[Federal Register Volume 62, Number 202 (Monday, October 20, 1997)]
[Notices]
[Pages 54462-54463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-27695]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Advisory Committee Meeting; Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
amendment to the notice of meeting of the Cardiovascular and Renal 
Drugs Advisory Committee. This meeting was announced in the Federal 
Register of September 18, 1997. The amendment is being made to: Remove 
the second agenda item scheduled on October 23, 1997; add a closed 
session to the agenda scheduled on October 23, 1997; and provide a new 
location site for this closed session. There are no other changes. This 
amendment will be announced at the beginning of the open portion of the 
meeting.

FOR FURTHER INFORMATION CONTACT: Joan C. Standaert, Center for Drug 
Evaluation and Research (HFD-110), 419-259-6211, or Danyiel D'Antonio 
(HFD-21), 301-443-5455, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, or FDA Advisory Committee Information Line, 
1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12533. 
Please call the Information Line for up-to-date information on this 
meeting.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 18, 
1997 (62 FR 49015), FDA announced that a meeting of the Cardiovascular 
and Renal Drugs Advisory Committee would be held on October 23 and 24, 
1997. This amendment is to provide an update to the information 
provided earlier pertaining to the October 23, 1997, meeting day. There 
are no changes for the October 24, 1997, meeting day. On page 49015, 
beginning in column 3, portions of the notice pertaining to the October 
23, 1997, meeting day are amended to read as follows:
    Location: October 23, 1997, 8:30 a.m. to 2 p.m., National 
Institutes of Health, Clinical Center, Bldg. 10, Jack Masur Auditorium, 
9000 Rockville Pike, Bethesda, MD.

[[Page 54463]]

    October 23, 1997, 2 p.m. to 5:30 p.m., Hyatt Regency Bethesda, 
Susquehanna/Severn Room, One Bethesda Metro Center, Bethesda, MD.
    Agenda: On October 23, 1997, the committee will discuss basic 
statistical considerations for the evaluation of active control 
clinical trials.
    Procedure: On October 23, 1997, from 8:30 a.m. to 2 p.m., the 
meeting is open to the public. 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 
October 16, 1997. Oral presentations from the public will be scheduled 
between approximately 8:30 a.m. and 9:30 a.m. on October 23, 1997. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person before 
October 16, 1997, 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.
    Closed Committee Deliberations: On October 23, 1997, from 2 p.m. to 
5:30 p.m., the meeting will be closed to permit discussion and review 
of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)). 
The committee will discuss pending investigational new drug 
applications.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: October 10, 1997.
 Michael A. Friedman,
 Deputy Commissioner for Operations.
[FR Doc. 97-27695 Filed 10-15-97; 11:17 am]
BILLING CODE 4160-01-F