[Federal Register Volume 63, Number 21 (Monday, February 2, 1998)]
[Rules and Regulations]
[Pages 5254-5255]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-2410]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 524, and 558

[Docket No. 97N-0508]


Animal Drugs, Feeds, and Related Products

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 remove those portions reflecting approval of eight 
new animal drug applications (NADA's) for which the sponsors have 
requested withdrawal of approval. The NADA's provide for use of 
products which are no longer made or marketed. In a notice published 
elsewhere in this issue of the Federal Register, FDA is withdrawing 
approval of the NADA's.

EFFECTIVE DATE: February 12, 1998.

FOR FURTHER INFORMATION CONTACT: Mohammad I. Sharar, Center for 
Veterinary Medicine (HFV-216), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1722.

SUPPLEMENTARY INFORMATION: In a notice published elsewhere in this 
issue of the Federal Register, FDA has withdrawn approval of the 
following NADA's:

                                                                        
------------------------------------------------------------------------
                                                       Sponsor name and 
           NADA No.                  Drug name             address      
------------------------------------------------------------------------
38-247........................  Hygromycin B Type A  Mountaire Feeds,   
                                 medicated article.   Inc., 124 East    
                                                      Fifth, P.O. Box   
                                                      5391, North Little
                                                      Rock, AR 72119,   
                                                      formerly Mountaire
                                                      Vitamins, Inc.,   
                                                      400 North Poplar  
                                                      St., P.O. Box     
                                                      9210, North Little
                                                      Rock, AR 72119    
44-013........................  Tylosin Type A       do.                
                                 medicated article.                     
65-273........................  Chloramphenicol      Zenith Goldline    
                                 capsules, USP.       Pharmaceuticals,  
                                                      Inc., 140 Legrand 
                                                      Ave., Northvale,  
                                                      NJ 07647, formerly
                                                      Zenith            
                                                      Laboratories,     
                                                      Inc., 50 Williams 
                                                      Dr., Ramsey, NJ   
                                                      07446             
65-456........................  Tetracycline HCl     do.                
                                 capsules, USP.                         
95-736........................  Hygromycin B Type A  Mountaire Feeds,   
                                 medicated article.   Inc.              
98-895........................  Starbar GX-118       Wellmark           
                                 Topical              International,    
                                 (phosmet)(prolate).  1000 Tower Lane,  
                                                      Bensenville, IL   
                                                      60106, formerly   
                                                      Sandoz Agro, Inc.,
                                                      1300 East Touhy   
                                                      Ave., Des Plaines,
                                                      IL 60018          
137-138.......................  Pyrantel tartrate    Mountaire Feeds,   
                                 Type A medicated     Inc.              
                                 article.                               
139-239.......................  Banminth (pyrantel   Growmark, Inc., 950
                                 tartrate) Type A     North Meridian    
                                 medicated article.   St., Indianapolis,
                                                      IN 46204-3909,    
                                                      formerly at 1701  
                                                      Towanda Ave.,     
                                                      Bloomington, IL   
                                                      61701             
------------------------------------------------------------------------

    The sponsors requested withdrawal of approval of the NADA's under 
21 CFR 514.115(d) because the products are no longer made or marketed.
    The regulations are amended in 21 CFR 520.390b(b)(1), 
520.2345a(b)(4), 524.1742(b), 558.274(a)(6) and (c)(1)(i), 
558.485(a)(21) and (a)(25), and 558.625(b)(84) to remove those portions 
which reflect approval of these NADA's.
    Also, with withdrawal of approval of these NADA's, these firms are 
no longer sponsors of approved NADA's. Therefore, 21 CFR 510.600(c)(1) 
and (c)(2) are amended to remove entries for the firms.

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Parts 520 and 524

    Animal drugs.

21 CFR Part 558

    Animal drugs, Animal feeds.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
the 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: 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

[[Page 5255]]

removing the entries for ``Growmark, Inc.,'' ``Mountaire Vitamins, 
Inc.,'' ``Sandoz Agro, Inc.,'' and ``Zenith Laboratories, Inc.,'' and 
in the table in paragraph (c)(2) by removing the entries for 
``000172'', ``011536'', ``020275'', and ``043734''.

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. 520.390b   [Amended]

    4. Section 520.390b Chloramphenicol capsules is amended in 
paragraph (b)(1) by removing ``000172''.


Sec. 520.2345a   [Amended]

    5. Section 520.2345a Tetracycline hydrochloride capsules is amended 
by removing paragraph (b)(4).

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: 21 U.S.C. 360b.


Sec. 524.1742   [Amended]

    7. Section 524.1742 N-(Mercaptomethyl) phthalimide S-(O,O-dimethyl 
phosphorodithioate) emulsifiable liquid is amended in paragraph (b) by 
removing the phrase ``and 011536''.

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

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

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


Sec. 558.274   [Amended]

    9. Section 558.274 Hygromycin B is amended by removing and 
reserving paragraph (a)(6) and in the table in paragraph (c)(1)(i), 
under the ``sponsor'' column, by removing ``043734''.


Sec. 558.485   [Amended]

    10. Section 558.485 Pyrantel tartrate is amended by removing and 
reserving paragraphs (a)(21) and (a)(25).


Sec. 558.625   [Amended]

    11. Section 558.625 Tylosin is amended by removing and reserving 
paragraph (b)(84).

    Dated: January 8, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-2410 Filed 1-30-98; 8:45 am]
BILLING CODE 4160-01-F