10304
`
`Federal Register / Vol. 66, No. 31 / Wednesday, February 14, 2001 / Notices
`
`Intermediary licenses have been
`reissued by the Federal Maritime
`Commission pursuant to section 19 of
`the Shipping Act of 1984, as amended
`
`by the Ocean Shipping Reform Act of
`1998 (46 U.S.C. app. 1718) and the
`regulations of the Commission
`pertaining to the licensing of Ocean
`
`Transportation Intermediaries, 46 CFR
`515.
`
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`
`Sandra L. Kusumoto,
`Director, Bureau of Consumer Complaints
`and Licensing.
`[FR Doc. 01–3766 Filed 2–13–01; 8:45 am]
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`Written comments should be received
`within 30 days of this notice.
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`Dated: January 29, 2001.
`Kerry Weems
`Acting Deputy Assistant Secretary, Budget.
`[FR Doc. 01–3737 Filed 2–13–01; 8:45 am]
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`d Food and Drug Administration,
`d Notice.
`
``
`
`€
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`\
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`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 March 13, 14, and 15, 2001, 8
`a.m. to 5 p.m.
`Location: Holiday Inn, The Ballroom,
`Two Montgomery Village Ave.,
`Gaithersburg, MD.
`Contact: Sandra L. Titus or Lauren W.
`Parcover, Center for Drug Evaluation
`and Research (HFD–21), Food and Drug
`Administration, 5600 Fishers Lane (for
`express delivery, 5630 Fishers Lane, rm.
`1093), Rockville, MD 20857, 301–827–
`7001, or e-mail: Tituss@cder.fda.gov, or
`FDA Advisory Committee Information
`Line, 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 March 13, 2001, the
`committee will discuss drug
`development for individuals with mild
`cognitive impairment (MCI). In the
`
`^
`^
`
`The Department of Health and Human
`Services, Office of the Secretary
`publishes a list of information
`collections it has submitted to the Office
`of Mnagement and Budget (OMB) for
`clearance in compliance with the
`Paperwork Reduction Act of 1995 (44
`U.S.C. Chapter 35) and 5 CFR 1320.5.
`The following are those information
`collections recently submitted to OMB.
`1. Office of Research Integrity
`Educational Program: A Needs
`Assessment—NEW—The Office of
`Research Integrity (ORI) is proposing a
`survey of officials of research
`institutions to collect information on
`training needs in the areas of the
`promotion of research integrity and the
`prevention of scientific misconduct. The
`results of this survey will be used to
`develop a strategic plan for the ORI
`educational program which will be
`consistent with the recent
`organizational change requiring ORI to
`place greater emphasis on education
`and prevention. Respondents: Research
`Institutions; Number of Respondents:
`500; Burden per Response: 10 minutes;
`Total Burden: 84 hours.
`OMB Desk Officer: Allison Eydt.
`Copies of the information collection
`packages listed above can be obtained
`by calling the OS Reports Clearance
`Officer on (202) 690–6207. Written
`comments and recommendations for the
`proposed information collection should
`be sent directly to the OMB desk officer
`designated above at the following
`address: Human Resources and Housing
`Branch, Office of Mnagement and
`Budget, New Executive Office Building,
`Room 10235, 725 17th Street NW.,
`Washington, DC 20503.
`Comments may also be sent to
`Cynthia Agens Bauer, OS Reports
`Clearance Officer, Room 503H,
`Humphrey Building, 200 Independence
`Avenue SW., Washington DC, 20201.
`
`Ÿ
`
`¢
`
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`
`Agency Holding the Meeting: Board of
`Governors of the Federal Reserve
`System.
`Time and Date: 11:00 a.m., Tuesday,
`February 20, 2001.
`Place: Marriner S. Eccles Federal
`Reserve Board Building, 20th and C
`Streets, NW., Washington, DC 20551.
`Status: Closed.
`Matters to be Considered:
`1. Personnel actions (appointments,
`promotions, assignments,
`reassignments, and salary actions)
`involving individual Federal Reserve
`System employees.
`2. Any items carried forward from a
`previously announced meeting.
`Contact Person for More Information:
`Lynn S. Fox, Assistant to the Board;
`202–452–3204.
`
`Y
`
`Z
`
`[
`
`Z
`
`\
`
`]
`
`^
`
`_
`
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`
`_
`
`[
`
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`
`]
`
`a
`
`c
`
`\
`
`d You may
`
`call 202–452–3206 beginning at
`approximately 5 p.m. two business days
`before the meeting for a recorded
`announcement of bank and bank
`holding company applications
`scheduled for the meeting; or you may
`contact the Board’s Web site at http://
`www.federalreserve.gov for an electronic
`announcement that not only lists
`applications, but also indicates
`procedural and other information about
`the meeting.
`
`V
`
`W
`
`X
`
`X
`5
`
`Dated: February 9, 2001.
`Robert deV. Frierson,
`Associate Secretary of the Board.
`[FR Doc. 01–3814 Filed 2–9–01; 4:49 pm]
`
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`—
`
`‘
`
`Page 1 of 2
`
`JAZZ EXHIBIT 2048
`Amneal Pharms. et al. (Petitioners) v. Jazz Pharms., Inc. (Patent Owner)
`Case IPR2015-00554
`
`

`
`Federal Register / Vol. 66, No. 31 / Wednesday, February 14, 2001 / Notices
`
`10305
`
`decide for themselves whether they will
`continue to use the services of an
`excluded party even though no program
`payments will be made for items and
`services provided by that excluded
`party. The exclusions have national
`effect and also apply to all Executive
`Branch procurement and non-
`procurement programs and activities.
`
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`
`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 March 1, 2001. On March 13
`and 14, 2001, oral presentations from
`the public will be scheduled between
`approximately 10:30 a.m. and 12:30
`p.m. Time allotted for each presentation
`may be limited. On March 15, 2001, oral
`presentations from the public will be
`scheduled between approximately 1
`p.m. and 1:30 p.m. Those desiring to
`make formal oral presentations should
`notify the contact person before March
`1, 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: February 6, 2001.
`Linda A. Suydam,
`Senior Associate Commissioner.
`[FR Doc. 01–3665 Filed 2–13–01; 8:45 am]
`
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`d Office of Inspector General,
`d Notice of program exclusions.
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`recent literature there has been a
`discussion of an entity referred to as
`MCI. While MCI is considered by some
`to be a distinct clinical entity, others
`consider that the majority of patients
`diagnosed with MCI have an early form
`of Alzheimer’s Disease. It is critical for
`regulatory purposes that the issues
`surrounding this diagnosis are fully
`explored. Toward that end the
`committee will listen to speakers and
`discuss the following and other related
`questions:
`1. Can MCI be clearly defined in a
`clinical setting?
`2. Are there valid criteria for the
`diagnosis of MCI?
`3. Can MCI be distinguished from
`Alzheimer’s Disease and other
`causes of dementia?
`4. What outcome measures are
`appropriate to use in clinical drug
`trials conducted in MCI?
`5. Should clinical drug trials in MCI
`incorporate any special features in
`their design?
`On March 14, 2001, the committee
`will discuss drug development for
`individuals with vascular dementia.
`While vascular dementia is considered
`by some to be a distinct entity others do
`not agree that it can be easily
`distinguished from Alzheimer’s Disease
`and/or other dementias. It is critical for
`regulatory purposes that the issues
`surrounding this diagnosis are fully
`explored. Toward that end the
`committee will listen to presentations
`and then discuss the following and
`other related questions:
`1. Can vascular dementia be clearly
`defined in a clinical setting?
`2. Are there valid criteria for the
`diagnosis of vascular dementia?
`3. Can vascular dementia be
`distinguished from Alzheimer’s
`Disease and other causes of
`dementia?
`4. What outcome measures are
`appropriate to use in clinical drug
`trials conducted in vascular
`dementia?
`5. Should clinical drug trials in
`vascular dementia incorporate any
`special features in their design?
`FDA will provide a background
`position paper on MCI and on vascular
`dementia prior to each meeting. When
`the background material becomes
`available, it will be posted under the
`Peripheral and Central Nervous Systems
`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.)
`On March 15, 2001, the committee
`will consider the safety and efficacy of
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`During the month of January 2001, the
`HHS Office of Inspector General
`imposed exclusions in the cases set
`forth below. When an exclusion is
`imposed, no program payment is made
`to anyone for any items or services
`(other than an emergency item or
`service not provided in a hospital
`emergency room) furnished, ordered or
`prescribed by an excluded party under
`the Medicare, Medicaid, and all Federal
`Health Care programs. In addition, no
`program payment is made to any
`business or facility, e.g., a hospital, that
`submits bills for payment for items or
`services provided by an excluded party.
`Program beneficiaries remain free to
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`Page 2 of 2