[Federal Register Volume 71, Number 51 (Thursday, March 16, 2006)]
[Rules and Regulations]
[Pages 13541-13543]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-2554]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, and 529


New Animal Drugs; Change of Sponsor's Drug Labeler Code

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of drug labeler code for Med-
Pharmex, Inc.

DATES: This rule is effective March 16, 2006.

FOR FURTHER INFORMATION CONTACT: Charles Eastin, Center for Veterinary 
Medicine (HFV-210), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-276-9077, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: FDA has found that the animal drug 
regulations do not reflect the correct drug labeler code for Med-
Pharmex, Inc. Accordingly, the agency is amending the regulations in 21 
CFR 510.600, 520.1044a, 520.1195, 520.1484, 520.1485, 520.2220a, 
520.2345d, 522.900, 524.1044b, 524.1044f, 524.1044g, 524.1193, 
524.1443, 524.1580b, 524.1580e, 524.1600a, 524.2481, and 529.1044b to 
correct this error. In addition, 21 CFR 524.1044b, 524.1044f, 524.1443, 
and 524.2481 are being revised to reflect a current format.
    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 Parts 520, 522, 524, and 529

    Animal drugs.

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 510, 
520, 522, 524, and 529 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.


0
2. Amend Sec.  510.600 in the table in paragraph (c)(1) in the entry 
for ``Med-Pharmex, Inc.'' by removing ``051259'' and by adding in its 
place ``054925''; and in the table in paragraph (c)(2) by removing the 
entry for ``051259'' and by

[[Page 13542]]

numerically adding a new entry for ``054925'' to read as follows:


Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                 Firm name and address
------------------------------------------------------------------------
                                * * * * *
054925                       Med-Pharmex, Inc., 2727 Thompson Creek Rd.,
                              Pomona, CA 91767-1861
                                * * * * *
------------------------------------------------------------------------

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.  520.1044a  [Amended]

0
4. In paragraph (b) of Sec.  520.1044a, remove ``051259'' and add in 
its place ``054925''.


Sec.  520.1195  [Amended]

0
5. In paragraph (b)(2) of Sec.  520.1195, remove ``051259'' and add in 
its place ``054925''.


Sec.  520.1484  [Amended]

0
6. In paragraph (b)(1) of Sec.  520.1484, remove ``051259'' and add in 
its place ``054925''.


Sec.  520.1485  [Amended]

0
7. In paragraph (b) of Sec.  520.1485, remove ``051259'' and add in its 
place ``054925''.


Sec.  520.2220a  [Amended]

0
8. In paragraphs (a)(1) and (a)(2) of Sec.  520.2220a, remove 
``051259'' and add in its place ``054925''.


Sec.  520.2345d  [Amended]

0
9. In paragraphs (b)(5), (d)(1)(iii), and (d)(2)(iii) of Sec.  
520.2345d, remove ``051259'' and add in its place ``054925''.

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

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

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


Sec.  522.900  [Amended]

0
11. In paragraph (b)(1) of Sec.  522.900, remove ``051259'' and add in 
its place ``054925''.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
12. The authority citation for 21 CFR part 524 continues to read as 
follows:

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

0
13. Revise Sec.  524.1044b to read as follows:


Sec.  524.1044b  Gentamicin sulfate, betamethasone valerate otic 
solution.

    (a) Specifications. Each milliliter of solution contains gentamicin 
sulfate equivalent to 3 milligrams (mg) gentamicin base and 
betamethasone valerate equivalent to 1 mg betamethasone alcohol.
    (b) Sponsors. See Nos. 000061 and 054925 in Sec.  510.600(c) of 
this chapter.
    (c) Conditions of use--(1) Amounts and indications for use--(i) For 
the treatment of acute and chronic otitis externa caused by bacteria 
sensitive to gentamicin in dogs, instill three to eight drops of 
solution into the ear canal twice daily for 7 to 14 days.
    (ii) For the treatment of infected superficial lesions caused by 
bacteria sensitive to gentamicin in dogs and cats, apply a sufficient 
amount of the drug to cover the treatment area twice daily for 7 to 14 
days.
    (2) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
14. Revise Sec.  524.1044f to read as follows:


Sec.  524.1044f  Gentamicin sulfate, betamethasone valerate topical 
spray.

    (a) Specifications. Each milliliter of spray contains gentamicin 
sulfate equivalent to 0.57 milligram (mg) gentamicin base and 
betamethasone valerate equivalent to 0.284 mg betamethasone.
    (b) Sponsors. See Nos. 000061 and 054925 in Sec.  510.600(c) of 
this chapter.
    (c) Conditions of use in dogs--(1) Amount. Hold bottle upright 3 to 
6 inches from the lesion and depress the sprayer head twice. Administer 
two spray actuations two to four times daily for 7 days.
    (2) Indications for use. For the treatment of infected superficial 
lesions caused by bacteria sensitive to gentamicin.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.


Sec.  524.1044g  [Amended]

0
15. In paragraph (b)(2) of Sec.  524.1044g, remove ``051259'' and add 
in its place ``054925''.


Sec.  524.1193  [Amended]

0
16. In paragraph (b)(2) of Sec.  524.1193, remove ``051259, 051311'' 
and add in its place ``051311, 054925''.

0
17. Revise Sec.  524.1443 to read as follows:


Sec.  524.1443  Miconazole.

    (a) Specifications--(1) Each gram of cream contains miconazole 
nitrate equivalent to 20 milligrams miconazole base.
    (2) Each gram of lotion or spray contains miconazole nitrate 
equivalent to 1 percent miconazole base.
    (b) Sponsors. See Sec.  510.600(c) of this chapter for use as in 
paragraph (c) of this section:
    (1) No. 000061 for use of cream, lotion, and spray;
    (2) Nos. 054925 and 058829 for use of lotion and spray.
    (c) Conditions of use in dogs and cats--(1) Amount. Apply once 
daily by rubbing into or spraying a light covering on the infected site 
and the immediate surrounding vicinity. Continue treatment for 2 to 4 
weeks until infection is completely eradicated as determined by 
appropriate laboratory examination.
    (2) Indications for use. For topical treatment of infections caused 
by Microsporum canis, Microsporum gypseum, and Trichophyton 
mentagrophytes.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.


Sec.  524.1580b  [Amended]

0
18. In paragraph (b)(1) of Sec.  524.1580b, remove ``051259'' and add 
in its place ``054925''.


Sec.  524.1580e  [Amended]

0
19. In paragraph (b) of Sec.  524.1580e, remove ``051259'' and add in 
its place ``054925''.


Sec.  524.1600a  [Amended]

0
20. In paragraph (b) of Sec.  524.1600a, remove both occurrences of 
``051259, and 053501'' and add in their places ``053501, and 054925''.

0
21. Revise Sec.  524.2481 to read as follows:


Sec.  524.2481  Triamcinolone cream.

    (a) Specifications. The vanishing cream contains 0.1 percent 
triamcinolone acetonide.
    (b) Sponsor. See Nos. 053501 and 054925 in Sec.  510.600(c) of this 
chapter.

[[Page 13543]]

    (c) Conditions of use in dogs--(1) Amount. Rub into affected areas 
two to four times daily for 4 to 10 days.
    (2) Indications for use. As an anti-inflammatory, antipruritic, and 
antiallergic agent for topical treatment of allergic dermatitis and 
summer eczema.
    (3) Limitations. Federal law restricts this drug to use only by or 
on the order of a licensed veterinarian.

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
22. The authority citation for 21 CFR part 529 continues to read as 
follows:

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


Sec.  529.1044b  [Amended]

0
23. In paragraph (b) of Sec.  529.1044b, remove ``Sponsor. See Nos. 
000061 and 051259'' and add in its place ``Sponsors. See Nos. 000061 
and 054925''.

    Dated: March 7, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 06-2554 Filed 3-15-06; 8:45 am]
BILLING CODE 4160-01-S