24390 Federal Register / Vol. 66, No. 93 / Monday, May 14, 2001 / Notices

This determination of the regulatory

review period establishes the maximum

potential length of a patent extension.

However, the U.S. Patent and

Trademark Office applies several

statutory limitations in its calculations

of the actual period for patent extension.

In its application for patent extension,

this applicant seeks 1,826 days of patent

term extension.

Anyone with knowledge that any of

the dates as published are incorrect may

submit to the Dockets Management

Branch (address above) written

comments and ask for a redetermination

by July 13, 2001. Furthermore, any

interested person may petition FDA for

a determination regarding whether the

applicant for extension acted with due

diligence during the regulatory review

period by November 13, 2001. To meet

its burden, the petition must contain

sufficient facts to merit an FDA

investigation. (See H. Rept. 857, part 1,

98th Cong., 2d sess., pp. 41-42, 1984.)

Petitions should be in the format

specified in 21 CFR 10.30.

Comments and petitions should be

submitted to the Dockets Management

Branch. Three copies of any information

are to be submitted, except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. Comments

and petitions may be seen in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: February 26, 2001.

Jane A. Axelrad,

Associate Director for Policy, Center for Drug

Evaluation and Research.

[FR Doc. 01–12025 Filed 5–11–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D–3082]

International Conference on

Harmonisation; Choice of Control

Group and Related Issues in Clinical

Trials; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance entitled ‘‘E10

Choice of Control Group and Related

Issues in Clinical Trials.’’ The guidance

was prepared under the auspices of the

International Conference on

Harmonisation of Technical

Requirements for Registration of

Pharmaceuticals for Human Use (ICH).

The guidance sets forth general

principles that are relevant to all

controlled trials and are especially

pertinent to the major clinical trials

intended to demonstrate drug (including

biological drug) efficacy. The guidance

describes the principal types of control

groups and discusses their

appropriateness in particular situations.

The guidance is intended to assist

sponsors and investigators in the choice

of control groups for clinical trials.

DATES: This guidance is effective May

14, 2001. Submit written comments on

agency guidances at any time.

ADDRESSES: Submit written requests for

single copies of the guidance to the Drug

Information Branch (HFD–210), Center

for Drug Evaluation and Research, Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, or the Office

of Communication, Training and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research (CBER), 1401 Rockville Pike,

Rockville, MD 20852–1448, 301–827–

3844, FAX: 888–CBERFAX. Send two

self-addressed adhesive labels to assist

the office in processing your requests.

Submit written comments on the

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. See the

SUPPLEMENTARY INFORMATION section for

electronic access to the guidance.

Requests and comments should be

identified with the docket number

found in brackets in the heading of this

document.

FOR FURTHER INFORMATION CONTACT:

Regarding the guidance: Robert

Temple, Center for Drug Evaluation

and Research (HFD–4), Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–

594–6758.

Regarding the ICH: Janet J. Showalter,

Office of International Affairs

(HFG–1), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–

0864.

SUPPLEMENTARY INFORMATION:

I. Background

In recent years, many important

initiatives have been undertaken by

regulatory authorities and industry

associations to promote international

harmonization of regulatory

requirements. FDA has participated in

many meetings designed to enhance

harmonization and is committed to

seeking scientifically based harmonized

technical procedures for pharmaceutical

development. One of the goals of

harmonization is to identify and then

reduce differences in technical

requirements for drug development

among regulatory agencies.

ICH was organized to provide an

opportunity for tripartite harmonization

initiatives to be developed with input

from both regulatory and industry

representatives. FDA also seeks input

from consumer representatives and

others. ICH is concerned with

harmonization of technical

requirements for the registration of

pharmaceutical products among three

regions: The European Union, Japan,

and the United States. The six ICH

sponsors are the European Commission,

the European Federation of

Pharmaceutical Industries Associations,

the Japanese Ministry of Health and

Welfare, the Japanese Pharmaceutical

Manufacturers Association, the Centers

for Drug Evaluation and Research and

Biologics Evaluation and Research,

FDA, and the Pharmaceutical Research

and Manufacturers of America. The ICH

Secretariat, which coordinates the

preparation of documentation, is

provided by the International

Federation of Pharmaceutical

Manufacturers Associations (IFPMA).

The ICH Steering Committee includes

representatives from each of the ICH

sponsors and the IFPMA, as well as

observers from the World Health

Organization, the Canadian Health

Protection Branch, and the European

Free Trade Area.

In accordance with the agency’s

regulation on good guidance practices

(GGP) (21 CFR 10.115; 65 FR 56468,

September 19, 2000), this document is

being called a guidance, rather than a

guideline.

To facilitate the process of making

ICH guidances available to the public,

the agency has changed its procedures

for publishing ICH guidances. Beginning

April 2000, we no longer include the

text of ICH guidances in the Federal

Register. Instead, we will publish a

notice in the Federal Register

announcing the availability of an ICH

guidance. The ICH guidance is placed in

the docket and can be obtained through

regular agency sources (see the

ADDRESSES section). Draft ICH guidances

are left in the original ICH format. Final

guidances are reformatted to conform to

the GGP style before publication.

In the Federal Register of September

24, 1999 (64 FR 51767), FDA published

a draft tripartite guidance entitled ‘‘E10

Choice of Control Group in Clinical

Trials.’’ The notice gave interested

persons an opportunity to submit

comments by December 23, 1999.

Federal Register / Vol. 66, No. 93 / Monday, May 14, 2001 / Notices 24391

After consideration of the comments

received and revisions to the guidance,

a final draft of the guidance was

submitted to the ICH Steering

Committee and endorsed by the three

participating regulatory agencies in July

2000.

This guidance sets forth general

principles that are relevant to all

controlled trials and are especially

pertinent to the major clinical trials

intended to demonstrate drug (including

biological drug) efficacy. The guidance

includes a description of the five

principal types of controls, a discussion

of two important purposes of clinical

trials, and an exploration of the critical

issue of assay sensitivity, i.e., whether a

trial could have detected a difference

between treatments when there was a

difference, a particularly important

issue in noninferiority/equivalence

trials. In addition, the guidance presents

a detailed description of each type of

control and considers, for each: (1) Its

ability to minimize bias; (2) ethical and

practical issues associated with its use;

(3) its usefulness and the quality of

inference in particular situations; (4)

modifications of study design or

combinations with other controls that

can resolve ethical, practical, or

inferential concerns; and (5) its overall

advantages and disadvantages.

This guidance represents the agency’s

current thinking on the choice of control

group in clinical trials. It does not create

or confer any rights for or on any person

and does not operate to bind FDA or the

public. An alternative approach may be

used if such approach satisfies the

requirements of the applicable statutes

and regulations.

II. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments on the

guidance at any time. Two copies of any

comments are to be submitted, except

that individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. The guidance

and received comments may be seen in

the Dockets Management Branch

between 9 a.m. and 4 p.m., Monday

through Friday.

III. Electronic Access

Persons with access to the Internet

may obtain the document at http://

www.fda.gov/cder/guidance/index.htm

or http://www.fda.gov/cber/

publications.htm.

Dated: May 4, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–12026 Filed 5–11–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Peripheral and Central Nervous

System Drugs Advisory Committee;

Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: This notice announces a

forthcoming meeting of a public

advisory committee of the Food and

Drug Administration (FDA). The

meeting will be open to the public.

Name of Committee: Peripheral and

Central Nervous System Drugs Advisory

Committee.

General Function of the Committee: To

provide advice and recommendations to the

agency on FDA’s regulatory issues.

Date and Time: The meeting will be held

on June 6, 2001, 8 a.m. to 5 p.m..

Location: Holiday Inn, 8120 Wisconsin

Ave., Bethesda, MD.

Contact: Sandra Titus, Food and Drug

Administration, Center for Drug Evaluation

and Research, (HFD–21), 5600 Fishers Lane,

Rockville MD 20857, 301–827–7001, e-mail:

Tituss@ cder.fda.gov. FAX 301–827–6801, or

FDA Advisory Committee Information Line

at 1–800–741–8138 (301–443–0572 in the

Washington, DC area) code 12543. Please call

the Information Line for up-to-date

information on this meeting.

Agenda: On June 6, 2001, the committee

will consider the safety and efficacy of new

drug application (NDA) 21–196, Xyrem

(sodium oxybate, Orphan Medical, Inc.)

proposed to reduce the incidence of

cataplexy and to improve the symptom of

daytime sleepiness for persons with

narcolepsy. A main focus of the deliberations

will be on risk management issues.

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 May 29, 2001.

Oral presentations from the public will be

scheduled between approximately 1 p.m. and

2 p.m. Time allotted for each presentation

may be limited. Those desiring to make

formal oral presentations should notify the

contact person before May 29, 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.

Background material from the sponsor and

FDA will be posted 24 hours before the

meeting at the Peripheral and Central

Nervous System Drugs Advisory Committee

docket site at http://www.fda.gov/ohrms/

dockets/ac/acmenu.htm. (Click on the year

2001 and scroll down to the Peripheral and

Central Nervous Systems Drugs meetings.)

This is the same Web site where you can find

the minutes, transcript, and slides from the

meeting. This material is generally posted

about 3 weeks after the meeting.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: May 8, 2001.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 01–12085 Filed 5–10–01; 10:28 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–267]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(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: Reinstatement, with change, of

a previously approved collection for

which approval has expired; Title of

Information Collection: Medicare Plus

Choice Program Requirements

Referenced in 42 CFR 422.000–422.700;

Form No.: HCFA–R–0267 (OMB# 0938–

0753); Use: Section 4001 of the

Balanced Budget Act of 1997 added

sections 1851 through 1859 to the Social

Security Act to establish a new Part C

of the Medicare Program, known as the

Medicare+Choice program. Under this

program, every individual entitled to

Medicare Part A and enrolled under Part