68972 Federal Register / Vol. 75, No. 217 / Wednesday, November 10, 2010 / Rules and Regulations 

and Surveillance Facility, Virginia 

Capes (FACSFAC VACAPES), NAS 

Oceana, Virginia Beach, VA’’ and 

inserting the words ‘‘Using agency. U.S. 

Navy, Fleet Area Control and 

Surveillance Facility, Virginia Capes 

(FACSFAC VACAPES), Virginia Beach, 

VA.’’ 

* * * * * 

Issued in Washington, DC, on November 4, 

2010. 

Edith V. Parish, 

Manager, Airspace, Regulations and ATC 

Procedures Group. 

[FR Doc. 2010–28388 Filed 11–9–10; 8:45 am] 

BILLING CODE 4910–13–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’s Name 

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’s name from North 

American Nutrition Companies, Inc., to 

Provimi North America, Inc. 

DATES: This rule is effective November 

10, 2010. 

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: North 

American Nutrition Companies, Inc., 

6531 State Rte. 503, Lewisburg, OH 

45338, has informed FDA that it has 

changed its name to Provimi North 

America, Inc. Accordingly, the Agency 

is amending the regulations in 21 CFR 

510.600 to reflect this change. 

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 

‘‘North American Nutrition Companies, 

Inc.’’; and alphabetically add a new 

entry for ‘‘Provimi North America, Inc.’’; 

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

revise the entry for ‘‘017790’’ 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 

* * * * * 

Provimi North America, Inc., 

6531 State Rte. 503, 

Lewisburg, OH 45338 ....... 017790 

* * * * * 

(2) * * * 

Drug labeler code Firm name and address 

* * * * * 

017790 ................... Provimi North America, 

Inc., 6531 State Rte. 

503, Lewisburg, OH 

45338. 

* * * * * 

Dated: October 28, 2010. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 2010–28307 Filed 11–9–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 878 

[Docket No. FDA–2010–N–0512] 

Medical Devices; General and Plastic 

Surgery Devices; Classification of 

Tissue Adhesive With Adjunct Wound 

Closure Device Intended for Topical 

Approximation of Skin 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is classifying the 

tissue adhesive with adjunct wound 

closure device intended for topical 

approximation into class II (special 

controls). The special control that will 

apply to the device is the guidance 

document entitled ‘‘Guidance for 

Industry and FDA Staff; Class II Special 

Controls Guidance Document: Tissue 

Adhesive With Adjunct Wound Closure 

Device Intended for the Topical 

Approximation of Skin.’’ The agency is 

classifying the device into class II 

(special controls) in order to provide 

reasonable assurance of safety and 

effectiveness of the device. Elsewhere in 

this issue of the Federal Register, FDA 

is announcing the availability of a 

guidance document that will serve as 

the special control for this device type. 

DATES: This final rule is effective 

December 10, 2010. The classification 

was effective April 30, 2010. 

FOR FURTHER INFORMATION CONTACT: 

George J. Mattamal, Center for Devices 

and Radiological Health, Food and Drug 

Administration, Bldg. 66, Rm. 4617, 

10903 New Hampshire Ave., Silver 

Spring, MD 20993–0002, 301–796–6396. 

SUPPLEMENTARY INFORMATION: 

I. What is the background of this 

rulemaking? 

The Federal Food, Drug, and Cosmetic 

Act (FD&C Act) (21 U.S.C. 301 et seq.) 

as amended by the Medical Device 

Amendments of 1976 (the 1976 

amendments) (Pub. L. 94–295), the Safe 

Medical Devices Act of 1990 (Pub. L. 

101–629), and the Food and Drug 

Administration Modernization Act (Pub. 

L. 107–250) established a 

comprehensive system for the regulation 

of medical devices intended for human 

use. Section 513 of the FD&C Act (21 

U.S.C. 306c) established three categories 

(classes) of devices, depending on the 

regulatory controls needed to provide 

reasonable assurance of their safety and 


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