62242 Federal Register / Vol. 62, No. 225 / Friday, November 21, 1997 / Rules and Regulations

Drug labeler code Firm name and address

* * * * * * *

063112 ...................................................................................................... Sioux Biochemical, Inc., 204 Third St. NW., Sioux Center, IA 51250

* * * * * * *

PART 522—IMPLANTATION OR

INJECTABLE DOSAGE FORM NEW

ANIMAL DRUGS

3. The authority citation for 21 CFR

part 522 continues to read as follows:

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

§ 522.1002 [Amended]

4. Section 522.1002 Follicle

stimulating hormone is amended in

paragraph (b)(2) by removing ‘‘000061’’

and adding in its place ‘‘063112’’.

Dated: November 6, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–30563 Filed 11–20–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 522 and 556

Animal Drugs, Feeds, and Related

Products; Doramectin

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 supplemental new animal

drug application (NADA) filed by Pfizer,

Inc. The supplemental NADA provides

for intramuscular use of doramectin in

swine for the treatment and control of

certain infections of nematode and

arthropod parasites.

EFFECTIVE DATE: November 21, 1997.

FOR FURTHER INFORMATION CONTACT:

Estella Z. Jones, Center for Veterinary

Medicine (HFV–135), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1643.

SUPPLEMENTARY INFORMATION: Pfizer,

Inc., 235 East 42d St., New York, NY

10017–5755, is sponsor of NADA 141–

061, which provides for the

subcutaneous and intramuscular use of

Dectomax 1 percent injectable solution

(doramectin) for treatment and control

of certain gastrointestinal roundworms,

lungworms, eyeworms, grubs, lice, and

mange mites of cattle, and to control

infections and to protect cattle from

reinfection with Ostertagia ostertagi for

21 days, and Cooperia punctata and

Dictyocaulus viviparus for 28 days after

treatment. The firm filed a supplemental

NADA that provides for intramuscular

use of doramectin in swine for the

treatment and control of certain

infections of gastrointestinal

roundworms, lungworms, kidney

worms, sucking lice, and mange mites.

The supplemental NADA is approved as

of September 18, 1997, and the

regulations are amended in 21 CFR

522.770(d) to reflect the approval. The

basis of approval is discussed in the

freedom of information summary.

In addition, a tolerance for residues of

doramectin in edible swine tissues has

not been previously established. Section

556.225 (21 CFR 556.225) is amended to

provide for a tolerance for residues of

doramectin in swine tissues.

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 supplemental

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.

Under section 512(c)(2)(F)(iii) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 360b(c)(2)(F)(iii)), this

supplemental approval for foodproducing animals qualifies for 3 years

of marketing exclusivity beginning

September 18, 1997, because the

supplement contains substantial

evidence of the effectiveness of the drug

involved, any studies of animal safety

or, in the case of food-producing

animals, human food safety studies

(other than bioequivalence or residue

studies) required for approval of the

supplemental application and

conducted or sponsored by the

applicant. Exclusivity applies only to

the added indication for the treatment

and control of gastrointestinal

roundworms, lungworms,

kidneyworms, sucking lice, and mange

mites in swine.

The agency has carefully considered

the potential environmental effects of

this action. FDA has concluded that the

action will not have a significant impact

on the human environment, and that an

environmental impact statement is not

required. The agency’s finding of no

significant impact and the evidence

supporting that finding, contained in an

environmental assessment, may be seen

in the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

List of Subjects

21 CFR Part 522

Animal drugs.

21 CFR Part 556

Animal drugs, Foods.

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 parts 522 and 556 are amended as

follows:

PART 522—IMPLANTATION OR

INJECTABLE DOSAGE FORM NEW

ANIMAL DRUGS

1. The authority citation for 21 CFR

part 522 continues to read as follows:

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

2. Section 522.770 is amended by

revising the heading of paragraph (d)

and redesignating paragraphs (d)(1),

(d)(2), and (d)(3) as paragraphs (d)(1)(i),

(d)(1)(ii), and (d)(1)(iii), respectively,

and by adding new paragraph (d)(2) to

read as follows:

§ 522.770 Doramectin.

* * * * *

(d) Conditions of use—(1) Cattle. (i)

Amount. * * *

* * * * *

(2) Swine. (i) Amount. 300

micrograms per kilogram (10 milligrams

per 75 pounds).

(ii) Indications for use. For treatment

and control of gastrointestinal

roundworms, lungworms, kidney

worms, sucking lice, and mange mites.
Federal Register / Vol. 62, No. 225 / Friday, November 21, 1997 / Rules and Regulations 62243

(iii) Limitations. Administer as a

single intramuscular injection. Do not

slaughter swine within 24 days of

treatment. Consult your veterinarian for

assistance in the diagnosis, treatment,

and control of parasitism.

PART 556—TOLERANCES FOR

RESIDUES OF NEW ANIMAL DRUGS

IN FOOD

3. The authority citation for 21 CFR

part 556 continues to read as follows:

Authority: 21 U.S.C. 342, 360b, 371.

4. Section 556.225 is revised to read

as follows:

§ 556.225 Doramectin.

A tolerance of 0.1 part per million

(ppm) is established for parent

doramectin (marker residue) in liver

(target tissue) of cattle and 0.16 ppm in

liver of swine.

Dated: October 22, 1997.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 97–30562 Filed 11–20–97; 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; Clopidol 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 abbreviated NADA

provides for using approved clopidol,

bacitracin zinc, and roxarsone Type A

medicated articles to make Type C

medicated broiler chicken feeds used for

prevention of coccidiosis, improved

feed efficiency, improved pigmentation,

and increased rate of weight gain.

EFFECTIVE DATE: November 21, 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 200–207 that provides for

combining approved clopidol,

bacitracin zinc, and roxarsone Type A

medicated articles to make Type C

medicated feeds for broilers containing

clopidol 113.5 grams per ton (g/t) and

bacitracin zinc 4 to 25 g/t with

roxarsone 45.4 g/t. The Type C

medicated feed is used as an aid in the

prevention of coccidiosis caused by

Eimeria tenella, E. necatrix, E.

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

maxima, and for increased rate of

weight gain, improved feed efficiency,

and improved pigmentation.

Alpharma Inc.’s ANADA 200–207 is

approved as a generic copy of RhonePoulenc, Inc.’s NADA 44–016. The

ANADA is approved as of November 21,

1997 and 21 CFR 558.175 is amended to

reflect the approval. The basis for

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, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857, from 9

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

Friday.

The agency has determined under 21

CFR 25.33(a)(1) 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.

§ 558.175 [Amended]

2. Section 558.175 Clopidol is

amended in paragraph (d)(1)(iii)(b) by

removing ‘‘No. 000061’’ and adding in

its place ‘‘Nos. 000061 and 046573.’’

Dated: November 7, 1997.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 97–30564 Filed 11–20–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 809 and 864

[Docket No. 96N–0082]

RIN 0910–ZA03

Medical Devices; Classification/

Reclassification; Restricted Devices;

Analyte Specific Reagents

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is issuing a final

rule to classify/reclassify analyte

specific reagents (ASR’s) presenting a

low risk to public health into class I

(general controls), and to exempt these

class I devices from the premarket

notification (510(k)) requirements. FDA

is classifying/reclassifying ASR’s used

in certain blood banking tests as class II

(special controls) because general

controls are insufficient to provide a

reasonable assurance of safety and

effectiveness. Finally, ASR’s presenting

a high risk are being classified or

retained in class III (premarket

approval). FDA is also designating all

ASR’s as restricted devices under the

Federal Food, Drug, and Cosmetic Act

(the act), and establishing restrictions on

their sale, distribution and use. The

scope of products covered by this final

rule includes both pre-1976 devices,

which have not been previously

classified, as well as post-1976 devices,

which are statutorily classified into

class III. The intent of this final rule is

to regulate these pre- and post-1976

devices in a consistent fashion. This

rulemaking does not affect requirements

for reagents that are subject to licensure

under the Public Health Service Act (the

PHS Act). This rulemaking also does not

affect reagents sold to nonclinical

settings, including those reagents sold

as components to manufacturers of

cleared or approved in vitro diagnostic

tests.

DATES: This rule is effective November

23, 1998.

FOR FURTHER INFORMATION CONTACT:

Steven I. Gutman, Center for Devices

and Radiological Health (HFZ–440),

Food and Drug Administration, 2098

Gaither Rd., Rockville, MD 20850, 301–

594–3084.

SUPPLEMENTARY INFORMATION:

I. Background

The the act (21 U.S.C. 201 et seq.), as

amended by the Medical Device