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
`
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