[Federal Register Volume 70, Number 106 (Friday, June 3, 2005)]
[Rules and Regulations]
[Pages 32488-32489]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-11031]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520, 522, and 558


New Animal Drugs; Change of Sponsor

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 a change of sponsor for 16 approved new 
animal drug applications (NADAs) from Purina Mills, Inc., to Virbac AH, 
Inc.

DATES: This rule is effective June 3, 2005.

FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Purina Mills, Inc., P.O. Box 66812, St. 
Louis, MO 63166-6812, has informed FDA that it has transferred 
ownership of, and all rights and interest in, the following 16 approved 
NADAs to Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137:

                                Table 1.
------------------------------------------------------------------------
    NADA  No.        21 CFR  Section               Trade Name
------------------------------------------------------------------------
011-779            522.940              Purina Pigemia 100
------------------------------------------------------------------------
013-214            558.274              Purina Hygromix-Swine
------------------------------------------------------------------------
013-663            520.100a             Purina Liquid Amprol
------------------------------------------------------------------------
040-205            520.2380a            Purina Horse Wormer Medicated
------------------------------------------------------------------------
042-116            558.185              Purina 6-Day Worm-Kill Feed
------------------------------------------------------------------------
042-660            558.630              Purina Pork-Plus Medicated
------------------------------------------------------------------------
043-387            558.625              Purina Hog Plus II
------------------------------------------------------------------------
046-700            558.365              Statyl
------------------------------------------------------------------------
049-729            520.2261a            Purina Sulfa
------------------------------------------------------------------------
097-258            558.485              Purina Ban Worm For Pigs
------------------------------------------------------------------------
099-767            558.630              Purina Tylan 40 Plus
                                         Sulfamethazine
------------------------------------------------------------------------
113-748            520.1182             Purina Oral Pigemia
------------------------------------------------------------------------
132-574            558.325              Purina Check-R-Ton LI
------------------------------------------------------------------------
135-941            558.485              Check-E-Ton BM
------------------------------------------------------------------------
136-116            520.905d             Purina Worm-A-Rest Litter Pack
------------------------------------------------------------------------
140-869            520.1840             Purina Bloat Block; Purina Saf-T-
                                         Block BG
------------------------------------------------------------------------

    Accordingly, the agency is amending the regulations in parts 520, 
522, and 558 (21 CFR parts 520, 522, and 558). Sections 520.100a, 
520.905d, 520.1182, 520.1840, 520.2261a, 520.2380a, 522.940, 558.185, 
558.274, 558.325, 558.365, 558.485, 558.625, and 558.630 will reflect 
the transfer of ownership and a current format. Sections 520.1182 and 
522.940 are being revised to reflect a current format.
    In addition, Sec.  520.2380a is being revised to correct the 
citation for the approved indications for Virbac AH's thiabendazole 
dewormer approved under NADA 040-205. The citation was corrected in the 
Federal Register of March 3, 1976 (41 FR 9149), but an error was 
reintroduced in the 1978 printing of the Code of Federal Regulations. 
This action is being taken to improve the accuracy of the regulations.
    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 Parts 520 and 522

    Animal drugs.

21 CFR Part 558

    Animal drugs, Animal feeds.

0
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, 
522, and 558 are amended as follows:

[[Page 32489]]

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

0
2. Section 520.100a is amended by revising paragraph (b) to read as 
follows:


Sec.  520.100a  Amprolium drinking water.

* * * * *
    (b) Sponsors. See Nos. 050604 and 051311 in Sec.  510.600(c) of 
this chapter.
* * * * *


Sec.  520.905d  [Amended]

0
3. Section 520.905d is amended in paragraph (b)(2) by removing 
``017800'' and by adding in its place ``051311''.

0
4. Section 520.1182 is revised to read as follows:


Sec.  520.1182  Iron dextran suspension.

    (a) Specifications. Each milliliter (mL) of suspension contains 
55.56 milligrams (mg) iron as ferric hydroxide in complex with a low 
molecular weight dextran.
    (b) Sponsor. See No. 051311 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in swine--(1) Amount. Administer 100 mg (1.8 
mL) orally by automatic dose dispenser.
    (2) Indications for use. For the prevention of iron deficiency 
anemia in baby pigs.
    (3) Limitations. Treat each pig within 24 hours of farrowing.


Sec.  520.1840  [Amended]

0
5. Section 520.1840 is amended in paragraph (b)(2) by removing 
``017800'' and by adding in its place ``051311''.


Sec.  520.2261a  [Amended]

0
6. Section 520.2261a is amended in paragraph (a) by removing ``017800'' 
and by adding in its place ``051311''.

0
7. Section 520.2380a is amended by revising the section heading and 
paragraph (c) to read as follows:


Sec.  520.2380a  Thiabendazole top dressing and mineral protein block.

* * * * *
    (c) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
use as in paragraph (e) of this section.
    (1) No. 051311 for use as in paragraph (e)(1)(i) of this section.
    (2) No. 050604 for use as in paragraph (e)(1)(ii) of this section.
    (3) No. 021930 for use as in paragraph (e)(2) of this section.
* * * * *

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
8. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

0
9. Section 522.940 is revised to read as follows:


Sec.  522.940  Ferric oxide injection.

    (a) Specifications. Each milliliter (mL) contains colloidal ferric 
oxide equivalent to 100 milligrams of iron with a low-viscosity 
dextrin.
    (b) Sponsors. See Nos. 051311 and 053501 in Sec.  510.600(c) of 
this chapter.
    (c) Conditions of use in swine--(1) For prevention of iron 
deficiency anemia, administer 1 mL by intramuscular injection at 2 to 5 
days of age. Dosage may be repeated at 2 weeks of age.
    (2) For treatment of iron deficiency anemia, administer 1 to 2 mL 
by intramuscular injection at 5 to 28 days of age.

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

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

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

0
11. Section 558.185 is amended by revising paragraph (b)(2); and by 
adding paragraph (b)(3) to read as follows:


Sec.  558.185  Coumaphos.

* * * * *
    (b) * * *
    (2) No. 017800 for use of Type A medicated articles containing 11.2 
percent coumaphos as in paragraph (e)(1) of this section.
    (3) No. 051311 for use of Type A medicated articles containing 1.12 
percent coumaphos as in paragraph (e)(1) of this section.
* * * * *


Sec.  558.274  [Amended]

0
12. Section 558.274 is amended in paragraph (a)(2) by removing 
``043733'' and by adding in its place ``Nos. 043733 and 051311''; and 
in the table in paragraph (c)(1)(ii) in the ``Sponsor'' column by 
adding in numerical sequence ``051311''.


Sec.  558.325  [Amended]

0
13. Section 558.325 is amended in paragraph (a)(13) by removing 
``017800'' and by adding in its place ``051311''; and in paragraphs 
(d)(2)(ii)(1), (d)(2)(iii)(1), and (d)(2)(iv) in the table in the 
``Sponsor'' column by removing ``017800'' and by adding in numerical 
sequence ``051311''.


Sec.  558.365  [Amended]

0
14. Section 558.365 is amended in paragraph (a) by removing ``017800'' 
and by adding in its place ``No. 051311''.


Sec.  558.485  [Amended]

0
15. Section 558.485 is amended in paragraph (b)(5) by removing 
``017800'' and by adding in its place ``051311''.


Sec.  558.625  [Amended]

0
16. Section 558.625 is amended in paragraph (b)(5) by removing 
``017800'' and by adding in its place ``No. 051311''.


Sec.  558.630  [Amended]

0
17. Section 558.630 is amended in paragraph (b)(5) by removing 
``017800'' and by adding in its place ``No. 051311''.

    Dated: May 11, 2005.
Steven D. Vaughn,
Director, Office of New animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 05-11031 Filed 6-2-05; 8:45 am]
BILLING CODE 4160-01-S