[Federal Register Volume 67, Number 86 (Friday, May 3, 2002)]
[Notices]
[Pages 22438-22440]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-11065]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Emergency Medical Services for Children; National Trauma Registry 
for Children Demonstration Project

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice of availability of funds.

-----------------------------------------------------------------------

SUMMARY: The Health Resources and Services Administration (HRSA) 
announces that up to $400,000 in fiscal year (FY) 2002 funds is 
available to fund two grants to assess the feasibility and value of 
developing a National Trauma Registry for Children (NTRC) as part of 
the Emergency Medical Services for Children (EMSC) program. Two grant 
awards are planned for 2002. One award of up to $150,000 will be made 
for a Data Identification, Collection and Use Planning Project to 
identify and prioritize data elements necessary for a pediatric trauma 
registry, develop sustainable data collection procedures that take into 
account the needs of all potential users, including but not limited to, 
State Emergency Medical Services (EMS) Offices, pediatric trauma 
surgeons, pre-hospital and hospital health care providers; and develop 
procedures for accessing the data. A second award of up to $250,000 
will be for a Registry Design and Technology Planning Project to assess 
existing trauma registries, assess the feasibility of obtaining and 
linking information from them, and assess the feasibility of collecting 
additional data elements identified by the Data Identification, 
Collection and Use Planning Project. A pediatric trauma registry could 
be useful to clinicians and program planners for understanding the 
epidemiology and improving the clinical management of pediatric trauma. 
These demonstration project grants will be awarded under the program 
authority of the Public Health Service Act, Title XIX, Section 1910 (42 
U.S.C. 300w-9), and will be administered by the Maternal and Child 
Health Bureau (MCHB), HRSA. Projects will be approved for up to a 2-
year period. However, funding beyond FY 2002 is contingent upon the 
availability of funds.

DATES: Applicants are expected to notify MCHB's Division of Child, 
Adolescent, and Family Health of their intent by June 14, 2002. The 
deadline for receipt of applications is July 15, 2002. 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 3, 2002.

ADDRESSES: To receive a complete application kit, applicants may 
telephone the HRSA Grants Application Center at 1-877-477-2123 (1-877-
HRSA-123) or register on-line at: 
http://www.hrsa.gov/g_order3.htm directly. The Emergency Medical 
Services for Children 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) #93.127J when 
requesting application kits. The CFDA is a Government wide compendium 
of enumerated Federal programs, project services, and activities that 
provide assistance. All applications must be mailed or delivered to 
Grants Management Officer, MCHB: HRSA Grants Application Center, 901 
Russell Avenue, Suite 450, Gaithersburg, MD 20879: 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 on the HRSA Home Page at http://www.hrsa.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: Cindy Doyle, RN, telephone, 301-443-3888; email: 
[email protected], mail,

[[Page 22439]]

HRSA/EMSC Program, Parklawn Building, Room 18A-38; 5600 Fishers Lane; 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Cindy Doyle, RN, 301-443-3888, 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); Mickey Reynolds, 301-443-
0724, email [email protected] (for grants policy, budgetary, and 
business questions).

SUPPLEMENTARY INFORMATION:

Program Background and Objectives

    Section 1910 of the Public Health Service Act authorizes the 
implementation of a program of grants to States or accredited schools 
of medicine in States to develop and evaluate improved emergency 
procedures and protocols for children. It covers the entire spectrum of 
emergency medical care, including education of emergency providers 
about pediatric care, primary prevention, acute clinical care, and 
rehabilitation, and is a critical component of the President's 
initiative to combat terrorism and bioterrorism.
    The standard emergency medical services (EMS) system was developed 
primarily for adults, to address cardiac arrest. Because children 
suffer from a different spectrum of disease and injuries than adults, 
emergency medical services for adults differ significantly from those 
that are needed by children. Children are smaller, often respond with 
different symptoms than adults display in similar traumatic 
circumstances, and require specialized equipment and provider training. 
EMSC is specialized care for children who experience a serious injury 
or an acute illness. EMSC is integrated into the standard EMS system, 
and enhances its capability to address the special needs of children.
    Each year, well over 31 million children and adolescents are seen 
in emergency departments. Fewer than half of all hospitals (46%) with 
emergency departments have all the necessary equipment for the 
stabilization of ill and injured children. Only five States currently 
require that advanced life support ambulances carry all the recommended 
equipment needed to stabilize a child. The most seriously ill and 
injured children may require care in pediatric specialty centers and 
access to rehabilitation services. Yet, no more than 11 States have 
guidelines for the identification of pediatric acute care facilities, 
to ensure that children get to the right hospital in a timely manner.
    EMS systems depend on successful coordination of services from many 
separate components, including pre-hospital care, emergency department 
care, inpatient care, and rehabilitation. Linking data across these 
different systems involves both technical challenges, and access 
issues. Other issues include a lack of common definitions across 
systems, a lack of consensus on needed data elements, a lack of 
validated measures of severity and acuity, a lack of validated measures 
of patient outcomes, and a lack of consensus on what outcomes to 
measure and when to measure them. Mortality is the most readily 
available and most widely used outcome, but relatively few children 
needing or receiving emergency care die. Other outcomes include the 
presence or absence of diseases, impairments, functional limitations, 
or disabilities interfering with age-appropriate activities; physical 
mobility and functioning; social and role functioning; and emotional 
and mental well-being. Measuring these reliably in children is a 
challenge. The purpose of the National Trauma Registry for Children 
Demonstration Project is to assess the feasibility of addressing some 
of these issues.

Authorization

    Title XIX, Section 1910, Public Health Service Act (42 U.S.C. 300w-
9).

Purpose

    This announcement invites proposals to demonstrate the feasibility 
and the value of developing a nationwide repository of information on 
the epidemiology and optimal clinical management of pediatric injury 
and trauma, which has the potential to improve the quality of care for 
children who have experienced traumatic injury. This demonstration 
project is structured into two parts:
    (a) Data Identification, Collection and Use Planning Grant. The 
purpose of this grant is to devise a process to identify and define a 
uniform set of variables that describe the type of pediatric trauma, 
clinical course and outcomes. Proposed data elements should ensure 
comparability across state and regional registries. MCHB assumes that 
the clinical data necessary to examine and enhance the care of injured 
children in the U.S. already exists as a subset of all data collected 
by hospitals on patient care. There are, however, barriers that hinder 
or even prohibit the aggregation of data from existing systems. One of 
the more obvious barriers is the lack of a standardized or common set 
of data elements.
    The grantee will be expected to propose data elements drawn from 
pre-hospital, emergency department, inpatient, rehabilitation, outcome, 
and vital statistics records. In the selection and justification of 
these data elements, the grantee will be expected to weigh the value 
and the cost of collection costs for each element. A list of data 
elements previously identified as possible candidates for a trauma 
registry is included in the grant guidance.
    The grantee will also be expected to address ideas for long-term 
sustainability, and patient privacy and confidentiality concerns that 
may arise as a result of data collection and linkage.
    (b) Registry Design and Technology Planning Grant. The purpose of 
this grant is to develop a pediatric trauma information system that 
will result in reliable and valid data for a variety of research and 
policy uses. Current trauma registry software packages are proprietary, 
and data are not easily exchanged across different platforms. The 
grantee will be expected to work with popular registry vendors to 
devise an export algorithm that will allow vendor data, using divergent 
platforms, to be downloaded to a central repository.
    Other issues to be addressed by the grantee include designing a 
system that can easily be adapted to add new data elements, obtaining 
voluntary participation by hospitals in providing data to the registry, 
electronic submission of data, and sample design considerations. MCHB's 
intent is to develop a registry system that is nationally 
representative, and large enough to enable analysis by specific type of 
pediatric injury.

Eligibility

    State governments and accredited schools of medicine are eligible 
for these grants. 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 Categories

    (1) Data Identification, Collection, and Use Planning Grant: MCHB 
expects to award one grant of up to $150,000 in this category to 
identify and prioritize data elements necessary for a trauma registry; 
develop sustainable data collection procedures that take into account 
the needs of all potential users, including but not limited to, State 
EMS Offices, pediatric trauma surgeons, pre-hospital and hospital 
health care providers; and develop procedures for

[[Page 22440]]

accessing the data. For the purposes of this demonstration project a 
registry is defined as the recording and compilation of predetermined 
data elements for the reporting and descriptive analysis of injury 
patterns, treatment and quality of care.
    (2) Registry Design and Technology Planning Grant: MCHB expects to 
award one grant of up to $250,000 in this category for a project to 
assess existing trauma registries; and to analyze the feasibility of 
obtaining and linking information from them, and to assess the 
feasibility of collecting data elements recommended by the recipient of 
the Data Identification, Collection, and Use Planning Grant, but not 
currently being collected.
    Applicants must specify the category of grant for which they are 
applying. Those applying for both types of grants must complete a 
separate application for each.

Funding Level/Project Period

    Approximately $400,000 in FY2002 funds is available to support two 
(2) awards. One award of up to $150,000 will be made for a Data 
Identification, Collection and Use Planning project, and one award of 
up to $250,000 will be made for a Registry Design and Technology 
Planning project. The initial budget period will be 12 months, with a 
subsequent budget period of 12 months. Continuation of any project from 
one budget period to the next is subject to satisfactory performance, 
program priorities, and availability of funds.

Review Criteria

    MCHB staff will screen applications for completeness and 
responsiveness to the program guidance. Applications that are 
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 technical merit by a peer review group convened 
specifically 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.
    Technical merit will be assessed using the following criteria:
    (a) Applicants' ability to accurately describe the significance of 
the injury and trauma problems facing the children of our nation and 
the rationale for establishing the NTRC;
    (b) Applicants' ability to clearly articulate the project's goals 
and the corresponding time-framed, measurable (e.g. quantified) 
objectives and activities to achieve these goals;
    (c) Applicants' ability to clearly articulate and identify a 
process for evaluating the outcome of this project;
    (d) Applicants' ability to successfully carry out the project as 
evidenced by a sufficient number of qualified project personnel and 
resources; and
    (e) Reasonableness of the proposed budget and soundness of the 
arrangement for fiscal management and ability to complete the proposed 
activities within the project period.
    Additional 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

    OMB approval for any data collection in connection with these 
grants will be sought, as required under the Paperwork Reduction Act of 
1995.

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 that 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 SPOC 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: April 29, 2002.
Elizabeth M. Duke,
Administrator.
[FR Doc. 02-11065 Filed 5-2-02; 8:45 am]
BILLING CODE 4165-15-P