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`INFURMATION
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`Federal Register/Vol. 66, No. 93/ Monday, May 14, 2001/ Notices
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`After consideration of the comments
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`received and revisions to the guidance,
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`a final draft of the guidance was
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`submitted to the ICH Steering
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`Committee and endorsed by the three
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`participating regulatory agencies in July
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`2000.
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`This guidance sets forth general
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`principles that are relevant to all
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`controlled trials and are especially
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`pertinent to the major clinical trials
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`intended to demonstrate drug (including
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`biological drug) efficacy. The guidance
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`includes a description of the five
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`principal types of controls, a discussion
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`of two important purposes of clinical
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`trials, and an exploration of the critical
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`issue of assay sensitivity, i.e., whether a
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`trial could have detected a difference
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`between treatments when there was a
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`difference, a particularly important
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`issue in noninferiority/equivalence
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`trials. In addition, the guidance presents
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`a detailed description of each type of
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`control and considers, for each: (1) Its
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`ability to minimize bias; (2) ethical and
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`practical issues associated with its use;
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`(3) its usefulness and the quality of
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`inference in particular situations; (4)
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`modifications of study design or
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`combinations with other controls that
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`can resolve ethical, practical, or
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`inferential concerns; and (5) its overall
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`advantages and disadvantages.
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`This guidance represents the agency’s
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`current thinking on the choice of control
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`group in clinical trials. It does not create
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`or confer any rights for or on any person
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`and does not operate to bind FDA or the
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`public. An alternative approach may be
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`used if such approach satisfies the
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`requirements of the applicable statutes
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`and regulations.
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`11. Comments
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`Interested persons may submit to the
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`Dockets Management Branch (address
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`above) written comments on the
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`guidance at any time. Two copies of any
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`comments are to be submitted, except
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`that individuals may submit one copy.
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`Comments are to be identified with the
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`docket number found in brackets in the
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`heading of this document. The guidance
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`and received comments may be seen in
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`the Dockets Management Branch
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`between 9 a.m. and 4 p.m., Monday
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`through Friday.
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`III. Electronic Access
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`Persons with access to the Internet
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`may obtain the document at http://
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`www.fda.gov/cder/guidance/index.htm
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`or http://www.fda.gov/cber/
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`publications.htm.
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`Dated: May 4, 2001.
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`Margaret M. Dotzel,
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`Associate Commissionerfor Policy.
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`[FR Doc. 01—12026 Filed 5—11—01; 8:45 am]
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`BILLING CODE 4160—01—8
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`DEPARTMENT OF HEALTH AND
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`HUMAN SERVICES
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`Food and Drug Administration
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`Peripheral and Central Nervous
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`System Drugs Advisory Committee;
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`Notice of Meeting
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`AGENCY: Food and Drug Administration,
`HHS.
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`ACTION: Notice.
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`SUMMARY: This notice announces a
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`forthcoming meeting of a public
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`advisory committee of the Food and
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`Drug Administration (FDA). The
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`meeting will be open to the public.
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`Name of Committee: Peripheral and
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`Central Nervous System Drugs Advisory
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`Committee.
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`General Function of the Committee: To
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`provide advice and recommendations to the
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`agency on FDA’s regulatory issues.
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`Date and Time: The meeting will be held
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`on June 6, 2001, 8 a.m. to 5 p.m..
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`Location: Holiday Inn, 8120 Wisconsin
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`Ave., Bethesda, MD.
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`Contact: Sandra Titus, Food and Drug
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`Administration, Center for Drug Evaluation
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`and Research, (HFD—21), 5600 Fishers Lane,
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`Rockville MD 20857, 301—827—7001, e-mail:
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`Tituss@ cder.fda.gov. FAX 301—827—6801, or
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`FDA Advisory Committee Information Line
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`at 1—800—741—8138 (301—443—05 72 in the
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`Washington, DC area) code 12543. Please call
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`the Information Line for up-to-date
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`information on this meeting.
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`Agenda: On June 6, 2001, the committee
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`will consider the safety and efficacy of new
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`drug application (NDA) 21—196, Xyrem®
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`(sodium oxybate, Orphan Medical, Inc.)
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`proposed to reduce the incidence of
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`cataplexy and to improve the symptom of
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`daytime sleepiness for persons with
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`narcolepsy. A main focus of the deliberations
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`will be on risk management issues.
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`Procedure: Interested persons may present
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`data, information, or views, orally or in
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`writing, on issues pending before the
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`committee. Written submissions may be
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`made to the contact person by May 29, 2001.
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`Oral presentations from the public will be
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`scheduled between approximately 1 p.m. and
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`2 p.m. Time allotted for each presentation
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`may be limited. Those desiring to make
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`formal oral presentations should notify the
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`contact person before May 29, 2001, and
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`submit a brief statement of the general nature
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`of the evidence or arguments they wish to
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`present, the names and addresses of
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`proposed participants, and an indication of
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`the approximate time requested to make their
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`presentation.
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`Background material from the sponsor and
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`FDA will be posted 24 hours before the
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`meeting at the Peripheral and Central
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`Nervous System Drugs Advisory Committee
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`docket site at http://www.fda.gov/ohrms/
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`dockets/ac/acmenu.htm. (Click on the year
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`2001 and scroll down to the Peripheral and
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`Central Nervous Systems Drugs meetings.)
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`This is the same Web site where you can find
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`the minutes, transcript, and slides from the
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`meeting. This material is generally posted
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`about 3 weeks after the meeting.
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`Notice of this meeting is given under
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`the Federal Advisory Committee Act (5
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`U.S.C. app. 2).
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`Dated: May 8, 2001.
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`Linda A. Suydam,
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`Senior Associate Commissioner.
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`[FR Doc. 01—12085 Filed 5—10—01; 10:28 am]
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`BILLING CODE 4160—01—8
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`DEPARTMENT OF HEALTH AND
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`HUMAN SERVICES
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`Health Care Financing Administration
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`[Document Identifier: HCFA—R—267]
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`Agency Information Collection
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`Activities: Submission for OMB
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`Review; Comment Request
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`In compliance with the requirement
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`of section 3506(c)(2)(A) of the
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`Paperwork Reduction Act of 1995, the
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`Health Care Financing Administration
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`(HCFA), Department of Health and
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`Human Services, has submitted to the
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`Office of Management and Budget
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`(OMB) the following proposal for the
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`collection of information. Interested
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`persons are invited to send comments
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`regarding the burden estimate or any
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`other aspect of this collection of
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`information, including any of the
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`following subjects: (1) The necessity and
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`utility of the proposed information
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`collection for the proper performance of
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`the agency’s functions; (2) the accuracy
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`of the estimated burden; (3) ways to
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`enhance the quality, utility, and clarity
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`of the information to be collected; and
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`(4) the use of automated collection
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`techniques or other forms of information
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`technology to minimize the information
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`collection burden.
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`Type of Information Collection
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`Request: Reinstatement, with Change, of
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`a previously approved collection for
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`which approval has expired; Title of
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`Information Collection: Medicare Plus
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`Choice Program Requirements
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`Referenced in 42 CFR 422.000—422.700;
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`Form No.: HCFA—R—0267 (OMB# 0938—
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`0753); Use: Section 4001 of the
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`Balanced Budget Act of 1997 added
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`sections 1851 through 1859 to the Social
`
`Security Act to establish a new Part C
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`of the Medicare Program, known as the
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`Medicare+Choice program. Under this
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`program, every individual entitled to
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`Medicare Part A and enrolled under Part
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`Footnote Here:
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`IPR of US. Patent No. 7,765,107
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`AMN1015
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`AMN1015
`IPR of U.S. Patent No. 7,765,107
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`