Federal Register / Vol. 62, No. 247 / Wednesday, December 24, 1997 / Rules and Regulations 67273

Division Directors, Office of

Compliance, CDRH, are authorized to

notify manufacturers of defects in, and

noncompliance of, electronic products

under section 359(e) of the act and

under § 1003.11(a) of this chapter; and

the chiefs of District Compliance

Branches are authorized to perform all

such functions relating to:

* * * * *

30. Section 5.90 is revised to read as

follows:

§ 5.90 Manufacturers requirement to

provide data to ultimate purchasers of

electronic products.

The Director and Deputy Directors,

Center for Devices and Radiological

Health, are authorized to require

manufacturers to provide performance

and technical data to the ultimate

purchaser of electronic products under

section 360A(c) of the Public Health

Service Act.

31. Section 5.91 is revised to read as

follows:

§ 5.91 Dealer and distributor direction to

provide data to manufacturers of electronic

products.

The Director and Deputy Directors,

Center for Devices and Radiological

Health (CDRH), the Director and Deputy

Director, Office of Compliance, CDRH,

and the Division Directors, Office of

Compliance, CDRH, are authorized to

direct dealers and distributors of

electronic products to furnish

information on first purchasers of such

products to the manufacturer of the

product under section 360A(f) of the

Public Health Service Act.

32. Section 5.92 is revised to read as

follows:

§ 5.92 Acceptance of assistance from

State and local authorities for enforcement

of radiation control legislation and

regulations.

The Director and Deputy Directors,

Center for Devices and Radiological

Health, are authorized to accept

assistance from State and local

authorities engaged in activities related

to health or safety or consumer

protection on a reimbursable basis or

otherwise, under section 360E of the

Public Health Service Act.

Dated: December 16, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–33482 Filed 12–23–97; 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; Decoquinate and Bacitracin

Zinc With Roxarsone

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 an abbreviated new animal

drug application (ANADA) filed by

ALPHARMA INC. The ANADA

provides for using approved

decoquinate, bacitracin zinc, and

roxarsone Type A medicated articles to

make Type C medicated broiler chicken

feeds used for prevention of coccidiosis,

increased rate of weight gain, and

improved feed efficiency.

EFFECTIVE DATE: December 24, 1997.

FOR FURTHER INFORMATION CONTACT:

Jeffrey M. Gilbert, Center for Veterinary

Medicine (HFV–128), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1602.

SUPPLEMENTARY INFORMATION:

ALPHARMA INC., One Executive Dr.,

P.O. Box 1399, Fort Lee, NJ 07024, is

sponsor of ANADA 200–206 that

provides for combining approved

decoquinate, bacitracin zinc, and

roxarsone Type A medicated articles to

make Type C medicated feeds for

broilers containing decoquinate 27.2

grams per ton (g/t) and bacitracin zinc

12 to 50 g/t with roxarsone 11 to 45 g/

t. The Type C medicated feed is used for

the prevention of coccidiosis caused by

Eimeria tenella, E. necatrix, E.

acervulina, E. mivati, E. maxima, and E.

brunetti, and for increased rate of weight

gain and improved feed efficiency.

ALPHARMA INC.’s, ANADA 200–206

is approved as a generic copy of Rhone

Poulenc Inc.’s NADA 91–326. The

ANADA is approved as of December 24,

1997 and the regulations are amended

in 21 CFR 558.195(d) to reflect the

approval. The basis for approval is

discussed in the freedom of information

summary.

This approval is for use of three single

ingredient Type A medicated articles to

make combination drug Type C

medicated feeds. One ingredient,

roxarsone, is a Category II drug as

defined in 21 CFR 558.3(b)(1)(ii). As

provided in 21 CFR 558.4(b), an

approved form FDA 1900 is required to

make a Type C medicated feed from a

Category II drug. Under section 512(m)

of the act (21 U.S.C. 360b(m)), as

amended by the Animal Drug

Availability Act of 1996 (Pub. L. 104–

250), medicated feed applications have

been replaced by a requirement for feed

mill licenses. Therefore, use of

decoquinate, bacitracin zinc, and

roxarsone Type A medicated articles to

make Type C medicated feeds as

provided in NADA 200–206 is limited

to manufacture in a licensed feed mill.

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, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857, between

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

Friday.

The agency has determined under 21

CFR 25.33 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.

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.

§ 558.195 [Amended]

2. Section 558.195 Decoquinate is

amended in the table in paragraph (d) in

the entry for ‘‘27.2 (0.003 pct),

Roxarsone 11 to 45 (0.0012–0.005 pct.)

plus Bacitracin 12 to 50’’ under

‘‘Limitations’’ by removing ‘‘No.

011716’’ and adding in its place ‘‘Nos.

011716 and 046573’’.

Dated: October 30, 1997.

Stephen F. Sundlof,

Director, Center for Veterinar Medicine.

[FR Doc. 97–33638 Filed 12–23–97; 8:45 am]

BILLING CODE 4160–01–F