### 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


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

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


### 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