Document ID: FDA-2013-N-0002-0021
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Change of Sponsor; Fentanyl; Iron Injection
Posted Date: 2013-07-24T04:00Z

[Federal Register Volume 78, Number 142 (Wednesday, July 24, 2013)]
[Rules and Regulations]
[Pages 44432-44433]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-17754]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 522, and 524

[Docket No. FDA-2013-N-0002]

New Animal Drugs; Change of Sponsor; Fentanyl; Iron Injection

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 two approved new 
animal drug applications (NADAs) from Alstoe, Ltd., Animal Health, to 
Sogeval S.A., and a change of sponsor for an NADA from Nexcyon 
Pharmaceuticals, Inc. to Elanco Animal Health, A Division of Eli Lilly 
& Co.

DATES: This rule is effective July 24, 2013.

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: Alstoe, Ltd., Animal Health, Pera Innovation 
Park, Nottingham Rd., Melton Mowbray, Leicestershire, England LE13 0PB 
has informed FDA that it has transferred ownership of, and all rights 
and interest in, NADA 099-667 for IMPOSIL (iron dextran complex) 
Injection and NADA 110-399 for GLEPTOSIL (gleptoferron) Injection to 
Sogeval S.A., 200 Avenue de Mayenne, 53000 Laval, France. Nexcyon 
Pharmaceuticals, Inc., 644 W. Washington Ave., Madison, WI 53703 has 
informed FDA that it has transferred ownership of, and all rights and 
interest in, NADA 141-337 for RECUVYRA (fentanyl) Transdermal Solution 
to Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate 
Center,

[[Page 44433]]

Indianapolis, IN 46285. Accordingly, the Agency is amending the 
regulations in 21 CFR parts 522 and 524 to reflect the transfers of 
ownership.
    Following these changes of sponsorship, Alstoe, Ltd., Animal 
Health, and Nexcyon Pharmaceuticals, Inc., are no longer sponsors of 
approved NADAs. Accordingly, FDA is amending 21 CFR 510.600 to remove 
the entries for these firms.
    In addition, Sogeval S.A. is now a sponsor of approved NADAs. 
Accordingly, FDA is amending 21 CFR 510.600 to add entries for this 
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 Parts 522 and 524

    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, 
522, and 524 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 the table in paragraph (c)(1) of Sec.  510.600, remove the 
entries for ``Alstoe, Ltd., Animal Health'' and ``Nexcyon 
Pharmaceuticals, Inc.'', and alphabetically add an entry for ``Sogeval 
S.A.''; and in the table in paragraph (c)(2), remove the entries for 
``050929'' and ``062408'', and numerically add an entry for ``059120'' 
to read as follows:

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

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

------------------------------------------------------------------------
                                                                 Drug
                   Firm name and address                       labeler
                                                                 code
------------------------------------------------------------------------
 
                                * * * * *
Sogeval S.A., 200 Avenue de Mayenne, 53000 Laval, France...       059120
 
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
         Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                                * * * * *
059120............................  Sogeval S.A., 200 Avenue de Mayenne,
                                     53000 Laval, France.
 
                                * * * * *
------------------------------------------------------------------------

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

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

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

Sec.  522.1182  [Amended]

0
4. In Sec.  522.1182, in paragraphs (b)(3) and (b)(8), remove 
``062408'' and in its place add ``059120''.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
5. The authority citation for 21 CFR part 524 continues to read as 
follows:

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

Sec.  524.916  [Amended]

0
6. In paragraph (b) of Sec.  524.916, remove ``050929'' and in its 
place add ``000986''.

    Dated: July 17, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-17754 Filed 7-23-13; 8:45 am]
BILLING CODE 4160-01-P