34848 Federal Register / Vol. 61, No. 129 / Wednesday, July 3, 1996 / Notices

ESTIMATED ANNUAL REPORTING BURDEN—Continued

Burden Element No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours Total Costs

Mail-in Response 200 1 200 0 N/A N/A

Telephone Followup 800 1 800 0.083 67 $1,118

Responses by Telephone Interview 480 1 480 0.5 240 $4,006

Mail-In Response After Receiving

Followup 22 1 22 0 N/A N/A

Total Burden 1,092 $18,225

There are no capital costs or continuing operating and maintenance costs associated with this survey. These burden estimates include the

time for reviewing instructions, searching existing data sources, gathering the data needed, and completing and reviewing the collection of information. The hour and cost burden estimates were derived from a pretest of nine randomly selected facilities.

Dated: June 26, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–16970 Filed 7–2–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96N–0121]

Bayer Corp., et al.; Withdrawal of

Approval of 29 NADA’s

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is withdrawing

approval of 29 new animal drug

applications (NADA’s). Twenty-four

NADA’s are held by Bayer Corp.,

Agriculture Division, Animal Health

(formerly Miles, Inc., Agriculture

Division, Animal Health Products),

three are held by Hubbard Milling Co.,

and one each is held by HoffmannLaRoche, Inc., and Ohmeda, Inc. The

firms notified the agency in writing that

the animal drug products are not being

manufactured or marketed and

requested that approval of the

applications be withdrawn. In a final

rule published elsewhere in this issue of

the Federal Register, FDA is amending

the animal drug regulations by removing

the entries which reflect approval of the

NADA’s.

EFFECTIVE DATE: July 15, 1996.

FOR FURTHER INFORMATION CONTACT:

Mohammad I. Sharar, Center for

Veterinary Medicine (HFV–216), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–827–

0159.

SUPPLEMENTARY INFORMATION: The

sponsors of the applications listed in the

table in this document have informed

FDA that these animal drug products are

not being manufactured or marketed

and have requested that FDA withdraw

approval of the applications.

NADA no. Drug name Sponsor name and address

6–462 ....................................... Diethylcarbamazine tablets ................................................ Bayer Corp., Agriculture Division, Animal Health,

P.O. Box 390, Shawnee Mission, KS 66201.

10–540 ..................................... Calcium disodium edetate injection ................................... Do.

11–380 ..................................... Diethylcarbamazine powder ............................................... Do.

12–054 ..................................... Protokylol hydrochloride tablets and injection ................... Do.

12–103 ..................................... Triamcinolone tablets ......................................................... Do.

12–392 ..................................... Triamcinolone injection ...................................................... Do.

12–598 ..................................... Disophenol sodium injection .............................................. Do.

15–161 ..................................... Trichlorfon powder ............................................................. Do.

15–965 ..................................... Coumaphos Type A medicated article ............................... Do.

30–045 ..................................... Triamcinolone/neomycin sulfate ointment .......................... Do.

34–394 ..................................... Niclosamide tablets ............................................................ Do.

35–263 ..................................... Styrylpyridinium chloride/diethylcarbamazine (as base)

oral liquid.

Do.

45–287 ..................................... Coumaphos crumbles ........................................................ Do.

48–645 ..................................... Tylosin Type A medicated articles (5, 10, 20, and 40

grams per pound).

Hubbard Milling Co., 424 North Riverfront Dr., P.O.

Box 8500, Mankato, MN 56002–8500.

49–555 ..................................... Styrylpyridinium chloride/diethylcarbamazine control diet

HRH/MSD.

Bayer Corp.

91–628 ..................................... Diethylcarbamazine citrate syrup ....................................... Do.

93–372 ..................................... Chlortetracycline calcium complex Type A medicated articles.Hoffmann-LaRoche, Inc., Nutley, NJ 07110.

94–402 ..................................... Tylosin and sulfamethazine Type A medicated articles .... Hubbard Milling Co.

95–078 ..................................... Trichlorfon oral liquid .......................................................... Bayer Corp.

96–031 ..................................... Styrylpyridinium chloride/diethylcarbamazine citrate tablets.Do.

100–201 ................................... Trichlorfon paste ................................................................ Do.

100–356 ................................... Styrylpyridinium chloride/diethylcarbamazine control diet

HRH.

Do.

100–670 ................................... Niclosamide Type A medicated article .............................. Do.

101–078 ................................... Dichlorophene and toluene capsules ................................. Do.

120–327 ................................... Diethylcarbamazine chewable tablets ................................ Do.

120–670 ................................... Styrylpyridinium, diethylcarbamazine edible tablets .......... Do.
Federal Register / Vol. 61, No. 129 / Wednesday, July 3, 1996 / Notices 34849

NADA no. Drug name Sponsor name and address

121–291 ................................... Enflurane liquid (anesthetic) .............................................. Ohmeda, Inc., Pharmaceutical Products Division,

P.O. Box 804, Liberty Corner, NJ 07938–0804.

121–813 ................................... Styrylpyridinium, diethylcarbamazine film-coated tablets Bayer Corp.

133–509 ................................... Pyrantel tartrate Type A medicated articles ...................... Hubbard Milling Co.

Therefore, under authority delegated

to the Commissioner of Food and Drugs

(21 CFR 5.10) and redelegated to the

Center for Veterinary Medicine (21 CFR

5.84), and in accordance with § 514.115

Withdrawal of approval of applications

(21 CFR 514.115), notice is given that

approval of NADA’s 6–462, 10–540, 11–

380, 12–054, 12–103, 12–392, 12–598,

15–161, 15–965, 30–045, 34–394, 35–

263, 45–287, 48–645, 49–555, 91–628,

93–372, 94–402, 95–078, 96–031, 100–

201, 100–356, 100–670, 101–078, 120–

327, 120–670, 121–291, 121–813, and

133–509, and all supplements and

amendments thereto is hereby

withdrawn, effective July 15, 1996.

In a final rule published elsewhere in

this issue of the Federal Register, FDA

is removing 21 CFR 520.500, 520.620a,

520.620b, 520.1520, 520.2022,

520.2160a, 520.2160b, 520.2160c,

520.2160d, 520.2480, 520.2520c,

520.2520d, 522.281, 522.740, 522.2022,

522.2480, 529.810, 558.367, and

558.565, and amending 21 CFR 520.580,

520.622a, 520.622b, 520.2520a, 558.185,

558.485, 558.625, and 558.630 to reflect

the withdrawal of approval of the above

mentioned NADA’s.

Dated: June 3,1996.

Michael J. Blackwell,

Acting Director, Center for Veterinary

Medicine.

[FR Doc. 96–16887 Filed 7–2–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96D–0159]

Compounding of Drugs for Use in

Animals; Compliance Policy Guide;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a Compliance Policy

Guide (CPG) section 608.400 entitled

‘‘Compounding of Drugs for Use in

Animals.’’ The purpose of this CPG is to

provide guidance to FDA’s field and

headquarters staff with regard to the

compounding of animal drugs by

veterinarians and pharmacists for use in

animals. The CPG contains information

that may be useful to industry and the

public. The text of the CPG is included

in this notice. This CPG does not bind

FDA, nor does it create or confer any

rights, privileges, benefits, or

immunities on or for any person.

DATES: Written comments may be

submitted at any time.

ADDRESSES: Submit written requests for

single copies of CPG section 608.400

entitled ‘‘Compounding of Drugs for Use

in Animals’’ to the Industry Information

Staff (HFV–12), Center for Veterinary

Medicine, Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855. Send two selfaddressed adhesive labels to assist that

office in processing your requests.

Submit written comments on CPG

section 608.400 entitled ‘‘Compounding

of Drugs for Use in Animals’’ to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. Two copies of any

comments are to be submitted, except

that individuals may submit one copy.

Requests and comments should be

identified with the docket number

found in brackets in the heading of this

document. A copy of CPG section

608.400 and received comments are

available for public examination in the

Dockets Management Branch between 9

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

Friday.

FOR FURTHER INFORMATION CONTACT:

Richard E. Geyer, Center for Veterinary

Medicine (HFV–200), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1764.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of CPG

section 608.400 entitled ‘‘Compounding

of Drugs for Use in Animals.’’ The

purpose of this CPG is to provide clear

policy and regulatory guidelines to

FDA’s field and headquarters staff with

regard to the compounding of animal

drugs by veterinarians and pharmacists

for use in animals. It also contains

information that may be useful to

industry and to the public.

The Federal Food, Drug, and Cosmetic

Act (the act) does not distinguish

compounding from manufacturing or

other processing of drugs for use in

animals. However, veterinarians and

pharmacists do manipulate drugs (e.g.,

combine or dilute finished dosage

forms, prepare finished dosage forms

from bulk drug substances, or prepare

injectables from powdered oral dosage

forms) to obtain products that differ

from the starting materials.

FDA acknowledges the use of

compounding within certain areas of

veterinary practice. The current state of

veterinary medicine requires products

to treat many conditions in a number of

different species, some of which are

known to have unique physiological

characteristics. While the agency

acknowledges the need for

compounding under certain

circumstances, it is also aware of recent

adverse reactions and animal deaths

caused by compounded drug products

and is concerned about the risks

associated with compounding practices

in veterinary medicine. In addition, the

agency is greatly concerned about

pharmacies that produce large

quantities of unapproved new animal

drugs that are essentially copies of FDAapproved products. These pharmacy

products are actively advertised and

promoted, and sometimes are priced

lower than the approved product. The

firms claim that they are practicing

within the scope of their State licenses.

However, it is apparent that some of

these firms use their pharmacy licenses

to circumvent the entire drug approval

process, and are mass marketing

products that have been produced under

little or no quality control,

manufacturing standards to ensure

purity, potency, and stability.

When the Animal Medicinal Drug Use

Clarification Act of 1994 (AMDUCA) is

implemented and becomes effective, it

will allow compounding from approved

drugs because it will permit the

extralabel use of approved animal and

human drugs. Extralabel use, including

compounding, under AMDUCA will be

subject to conditions specified by the

implementing regulations. The scope of

compounding made legal upon the

effective date of AMDUCA will be

addressed by those regulations.

CPG section 608.400 represents FDA’s

current position and interpretation of

the act. The CPG is intended to provide

clear guidance to FDA field and

headquarters staff and also could