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 


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Federal Register / Vol. 76, No. 56 / Wednesday, March 23, 2011 / Proposed Rules 16351 

identified as needing surgery for pelvic 

mass or without reference to an 

independent clinical/radiological 

evaluation of the patient), may lead to 

a high frequency of unnecessary further 

testing and surgery due to false positive 

results, or to delay in tumor diagnosis 

due to false negative results. 

II. Why is FDA proposing to require 

black box warnings on ovarian adnexal 

mass assessment score test system 

labeling, advertising, and promotional 

material? 

FDA has determined that in order to 

provide reasonable assurance of safety 

and effectiveness, it is necessary to 

restrict the ovarian adnexal mass 

assessment score test system to sale, 

distribution, and use with labeling, 

advertising, and promotional material 

that bears a warning statement in a 

black box that alerts users to the risk 

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. While FDA 

is establishing as a special control 

‘‘Guidance for Industry and FDA Staff; 

Class II Special Controls Guidance 

Document: Ovarian Adnexal Mass 

Assessment Score Test System’’ which 

recommends a black box warning to 

address the risk of off-label use, FDA 

believes it is necessary to require this 

warning in labeling and advertising by 

restricting the device under section 

520(e) of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

360j(e)). A notice of availability of this 

special controls guidance document is 

published elsewhere in this issue of the 

Federal Register. 

In cases in which class II and class III 

devices have significant risks that 

would make the devices unsafe if used 

inappropriately, FDA believes the risks 

need to be explained in warning 

statements placed in a black box that is 

displayed prominently in the labeling, 

advertising, and promotional material to 

ensure awareness by the end user. 

Awareness of these important risks by 

the end user enables these devices to be 

used safely. In this case, a prominent 

black box warning, which alerts the user 

to the limitations of this device, is 

necessary in all labeling, advertising, 

and promotional materials to allow 

ovarian adnexal mass assessment score 

test system devices to be used safely. 

The proposed prominent black box 

warning would read as follows: 

III. What is the legal authority for this 

proposed rule? 

FDA is issuing this proposed rule 

under the authority of section 520(e) of 

the FD&C Act, which authorizes FDA to 

restrict sale, distribution, and use of 

devices upon certain conditions. FDA is 

also issuing this proposed rule under 

general device and administrative 

provisions of the FD&C Act (sections 

501, 510, 513, 515, 520, and 701 (21 

U.S.C. 351, 360, 360c, 360e, 360j, and 

371, respectively)). 

IV. What is the environmental impact 

of this proposed rule? 

FDA has determined under 21 CFR 

25.34(b) and (f) that this action is of a 

type that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

V. What is the economic impact of this 

proposed rule? 

FDA has examined the impacts of the 

proposed rule under Executive Order 

12866 and the Regulatory Flexibility Act 

(5 U.S.C. 601–612), and the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4). Executive Order 12866 directs 

Agencies to assess all costs and benefits 

of available regulatory alternatives and, 

when regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). The 

Agency believes that this proposed rule 

is not a significant regulatory action as 

defined by the Executive order. 

The Regulatory Flexibility Act 

requires Agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because this proposed rule 

would strengthen existing cautions 

against misuse of a new product, the 

Agency proposes to certify that the final 

rule will not have a significant 

economic impact on a substantial 

number of small entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that Agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $135 

million, using the most current (2009) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this proposed rule to result in any 

1-year expenditure that would meet or 

exceed this amount. 

An ovarian adnexal mass assessment 

test system is a device that measures 

one or more proteins in serum to yield 

a single result for the likelihood that an 

adnexal pelvic mass in a woman is 

malignant. Such a test would identify 

women whose planned gynecologic 

surgery would benefit from referral to a 

gynecological oncologist, despite 

negative results from other clinical and 

radiographic tests for ovarian cancer. 

In considering the appropriate level of 

regulatory oversight for this device, FDA 

concluded in classifying the device that 

general and special controls to minimize 

the risk of false positive and false 


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16352 Federal Register / Vol. 76, No. 56 / Wednesday, March 23, 2011 / Proposed Rules 

negative results, and risks associated 

with improper off-label use would 

provide a reasonable assurance of safety 

and effectiveness of the ovarian adnexal 

mass assessment test system. The 

special controls guidance recommends 

use of a black box warning to minimize 

these risks. Without such a strong 

warning, ovarian adnexal mass 

assessment test systems might be used 

as a screening test, stand-alone 

diagnostic test, or as a test to determine 

whether or not to proceed with surgery. 

Off-label use of the test or the use of test 

results without consideration of other 

diagnostic testing and clinical 

assessment could pose a risk for 

morbidity and mortality due to 

nonreferral for oncologic evaluation and 

treatment. 

In order to require the specific black 

box warning on labeling and on all 

advertising and promotional materials 

for the device, FDA is issuing this 

proposed rule under section 520(e) of 

the FD&C Act. Through this action, the 

Agency proposes to require a black box 

warning on product labeling, 

advertising, and promotional materials 

for ovarian adnexal mass assessment 

test systems. This warning would make 

users aware of the limitations of this 

device and the serious risks associated 

with its misuse. With the proposed 

addition of this black box warning to 

product labeling, advertising, and 

marketing materials, the Agency 

concludes there would be a reasonable 

assurance of the safety and effectiveness 

of ovarian adnexal mass assessment test 

systems. 

The economic impact of this proposed 

rule is expected to be very small. We are 

aware of a single manufacturer 

producing a single product that would 

be affected by this black box warning. 

The manufacturer should be able to 

incorporate the warning in the course of 

developing its product labeling. The 

admonition against off-label use for this 

device already exists, so the addition of 

this type of warning is not expected to 

have a significant effect on the market 

for this product. The expected impact of 

this proposal on the market for this 

product would be a reduction in offlabel use among the small number of 

users who would be undeterred by a 

less visible warning. 

The Regulatory Flexibility Act 

requires Agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. This proposal would impose 

almost no cost on manufacturers. The 

proposed black box warning would 

strengthen an existing admonition 

against off-label use and would not 

significantly affect usage. Impacts on 

any entities would be so small as to be 

difficult to quantify. For these reasons, 

the Agency proposes to certify that this 

rule would not have a significant 

economic impact on a substantial 

number of small entities. 

VI. How does the Paperwork Reduction 

Act of 1995 apply to this proposed rule? 

FDA concludes that labeling 

provisions of this proposed rule are not 

subject to review by the Office of 

Management and Budget because they 

do not constitute a ‘‘collection of 

information’’ under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). Rather, the black box warning on 

all labeling, advertising, and 

promotional materials for ovarian 

adnexal mass assessment score test 

system devices is a ‘‘public disclosure of 

information originally supplied by the 

Federal Government to the recipient for 

the purpose of disclosure to the public.’’ 

(see 5 CFR 1320.3(c)(2)). 

VII. What are the federalism impacts of 

this proposed rule? 

FDA has analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. Section 

4(a) of the Executive order requires 

Agencies to ‘‘construe * * * a Federal 

statute to preempt State law only where 

the statute contains an express 

preemption provision or there is some 

other clear evidence that the Congress 

intended preemption of State law, or 

where the exercise of State authority 

conflicts with the exercise of Federal 

authority under the Federal statute.’’ 

Federal law includes an express 

preemption provision that preempts 

certain State requirements ‘‘different 

from or in addition to’’ certain Federal 

requirements applicable to devices (21 

U.S.C. 360k; See Medtronic v. Lohr, 518 

U.S. 470 (1996); Riegel v. Medtronic, 

Inc., 552 U.S. 312 (2008)). If this 

proposed rule is made final, the final 

rule would create a requirement under 

21 U.S.C. 360k for a black box warning 

statement that must appear in all 

advertising, labeling, and promotional 

material for ovarian adnexal mass 

assessment score test systems. 

VIII. How do you submit comments on 

this proposed rule? 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

List of Subjects in 21 CFR Part 866 

Biologics, Laboratories, Medical 

devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, FDA proposes to 

amend 21 CFR part 866 as follows. 

PART 866—IMMUNOLOGY AND 

MICROBIOLOGY DEVICES 

1. The authority citation for 21 CFR 

part 866 continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 371. 

2. In § 866.6050 of subpart G, add new 

paragraph (c) to read as follows: 

§ 866.6050 Ovarian adnexal mass 

assessment score test system. 

* * * * * 

(c) Black Box Warning. Under section 

520(e) of the Federal Food, Drug, and 

Cosmetic Act these devices are subject 

to the following restriction: A warning 

statement must be placed in a black box 

and must appear in all advertising, 

labeling, and promotional material for 

these devices. That warning statement 

must read: 


jlentini on DSKJ8SOYB1PROD with PROPOSALS
Federal Register / Vol. 76, No. 56 / Wednesday, March 23, 2011 / Proposed Rules 16353 

Dated: March 16, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–6621 Filed 3–22–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF STATE 

22 CFR Part 123 

[Public Notice: 7384] 

RIN 1400–AC71 

International Traffic in Arms 

Regulations: Exemption for Temporary 

Export of Chemical Agent Protective 

Gear 

AGENCY: Department of State. 

ACTION: Proposed rule. 

SUMMARY: The Department of State is 

proposing to amend the International 

Traffic in Arms Regulations (ITAR) to 

add an exemption for the temporary 

export of chemical agent protective gear 

for exclusive personal use to 

destinations not subject to restrictions 

and to Afghanistan and Iraq under 

specified conditions. Additionally, an 

exemption for firearms and ammunition 

is clarified by removing certain 

extraneous language that does not 

change the meaning of the exemption. 

DATES: The Department of State will 

accept comments on this proposed rule 

until May 23, 2011. 

ADDRESSES: Interested parties may 

submit comments within 60 days of the 

date of the publication by any of the 

following methods: 

• E-mail: 

DDTCResponseTeam@state.gov, with 

the subject line, ‘‘Regulatory Change— 

Section 123.17.’’ 

• Mail: Department of State, 

Directorate of Defense Trade Controls, 

Office of Defense Trade Controls Policy, 

ATTN: Regulatory Change—Section 

123.17, SA–1, 12th Floor, Washington, 

DC 20522–0112. 

• Internet: View this notice by going 

to the regulations.gov Web site at 

http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Nicholas Memos, Office of Defense 

Trade Controls Policy, Department of 

State, Telephone (202) 663–2804, or Fax 

(202) 261–8199; e-mail 

memosni@state.gov. ATTN: Regulatory 

Change, Sec. 123.17. 

SUPPLEMENTARY INFORMATION: U.S. 

individuals are traveling to hazardous 

areas in foreign countries where they 

need to wear body armor or chemical 

agent protective gear for personal safety. 

In August 2009, the ITAR was amended 

to provide an exemption for the 

temporary export of body armor covered 

by 22 CFR 121.1, Category X(a)(1). Now, 

the Department of State is proposing to 

amend the ITAR at §§ 123.17(f) and (g) 

to add an exemption for the temporary 

export of chemical agent protective gear 

covered by 22 CFR 121.1, Category 

XIV(f)(4). The proposed exemption will 

be available for temporary exports to 

countries not subject to restrictions 

under ITAR § 126.1 and to Afghanistan 

and Iraq under specified conditions. In 

order to use the exemption, the 

chemical agent protective gear must be 

for the individual’s exclusive use and 

must be returned to the United States. 

The individual may not re-export the 

protective gear to a foreign person or 

otherwise transfer ownership. The 

protective gear may not be exported to 

any country where the importation 

would be in violation of that country’s 

laws. 

In the event the chemical agent 

protective gear is lost, stolen or 

otherwise not returned to the United 

States with the individual that 

temporarily exported the gear, a detailed 

report about the incident must be 

submitted to the Office of Defense Trade 

Controls Compliance. If the chemical 

agent protective gear is lost, the report 

should describe all attempts to locate 

the gear and explain the circumstances 

leading to its loss. In the event the 

chemical agent protective gear is used 

and disposed according to HAZMAT 

guidelines, the report should provide a 

disposal date and location details for the 

approved HAZMAT facility used, along 

with a receipt for disposal services. If a 

HAZMAT facility is not available, the 

report should describe the date, location 

and method used to dispose of the 

protective gear. 

The proposed change removes at 

(g)(2) the requirement that assistance to 

the government of Iraq be 

‘‘humanitarian’’ to more accurately 

match the language of United Nations 

Security Council restrictions, which do 

not limit assistance to humanitarian 

assistance. 

Section (c)(3) is to be revised to 

remove what is in practice extraneous 

language. Subject to the requirements of 

(c)(1)–(3), the exemption applies to all 

eligible individuals (with the noted 

exceptions). Thus, while the text is 

revised, the meaning of (c)(3) is not 

changed. 

Regulatory Analysis and Notices 

Administrative Procedure Act 

The Department of State is of the 

opinion that controlling the import and 

export of defense articles and services is 

a foreign affairs function of the United 

States Government and that rules 

implementing this function are exempt 

from section 553 (Rulemaking) and 

section 554 (Adjudications) of the 

Administrative Procedure Act. Although 

the Department is of the opinion that 

this rule is exempt from the rulemaking 

provisions of the APA, the Department 

is publishing this rule with a 60-day 

provision for public comment and 

without prejudice to its determination 

that controlling the import and export of 

defense services is a foreign affairs 

function. 

Regulatory Flexibility Act 

Since this proposed amendment is not 

subject to the notice and comment 

procedures of 5 U.S.C. 553, it does not 

require analysis under the Regulatory 

Flexibility Act. 


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