[Federal Register Volume 60, Number 150 (Friday, August 4, 1995)]
[Rules and Regulations]
[Pages 39846-39847]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-19091]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, and 558


Animal Drugs, Feeds, and Related Products; Piperazine Adipate 
Powder, Diprenorphine Hydrochloride Injection, Etorphine Hydrochloride 
Injection, and Certain Nitrofuran and Buquinolate 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 16 new 
animal drug applications (NADA's) held by Proctor & Gamble 
Pharmaceuticals, Inc., Happy Jack, Inc., and Lemmon Co. The NADA's 
provide for the use of piperazine adipate powder, diprenorphine 
hydrochloride (diprenorphine HCl) injection, etorphine HCl injection, 
certain nitrofuran dosage form products, and separately approved Type A 
medicated articles containing buquinolate or certain other drugs in 
manufacturing several Type C medicated feeds for chickens. In a notice 
published in the July 21, 1995, issue of the Federal Register, FDA is 
withdrawing approval of the NADA's.

EFFECTIVE DATE: August 14, 1995.

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 in the July 21, 1995, 
issue of the Federal Register (60 FR 37651), FDA is withdrawing 
approval of the following NADA's:

                                                                        
------------------------------------------------------------------------
  NADA No.             Drug name              Sponsor name and address  
------------------------------------------------------------------------
10-158.....  Furamazone, bismuth            Proctor & Gamble            
              subsalicylate bolus.           Pharmaceuticals, Inc., P.O.
                                             Box 191, Norwich, NY 13815.
10-358.....  Nitrofurantoin tablets and         Do.                     
              boluses.                                                  
12-291.....  Nitrofurantoin oral                Do.                     
              suspension.                                               
12-612.....  Nitrofurazone, nifuroxime,         Do.                     
              diperodon HCl ear solution.                               
34-716.....  Buquinolate..................      Do.                     
35-314.....  Buquinolate and bacitracin         Do.                     
              zinc.                                                     
35-315.....  Buquinolate, bacitracin zinc,      Do.                     
              and penicillin.                                           
35-317.....  Buquinolate and penicillin...      Do.                     
35-327.....  Buquinolate, bacitracin            Do.                     
              methylene disalicylate                                    
              (bacitracin MD), and                                      
              penicillin.                                               
35-329.....  Buquinolate and bacitracin MD      Do.                     
38-657.....  Buquinolate and                    Do.                     
              chlortetracycline.                                        
39-925.....  Buquinolate and roxarsone          Do.                     
              combination.                                              
39-926.....  Buquinolate and roxarsone....      Do.                     
41-744.....  Nitrofurantoin sodium              Do.                     
              injection.                                                
95-017.....  Etorphine HCl injection and    Lemmon Co., Sellersville, PA
              diprenorphine HCl injection.   18960.                     
115-580....  Piperazine adipate powder....  Happy Jack, Snow Hill, NC   
                                             28580.                     
------------------------------------------------------------------------

    The sponsors requested withdrawal of approval of the NADA's. This 
final rule removes 21 CFR 520.1560, 520.1560a, 520.1560b, 520.1801, 
520.1801a, and 522.1563; amends 21 CFR 522.723 and 522.883 to reflect 
the withdrawal of approval of these NADA's; removes and reserves 21 CFR 
524.1580a and 558.105; and amends 21 CFR 558.62, 558.128, 558.325, 
558.460, and 558.530.
    In addition, 21 CFR 510.600(c) is amended to remove the entries for 
Proctor & Gamble Pharmaceuticals, Inc., from the list of approved drug 
sponsors because it no longer holds any approved NADA's.

List of Subjects

21 CFR Part 510

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

21 CFR Parts 520, 522, and 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, 522, 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).

Sec. 510.600  [Amended]

    2. Section 510.600 is amended in the table in paragraph (c)(1) by 
removing the entry for ``Proctor & Gamble Pharmaceuticals, Inc.'' and 
in the table in paragraph (c)(2) by removing the entry for ``000149''.

[[Page 39847]]


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. 520.1560  [Removed]

    4. Section 520.1560 Nitrofurantoin oral dosage forms is removed.


Sec. 520.1560a  [Removed]

    5. Section 520.1560a Nitrofurantoin oral suspension is removed.


Sec. 520.1560b  [Removed]

    6. Section 520.1560b Nitrofurantoin tablets and boluses is removed.


Sec. 520.1801  [Removed]

    7. Section 520.1801 Piperazine adipate oral dosage forms is 
removed.


Sec. 520.1801a  [Removed]

    8. Section 520.1801a Piperazine adipate powder is removed.

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

    9. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

Sec. 522.723  [Amended]

    10. Section 522.723 Diprenorphine hydrochloride injection is 
amended in paragraph (c) by removing the phrase ``Nos. 010042 and 
000693'' and adding in its place the phrase ``No. 010042''.


Sec. 522.883  [Amended]

    11. Section 522.883 Etorphine hydrochloride injection is amended in 
paragraph (c) by removing the phrase ``Nos. 010042 and 000693'' and 
adding in its place the phrase ``No. 010042''.


Sec. 522.1563  [Removed]

    12. Section 522.1563 Nitrofurantoin sodium injection is removed.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

    13. 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. 524.1580a  [Removed]

    14. Section 524.1580a Nitrofurazone-nifuroxime-diperodon 
hydrochloride ear solution is removed and reserved.

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

    15. 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. 558.62  [Amended]

    16. Section 558.62 Arsanilic acid is amended by removing paragraph 
(c)(2)(v) and by redesignating paragraph (c)(2)(vi) as paragraph 
(c)(2)(v).


Sec. 558.105  [Removed]

    17. Section 558.105 Buquinolate is removed and reserved.


Sec. 558.128  [Amended]

    18. Section 558.128 Chlortetracycline is amended by removing and 
reserving paragraph (c)(5)(iii).


Sec. 558.325  [Amended]

    19. Section 558.325 Lincomycin is amended by removing and reserving 
paragraph (c)(3)(iv).


Sec. 558.460  [Amended]

    20. Section 558.460 Penicillin is amended by removing and reserving 
paragraph (c)(2)(v).


Sec. 558.530  [Amended]

    21. Section 558.530 Roxarsone is amended by removing and reserving 
paragraph (d)(3)(vii).

    Dated: July 13, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-19091 Filed 8-3-95; 8:45 am]
BILLING CODE 4160-01-F