[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                                                                
------------------------------------------------------------------------
                                  *****                                 
050749.....  Hess & Clark, Inc., Seventh and Orange Sts., Ashland, OH   
              44805                                                     
                                 *****                                  
------------------------------------------------------------------------

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