[Federal Register Volume 63, Number 98 (Thursday, May 21, 1998)]
[Rules and Regulations]
[Pages 27844-27846]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-13161]
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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.
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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]]
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Firm name and address Drug labeler code
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* * * * * *
*
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
* * * * * *
*
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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. 98-13161 Filed 5-20-98; 8:45 am]
BILLING CODE 4160-01-F
