Federal Register / Vol. 76, No. 56 / Wednesday, March 23, 2011 / Proposed Rules 16349 

International Airport, Duluth, MN. 

Controlled airspace is needed for the 

safety and management of IFR 

operations at the airport. Geographic 

coordinates would also be updated to 

coincide with the FAA’s aeronautical 

database. 

Class E airspace areas are published 

in Paragraphs 6004 and 6005, 

respectively, of FAA Order 7400.9U, 

dated August 18, 2010 and effective 

September 15, 2010, which is 

incorporated by reference in 14 CFR 

71.1. The Class E airspace designation 

listed in this document would be 

published subsequently in the Order. 

The FAA has determined that this 

proposed regulation only involves an 

established body of technical 

regulations for which frequent and 

routine amendments are necessary to 

keep them operationally current. It, 

therefore, (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. 

The FAA’s authority to issue rules 

regarding aviation safety is found in 

Title 49 of the U.S. Code. Subtitle 1, 

section 106 describes the authority of 

the FAA Administrator. Subtitle VII, 

Aviation Programs, describes in more 

detail the scope of the agency’s 

authority. This rulemaking is 

promulgated under the authority 

described in subtitle VII, part A, subpart 

I, section 40103. Under that section, the 

FAA is charged with prescribing 

regulations to assign the use of airspace 

necessary to ensure the safety of aircraft 

and the efficient use of airspace. This 

regulation is within the scope of that 

authority as it would amend controlled 

airspace at Duluth International Airport, 

Duluth, MN. 

List of Subjects in 14 CFR Part 71 

Airspace, Incorporation by reference, 

Navigation (air). 

The Proposed Amendment 

In consideration of the foregoing, the 

Federal Aviation Administration 

proposes to amend 14 CFR part 71 as 

follows: 

PART 71—DESIGNATION OF CLASS A, 

B, C, D, AND E AIRSPACE AREAS; AIR 

TRAFFIC SERVICE ROUTES; AND 

REPORTING POINTS 

1. The authority citation for part 71 

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. 

§ 71.1 [Amended] 

2. The incorporation by reference in 

14 CFR 71.1 of FAA Order 7400.9U, 

Airspace Designations and Reporting 

Points, dated August 18, 2010, and 

effective September 15, 2010, is 

amended as follows: 

Paragraph 6004 Class E Airspace areas 

designated as an extension to a Class D or 

Class E Surface Area. 

* * * * * 

AGL MN E4 Duluth, MN [Amended] 

Duluth International Airport, MN 

(Lat. 46°50′32′′ N., long. 92°11′37′′ W.) 

Duluth VORTAC 

(Lat. 46°48′08′′ N., long. 92°12′10′′ W.) 

That airspace extending upward from the 

surface within 3.4 miles each side of the 

Duluth VORTAC 193° radial extending from 

the 4.9-mile radius of Duluth International 

Airport to 14.2 miles south of the VORTAC, 

and within 3.6 miles each side of the 267° 

bearing from Duluth International Airport 

extending from the 4.9-mile radius of the 

airport to 9.7 miles west of the airport. 

Paragraph 6005 Class E Airspace areas 

extending upward from 700 feet or more 

above the surface of the earth. 

* * * * * 

AGL MN E5 Duluth, MN [Amended] 

Duluth International Airport, MN 

(Lat. 46°50′32′′ N., long. 92°11′37′′ W.) 

That airspace extending upward from the 

700 feet above the surface within a 7.1-mile 

radius of Duluth International Airport, and 

within 4.4 miles each side of the 267° bearing 

from the airport extending from the 7.1-mile 

radius to 7.7 miles west of the airport. 

Issued in Fort Worth, TX, on March 15, 

2011. 

Richard J. Kervin, Jr., 

Acting Manager, Operations Support Group, 

ATO Central Service Center. 

[FR Doc. 2011–6847 Filed 3–22–11; 8:45 am] 

BILLING CODE 4901–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Chapter 1 

Notice of Policy Regarding Civil 

Aircraft Operators Providing Contract 

Support to Government Entities 

(Public Aircraft Operations) 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Notification of policy change; 

request for comments. 

SUMMARY: This notice states the Federal 

Aviation Administration’s (FAA) policy 

pertaining to civil aircraft operators that 

provide contract support to government 

entities. 

DATES: Comments must be received 

before April 22, 2011. 

ADDRESSES: This is a statement of policy 

only. We are accepting comments 

concerning the implementation of this 

policy only from government entities 

via e-mail at PublicAircraft@faa.gov. 

FOR FURTHER INFORMATION CONTACT: 

Monica C. Buenrostro, General Aviation 

and Commercial Division, Flight 

Standards Service, AFS–800, Federal 

Aviation Administration, 800 

Independence Avenue, SW., 

Washington, DC 20591; telephone: (202) 

267–8212; e-mail: 

monica.c.buenrostro@faa.gov. 

SUPPLEMENTARY INFORMATION: Title 49 of 

the United States Code (U.S.C), section 

40102 (a)(41) provides the definition of 

‘‘Public Aircraft’’ and Title 49 U.S.C 

40125 provides the Qualifications for 

Public Aircraft Status. These statutory 

provisions provide the legal basis for 

public aircraft operations in the United 

States. 

The FAA recognizes that these 

statutory provisions are difficult to 

apply to aircraft operations conducted 

by civil contractors for government 

entities. The FAA is therefore clarifying 

its policy toward these operators by 

better defining the responsibilities of the 

parties affected by these contracts. 

Public Aircraft Operation is limited 

by the statute to certain government 

operations within U.S. airspace. 

Although these operations must comply 

with certain general operating rules 

(including those applicable to all 

aircraft in the National Airspace 

System), other civil certification and 

safety oversight regulations do not 

apply. Whether an operation may be 

considered public is determined on a 

flight-by-flight basis, under the terms of 

the statute (49 U.S.C 40102 and 49 

U.S.C 40125) and considers aircraft 


jlentini on DSKJ8SOYB1PROD with PROPOSALS
16350 Federal Register / Vol. 76, No. 56 / Wednesday, March 23, 2011 / Proposed Rules 

ownership, operator, the purpose of the 

flight and the persons on board the 

aircraft. 

FAA Policy 

• Public aircraft status is not an 

‘‘automatic’’ status granted by the 

existence of a contract between a civil 

operator and a government agency. 

• The FAA considers ALL contracted 

operations to be civil aircraft operations, 

unless: 

• The contracting government entity 

provides the operator with a written 

declaration (from the contracting officer 

or higher-level official) of public aircraft 

status for designated, qualified flights; 

• The contracted operator notifies the 

FAA Flight Standards District Office 

(FSDO) having oversight of the operator 

(or the operation, as appropriate) that it 

has contracted with a government entity 

to conduct ‘‘eligible’’ public aircraft 

operations; 

• The contracted operator submits the 

written declaration to the FSDO with 

jurisdiction having oversight; 

• The flight(s) in question are 

determined to be legitimate public 

aircraft operations under the terms of 

the statute; and 

• The declaration is made in advance 

of the proposed public aircraft flight. 

• To implement this policy and 

collect data, the FSDO having oversight 

of the contracted operator will record 

receipt of these declarations by 

electronic means. 

Contracted government entities are 

cautioned that public aircraft operations 

performed by civil operators create a 

significant transfer of liability to the 

contracting government entity, and that 

FAA oversight ceases. 

Civil operators are cautioned that 

unless there is a declaration of public 

aircraft status, all operations must be 

conducted in accordance with all 

applicable civil aviation regulations, 

and that the FAA retains oversight and 

enforcement authority for any deviation 

from the provisions of Title 14 of the 

Code of Federal Regulations (14 CFR). 

Operators are also cautioned that it is 

their responsibility to refuse a contract 

to perform operations that violate 14 

CFR if they cannot ensure that the 

government entity offering the contract 

has declared that operation as a public 

aircraft operation and that such flight 

meets the public aircraft eligibility 

requirements as outlined in the statute. 

The FAA is revising Advisory 

Circular 00.1–1, Government Aircraft 

Operations, and FAA Order 8900.1, 

Flight Standards Information 

Management System. These revisions 

will more fully address public aircraft 

policy issues and implementation. 

Government entities with experience 

using civil operators under contract are 

invited to share their experience and 

suggestions concerning implementation 

of this policy. Government entities may 

submit comments to 

PublicAircraft@faa.gov to be considered 

as the FAA continues to refine the 

public aircraft operations policy. 

Issued in Washington, DC, on March 17, 

2011. 

John W. McGraw, 

Acting Director, Flight Standards Service. 

[FR Doc. 2011–6894 Filed 3–22–11; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 866 

[Docket No. FDA–2010–N–0029] 

Medical Devices; Ovarian Adnexal 

Mass Assessment Score Test System; 

Labeling; Black Box Restrictions 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is proposing to 

amend the regulation classifying ovarian 

adnexal mass assessment score test 

systems to restrict these devices so that 

a prescribed warning statement that 

addresses a risk identified in the special 

controls guidance document must be in 

a black box and must appear in all 

labeling, advertising, and promotional 

material. The black box warning 

mitigates the risk to health associated 

with off-label use as a screening test, 

stand-alone diagnostic test, or as a test 

to determine whether or not to proceed 

with surgery. Elsewhere in this issue of 

the Federal Register, FDA is 

announcing a final rule that classifies 

the ovarian adnexal mass assessment 

score test system into class II (special 

controls). 

DATES: Submit either electronic or 

written comments by May 23, 2011. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2010–N– 

0029, by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• Fax: 301–827–6870. 

• Mail/Hand delivery/Courier (for 

paper, disk, or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

Instructions: All submissions received 

must include the Agency name and 

Docket No. FDA–2010–N–0029. All 

comments received may be posted 

without change to http:// 

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Scott McFarland, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 5543, Silver Spring, 

MD 20993–0002, 301–796–6217. 

SUPPLEMENTARY INFORMATION: 

I. What is the background of this 

proposed rule? 

A. Ovarian Adnexal Mass Assessment 

Score Test System 

An ovarian adnexal mass assessment 

score test system measures one or more 

analytes in serum and combines the 

values into a single score that is then 

used to determine the likelihood that 

the pre-surgical adnexal mass in a 

woman not yet referred to an oncologist, 

is malignant. An ovarian adnexal mass 

assessment score test system is intended 

for use in those patients for whom 

surgery is planned, and should not be 

used to decide whether or not a patient 

should receive surgery. The test is used 

in conjunction with a clinical and 

radiological evaluation of the patient by 

physicians in determining whether the 

patient should be referred to a 

gynecologic oncologist for surgery. 

B. Identified Risk to Health 

The ovarian adnexal mass assessment 

score test system is not indicated for use 

as a screening or diagnostic test for 

ovarian cancer. Off-label use of the test 

(e.g., in patients who are not already 


jlentini on DSKJ8SOYB1PROD with PROPOSALS