral level and back again can be melded into optimally
productive research protocols at multiple levels of endeavor with the focus on
the neurobiology of alcohol-related fetal injury.
Organization of the Consortium
The following structure of CIFASD is envisioned. The CIFASD Consortium will
consist of a cluster of integrated cooperative agreement research applications
(U01s), appropriate and necessary core facilities (U24s), and will be led by a
Consortium Coordinator. The proposed U24 core facilities must be fully
justified and must support 1 or more companion U01 research projects.
A highly integrated multidisciplinary research consortium will thus be formed
from a group of investigators and clinicians (within and across institutions)
whose scientific and technical expertise will enable them to interactively
study the neurobehavioral effects of pre-natal alcohol exposure, approaches to
their clinical management, and the basic neuroscience and neurobehavioral
mechanisms that can contribute to an understanding and management of these
problems. The approaches used will reflect the blend of experience and
creativity of the CIFASD components and will be originated by these
investigators. Through formation of CIFASD, the integrated research project
component groups will have access through the core facilities to resources,
data analyses, information, technologies, ideas, and expertise that are beyond
the scope of any single research team. The consortium will also promote the
support of pilot studies to quickly pursue innovative or unique research
opportunities that may emerge as the research is in progress. In addition, the
consortium will recruit complimentary expertise and approaches currently
outside the realm of fetal alcohol research and establish state-of-the-art
research resources and information networks for fetal alcohol research.
The Consortium Coordinator is the scientist who assembles the integrated and
collaborative research consortium and is responsible for submitting the cluster
of applications in response to this RFA and for performance of the project. The
Consortium Coordinator must be recognized in the area of fetal alcohol
research, especially in one of the required interactive research areas or
domains of CIFASD described below. Because a substantial level of effort will
be necessary to manage a project of this magnitude, the Consortium Coordinator
is expected to make a major commitment to directing, managing and executing the
goals and collaborative nature of this project.
The Consortium Coordinator application will be the lead application of the
consortium and should include the Administrative Coordinating Core, together
with the Administrative Management Plan, Plan for Data Sharing and Intellectual
Property and the Pilot Project Component (more details are given elsewhere in
this announcement). The lead application should discuss the theme and goals of
the consortium and should include a scientific rationale for the various
research project component and resource core applications that make up the
consortium. It should further describe the benefits of the proposed
integration between projects and how the individual applications complement
each other to enhance the scientific goals of the consortium. Given that an
important element of this Initiative is the collaboration between leading
scientists in the fetal alcohol spectrum field and, as appropriate to assure
the success of the effort, prominent investigators from other fields, the lead
application should also discuss how the consortium has achieved that goal. It
should describe how investigators not previously active in fetal alcohol
research will participate in either the research project components or the
resource core facilities applications of CIFASD. The lead application should
also include a composite budget of the whole consortium in addition to its own
individual budget. It is acceptable for the Consortium Coordinator to submit a
research project component or a resource core application in addition to the
lead application.
While each application will originate from the principal investigator(s)
research institution and awards will be made to individual institutions, it is
the responsibility of the Consortium Coordinator to submit the cluster of
applications of the consortium together with the appropriate cover letter as
one package (See the "Submitting an Application" section of the RFA, below).
Research Project Components
Specific research project components to be undertaken under the consortium will
take the form of U01 grant applications and are expected to be integrated with
the other research projects of CIFASD. These research project component
applications are expected to address at least one of the research areas or
domains, namely basic, neurobehavioral morphological/neuroanatomical,
neuropharmacologic or early intervention domains (discussed in more detail
below). It is anticipated that several of the applications within the
consortium may address the same research domain, but will differ in emphasis,
study population, approaches and research questions being addressed. Research
project applications can request a maximum support period of five years.
Applications should include a detailed budget and must follow the traditional
PHS 398 application instructions.
The research project applications may utilize the resources and the new
technologies developed by one or more resource cores at one or more sites and
advance the scientific goals of CIFASD. However, the research undertaken under
a research project application can be performed at a research site other than
the one housing the core site. Exploratory and developmental projects will
also use the U19 mechanism but will be limited to three years of support and
with a maximum budget of up to $100,000 direct costs per year.
Pre-clinical and Clinical Morphological/Neuroanatomical and Neurobehavioral
Research.
Each project will be developed to serve as the bases for interactive
collaborations with other components of CIFASD. Inter-related pre-clinical and
clinical research projects will be designed to translate and apply findings
from one component to others. Research areas include:
Research to identify and analyze gross morphological characteristics of Fetal
Alcohol Spectrum Disorders using state-of-the-art-imaging techniques to
definitively characterize an FASD phenotype and how that phenotype may vary or
remain constant across racial/ethnic groups For example, the use of three-
dimensional facial photography and other techniques might be explored. Pre-
clinical research to inform this investigation might be included.
Clinical and pre-clinical research using electrophysiological, neurochemical,
and other techniques is needed to explore the changes in neural circuitry
underlying the various behavioral and cognitive deficits associated with
prenatal exposure to alcohol.
Molecular and biochemical studies that directly relate to genetic and
biological vulnerability, biomarkers of exposure, and the development and
testing of interventions to address the effects of prenatal alcohol exposure
may be included.
Animal models of alcohol-related fetal injury may be used to further elucidate
the effects of prenatal exposure to alcohol on the function of the neural
circuitry in regions of the brain which are especially vulnerable to alcohol
during fetal development. Separate animal models may be needed depending on
the specific phenomenon being studied and the appropriateness of the animal
model.
The behavioral manifestations of neurophysiologic effects will be of particular
interest, since they will shed light on the mechanisms by which fetal alcohol
exposure causes the psychological, cognitive, and behavioral deficits observed
in individuals with FASD, and on effective approaches to remediating those
deficits.
Studies to determine the effects of prenatal environmental conditions
influencing severity and locus of fetal injury, as well as genetically-based
strain differences may be included.
Youth with a history of prenatal exposure to alcohol must be evaluated within
the consortia for level of emotional, psychological, and cognitive function.
Specifically, performance on measures of frontal lobe function, executive
function, response inhibition, and visuospatial, verbal and other aspects of
memory may be evaluated to address the question of whether a set of core
cognitive and behavioral deficits may be identified in individuals with
prenatal alcohol exposure. The identification of specific and consistent
differences between youth prenatally exposed to alcohol and matched controls
will inform research on behavioral, educational and other interventions. An
important goal of this component will be to identify and/or develop the most
appropriate (sensitive and specific) assessment tools for identifying fetal
alcohol injury.
Intervention Research
This research will extend and apply findings from the neurobehavioral and
neurophysiological research conducted in this consortium with the aim of
increasing the proportion of individuals with fetal alcohol injury who receive
accurate diagnosis and appropriate research based interventions for their
alcohol-related deficits Specifically, this research will seek to develop and
evaluate the effectiveness of educational interventions on affected children.
Most important, this approach will demonstrate how specific impairments
associated with FASD identified in other research clusters in this consortium,
particularly emotional disturbances and impairments in attention, language,
sensory integration, and certain behavioral problems, may be modified by
specific interventions in educational and other early child care settings.
Resource Core Facilities
A consortium may include one or more U24 resource cores to provide specific
services or resources to multiple performance sites within the consortium. An
Administrative Core is specifically required as part of the consortium. Other
cores may be added as needed to support the consortium. The proposed U24 core
facilities must be fully justified and must support 1 or more companion U01
research projects.
Each core may be located at multiple physical sites. Examples of potential
cores include an Administrative Coordinating Core, an Imaging Core, and an
Informatics Cores to provide facilities for central processing of information
generated at different sites. All information obtained will be shared by the
Research Components. In the case of a single core shared among several sites,
an application should be submitted from each of the sites with a detailed
scientific rationale and budget for that core site. The Consortium Coordinator
should clearly detail, as part of the Administrative Management Plan, the
number, location and specialties of the sites comprising every core facility.
Each core component is expected to be directed by an investigator with
established expertise relative to the support or service provided, usually a
faculty-level individual.
Administrative Coordinating Core: The Administrative Coordinating Core will
provide the organizational framework for the management, direction, and overall
coordination of the consortium. It will coordinate use of core resources to
the Research Project Components and acquire and direct data from the Research
Components to an Informatics Core. The Consortium Coordinator will manage the
administrative core. The Administrative Coordinating Core will include an
Administrative Management plan (See below) and this core will also be
responsible for the collaborative responsibilities such as the functions of the
four membered Scientific Advisory Panel and the overseeing of a Steering
Committee to help develop interactive protocols, evaluate results, and suggest
future directions. The core will also administer the Pilot Projects Component
of CIFASD (discussed below) as well as the sharing of data and information
between the CIFASD components. This core is responsible for scientific
enrichment activities such as workshops for the researchers and investigators
of CIFASD. In addition, the core will be responsible for organizing an annual
meeting of the CIFASD investigators.
Imaging Core: This core may provide imaging services to the components. Such
a core could focus on multiple imaging technologies. Technology research and
development of innovative new imaging technologies appropriate for FASD
research in humans and/or appropriate animal models, as well as refinement and
development of technologies already established may also be an additional focus
of this core.
Informatics Core: This type of core collects and stores data generated by the
Research Project Components and can provide an interactive user interface for
all components. It will devise methods for integrating data from different
levels of analysis from the molecular to the behavioral levels. This component
will provide input to the design of projects and coordinate the combining of
data and the analysis of data across and within components, where appropriate.
In addition, it will be responsible for creating a database to support each
component.
With the establishment of these databases, there is also a need for additional
refinement of bioinformatic tools (such as developing interoperable informatics
software packages) to facilitate extraction and efficient dissemination of
information from these databases. Consistent with NIH policy
(https://grants.nih.gov/archive/grants/policy/nihgps/part_ii_5.htm and
https://grants.nih.gov/grants/policy/policy.htm), it is expected that the
databases developed will be available for use by non-Consortia member
investigators. Applicants will need to develop a plan to be approved by the
Institute indicating how they will comply with the policy.
Pilot Project Component: Pilot projects provide the consortium with a flexible
means to develop and explore quickly new research activities or directions, and
unique scientific opportunities that could evolve into independently funded
research projects. These funds are not intended to supplement ongoing
projects. Pilot projects must be in a separate pilot project component that
incorporates all of the pilot studies of the proposed consortium and should be
included in the Consortium Coordinator's application. The total costs for the
Pilot Project component should not exceed $150,000 per year.
The process for selecting pilot projects should be fully, though concisely
described. For the first 2 years that funds are requested for pilot projects,
the application must provide descriptions of the projects to be supported. It
is recognized that some pilot funds will be reserved for the support of
research opportunities that arise during the course of the year. For years 3-
5, it may not be possible to provide descriptions of the pilot projects to be
supported, since some of these projects will develop on the basis of scientific
breakthroughs or directions occurring at the time. However, the application
must provide the specific number of pilots planned in each year. While the
specific number of pilot projects to be proposed is at the discretion of the
Principal Investigator, requested direct cost funding for each pilot study may
not exceed $30,000 per year.
All proposed pilot projects for a funding period need not be ongoing at any one
time, but may be phased in at different points during the course of the year.
It is recognized that the relative priority or need for specific pilot projects
may change over time. While the consortium's framework for management of pilot
funds and the mechanism for operating the program are left to the discretion of
the Consortia Coordinator, the application must provide specific information to
enable adequate scientific evaluation by a peer review committee.
The application should include: a full description of the management of the
pilot project component, including a description of the process to be followed
by the consortium's program coordinator in selecting new pilot projects and
replacing projects should it become necessary. A full description of each
pilot study proposed in the first 2 years will include its rationale,
objectives, approach, investigators, and significance for the consortium. A
description of the number and anticipated direction of pilot projects in the 3-
5 years will be provided including their significance to the consortium. The
research description of any individual pilot project may not exceed five pages;
the entire narrative for this Pilot Project Component may not exceed 25 pages
irrespective of the number of pilot projects proposed.
OTHER ELEMENTS OF THE INTEGRATED AND COLLABORATIVE PROJECT – CIFASD
Administrative and Project Management Plans: The Consortium Coordinator must
include an Administrative Management Plan that outlines the policies and
procedures for access of participating investigators to the collaborative
project resources. The application should address the flow of information
within the project, the integration among individual projects and plans for how
the information will be integrated into the solution of the overall scientific
theme or question being addressed. The application must include a Project
Management Plan, including an ongoing evaluation plan, to ensure consistent
forward progress of the project. The mechanism to add new participating
investigators and dealing with members whose association with the project has
not been productive should be documented in the proposal. The plan should also
include proposed methods for information dissemination both within the
collaborative project and to the scientific community. Furthermore, the
application will include a mechanism to consider and respond to concerns of the
scientific community directly affected by the operation and impact of the
project. A discussion of scientific community views will be part of the agenda
for annual meetings of the Steering Committee with the Scientific Advisory
Panel.
Plan for Data Sharing and Intellectual Property: NIH requires applicants who
respond to this RFA to develop and propose specific plans for sharing the data
and materials generated through the large-scale collaborative project. This
requirement addresses the interests of the Government in the availability of,
and access to, the results of publicly funded research. The initial review
group will comment on the proposed plans. In addition, as one of the criteria
for award, NIAAA staff will also consider the adequacy of the plans. Because
dissemination is a critical and important aspect of this RFA, the proposed
sharing and data release plans, after negotiation with the applicant when
necessary, will be made a condition of the award. The members of the
consortium should disclose to the Steering Committee their ties to profit-
making organizations to aid the project in avoiding conflict of interest
situations. Applicants are also reminded that the grantee institution is
required to disclose each subject invention to NIAAA within two months after
the inventor discloses it in writing to grantee institution personnel
responsible for patent matters.
MECHANISM(S) OF SUPPORT
The NIH (U01 and U24) awards are cooperative agreement award mechanisms in
which the Principal Investigator retains the primary responsibility and
dominant role for planning, directing, and executing the proposed project, with
NIH staff being substantially involved as a partner with the Principal
Investigator, as described under the section "Cooperative Agreement Terms and
Conditions of Award"
FUNDS AVAILABLE
The NIAAA intends to commit approximately $3,500,000 in FY 2003 to fund a
consortium of cooperative agreements in response to this RFA. An applicant may
request a project period up to a maximum of 5 years support. There is a cap of
$2,400,000 in direct costs for the consortium or cluster of applications
responding to this RFA for the first year budget period (with a maximum
increase in cost in subsequent years of three percent). Because the nature and
scope of the research proposed in response to this RFA might vary, it is
anticipated that the size of awards to individual applications in the
consortium will vary also. Although this program is provided for in the
financial plans of the NIAAA, awards pursuant to this RFA are contingent upon
the availability of funds for this purpose and the receipt of applications of
outstanding scientific and technical merit.
Funds provided under this program may not be used for the purchase of land, nor
for the purchase, construction, preservation, or repair of any building.
However, costs of alteration and renovation of existing facilities necessary to
accomplish the objectives of the grant may be allowed subject to NIH grants
policy limitations and approval by NIAAA staff.
This RFA is a one-time solicitation. The total project period for an
application submitted in response to this RFA may not exceed 5 years, with an
anticipated award date of September, 2003. In addition, meritorious Research
Components from other peer reviewed applications not funded through the
consortium may be added to the funded consortium at the discretion of NIAAA and
taking into account budget limitations and input from its National Advisory
Council as may be required.
ELIGIBILITY REQUIREMENTS
You may submit (an) application(s) if your institution has any of the following
characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals,
and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic or foreign
o Faith-based or community-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.
SPECIAL REQUIREMENTS FOR COOPERATIVE AGREEMENTS
Cooperative Agreement Terms and Conditions of Award
The following Terms and Conditions will be incorporated into the award
statement and will be provided to the Consortium Coordinator, to the principal
investigators of the individual research components and core facilities, and to
the appropriate institutional officials at the time of award. The following
special terms of award are in addition to, and not in lieu of, otherwise
applicable OMB administrative guidelines, HHS grant administration regulations
at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local
Governments are eligible to apply), and other HHS, PHS, and NIH grant
administration policies. The administrative and funding instrument used for
this program will be the cooperative agreement, an "assistance" mechanism
(rather than an "acquisition" mechanism), in which substantial NIAAA
programmatic involvement with the awardees is anticipated during performance of
the activities. Under the cooperative agreement, the NIAAA supports and
stimulates the recipients' activities by involvement in and otherwise working
jointly with the award recipients in a partnership role; it is not to assume
direction, prime responsibility, or a dominant role in the activities.
Consistent with this concept, the dominant role and prime responsibility
resides with the awardees for the project as a whole. Awardees will retain
custody of and have primary rights to the data developed under these awards,
subject to Government rights of access consistent with current HHS, PHS, and
NIH policies. Awardees should comply with their institutional intellectual
property policies and practices as approved in the award. However, awardees
will be expected to share (make available) these data openly with the
scientific community.
1. Awardee Responsibilities
a. Consortium Coordinator's Responsibilities:
The Consortium Coordinator will coordinate project activities scientifically
and administratively at the awardee institution. The Consortium Coordinator
will have the overall responsibility for the scientific and technical direction
and the administration and overall operation of the consortium. To assist the
Consortium Coordinator with the governing of the project, a steering committee
will be established from among the participating investigators and NIAAA staff.
The Consortium Coordinator will chair the steering committee. As for all
participating investigators, the Consortium Coordinator must abide by the
operating rules and guidelines developed by the steering committee. The
Consortium Coordinator will agree to accept participation of NIAAA staff in
those aspects of management of the project described under "NIAAA Program
Official's Responsibilities." The Consortium Coordinator will also ensure the
timely dissemination of information generated by the consortium component
projects to both the consortium project members and the scientific public.
b. Participating Investigator Responsibilities:
In addition to the Consortium Coordinator, as well as principal investigators
(PIs) of individual research project components and core facilities of the
consortium, each research project component will include a team of
investigators who will contribute to and benefit from participation in the
consortium. These members of the consortium will be referred to collectively
as participating investigators. They will receive separate awards and have
control over their own operating budgets. The PI of the individual research
project award and the resource core award will be responsible for the
scientific and technical direction of the project, as well as for following
consortium policies and rules. Participating investigators must also agree to
abide by the policies and rules set up for the collaborative research
consortium. It is expected that over the period of the award, additional
applications for participation in the consortium will be submitted to NIAAA for
review and award consideration, as deemed appropriate by the Consortium
Coordinator and steering committee and with the approval of the NIAAA program
official; these additions will be reported in the annual progress report.
2. NIAAA Staff Responsibilities
Two NIAAA Staff Collaborators will have substantial scientific-programmatic
involvement during conduct of this activity, through technical assistance,
advice and coordination above and beyond normal program stewardship for grants,
as described below. The dominant role and prime responsibility for the activity
resides with the awardees for the project as a whole, although specific tasks
and activities in carrying out the studies will be shared among the awardees
and the Staff Collaborators.
The two NIAAA Staff Collaborators will have voting membership (one vote) on the
Steering Committee and, as determined by that committee, its subcommittees.
The NIAAA Staff Collaborators will coordinate and facilitate the CIFASD
Consortium programs, will attend and participate as a voting member in all
meetings of the CIFASD Steering Committee, and will provide liaison between the
Steering Committee, the CIFASD Consortium, and the NIAAA.
The NIAAA Staff Collaborators will assist the Steering Committee in developing
and drafting operating policies and policies for dealing with recurring
situations that require coordinated action.
The NIAAA Program Official is responsible for normal program stewardship and
will review the scientific progress of individual components, review components
for compliance with the operating policies developed by the Steering Committee,
and may recommend withholding of support, suspension, or termination of an
award for lack of scientific progress or failure to adhere to policies
established by the Steering Committee. The NIAAA Program Official will attend
the Steering Committee meetings as a non-voting member.
3. Collaborative Responsibilities
Scientific Advisory Panel
The CIFASD project will include an external scientific advisory panel whose
purpose is to meet annually with the Consortium Coordinator and the steering
committee to assess progress and provide feedback to the CIFASD investigators
and NIAAA on proposed goals for the next year of support. The members will be
designated by the NIAAA in consultation with the steering committee, after the
award has been made, and will be drawn from research scientists not involved in
the project. The NIAAA staff collaborators will attend the meeting of the
scientific advisory panel as members of the steering committee, but will not be
members of the scientific advisory panel. The scientific advisory panel will
meet at least once a year immediately prior to the submission of the annual
progress report.
Steering Committee
The NIAAA staff collaborators and the awardees that comprise the CIFASD will be
responsible for forming a Steering Committee as defined below. The Steering
Committee will be the main governing board. It will develop collaborative
protocols, and to set priorities, define parameters for study, identify
technological impediments to success and strategies to overcome them.
The Steering Committee will be composed of the Consortium Coordinator,
principal investigators of the research project components and core facilities,
and the NIAAA staff collaborators. The members of the Steering Committee will
each have one vote. The chairperson of the steering committee will be the
Consortium Coordinator. NIAAA reserves the right to appoint additional members
of NIAAA staff as nonvoting members of the Steering Committee and
Subcommittees.
The Steering Committee may, when deemed necessary, invite additional, non-
voting scientific advisors to the meetings at which research priorities and
opportunities are discussed. NIAAA reserves the right to augment the
scientific or consumer expertise of the Steering Committee when necessary.
There will be two Steering Committee meetings initially (during the first two
years of support), one in the Washington, D.C. area, and the other at a time
and site agreed upon by the Steering Committee and the NIAAA. In years 3-5,
the Steering Committee will meet once a year. The first meeting of CIFASD will
be a Planning Meeting, which will take place in the Washington, D.C. area
shortly after award of the grants. At the Planning Meeting, the Committee
will: a) determine the size of the Steering Committee and the representation of
individual research project and resource core awardees on the Steering
Committee; b) draft a charter, the purpose of which is to define the
administrative policies and procedures for oversight of the project, the
process for monitoring compliance with those policies and procedures, and the
process for recommending that the NIAAA act on evidence of non-compliance of
any consortium component with Steering Committee policies; c) agree upon the
terms of the charter; d) discuss the approaches that were proposed in the
individual component and core applications, any relevant new information, and
set initial priorities for research and for new technologies to be developed;
and, e) discuss and set initial standards for validation of findings and
derived models. At the first meeting each year, the Steering Committee will
formulate plans for any new pilot projects to be funded. They will discuss
projects to be pursued jointly with funds set aside from the pilot projects
budget. At subsequent meetings, the Steering Committee will refine the
scientific objectives and characterization and validation strategies of FASD,
as necessary, consistent with progress in the CIFASD consortium components and
other laboratories, and with the goals of identifying available models with
sufficient promise for further analysis.
The Steering Committee may establish subcommittees as it deems appropriate.
The NIAAA Program Official and the other NIAAA/NIH staff may serve on
subcommittees.
Awardees will be required to accept actions and recommendations approved by the
Steering Committee.
4. Arbitration
Any disagreement that may arise on scientific or programmatic matters (within
the scope of the collaborative mechanism award) between awardees and the NIAAA
may be brought to arbitration. An arbitration panel will be composed of three
members: one selected by the Steering Committee (with the NIAAA Program
Official not voting), or by the individual awardee in the event of an
individual disagreement; a second member selected by the NIAAA; and, the third
member selected by the two prior selected members. This special arbitration
procedure in no way affects the awardee's right to appeal an adverse action
that is otherwise appealable in accordance with the PHS regulations at 42 CFR
Part 50, Subpart D and HHS regulation at 45 CFR Part 16.
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:
Dr. Deidra Roach
Office of Collaborative Research
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard; Suite 302
Bethesda, MD 20892-7003
(office) 301 443-5820
(fax) 301 480-2358
Email: droach@willco.niaaa.nih.gov
Dr. Faye Calhoun
Office of Collaborative Research
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard; Suite 302
Bethesda, MD 20892-7003
(office) 301-443-2593
(fax) 301-480-2358
Email: fcalhoun@willco.niaaa.nih.gov
o Direct your questions about peer review issues to:
Eugene G. Hayunga, Ph.D.
Chief, Extramural Project Review Branch
Office of Scientific Affairs
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Room 409, MSC 7003
Bethesda, MD 20892-7003
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-4375
Fax: (301) 443-6077
o Direct your questions about financial or grants management matters to:
Judy Fox
Chief, Grants Management Branch
Office of Planning and Resource Management
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 504
6000 Executive Boulevard, MSC 7003
Bethesda, MD 20892-7003
(301) 443-4704 (telephone)
(301) 443-3891 (fax)
Email: jsimons@willco.niaaa.nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes the
following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does not enter
into the review of a subsequent application, the information that it contains
allows IC staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed at the beginning of this
document. The letter of intent should be sent to:
Extramural Project Review Branch
ATTN: RFA AA-03-002
Office of Scientific Affairs, NIAAA
6000 Executive Boulevard, Suite 409
Bethesda, MD 20892-5452
(for express/courier service: Rockville, MD 20852)
Telephone: (301) 443-4375
FAX: (301) 443-6077
by the letter of intent receipt date listed.
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.
SUPPLEMENTAL INSTRUCTIONS:
See the "Scope and Organization of CIFASD" section of the RFA, above, for
descriptions of the consortium components and application requirements for the
research project and resource core components of the consortium.
Each application submitted as part of a consortium must clearly indicate
whether it is to be considered as a U01 research project or U24 resource core.
Research applications should state "(U01 Research Project)" after the title of
the project in box 1 of the PHS 398. Core applications should state "(U24
Core)" after the title in box 1 of the PHS 398.
The U24 application submitted by the consortium coordinator must be accompanied
by a cover letter that identifies the total number of applications in the
consortium and the principal investigator for each research project and
resource core.
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:
RFA: AA-03-002
Extramural Project Review Branch
Office of Scientific Affairs
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Room 409
6000 Executive Boulevard, MSC 7003
Bethesda, MD 20892-7003
Rockville, MD 20852 (for express/courier service)
FAX: (301) 443-6077
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.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by NIAAA. Incomplete 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
NIAAA 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 NIAAA National Advisory Council.
REVIEW CRITERIA
Upon receipt, each cluster of applications will be reviewed for completeness by
the Center for Scientific review (CSR) and for responsiveness by the NIAAA.
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 NIAAA in accordance with the
review criteria stated below. As part of the initial scientific merit review, a
process may be used by the initial review group in which applications 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 the
applications under review, will be discussed, assigned a priority score, and
receive a second level review by the National Advisory Council on Alcohol Abuse
and Alcoholism.
Review Criteria for the Consortium Coordinator Application (lead application
and overall consortium)
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
multidisciplinary Initiative 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.
a. Significance: Does this interactive multidisciplinary consortium project
address a complex biological problem of overarching significance to biomedical
science that would be difficult to address by separate grants? If the aims of
the overall consortium are achieved, how will the scientific knowledge be
advanced? What will be the effect of these studies on the concepts or methods
that drive this field? Do the arrangements for data sharing maximize the
impact of the interactive consortium project?
b. Approach: Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the scientific aims
of the collaborative project? Does the applicant acknowledge potential problem
areas and consider alternative tactics or designs? Is the project management
plan adequate? Is the administrative framework appropriate? Do milestones
articulate key indicators set for appropriate times that will demonstrate
significant forward progress for the consortium project? Are the plans to
monitor and evaluate progress of the consortium project adequate? Are the
plans to share the data and findings within the consortium and the larger
scientific community adequate?
c. Innovation: Does the project employ novel concepts, approaches, theories,
or methods? Are the aims original and innovative? Will the multidisciplinary
collaborative consortium challenge existing paradigms or develop new
methodologies or technologies? Will the multidisciplinary consortium attack a
problem in a significantly new way?
d. Investigators: Is the Consortium Coordinator's major research activity
within the research area of the multidisciplinary consortium? Is the
Consortium Coordinator well suited to the scientific and administrative
leadership required to carry out this work? Is the level of effort proposed
for the Consortium Coordinator appropriate? Is the work proposed appropriate
to the experience level of the multidisciplinary consortium's research and
technical staff? Are the research project component applications of the
participating investigators within the area of the multidisciplinary
consortium? Are the participating investigators well chosen for their roles in
the collaborative project?
e. Environment. Do the scientific environments in which the work will be done
contribute to the probability of success? Are support personnel and resources
in place to advance the work? Will the proposed multidisciplinary consortium
take advantage of unique features of the scientific environments of the
component projects? Is there evidence of institutional support? Are the
requested core facilities critical to achieving the scientific goals of the
multidisciplinary consortium; are they cost effective? Is access to the core
facilities appropriate?
f. Budget: Is the requested budget and estimation of time to completion of the
study appropriate for the proposed research?
In accordance with NIH policy, all applications will 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.
Review Criteria for Core Resources
Consideration of the technical merit of the core units will include:
a. Facilities within the resource cores compared to the state-of-the-art. The
contributions of the resource cores to fulfilling the goals of the consortium.
b. The adequacy of the approaches, methods and operational procedures for
interacting with the consortium investigators.
c. The extent to which resource core units promote greater collaboration and
cohesiveness among the participating investigators.
d. Qualifications, experience, and commitment to the consortium mission of the
investigators responsible for the core resources and their abilities to devote
the required time and effort to the program.
e. Appropriateness of the budgetary requests.
Review Criteria for Research Project Components
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
each research project application in order to judge the likelihood that the
proposed research will have a substantial impact on the pursuit of these goals.
Each of the criteria listed below will be addressed and considered in assigning
the score for a research project, weighting them as appropriate for each
project. Note that the project 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. In their evaluations, reviewers will comment on:
a. 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 achieving the goals of the
collaborative projects or consortium? Will the project tie or enhance the
independent work of the participating investigator to the collaborative
project, or will the project add an essential missing aspect to the
collaborative project?
b. 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?
c. 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?
d. 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)?
e. 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?
In addition to the above criteria, in accordance with NIH policy, all
individual scientific projects will 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. The scientific review group will also examine the
provisions for the protection of human subjects and the safety of the research
environment.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: February 11, 2003
Application Receipt Date: March 11, 2003
Peer Review Date: May-June 2003
Council Review: September 2003
Earliest Anticipated Start Date: September 29, 2003
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o scientific merit (as determined by peer review).
o availability of funds.
o programmatic priorities.
REQUIRED FEDERAL CITATIONS
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 are
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.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on
hESCs can be found at https://grants.nih.gov/grants/stem_cells.htm and at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only
research using hESC lines that are registered in the NIH Human Embryonic Stem
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).
It is the responsibility of the applicant to provide the official NIH
identifier(s)for the hESC line(s)to be used in the proposed research.
Applications that do not provide this information will be returned without
review.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a project
that is supported in whole or in part with Federal funds and (2) cited publicly
and officially by a Federal agency in support of an action that has the force
and effect of law (i.e., a regulation) may be accessed through FOIA. It is
important for applicants to understand the basic scope of this amendment. NIH
has provided guidance at
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this PA in a public archive,
which can provide protections for the data and manage the distribution for an
indefinite period of time. If so, the application should include a description
of the archiving plan in the study design and include information about this in
the budget justification section of the application. In addition, applicants
should think about how to structure informed consent statements and other human
subjects procedures given the potential for wider use of data collected under
this award.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Furthermore, we
caution reviewers that their anonymity may be compromised when they directly
access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving
the health promotion and disease prevention objectives of "Healthy People
2010," a PHS-led national activity for setting priority areas. This RFA is
related to one or more of the priority areas. Potential applicants may obtain a
copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
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.
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic
Assistance, No. 93.891. Awards are made under the authorization of the
Public Health Service Act, Sections 301 and 464J, and administered
under the Federal Regulations at Title 42 CFR Part 549, "Grants for
National Alcohol Research Centers" and 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 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 American people.