Document ID: FDA-2012-N-0002-0025
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Change of Sponsor; Change of Sponsor Address; Lincomycin and Spectinomycin Soluble Powder; Sulfadimethoxine Oral Solution and Soluble Powder; Tiamulin
Posted Date: 2012-09-14T04:00Z

[Federal Register Volume 77, Number 179 (Friday, September 14, 2012)]
[Rules and Regulations]
[Pages 56769-56770]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-22646]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 520

[Docket No. FDA-2012-N-0002]

New Animal Drugs; Change of Sponsor; Change of Sponsor Address; 
Lincomycin and Spectinomycin Soluble Powder; Sulfadimethoxine Oral 
Solution and Soluble Powder; Tiamulin

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 reflect a change of sponsor for three abbreviated 
new animal drug applications (ANADAs) from Teva Animal Health, Inc., to 
Phibro Animal Health Corp. FDA is also amending the regulations to 
reflect a change of sponsor's address for Phibro Animal Health Corp. 
and for Eka Chemicals, Inc.

DATES: This rule is effective September 14, 2012.

FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7520 
Standish Pl., Rockville, MD 20855, 240-276-8300, Email: 
steven.vaughn@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Teva Animal Health, Inc., 3915 South 48th 
Street Ter., St. Joseph, MO 64503, has informed FDA that it has 
transferred ownership of, and all rights and interest in, ANADA 200-258 
for Sulfadimethoxine Soluble Powder, ANADA 200-344 for Tiamulin Soluble 
Antibiotic, and ANADA 200-345 for Lincomycin-Spectinomycin Soluble 
Powder to Phibro Animal Health Corp., 65 Challenger Rd., 3d floor, 
Ridgefield Park, NJ 07660.
    In addition, Phibro Animal Health Corp. has informed FDA of a 
change of address to GlenPointe Centre East, 3d floor, 300 Frank W. 
Burr Blvd., suite 21, Teaneck, NJ 07666. Eka Chemicals, Inc., 1775 West 
Oak Commons Ct., Marietta, GA 30062 has informed FDA of a change of 
address to 1850 Parkway Pl. SE., suite 1200, Marietta, GA 30067. 
Accordingly, the Agency is amending the regulations in 21 CFR 510.600 
to reflect these changes.
    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.

    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 and 
520 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. In Sec.  510.600, in the table in paragraph (c)(1), revise the 
entries for ``Eka Chemicals, Inc.'' and ``Phibro Animal Health''; and 
in the table in paragraph (c)(2), revise the entries for ``061088'' and 
``066104'' 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
------------------------------------------------------------------------
 
                              * * * * * * *
Eka Chemicals, Inc., 1850 Parkway Pl. SE., suite                  061088
 1200, Marietta, GA 30067..........................
 
                              * * * * * * *
Phibro Animal Health Corp., GlenPointe Centre East,               066104
 3d floor, 300 Frank W. Burr Blvd., suite 21,
 Teaneck, NJ 07666.................................
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

[[Page 56770]]

------------------------------------------------------------------------
         Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                              * * * * * * *
061088.............................  Eka Chemicals, Inc., 1850 Parkway
                                      Pl. SE., suite 1200, Marietta, GA
                                      30067
 
                              * * * * * * *
066104.............................  Phibro Animal Health Corp.,
                                      GlenPointe Centre East, 3d floor,
                                      300 Frank W. Burr Blvd., suite 21,
                                      Teaneck, NJ 07666
 
                              * * * * * * *
------------------------------------------------------------------------

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.  520.1265  [Amended]

0
4. In paragraph (b)(2) of Sec.  520.1265, remove ``Nos. 057561, 059130, 
and 061623'' and in its place add ``Nos. 057561, 061623, and 066104''.

Sec.  520.2220a  [Amended]

0
5. In paragraph (a)(2) of Sec.  520.2220a, remove ``Nos. 000069, 
054925, 057561, 058829, 059130, and 061623'' and in its place add 
``Nos. 000069, 054925, 057561, 058829, 061623, and 066104''.

Sec.  520.2455  [Amended]

0
6. In paragraph (b)(2) of Sec.  520.2455, remove ``No. 059130'' and in 
its place add ``No. 066104''.

    Dated: September 6, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-22646 Filed 9-13-12; 8:45 am]
BILLING CODE 4160-01-P