30936 Federal Register / Vol. 66, No. 111 / Friday, June 8, 2001 / Notices

Administration, 5600 Fishers Lane (for

express delivery, 5630 Fishers Lane, rm.

1093), Rockville, MD 20857, 301–827–

7001, FAX 301–827–6776, or e-mail:

reedyk@cder.fda.gov, or FDA Advisory

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), code 12536.

Please call the Information Line for upto-date information on this meeting.

Agenda: On July 26, 2001, the

committee will discuss new drug

application (NDA) 21–332, SymlinTM

(pramlintide acetate, Amylin

Pharmaceuticals, Inc.) as an adjunctive

therapy to insulin to improve glycemic

and metabolic control in patients with

type 1 or type 2 diabetes mellitus alone

or in combination with oral

hypoglycemic agents. On July 27, 2001,

the committee will discuss NDA 21–

318, Forte ́oTM (teriparatide injection,

rDNA origin, Eli Lilly and Co.) for the

treatment of osteoporosis in men and in

postmenopausal women.

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by July 20, 2001. Oral

presentations from the public will be

scheduled between approximately 11

a.m. and 11:30 a.m. each day. Time

allotted for each presentation may be

limited. Those desiring to make formal

oral presentations should notify the

contact person before July 20, 2001, and

submit a brief statement of the general

nature of the evidence or arguments

they wish to present, the names and

addresses of proposed participants, and

an indication of the approximate time

requested to make their presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: May 31, 2001.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 01–14410 Filed 6–7–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–1194–N]

Medicare Program; Meeting of the

Practicing Physicians Advisory

Council on June 25, 2001

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice of meeting.

SUMMARY: In accordance with section

10(a) of the Federal Advisory Committee

Act, this notice announces a meeting of

the Practicing Physicians Advisory

Council. This meeting is open to the

public.

DATES: The meeting is scheduled for

June 25, 2001, from 8:30 a.m. until 5

p.m., e.d.t.

ADDRESSES: The meeting will be held in

Room 505A, 5th Floor, Hubert H.

Humphrey, 200 Independence Avenue,

SW., Washington, DC 20201.

FOR FURTHER INFORMATION CONTACT: Paul

Rudolf, M.D., J.D., Executive Director,

Practicing Physicians Advisory Council,

Room 435–H, Hubert H. Humphrey

Building, 200 Independence Avenue,

SW., Washington, DC 20201, (202) 690–

7874. News media representatives

should contact the HCFA Press Office,

(202) 690–6145. Please refer to the

HCFA Advisory Committees

Information Line (1–877–449–5659 toll

free)/(410 786–9379 local) or the

internet (http://www.hcfa.gov/fac) for

additional information and updates on

committee activities.

SUPPLEMENTARY INFORMATION: The

Secretary of the Department of Health

and Human Services (the Secretary) is

mandated by section 1868 of the Social

Security Act to appoint a Practicing

Physicians Advisory Council (the

Council) based on nominations

submitted by medical organizations

representing physicians. The Council

meets quarterly to discuss certain

proposed changes in regulations and

carrier manual instructions related to

physicians’ services, as identified by the

Secretary. To the extent feasible and

consistent with statutory deadlines, the

consultation must occur before

publication of the proposed changes.

The Council submits an annual report

on its recommendations to the Secretary

and the Administrator of the Health

Care Financing Administration not later

than December 31 of each year.

The Council consists of 15 physicians,

each of whom has submitted at least 250

claims for physicians’ services under

Medicare or Medicaid in the previous

year. Members of the Council include

both participating and nonparticipating

physicians, and physicians practicing in

rural and underserved urban areas. At

least 11 members must be doctors of

medicine or osteopathy authorized to

practice medicine and surgery by the

States in which they practice. Members

have been invited to serve for

overlapping 4-year terms. In accordance

with section 14 of the Federal Advisory

Committee Act, this Council

automatically terminates two years after

its date of establishment, unless the

Council is renewed before the

termination date by appropriate agency

action. Therefore, terms of more than

two years for members are contingent

upon the renewal.

The Council held its first meeting on

May 11, 1992.

The current members are: Jerold M.

Aronson, M.D.; Richard Bronfman,

D.P.M.; Joseph Heyman, M.D.; Sandral

Hullett, M.D.; Stephen A. Imbeau, M.D.;

Angelyn L. Moultrie, D.O.; Derrick K.

Latos, M.D. (pending re-appointment);

Dale Lervick, O.D.; Sandra B. Reed,

M.D.; Amilu Rothhammer, M.D.; Victor

Vela, M.D.; and Kenneth M. Viste, Jr.,

M.D.; and Douglas L. Wood, M.D. The

Council chairperson is pending

selection.

The agenda will provide for

discussion and comment on the

following topics:

• Inputs and insights on the draft

instructions to implement Advance

Beneficiary Notices.

• Physician Regulatory Issues Team

(PRIT) update.

• Evaluation and Management

Documentation Guidelines (update and

discussion on medical review form).

• Physician Participation in

Evaluation and Management Guidelines

Pilot Studies (How to address issues of

miscoding and medical review in the

studies).

• Contractor Oversight Issues

(provider education, customer service,

medical review, and contractor

performance evaluation).

For additional information and

clarification on the topics listed, call the

contact person in the FOR FURTHER

INFORMATION CONTACT section of this

notice.

Individual physicians or medical

organizations that represent physicians

and who wish to be scheduled to make

5-minute oral presentations on agenda

issues should contact the Executive

Director by 12 noon, June 15, 2001.

Testimony is limited to the listed

agenda issues only. The number of oral

presentations may be limited by the

time available. A written copy of the

presenter’s oral remarks should be

submitted to the Executive Director no

later than 12 noon, June 18, 2001, for

distribution to Council members for

review prior to the meeting. Physicians

and organizations not scheduled to

speak may also submit written

comments to the Executive Director and

Council members. The meeting is open

to the public, but attendance is limited

to the space available. Individuals

requiring sign language interpretation

for the hearing impaired or other special

accommodation should contact John

Federal Register / Vol. 66, No. 111 / Friday, June 8, 2001 / Notices 30937

Lanigan (202) 690–7418 at least 10 days

before the meeting.

(Section 1868 of the Social Security Act (42

U.S.C. 1395ee) and section 10(a) of Public

Law 92–463 (5 U.S.C. App. 2, section 10(a))

(Catalog of Federal Domestic Assistance

Program No. 93.773, Medicare—Hospital

Insurance; and Program No. 93.774,

Medicare—Supplementary Medical

Insurance Program)

Dated: June 6, 2001.

Thomas A. Scully,

Administrator, Health Care Financing

Administration.

[FR Doc. 01–14595 Filed 6–7–01; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

State Grants for Traumatic Brain Injury

AGENCY: Health Resources and Services

Administration, HHS.

ACTION: Notice of availability of funds.

SUMMARY: The Health Resources and

Services Administration (HRSA)

announces that about $1.2 million in

fiscal year (FY) 2001 funds is available

for up to 14 State Grants for Traumatic

Brain Injury (TBI) awards. Grant

programs for TBI provide health and

other services for people who have

sustained a traumatic brain injury.

Awards will be made in two

categories—Planning Grants, to assist

States in developing the infrastructure

needed to implement a State TBI

program; and a new category of Post

Demonstration Grants for States which

have successfully completed a TBI

Implementation Grant. All grants will be

made under the program authority of

the Public Health Service Act, Title XII,

Section 1252 (42 U.S.C. 300d–52), as

amended, and will be administered by

the Maternal and Child Health Bureau

(MCHB), HRSA. Awards for TBI

Planning Grants (CFDA #93.234B) may

be approved for up to two years, and

range from $50,000 to $75,000. Awards

for TBI Post Demonstration Grants

(CFDA #93.234C) are available for only

one year, in amounts up to $100,000.

Funding for these grant categories

beyond FY 2001 is contingent upon the

availability of funds.

DATES: Entities which intend to submit

an application for this grant program are

expected to notify MCHB’s Division of

their intent by June 18, 2001. The

deadline for receipt of applications is

July 16, 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 29, 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 June 4, 2001, or

register on-line at: http://www.hrsa.gov/

_order3.htm directly. The Traumatic

Brain Injury State Grant 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) #93.234B when

requesting an application kit. 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 should be directed to Betty

Hastings, M.S.W., by email,

bhastings@hrsa.gov/; or mail, MCHB,

HRSA; Division of Child, Adolescent

and Family Health, Parklawn Building,

Room 18A–38; 5600 Fishers Lane;

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Betty Hastings, M.S.W., 301/443–5599,

or email: bhastings@hrsa.gov/ (for

questions specific to project objectives

and activities of the program; or the

required Letter of Intent); Marilyn

Stewart, 301/443–1440, email

mstewart@hrsa.gov/ (for grants policy,

budgetary, and business questions).

SUPPLEMENTARY INFORMATION: Traumatic

brain injury (i.e., cranio-cerebral head

trauma) is an occurrence of injury to the

head arising from blunt or penetrating

trauma or from accelerationdeceleration forces that is associated

with any of these symptoms or signs

attributed to the injury: Decreased level

of consciousness, amnesia, other

neurologic or neuropsychologic

abnormalities, skull fracture, diagnosed

intracranial lesions, or death.

Motor vehicle crashes, falls, violence,

and sports injuries are the major causes

of TBI; the number one killer and cause

of disability for young people in the

United States. The Centers of Disease

Control and Prevention has found that

approximately 5.3 million Americans

live with the effects of TBI. About half

the estimated 1.9 million Americans

who experience TBI each year incur at

least short-term disability; 52,000

people die as a result of their injuries

and more than 90,000 people sustain

severe brain injuries leading to

debilitating loss of function. The direct

medical costs for treatment of TBI have

been estimated at more than $4 billion

annually.

In 1996, Public Law 104–166

established a program of grants to States

to carry out TBI demonstration projects

to increase access to rehabilitation,

employment, education, and other longterm community support services, in

addition to health and medical services.

State Grants for TBI support projects

by States to implement statewide

systems, ensuring access to

comprehensive and coordinated TBI

Services. These projects are successfully

bringing together representatives of

relevant State agencies, disciplines,

organizations, and consumers.

Until FY 2001, two categories of TBI

demonstration grant programs were

available—State TBI Planning Grants

and State TBI Implementation Grants.

To date, 31 States and the District of

Columbia have received basic planning

support to establish the necessary

infrastructure core capacity components

needed to develop an Action Plan to

improve the State’s TBI service system.

State TBI planning grantees develop

four ‘‘core capacity’’ components,

identified as the essential elements in

any plan for State implementation of a

TBI service system. These include: (1) A

statewide TBI Advisory Board; (2)

Designated State agency and staff

position(s) responsible for State TBI

activities; (3) a statewide needs/resource

assessment to address the full spectrum

of services from initial acute treatment

through rehabilitation and long-term

community services for individuals

with TBI; and (4) a statewide Action

Plan to develop a comprehensive,

community-based system of care that

encompasses physical, psychological,

educational, vocational, and social

aspects of TBI services. This Action