1684 Federal Register / Vol. 66, No. 6 / Tuesday, January 9, 2001 / Notices

Respondents Number of

respondents

Number of

responses

Average hour

burden per

response

Directly Funded CBOs ................................................................................................................. 184 1 30/60

Indirectly Funded CBOs .............................................................................................................. 1816 1 30/60

Dated: January 2, 2001.

Nancy E. Cheal,

Acting Associate Director for Policy, Planning

and Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 01–475 Filed 1–8–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1669]

Electronic Filing of Drug Registration

and Listing Information: Notice of Pilot

Project

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is seeking

volunteers to participate in a pilot

project involving the electronic filing of

drug registration and listing

information, as described in FDA’s

regulations. Manufacturers, repackers,

and relabelers who engage in the

manufacture, preparation, propagation,

or processing of human or veterinary

drugs and human biological products

are required under current regulations

to submit a listing of every product in

commercial distribution. This

information is currently submitted in

paper format. FDA is developing an

electronic system for submitting the

required information, and is seeking

volunteers to test the pilot system.

DATES: Submit written requests to

participate in the pilot project by

February 8, 2001. Comments on this

pilot project can be submitted at any

time.

ADDRESSES: Submit written requests to

participate and comments regarding this

pilot project to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

James R. Hunter, Food and Drug

Administration, Center for Drug

Evaluation and Research (HFD–9), 5600

Fishers Lane, Rockville, MD 20857,

301–594–6779, e-mail:

hunterj@cder.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

Under current FDA’s regulations (part

207 (21 CFR part 207)), manufacturers,

repackers, and relabelers who engage in

the manufacture, preparation,

propagation, compounding, or

processing of human or veterinary drugs

and human biological products must

register annually with FDA by

submitting Form FDA 2656 (Registration

of Drug Establishment). In addition,

registrants must update their product

listing information by using Form FDA

2657 and/or Form FDA 2658 every June

and December, or at the discretion of the

establishment, when any change occurs.

This entire process is currently done

manually (i.e., with a paper process).

This process is very labor intensive and

time consuming. FDA is trying to

streamline the process by developing an

electronic system in which registrants

could automatically register and list, as

well as provide updates.

The purpose of the pilot project is

twofold. First, the pilot project will test

FDA’s systems for receiving electronic

filings under part 207. Second, the pilot

project will provide volunteers with

experience in using the prototype

system that will enable them to provide

technical feedback to FDA about the

system.

II. Pilot Project Description

The pilot project is part of FDA’s

efforts to implement electronic filing.

Eventually, FDA staff expects to

recommend that FDA require electronic

filings under part 207. Participants in

this pilot project will have the

opportunity not only to assist FDA in

making its determination on electronic

filing, but also to familiarize themselves

with the process at an early stage of

development.

A. Initial Approach

Initially, a limited group of voluntary

participants will take part in testing the

electronic filing prototype. This group

will be incrementally expanded during

the pilot project to ensure that as many

volunteers as possible get the

opportunity to participate and that all

functional components of the system are

adequately tested. The initial group of

participants will include manufacturers,

repackers, relabelers, and private label

distributors of human prescription and

over the counter drug and biological

products and manufacturers of

veterinary drug products that currently

have more than 25 products listed with

the agency. During the pilot project,

information submitted will be made

available to the public by the agency via

the Internet at http://www.fda.gov/cder.

Participants in the pilot project will be

asked to test specific aspects of the

electronic filing system and to provide

technical feedback.

B. Scope

Existing registration and listing

requirements will not be waived,

suspended, or modified for purposes of

this pilot project. Thus, participants

must continue to submit paper

documents in accordance with FDA’s

existing filing requirements (part 207).

The paper copy will serve as the official

copy under existing regulations during

the pilot project.

The pilot project will test a prototype

for electronic filing over the Internet of

information to fulfill the requirements

of section 510 of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 360).

Written requests to participate in the

pilot project should be submitted to the

Dockets Management Branch (address

above) and identified with the docket

number found in brackets in the

heading of this document. Include the

participants name, company name,

company address, and telephone

number. In addition, include in your

written request to participate the

number of products you currently have

listed with the agency, the number of

establishments you currently have

registered with the agency, the type of

products you process (i.e., human,

biologic, or veterinary), the process(es)

you perform (i.e., manufacture,

repackage, relabel, distribute), and the

kind of products you process (i.e.,

prescription, over the counter, active

pharmaceutical ingredients (bulk), or,

homeopathic).

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding this

pilot project. Two copies of any

comment are to be submitted, except

that individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. FDA will

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,