81 FR 63053 - New Animal Drugs for Use in Animal Feeds; Chlortetracycline and Sulfamethazine; Chlortetracycline, Procaine Penicillin, and Sulfamethazine

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 178 (September 14, 2016)

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 3-way, fixed-ratio, combination drug Type A medicated article that pertain to use of the procaine penicillin component for production indications in swine and to reflect the reformulation of the Type A medicated article as a 2- way, fixed-ratio, combination drug product without penicillin.

[Federal Register Volume 81, Number 178 (Wednesday, September 14, 2016)]
[Rules and Regulations]
[Pages 63053-63054]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-21985]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2016-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 3-way, fixed-ratio, 
combination drug Type A medicated article that pertain to use of the 
procaine penicillin component for production indications in swine and 
to reflect the reformulation of the Type A medicated article as a 2-
way, fixed-ratio, combination drug product without penicillin.

DATES: This rule is effective September 14, 2016.

FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-402-0817, email: 
[email protected].

SUPPLEMENTARY INFORMATION: Pharmgate LLC (Pharmgate), 1015 Ashes Dr., 
Suite 102, Wilmington, NC 28405 has requested that FDA withdraw 
approval of those parts of NADA 138-934 for PENNCHLOR SP 500 
(chlortetracycline, procaine penicillin, and sulfamethazine) Type A 
medicated article that pertain to use of the procaine penicillin 
component for the production indications of growth promotion and 
increased feed efficiency in swine. Pharmgate requested voluntary 
withdrawal of approval of these indications for use because PENNCHLOR 
SP 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 138-934 was 
reformulated as PENNCHLOR S 40/40 (chlortetracycline and 
sulfamethazine) Type A Medicated Article, a 2-way, fixed-ratio, 
combination drug Type A medicated article that does not contain 
penicillin procaine and is not labeled for production indications.

[[Page 63054]]

    The Agency has determined under 21 CFR 25.33(a) that this action is 
categorically excluded from the requirement to submit an environmental 
assessment or an environmental impact statement because it is of a type 
that does 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 138-934 pertaining to the 
procaine penicillin component indications for growth promotion and 
increased feed efficiency in swine is withdrawn, effective September 
14, 2016. 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 138-934 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 part 558 continues to read as follows:

    Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.


Sec.  558.140  [Amended]

0
2. In Sec.  558.140, in paragraph (b)(2), remove ``No. 054771'' and in 
its place add ``Nos. 054771 and 069254''.


Sec.  558.145  [Amended]

0
3. In Sec.  558.145, remove and reserve paragraph (a)(2).

    Dated: September 6, 2016.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2016-21985 Filed 9-13-16; 8:45 am]
BILLING CODE 4164-01-P