21824 Federal Register / Vol. 60, No. 85 / Wednesday, May 3, 1995 / Notices

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

The agency encourages any person

who submits relevant information on

the application to do so by May 15,

1995, and to provide an additional copy

of the submission directly to the contact

person identified above, to facilitate

consideration of the information during

the 30-day review period.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(sec. 802 (21 U.S.C. 382)) and under

authority delegated to the Commissioner

of Food and Drugs (21 CFR 5.10) and

redelegated to the Center for Biologics

Evaluation and Research (21 CFR 5.44).

Dated: April 12, 1995.

James C. Simmons,

Acting Director, Office of Compliance, Center

for Biologics Evaluation and Research.

[FR Doc. 95–10898 Filed 5–2–95; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

[HSQ–227–N]

Medicare Program; Peer Review

Organization Contracts: Solicitation of

Statements of Interest From In-State

Organizations—Alaska, Delaware, the

District of Columbia, Idaho, Kentucky,

Maine, Nebraska, Nevada, South

Carolina, Vermont, and Wyoming

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: General notice.

SUMMARY: This notice, in accordance

with section 1153(i) of the Social

Security Act, announces the scheduled

expiration dates of the current contracts

between HCFA and several out-of-State

Utilization and Quality Control Peer

Review Organizations. It also specifies

the period of time in which in-State

organizations may submit a statement of

interest so that they may be eligible to

compete for these contracts. The States

currently affected and their respective

expiration dates are as follows:

Delaware ........................... March 31, 1996.

Nevada .............................. March 31, 1996.

Wyoming ........................... March 31, 1996.

Alaska ............................... June 30, 1996.

District of Columbia ......... June 30, 1996.

Idaho ................................. June 30, 1996.

Maine ................................ June 30, 1996.

Vermont ............................ June 30, 1996.

Nebraska ........................... September 30,

1996.

Kentucky ........................... September 30,

1996.

South Carolina .................. September 30,

1996.

DATES: Written statements of interest

must be received at the address

specified no later than 5 p.m. EST, June

2, 1995. Due to staffing and resource

limitations, we cannot accept statements

submitted by facsimile (FAX)

transmission.

ADDRESSES: Statements of interest must

be submitted to—Health Care Financing

Administration, OFHR, OAG, Attn.:

Brian Hebbel, Room G–M–1, East Low

Rise Building, 6325 Security Boulevard,

Baltimore, Maryland 21207.

FOR FURTHER INFORMATION CONTACT:

Kathleen Kelso, (410) 966–7214.

SUPPLEMENTARY INFORMATION:

I. Background

The Peer Review Improvement Act of

1982 (Title I, Subtitle C of the Tax

Equity and Fiscal Responsibility Act of

1982 (TEFRA), Pub. L. 97–248)

amended Part B of Title XI of the Social

Security Act (the Act) by establishing

the Utilization and Quality Control Peer

Review Organization (PRO) program.

Congress created the PRO program in

order to redirect, simplify, and enhance

the cost-effectiveness and efficiency of

the peer review process.

PROs currently review certain health

care services furnished under Title

XVIII of the Act (Medicare) and under

certain other Federal programs to

determine whether those services are

reasonable, medically necessary,

furnished in the appropriate setting, and

are of a quality that meets professionally

recognized standards. PRO activities are

a part of the Health Care Quality

Improvement Program (HCQIP) that

supports HCFA’s mission of assuring

health care security for its eligible

beneficiaries. The HCQIP is carried out

locally by the PRO in each State. Under

the HCQIP, PROs provide information

for health care plans, providers, and

practitioners to improve the quality of

care furnished to Medicare

beneficiaries.

In June 1984, HCFA began awarding

contracts to PROs. We currently

maintain 53 PRO contracts with

organizations that provide medical

review activities for 49 of the United

States, the District of Columbia, Puerto

Rico, and the Virgin Islands. The

organizations that are eligible to

contract as PROs have satisfactorily

demonstrated that they are either

physician-sponsored or physicianaccess organizations in accordance with

sections 1152 and 1153 of the Act and

our regulations at 42 CFR 462.102 and

462.103. A physician-sponsored

organization is one that is both

composed of a substantial number of the

licensed doctors of medicine or

osteopathy practicing medicine or

surgery in the respective review area

and is representative of the physicians

practicing in the review area. A

physician-access organization is one

that has available to it, by arrangement

or otherwise, the services of a sufficient

number of licensed doctors of medicine

or osteopathy practicing medicine or

surgery in the review area to assure

adequate peer review of the services

furnished by the various medical

specialties and subspecialties. In

addition, the organization must not be a

health care facility, health care facility

association, or a health care facility

affiliate, and must have a consumer

representative on its governing board.

The Omnibus Budget Reconciliation

Act of 1987 (Pub. L. 100–203) amended

section 1153 of the Act by adding a new

subsection (i) that prohibits the

Secretary from renewing the contract of

any PRO that is not an in-State

organization without first publishing in

the Federal Register a notice

announcing when the contract will

expire. This notice must be published

no later than 6 months before the date

of expiration, and must specify the

period of time during which an in-State

organization may submit a proposal for

the contract. If one or more qualified inState organizations submits a proposal

within the specified period of time,

HCFA may not automatically renew the

contract on a noncompetitive basis but

must instead provide for competition for

the contract in the same manner used

for a new contract. An in-State

organization is defined as an

organization that has its primary place

of business in the State in which review

will be conducted or that is owned by

a parent corporation, the headquarters

of which is located in that State.

There are currently 11 PRO contracts

with entities that do not meet the

statutory definition of an in-State

organization. The areas affected for

purposes of this notice are Alaska,

Delaware, the District of Columbia,

Idaho, Kentucky, Maine, Nebraska,

Nevada, South Carolina, Vermont, and

Wyoming.

II. Provisions of the Notice

This notice announces the scheduled

expiration dates of the current contracts

between HCFA and the out-of-State

PROs responsible for review in Alaska,

Delaware, the District of Columbia,

Idaho, Kentucky, Maine, Nebraska,

Nevada, South Carolina, Vermont, and

Wyoming. Interested in-State

organizations may submit statements of

interest to be the PRO for the

aforementioned States. The statements

must be received by HCFA no later than

June 2, 1995. In its statement of interest,

the organization must furnish materials
Federal Register / Vol. 60, No. 85 / Wednesday, May 3, 1995 / Notices 21825

that demonstrate that it meets the

definition of an in-State organization.

Specifically, the organization must have

its primary place of business in the State

in which review will be conducted or be

owned by a parent corporation, the

headquarters of which is located in that

State. In its statement, each interested

organization must further demonstrate

that it meets the following requirements:

A. Be Either a Physician-Sponsored or a

Physician-Access Organization

1. Physician-Sponsored Organization

i. The organization must be composed

of a substantial number of the licensed

doctors of medicine and osteopathy

practicing medicine or surgery in the

review area, and be representative of the

physicians practicing in the review area.

ii. The organization must not be a

health care facility, health care facility

association, or health care facility

affiliate.

iii. In order to meet the substantial

number requirement of A.l.i., an

organization must be composed of at

least 10 percent of the licensed doctors

of medicine and osteopathy practicing

medicine or surgery in the review area.

In order to meet the representation

requirement of A.l.i., an organization

must state and have documentation in

its files demonstrating that it is

composed of at least 20 percent of the

licensed doctors of medicine and

osteopathy practicing medicine or

surgery in the review area; or, if the

organization does not demonstrate that

it is composed of at least 20 percent of

the licensed doctors of medicine and

osteopathy practicing medicine or

surgery in the review area, then the

organization must demonstrate in its

statement of interest, through letters of

support from physicians or physician

organizations, or through other means,

that it is representative of the area

physicians.

2. Physician-Access Organization

i. The organization must have

available to it, by arrangement or

otherwise, the services of a sufficient

number of licensed doctors of medicine

or osteopathy practicing medicine or

surgery in the review area to assure

adequate peer review of the services

provided by the various medical

specialties and subspecialties.

ii. The organization must not be a

health care facility, health care facility

association, or health care facility

affiliate.

iii. An organization meets the

requirements of A.2.i. if it demonstrates

that it has available to it at least one

physician in every generally recognized

specialty; and has an arrangement or

arrangements with physicians under

which the physicians would conduct

review for the organization.

B. Have at Least One Individual Who Is

a Representative of Consumers on Its

Governing Board

If one or more organizations meet the

above requirements in a PRO area, and

submit statements of interest in

accordance with this notice, HCFA will

consider those organizations to be

potential sources for the aforementioned

contracts upon their expiration. These

organizations will be entitled to

participate in a full and open

competition for the PRO contract to

provide medical review services.

III. Information Collection

Requirements

This notice contains information

collection requirements that have been

approved and assigned Control Number

OMB 0938–0526 by the Office of

Management and Budget under the

authority of the Paperwork Reduction

Act of 1980 (44 U.S.C. 3501 et seq.).

This approval expires on October 31,

1997.

IV. Other

In accordance with the provisions of

Executive Order 12866, this regulation

was not reviewed by the Office of

Management and Budget.

Authority: Section 1153 of the Social

Security Act (42 U.S.C. 1320c–2).

(Catalog of Federal Domestic Assistance

Program No. 93.773, Medicare—Hospital

Insurance Program; and No. 93.774,

Medicare—Supplementary Medical

Insurance Program)

Dated: March 23, 1995.

Bruce C. Vladeck,

Administrator, Health Care Financing

Administration.

[FR Doc. 95–10793 Filed 5–2–95; 8:45 am]

BILLING CODE 4120–01–P

Substance Abuse and Mental Health

Services Administration (SAMHSA)

Correction of Meeting Notices

Public notice was given in the Federal

Register on April 18, 1995, Vol. 60, No.

74, page 19405, that the Substance

Abuse and Mental Health Services

Administration (SAMHSA) National

Advisory Council meeting on May 15,

1995, would be open from 9:00 a.m. to

3:00 p.m. and closed for review of

contract proposals from 3:15 p.m. to

6:00 p.m. Due to unforeseen

circumstances, the meeting schedule

has been revised. The closed session is

now scheduled from 9:00 a.m. to 10:30

a.m., and the open session will be from

10:45 a.m. until adjournment. In

addition, a status report from the

Council’s AIDS workgroup will not be

presented at this meeting.

Public notice was also given in the

Federal Register on April 19, 1995, Vol.

60, No. 75, page 19602, that the Center

for Substance Abuse Prevention (CSAP)

National Advisory Council would be

meeting on May 25 and 26, 1995.

However, the meeting will now be held

for only one day, May 25.

Dated: April 27, 1995.

Jeri Lipov,

Committee Management Officer, Substance

Abuse and Mental Health Services

Administration.

[FR Doc. 95–10899 Filed 5–2–95; 8:45 am]

BILLING CODE 4162–20–P

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

Conference of the Parties to the

Convention on International Trade in

Endangered Species of Wild Fauna

and Flora; Thirty-fifth Meeting of the

Standing Committee; Meeting of the

Animals Committee; Meeting of the

Plants Committee; Public Meeting

AGENCY: Fish and Wildlife Service,

Interior.

ACTION: Notice.

SUMMARY: With this notice the U.S. Fish

and Wildlife Service (Service)

announces a public meeting to discuss

the results of the thirty-fifth meeting of

the Convention on International Trade

in Endangered Species of Wild Fauna

and Flora (CITES) Standing Committee,

held March 21–24, 1995, in Geneva,

Switzerland, and to discuss matters

related to the upcoming meetings of the

CITES Animals and Plants Committees.

DATES: The public meeting will be held

on June 13, 1995, from 1:30 p.m. to 3:30

p.m.

ADDRESSES: The public meeting will be

held in Room 7000 A and B of the

Department of the Interior, 18th and C

Streets, NW., Washington, DC.

FOR FURTHER INFORMATION CONTACT:

Kenneth B. Stansell or Susan S.

Lieberman, Office of Management

Authority, 4401 N. Fairfax Drive, Room

420–C, Arlington, VA 22203; telephone

703/358–2093.

SUPPLEMENTARY INFORMATION:

Background

The Convention on International

Trade in Endangered Species of Wild