Animal drugs, feeds, and related products: Sponsor name and address changes— Roche Vitamins, Inc.,

[Federal Register: May 21, 1998 (Volume 63, Number 98)]

[Rules and Regulations]

[Page 27844-27846]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr21my98-8]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 558

Animal Drugs, Feeds, and Related Products; Change of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 96 new animal drug applications (NADA's) and 4 abbreviated animal drug applications (ANADA's) from Hoffmann-La Roche, Inc., to Roche Vitamins, Inc.

EFFECTIVE DATE: May 21, 1998.

FOR FURTHER INFORMATION CONTACT: Thomas J. McKay, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0213.

SUPPLEMENTARY INFORMATION: Hoffmann-La Roche, Inc., Nutley, NJ 07110, has informed FDA that it has transferred the ownership of and all rights and interests in approved NADA's and ANADA's to Roche Vitamins, Inc., 45 Waterview Blvd., Parsippany, NJ 07054-1298. Accordingly, the agency is amending the regulations in 21 CFR parts 510 and 558 to reflect the change of sponsor. The agency is also amending the regulations in Sec. 510.600(c)(1) and (c)(2) by removing Hoffmann-La Roche, Inc., because the sponsor no longer sponsors any approved new animal drugs, and by alphabetically adding an entry for Roche Vitamins, Inc.

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.

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

2. Section 510.600 is amended in the table in paragraph (c)(1) by removing the entry for ``Hoffmann-La Roche, Inc.,'' and by alphabetically adding an entry for ``Roche Vitamins, Inc.,'' and in the table in paragraph (c)(2) by removing the entry for ``000004'' and by numerically adding an entry for ``063238'' to read as follows:

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

   * * * * *

   (c) * * *

   (1) * * *

   [[Page 27845]]

   Firm name and address

   Drug labeler code

   *

   *

   *

   *

   *

   *

   *

   Roche Vitamins, Inc., 45 Waterview Blvd., Parsippany, 063238

   NJ 07054-1298

   *

   *

   *

   *

   *

   *

   *

   (2) * * *

   Drug labeler code

   Firm name and address

   *

   *

   *

   *

   *

   *

   *

   063238

   Roche Vitamins, Inc., 45 Waterview Blvd., Parsippany, NJ 07054-1298

   *

   *

   *

   *

   *

   *

   *

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

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

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

   Sec. 558.58 [Amended]

3. Section 558.58 Amprolium and ethopabate is amended in the table in paragraph (d)(1)(iii), under the ``Limitations'' column in the entries for ``Bacitracin 4 to 50'', ``Bacitracin 5 to 35 plus roxarsone 34 (0.00375%)'', and ``Bacitracin 10 to 50 plus roxarsone 15.4 to 45.4 (0.0017% to 0.005%)'' by removing ``000004 and 046573'' and adding in its place ``046573 and 063238'', and under the ``Sponsor'' column by removing ``000004'' wherever it appears and adding in its place ``063238''.

   Sec. 558.78 [Amended]

4. Section 558.78 Bacitracin zinc is amended in paragraph (a)(2), in the table in paragraph (d)(1), under the ``Sponsor'' column, and in paragraph (d)(2)(ii) by removing ``000004'' wherever it appears and adding in its place ``063238''.

   Sec. 558.95 [Amended]

5. Section 558.95 Bambermycins is amended in paragraph (d)(1)(xi)(b) and (d)(1)(xii)(b) by removing ``Nos. 012799 and 000004'' and adding in its place ``Nos. 012799 and 063238''.

   Sec. 558.120 [Amended]

6. Section 558.120 Carbarsone (not U.S.P.) is amended in paragraph (d)(1)(iii)(b) by removing ``Nos. 000004 and 046573'' and adding in its place ``Nos. 046573 and 063238''.

   Sec. 558.128 [Amended]

7. Section 558.128 Chlortetracycline is amended in paragraph (a)(1) by removing ``000004'' and adding in its place ``063238'', and in the table in paragraph (d)(1), under the ``Sponsors'' column, by removing ``000004'' wherever it appears and adding in its place ``063238''.

   Sec. 558.145 [Amended]

8. Section 558.145 Chlortetracycline, procaine penicillin, and sulfamethazine is amended in paragraph (a)(1) by removing ``000004 and 046573'' and adding in its place ``046573 and 063238'', and in paragraph (a)(2) by removing ``000004'' and adding in its place ``063238''.

   Sec. 558.175 [Amended]

9. Section 558.175 Clopidol is amended in paragraph (d)(1)(iii)(b) and (d)(1)(iv)(b) by removing ``Nos. 000004 and 046573'' and adding in its place ``Nos. 046573 and 063238''.

   Sec. 558.195 [Amended]

10. Section 558.195 Decoquinate is amended in the table in paragraph (d) in the entry for ``27.2 (0.003 pct.), Roxarsone 11 to 45 (0.0012-0.005 pct.) plus Bacitracin 12 to 50'' under the ``Limitations'' column by removing ``Nos. 000004, 011716, and 046573'' and adding in its place ``Nos. 011716, 046573, and 063238''.

    Sec. 558.305 [Amended]

11. Section 558.305 Laidlomycin propionate potassium is amended in paragraph (a) by removing ``000004'' and adding in its place ``063238''.

    Sec. 558.311 [Amended]

12. Section 558.311 Lasalocid is amended in paragraphs (b)(2), (b)(3), (b)(4), (b)(5), (b)(6), and (b)(7) by removing ``000004'' and adding in its place ``063238''; in the table in paragraph (e)(1)(v) under the ``Limitations''column by removing ``000004'' and adding in its place ``063238'' and under the ``Sponsors'' column by removing ``000007'' and adding in its place ``063238''; and in paragraphs (e)(2)(v) and (e)(3)(v) by removing ``000004'' and adding in its place ``063238''.

    Sec. 558.340 [Amended]

13. Section 558.340 Maduramicin ammonium is amended in paragraph (a) by removing ``000004'' and adding in its place ``063238''.

    Sec. 558.342 [Amended]

14. Section 558.342 Melengestrol acetate is amended in paragraph (d)(3)(ii) by removing ``000004'' and adding in its place ``063238'', and in paragraph (d)(6)(ii) by removing ``Nos. 000004, 000009, and 000986'', and adding in its place ``Nos. 000009, 000986, and 063238''.

    Sec. 558.355 [Amended]

15. Section 558.355 Monensin is amended in paragraphs (b)(8), (b)(9), (f)(1)(iv)(b), (f)(1)(v)(b), (f)(1)(xiv)(b), (f)(1)(xv)(b) by removing ``000004'' and adding in its place ``063238'', and in paragraph (f)(1)(xvi)(b) by removing ``Nos. 000004 and 046573'' and adding in its place ``Nos. 046573 and 063238''.

    Sec. 558.515 [Amended]

16. Section 558.515 Robenidine hydrochloride is amended in paragraphs (a) and (d)(1)(vi)(b) by removing ``000004'' and adding in its place ``063238''.

    [[Page 27846]]

    Sec. 558.550 [Amended]

17. Section 558.550 Salinomycin is amended in paragraphs (a)(1), (d)(1)(vii)(c), (d)(1)(xv)(c), and (d)(1)(xvi)(c) by removing ``000004'' and adding in its place ``063238'', and in paragraph (d)(1)(ix)(c) by removing ``Nos. 000004 and 046573'' and adding in its place ``Nos. 046573 and 063238''.

    Sec. 558.575 [Amended]

18. Section 558.575 Sulfadimethoxine, ormetoprim is amended in paragraphs (a)(1) and (a)(2) by removing ``000004'' and adding in its place ``063238''.

    Sec. 558.582 [Amended]

19. Section 558.582 Sulfamerazine is amended in paragraph (a) by removing ``000004'' and adding in its place ``063238''.

    Sec. 558.600 [Amended]

20. Section 558.600 Tiamulin is amended in paragraph (c)(4)(ii) by removing ``000004 and 046573'' and adding in its place ``046573 and 063238''.

    Dated: May 8, 1998. Andrew J. Beaulieu, Acting Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.

    [FR Doc. 98-13161Filed5-20-98; 8:45 am]

    BILLING CODE 4160-01-F