[Federal Register Volume 66, Number 116 (Friday, June 15, 2001)]
[Notices]
[Pages 32631-32633]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-15085]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Emergency Medical Service for Children; Cooperative Agreements 
for Emergency Medical Services for Children Network Development 
Demonstration Projects

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice of availability of funds.

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SUMMARY: The Health Resources and Services Administration (HRSA) 
announces that up to $1.8 million in fiscal year (FY) 2001 funds is 
available to fund up to three cooperative agreements for demonstration 
projects to develop and potentially replicate a system of regional 
applied pediatric emergency medical services research centers designed 
to expand and improve emergency services for children who need 
treatment for trauma or critical care. These regional centers will be 
linked together, as nodes in a network, with their affiliated hospital 
emergency departments, to demonstrate a capacity to conduct 
observational studies and clinical trials on issues relating to the 
management of emergency pediatric events that occur in medical settings 
as well as in transport to and from such settings. Substantial HRSA 
scientific and/or programmatic involvement in the administration of 
network activities is anticipated. All of the cooperative agreements 
will be made under the program authority of the Public Health Service 
Act, Title XIX, Section 1910 (42 U.S.C. 300w-9), Emergency Medical 
Services for Children, and will be administered by the Maternal and 
Child Health Bureau (MCHB), HRSA. Projects will be approved for up to a 
3-year period, with average yearly awards varying from $350,000 to 
$600,000. However, funding for Emergency Medical Services for Children 
(EMSC) Network Development Cooperative Agreements (CFDA #93.127L) 
beyond FY 2001 is contingent upon the availability of funds. 
Announcements may be made after the initial 3-year project period to 
demonstrate the effectiveness of expanding the number of regional 
centers in the network.

DATES: Entities which intend to submit an application for this program 
are expected to notify MCHB's Division of their intent by July 2, 2001. 
The deadline for receipt of applications is August 1, 2001. 
Applications will be considered ``on time'' if they are either received 
on or before the deadline date or postmarked on or before the deadline 
date. The projected award date is September 30, 2001.

ADDRESSES: To receive a complete application kit, applicants may 
telephone the HRSA Grants Application Center at 1-877-477-2123 (1-877-
HRSA-123) beginning May 29, 2001, or register on-line at: http://
www.hrsa.gov/--order3.htm directly. The Pediatric Emergency Medical 
Services Network Development program uses the standard Form PHS 5161-1 
(rev. 7/00) for applications (approved under OMB No. 0920-0428). 
Applicants must use Catalog of Federal Domestic Assistance (CFDA) 
#93.127L when requesting application kits. The CFDA is a Government 
wide compendium of enumerated Federal programs, project services, and 
activities which provide assistance. All applications must be mailed or 
delivered to Grants Management Officer, MCHB: HRSA Grants Application 
Center, 1815 N. Fort Meyer Drive, Suite 300, Arlington, Virginia 22209: 
telephone 1-877-477-2123: E-mail: [email protected].
    Necessary application forms and an expanded version of this Federal 
Register notice may be downloaded in either Microsoft Office 2000 or 
Adobe Acrobat format (.pdf) from the MCHB Home Page at http://www.mchb.hrsa.gov. Please contact Joni Johns, at 301/443-2088, or 
[email protected]/, if you need technical assistance in accessing the 
MCHB Home Page via the Internet.
    This notice will appear in the Federal Register and/or HRSA Home 
Page at http://www.hrsa.dhhs.gov/. Federal Register notices are found 
on the World Wide Web by following instructions at: http://www.access.gpo.gov/su_docs/aces/aces140.html.
    Letter of Intent: Notification of intent to apply can be made in 
one of three ways: Telephone, 301-443-2190; email, [email protected]/; 
mail, Research Branch, MCHB Division of Research,

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Training and Education; Parklawn Building, Room 18A-55; 5600 Fishers 
Lane; Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Kishena Wadhwani, 301/443-4842, email: 
[email protected]/ (for questions specific to project objectives and 
activities of the program; or the required Letter of Intent, which is 
further described in the application kit); Jamie King, 301/443-1123, 
email [email protected]/ (for grants policy, budgetary, and business 
questions).

SUPPLEMENTARY INFORMATION: Improving the care of ill and injured 
pediatric patients has been a major goal of the EMSC program since its 
inception in 1984. This program is administered by MCHB in 
collaboration with the National Highway Traffic Safety Administration 
(NHTSA), U.S. Department of Transportation. Almost every State has 
received EMSC funding for demonstration projects to expand and improve 
pediatric emergency care and many new methods have been implemented, 
including system development, education of emergency providers, 
integration of pediatric components into adult emergency medical 
services (EMS) systems, and data collection and analysis to delineate 
existing and emergent problems and develop cause-and-effect hypotheses.
    Despite the many advances in creating and improving EMS systems and 
incorporating pediatric components into them, relatively little 
empirical data has been collected about how EMS and EMSC systems 
operate, about the efficacy of the clinical procedures being employed 
at the hospital level to treat and manage children who have experienced 
an emergency event, or about the efficacy of the transport systems and 
clinical procedures used to treat and manage children prior to their 
arrival at the hospital. Information on the cost effectiveness of the 
various EMS and EMSC system configurations and of the various ways 
being used to handle clinical pediatric emergencies is also lacking.
    The dearth of science-based knowledge about pediatric emergencies 
and how to best manage them has not gone unnoticed. The issue has been 
raised by professionals in the field, who have found that it 
constitutes a major barrier to the reduction of the annual toll in 
mortality and morbidity. Calls by experts to mount a nation wide 
research initiative in emergency medical services were made in 1991 and 
1993. These led to the publication of comprehensive research agenda 
reports for researchers working independently. More recently, in 2001, 
a joint report from the National Association of EMS Physicians and 
NHTSA delineates what areas of research--unspecified as to adult or 
children--need to be addressed. This report alludes to the nationwide 
scarcity of available funds for research in EMS and EMSC. The same 
report emphasizes that because the incidence rates for all emergency 
events are relatively small, more so for children, the pooling of sites 
and treatment experiences for applied research is highly desirable.
    The encouragement of a research focus for the EMSC program was also 
reflected by the Senate Appropriations Committee in its FY 2001 
committee report language (S.Report No. 106-293, at 73 (2000)). In it, 
the Committee encourages MCHB's EMSC program to ``develop * * * quality 
of care assessment and enhancement initiatives'' and ``to develop a 
means of collecting data to ensure accountability and to better track 
accomplishments and needs.'' Id.
    The EMSC Network Development Demonstration Projects described in 
this announcement are a measured response to the national concerns 
outlined above. Within five years, the intent is to demonstrate that: 
(1) A well-conceived and fully-operational infrastructure can be put in 
place to conduct clinical trials and observational studies on EMSC 
using rigorous study designs and methodologies; (2) a consensus-derived 
and well-informed research agenda can be developed and used to actively 
guide the network's activities; (3) a research and development process 
can be instituted fully within the network to develop proposals, 
conduct pilot studies, and carry out full-blown investigation with 
support from MCHB and other Federal agencies; and (4) a plan to study 
and encourage the transfer of network findings to EMSC practices can be 
designed and instituted.
    Authorization: Title XIX, Section 1910, Public Health Service Act 
(42 U.S.C. 300w-9).

Purpose

    The purpose of this program is to design and evaluate an 
infrastructure to test the efficacy of treatments, transport and care 
responses that precede the arrival of children to hospital emergency 
departments. Creation of a successful infrastructure will help overcome 
present difficulties in assessing the efficacy and quality of care and 
ensuring accountability in State EMSC programs that result from the 
relatively small incidence rates of pediatric emergency events and the 
lack of a current mechanism to pool sites and treatment experiences and 
can also be expected to facilitate observational studies on a variety 
of issues related to EMSC, including the processes involved in 
transferring research results to treatment settings.

Eligibility

    Applications may be submitted by State governments and accredited 
schools of medicine. The term ``schools of medicine'' for the purpose 
of this solicitation is defined as having the same meaning as set forth 
in section 799B(1)(A) of the PHS Act (42 U.S.C. 295p(1)(A)). 
``Accredited'' in this context has the same meaning as set forth in 
section 799B(1)(E) of the PHS Act (42 U.S.C. 295p(1)(E)).

Funding Mechanism

    The administrative and funding instrument to be used for this 
program will be the cooperative agreement, in which substantial MCHB 
scientific and/or programmatic involvement with awardees is anticipated 
during the performance of the project. Under the cooperative agreement, 
MCHB will support and stimulate awardees' activities by working with 
the awardees in a partnership role. Federal involvement may include, 
but is not limited to, planning, guidance, coordination and 
participation in programmatic activities. Periodic meetings and/or 
communications with the award recipient may be held to review mutually 
agreed upon goals and objectives and to assess progress. Details of the 
responsibilities of MCHB, awardees, and their expected relationships 
under these cooperative agreements are included in the ``Terms and 
Conditions of Award'' section of the application guidance material, 
which is part of the application kit sent to prospective applicants 
upon request, or downloaded by prospective applicants from the MCHB web 
site.

Funding Level/Project Period

    Approximately $1.8 million in FY 2001 funds is available to support 
the EMSC Network Development Demonstration Projects. This level of 
support is dependent on the receipt of a sufficient number and 
diversity of applications of high scientific merit.
    Three awards are anticipated in FY 2001, for project periods of up 
to three years. Because the nature and scope of activities proposed in 
response to this announcement may vary, it is anticipated that the size 
of individual awards will also vary. The initial budget period is 
expected to be 12 months, with subsequent budget periods being 12 
months. Continuation of any project from one budget period to the next 
is subject to satisfactory performance,

[[Page 32633]]

availability of funds, and program priorities.
    Competing continuation applications may be invited upon expiration 
of the initial funding period. Any awards made subsequent to the 
initial 3-year project period would be expected to demonstrate the 
feasibility of adding sites to the Network.

Review Criteria

    Applications will be screened by MCHB staff for completeness and 
programmatic responsiveness to the program guidance. Those judged to be 
incomplete or non-responsive will be returned to the applicant without 
review.
    Applications that are complete and responsive to the guidance will 
be evaluated for scientific and technical merit by an appropriate peer 
review group specifically convened for this solicitation and in 
accordance with HRSA grants management policies and procedures. As part 
of the initial merit review, all applications will receive a written 
critique. All applications recommended for approval will be discussed 
fully by the ad hoc peer review group and assigned a priority score for 
funding.
    Applications will be reviewed for scientific and technical merit 
using a set of criteria covering the following areas:
    (1) Quality of plan for the establishment of the cooperative 
regional research center and the nature and technical quality of the 
investigations proposed;
    (2) Principal investigator's documented history of leadership in 
the conduct of complex multi-site clinical trials and observational 
investigations and substantial publication record in the field of 
emergency medical services;
    (3) Infrastructure to conduct research;
    (4) Collaboration between hospital emergency departments and 
regional center;
    (5) Administrative and management plan;
    (6) Budget. Budget requests should be commensurate with the 
complexities involved in what is being proposed and carefully 
justified;
    (7) Positive evaluation of pre-award site visits to all applicants.
    Final criteria used to review and rank applications for this 
competition are included in the application kit. Applicants should pay 
strict attention to addressing these criteria, as they are the basis 
upon which their applications will be judged.

Paperwork Reduction Act

    If the cooperative agreements described in this announcement 
involve data collection activities that fall under the purview of the 
Paperwork Reduction Act of 1995, OMB clearance will be sought prior to 
collection of data.

Executive Order 12372

    This program has been determined to be a program which is subject 
to the provisions of Executive Order 12372 concerning intergovernmental 
review of Federal programs by appropriate health planning agencies, as 
implemented by 45 CFR part 100. Executive Order 12372 allows States the 
option of setting up a system for reviewing applications from within 
their States for assistance under certain Federal programs. The 
application packages to be made available under this notice will 
contain a listing of States which have chosen to set up such a review 
system and will provide a single point of contact (SPOC) in the States 
for review. Applicants (other than federally-recognized Indian tribal 
governments) should contact their State SPECS as early as possible to 
alert them to the prospective applications and receive any necessary 
instructions on the State process. For proposed projects serving more 
than one State, the applicant is advised to contact the SPOC of each 
affected State. The due date for State process recommendations is 60 
days after the application deadline for new and competing awards. The 
granting agency does not guarantee to ``accommodate or explain'' for 
State process recommendations it receives after that date. (See part 
148, Intergovernmental Review of PHS Programs under Executive Order 
12372 and 45 CFR part 100 for a description of the review process and 
requirements).

    Dated: June 7, 2001.
Betty James Duke,
Acting Administrator.
[FR Doc. 01-15085 Filed 6-14-01; 8:45 am]
BILLING CODE 4160-15-P