[Federal Register Volume 69, Number 206 (Tuesday, October 26, 2004)]
[Rules and Regulations]
[Pages 62406-62407]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-23854]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, and 558


New Animal Drugs; Correction of Sponsor's Drug Labeler Codes

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 correction of sponsor's drug labeler code 
for Pennfield Oil Co.

DATES: This rule is effective October 26, 2004.

FOR FURTHER INFORMATION CONTACT:  David R. Newkirk, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: FDA has found that the animal drug 
regulations do not reflect the correct sponsor's drug labeler code for 
Pennfield Oil Co. Accordingly, the agency is amending the regulations 
in 21 CFR 510.600, 520.445b, 520.1660d, 522.1660a, 558.76, 558.78, 
558.128, 558.140, 558.145, 558.195, 558.355, 558.450, 558.550, 558.600, 
558.625, and 558.630 to correct this error.
    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.

0
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

0
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.

0
2. Section 510.600 is amended in the table in paragraph (c)(1) in the 
entry for ``Pennfield Oil Co.'' by removing ``053389'' and by adding in 
its place ``048164''; and in the table in paragraph (c)(2) by removing 
the entry for ``053389'' and by adding in numerical sequence an entry 
for ``048164'' to read as follows:


Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
            Firm name and address                  Drug labeler code
------------------------------------------------------------------------
                                * * * * *
Pennfield Oil Co., 14040 Industrial Rd.,      048164
 Omaha, NE 68144
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                 Firm name and address
------------------------------------------------------------------------
                                * * * * *
048164                        Pennfield Oil Co., 14040 Industrial Rd.,
                              Omaha, NE 68144
                                * * * * *
------------------------------------------------------------------------

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 520 continues to read as 
follows:

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


Sec.  520.445b  [Amended]

0
4. Section 520.445b is amended in paragraph (b) by removing ``053389'' 
and by adding in its place ``048164''.


Sec.  520.1660d  [Amended]

0
5. Section 520.1660d is amended in paragraph (b)(6) by removing 
``053389'' and by adding in its place ``048164''.

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

0
6. The authority citation for 21 CFR part 522 continues to read as 
follows:

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


Sec.  522.1660a  [Amended]

0
7. Section 522.1660a is amended in paragraph (b) by removing ``053389'' 
and by adding in its place ``048164''.

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

0
8. The authority citation for 21 CFR part 558 continues to read as 
follows:

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


Sec.  558.76  [Amended]

0
9. Section 558.76 is amended in the table in paragraph (d)(1)(iv) in 
the ``Limitations'' and ``Sponsor'' columns by removing ``053389'' and 
by adding in its place ``048164''.

0
10. Section 558.78 is amended by revising paragraphs (a) and (b); in 
the table in paragraph (d)(1) by redesignating paragraphs (d)(1)(ii) 
through (d)(1)(vi) as paragraphs (d)(1)(iii) through (d)(1)(vii); and 
by revising paragraph (d)(1)(i); and by adding new paragraph (d)(1)(ii) 
to read as follows:


Sec.  558.78  Bacitracin zinc.

    (a) Specifications. Type A medicated articles containing bacitracin 
zinc equivalent to 5, 10, 25, 40, or 50 grams per pound bacitracin.
    (b) Approvals. See sponsors in Sec.  510.600(c) of this chapter for 
uses as follows:
    (1) No. 046573: 10, 25, 40, and 50 grams per pound for uses as in 
paragraph (d) of this section.
    (2) No. 048164: 5 and 50 grams per pound for use as in as in 
paragraph (d)(1)(i) of this section.
* * * * *
    (d) * * *
    (1) * * *

[[Page 62407]]



----------------------------------------------------------------------------------------------------------------
                                    Combinations in grams
 Bacitracin zinc in grams per ton'         per ton         Indications for use     Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 4 to 50.......................  .....................  Chickens: for        Growing chickens   046573
                                                            increased rate of                      048164
                                                            weight gain and
                                                            improved feed
                                                            efficiency
----------------------------------------------------------------------------------------------------------------
(ii) 4 to 50......................  .....................  Turkeys and          Growing turkeys    046573
                                                            pheasants: for       and pheasants
                                                            increased rate of
                                                            weight gain and
                                                            improved feed
                                                            efficiency
 
----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *


Sec.  558.128  [Amended]

0
11. Section 558.128 is amended in paragraph (b)(1) by removing 
``053389'' and by adding in its place ``048164''; and in the tables in 
paragraphs (e)(1), (e)(2), (e)(3), (e)(4), and (e)(5) in the 
``Sponsor'' column by removing ``053389'' wherever it appears and by 
adding in its place ``048164''.


Sec.  558.140  [Amended]

0
12. Section 558.140 is amended in paragraph (a) by removing ``053389'' 
and by adding in its place ``048164''.


Sec.  558.145  [Amended]

0
13. Section 558.145 is amended in paragraph (a)(2) by removing 
``053389'' and by adding in its place ``048164''.


Sec.  558.195  [Amended]

0
14. Section 558.195 is amended in the table in paragraph (e)(2)(iii) in 
the ``Limitations'' and ``Sponsor'' columns by removing ``053389'' and 
by adding in its place ``048164''.


Sec.  558.355  [Amended]

0
15. Section 558.355 is amended in paragraph (f)(1)(xiv)(b) by removing 
``053389'' and by adding in its place ``048164''.


Sec.  558.450  [Amended]

0
16. Section 558.450 is amended in paragraph (a)(2) by removing 
``053389'' and by adding in its place ``048164''; in the table in 
paragraphs (d)(1)(i), (d)(1)(v), (d)(1)(vii), and (d)(1)(viii) in the 
``Sponsor'' column by removing ``053389'' wherever it appears and by 
adding in its place ``048164''; and in the table in paragraph 
(d)(1)(ix) in the ``Limitations'' column by removing ``053389'' 
wherever it appears and by adding in its place ``048164''.

0
17. Section 558.550 is amended in paragraphs (d)(1)(xv)(c) and 
(d)(1)(xvi)(c) by removing ``053389'' and by adding in its place 
``048164''; and by revising paragraph (a) and adding paragraph (b) to 
read as follows:


Sec.  558.550  Salinomycin.

    (a) Specifications. Type A medicated articles containing 30 or 60 
grams of salinomycin activity per pound (as salinomycin sodium 
biomass).
    (b) Approvals. See sponsors in Sec.  510.600(c) of this chapter for 
use as in paragraph (d) of this section:
    (1) No. 046573 for use as in paragraph (d) of this section.
    (2) No. 057926 for use as in paragraphs (d)(1)(i), (d)(1)(iii) 
through (d)(1)(xvi), (d)(2)(i), and (d)(3)(i) of this section.
    (3) No. 048164 for use as in paragraphs (d)(1)(xv) and (d)(1)(xvi) 
of this section.
* * * * *


Sec.  558.600  [Amended]

0
18. Section 558.600 is amended in the table in paragraph (e)(1)(iii) in 
the ``Limitations'' and ``Sponsor'' columns by removing ``053389'' and 
by adding in its place ``048164''.


Sec.  558.625  [Amended]

0
19. Section 558.625 is amended in paragraph (b)(89) by removing 
``053389'' and by adding in its place ``048164''.


Sec.  558.630  [Amended]

0
20. Section 558.630 is amended in paragraph (b)(10) by removing 
``053389'' and by adding in numerical sequence ``048164''.

    Dated: October 14, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 04-23854 Filed 10-25-04; 8:45 am]
BILLING CODE 4160-01-S