Document ID: FDA-2013-N-0839-0001
Agency: fda
Document Type: Rule
Title: Withdrawal of Approval of New Animal Drug Applications; Quali-Tech Products, Inc.; Bambermycins; Pyrantel; Tylosin; Virginiamycin
Posted Date: 2013-08-23T04:00Z

[Federal Register Volume 78, Number 164 (Friday, August 23, 2013)]
[Rules and Regulations]
[Pages 52429-52430]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-20540]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, and 558

[Docket No. FDA-2013-N-0839]

New Animal Drugs; Withdrawal of Approval of New Animal Drug 
Applications; Diethylcarbamazine; Nicarbazin; Penicillin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect the withdrawal of approval of three new 
animal drug applications (NADAs) at the sponsors' request because the 
products are no longer manufactured or marketed.

DATES: This rule is effective September 3, 2013.

FOR FURTHER INFORMATION CONTACT: David Alterman, Center for Veterinary 
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-453-6843, email: david.alterman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Phibro Animal Health Corp., 65 Challenger 
Rd., 3d Floor, Ridgefield Park, NJ 07660 has requested that FDA 
withdraw approval of NADA 098-371 for use of nicarbazin, penicillin, 
and roxarsone in 3-way, combination drug Type C medicated feeds for 
broiler chickens and NADA 098-374 for use of nicarbazin and penicillin 
in 2-way, combination drug Type C medicated feeds for broiler chickens 
because the products are no longer manufactured or marketed. 
Accordingly, 21 CFR 558.366 and 558.460 are being amended to reflect 
the withdrawal of approval.
    R. P. Scherer North America, P.O. Box 5600, Clearwater, FL 33518 
has requested that FDA withdraw approval of NADA 123-116 for 
Diethylcarbamazine Citrate Capsules used in dogs for the prevention of 
heartworm disease because the product is no longer manufactured or 
marketed. Accordingly, 21 CFR 520.622d is being amended to reflect the 
withdrawal of approval.
    Following this withdrawal of approval, R. P. Scherer North America 
is no longer the sponsor of an approved application. Accordingly, 21 
CFR 510.600(c) is being amended to remove the entries for these firms.
    Elsewhere in this issue of the Federal Register, FDA gave notice 
that approval of NADA 098-371, NADA 098-374, and NADA 123-116, and all 
supplements and amendments thereto, is withdrawn. As provided in the 
regulatory text of this document, the animal drug regulations are 
amended to reflect these voluntary withdrawals of approval.
    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

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 520

    Animal drugs.

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 510, 
520, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

Sec.  510.600  [Amended]

0
2. In Sec.  510.600, in the table in paragraph (c)(1), remove the entry 
for ``R. P. Scherer North America''; and in the table in paragraph 
(c)(2), remove the entry for ``011014''.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

Sec.  520.622d  [Removed]

0
4. Remove Sec.  520.622d.

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

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

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

Sec.  558.366  [Amended]

0
6. In Sec.  558.366, in the table in paragraph (d), in the entry for 
``90.8 to 181.6 (0.01 to 0.02 pct)'', remove the

[[Page 52430]]

entries for ``Penicillin 2.4 to 50'' and ``Penicillin 2.4 to 50 and 
roxarsone 22.7 to 45.4''.

Sec.  558.460  [Amended]

0
7. In Sec.  558.460, remove and reserve paragraph (d)(2)(iv).

    Dated: August 19, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-20540 Filed 8-22-13; 8:45 am]
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