[Federal Register Volume 59, Number 123 (Tuesday, June 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-15602]
[Federal Register: June 28, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 510, 520, 524, and 558
New Animal Drugs; Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect the correct drug labeler code for Hess &
Clark, Inc. The agency codified an incorrect drug labeler code. This
action corrects that error.
EFFECTIVE DATE: June 28, 1994.
FOR FURTHER INFORMATION CONTACT: Judy M. O'Haro, Center for Veterinary
Medicine (HFV-238), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1737.
SUPPLEMENTARY INFORMATION: In a document published in the Federal
Register of February 3, 1981 (46 FR 10462), the animal drug regulations
were amended to reflect a change of sponsor for certain NADA's from
Hess & Clark, Division of Rhone-Poulenc, Inc., to Hess & Clark, Inc.
This sponsor change necessitated a new entry in 21 CFR 510.600 for Hess
& Clark, Inc. However, the February 3, 1981, final rule codified an
incorrect drug labeler code for the firm. This document corrects that
error.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 520
Animal drugs.
21 CFR Part 524
Animal drugs.
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,
520, 524, 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: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the
Federal Food, Drug, and Cosmetic Act (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) in
the entry for ``Hess & Clark, Inc.,'' by removing the drug labeler code
``011801'' and adding in its place ``050749,'' and in the table in
paragraph (c)(2) by removing the entry for ``011801,'' and by
numerically adding a new entry for ``050749'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(2) * * *
------------------------------------------------------------------------
Drug
labeler Firm name and address
code
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*****
050749..... Hess & Clark, Inc., Seventh and Orange Sts., Ashland, OH
44805
*****
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PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
3. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
Sec. 520.2325a [Amended]
4. Section 520.2325a Sulfaquinoxaline drinking water is amended in
paragraph (c) by removing ``011801'' and adding in its place
``050749''.
Sec. 520.2325b [Amended]
5. Section 520.2325b Sulfaquinoxaline drench is amended in
paragraph (c) by removing ``011801'' and adding in its place
``050749''.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
6. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
Sec. 524.1580b [Amended]
7. Section 524.1580b Nitrofurazone ointment is amended in paragraph
(b) by removing ``011801'' and adding in its place ``050749''.
Sec. 524.1580c [Amended]
8. Section 524.1580c Nitrofurazone soluble powder is amended in
paragraph (b) by removing ``011801'' and adding in its place
``050749''.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
9. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: Secs. 512, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b, 371).
Sec. 558.95 [Amended]
10. Section 558.95 Bambermycins is amended in paragraphs
(b)(1)(x)(b) and (b)(1)(xi)(b) by removing ``011801'' and adding in its
place ``050749''.
Sec. 558.311 [Amended]
11. Section 558.311 Lasalocid is amended in the table in paragraph
(e)(1), in entry (ii), in the ``Limitations'' column for the
combinations with ``Roxarsone 45.4,'' ``Roxarsone 45.4 plus
bambermycins 1,'' ``Roxarsone 45.4 plus lincomycin 2.0,'' ``Roxarsone
45.4 plus bacitracin 10 to 25,'' and ``Roxarsone 45.4 plus bacitracin
10 or 30,'' by removing ``011801'' and adding in its place ``050749''.
Sec. 558.355 [Amended]
12. Section 558.355 Monensin is amended in paragraphs
(f)(1)(xii)(b) and (f)(1)(xx)(b) by removing ``011801'' and adding in
its place ``050749''.
Sec. 558.550 [Amended]
13. Section 558.550 Salinomycin is amended in paragraph
(b)(1)(ii)(c) by removing ``011801'' and adding in its place
``050749''.
Sec. 558.586 [Amended]
14. Section 558.586 Sulfaquinoxoline is amended in paragraph (a) by
removing ``011801'' and adding in its place ``050749''.
Dated: June 21, 1994.
George A. Mitchell,
Director, Office of Surveillance and Compliance, Center for Veterinary
Medicine.
[FR Doc. 94-15602 Filed 6-27-94; 8:45 am]
BILLING CODE 4160-01-F
