68970 Federal Register / Vol. 75, No. 217 / Wednesday, November 10, 2010 / Rules and Regulations 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 73 

[Docket No. FAA–2010–1070; Airspace 

Docket No. 10–AEA–18] 

RIN 2120–AA66 

Amendment of Using Agency for 

Restricted Areas R–4002, R–4005, 

R–4006 and R–4007; MD 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule. 

SUMMARY: This action makes a minor 

change to the name of the using agency 

for restricted areas R–4002, Bloodsworth 

Island, MD; and R–4005, R–4006 and 

R–4007, Patuxent River, MD to ‘‘U.S. 

Navy, Commanding Officer, NAS 

Patuxent River, MD.’’ This is an 

administrative change only and there 

are no changes to the dimensions, time 

of designation or activities conducted 

within the affected restricted areas. 

DATES: Effective date 0901 UTC, January 

13, 2011. 

FOR FURTHER INFORMATION CONTACT: Paul 

Gallant, Airspace, Regulations and ATC 

Procedures Group, Office of Airspace 

Services, Federal Aviation 

Administration, 800 Independence 

Avenue, SW., Washington, DC 20591; 

telephone: (202) 267–8783. 

SUPPLEMENTARY INFORMATION: 

Background 

The U.S. Navy requested a minor 

change to the name of the using agency 

for restricted areas R–4002, R–4005, 

R–4006 and R–4007 in Maryland, in 

order to reflect the correct organization 

responsible for operation of the areas 

and to standardize the using agency 

listing in the area legal descriptions. 

The Rule 

This action amends Title 14 Code of 

Federal Regulations (14 CFR) part 73 by 

changing the using agency name from 

‘‘Commanding Officer, Naval 

Amphibious School Little Creek, 

Norfolk, VA,’’ To ‘‘U.S. Navy, 

Commanding Officer, NAS Patuxent 

River, MD’’ for restricted area R–4002, 

Bloodsworth Island, MD; and restricted 

areas R–4005, R–4006 and R–4007, 

Naval Air Station Patuxent River, MD, 

from ‘‘Commanding Officer, NAS 

Patuxent River, MD,’’ to ‘‘U.S. Navy, 

Commanding Officer, NAS Patuxent 

River, MD.’’ This is an administrative 

change and does not affect the 

boundaries, designated altitudes, or 

activities conducted within the 

restricted area; therefore, notice and 

public procedures under 5 U.S.C. 553(b) 

are unnecessary. 

The FAA has determined that this 

action only involves an established 

body of technical regulations for which 

frequent and routine amendments are 

necessary to keep them operationally 

current. Therefore, this regulation: (1) Is 

not a ‘‘significant regulatory action’’ 

under Executive Order 12866; (2) is not 

a ‘‘significant rule’’ under DOT 

Regulatory Policies and Procedures 

(44 FR 11034; February 26, 1979); and 

(3) does not warrant preparation of a 

regulatory evaluation as the anticipated 

impact is so minimal. Since this is a 

routine matter that will only affect air 

traffic procedures and air navigation, it 

is certified that this rule, when 

promulgated, will not have a significant 

economic impact on a substantial 

number of small entities under the 

criteria of the Regulatory Flexibility Act. 

Environmental Review 

The FAA has determined that this 

action qualifies for categorical exclusion 

under the National Environmental 

Policy Act in accordance with 311d., 

FAA Order 1050.1E, Environmental 

Impacts: Policies and Procedures. This 

airspace action is an administrative 

change to the descriptions of the 

affected restricted areas to update the 

using agency name. It does not alter the 

dimensions, altitudes, or times of 

designation of the airspace; therefore, it 

is not expected to cause any potentially 

significant environmental impacts, and 

no extraordinary circumstances exists 

that warrant preparation of an 

environmental assessment. 

List of Subjects in 14 CFR Part 73 

Airspace, Prohibited areas, Restricted 

areas. 

Adoption of the Amendment 

■ In consideration of the foregoing, the 

Federal Aviation Administration 

amends 14 CFR part 73, as follows: 

PART 73—SPECIAL USE AIRSPACE 

■ 1. The authority citation for part 73 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40103, 40113, 

40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– 

1963 Comp., p. 389. 

§ 73.40 [Amended] 

■ 2. § 73.40 is amended as follows: 

* * * * * 

1. R–4002 Bloodsworth Island, MD 

[Amended] 

By removing the words ‘‘Using 

agency. Commanding Officer, Naval 

Amphibious School Little Creek, 

Norfolk, VA’’ and inserting the words 

‘‘Using agency. U.S. Navy, Commanding 

Officer, NAS Patuxent River, MD.’’ 

2. R–4005 Patuxent River, MD 

[Amended] 

By removing the words ‘‘Using 

agency. Commanding Officer, NAS 

Patuxent River, MD’’ and inserting the 

words ‘‘Using agency. U.S. Navy, 

Commanding Officer, NAS Patuxent 

River, MD.’’ 

3. R–4006 Patuxent River, MD 

[Amended] 

By removing the words ‘‘Using 

agency. Commanding Officer, NAS 

Patuxent River, MD’’ and inserting the 

words ‘‘Using agency. U.S. Navy, 

Commanding Officer, NAS Patuxent 

River, MD.’’ 

4. R–4007 Patuxent River, MD 

[Amended] 

By removing the words ‘‘Using 

agency. Commanding Officer, NAS 

Patuxent River, MD’’ and inserting the 

words ‘‘Using agency. U.S. Navy, 

Commanding Officer, NAS Patuxent 

River, MD.’’ 

Issued in Washington, DC, on November 4, 

2010. 

Edith V. Parish, 

Manager, Airspace, Regulations and ATC 

Procedures Group. 

[FR Doc. 2010–28387 Filed 11–9–10; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 73 

[Docket No. FAA–2010–1071; Airspace 

Docket No. 10–ASO–28] 

RIN 2120–AA66 

Amendment of Using Agency for 

Restricted Areas R–5301; R–5302A, B, 

and C; and R–5313A, B, C and D; NC 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule. 

SUMMARY: This action makes a minor 

change to the name of the using agency 

for restricted areas R–5301 Albemarle 

Sound, NC; R–5302A, B and C, Harvey 

Point, NC; and R–5313A, B, C and D, 

Long Shoal Point, NC to read ‘‘U.S. 

Navy, Fleet Area Control and 

Surveillance Facility, Virginia Capes 

(FACSFAC VACAPES), Virginia Beach, 

VA.’’ This is an administrative change 

only and there are no changes to the 


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Federal Register / Vol. 75, No. 217 / Wednesday, November 10, 2010 / Rules and Regulations 68971 

dimensions, time of designation or 

activities conducted within the affected 

restricted areas. 

DATES: Effective date 0901 UTC, January 

13, 2011. 

FOR FURTHER INFORMATION CONTACT: Paul 

Gallant, Airspace, Regulations and ATC 

Procedures Group, Office of Airspace 

Systems, Federal Aviation 

Administration, 800 Independence 

Avenue, SW., Washington, DC 20591; 

telephone: (202) 267–8783. 

SUPPLEMENTARY INFORMATION: 

Background 

The U.S. Navy requested a minor 

change to the name of the using agency 

for restricted areas R–5301; R–5302A, B 

and C; and R–5313A, B, C and D, in 

North Carolina by removing the words 

‘‘NAS Oceana’’ from the description in 

order to reflect the organization’s 

current designation. 

The Rule 

This action amends Title 14 Code of 

Federal Regulations (14 CFR) part 73 by 

changing the using agency names for 

restricted area R–5301 Albemarle 

Sound, NC; restricted areas R–5302A, B 

and C, Harvey Point, NC; and restricted 

areas R–5313A, B, C and D, Long Shoal 

Point, NC from ‘‘U.S. Navy, Fleet Area 

Control and Surveillance Facility, 

Virginia Capes (FACSFAC VACAPES), 

NAS Oceana, Virginia Beach, VA,’’ to 

‘‘U.S. Navy, Fleet Area Control and 

Surveillance Facility, Virginia Capes 

(FACSFAC VACAPES), Virginia Beach, 

VA.’’. This is an administrative change 

and does not affect the boundaries, 

designated altitudes, or activities 

conducted within the restricted area; 

therefore, notice and public procedures 

under 5 U.S.C. 553(b) are unnecessary. 

The FAA has determined that this 

action only involves an established 

body of technical regulations for which 

frequent and routine amendments are 

necessary to keep them operationally 

current. Therefore, this regulation: (1) Is 

not a ‘‘significant regulatory action’’ 

under Executive Order 12866; (2) is not 

a ‘‘significant rule’’ under DOT 

Regulatory Policies and Procedures 

(44 FR 11034; February 26, 1979); and 

(3) does not warrant preparation of a 

regulatory evaluation as the anticipated 

impact is so minimal. Since this is a 

routine matter that will only affect air 

traffic procedures and air navigation, it 

is certified that this rule, when 

promulgated, will not have a significant 

economic impact on a substantial 

number of small entities under the 

criteria of the Regulatory Flexibility Act. 

Environmental Review 

The FAA has determined that this 

action qualifies for categorical exclusion 

under the National Environmental 

Policy Act in accordance with 311d., 

FAA Order 1050.1E, Environmental 

Impacts: Policies and Procedures. This 

airspace action is an administrative 

change to the descriptions of the 

affected restricted areas to update the 

using agency name. It does not alter the 

dimensions, altitudes, or times of 

designation of the airspace; therefore, it 

is not expected to cause any potentially 

significant environmental impacts, and 

no extraordinary circumstances exist 

that warrant preparation of an 

environmental assessment. 

List of Subjects in 14 CFR Part 73 

Airspace, Prohibited areas, Restricted 

areas. 

Adoption of the Amendment 

■ In consideration of the foregoing, the 

Federal Aviation Administration 

amends 14 CFR part 73, as follows: 

PART 73—SPECIAL USE AIRSPACE 

■ 1. The authority citation for part 73 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40103, 40113, 

40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– 

1963 Comp., p. 389. 

§ 73.53 [Amended] 

■ 2. § 73.53 is amended as follows: 

* * * * * 

1. R–5301 Albemarle Sound, NC 

[Amended] 

By removing the words ‘‘Using 

agency. U.S. Navy, Fleet Area Control 

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.’’ 

2. R–5302A Harvey Point, NC 

[Amended] 

By removing the words ‘‘Using 

agency. U.S. Navy, Fleet Area Control 

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.’’ 

3. R–5302B Harvey Point, NC 

[Amended] 

By removing the words ‘‘Using 

agency. U.S. Navy, Fleet Area Control 

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.’’ 

4. R–5302C Harvey Point, NC 

[Amended] 

By removing the words ‘‘Using 

agency. U.S. Navy, Fleet Area Control 

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.’’ 

5. R–5313A Long Shoal Point, NC 

[Amended] 

By removing the words ‘‘Using 

agency. U.S. Navy, Fleet Area Control 

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.’’ 

6. R–5313B Long Shoal Point, NC 

[Amended] 

By removing the words ‘‘Using 

agency. U.S. Navy, Fleet Area Control 

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.’’ 

7. R–5313C Long Shoal Point, NC 

[Amended] 

By removing the words ‘‘Using 

agency. U.S. Navy, Fleet Area Control 

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.’’ 

8. R–5313D Long Shoal Point, NC 

[Amended] 

By removing the words ‘‘Using 

agency. U.S. Navy, Fleet Area Control 


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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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