Document ID: FDA-2010-N-0002-0090
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Follicle Stimulating Hormone; Change of Sponsor
Posted Date: 2011-01-18T05:00Z

[Federal Register: January 18, 2011 (Volume 76, Number 11)]
[Rules and Regulations]               
[Page 2807-2808]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18ja11-9]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 522

[Docket No. FDA-2010-N-0002]

 
New Animal Drugs; Change of Sponsor; Follicle Stimulating Hormone

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 a new animal drug 
application (NADA) for follicle stimulating hormone from Ausa 
International, Inc., to Therio, Inc.

DATES: This rule is effective January 18, 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, e-mail: 
steven.vaughn@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Ausa International, Inc., Rt. 8, P.O. Box 
324-12, Tyler, TX 75703 has informed FDA that it has transferred 
ownership of, and all rights and interest in, NADA 141-014 for SUPER-OV 
(follicle stimulating hormone) to Therio, Inc., 8801 Anderson Ave., 
Manhattan, KS 66503. Accordingly, the Agency is amending the 
regulations in 21 CFR 522.1002 to reflect the transfer of ownership.
    Following this change of sponsorship, Ausa International, 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.

[[Page 2808]]

    In addition, Therio, 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 ``Ausa International, Inc.''; and alphabetically add a new entry 
for ``Therio, Inc.''; and in the table in paragraph (c)(2), remove the 
entry for ``059521''; and in numerical sequence add a new entry for 
``052923'' 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
------------------------------------------------------------------------

                                * * * * *
Therio, Inc., 8801 Anderson Ave., Manhattan, KS 66503........     052923

                                * * * * *
------------------------------------------------------------------------

     (2) * * *

------------------------------------------------------------------------
   Drug
 labeler                       Firm name and address
   code
------------------------------------------------------------------------

                                * * * * *
   052923  Therio, Inc., 8801 Anderson Ave., Manhattan, KS 66503

                                * * * * *
------------------------------------------------------------------------

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.  522.1002  [Amended]

0
4. In paragraph (a)(2) of Sec.  522.1002, remove ``059521'' and add in 
its place ``No. 052923''.

    Dated: January 12, 2011.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 2011-909 Filed 1-14-11; 8:45 am]
BILLING CODE 4160-01-P