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contains regulatory documents having general

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Rules and Regulations Federal Register

49649 

Vol. 76, No. 155 

Thursday, August 11, 2011 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 520 

[Docket No. FDA–2011–N–0003] 

Oral Dosage Form New Animal Drugs; 

Change of Sponsor; Chlortetracycline; 

Sulfamethazine 

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 five new animal 

drug applications (NADAs) from Fort 

Dodge Animal Health, Division of 

Wyeth Holdings Corp., a wholly owned 

subsidiary of Pfizer, Inc., to Boehringer 

Ingelheim Vetmedica, Inc. 

DATES: This rule is effective August 11, 

2011. 

FOR FURTHER INFORMATION CONTACT: 

Steven D. Vaughn, Center for Veterinary 

Medicine (HFV–100), Food and Drug 

Administration, 7520 Standish Pl., 

Rockville, MD 20855, 240–276–8300, 

e-mail: steven.vaughn@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Fort 

Dodge Animal Health, Division of 

Wyeth Holdings Corp., a wholly owned 

subsidiary of Pfizer, Inc., 235 East 42d 

St., New York, NY 10017 has informed 

FDA that it has transferred ownership 

of, and all rights and interest in, five 

approved NADAs (NADAs 055–012, 

055–018, 055–039, 065–071, and 065– 

440) to Boehringer Ingelheim 

Vetmedica, Inc., 2621 North Belt 

Highway, St. Joseph, MO 64506–2002. 

Accordingly, the Agency is amending 

the regulations in 21 CFR part 520 to 

reflect the transfer of ownership. 

This rule does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a rule of ‘‘particular applicability.’’ 

Therefore, it is not subject to the 

congressional review requirements in 

5 U.S.C. 801–808. 

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: 21 U.S.C. 360b. 

■ 2. Revise § 520.445 to read as follows: 

§ 520.445 Chlortetracycline and 

sulfamethazine powder. 

(a) Specifications. Each pound of 

soluble powder contains 

chlortetracycline bisulfate equivalent to 

102.4 grams (g) of chlortetracycline 

hydrochloride and sulfamethazine 

bisulfate equivalent to 102.4 g of 

sulfamethazine. 

(b) Sponsor. See No. 000010 in 

§ 510.600(c) of this chapter. 

(c) Related tolerances. See §§ 556.150 

and 556.670 of this chapter. 

(d) Conditions of use in swine. 

Administer in drinking water as follows: 

(1) Amount. 250 milligrams (mg) of 

chlortetracycline and 250 mg of 

sulfamethazine per gallon. 

(2) Indications for use. For the 

prevention and treatment of bacterial 

enteritis; as an aid in the reduction of 

the incidence of cervical abscesses; and 

as an aid in the maintenance of weight 

gains in the presence of bacterial 

enteritis and atrophic rhinitis. 

(3) Limitations. Use as the sole source 

of chlortetracycline and sulfonamide. 

Not to be used for more than 28 

consecutive days. Withdraw 15 days 

before slaughter. 

§ 520.445a [Removed] 

■ 3. Remove § 520.445a. 

§ 520.445b [Redesignated as § 520.441] 

■ 4. Redesignate § 520.445b as 

§ 520.441. 

■ 5. Amend newly redesignated 

§ 520.441 by revising paragraphs (b)(2), 

(b)(3), and the last sentence of paragraph 

(d)(4)(iii)(C) to read as follows: 

§ 520.441 Chlortetracycline powder. 

* * * * * 

(b) * * * 

(2) Nos. 046573 and 000010 for use as 

in paragraph (d) of this section. 

(3) No. 000010 for use as in 

paragraphs (d)(4)(i)(A), (d)(4)(i)(B), and 

(d)(4)(ii) through (d)(4)(iv) of this 

section. 

* * * * * 

(d) * * * 

(4) * * * 

(iii) * * * 

(C) * * * For Nos. 000010 and 

021930, do not slaughter animals for 

food within 5 days of treatment. For No. 

000010, do not slaughter animals for 

food within 24 hours of treatment. 

* * * * * 

§ 520.445c [Redesignated as § 520.443] 

■ 6. Redesignate § 520.445c as 

§ 520.443. 

■ 7. Amend newly redesignated 

§ 520.443 as follows: 

■ a. Revise paragraphs (a) and (b); 

■ b. Remove paragraph (d); 

■ c. Redesignate paragraph (e) as 

paragraph (d); and 

■ d. Revise the heading for newly 

redesignated paragraph (d) introductory 

text. 

The revisions read as follows: 

§ 520.443 Chlortetracycline tablets and 

boluses. 

(a) Specifications. Each tablet/bolus 

contains 25, 250, or 500 milligrams (mg) 

chlortetracycline hydrochloride. 

(b) Sponsor. See No. 000010 in 

§ 510.600(c) of this chapter. 

* * * * * 

(d) Conditions of use in calves—* * * 

* * * * * 

Dated: August 4, 2011. 

Elizabeth Rettie, 

Deputy Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 2011–20404 Filed 8–10–11; 8:45 am] 

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