[Federal Register Volume 72, Number 6 (Wednesday, January 10, 2007)]
[Rules and Regulations]
[Pages 1173-1174]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-118]


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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

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 14 approved new 
animal drug applications (NADAs) from ADM Animal Health & Nutrition 
Division to ADM Alliance Nutrition, Inc.

DATES: This rule is effective January 10, 2007.

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: ADM Animal Health & Nutrition Division, 1000 
North 30th St., Box 1C, Quincy, IL 62305-3115 has informed FDA that it 
has transferred ownership of, and all rights and interest in, the 
following 14 approved NADAs to ADM Alliance Nutrition, Inc., 1000 North 
30th St., Quincy, IL 62305-3115:

------------------------------------------------------------------------
         Application No.                       Trade name(s)
------------------------------------------------------------------------
048-480                           Chloratet 50
------------------------------------------------------------------------
065-256                           Chlortet-Soluble-O
------------------------------------------------------------------------
091-582                           Gilt Edge TYLAN Mix
------------------------------------------------------------------------
107-957                           TYLAN 20 Sulfa-G, TYLAN 40 Sulfa-G
------------------------------------------------------------------------
108-484                           HFA Tylosin-10 Plus Sulfa
------------------------------------------------------------------------
110-045                           Good-Life TYLAN 10 Premix
------------------------------------------------------------------------
110-439                           HFA Hygromix 2.4 Medicated Premix
------------------------------------------------------------------------
118-877                           Ban-A-Worm Pyrantel Tartrate Ton Pack
------------------------------------------------------------------------
128-411                           TYLAN 5 Sulfa Premix
------------------------------------------------------------------------
131-956                           TYLAN Sulfa-G
------------------------------------------------------------------------
131-957                           TYLAN 10, TYLAN 20, TYLAN 40, TYLAN 5
------------------------------------------------------------------------
132-448                           FLAVOMYCIN
------------------------------------------------------------------------
133-490                           Ban-D-Wormer II BANMINTH
------------------------------------------------------------------------
140-842                           Hygromix 2.4 Premix
------------------------------------------------------------------------

    Accordingly, the agency is amending the regulations in 21 CFR 
520.445b, 558.95, 558.128, 558.274, 558.485, 558.625, and 558.630 to 
reflect the transfer of ownership and a current format.
    In addition, ADM Animal Health & Nutrition Division is no longer a 
sponsor of an approved application. Accordingly, 21 CFR 510.600(c) is 
being amended to remove entries for the firm.
    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.

[[Page 1174]]

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), remove the entry 
for ``ADM Animal Health & Nutrition Division''; and in the table in 
paragraph (c)(2), remove the entry for ``017519''.

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.

0
4. In Sec.  520.445b, revise the section heading, and paragraphs (b) 
and (d)(4)(iii)(C) to read as follows:


Sec.  520.445b  Chlortetracycline powder.

* * * * *
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
use as in paragraph (d) of this section.
    (1) No. 048164 for use as in paragraph (d) of this section.
    (2) No. 053501 for use as in paragraph (d)(4) of this section.
    (3) No. 000010 for use as in paragraphs (d)(4)(i)(A), (d)(4)(i)(B), 
and (d)(4)(ii) through (iv) of this section.
    (4) Nos. 021930 and 059130 for use as in paragraphs (d)(4)(i)(A), 
(d)(4)(i)(B), (d)(4)(ii), and (d)(4)(iii) of this section.
* * * * *
    (d) * * *
    (4) * * *
    (iii) * * *
    (C) Limitations. Prepare fresh solution daily; as sole source of 
chlortetracycline; do not use for more than 5 days. For Nos. 000010 and 
021930, do not slaughter animals for food within 5 days of treatment; 
for No. 053501, do not slaughter animals for food within 24 hours of 
treatment.
* * * * *

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

0
5. 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
6. In paragraph (a)(4) of Sec.  558.95, remove ``016968, 017519, and 
017790'' and in its place add ``Nos. 016968, 017790, and 021930''.


Sec.  558.128  [Amended]

0
7. In Sec.  558.128, in paragraph (b)(2), remove ``017519'' and in its 
place add ``021930''; and in the tables in paragraphs (e)(1) through 
(e)(4), in the ``Sponsor'' column remove ``017519'' wherever it occurs 
and in its place add ``021930''.


Sec.  558.274  [Amended]

0
8. In Sec.  558.274, in paragraph (a)(7), remove ``017519'' and in its 
place add ``021930''; and in the table in paragraphs (c)(1)(i) and 
(c)(1)(ii), in the ``Sponsor'' column remove ``017519'' and in 
numerical sequence add ``021930''.


Sec.  558.485  [Amended]

0
9. In paragraph (b)(3) of Sec.  558.485, remove ``017519'' and in 
numerical sequence add ``021930''.


Sec.  558.625  [Amended]

0
10. In paragraph (b)(10) of Sec.  558.625, remove ``017519'' and in its 
place add ``021930''.


Sec.  558.630  [Amended]

0
11. In Sec.  558.630, remove and reserve paragraphs (b)(3) and (b)(8); 
and in paragraph (b)(10) remove ``017519''.

    Dated: December 29, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E7-118 Filed 1-9-07; 8:45 am]
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