Federal Register / Vol. 76, No. 11 / Tuesday, January 18, 2011 / Rules and Regulations 2807 

7217, section 19(b)(2) of the Act, 15 

U.S.C. 78s(b)(2), and section 19(b)(3) of 

the Act, 15 U.S.C. 78s(b)(3), to institute 

proceedings to determine whether a 

proposed rule change of the Public 

Company Accounting Oversight Board 

should be disapproved and to provide to 

the Public Company Accounting 

Oversight Board notice of the grounds 

for disapproval under consideration. In 

addition, pursuant to section 107 of the 

Sarbanes-Oxley Act of 2002, 15 U.S.C. 

7217, and section 19(b)(2)(B) of the Act, 

15 U.S.C. 78s(b)(2)(B), to extend for a 

period not exceeding 240 days from the 

date of publication of notice of the filing 

of a proposed rule change pursuant to 

section 19(b)(1) of the Act, 15 U.S.C. 

78s(b)(1), the period during which the 

Commission must issue an order 

approving or disapproving the proposed 

rule change and to determine whether 

such longer period is appropriate and 

publish the reasons for such 

determination. 

(5) Pursuant to section 107 of the 

Sarbanes-Oxley Act of 2002, 15 U.S.C. 

7217, and section 19(b)(3)(C) of the Act, 

15 U.S.C. 78s(b)(3)(C), to temporarily 

suspend a rule of the Public Company 

Accounting Oversight Board. 

* * * * * 

Dated: January 11, 2011. 

By the Commission. 

Elizabeth M. Murphy, 

Secretary. 

[FR Doc. 2011–835 Filed 1–14–11; 8:45 am] 

BILLING CODE 8011–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 510 

[Docket No. FDA–2010–N–0002] 

New Animal Drugs; Change of Sponsor 

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 hemoglobin 

glutamer-200 from Biopure Corp. to 

OPK Biotech, LLC. 

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: Biopure 

Corp., 11 Hurley St., Cambridge, MA 

02141 has informed FDA that it has 

transferred ownership of, and all rights 

and interest in, NADA 141–067 for 

OXYGLOBIN (hemoglobin glutamer200) to OPK Biotech, LLC, 11 and 39 

Hurley St., Cambridge, MA 02141. 

There is no change in drug labeler code. 

Following this change of sponsorship, 

Biopure Corp. is no longer the sponsor 

of an approved application. In addition, 

OPK Biotech, LLC, is not currently 

listed in the animal drug regulations as 

a sponsor of an approved application. 

Accordingly, § 510.600 is being 

amended 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 in 21 CFR Part 510 

Administrative practice and 

procedure, Animal drugs, Labeling, 

Reporting and recordkeeping 

requirements. 

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 part 510 is amended as follows: 

PART 510—NEW ANIMAL DRUGS 

■ 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. 

■ 2. In § 510.600, in the table in 

paragraph (c)(1), remove the entry for 

‘‘Biopure Corp.’’; and alphabetically add 

a new entry for ‘‘OPK Biotech, LLC’’; and 

in the table in paragraph (c)(2), revise 

the entry for ‘‘063075’’ to read as 

follows: 

§ 510.600 Names, addresses, and drug 

labeler codes of sponsors of approved 

applications. 

* * * * * 

(c) * * * 

(1) * * * 

Firm name and address 

Drug 

labeler 

code 

* * * * * 

OPK Biotech, LLC, 11 and 39 

Hurley St., Cambridge, MA 

02141 ........................................ 063075 

* * * * * 

(2) * * * 

Drug labeler 

code 

Firm name and address 

* * * * * 

063075 OPK Biotech, LLC, 11 and 39 

Hurley St., Cambridge, MA 

02141 

* * * * * 

Dated: January 11, 2011. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 2011–904 Filed 1–14–11; 8:45 am] 

BILLING CODE 4160–01–P 

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. 

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, § 510.600 (21 CFR 

510.600) is being amended to remove 

the entries for this firm. 

WReier-Aviles on DSKDVH8Z91PROD with RULES