Federal Register / Vol. 66, No. 116 / Friday, June 15, 2001 / Notices 32631

(HCFA), Department of Health and

Human Services, has submitted to the

Office of Management and Budget

(OMB) the following proposal for the

collection of information. Interested

persons are invited to send comments

regarding the burden estimate or any

other aspect of this collection of

information, including any of the

following subjects: (1) The necessity and

utility of the proposed information

collection for the proper performance of

the agency’s functions; (2) the accuracy

of the estimated burden; (3) ways to

enhance the quality, utility, and clarity

of the information to be collected; and

(4) the use of automated collection

techniques or other forms of information

technology to minimize the information

collection burden.

Type of Information Collection

Request: Extension of a currently

approved collection;

Title of Information Collection:

Subpart D—Private Contracts and

Supporting Regulations in 42 CFR

405.410, 405.430, 405.435, 405.440,

405.445, 405.455, 410.61, 415.110, and

424.24;

Form No.: HCFA–R–234 (OMB #

0938–0730);

Use: Section 4507 of the BBA of 1997

amended section 1802 of the Social

Security Act to permit certain

physicians and practitioners to opt-out

of Medicare and to provide through

private contracts services that would

otherwise be covered by Medicare.

Under such contracts the mandatory

claims submission and limiting charge

rules of section 1848(g) of the Act would

not apply. Subpart D and the

Supporting Regulations contained in 42

CFR 405.410, 405.430, 405.435, 405.440,

405.445, and 405.455, counters the

effect of certain provisions of Medicare

law that, absent section 4507 of BBA

1997, preclude physicians and

practitioners from contracting privately

with Medicare beneficiaries to pay

without regard to Medicare limits;

Frequency: Biennially;

Affected Public: Business or other forprofit;

Number of Respondents: 26,820;

Total Annual Responses: 26,820;

Total Annual Hours: 7,197.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, access

HCFA’s WEB SITE ADDRESS at http://

www.hcfa.gov/regs/prdact95.htm, or Email your request, including your

address and phone number, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.

Written comments and

recommendations for the proposed

information collections must be mailed

within 30 days of this notice directly to

the OMB Desk Officer designated at the

following address:

OMB Human Resources and Housing

Branch, Attention: Allison Eydt, New

Executive Office Building, Room 10235,

Washington, D.C. 20503.

Dated: May 22, 2001.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA,

Office of Information Services,Security and

Standards Groups, Division of HCFA

Enterprise Standards.

[FR Doc. 01–15096 Filed 6–14–01; 8:45 am]

BILLING CODE 4120–03–P

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.

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,

32632 Federal Register / Vol. 66, No. 116 / Friday, June 15, 2001 / Notices

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,

Federal Register / Vol. 66, No. 116 / Friday, June 15, 2001 / Notices 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

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Substance Abuse and Mental Health

Services Administration

Fiscal Year (FY) 2001 Funding

Opportunities

AGENCY: Substance Abuse and Mental

Health Services Administration, HHS.

ACTION: Notice of funding availability.

SUMMARY: The Substance Abuse and

Mental Health Services Administration

(SAMHSA) Center for Mental Health

Services (CMHS) announces the

availability of FY 2001 funds for

cooperative agreements for the

following activity. This notice is not a

complete description of the activity;

potential applicants must obtain a copy

of the Guidance for Applicants (GFA),

including Part I, Cooperative

Agreements to Develop a National

Infrastructure for the Improvement of

Treatment and Services for Children

and Adolescents Who Experience

Trauma, and Part II, General Policies

and Procedures Applicable to all

SAMHSA Applications for

Discretionary Grants and Cooperative

Agreements, before preparing and

submitting an application.

Activity Application deadline

Est.

funds

FY

2001

(in millions)

Est. number

of awards

Project period

(in yrs.)

Child Traumatic Stress Initiative ............................... July 30, 2001 ........................................................... *$9.5 ... *18 *3

*See the text below for more details on the funding, number of awards, and the project period. This will vary with the three types of awards.

The actual amount available for the

award may vary, depending on

unanticipated program requirements

and the number and quality of

application received. FY 2001 funds for

the activity discussed in this

announcement were appropriated by

Congress under Public Law No. 106–

310. SAMHSA’s policies and

procedures for peer review and

Advisory Council review of grant and

cooperative agreement application were

published in the Federal Register (Vol.

58, No. 126) on July 2, 1993.

General Instructions: Applicants must

use application form PHS 5161–1 (Rev.

7/00). The application kit contains the

two-part application materials