[Federal Register Volume 66, Number 90 (Wednesday, May 9, 2001)]
[Rules and Regulations]
[Pages 23588-23589]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-11621]



[[Page 23588]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, and 558


Animal Drugs, Feeds, and Related Products; Trichlorfon, 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 to remove those portions that reflect approval of 11 
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 21, 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)
------------------------------------------------------------------------
Purina Mills, Inc., P.O. Box     NADA 48-915           520.2520a
 66812, St. Louis, MO 63166-      Purina      (017800)
 6812.                            Bot Control
                                  (trichlorfon).
Golden Sun Feeds, Inc., 111      NADA 97-567           558.625(b)(17)
 South Fifth St., Estherville,    Tylan 10    (021780)
 IA 51334.                        Premix (tylosin
                                  phosphate).
 ..............................  NADA 97-615 Swine     558.630(b)(4) and
                                  Med-A-Mix TS 8000     (b)(10) (021780)
                                  Premix,
                                  Tylan 5,
                                  10, 20, 40 Sulfa-G
                                  (tylosin phosphate
                                  and sulfamethazine).
Quali-Tech Products, Inc., 318   NADA 110-440          558.274(a)(2),
 Lake Hazeltine Dr., Chaska, MN   Hygromix              (a)(3), (a)(4),
 55318-1093.                      Hygrowormer           (c)(1)(i), and
                                  Hyanthelmix           (c)(1)(ii)
                                  (hygromycin B).       (016968)
Steris Laboratories Inc., 620    NADA 45-578           522.1258 (000402)
 North 51st Ave., Phoenix, AZ     Lidocaine
 85043-4705.                      Hydrochloride With
                                  Epinephrine
                                  Injection 2%.
 ..............................  NADA 44-585 Oxytocin  522.1680 (000402)
                                  Injection.
 ..............................  NADA 45-737 Sodium    522.1704(b)
                                  Pentobarbital         (000402)
                                  Injection.
 ..............................  NADA 45-848           522.1720 (000402)
                                  Phenylbutazone
                                  Injection.
 ..............................  NADA 110-349          522.540(c)(2)
                                  Dexamethasone         (000402)
                                  Injection.
 ..............................  NADA 110-350           522.540(b)(2)(ii
                                  Dexamethasone         ) (000402)
                                  Injection.
 ..............................  NADA 117-973           522.1884(c)
                                  Prednisolone Sodium   (000402)
                                  Succinate for
                                  Injection.
------------------------------------------------------------------------

    Following the withdrawal of approval of these NADAs, Golden Sun 
Feeds, Inc., is no longer the sponsor of any approved applications. 
Therefore, 21 CFR 510.600(c) is amended to remove entries for the 
sponsor.
    Steris Laboratories currently has another approved application for 
dexamethasone injection (NADA 104-606). Therefore, the regulation is 
not amended to reflect the withdrawal of approval of NADA 110-349 
(dexamethasone injection).
    Steris Laboratories NADA 44-585 oxytocin injection is not codified 
under 21 CFR 522.1680 oxytocin injection. Also, Steris Laboratories 
NADA 45-848 phenylbutazone injection is not codified under 21 CFR 
522.1720 phenylbutazone injection. Therefore, amendments of the cited 
regulations are 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 and 522

    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, 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 ``Golden Sun Feeds, Inc.'', and in the 
table in paragraph (c)(2) by removing the entry ``021780''.

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. 520.2520a  [Removed]

    4. Section 520.2520a Trichlorfon oral is removed.

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

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

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


Sec. 522.1258  [Removed]

    6. Section 522.1258 Lidocaine injection with epinephrine is 
removed.


Sec.  522.1704  [Amended]

    7. Section 522.1704 Sodium pentobarbital injection is amended by 
removing and reserving paragraph (b).


Sec. 522.1884  [Amended]

    8. Section 522.1884 Prednisolone sodium succinate injection is 
amended by removing the second sentence of

[[Page 23589]]

paragraph (c) and by removing paragraph (d)(2)(iv).

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

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

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


Sec. 558.274  [Amended]

    10. Section 558.274 Hygromycin B is amended as follows:
    a. In paragraph (a)(2) by removing ``016968 and'';
    b. By removing and reserving paragraph (a)(3);
    c. In paragraph (a)(4) by removing ``016968,'';
    d. In the table in paragraph (c)(1) in the fifth column of the 
first entry in items (i) and (ii) by removing ``016968,''.


Sec. 558.625  [Amended]

    11. Section 558.625 Tylosin is amended by removing and reserving 
paragraph (b)(17).


Sec. 558.630  [Amended]

    12. Section 558.630 Tylosin and sulfamethazine is amended by 
removing and reserving paragraph (b)(4), and in paragraph (b)(10) by 
removing ``021780,''.

    Dated: May 2, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-11621 Filed 5-8-01; 8:45 am]
BILLING CODE 4160-01-S