Federal Register / Vol. 62, No. 147 / Thursday, July 31, 1997 / Rules and Regulations 40931

NADA No. Drug Name

139–913 .................................................................................................... Equron

140–909 .................................................................................................... Sulka-S-Bolus

Accordingly, the agency is amending

the regulations in 21 CFR 510.600(c)(1)

and (c)(2) to reflect the change of

sponsor. The drug labeler code assigned

to Solvay Animal Health is being

retained as the drug labeler code for the

new sponsor.

List of Subjects in 21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

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 510 is amended as follows:

PART 510—NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 510 continues to read as follows:

Authority: Secs. 201, 301, 501, 502, 503,

512, 701, 721 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321, 331, 351, 352,

353, 360b, 371, 379e).

§ 510.600 [Amended]

2. Section 510.600 Names, addresses,

and drug labeler codes of sponsors of

approved applications is amended in

the table in paragraph (c)(1) by

removing the entry for ‘‘Solvay Animal

Health, Inc.’’ and by alphabetically

adding a new entry for ‘‘Fort Dodge

Animal Health, A Division of American

Cyanamid Co., P.O. Box 1339, Fort

Dodge, IA 50501’’ and in the table in

paragraph (c)(2) in the entry for

‘‘053501’’ by removing the sponsor

name and address ‘‘Solvay Animal

Health, Inc., 1201 Northland Dr.,

Mendota Heights, MN 55120’’ and

adding in its place ‘‘Fort Dodge Animal

Health, A Division of American

Cyanamid Co., P.O. Box 1339, Fort

Dodge, IA 50501’’.

Dated: July 22, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–20249 Filed 7-30-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 524

New Animal Drugs; Change of Sponsor

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect a

change of sponsor for three approved

new animal drug applications (NADA’s)

from Syntex Animal Health, Inc.,

Division of Syntex Agribusiness, Inc., to

Medicis Dermatologics, Inc.

EFFECTIVE DATE: July 31, 1997.

FOR FURTHER INFORMATION CONTACT:

Thomas J. McKay, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0213.

SUPPLEMENTARY INFORMATION: Syntex

Animal Health, Inc., Division of Syntex

Agribusiness, Inc., 3401 Hillview Ave.,

P.O. Box 10850, Palo Alto, CA 94303,

has informed FDA that it has transferred

ownership of, and all rights and

interests in NADA’s 15–151

(fluocinolone acetonide, neomycin

sulfate cream), 15–152 (fluocinolone

acetonide cream), and 15–298

(fluocinolone acetonide solution) to

Medicis Dermatologics, Inc., 4343 East

Camelback Rd., suite 250, Phoenix, AZ

85018–2700. Accordingly, the agency is

amending the regulations in 21 CFR

524.981a, 524.981b, and 524.981c to

reflect the transfer of ownership. The

agency is also amending the regulations

in 21 CFR 510.600(c)(1) and (c)(2) by

alphabetically adding a new listing for

Medicis Dermatologics, Inc.

List of Subjects

21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

21 CFR Part 524

Animal drugs.

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 510 and 524 are amended as

follows:

PART 510—NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 510 continues to read as follows:

Authority: Secs. 201, 301, 501, 502, 503,

512, 701, 721 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321, 331, 351, 352,

353, 360b, 371, 379e).

2. Section 510.600 is amended in the

table in paragraph (c)(1) by

alphabetically adding a new entry for

‘‘Medicis Dermatologics, Inc.’’ and in

the table in paragraph (c)(2) by

numerically adding a new entry for

‘‘099207’’ to read as follows:

§ 510.600 Names, addresses, and drug

labeler codes of sponsors of approved

applications.

* * * * *

(c) * * *

(1) * * *

Firm name and address Drug labeler code

* * * * * * *

Medicis Dermatologics, Inc., 4343 East Camelback Rd., suite 250,

Phoenix, AZ 85018–2700.

099207

* * * * * * *

(2) * * *
40932 Federal Register / Vol. 62, No. 147 / Thursday, July 31, 1997 / Rules and Regulations

Drug labeler code Firm Name and address

* * * * * * *

099207 ...................................................................................................... Medicis Dermatologics, Inc., 4343 East Camelback Rd., suite 250,

Phoenix, AZ 85018–2700.

* * * * * * *

PART 524—OPHTHALMIC AND

TOPICAL DOSAGE FORM NEW

ANIMAL DRUGS

3. The authority citation for 21 CFR

part 524 continues to read as follows:

Authority: Sec. 512 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 360b).

§ 524.981a [Amended]

4. Section 524.981a Fluocinolone

acetonide cream is amended in

paragraph (b) by removing ‘‘000033’’

and adding in its place ‘‘099207’’.

§ 524.981b [Amended]

5. Section 524.981b Fluocinolone

acetonide solution is amended in

paragraph (b) by removing ‘‘000033’’

and adding in its place ‘‘099207’’.

§ 524.981c [Amended]

6. Section 524.981c Fluocinolone

acetonide, neomycin sulfate cream is

amended in paragraph (b) by removing

‘‘000033’’ and adding in its place

‘‘099207’’.

Dated: July 23, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–20248 Filed 7-30-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Animal Drugs, Feeds, and Related

Products; Change of Sponsor;

Corrections

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a

document that appeared in the Federal

Register of June 30, 1997 (62 FR 35075

at 35076). The document amended the

animal drug regulations to reflect the

change of sponsor for 52 approved new

animal drug applications (NADA’s) from

Fermenta Animal Health Co. to

Boehringer Ingelheim Animal Health,

Inc. The document was published with

two inadvertent errors. This document

corrects those errors.

EFFECTIVE DATE: July 31, 1997.

FOR FURTHER INFORMATION CONTACT:

Thomas J. McKay, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0213.

In FR Doc. 97–16967, appearing on

page 35075, in the Federal Register of

Monday, June 30, 1997, the following

corrections are made: On page 35076, in

the first column, in amendment 11, in

the third line, ‘‘(a)(6)’’ is corrected to

read ‘‘(b)(6)’’; and on the same page, in

the second column, in amendment 19,

beginning in the fourth line, ‘‘000069,

054273, and 057561’’ is corrected to

read ‘‘000069, 054273, 057561, and

059130’’.

Dated: July 21, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–20250 Filed 7-30-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 556

Tolerances for Residues of New

Animal Drugs in Food; Apramycin

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 two supplemental new

animal drug applications (NADA’s) filed

by Elanco Animal Health, A Division of

Eli Lilly & Co. The supplemental

NADA’s provide for revised tolerances

for total residues of apramycin (i.e., the

safe concentration) in edible swine

tissues.

EFFECTIVE DATE: July 31, 1997.

FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary

Medicine (HFV–133), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1644.

SUPPLEMENTARY INFORMATION: Elanco

Animal Health, A Division of Eli Lilly

& Co., Lilly Corporate Center,

Indianapolis, IN 46285, is sponsor of

supplemental NADA 106–964 that

provides for the use of Apralan

(apramycin sulfate) soluble powder in

swine drinking water and supplemental

NADA 126–050 that provides for the use

of Apralan (apramycin sulfate) Type A

medicated article in swine feed, both for

control of porcine colibacillosis

(weanling pig scours) caused by strains

of Escherichia coli sensitive to

apramycin. These supplemental

NADA’s provide for a change in the

tolerance for total residues of apramycin

(i.e., the safe concentration) in edible

swine tissues as provided in § 556.52

(21 CFR 556.52). Review of these

supplements involved a review of new

toxicology studies and information in

the original approvals.

In evaluating these supplements,

FDA’s Center for Veterinary Medicine

also considered that the proof of human

food safety for antimicrobial animal

drug residues includes a determination

of their antimicrobial activity for all

antimicrobial new animal drug

products. In the absence of studies to

determine the microbiological safety of

antimicrobial drug residues, the

acceptable daily intake (ADI) for

apramycin is limited to 25 micrograms

per kilogram (μg/kg) of body weight per

day (for appropriate studies see

‘‘Guidance: Microbial Testing of

Antimicrobial Drug Residues in Food,’’

January, 1996). As indicated in the

freedom of information summaries, the

safe concentration for total apramycin

residues is established at 5 parts per

million (ppm) for muscle, 15 ppm for

liver, and 30 ppm for fat and kidney.

These revised safe concentrations

warrant removal of the existing

tolerances for total residues in § 556.52,

because those tolerances are now

incorrect. Because this approval does

not result in a different tolerance than

that currently codified for marker

residue in swine kidney, and because

the sponsor did not petition FDA to

change the tolerance, the tolerance of

0.1 ppm in swine kidney remains

codified. FDA is also codifying the ADI

for apramycin of 25 μg/kg of body

weight per day. The supplement is