Document ID: FDA-2011-N-0003-0055
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Change of Sponsor; Zinc Gluconate
Posted Date: 2011-12-21T05:00Z

[Federal Register Volume 76, Number 245 (Wednesday, December 21, 2011)]
[Rules and Regulations]
[Page 79064]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32591]

[[Page 79064]]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 522

[Docket No. FDA-2011-N-0003]

New Animal Drugs; Change of Sponsor; Zinc Gluconate

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor for a new animal drug 
application (NADA) for zinc gluconate injectable solution from 
Technology Transfer, Inc., to Ark Sciences, Inc.

DATES: This rule is effective December 21, 2011.

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: Technology Transfer, Inc., 33 East Broadway, 
suite 190, Columbia, MO 65203 has informed FDA that it has transferred 
ownership of, and all rights and interest in, NADA 141-217 for 
NEUTERSOL (zinc gluconate) Injectable Solution to Ark Sciences, Inc., 
1101 East 33rd St., suite B304, Baltimore, MD 21218. Accordingly, the 
Agency is amending the regulations in 21 CFR 522.2690 to reflect the 
transfer of ownership.
    Following this change of sponsorship, Technology Transfer, Inc., is 
no longer the sponsor of an approved application. Accordingly, Sec.  
510.600 (21 CFR 510.600) is being amended to remove the entries for 
this firm.
    In addition, Ark Sciences, Inc., is not currently listed in the 
animal drug regulations as a sponsor of an approved application. 
Accordingly, Sec.  510.600 is being amended to add entries for this 
sponsor.
    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 522

    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 
522 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), remove the entry 
for ``Technology Transfer, Inc.''; alphabetically add a new entry for 
``Ark Sciences, Inc.''; and in the table in paragraph (c)(2), remove 
the entry for ``067647''; and in numerical sequence add a new entry for 
``076175'' 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
------------------------------------------------------------------------
 
                                * * * * *
Ark Sciences, Inc., 1101 East 33rd St., suite B304,               076175
 Baltimore, MD 21218.......................................
 
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
         Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                                * * * * *
076175............................  Ark Sciences, Inc., 1101 East 33rd
                                     St., suite B304, Baltimore, MD
                                     21218.
 
                                * * * * *
------------------------------------------------------------------------

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.  522.2690  [Amended]

0
4. In paragraph (b) of Sec.  522.2690, remove ``067647'' and in its 
place add ``076175''.

    Dated: December 8, 2011.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 2011-32591 Filed 12-20-11; 8:45 am]
BILLING CODE 4160-01-P