Federal Register / Vol. 65, No. 88 / Friday, May 5, 2000 / Notices 26217

The OR and a researcher from the

University of Arizona have provided

human food safety data for the use of

oxytetracycline in shrimp. The OR

provided analytical support to complete

a tissue residue depletion study

conducted by the researcher from the

University of Arizona for

oxytetracycline in shrimp. The

University of Arizona researcher

directed the in-life portion of the study.

Juvenile Pacific shrimp, Penaeus

vannamei, were fed 3.4 grams

oxytetracycline/kilogram feed for 14

days and then sampled at 0, 12, 24, 36,

48, 72, and 96 hours after treatment.

Feed and tissue samples were sent to

the OR laboratory for analysis. The OR

analyzed the feed samples by the

regulatory high performance liquid

chromatography (HPLC) method

entitled ‘‘Determination of

Oxytetracycline in Milk Replacer (FDA/

CVM, Revision 1.2, April 1, 1998).’’ The

tissue samples were analyzed by a 1997

version of the regulatory HPLC method

for determining oxytetracycline residues

in shrimp. While validating the method

prior to analyzing the test samples, the

OR found that the 1997 method should

be revised to emphasize complete

collection of the aqueous phase during

extraction. The revised regulatory

method for analysis of oxytetracycline

in shrimp is entitled ‘‘Method for the

Determination of Oxytetracycline

Residues in Uncooked Shrimp Using

High Performance Liquid

Chromatography,’’ by Steven W. Hadley,

Susan K. Braun, and Marleen M.

Wekell, FDA, Office of Regulatory

Affairs, Division of Field Science,

Seafood Products Research Center,

December 23, 1999.

At 0 hours withdrawal,

oxytetracycline tissue levels ranged

from 3.2 to 5.6 parts per million (ppm);

at 12 hours, 1.5 to 4.1 ppm; at 24 hours,

1.5 to 2.1 ppm; at 36 hours, 1.2 to 2.0

ppm; at 48 hours, 0.31 to 0.64 ppm; and

at 72 hours, <0.25 ppm. The 96-hour

samples were not analyzed because

residues were below the lowest point on

the standard curve by 72 hours

withdrawal.

Data and information on human food

safety are contained in PMF 5662.

Sponsors of NADA’s or supplemental

NADA’s may, without further

authorization, reference the PMF to

support approval of an application filed

under 21 CFR 514.1(d). An NADA or

supplemental NADA must include, in

addition to reference to the PMF:

Effectiveness data, target animal safety

data, animal drug labeling, and other

information needed for approval. Other

information needed for approval may

include data supporting extrapolation

from a major species in which the drug

is currently approved or authorized

reference to such data; data concerning

manufacturing methods, facilities, and

control; and information addressing

potential environmental impacts of the

manufacturing process. Persons desiring

more information concerning the PMF

or requirements for approval of an

NADA or supplement may contact Julia

A. Oriani (address above).

In accordance with the freedom of

information provisions of 21 CFR part

20 and 514.11(e)(2)(ii), a summary of

safety and effectiveness data and

information provided in this PMF to

support approval of an application may,

upon approval of such application, be

seen in the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852, between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: April 28, 2000.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 00–11329 Filed 5–4–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Transmissible Spongiform

Encephalopathies (TSE) 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 1, 2000, 8:30 a.m. to 5:30 p.m. and

on June 2, 2000, 8:30 a.m. to 3:30 p.m.

Location: Holiday Inn, Ballroom II,

Montgomery Village Ave., Gaithersburg, MD.

Contact Person: 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 up-to-date

information on this meeting.

Agenda: On June 1, 2000, the committee

will discuss policies for deferral of blood and

plasma donors because of their possible

exposure to the agent of bovine spongiform

encephalopathy (BSE). On June 2, 2000, the

committee will discuss the scientific merit of

leukoreduction as a method to reduce the

theoretical risk of Creutzfeldt-Jakob Disease

(CJD) and/or new variant CJD (nvCJD) in

blood and blood components for transfusions

as well as plasma for manufacture into

derivatives. In the afternoon, the committee

will receive an update on the regulatory

status of human dura mater.

Procedure: On June 1, 2000, from 8:30 a.m.

to 5 p.m. and June 2, 2000, from 8:30 a.m.

to 3:30 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 15, 2000. Oral presentations

from the public will be scheduled between

approximately 8:30 a.m. to 9 a.m., and 1 p.m.

to 1:30 p.m. on June 1, 2000, and between

8:30 a.m. to 9 a.m. and 1 p.m. to 1:30 p.m.

on June 2, 2000. Time allotted for each

presentation may be limited. These desiring

to make formal oral presentations should

notify the contact person before May 22,

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 June

1, 2000, from 5 p.m. to 5:30 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)). This

portion of the meeting will be closed to

permit discussion of this material.

Notice of this is given under the Federal

Advisory Committee Act (5 U.S.C. app. 2).

Dated: April 21, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–11200 Filed 5–4–00; 8:45 am]

BILLING CODE 4160–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1266]

Report to Congress on Pediatric

Exclusivity; Request for Comments

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; request for comments.

SUMMARY: The Food and Drug

Administration (FDA) is requesting

comments on the pediatric exclusivity

program established by the Food and

Drug Administration Modernization Act

of 1997 (the Modernization Act). This

action is being taken to assist the agency

in preparing a report to Congress on