27022 Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Rules and Regulations

3. Memorandum from J. Madden, FDA, to

the Biotechnology Policy Branch, FDA,

October 20, 1995.

4. Memorandum from R. D. Benz, FDA, to

K. C. Raffaele, FDA, July 20, 1995.

5. Memorandum from the Division of

Health Effects Evaluation, FDA, to R. H.

Alrefai, FDA, May 4, 1999.

6. Food Chemicals Codex, 1996, 4th ed.,

National Academy Press, Washington, DC,

pp. 133–134.

7. Memorandum from the Division of

Health Effects Evaluation, FDA, to R. H.

Alrefai, FDA, August 20, 1999.

List of Subjects in 21 CFR Part 173

Food additives, Incorporation by

reference.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 173 is

amended as follows:

PART 173—SECONDARY DIRECT

FOOD ADDITIVES PERMITTED IN

FOOD FOR HUMAN CONSUMPTION

1. The authority citation for 21 CFR

part 173 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 348.

2. Section 173.115 is added to subpart

B to read as follows:

§ 173.115 Alpha-acetolactate

decarboxylase (α-ALDC) enzyme

preparation derived from a recombinant

Bacillus subtilis.

The food additive alpha-acetolactate

decarboxylase (α-ALDC) enzyme

preparation, may be safely used in

accordance with the following

conditions:

(a) The food additive is the enzyme

preparation derived from a modified

Bacillus subtilis strain that contains the

gene coding for α-ALDC from Bacillus

brevis.

(b)(1) The manufacturer produces the

additive from a pure culture

fermentation of a strain of Bacillus

subtilis that is nonpathogenic and

nontoxigenic in man or other animals.

(2) The manufacturer may stabilize

the enzyme preparation with

glutaraldehyde or with other suitable

approved food additives or generally

recognized as safe substances.

(3) The enzyme preparation must

meet the general and additional

requirements for enzyme preparations

in the Food Chemicals Codex, 4th ed.,

1996, pp. 133–134, which is

incorporated by reference. The Director

of the Office of the Federal Register

approves this incorporation by reference

in accordance with 5 U.S.C. 552(a) and

1 CFR part 51. Copies may be obtained

from the National Academy Press, 2101

Constitution Ave. NW., Washington, DC

20055, or may be examined at the

Center for Food Safety and Applied

Nutrition, 200 C St. SW., rm. 3321,

Washington, DC, or at the Office of the

Federal Register, 800 North Capitol St.

NW., suite 700, Washington, DC.

(c) The additive is used in an amount

not in excess of the minimum required

to produce its intended effect as a

processing aid in the production of

alcoholic malt beverages and distilled

liquors.

Dated: May 4, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–12225 Filed 5–15–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

New Animal Drugs For Use in Animal

Feeds; Narasin, Nicarbazin, and

Bambermycins

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect

approval of a new animal drug

application (NADA) filed by Elanco

Animal Health. The NADA provides for

use of approved narasin/nicarbazin and

bambermycins Type A medicated

articles to make three-way combination

Type C medicated feeds used for

prevention of coccidiosis, increased rate

of weight gain, and improved feed

efficiency in broiler chickens.

DATES: This rule is effective May 16,

2001.

FOR FURTHER INFORMATION CONTACT:

Charles J. Andres, Center for Veterinary

Medicine (HFV–128), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–1600.

SUPPLEMENTARY INFORMATION: Elanco

Animal Health, A Division of Eli Lilly

& Co., Lilly Corporate Center,

Indianapolis, IN 46285, filed NADA

140-942 that provides for use of

Maxiban (36 grams per pound (g/lb)

each of narasin and nicarbazin) and

Flavomycin (2, 4, or 10 g/lb of

bambermycins activity) Type A

medicated articles to make three-way

combination Type C medicated feeds for

use in broiler chickens. The

combination Type C medicated feeds

contain 27 to 45 g/ton narasin and 27 to

45 g/ton nicarbazin (in a fixed 1:1 ratio)

and 1 to 2 g/ton bambermycins, and are

used for prevention of coccidiosis

caused by Eimeria tenella, E. necatrix,

E. acervulina, E. brunetti, and E. mivati,

and for increased rate of weight gain

and improved feed efficiency. The

NADA is approved as of March 8, 2001,

and the regulations are amended in 21

CFR 558.95 and 558.363 to reflect the

approval. The basis of approval is

discussed in the freedom of information

summary

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 submitted to support

approval of this application may 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.

The agency has determined under 21

CFR 25.33(a)(2) that this action is of a

type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

This rule does not meet the definition

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because

it is a rule of ‘‘particular applicability.’’

Therefore, it is not subject to the

congressional review requirements in 5

U.S.C. 801–808.

List of Subjects in 21 CFR Part 558

Animal drugs, Animal feeds.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Center for Veterinary Medicine, 21

CFR part 558 is amended as follows:

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

1. The authority citation for 21 CFR

part 558 continues to read as follows:

Authority: 21 U.S.C. 360b, 371.

§ 558.95 [Amended]

2. Section 558.95 Bambermycins is

amended in paragraph (d)(5)(iv) by

adding ‘‘nicarbazin or’’ following

‘‘with’’, and in paragraph (d)(5)(v) by

removing ‘‘Nicarbazine’’ and adding in

its place ‘‘Nicarbazin’’.

3. Section 558.363 is amended by

adding paragraph (d)(1)(xii) to read as

follows:

§ 558.363 Narasin.

* * * * *

Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Rules and Regulations 27023

(d) * * *

(1) * * *

(xii) Amount per ton. Narasin, 27 to

45 grams; nicarbazin, 27 to 45 grams;

and bambermycins, 1 to 2 grams.

(A) Indications for use. For the

prevention of coccidiosis caused by

Eimeria tenella, E. necatrix, E.

acervulina, E. maxima, E. brunetti, and

E. mivati, and for increased rate of

weight gain and improved feed

efficiency.

(B) Limitations. Feed continuously as

the sole ration. Do not allow adult

turkeys, horses, or other equines access

to formulations containing narasin.

Ingestion of narasin by these animals

has been fatal. Do not feed to laying

hens. Withdraw 5 days before slaughter.

Narasin and nicarbazin as provided by

000986, bambermycins by 012799 in

§ 510.600(c) of this chapter.

* * * * *

Dated: April 23, 2001.

Linda Tollefson,

Deputy Director, Center for Veterinary

Medicine.

[FR Doc. 01–12229 Filed 5–15–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 864 and 876

[Docket No. 01P–0087]

Gastroenterology-Urology Devices;

Classification of Tissue Culture Media

for Human Ex Vivo Tissue and Cell

Culture Processing Applications

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is classifying

tissue culture media for human ex vivo

tissue and cell culture processing

applications into class II (special

controls). The special control that will

apply to this device is a guidance

document entitled ‘‘Class II Special

Controls Guidance Document: Tissue

Culture Media for Human Ex Vivo

Tissue and Cell Culture Processing

Applications; Final Guidance for

Industry and FDA Reviewers.’’ The

agency is taking this action in response

to a petition submitted under the

Federal Food, Drug, and Cosmetic Act

(the act) as amended by the Medical

Device Amendments of 1976, the Safe

Medical Devices Act of 1990, and the

Food and Drug Administration

Modernization Act of 1997. The agency

is classifying these devices into class II

(special controls) in order to provide a

reasonable assurance of the safety and

effectiveness of the devices.

DATES: This rule is effective May 16,

2001.

FOR FURTHER INFORMATION CONTACT:

Carolyn Y. Neuland, Center for Devices

and Radiological Health (HFZ–473),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1220.

SUPPLEMENTARY INFORMATION:

I. Background

In accordance with section 513(f)(1) of

the act (21 U.S.C. 360c(f)(1)), devices

that were not in commercial distribution

before May 28, 1976, the date of

enactment of the Medical Device

Amendments of 1976, generally referred

to as postamendments devices, are

classified automatically by statute into

class III without any FDA rulemaking

process. These devices remain in class

III and require premarket approval,

unless and until the device is classified

or reclassified into class I or II or FDA

issues an order finding the device to be

substantially equivalent, in accordance

with section 513(i) of the act, to a

predicate device that does not require

premarket approval. The agency

determines whether new devices are

substantially equivalent to previously

marketed devices by means of

premarket notification procedures in

section 510(k) of the act (21 U.S.C.

360(k)) and 21 CFR part 807 of the FDA

regulations.

Section 513(f)(2) of the act provides

that any person who submits a

premarket notification under section

510(k) of the act for a device that has not

previously been classified may, within

30 days after receiving an order

classifying the device in class III under

section 513(f)(1) of the act, request FDA

to classify the device under the criteria

set forth in section 513(a)(1) of the act.

FDA shall, within 60 days of receiving

such a request, classify the device by

written order. This classification shall

be the initial classification of the device.

Within 30 days after the issuance of an

order classifying the device, FDA must

publish a notice in the Federal Register

announcing such classification.

In accordance with section 513(f)(1) of

the act, FDA issued an order on

December 5, 2000, classifying the

Dulbecco’s Modified Eagle medium for

human ex vivo tissue and cell culture

processing applications in class III,

because it was not substantially

equivalent to a device that was

introduced or delivered for introduction

into interstate commerce for commercial

distribution before May 28, 1976, or a

device that was subsequently

reclassified into class I or class II.

On December 19, 2000, FDA filed a

petition submitted by Life Technologies,

Inc., requesting classification of the

Dulbecco’s Modified Eagle medium for

human ex vivo tissue and cell culture

processing applications into class II

under section 513(f)(2) of the act. After

review of the information submitted in

the petition, FDA determined that the

Dulbecco’s Modified Eagle medium for

human ex vivo tissue and cell culture

processing applications can be classified

in class II with the establishment of

special controls. The solutions are

indicated for use in human ex vivo

tissue and cell culture processing

applications. FDA believes that class II

special controls, in addition to the

general controls, will provide

reasonable assurance of the safety and

effectiveness of the device for this

intended use.

In addition to the general controls of

the act, the Dulbecco’s Modified Eagle

medium for human ex vivo tissue and

cell culture processing applications is

subject to a special control guidance

document entitled ‘‘Class II Special

Controls Guidance Document: Tissue

Culture Media for Human Ex Vivo

Tissue and Cell Culture Processing

Applications; Final Guidance for

Industry and FDA Reviewers.’’

Section 510(m) of the act provides

that FDA may exempt a class II device

from the premarket notification

requirements under section 510(k) of the

act, if FDA determines that premarket

notification is not necessary to provide

reasonable assurance of the safety and

effectiveness of the device. FDA has

determined that premarket notification

is necessary to provide reasonable

assurance of the safety and effectiveness

of this type of device for this intended

use and, therefore, the device is not

exempt from the premarket notification

requirements. FDA review of bench data

and labeling will ensure that minimum

levels of performance for both safety

and effectiveness are addressed before

marketing clearance. Thus, persons who

intend to market this device for this

intended use must submit to FDA a

premarket notification submission

containing information on the device

before marketing the device.

On February 16, 2001, FDA issued an

order to the petitioner classifying the

Dulbecco’s Modified Eagle medium for

human ex vivo tissue and cell culture

processing applications, and

substantially equivalent devices of this

generic type, into class II under the

generic name, tissue culture media for