Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### Health Resources and Services Administration

# 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 $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:                         *hrsagac@hrsa.gov*.                    

                        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                         *jjohns@hrsa.gov/*, 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,                         *kwadhwani@hrsa.gov/*; mail, Research Branch, MCHB Division of Research,                               ( print page 32632)                            Training and Education; Parklawn Building, Room 18A-55; 5600 Fishers Lane; Rockville, MD 20857.                    

# FOR FURTHER INFORMATION CONTACT:

                        Kishena Wadhwani, 301/443-4842, email:                         *kwadhwani@hrsa.gov/*                         (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                         *jking@hrsa.gov/*                         (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,                           ( print 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