-
Start Preamble
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Final rule; technical amendment.
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.
Start Further InfoFOR 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: charles.eastin@fda.hhs.gov.
End Further Info End Preamble Start Supplemental InformationSUPPLEMENTARY 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.
Start List of SubjectsList 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
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:
End Amendment Part Start PartPART 510—NEW ANIMAL DRUGS
End Part Start Amendment Part1. The authority citation for 21 CFR part 510 continues to read as follows:
End Amendment Part Start Amendment Part2. Amend § 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 Start Printed Page 13542numerically adding a new entry for “054925” to read as follows:
End Amendment PartNames, addresses, and drug labeler codes of sponsors of approved applications.* * * * *(c) * * *
(2) * * *
Start PartDrug 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
End Part Start Amendment Part3. The authority citation for 21 CFR part 520 continues to read as follows:
End Amendment PartStart Amendment Part[Amended]4. In paragraph (b) of § 520.1044a, remove “051259” and add in its place “054925”.
End Amendment PartStart Amendment Part[Amended]5. In paragraph (b)(2) of § 520.1195, remove “051259” and add in its place “054925”.
End Amendment PartStart Amendment Part[Amended]6. In paragraph (b)(1) of § 520.1484, remove “051259” and add in its place “054925”.
End Amendment PartStart Amendment Part[Amended]7. In paragraph (b) of § 520.1485, remove “051259” and add in its place “054925”.
End Amendment PartStart Amendment Part[Amended]8. In paragraphs (a)(1) and (a)(2) of § 520.2220a, remove “051259” and add in its place “054925”.
End Amendment PartStart Amendment Part[Amended]9. In paragraphs (b)(5), (d)(1)(iii), and (d)(2)(iii) of § 520.2345d, remove “051259” and add in its place “054925”.
End Amendment Part Start PartPART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
End Part Start Amendment Part10. The authority citation for 21 CFR part 522 continues to read as follows:
End Amendment PartStart Amendment Part[Amended]11. In paragraph (b)(1) of § 522.900, remove “051259” and add in its place “054925”.
End Amendment Part Start PartPART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
End Part Start Amendment Part12. The authority citation for 21 CFR part 524 continues to read as follows:
End Amendment Part Start Amendment Part13. Revise § 524.1044b to read as follows:
End Amendment PartGentamicin 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 § 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.
Start Amendment Part14. Revise § 524.1044f to read as follows:
End Amendment PartGentamicin 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 § 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.
Start Amendment Part[Amended]15. In paragraph (b)(2) of § 524.1044g, remove “051259” and add in its place “054925”.
End Amendment PartStart Amendment Part[Amended]16. In paragraph (b)(2) of § 524.1193, remove “051259, 051311” and add in its place “051311, 054925”.
End Amendment Part Start Amendment Part17. Revise § 524.1443 to read as follows:
End Amendment PartMiconazole.(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 § 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.
Start Amendment Part[Amended]18. In paragraph (b)(1) of § 524.1580b, remove “051259” and add in its place “054925”.
End Amendment PartStart Amendment Part[Amended]19. In paragraph (b) of § 524.1580e, remove “051259” and add in its place “054925”.
End Amendment PartStart Amendment Part[Amended]20. In paragraph (b) of § 524.1600a, remove both occurrences of “051259, and 053501” and add in their places “053501, and 054925”.
End Amendment Part Start Amendment Part21. Revise § 524.2481 to read as follows:
End Amendment PartTriamcinolone cream.(a) Specifications. The vanishing cream contains 0.1 percent triamcinolone acetonide.
(b) Sponsor. See Nos. 053501 and 054925 in § 510.600(c) of this chapter.
Start Printed 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.
Start PartPART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
End Part Start Amendment Part22. The authority citation for 21 CFR part 529 continues to read as follows:
End Amendment PartStart Amendment Part[Amended]23. In paragraph (b) of § 529.1044b, remove “ Sponsor. See Nos. 000061 and 051259” and add in its place “Sponsors. See Nos. 000061 and 054925”.
End Amendment Part Start SignatureEnd Signature End Supplemental InformationDated: 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
Document Information
- Effective Date:
- 3/16/2006
- Published:
- 03/16/2006
- Department:
- Food and Drug Administration
- Entry Type:
- Rule
- Action:
- Final rule; technical amendment.
- Document Number:
- 06-2554
- Dates:
- This rule is effective March 16, 2006.
- Pages:
- 13541-13543 (3 pages)
- PDF File:
- 06-2554.pdf
- CFR: (18)
- 21 CFR 510.600
- 21 CFR 520.1195
- 21 CFR 520.1484
- 21 CFR 520.1485
- 21 CFR 522.900
- More ...