Federal Register / Vol. 61, No. 113 / Tuesday, June 11, 1996 / Rules and Regulations 29477

§ 310.304 [Removed]

8. Section 310.304 Drugs that are

subjects of approved new drug

applications and that require special

studies, records, and reports is removed.

Dated: June 3, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–14587 Filed 6–10–96; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Pyrantel Pamoate Suspension

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

Lambert-Kay, Div. of Carter-Wallace,

Inc. The ANADA provides for oral use

of pyrantel pamoate suspension for

removal of large roundworms and

hookworms in puppies and dogs and to

prevent reinfections of Toxocara canis

in puppies and adult dogs and in

lactating bitches after whelping.

EFFECTIVE DATE: June 11, 1996.

FOR FURTHER INFORMATION CONTACT:

Sandra K. Woods, Center for Veterinary

Medicine (HFV–114), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1616.

SUPPLEMENTARY INFORMATION: LambertKay, Div. of Carter-Wallace, Inc., P.O.

Box 1001, Half Acre Rd., Cranbury, NJ

08512–0181, filed ANADA 200–028,

which provides for oral use of Evict,

Lassie, and Vet’s OwnTM (pyrantel

pamoate) liquid wormer for removal of

large roundworms (T. canis and

Toxascaris leonina) and hookworms

(Ancylostoma caninum and Uncinaria

stenocephala) in puppies and dogs and

to prevent reinfections of T. canis in

puppies and adult dogs and in lactating

bitches after whelping. The product

contains pyrantel pamoate equivalent to

2.27 milligrams of pyrantel base.

Approval of ANADA 200–028 for

Lambert-Kay’s pyrantel pamoate

suspension is as a generic copy of

Pfizer’s NADA 100–237 NemexTM

(pyrantel pamoate). The ANADA is

approved as of March 28, 1996, and the

regulations in 21 CFR 520.2043(b)(2) are

amended 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 part 20 (21

CFR part 20) and § 514.11(e)(2)(ii) (21

CFR 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 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 in 21 CFR Part 520

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 part 520 is amended as follows:

PART 520—ORAL DOSAGE FORM

NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 520 continues to read as follows:

Authority: Sec. 512 of the Federal Food,

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

2. Section 520.2043 is amended by

revising paragraph (b)(2) to read as

follows:

§ 520.2043 Pyrantel pamoate suspension.

* * * * *

(b) * * *

(2) Sponsors. See No. 000069 for use

of 2.27 and 4.54 milligrams per

milliliter product. See No. 011615 for

use of 2.27 milligrams per milliliter

product.

* * * * *

Dated: May 15, 1996.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 96–14647 Filed 6–10–96; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Parts 520, 556, and 558

Animal Drugs, Feeds, and Related

Products; Fenbendazole-Containing

Animal Drug and Feed Products

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 three supplemental new

animal drug applications (NADA’s) filed

by Hoechst-Roussel Agri-Vet Co. The

supplemental NADA’s expand use of

fenbendazole-containing suspension,

paste, and medicated animal feed

products to include use in dairy cattle

of breeding age for the removal and

control of gastrointestinal parasites and

lungworm. They also provide for the

establishment of a safe concentration

and tolerance for fenbendazole residues

in milk of treated dairy cattle and no

requirement for discard of milk from the

animals.

EFFECTIVE DATE: June 11, 1996.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary

Medicine (HFV–135), Food and Drug

Administration, 7500 Standish Place,

Rockville, MD 20855, 301–594–1643.

SUPPLEMENTARY INFORMATION: HoechstRoussel Agri-Vet Co., Rt. 202–206

North, P.O. Box 2500, Somerville, NJ

08876–1258, is the sponsor of NADA’s

which cover the following

fenbendazole-containing animal drug

and medicated feed products: 128–620

for 10 percent suspension, 132–872 for

10 percent paste, and 137–600 for 20

percent Type A medicated article, 0.5

percent pelleted top dressing, and 35

percent free-choice mineral feed. The

firm holds approvals for use of the

products in beef and dairy cattle not of

breeding age for the removal and control

of gastrointestinal parasites and

lungworm (as provided for in

§§ 520.905a, 520.905c, and 558.258 (21

CFR 520.905a, 520.905c, and 558.258)).

The firm has submitted supplements to

the NADA’s providing for expanding

use of the drug products to include use

in dairy cattle of breeding age for the

same uses currently approved for the

above-mentioned production classes.

Safe concentrations for total

fenbendazole residues in edible cattle

tissues, a tolerance for parent

fenbendazole in cattle liver (21 CFR

556.275), and a safe withdrawal time for

treated beef cattle were established

based on data and information

submitted with the original NADA 128–

620. Based on the evaluation of data

generated by additional studies

submitted with these supplements, the

agency is establishing a safe

concentration and tolerance for

fenbendazole residues in milk of treated

dairy cattle. Also, based on the data, no

discard of milk (zero milk withdrawal)

is required and the slaughter
29478 Federal Register / Vol. 61, No. 113 / Tuesday, June 11, 1996 / Rules and Regulations

withdrawal time for treated dairy cattle

of breeding age is the same as that

established for beef cattle in the original

NADA 128–620.

Supplemental NADA’s 128–620 and

132–872 are approved as of March 28,

1996, and §§ 520.905a and 520.905c are

amended to reflect the approvals.

Supplemental NADA 137–600 is

approved as of (insert date of

publication in the Federal Register),

and § 558.258 is amended to reflect the

approval. The basis for the approvals is

discussed in the freedom of information

summaries.

Approval of NADA 137–600 is for use

of fenbendazole Type A medicated

article to make Type C medicated feed.

Fenbendazole is a Category II drug

which, as provided in 21 CFR 558.4,

requires an appproved Form FDA 1900

for making a Type C medicated feed.

Therefore, use of fenbendazole Type A

medicated articles to Type C medicated

feeds as in NADA 137–600 requires an

approved Form FDA 1900.

In accordance with the freedom of

information provisions of part 20 (21

CFR part 20) and § 514.11(e)(2)(ii) (21

CFR 514.11(e)(2)(ii)), summaries of

safety and effectiveness data and

information submitted to support

approval of these applications 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)), these

approvals for food-producing animals

do not qualify for exclusivity because

the supplemental applications do not

contain new clinical or field

investigations (other than

bioequivalence or residue studies) and

new human food safety studies (other

than bioequivalence or residue studies)

essential to the approvals and

conducted or sponsored by the

applicant.

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 520

Animal drugs.

21 CFR Part 556

Animal drugs, Foods.

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 parts 520, 556, and 558 are

amended as follows:

PART 520—ORAL DOSAGE FORM

NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 520 continues to read as follows:

Authority: Sec. 512 of the Federal Food,

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

§ 520.905a [Amended]

2. Section 520.905a Fenbendazole

suspension is amended in paragraph

(d)(2) by revising the paragraph heading

to read ‘‘Beef and dairy cattle’’ and in

paragraph (d)(2)(i)(B) by removing the

third sentence.

§ 520.905c [Amended]

3. Section 520.905c Fenbendazole

paste is amended in paragraph (d)(2) by

revising the paragraph heading to read

‘‘Beef and dairy cattle’’ and in

paragraph (d)(2)(iii) by removing the

third sentence.

PART 556—TOLERANCES FOR

RESIDUES OF NEW ANIMAL DRUGS

IN FOOD

4. The authority citation for 21 CFR

part 556 continues to read as follows:

Authority: Secs. 402, 512, 701 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 342, 360b, 371).

5. Section 556.275 is amended by

adding new paragraph (c) to read as

follows:

§ 556.275 Fenbendazole.

* * * * *

(c) Cattle milk. A safe concentration of

1.67 parts per million is established for

total fenbendazole residues. A tolerance

of 0.6 part per million is established

based on the fenbendazole sulfoxide

metabolite (marker residue).

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

6. The authority citation for 21 CFR

part 558 continues to read as follows:

Authority: Secs. 512, 701 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

360b, 371).

7. Section 558.258 is amended by

revising the introductory text of

paragraph (c)(2), by removing the last

sentence of paragraph (c)(2)(iii), by

revising the introductory text of

paragraph (c)(3) , and by removing the

fourth sentence of paragraph (c)(3)(iii) to

read as follows:

§ 558.258 Fenbendazole.

* * * * *

(c) * * *

(2) It is used in the feed of beef and

dairy cattle as follows:

* * * * *

(3) It is used in free-choice beef and

dairy cattle feed as follows:

* * * * *

Dated: May 28, 1996.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 96–14645 Filed 6–10–96; 8:45 am]

BILLING CODE 4160–01–F

Food and Drug Administration

21 CFR Part 522

Implantation or Injectable Dosage

Form New Animal Drugs; Ceftiofur

Hydrochloride Sterile Suspension

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 The

Upjohn Co. The NADA provides for use

of ceftiofur hydrochloride sterile

suspension for intramuscular injection

in swine for treatment and control of

certain forms of swine bacterial

respiratory disease.

EFFECTIVE DATE: June 11, 1996.

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: The

Upjohn Co., Kalamazoo, MI 49001, is

sponsor of NADA 140–890, which

provides for use of Excenel Sterile

Suspension (ceftiofur hydrochloride

equivalent to 50 milligrams (mg) per

milliliter ceftiofur). The NADA provides

for intramuscular injection in swine for

treatment and control of swine bacterial

respiratory disease (swine bacterial

pneumonia) associated with

Actinobacillus (Haemophilus)