[Federal Register Volume 66, Number 86 (Thursday, May 3, 2001)]
[Rules and Regulations]
[Pages 22116-22118]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-11070]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, 529, and 558


Animal Drugs, Feeds, and Related Products; Tylosin Tartrate for 
Injection, etc.; Withdrawal of Approval of NADAs

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 by removing those portions that reflect approval of 13 
new animal drug applications (NADAs) listed below. In a notice 
published elsewhere in this issue of the Federal Register, FDA is 
withdrawing approval of the NADAs.

DATES: This rule is effective May 14, 2001.

FOR FURTHER INFORMATION CONTACT: Pamela K. Esposito, Center for 
Veterinary Medicine (HFV-210), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-5593.

SUPPLEMENTARY INFORMATION: The following sponsors have requested that 
FDA withdraw approval of the NADAs listed below because the products 
are no longer manufactured or marketed:

------------------------------------------------------------------------
                                                          21 CFR Cite
                                  NADA Number Product       Affected
            Sponsor                     (Drug)           (Sponsor Drug
                                                         Labeler Code)
------------------------------------------------------------------------
Elanco Animal Health, A Div. of  NADA 12-585 Tylan     522.2640b
 Eli Lilly & Co., Lilly           Injectable (tylosin   (000986)
 Corporate Center,                tartrate).
 Indianapolis, IN 46285.
                                 NADA 15-207 Hyferdex  522.1183(c)
                                  Injection (iron       (000986)
                                  dextran complex).
                                 NADA 30-330 Tylocine  not applicable
                                  Sulfa Tablets
                                  (sulfadiazine,
                                  sulfamerazine,
                                  sulfamethazine,
                                  tylosin).

[[Page 22117]]

 
                                 NADA 31-962 Tylan     524.2640 (000986)
                                  plus Neomycin Eye
                                  Powder (neomycin
                                  sulfate, tylosin).
                                 NADA 40-123 Toptic    524.321 (000986)
                                  Ointment
                                  (cephalonium,
                                  flumethasone,
                                  iodochlorhydroxyqui
                                  n, piperocaine
                                  hydrochloride,
                                  polymyxin B
                                  sulfate).
                                 NADA 47-092           520.2460a
                                  Tribodine             (000986)
                                  (ticarbodine).
                                 NADA 47-353 Ferti-    522.1081(b)
                                  Cept (chorionic       (000986)
                                  gonadotropin).
                                 NADA 92-602           529.360 (000986)
                                  Cephalothin Discs
                                  (cephaloridine).
                                 NADA 96-678           520.2460b
                                  Tribodine Capsules    (000986)
                                  (ticarbodine).
Bioproducts, Inc., 320           NADA 93-518           558.625(b)(2)
 Springside Dr., suite 300,       Tylan<Register> 10    (051359)
 Fairlawn, OH 44333-2435.         Plus (tylosin
                                  phosphate).
Young's, Inc., Roaring Spring,   NADA 96-162 Hog Grow- 558.625(b)(13)
 PA 16673.                        R-Mix-4000, Hog       (035393)
                                  Grow-R-Mix-800
                                  (tylosin phosphate).
Veterinary Laboratories, Inc.,   NADA 42-889 Oxytocin  522.1680(b)
 12340 Santa Fe Dr., Lenexa, KS   Injection             (000857)
 66215.                           (oxytocin).
Webel Feeds, Inc., Pittsfield,   NADA 116-196 Webel    558.625(b)(73)
 IL 62363.                        Tylan Premix          (035098)
                                  (tylosin phosphate).
------------------------------------------------------------------------

    Following the withdrawal of approval of these NADAs, Young's, Inc., 
is no longer the sponsor of any approved applications. Therefore, 21 
CFR 510.600(c) is amended to remove the entries for the sponsor.
    Elanco Animal Health's NADA 30-330 Tylocine Sulfa Tablets is not 
codified in 21 CFR part 520. Therefore, an amendment to the regulations 
for this withdrawal is not required.
    As provided below, the animal drug regulations are amended to 
reflect the withdrawal of approvals.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects

21 CFR Part 510

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

21 CFR Parts 520, 522, 524, and 529

    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, 529, 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 entry for ``Young's, Inc.'', and in the table in 
paragraph (c)(2) by removing the entry ``035393''.

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. 520.2460  [Removed]

    4. Section 520.2460 Ticarbodine oral dosage forms is removed.


Sec. 520.2460a  [Removed]

    5. Section 520.2460a Ticarbodine tablets is removed.


Sec. 520.2460b  [Removed]

    6. Section 520.2460b Ticarbodine capsules is removed.

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

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

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


Sec. 522.1081  [Amended]

    8. Section 522.1081 Chorionic gonadotropin for injection; chorionic 
gonadotropin suspension is amended by removing and reserving paragraph 
(b).


Sec. 522.1183  [Amended]

    9. Section 522.1183 Iron hydrogenated dextran injection is amended 
by removing and reserving paragraph (c).


Sec. 522.1680  [Amended]

    10. Section 522.1680 Oxytocin injection is amended in paragraph (b) 
by removing ``000857,''.


Sec. 522.2640b  [Removed]

    11. Section 522.2640b Tylosin tartrate for injection is removed.

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

    12. The authority citation for 21 CFR part 524 continues to read as 
follows:

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


Sec. 524.321  [Removed]

    13. Section 524.321 Cephalonium, polymyxin B sulfate, flumethasone, 
iodochlorhydroxyquin, piperocaine hydrochloride topical-otic ointment 
is removed.


Sec. 524.2640  [Removed]

    14. Section 524.2640 Tylosin, neomycin eye powder is removed.

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

    15. The authority citation for 21 CFR part 529 continues to read as 
follows:

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


Sec. 529.360  [Removed]

    16. Section 529.360 Cephalothin discs is removed.

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

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

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


Sec. 558.625  [Amended]

    18. Section 558.625 Tylosin is amended by removing and reserving 
paragraphs (b)(2), (b)(13), and (b)(73).


[[Page 22118]]


    Dated: April 23, 2001.
Linda Tollefson,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 01-11070 Filed 5-2-01; 8:45 am]
BILLING CODE 4160-01-S