[Federal Register Volume 62, Number 205 (Thursday, October 23, 1997)]
[Rules and Regulations]
[Pages 55159-55160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-28011]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, and 558


New Animal Drugs 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 three new animal 
drug applications (NADA's) and three abbreviated new animal drug 
applications (ANADA's) from Wade-Jones Co., Inc., and its manufacturing 
subsidiary Arkansas Micro Specialties, Inc., to Alpharma Inc. The 
agency is also correcting a final rule that appeared in the Federal 
Register of June 20, 1996 (61 FR 31398).

EFFECTIVE DATE: October 23, 1997.
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: Wade-Jones Co., Inc., 409 North Bloomington, 
Lowell, AR 72745, and its manufacturing subsidiary Arkansas Micro 
Specialties, Inc., P.O. Box 308, Highway 71 North, Lowell, AR 72745, 
has informed FDA that it has transferred ownership of, and all rights 
and interests in, the following approved NADA's and ANADA's to Alpharma 
Inc., One Executive Dr., Fort Lee, NJ 07024.

                                                                                                                
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                  NADA/ANADA                                               Ingredient                           
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065-140                                        Tetracycline Hcl Soluble Powder                                  
140-443                                        Hygromycin B Type A Medicated Articles                           
140-578                                        Tetracycline Hcl Soluble Powder                                  
200-122                                        Penicillin G Potassium Soluble Powder                            
200-130                                        Neomycin Sulfate Soluble Powder                                  
200-233                                        Lincomycin Hcl Soluble Powder                                    
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    The agency is amending parts 510, 520, and 558 (21 CFR parts 510, 
520 and 558) to reflect the change of sponsor. The agency is amending 
Sec. 510.600(c)(1) and (c)(2) to remove the sponsor name for Wade-Jones 
Co., Inc., and Arkansas Micro Specialties, Inc., because the firm no 
longer is the holder of any approved NADA's.
    The agency is also correcting a final rule that appeared in the 
Federal Register of June 20, 1996 (61 FR 31398). This document amended 
the animal drug regulations to reflect approval of a supplemental NADA 
filed by The Upjohn Co., and two supplemental ANADA's, one filed by 
Pfizer, Inc., and the other filed by Rhone Merieux, Inc, respectively. 
In Sec. 520.1484(c)(3), the drug labeler code (047864) for Wade-Jones 
Co., Inc., was inadvertently omitted from the document. After that 
document published, Wade-Jones Co., Inc., transferred ownership of and 
all rights and interest to Alpharma Inc. Accordingly, this document 
adds a drug labeler code for Alpharma Inc. and, thereby, corrects the 
error in the final rule (61 FR 31398).

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 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, 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  [Amended]

    2. Section 510.600 Names, addresses, and drug labeler codes of 
sponsors of approved applications is amended in the table in paragraph 
(c)(1) by removing the entries for ``Arkansas Micro Specialties, 
Inc.''and ``Wade-Jones'' and in the table in paragraph (c)(2) by 
removing the entries ``047863'' and ``047864''.


[[Page 55160]]



PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    3. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

Sec. 520.1484  [Amended]

    4. Section 520.1484 Neomycin sulfate soluble powder is amended in 
paragraph (b) by removing ``047864'' and adding in its place ``046573'' 
and in paragraph (c)(3) by revising the words in the last sentence 
``for sponsors 000009, 000069, 050604'' to read as ``for sponsors 
000009, 000069, 046573, 050604''.

Sec. 520.1696b  [Amended]

    5. Section 520.1696b Penicillin G potassium in drinking water is 
amended in paragraph (b) by removing ``047864, and'' and adding in its 
place ``046573,''.

Sec. 520.2345d  [Amended]

    6. Section 520.2345d Tetracycline hydrochloride soluble powder is 
amended in paragraphs (a)(1), (d)(1)(iii), and (d)(2)(iii) by removing 
``047864'', and adding in its place ``046573'' and in paragraph (a)(4) 
by removing ``047863'' and adding in its place ``046573''.

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

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

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

Sec. 558.274  [Amended]

    8. Section 558.274 Hygromycin B is amended in paragraph (a)(8) by 
removing ``047863'' and in the table in paragraphs (c)(1)(i) and 
(c)(1)(ii), under the ``sponsor'' column, by removing ``047863'' and 
numerically adding ``046573''.

    Dated: September 9, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 97-28011 Filed 10-22-97; 8:45 am]
BILLING CODE 4160-01-F