[Federal Register Volume 66, Number 180 (Monday, September 17, 2001)]
[Rules and Regulations]
[Pages 47962-47964]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-23044]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520 and 558


New Animal Drugs; Change of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor for 30 approved new 
animal drug applications (NADAs) from Pfizer, Inc., to Phibro Animal 
Health, Inc. The technical amendments made by this final rule are 
intended to provide accuracy and clarity to the agency's regulations.

DATES: This rule is effective September 17, 2001.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0209.

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 
10017-5755, has informed FDA that it has transferred ownership of, and 
all rights and interest in, the following NADAs to Phibro Animal 
Health, Inc., One Parker Plaza, Fort Lee, NJ 07024:

------------------------------------------------------------------------
             NADA No.                           Product Name
------------------------------------------------------------------------
32-704...........................  Bloat Guard Top Dressing
35-287...........................  OM-5 Premix
38-281...........................  Bloat Guard Liquid Premix
41-061...........................  Mecadox Premix 10
43-290...........................  Banminth Premix 80
46-668...........................  Penicillin G Procaine 50% and 100%
                                    Type A Medicated Articles
91-467...........................  Stafac 20, 500 Type A
                                    Medicated Articles
91-513...........................  Stafac Type A Medicated
                                    Articles
92-286...........................  CTCL 10, 20, 30, 50, 70 Type A
                                    Medicated Article
92-287...........................  CTCL 50 MR, 100 MR Type A Medicated
                                    Article
92-444...........................  Rumatel Premix 88
92-955...........................  Mecadox/Banminth
98-431...........................  Tylan 10 Premix
99-006...........................  Terramycin/Coban
101-666..........................  Terramycin/Robenz
110-047..........................  Banminth/Tylan
116-044..........................  Banminth/Lincomix
120-724..........................  Stafac/Coban/3-
                                    Nitro
122-481..........................  Stafac/Coban
122-608..........................  Stafac/Avatec
122-822..........................  Stafac/Amprol HI-
                                    E
138-828..........................  Stafac/Biocox
138-953..........................  Stafac/Biocox/3-
                                    Nitro
140-448..........................  Biocox/Terramycin
140-940..........................  Aviax Type A Medicated
                                    Article
140-998..........................  V-Max Type A Medicated Article
141-058..........................  Aviax/BMD/3-
                                    Nitro
141-058..........................  Aviax/BMD/3-
                                    Nitro
141-065..........................  Aviax/BMD
141-066..........................  Aviax/3-Nitro
141-114..........................  Aviax/Stafac
------------------------------------------------------------------------

    Accordingly, the agency is amending the regulations in 
Secs. 520.1840, 558.58, 558.115, 558.128, 558.198, 558.311, 558.355, 
558.360, 558.435, 558.450, 558.460, 558.465, 558.485, 558.515, 558.550, 
558.555, 558.625, and 558.635 (21 CFR 520.1840, 558.58, 558.115, 
558.128, 558.198, 558.311, 558.355, 558.360, 558.435, 558.450, 558.460, 
558.465, 558.485, 558.515, 558.550, 558.555, 558.625, and 558.635) to 
reflect the transfer of ownership. In addition, Secs. 520.1840 and 
558.485 are being revised to reflect current format.
    Section 558.450 is also being amended to remove the entries for 
combination uses of oxytetracycline (OTC) with monensin, provided under 
NADA 99-066, because they are redundant with entries in Sec. 558.355. 
The entry for the use of 400 grams per (g/) ton OTC with 90 to 110 g/
ton monensin in Sec. 558.450(d)(1)(vi) is an error created during prior 
revisions (61 FR 51588, Oct. 3, 1996). The correct drug levels, 200 g/
ton OTC with 90 to 110 g/ton monensin, for the same indications are 
codified in

[[Page 47963]]

Sec. 558.355(f)(1)(viii). The entry for the use of 500 g/ton OTC with 
90 to 110 g/ton monensin in Sec. 558.450(d)(1)(vii) is redundant with 
Sec. 558.355(f)(1)(xxii).
    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 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 520 and 
558 are amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

    2. Section 520.1840 is amended by revising paragraphs (a), (b), and 
(c) to read as follows.


Sec. 520.1840  Poloxalene.

    (a) Specifications. Polyoxypropylene-polyoxyethylene glycol 
nonionic block polymer.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
use as in paragraph (d) of this section.
    (1) No. 000069 for use as in paragraphs (d)(1) and (d)(3) of this 
section.
    (2) No. 017800 for use as in paragraph (d)(4) of this section.
    (3) No. 036904 for use as in paragraph (d)(2) of this section.
    (4) No. 066104 for use as in paragraph (d)(3) of this section.
    (c) [Reserved]
* * * * *

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

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

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


Sec. 558.58  [Amended]

    4. Section 558.58 Amprolium and ethopabate is amended in the table 
in paragraph (d)(1)(iii) under the ``Limitations'' column in the entry 
for ``Virginiamycin 15'' by removing ``000069'' and by adding in its 
place ``066104''.


Sec. 558.115  [Amended]

    5. Section 558.115 Carbadox is amended in paragraph (a) by removing 
``000069'' and by adding in its place ``066104''.


Sec. 558.128  [Amended]

    6. Section 558.128 Chlortetracycline is amended in paragraph (a)(1) 
by removing ``000069, 046573, and 053389'' and by adding in its place 
``046573, 053389, and 066104''; and in the table in paragraph (d)(1) 
under the ``Sponsor'' column by removing ``000069'' wherever it occurs 
and by adding in its place in numerical sequence ``066104''.


Sec. 558.198  [Amended]

    7. Section 558.198 Diclazuril is amended in the table in paragraphs 
(d)(1)(iv) and (d)(1)(v) by removing ``000069'' under the 
``Limitations'' column and by adding in its place ``066104''.


Sec. 558.311  [Amended]

    8. Section 558.311 Lasalocid is amended in paragraph (b)(2) by 
removing ``000069'' and by adding in its place ``066104'' and in the 
table in paragraph (e)(1)(xv) in the entry for ``Virginiamycin 10 to 
20'' under the ``Limitations'' column by removing ``000069'' and by 
adding in its place ``066104''.


Sec. 558.355  [Amended]

    9. Section 558.355 Monensin is amended in paragraphs (b)(5), 
(b)(12), (f)(1)(xxii)(b), and (f)(2)(iv)(b) by removing ``000069'' and 
by adding in its place ``066104''; in paragraphs (f)(1)(xiii)(b) and 
(f)(1)(xxi)(b) by removing ``000007'' and by adding in its place 
``066104''; and in paragraph (f)(1)(xx)(b) by removing ``as monensin 
sodium; as roxarsone'' and by adding in its place ``as monensin sodium 
provided by No. 000986 in Sec. 510.600(c) of this chapter; as 
virginiamycin provided by No. 066104 in Sec. 510.600(c) of this 
chapter; roxarsone''.


Sec. 558.360  [Amended]

    10. Section 558.360 Morantel tartrate is amended in paragraph (a) 
by removing ``000069'' and by adding in its place ``066104''.


Sec. 558.435  [Amended]

    11. Section 558.435 Oleandomycin is amended in paragraph (a) by 
removing ``000069'' and by adding in its place ``066104''.


Sec. 558.450  [Amended]

    12. Section 558.450 Oxytetracycline is amended in table 1 in 
paragraph (d)(1) by removing the entries for ``Monensin 90 to 110 g/
ton'' in paragraphs (d)(1)(vi) and (d)(1)(vii); in paragraph 
(d)(1)(vii) in the entry for ``Salinomycin 40 to 60 g/ton'' by removing 
``000069'' under the ``Sponsor'' column and by adding in its place in 
numerical sequence ``066104''.


Sec. 558.460  [Amended]

    13. Section 558.460 Penicillin is amended in paragraph (b) by 
removing ``000069'' and by adding in its place ``066104''.


Sec. 558.465  [Amended]

    14. Section 558.465 Poloxalene free-choice liquid Type C feed is 
amended in paragraph (a) by removing ``000069'' and by adding in its 
place ``066104''.
    15. Section 558.485 is amended by revising paragraphs (a), (b), and 
(d)(1) to read as follows:


Sec. 558.485  Pyrantel.

    (a) Specifications. Type A medicated articles containing 9.6, 19.2, 
48, or 80 grams per pound pyrantel tartrate.
    (b) Approvals. See sponsors in Sec. 510.600(c) of this chapter for 
uses as in paragraph (e) of this section:
    (1) No. 066104: 9.6, 19.2, and 80 grams per pound for use as in 
paragraph (e)(1) of this section.
    (2) No. 001800: 9.6 grams per pound for use as in paragraphs 
(e)(1)(i) through (e)(1)(iii) of this section.
    (3) Nos. 010439, 011490, 011749, 016968, 017473, 017519, 017790, 
043733, 049685, 050568, 050639, and 051359: 9.6 and 19.2 grams per 
pound for use as in paragraphs (e)(1)(i) through (e)(1)(iii) of this 
section.
    (4) No. 021676: 19.2 grams per pound for use as in paragraphs 
(e)(1)(i) through (e)(1)(iii) of this section.
    (5) No. 017800: 19.2 and 48 grams per pound for use as in 
paragraphs (e)(1)(i) through (e)(1)(iii) of this section.
    (6) Nos. 034936 and 046987: 9.6 and 19.2 grams per pound for use as 
in paragraphs (e)(1)(i) and (e)(1)(ii) of this section.
    (7) Nos. 000069, 017135, and 062240: 48 grams per pound for use as 
in paragraph (e)(2) of this section.
* * * * *
    (d) Special considerations. (1) See Sec. 500.25 of this chapter. 
Consult a veterinarian before using in severely debilitated animals.
* * * * *


Sec. 558.515  [Amended]

    16. Section 558.515 Robenidine hydrochloride is amended in the 
table in paragraph (d) in the entry for ``Oxytetracycline 400'' under 
the ``Sponsor'' column by removing ``000069'' and by adding in its 
place ``066104''.

[[Page 47964]]

Sec. 558.550  [Amended]

    17. Section 558.550 Salinomycin is amended in paragraphs 
(d)(1)(x)(c) and (d)(1)(xii)(c) by removing ``053571'' and by adding in 
its place ``066104''.
    18. Section 558.555 is amended by revising paragraph (a); by 
removing paragraph (c); by redesignating paragraph (b) as paragraph 
(c); in paragraph (d) by removing ``000069'' wherever it appears and by 
adding in its place ``066104''; and by adding new paragraph (b) to read 
as follows:


Sec. 558.555  Semduramicin.

    (a) Specifications. Type A medicated article containing 22.7 grams 
per pound (50 grams per kilogram) semduramicin sodium.
    (b) Approvals. See No. 066104 in Sec. 510.600(c) of this chapter 
for use as in paragraph (d) of this section.
* * * * *


Sec. 558.625  [Amended]

    19. Section 558.625 Tylosin is amended in paragraph (b)(25) by 
removing ``000069'' and by adding in its place ``066104''.


Sec. 558.635  [Amended]

    20. Section 558.635 Virginiamycin is amended in paragraph (a)(1) by 
removing ``000069'' and by adding in its place ``066104''.

    Dated: August 31, 2001.
Claire M. Lathers,
Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 01-23044 Filed 9-14-01; 8:45 am]
BILLING CODE 4160-01-S