Document ID: FDA-2008-N-0039-0058
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Change of Sponsors Drug Labeler Code
Posted Date: 2008-06-23T04:00Z

[Federal Register: June 23, 2008 (Volume 73, Number 121)]
[Rules and Regulations]               
[Page 35340-35341]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23jn08-3]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, and 558

 
New Animal Drugs; Change of Sponsor's Drug Labeler Code

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's drug labeler code for 
ADM Alliance Nutrition, Inc. This action is being taken to improve the 
accuracy of the regulations.

DATES:  This rule is effective June 23, 2008.

FOR FURTHER INFORMATION CONTACT: Charise Kasser, Center for Veterinary 
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-276-9069, e-mail: charise.kasser@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: ADM Alliance Nutrition, Inc., 1000 North 
30th St., Quincy, IL 62305-3115, has informed FDA that it has obtained 
a new drug labeler code (DLC) in 2007, which has not been reflected in 
the animal drug regulations. Accordingly, the regulations in 21 CFR 
510.600, 520.445b, 520.2380a, 558.95, 558.128, 558.274, 558.311, 
558.355, 558.485, 558.625, and 558.630 are amended to reflect this new 
DLC. This action is being taken to improve the accuracy of the 
regulations.
    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 Part 520

    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, 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.

Sec.  510.600  [Amended]

0
2. In Sec.  510.600, in the table in paragraph (c)(1), revise the entry 
for ``ADM Alliance Nutrition, Inc.''; and in the table in paragraph 
(c)(2), remove the entry for ``021930'' and in numerical sequence add 
an entry for ``012286'' 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
------------------------------------------------------------------------
                                * * * * *
ADM Alliance Nutrition, Inc., 1000 North      012286
 30th St., Quincy, IL 62305-3115
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                 Firm name and address
------------------------------------------------------------------------
                                * * * * *
012286                       ADM Alliance Nutrition, Inc., 1000 North
                              30th St., Quincy, IL 62305-3115
                                * * * * *
------------------------------------------------------------------------

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. In paragraph (b)(4) of Sec.  520.445b, remove ``021930'' and in its 
place add ``012286''.

Sec.  520.2380a  [Amended]

0
5. In paragraph (c)(3) of Sec.  520.2380a, remove ``021930'' and in its 
place add ``012286''.

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

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

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

Sec.  558.95  [Amended]

0
7. In paragraph (a)(4) of Sec.  558.95, remove ``016968, 017790, and 
021930'' and in its place add ``012286, 016968, and 017790''.

Sec.  558.128  [Amended]

0
8. In Sec.  558.128, in paragraph (b)(2), remove ``021930'' and in its 
place add ``012286''; and in the tables in paragraphs (e)(1) through 
(e)(4), in the ``Sponsor'' column, remove ``021930'' wherever it occurs 
and in its place add ``012286''.

Sec.  558.274  [Amended]

0
9. In Sec.  558.274, in paragraph (a)(7), remove ``021930'' and in its 
place add ``No. 012286''; and in the table in paragraphs (c)(1)(i) and 
(c)(1)(ii) in the ``Sponsor'' column, remove ``021930'' and in 
numerical sequence add ``012286''.

Sec.  558.311  [Amended]

0
10. In paragraph (b)(5) of Sec.  558.311, remove ``017800 and 021930'' 
and in its place add ``012286 and 017800''.

Sec.  558.355  [Amended]

0
11. In paragraph (b)(13) of Sec.  558.355, remove ``021930'' and in its 
place add ``No. 012286''.

[[Page 35341]]

Sec.  558.485  [Amended]

0
12. In paragraph (b)(3) of Sec.  558.485, remove ``021930'' and in 
numerical sequence add ``012286''.

Sec.  558.625  [Amended]

0
13. In paragraphs (b)(10) and (b)(12) of Sec.  558.625, remove 
``021930'' and in its place add ``No. 012286''.

Sec.  558.630  [Amended]

0
14. In Sec.  558.630, in paragraph (b)(2), remove ``021930'' and in its 
place add ``012286; and in paragraph (b)(5), remove ``021930'' and in 
numerical sequence add ``012286''.

    Dated: June 9, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-14149 Filed 6-20-08; 8:45 am]

BILLING CODE 4160-01-S