Federal Register / Vol. 65, No. 129 / Wednesday, July 5, 2000 / Notices 41475

Contact Person: Freddie M. Poole,

Center for Devices and Radiological

Health (HFZ–440), Food and Drug

Administration, 2098 Gaither Rd.,

Rockville, MD 20850, 301–594–2096, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12517. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: On July 27, 2000, the

committee will discuss and make

recommendations on issues concerning

the appropriate types of data and

information required to assess the safety

and effectiveness of diagnostic tests

intended to identify biothreat agents, or

to provide evidence of exposure to

biothreat agents, when used on different

specimen types and under different

conditions for use.

The following draft questions are

proposed for discussion and may be

subject to changes prior to the

committee meeting:

1. What types of data and information

would be recommended to evaluate

effectiveness when the assay is used:

(a) To definitively identify or rule-out

identification of isolates;

(b) to identify biothreat agents directly

in specimens from individuals

suspected (clinically or using other

diagnostic procedures) to have been

infected with the agent of interest; and

(c) to identify/detect the biothreat

agent directly in specimens from

individuals without clinical or other

diagnostic evidence of infection, who

may have been exposed to the biothreat

agent.

2. For each of these potential uses

what is the level of inaccuracy that can

be tolerated, or would the same criteria

apply to all?

3. To determine or infer effectiveness

for these devices, can specimens from

naturally- or experimentally-infected

animals be used when appropriate

specimens from humans cannot be

obtained? What are the constraints/

limitations for use of animal data as

evidence for effectiveness?

4. Are there any other issues not

addressed in the previous questions that

would affect the reliable use of these

assays for human diagnosis?

FDA will consider these

recommendations in the future

development of review criteria for in

vitro diagnostic devices, developed in

response to the threat of bioterrorism,

for the identification of biothreat agents,

as valid scientific evidence to determine

whether there is reasonable assurance

that these devices are safe and effective.

On July 28, 2000, the committee will

discuss, make recommendations, and

vote on a premarket approval

application (PMA) for an in vitro

diagnostic nucleic acid amplification

test for the qualitative detection of

hepatitis C virus (HCV) ribonucleic acid

(RNA) in human serum or plasma. On

the same day the committee will

discuss, make recommendations, and

vote on a PMA for an automated in vitro

diagnostic nucleic acid amplification

test for the qualitative detection of HCV

RNA in human serum or plasma. These

devices are not intended for use in

blood or plasma donor screening.

Procedure: On July 27, 2000, from

10:30 a.m. to 5:30 p.m. and on July 28,

2000, from 9 a.m. to 5 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 July 12, 2000. Oral

presentations from the public will be

scheduled between approximately 11:45

a.m. and 12:30 p.m. on July 27, 2000,

and between approximately 11:30 a.m.

and 12:15 p.m., and 3 p.m. and 3:30

p.m. on July 28, 2000. Time allotted for

each presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before July 12, 2000, 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

July 28, 2000, from 8 a.m. to 9 a.m., the

meeting will be closed to permit FDA

staff to present to the committee trade

secret and/or confidential commercial

information regarding pending and

future device submissions. This portion

of the meeting will be closed to permit

discussion of this 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: June 26, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–16809 Filed 7–3–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Ear, Nose, and Throat Devices Panel of

the Medical Devices 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: Ear, Nose, and

Throat Devices Panel of the Medical

Devices 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 July 20, 2000, 9:45 a.m. to 5

p.m., and July 21, 2000, 8:30 a.m. to 5

p.m.

Location: Holiday Inn, Goshen Room,

Two Montgomery Village Ave.,

Gaithersburg, MD.

Contact Person: Sara M. Thornton,

Center for Devices and Radiological

Health (HFZ–460), Food and Drug

Administration, 9200 Corporate Blvd.,

Rockville, MD 20850,

SMT@CDRH.FDA.GOV, or FDA

Advisory Committee Information Line,

1–800–741–8138 (301–443–0572 in the

Washington, DC area), code 12522.

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

Agenda: On July 20, 2000, the

committee will discuss, make

recommendations, and vote on a

premarket approval application (PMA)

for a direct-drive implantable middle

ear hearing device intended to provide

a useful level of sound perception via

mechanical stimulation of the ossicles.

On July 21, 2000, the committee will

discuss, make recommendations and

vote on a PMA for an implant intended

to restore useful hearing to individuals

with Neurofibromatosis Type II who

have become deaf as a result of surgery

to remove bilateral auditory nerve

tumors.

Procedure: On July 20, 2000, from

9:45 a.m. to 5 p.m., and on July 21,

2000, from 9:15 a.m. to 5 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 July 13, 2000. Oral

presentations from the public will be

41476 Federal Register / Vol. 65, No. 129 / Wednesday, July 5, 2000 / Notices

scheduled between approximately 10

a.m. and 10:30 a.m. on July 20, 2000,

and between approximately 9:30 a.m.

and 10 a.m. on July 21, 2000. On both

days, near the end of the committee

deliberations on the PMA, a 30-minute

open public session will be conducted

for interested persons to address issues

specific to the submission before the

committee. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before July 13, 2000, 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

July 21, 2000, from 8:30 a.m. to 9:15

a.m., the meeting will be closed to

permit FDA to present to the committee

trade secret and/or confidential

commercial information regarding

pending issues and applications. This

portion of the meeting will be closed to

permit discussion of this 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: June 26, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–16810 Filed 7–3–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

The FDA Review Process for New

Product Applications: An Interactive

Workshop

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of workshop.

The Food and Drug Administration

(FDA), Los Angeles District Office, in

cosponsorship with the Orange County

Regulatory Affairs Discussion Group

(OCRA) is announcing a workshop

intended to give the medical products

industry (drugs and medical devices) an

opportunity to learn and discuss the

process by which the FDA centers and

district offices review new product

applications. Reviewing staff from the

Center for Drug Evaluation and Research

and the Center for Devices and

Radiological Health will make

presentations to provide guidance on

the elements of submissions to make the

review process more effective.

Date and Time: The workshop will be

held on July 10 and 11, 2000, from 7:30

a.m. to 5 p.m.

Location: The workshop will be held

at the Doubletree Hotel, 3050 Bristol St.,

Costa Mesa, CA 92626.

Contact: Ramlah Oma, FDA Los

Angeles District Office, 19900

MacArthur Blvd., Irvine, CA 92612–

2445, 949–798–7612, or FAX 949–798–

7771, for further information including

a registration form.

Registration: Space is limited.

Preregistration and confirmation is

required. Registration forms can be

obtained on the Internet at http://

www.ocra-dg.org by clicking on ‘‘OCRA

Meetings’’ or from the contact person

listed above. There is a $325 registration

fee if postmarked by June 30, 2000 ($375

on or after July 1) payable to OCRA.

Send the registration fee and form to

PeriAnn DiRocco at OCRA Submissions

Conference, PMB 624, 5405 Alton

Pkwy., suite 5A, Irvine, CA 92604, FAX

and voice 949–348–9141. The

registration fee will cover actual

expenses including refreshments, lunch,

materials, and speaker expenses. After

July 4, 2000, please call 949–348–9141

to check for space availability.

If you need special accommodations

due to a disability, please contact

Ramlah Oma at least 7 days in advance.

Dated: June 28, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–16963 Filed 6–29–00; 4:37 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Joint Meeting of the Transmissible

Spongiform Encephalopathies

Advisory Committee and the Vaccines

and Related Biological Products

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

joint meeting of two public advisory

committees of the Food and Drug

Administration (FDA). At least one

portion of the joint meeting will be

closed to the public.

Names of Committees: Transmissible

Spongiform Encephalopathies Advisory

Committee and the Vaccines and

Related Biological Products Advisory

Committee.

General Function of the Committees:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.

Date and Time: The meeting will be

held on July 27, 2000, 8 a.m. to 4 p.m.

Location: Holiday Inn, Versailles

Ballrooms I and II, 8120 Wisconsin

Ave., Bethesda, MD.

Contact Person: William Freas or

Sheila D. Langford; Nancy Cherry or

Denise H. Royster, Center for Biologics

Evaluation 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), codes 12392 and

12391. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: On July 27, 2000, in joint

session, the committees will discuss

bovine spongiform encephalopathy

issues related to the manufacture of

vaccines, specifically the use of

European fetal calf serum in cell banks

and viral seeds, and the use of European

beef skeletal muscle and other tissues in

manufacturing vaccines.

Procedure: On July 27, 2000, from 9

a.m. to 4 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 July 13, 2000. 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 July 17, 2000, 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 presentations.

Closed Committee Deliberations: On

July 27, 2000, from 8 a.m. to 9 a.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: June 23, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–16811 Filed 7–3–00; 8:45 am]

BILLING CODE 4160–01–F