[Federal Register Volume 76, Number 11 (Tuesday, January 18, 2011)]
[Rules and Regulations]
[Pages 2807-2808]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-909]
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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:
[email protected].
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
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* * * * *
Therio, Inc., 8801 Anderson Ave., Manhattan, KS 66503........ 052923
* * * * *
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(2) * * *
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Drug
labeler Firm name and address
code
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* * * * *
052923 Therio, Inc., 8801 Anderson Ave., Manhattan, KS 66503
* * * * *
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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