31938 Federal Register / Vol. 66, No. 114 / Wednesday, June 13, 2001 / Notices

V. Comments and Electronic Access

Interested persons may submit to the

Committee on Food Chemicals Codex

written comments regarding the

monographs, general test procedure, and

test solutions identified in this notice by

July 30, 2001. Timely submission will

allow comments to be considered for the

third supplement to the fourth edition

of the Food Chemicals Codex.

Comments received after this date may

not be considered for the third

supplement, but will be considered for

the fifth edition of the Food Chemicals

Codex. Those wishing to make

comments are encouraged to submit

supporting data and documentation

with their comments. Two copies of any

comments regarding the monographs,

the general test procedure, or the test

solutions listed in this notice are to be

submitted to the Committee on Food

Chemicals Codex (address above).

Comments and supporting data or

documentation are to be identified with

the docket number found in brackets in

the heading of this document and each

submission should include the

statement that it is in response to this

Federal Register notice. The committee

staff will forward a copy of each

comment to the Dockets Management

Branch (address above). Received

comments may be seen in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday. Copies

of the proposed changes may also be

obtained through the Internet at http://

www.iom.edu/fcc.

Dated: June 4, 2001.

L. Robert Lake,

Director of Regulations and Policy, Center

for Food Safety and Applied Nutrition.

[FR Doc. 01–14864 Filed 6–12–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Transmissible Spongiform

Encephalopathies 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: Transmissible

Spongiform Encephalopathies (TSE)

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 June 28, 2001, 8 a.m. to 5 p.m.

and on June 29, 2001, 8 a.m. to 11:30

a.m.

Location: Holiday Inn, Versailles

Ballroom I and II, 8120 Wisconsin Ave.,

Bethesda, MD.

Contact: William Freas, or Sheila D.

Langford, Center for Biologics

Evaluation and Research (HFM–71),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–827–0314, or FDA Advisory

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), code 12392.

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

Agenda: On June 28, 2001, the

committee will review and discuss the

suitability of blood donors who have

lived or traveled in various countries

based on recent information concerning

new-variant Creutzfeldt-Jakob disease

and bovine spongiform encephalopathy

in those countries. In the afternoon, the

committee will discuss the safety of

FDA-regulated plasma derivatives

prepared in establishments proposing to

use on the same manufacturing line,

plasma which does and plasma which

does not comply with current U.S.

standards, with regard to donor deferral

for vCJB risk factors. On June 29, 2001,

the committee will discuss the interim

results of a new study on the

inactivation of TSE agent by the

manufacturing process for gelatin.

Procedure: On June 28, 2001, from 8

a.m. to 4:30 p.m. and June 29, 2001,

from 8 a.m. to 11:30 a.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 June 15, 2001. Oral

presentations from the public will be

scheduled between approximately 10:50

a.m. and 11:30 a.m., and between

approximately 2:30 p.m. and 3:10 p.m.

on June 28, 2001, and between

approximately 10 a.m. and 10:30 a.m.

on June 29, 2001. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before June 15, 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

June 28, 2001, from 4:30 p.m. to 5 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)). This portion of the

meeting will be closed to permit

discussion of this material.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: June 5, 2001.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 01–14812 Filed 6–12–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D–0224]

Draft Guidance for Industry: Mass

Spectrometry for Confirmation of the

Identity of Animal Drug Residues;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance entitled

‘‘Guidance for Industry: Mass

Spectrometry for Confirmation of the

Identity of Animal Drug Residues.’’ This

draft guidance describes the basic

principles the agency recommends for

development, evaluation, or application

of qualitative mass spectrometric

methods for confirming the identity of

new animal drug residues. This draft

document is intended for technical

professionals familiar with mass

spectrometry. A glossary at the end of

the draft guidance defines key terms

used throughout the document.

DATES: Submit written comments by

September 11, 2001.

ADDRESSES: Submit written requests for

single copies of this draft guidance to

the Communications Staff (HFV–12),

Center for Veterinary Medicine (CVM),

Food and Drug Administration, 7500

Standish Pl., Rockville, MD 20855. Send

one self-addressed adhesive label to

assist the office in processing your

requests. See the SUPPLEMENTARY

INFORMATION section for electronic

access to the draft guidance document.

Submit written comments to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852, e-mail: