26216 Federal Register / Vol. 65, No. 88 / Friday, May 5, 2000 / Notices

published to give all interested parties

an opportunity to comment on how

these new resources may best be applied

to address public health issues related

to the timely approval and safe use of

food and color additives. CFSAN will

consider administrative and procedural

enhancements to ensure that program

goals are met while maintaining high

standards of safety and scientific

credibility.

DATES: Submit written comments by

July 19, 2000.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Alan M. Rulis, Center for Food Safety

and Applied Nutrition (HFS–200), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3100,

e-mail: arulis@cfsan.fda.gov.

SUPPLEMENTARY INFORMATION: The Office

of Premarket Approval (OPA) in CFSAN

manages the following programs:

Petitions for new uses of food and color

additives, consultations on foods

developed using new methods of

biotechnology, generally recognized as

safe (GRAS) notices, threshold of

regulation (TOR) exemption requests,

and premarket notifications for food

contact substances (PMN). In addition to

these programs, OPA is the lead

technical authority for food additives for

the U.S. Government. OPA provides

expertise and leadership in the

international forums of the Joint Food

Agricultural Organization (FAO)/World

Health Organization (WHO) Expert

Committee on Food Additives, the

North American Free Trade Agreement,

and the Codex Alimentarius

Commission to define international

standards, promote harmonization, and

evaluate equivalency agreements for

food additives and other food

ingredients. OPA also has laboratory

research and sample analysis

components that provide technical

support for the enforcement of the food

additive regulations.

The current process of reviewing food

and color additive petitions has evolved

over 40 years since the passage of the

1958 Food Additives Amendment to the

Federal Food, Drug, and Cosmetic Act

(the act). Approvals of food and color

additives have been based on a critical

scientific evaluation of safety

information submitted by petitioners.

The primary components of this

evaluation are the review of chemical,

toxicological, and environmental

scientific data and information and an

estimation of the probable human

dietary exposure to additives. During its

review of safety of new food additive

uses, OPA develops an administrative

record that relies on scientific data and

information to support the agency’s

safety conclusions. Although this

framework has a high level of scientific

credibility, CFSAN recognizes that

improvements could be made to ensure

that the process is more efficient while

maintaining the current high scientific

standards. With this notice, CFSAN is

soliciting comments on ways to improve

the timeliness, transparency, and

predictability of its review of food and

color additive petitions, and its

monitoring of the safety of food and

color additives over time.

To help focus comments, FDA

requests that comments regarding food

and color additive review address the

following:

1. The act requires that the agency

base its safety decisions for the

premarket review of additives on ‘‘a fair

evaluation of the data’’ and requires that

new uses of food additives be consistent

with the agency safety standard of

‘‘reasonable certainty of no harm.’’ What

specific changes can be made to the

current review process to make that

process more efficient, i.e., transparent,

timely, responsive, and predictable,

while preserving these high standards of

data review and of safety?

2. On January 5, 1999 (64 FR 517),

CFSAN made available a guidance

describing a policy to expedite the

review of petitions for food additives

that are intended to significantly

decrease human pathogens or their

toxins in/on food. Should the Center

consider broadening the criteria for

eligibility for such expedited petition

review? If so, petitions for what types of

uses should be added?

3. How should the increased

appropriation to CFSAN that is targeted

for the safety review of food and color

additives be allocated? For example, to

what extent should new resources be

allocated to: (1) Performing prefiling

consultations with prospective

applicants for new uses of food

ingredients, (2) adding personnel

resources to the review process, (3)

enhancing electronic data management

systems such as automated workflow

management or data warehousing, and

(4) acquiring or monitoring new safety

information on already approved

additives?

4. What specific program

enhancements should be given the

highest priority?

Interested persons may, on or before

July 19, 2000, submit to the Dockets

Management Branch (address above)

written comments regarding this

document. Two copies of any comments

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. Received

comments may be seen in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Dated: April 28, 2000.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.

[FR Doc. 00–11331 Filed 5–4–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Oxytetracycline in Shrimp; Availability

of Data

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of human food safety data

that may be used in support of a new

animal drug application (NADA) or

supplemental NADA for the treatment

of shrimp with oxytetracycline via

medicated feed for bacterial infections.

The data, contained in Public Master

File (PMF) 5662, were compiled by

FDA, Center for Veterinary Medicine

(CVM), Office of Research (OR).

ADDRESSES: Submit NADA’s or

supplemental NADA’s to the Document

Control Unit (HFV–199), Center for

Veterinary Medicine, Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855. Copies of the

analytical methods used to analyze the

feed and tissue samples used in this

study are available from the Center for

Veterinary Medicine, Office of Research,

8401 Muirkirk Rd., Laurel, MD 20708.

FOR FURTHER INFORMATION CONTACT: Julia

A. Oriani, Center for Veterinary

Medicine (HFV–151), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–6976.

SUPPLEMENTARY INFORMATION:

Oxytetracycline used for the treatment

of bacterial infections in shrimp is a

new animal drug under section 201(v) of

the Federal Food, Drug, and Cosmetic

Act (the act) (21 U.S.C. 321(v)). As a

new animal drug, oxytetracycline is

subject to section 512 of the act (21

U.S.C. 360b), requiring that its use in

shrimp be the subject of an approved

NADA or supplemental NADA. Shrimp

are a minor species under 21 CFR

514.1(d)(1)(ii).

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