[Federal Register Volume 61, Number 80 (Wednesday, April 24, 1996)]
[Rules and Regulations]
[Pages 18081-18082]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10019]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs; 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 the change of sponsor for 33 approved new
animal drug applications (NADA's) from American Cyanamid Co. to
Hoffmann-La Roche, Inc. In addition, the agency is amending its
regulations to correct some errors. This action is being taken to
clarify and improve the accuracy of the animal drug regulations.
EFFECTIVE DATE: April 24, 1996.
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: American Cyanamid Co., Berdan Ave., Wayne,
NJ 07470, has informed FDA that it has transferred ownership of, and
all rights and interests in, the following approved NADA's to Hoffmann-
La Roche, Inc., Nutley, NJ 07110-1199.
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NADA no. Ingredients
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33-950.................................... Sulfamerazine.
35-688................................... Chlortetracycline Calcium
Complex, Penicillin G
Procaine, Sulfamethazine
35-805.................................... Chlortetracycline
Hydrochloride,
Sulfamethazine.
36-361.................................... Chlortetracycline Calcium
Complex, Amprolium ,
Ethopabate, Sodium Sulfate.
41-647.................................... Sulfamethazine,
Chlortetracycline Calcium
Complex.-
41-648.................................... Sulfamethazine,
Chlortetracycline Calcium
Complex.
41-649................................... Sulfamethazine,
Chlortetracycline Calcium
Complex.
41-650.................................... Sulfamethazine,
Chlortetracycline Calcium
Complex.
41-651.................................... Sulfamethazine,
Chlortetracycline Calcium
Complex.
41-652.................................... Sulfamethazine,
Chlortetracycline Calcium
Complex.
41-653.................................... Sulfamethazine,
Chlortetracycline Calcium
Complex.
41-654.................................... Sulfamethazine,
Chlortetracycline Calcium
Complex.
46-920.................................... Bacitracin zinc.
48-486.................................... Robenidine Hydrochloride.
48-761.................................... Chlortetracycline Calcium
Complex.
48-762.................................... Chlortetracycline Calcium
Complex.
48-763.................................... Chlortetracycline Calcium
Complex.
55-040.................................... Chlortetracycline
Hydrochloride.
92-507.................................... Chlortetracycline Calcium
Complex, Robenidine
Hydrochloride.
93-372.................................... Chlortetracycline
Hydrochloride.
95-546.................................... Robenidine Hydrochloride,
Roxarsone.
96-933.................................... Bacitracin zinc, Robenidine
Hydrochloride.
97-085.................................... Robenidine Hydrochloride,
Bacitracin MD.
105-758................................... Bacitracin zinc, Amprolium,
Ethopabate, Roxarsone.
114-794................................... Bacitracin zinc, Amprolium,
Ethopabate.
121-553................................... Monensin Sodium,
Chlortetracycline
Hydrochloride.
123-154................................... Monensin Sodium, Bacitracin
ZN, Roxarsone.
136-484................................... Bacitracin zinc, Carbasone.
139-075................................... Maduramicin ammonium.
139-190................................... Bacitracin zinc,
Salinomycin, Sodium
Roxarsone.
139-235................................... Bacitracin zinc,
Salinomycin, Sodium
Roxarsone.
140-859................................... Chlortetracycline Calcium
Complex, Salinomycin
Sodium.
140-867................................... Chlortetracycline Calcium
Complex, Roxarsone,
Salinomycin Sodium.
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Accordingly, the agency is amending the regulations in part 558 (21
CFR part 558) to reflect the change of sponsor. FDA is also correcting
some errors that have been incorporated into the agency's codified
regulations. The errors in the regulations are as follows:
In Sec. 558.95(b)(1)(xiii)(b) the reference to the limitations
cited in (e)(1)(vii)(b) is incorrect; the correct cite is ``paragraph
(b)(1)(vii)(b) of this section''. In Sec. 558.355(b)(9) the cited
reference ``paragraphs (f)(1)(xv), (xvi), and (xvii)'' incorrectly
listed the sponsor, ``(xvii)'' should refer to sponsor 012799. The
agency is correcting this error by removing ``(xvii)'' from
Sec. 558.355(b)(9) and adding sponsor 012799 to Sec. 558.355(b)(10).
List of Subjects in 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 part 558 is
amended as follows:
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR part 558 continues to read as
follows:
[[Page 18082]]
Authority: Secs. 512, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b, 371).
Sec. 558.58 [Amended]
2. Section 558.58 Amprolium and ethopabate is amended in the table
in paragraph (d)(1), in the entry for (iii), under the ``Limitations''
and the ``Sponsor'' columns by removing ``010042'' wherever it appears
and adding in its place ``000004''.
Sec. 558.78 [Amended]
3. Section 558.78 Bacitracin zinc is amended in paragraph (a)(2),
and in the table in paragraph (d)(1) in the entries for (i), (ii), (v),
and (vi) under the ``Sponsor'' column, and in paragraph (d)(2)(ii) by
removing ``010042'' and adding in its place ``000004''.
Sec. 558.95 [Amended]
4. Section 558.95 Bambermycins is amended in paragraph
(b)(1)(xiii)(b) by removing ``(e)(1)(vii)(b)'' and adding in its place
``(b)(1)(vii)(b)''.
Sec. 558.120 [Amended]
5. Section 558.120 Carbarsone (not U.S.P.) is amended in paragraph
(c)(1)(iii)(b) by removing ``010042'' and adding in its place
``000004''.
Sec. 558.128 [Amended]
6. Section 558.128 Chlortetracycline is amended in paragraph (a) by
removing ``010042'' and adding in its place ``000004''.
Sec. 558.145 [Amended]
7. Section 558.145 Chlortetracycline, procaine penicillin, and
sulfamethazine is amended in paragraphs (a)(1) and (a)(2) by removing
``010042'' and adding in its place ``000004''.
Sec. 558.340 [Amended]
8. Section 558.340 Maduramicin ammonium is amended in paragraph (a)
by removing ``010042'' and adding in its place ``000004''.
Sec. 558.355 [Amended]
9. Section 558.355 is amended in paragraphs (b)(8), (b)(9),
(f)(1)(iv)(b), (f)(1)(v)(b), (f)(1)(xiv)(b), (f)(1)(xv)(b), and
(f)(1)(xvi)(b) by removing ``010042'' and adding in its place
``000004'', in paragraph (b)(9) by removing ``, (xvi), and (xvii)'' and
adding in its place ``and (xvi)'', and by adding paragraph (b)(10) to
read as follows:
Sec. 558.355 Monensin.
* * * * *
(b) * * *
(10) To 012799: 45 and 60 grams per pound, as monensin sodium,
paragraph (f)(1)(xvii) of this section.
* * * * *
Sec. 558.515 [Amended]
10. Section 558.515 Robenidine hydrochloride is amended in
paragraphs (a), (d)(1)(iii)(b), (d)(1)(iv)(b), and (d)(1)(v)(b) by
removing ``010042'' and adding in its place ``000004'' and in paragraph
(d)(1)(vi)(b) by removing ``No. 011716'' and adding in its place ``Nos.
000004 and 011716''.
Sec. 558.550 [Amended]
11. Section 558.550 Salinomycin is amended in paragraphs
(b)(1)(vii)(c), (b)(1)(ix)(c), (b)(1)(xv)(c), and (b)(1)(xvi)(c) by
removing ``010042'' and adding in its place ``000004''.
Sec. 558.582 [Amended]
12. Section 558.582 Sulfamerazine is amended in paragraph (a) by
removing ``010042'' and adding in its place ``000004''.
Dated: April 4, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 96-10019 Filed 4-23-96; 8:45 am]
BILLING CODE 4160-01-F
