[Federal Register Volume 79, Number 127 (Wednesday, July 2, 2014)]
[Rules and Regulations]
[Pages 37622-37623]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-15274]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2014-N-0002]


New Animal Drugs for Use in Animal Feeds; Chlortetracycline and 
Sulfamethazine; Chlortetracycline; Procaine Penicillin; and 
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 the withdrawal of approval of those parts 
of a new animal drug application (NADA) for a three-way, fixed-ratio, 
combination drug Type A medicated article that pertain to use of the 
procaine penicillin component for growth promotion indications in swine 
and to reflect the reformulation of the Type A medicated article as a 
two-way, fixed-ratio, combination drug product without penicillin.

DATES: This rule is effective July 2, 2014.

FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8341, email: 
[email protected].

SUPPLEMENTARY INFORMATION: Zoetis Inc. (Zoetis), 333 Portage St., 
Kalamazoo, MI 49007 has requested that FDA withdraw approval of those 
parts of NADA 035-688 for AUREOMIX Granular 500 (chlortetracycline, 
procaine penicillin, and sulfamethazine) Type A medicated article that 
pertain to use of the procaine penicillin component for growth 
promotion indications in swine. Zoetis requested voluntary withdrawal 
of approval of these indications for use because AUREOMIX Granular 500 
Type A medicated article is no longer manufactured.
    With the withdrawal of approval of the production indications for 
procaine penicillin, the product approved under NADA 035-688 was 
reformulated as AUREOMIX S Granular (chlortetracycline and 
sulfamethazine) Type A Medicated Article, a two-way, fixed-ratio, 
combination drug Type A medicated article that does not contain 
penicillin procaine and is not labeled for production indications.
    The Agency has determined under 21 CFR 25.33(a)(3) and (g) that 
these actions are categorically excluded from the requirement to submit 
an environmental assessment or an environmental impact statement 
because they are of a type that do not individually or cumulatively 
have a significant effect on the human environment.
    Elsewhere in this issue of the Federal Register, FDA gave notice 
that the approval of those parts of NADA 035-688 pertaining to the 
procaine penicillin component indications for growth promotion and 
increased feed efficiency in swine is withdrawn, effective July 2, 
2014. As provided for in the regulatory text of this document, the 
animal drug regulations are amended to reflect this partial withdrawal 
of approval and subsequent product reformulation.
    NADA 035-688 was identified as being affected by guidance for 
industry (GFI) 213, ``New Animal Drugs and New Animal Drug 
Combination Products Administered in or on Medicated Feed or Drinking 
Water of Food-Producing Animals: Recommendations for Drug Sponsors for 
Voluntarily Aligning Product Use Conditions With GFI 209'', 
December 2013.
    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 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 Director of the Center for Veterinary Medicine, 21 
CFR part 558 is amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
1. The authority citation for 21 CFR part 558 continues to read as 
follows:

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

0
2. Revise Sec.  558.140 to read as follows:


Sec.  558.140  Chlortetracycline and sulfamethazine.

    (a) Specifications. Type A medicated articles containing:
    (1) 35 grams (g) per pound (/lb) each, chlortetracycline and 
sulfamethazine.
    (2) 40 g/lb each, chlortetracycline and sulfamethazine.
    (b) Sponsors. See sponsors numbers in Sec.  510.600(c) of this 
chapter as follow:
    (1) Nos. 054771 and 048164 for use of product described in 
paragraph (a)(1) as in paragraph (d)(1) of this section.
    (2) No. 054771 for use of product described in paragraph (a)(2) as 
in paragraph (d)(2) of this section.
    (c) Related tolerances. See Sec. Sec.  556.150 and 556.670 of this 
chapter.
    (d) Conditions of use--(1) Cattle. It is used in feed for beef 
cattle as follows:
    (i) Amount. 350 milligrams per head per day each, chlortetracycline 
and sulfamethazine.
    (ii) Indications for use. Aid in the maintenance of weight gains in 
the presence of respiratory disease such as shipping fever.
    (iii) Limitations. Feed for 28 days; withdraw 7 days prior to 
slaughter. A withdrawal period has not been established for this 
product in pre-ruminating calves. Do not use in calves to be processed 
for veal.
    (2) Swine. It is used in swine feed as follows:
    (i) Amount. 100 g/ton each, chlortetracycline and sulfamethazine.

[[Page 37623]]

    (ii) Indications for use. For reduction of the incidence of 
cervical abscesses; treatment of bacterial swine enteritis 
(salmonellosis or necrotic enteritis caused by Salmonella choleraesuis 
and vibrionic dysentery); prevention of these diseases during times of 
stress; and maintenance of weight gains in the presence of atrophic 
rhinitis.
    (iii) Limitations. Feed as the sole ration. Withdraw 15 days prior 
to slaughter.


Sec.  558.145  [Amended]

0
3. In Sec.  558.145, in paragraph (a)(2), remove ``Nos. 048164 and 
054771'' and in its place add ``No. 048164''.

    Dated: June 25, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-15274 Filed 6-30-14; 11:15 am]
BILLING CODE 4164-01-P