Federal Register / Vol. 66, No. 6 / Tuesday, January 9, 2001 / Notices 1685

consider comments in making its

determination on electronic filing and

in drafting a guidance document for

submitting drug registration and listing

information electronically. Received

comments may be seen in the Dockets

Management Branch between 9 a.m. and

5 p.m., Monday through Friday.

Dated: December 29, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–534 Filed 1–8–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Adenoviral Vector Safety; Public

Meeting and Workshop

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

The Food and Drug Administration

(FDA) is announcing a public meeting

entitled ‘‘Adenoviral Vector Safety’’ and

a workshop of the ‘‘Adenoviral

Standards Working Group.’’ The

purpose of the public meeting and

workshop is to discuss the scientific and

technological issues related to

developing voluntary industry reference

standards for adenoviral vectors used to

deliver human gene therapies. The

voluntary industry reference standards

will be used to help ensure the safety of

adenoviral vectors intendedfor use in

humans.

Date and Time: The public meeting

and workshop will be held on February

1, 2001. The Adenoviral Vector Safety

meeting will be held from 9:30 a.m. to

12 noon.

The Adenoviral Standards Working

Group workshop will be held from 1

p.m. to 5 p.m.

Location: The Adenoviral Vector

Safety meeting will be held at the

Wilson Auditorium, National Institutes

of Health, Bldg. 1, 8600 Rockville Pike,

Bethesda, MD 20894.

The Adenoviral Standards Working

Group workshop will be held at the

National Institutes of Health, Bldg. 29B,

Conference Rooms A, B, and C, 8600

Rockville Pike, Bethesda, MD 20894.

Contact: Steven R. Bauer, Center for

Biologics Evaluation and Research

(HFM–521), Food and Drug

Administration, Bldg. 29B, rm. 2NN11,

Bethesda, MD 20894, 301–827–0684,

FAX 301–827–0449, or e-mail:

bauer@cber.fda.gov.

Registration: Mail or fax your

registration information (including

name, title, firm name, address,

telephone, fax number, and e-mail

address) to Steven R. Bauer (address

above) by Friday, January 19, 2001.

There is no registration fee for the

meeting or workshop. Seating is limited,

therefore, interested parties are

encouraged to register early.

Registration at the site will be done on

a space available basis on the day of the

meeting and workshop, beginning at

8:30 a.m. If you need special

accommodations due to a disability,

please contact Steven R. Bauer at least

7 days in advance.

Agenda: The Adenoviral Vector

Safety meeting will provide a forum for

all members of the public to express

their concerns about adenoviral vector

safety and explore alternatives for

enhancing the safety of adenoviral

vectors.

The Adenoviral Standards Working

Group workshop is cosponsored by

FDA’s Center for Biologics and Research

(CBER) and the Williamsburg

BioProcessing Foundation. The

workshop will be of primary interest to

public health professionals developing

new human gene therapy products and

manufacturers contemplating the

production of such products. The

objectives of the workshop are to: (1)

Select adenoviruses to use as voluntary

reference standards for adenoviral

vectors used for human gene therapy

products; (2) describe the conditions

and facilities to be used when

producing bulk quantities of a voluntary

reference standard; (3) establish

characterization protocols for voluntary

reference standards; and (4) address

other issues related to voluntary

reference standards for adenoviral

vectors.

Transcripts: Transcripts of the

Adenoviral Vector Safety meeting may

be requested in writing from the

Freedom of Information Office (HFI–35),

Food and Drug Administration, 5600

Fishers Lane, rm. 12A–16, Rockville,

MD 20857, approximately 15 working

days after the meeting at a cost of 10

cents per page. The transcript will also

be available on the Internet at http://

www.fda.gov/cber/minutes/workshopmin.htm.

Dated: December 29, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–531 Filed 1–8–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Psychopharmacologic Drugs 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). The meeting will be open to the

public.

Name of Committee:

Psychopharmacologic 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 February 14 and 15, 2001, 8

a.m. to 5 p.m.

Location: Holiday Inn, The Ballroom,

Two Montgomery Village Ave.,

Gaithersburg, MD.

Contact Person: Sandra I. 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, 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 12544.

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

Agenda: On February 14, 2001, the

committee will consider the safety and

efficacy of new drug application (NDA)

21–253, Zyprexa (olanzapine

intramuscular, Eli Lilly, Inc.), proposed

for the rapid control of agitation. On

February 15, 2001, the committee will

consider the safety and efficacy of NDA

20–919, ZeldoxTM (ziprasidone mesylate

intramuscular, Pfizer, Inc.), proposed for

the acute control and short-term

management of the agitated psychotic

patient.

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 February 7, 2001. Oral

presentations from the public will be

scheduled each day between

approximately 1 p.m. to 1:30 p.m. Time

allotted for each presentation may be

limited. Those desiring to make formal

oral presentations should notify the

contact person before February 2, 2001,