[Federal Register Volume 60, Number 175 (Monday, September 11, 1995)]
[Rules and Regulations]
[Pages 47051-47053]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-22369]



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[[Page 47052]]


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, and 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 a change of sponsor name from Premiere Agri 
Technologies, Inc., to ADM Animal Health & Nutrition Div., and a change 
of sponsor of several new animal drug applications (NADA's) from 
wholly-owned subsidiaries to ADM Animal Health & Nutrition Div.

EFFECTIVE DATE: September 11, 1995.

FOR FURTHER INFORMATION CONTACT: Benjamin A. Puyot, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1646.

SUPPLEMENTARY INFORMATION: ADM Animal Health & Nutrition Div., P.O. Box 
2508, Fort Wayne, IN 46801-2508, has informed FDA of a change of 
sponsor name in approved NADA 91-582 (Tylosin) from Premiere Agri 
Technologies, Inc. ADM Animal Health & Nutrition Div., has also 
informed FDA that it has assumed sponsorship of the following NADA's 
previously owned by its subsidiaries:

                                                                        
------------------------------------------------------------------------
                                               Former sponsor name and  
  NADA No.             Drug name                       address          
------------------------------------------------------------------------
48-480a....  Chlortetracycline............  Feed Specialties Co., Inc., 
                                             1877 NE. 58th Ave., Des    
                                             Moines, IA 50313.          
65-256.....  Chlortetracycline                  Do.                     
              hydrochloride.                                            
107-957....  Tylosin and sulfamethazine...      Do.                     
108-484....  Tylosin and sulfamethazine...      Do.                     
110-045....  Tylosin......................  Good-Life, Division of      
                                             Central Soya Co., Inc.,    
                                             Good-Life Dr., P.O. Box    
                                             687, Effingham, IL 62401.  
110-439....  Hygromycin B.................  Feed Specialties Co., Inc.  
118-877....  Pyrantel tartrate............      Do.                     
128-411....  Tylosin and sulfamethazine...  Good-Life, Division of      
                                             Central Soya Co., Inc.     
131-956....  Tylosin and sulfamethazine...  MAC-PAGE, Inc., 1600 South  
                                             Wilson Ave., Dunn, NC      
                                             28334.                     
132-448....  Bambermycins.................  Feed Specialties Co., Inc.  
133-490....  Pyrantel tartrate............  MAC-PAGE, Inc.              
140-842....  Hygromycin B.................      Do.                     
------------------------------------------------------------------------

    Accordingly, the agency is amending the regulations in 21 CFR 
510.600(c)(1) and (c)(2) by removing Feed Specialties, Co., Inc., Good-
Life, Division of Central Soya Co., and MAC-PAGE, Inc., because the 
firms are no longer the sponsors of any approved NADA's. The agency is 
also amending the drug labeler codes in 21 CFR 520.445b, 558.95, 
558.274, 558.485, 558.625, and 558.630 providing for use of the above 
mentioned veterinary drug products. The sponsor labeler code of 
Premiere Agri Technologies, Inc., is being retained for the new 
sponsor.

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: 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).


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 entry for ``Premiere Agri Technologies, Inc.,'' 
and by alphabetically adding a new entry for ``ADM Animal Health & 
Nutrition Div., by removing the entries for ``Feed Specialties Co., 
Inc., Good-Life, Division of Central Soya Co., and MAC-PAGE, Inc.''; 
and in the table in paragraph (c)(2) in the entry for ``012286'' by 
removing the sponsor name ``Premiere Agri Technologies, Inc.,'' and 
adding in its place ``ADM Animal Health & Nutrition Div.,'' and by 
removing the entries for ``017274, 021810, and 047427''.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    3. The authority citation of 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. 520.445b  [Amended]

    4. Section 520.445b Chlortetracycline powder (chlortetracycline 
hydrochloride or chlortetracycline bisulfate) is amended in paragraphs 
(b) and (d)(4)(iii)(C) by removing ``017274'' and adding in its place 
``012286''.

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

    5. 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]

    6. Section 558.95 Bambermycins is amended in paragraph (a)(4) by 
removing the entry for ``017274'' and numerically adding ``012286''.


Sec. 558.274  [Amended]

    7. Section 558.274 Hygromycin B is amended in paragraph (a)(7) and 
in the table in paragraphs (c)(1)(i) and (c)(1)(ii) by removing the 
entry for ``047427'' and numerically adding ``012286''.


Sec. 558.485  [Amended]

    8. Section 558.485 Pyrantel tartrate is amended in paragraph 
(a)(11) by 

[[Page 47053]]
removing ``017274'' and adding in its place ``012286''.


Sec. 558.625  [Amended]

    9. Section 558.625 Tylosin is amended in paragraph (b)(52) by 
removing ``021810'' and adding in its place ``012286''.


Sec. 558.630-  [Amended]

    10. Section 558.630 Tylosin and sulfamethazine is amended in 
paragraphs (b)(3) and (b)(8) by removing ``017274'' and adding 
``012286'' and in paragraph (b)(10) by removing ``017274, 021810, and 
047427'' and numerically adding ``012286''.

    Dated: August 31, 1995.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine
[FR Doc. 95-22369 Filed 9-8-95; 8:45 am]
BILLING CODE 4160-01-F