21160 Federal Register / Vol. 66, No. 82 / Friday, April 27, 2001 / Notices

Agenda: On May 24, 2001, the

committee will discuss: (1) Published

interim analyses of ALLHAT

(antihypertensive and lipid lowering

treatment to prevent heart attack trial)

sponsored by the National Heart, Lung,

and Blood Institute, NIH, and (2)

response to the citizen’s petition of

Lawrence D. Bernhardt and Arnold

Liebman, regarding new drug

application (NDA) 19–668, Cardura

(doxazosin), Pfizer, Inc. On May 25,

2001, the committee will discuss NDA

20–920 Natrecor (nesiritide), Scios,

Inc., for treatment of acute heart failure.

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 18, 2001. Oral

presentations from the public will be

scheduled between approximately 8:30

a.m. and 9:30 a.m. Time allotted for

each presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before May 18, 2001, and submit

a brief statement on 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: April 11, 2001.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 01–10450 Filed 4–26–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Vaccines and Related Biological

Products Advisory Committee; Notice

of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). At least one portion of the

meeting will be closed to the public.

Name of Committee: Vaccines and

Related Biological Products 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 May 16, 2001, from 8 a.m. to

6:30 p.m., and May 17, 2001, from 8

a.m. to 1:30 p.m.

Location: Holiday Inn, Grand

Ballroom, Two Montgomery Village

Ave., Gaithersburg, MD.

Contact: Nancy T. Cherry or Denise H.

Royster, Center for Biologics

Evaluations and Research (HFM–71),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852,

301–827–0314, or FDA Advisory

Committee Information Line, 1–800–

741–8138, (301–443–0572 in the

Washington, DC area), code 12391.

Please call the Information Line for upto-date information on this meeting.

Agenda: On May 16, 2001, the

committee will discuss adventitious

agent testing, tumorigenicity testing,

and issues related to residual cell

substrate deoxyribonucleic acid (DNA)

of novel and neoplastic cell substrates

used to manufacture viral vaccines.

Procedure: On May 16, 2001, from 9

a.m. to 6:30 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 May 8, 2001. Oral

presentations from the public will be

held between approximately 2:30 p.m.

and 3:30 p.m. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before May 8, 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.

Closed Committee Deliberations: On

May 16, 2001, from 8 a.m. to 9 a.m. and

on May 17, 2001, from 8 a.m. to 1:30

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)).

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: April 19, 2001.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 01–10451 Filed 4–26–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D–3028]

Draft Guidance for Industry; Premarket

Approval Applications for In Vitro

Diagnostic Devices Pertaining to

Hepatitis C Viruses (HCV); Assays

Intended for Diagnosis, Prognosis, or

Monitoring of HCV Infection, Hepatitis

C, or Other HCV-Associated Disease;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the draft guidance

entitled ‘‘Premarket Approval

Applications for In Vitro Diagnostic

Devices Pertaining to Hepatitis C

Viruses (HCV): Assays Intended for

Diagnosis, Prognosis, or Monitoring of

HCV Infection, Hepatitis C, or Other

HCV-Associated Disease; Draft

Guidance for Industry and FDA.’’ FDA

is issuing this draft guidance to provide

current recommendations about the

design, data collection, and data

analysis of studies that are important to

the premarket approval application

(PMA) process for in vitro diagnostic

(IVD) devices pertaining to HCV. This

draft guidance is not final nor is it in

effect at this time.

DATES: Submit written comments on the

draft guidance by July 26, 2001.

ADDRESSES: Submit written requests for

single copies on a 3.5′′ diskette of the

draft guidance entitled ‘‘Premarket

Approval Applications for In Vitro

Diagnostic Devices Pertaining to

Hepatitis C Viruses (HCV): Assays

Intended for Diagnosis, Prognosis, or

Monitoring of HCV Infection, Hepatitis

C, or Other HCV-Associated Disease;

Draft Guidance for Industry and FDA’’

to the Division of Small Manufacturers

Assistance (HFZ–220), Center for

Devices and Radiological Health, Food

and Drug Administration, 1350 Piccard

Dr., Rockville, MD 20850. Send two selfaddressed adhesive labels to assist that

office in processing your request, or fax

your request to 301–443–8818. Submit

written comments on the draft guidance

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. Comments

should be identified with the docket

number found in brackets in the

heading of this document. See the

SUPPLEMENTARY INFORMATION section for