00-22949. Animal Drugs, Feeds, and Related Products; Technical Amendment

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

SUMMARY:

The Food and Drug Administration (FDA) is updating the animal drug regulations to add Triple “F”, Inc., to the list of sponsors of approved animal drug applications, and to add the drug labeler code (DLC) number for ADM Animal Health & Nutrition Division (ADM) to the list of approvals for bambermycins. These corrections amend the animal drug regulations to reflect currently approved new animal drug applications (NADA's).

DATES:

This rule is effective September 7, 2000.

FOR FURTHER INFORMATION CONTACT:

Judith M. O'Haro, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-3664.

SUPPLEMENTARY INFORMATION:

FDA has found that the April 1, 2000, edition of Title 21, Parts 500 to 599 of the Code of Federal Regulations (CFR) does not fully reflect several approved NADA's. Triple “F”, Inc., is the holder of approved new animal drug applications (NADA's). The former DLC number for Triple “F”, Inc., 011490, is listed in the regulation for bambermycins in § 558.95 (21 CFR 558.95) and for pyrantel tartrate in 21 CFR 558.485, but the sponsor and DLC are not listed under sponsors of approved applications in § 510.600(c) (21 CFR 510.600(c)). In a document published in the Federal Register of April 1, 1999 (64 FR 15683), the listing for Triple “F,” Inc., was inadvertently deleted from § 510.600(c). ADM is a holder of approved NADA 132-448 for the use of bambermycins, but is not listed in the bambermycins regulations (§ 558.95) by its current DLC. ADM is listed in § 558.95(a)(4) by its former DLC, 012286. This DLC was changed to 017519 in the Federal Register of May 21, 1997 (62 FR 27691), but the change was not reflected in § 558.95. At this time, FDA is amending the regulations to correct these errors in §§ 510.600(c) and 558.95(a).

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 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 and 558 are amended as follows:

PART 510—NEW ANIMAL DRUGS

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.

2. Section 510.600 is amended in the table in paragraph (c)(1) by adding alphabetically an entry for “Triple ‘F’,” Inc.” and in the table in paragraph (c)(2) by adding numerically an entry for “011490” to read as follows:

§ 510.600

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

* * * * *

(c) * * *

(1) * * *

Firm name and address	Drug labeler code
*          *          *          *          *          *          *
Triple “F”, Inc., 10104 Douglas Ave., Des Moines, IA 50322	011490
*          *          *          *          *          *          *

(2) * * *

Drug labeler code	Firm name and address
*          *          *          *          *          *          *
011490	Triple “F”, Inc., 10104 Douglas Ave., Des Moines, IA 50322
*          *          *          *          *          *          *

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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

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

§ 558.95

[Amended]

4. Section 558.95 Bambermycins is amended in paragraph (a)(4) by removing “012286” and by numerically adding “017519,”.

Dated: August 23, 2000.

Claire M. Lathers,

Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.