16294 Federal Register / Vol. 76, No. 56 / Wednesday, March 23, 2011 / Rules and Regulations 

proposing to require the application of 

the black box warning to labeling and 

advertising through notice and comment 

rulemaking. For the purposes of this 

analysis, we assume that this final rule 

will establish special controls with a 

reference to a black box warning 

regarding off-label use, but the analysis 

of the impact of the addition of the 

warning to the product label will be 

included in a separate rulemaking. 

B. Costs of the Final Rule 

This final rule is deregulatory. Device 

manufacturers currently subject to class 

III requirements will be subject to the 

less burdensome requirements for 

makers of class II devices. Through this 

classification, manufacturers of ovarian 

adnexal mass assessment test system 

devices will be relieved of the obligation 

to submit a PMA prior to marketing. The 

cost of submitting a PMA can reach 

$1,000,000, plus user fees of an 

additional $217,787 in FY 2010, 

increasing to $256,384 in 2012. This 

device classification will substantially 

reduce an existing burden on 

manufacturers of ovarian adnexal mass 

assessment test system devices. 

Considering the cost of submitting a 

PMA plus the relevant user fees, the 

reduction could be $1,000,000 per 

device. 

The Regulatory Flexibility Act 

requires Agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Classification of the affected 

device into class II after it had 

automatically been placed in class III 

will relieve manufacturers of the cost of 

complying with the premarket approval 

requirements of section 515 of the FD&C 

Act. Because of the reduced burden, the 

Agency does not believe that this final 

rule will have a significant economic 

impact on a substantial number of small 

entities. 

VII. Federalism 

FDA has analyzed this final 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 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). The special 

controls established by this rulemaking 

create ‘‘requirements’’ to address each 

identified risk to health presented by 

these specific medical devices under 21 

U.S.C. 360k, even though product 

sponsors may have flexibility in how 

they meet those requirements. Cf. 

Papike v. Tambrands, Inc., 107 F.3d 

737, 740–42 (9th Cir. 1997). 

VIII. Paperwork Reduction Act of 1995 

This final rule establishes as special 

controls a guidance document that 

refers to previously approved 

collections of information found in 

other FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3520). 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a notice 

announcing the availability of the 

guidance document entitled ‘‘Guidance 

for Industry and FDA Staff; Class II 

Special Controls Guidance Document: 

Ovarian Adnexal Mass Assessment 

Score Test System.’’ The notice contains 

an analysis of the paperwork burden for 

the guidance. 

IX. References 

The following reference has been 

placed on display in the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852, 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

1. Petition from Vermillion, Inc., for 

reclassification of the OVA1TM Test 

submitted July 22, 2009. 

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, 21 CFR part 866 is 

amended 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. Section 866.6050 is added to 

subpart G to read as follows: 

§ 866.6050 Ovarian adnexal mass 

assessment score test system. 

(a) Identification. An ovarian/adnexal 

mass assessment test system is a device 

that measures one or more proteins in 

serum or plasma. It yields a single result 

for the likelihood that an adnexal pelvic 

mass in a woman, for whom surgery is 

planned, is malignant. The test is for 

adjunctive use, in the context of a 

negative primary clinical and 

radiological evaluation, to augment the 

identification of patients whose 

gynecologic surgery requires oncology 

expertise and resources. 

(b) Classification. Class II (special 

controls). The special control for this 

device is FDA’s guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Ovarian Adnexal 

Mass Assessment Score Test System.’’ 

For the availability of this guidance 

document, see § 866.1(e). 

Dated: March 16, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–6620 Filed 3–22–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2011–0100] 

RIN 1625–AA09 

Drawbridge Operation Regulation; 

Buffalo Bayou, Mile 4.3, Houston, 

Harris County, TX 

AGENCY: Coast Guard, DHS. 

ACTION: Final rule. 

SUMMARY: The Coast Guard is removing 

the existing drawbridge operation 

regulation for the drawbridge across 

Buffalo Bayou, mile 4.3, Houston, Harris 

County, Texas. The bridge was replaced 

with a fixed bridge in 1991 and the 

operating regulation is no longer 

applicable or necessary. 

DATES: This rule is effective March 23, 

2011. 

ADDRESSES: Documents indicated in this 

preamble as being available in the 

docket, are part of docket USCG–2011– 

0100 and are available by going to 

http://www.regulations.gov, inserting 

USCG–2011–0100 in the ‘‘Keyword’’ 

box, and then clicking ‘‘Search.’’ This 

material is also available for inspection 

or copying at the Docket Management 

Facility (M–30), U.S. Department of 

Transportation, West Building Ground 


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Federal Register / Vol. 76, No. 56 / Wednesday, March 23, 2011 / Rules and Regulations 16295 

Floor, Room W12–140, 1200 New Jersey 

Avenue, SE., Washington, DC 20590, 

between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

e-mail Mr. Jim Wetherington, Bridge 

Specialist, Coast Guard; telephone 504– 

671–2128, e-mail 

james.r.wetherington@uscg.mil. If you 

have questions on viewing the docket, 

call Renee V. Wright, Program Manager, 

Docket Operations, telephone 202–366– 

9826. 

SUPPLEMENTARY INFORMATION: 

Regulatory Information 

The Coast Guard is issuing this final 

rule without prior notice and 

opportunity to comment pursuant to 

authority under section 4(a) of the 

Administrative Procedure Act (APA) (5 

U.S.C. 553(b)). This provision 

authorizes an agency to issue a rule 

without prior notice and opportunity to 

comment when the agency for good 

cause finds that those procedures are 

‘‘impracticable, unnecessary, or contrary 

to the public interest.’’ Under 5 U.S.C. 

553(b), the Coast Guard finds that good 

cause exists for not publishing a notice 

of proposed rulemaking (NPRM) with 

respect to this rule because the 

drawbridge requiring draw operations in 

33 CFR 117.955(b), was removed and 

replaced with a fixed span bridge in 

1991. The bridge operator and those 

transiting in the vicinity of this bridge 

have not been governed by the draw 

operations since the bridge was 

removed and replaced. Therefore, the 

regulation is no longer applicable and 

should be removed from publication. 

Under 5 U.S.C. 553(d)(1), a rule that 

relieves a restriction is not required to 

provide the 30 day notice period before 

its effective date. This rule removes the 

draw operations requirements under 33 

CFR 117.955(b), thus removing a 

regulatory restriction on the public. 

Additionally, under 5 U.S.C. 553(d)(3), 

the Coast Guard finds that good cause 

exists for making this rule effective in 

less than 30 days after publication in the 

Federal Register. The bridge has been a 

fixed bridge for 20 years and this rule 

only requires an administrative change 

to the Federal Register, omitting a 

regulatory requirement that is no longer 

applicable or necessary. 

Basis and Purpose 

The drawbridge across Buffalo Bayou, 

mile 4.3, was removed and replaced 

with a fixed bridge in 1991. The 

elimination of this drawbridge 

necessitates the removal of the 

drawbridge operation regulation 

pertaining to this drawbridge. 

The regulation governing the 

operation of the bridge is found in 33 

CFR 117.955(b). The purpose of this rule 

is to remove the section of 33 CFR 

117.955 (b) that refers to the bridge at 

mile 4.3, from the Code of Federal 

Regulations since it governs a bridge 

that is no longer able to be opened. 

Discussion of Rule 

The Coast Guard is changing the 

regulation in 33 CFR 117 by removing 

restrictions and the regulatory burden 

related to the draw operations for this 

bridge that is no longer in existence 

without publishing an NPRM. The 

change removes the section of the 

regulation governing the bridge since 

the bridge has been replaced with a 

fixed bridge. This change does not affect 

vessel operators using the waterway. 

Thus, it is not necessary to publish an 

NPRM. 

Regulatory Analyses 

We developed this rule after 

considering numerous statutes and 

executive orders related to rulemaking. 

Below we summarize our analyses 

based on 13 of these statutes or 

executive orders. 

Regulatory Planning and Review 

This rule is not a significant 

regulatory action under section 3(f) of 

Executive Order 12866, Regulatory 

Planning and Review, and does not 

require an assessment of potential costs 

and benefits under section 6(a)(3) of that 

Order. The Office of Management and 

Budget has not reviewed it under that 

Order. 

The Coast Guard does not consider 

this rule to be ‘‘significant’’ under that 

Order because it is an administrative 

change and does not affect the way 

vessels operate on the waterway. 

Small Entities 

Under the Regulatory Flexibility Act 

(5 U.S.C. 601 et seq.), the Coast Guard 

considers whether this final rule will 

have a significant economic impact on 

a substantial number of small entities. 

‘‘Small entities’’ include (1) small 

businesses, not-for-profit organizations 

that are independently owned and 

operated and are not dominant in their 

fields, and (2) governmental 

jurisdictions with populations of less 

than 50,000. 

Since the drawbridge across the 

Buffalo Bayou, mile 4.3 at Houston, 

Texas, has been removed and replaced 

with a fixed bridge, the regulation 

governing draw operations for this 

bridge is no longer needed. There is no 

new restriction or regulation being 

imposed by this rule; therefore, the 

Coast Guard certifies under 5 U.S.C. 

605(b) that this final rule will not have 

a significant economic impact on a 

substantial number of small entities. 

Collection of Information 

This rule calls for no new collection 

of information under the Paperwork 

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

3520). 

Federalism 

A rule has implications for federalism 

under Executive Order 13132, 

Federalism, if it has a substantial direct 

effect on State or local governments and 

would either preempt State law or 

impose a substantial direct cost of 

compliance on them. We have analyzed 

this rule under that Order and have 

determined that it does not have 

implications for federalism. 

Unfunded Mandates Reform Act 

The Unfunded Mandates Reform Act 

of 1995 (2 U.S.C. 1531–1538) requires 

Federal agencies to assess the effects of 

their discretionary regulatory actions. In 

particular, the Act addresses actions 

that may result in the expenditure by a 

State, local, or tribal government, in the 

aggregate, or by the private sector of 

$100,000,000 (adjusted for inflation) or 

more in any one year. Though this rule 

will not result in such an expenditure, 

we do discuss the effects of this rule 

elsewhere in this preamble. 

Taking of Private Property 

This rule will not cause a taking of 

private property or otherwise have 

taking implications under Executive 

Order 12630, Governmental Actions and 

Interference with Constitutionally 

Protected Property Rights. 

Civil Justice Reform 

This rule meets applicable standards 

in sections 3(a) and 3(b)(2) of Executive 

Order 12988, Civil Justice Reform, to 

minimize litigation, eliminate 

ambiguity, and reduce burden. 

Protection of Children 

We have analyzed this rule under 

Executive Order 13045, Protection of 

Children from Environmental Health 

Risks and Safety Risks. This rule is not 

an economically significant rule and 

would not create an environmental risk 

to health or risk to safety that might 

disproportionately affect children. 

Indian Tribal Governments 

This rule does not have tribal 

implications under Executive Order 

13175, Consultation and Coordination 

with Indian Tribal Governments, 

because it does not have a substantial 


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16296 Federal Register / Vol. 76, No. 56 / Wednesday, March 23, 2011 / Rules and Regulations 

direct effect on one or more Indian 

tribes, on the relationship between the 

Federal Government and Indian tribes, 

or on the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes. 

Energy Effects 

We have analyzed this rule under 

Executive Order 13211, Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use. We have 

determined that it is not a ‘‘significant 

energy action’’ under that order because 

it is not a ‘‘significant regulatory action’’ 

under Executive Order 12866 and is not 

likely to have a significant adverse effect 

on the supply, distribution, or use of 

energy. The Administrator of the Office 

of Information and Regulatory Affairs 

has not designated it as a significant 

energy action. Therefore, it does not 

require a Statement of Energy Effects 

under Executive Order 13211. 

Technical Standards 

The National Technology Transfer 

and Advancement Act (NTTAA) 

(15 U.S.C. 272 note) directs agencies to 

use voluntary consensus standards in 

their regulatory activities unless the 

agency provides Congress, through the 

Office of Management and Budget, with 

an explanation of why using these 

standards would be inconsistent with 

applicable law or otherwise impractical. 

Voluntary consensus standards are 

technical standards (e.g., specifications 

of materials, performance, design, or 

operation; test methods; sampling 

procedures; and related management 

systems practices) that are developed or 

adopted by voluntary consensus 

standards bodies. 

This rule does not use technical 

standards. Therefore, we did not 

consider the use of voluntary consensus 

standards. 

Environment 

We have analyzed this rule under 

Department of Homeland Security 

Management Directive 023–01 and 

Commandant Instruction M16475.lD, 

which guides the Coast Guard in 

complying with the National 

Environmental Policy Act of 1969 

(NEPA) (42 U.S.C. 4321–4370f), and 

have concluded that this action is one 

of a category of actions which do not 

individually or cumulatively have a 

significant effect on the human 

environment. This rule is categorically 

excluded, under figure 2–1, paragraph 

(32)(e), of the Instruction. 

Under figure 2–1, paragraph (32)(e), of 

the Instruction, an environmental 

analysis checklist and a categorical 

exclusion determination are not 

required for this rule. 

List of Subjects in 33 CFR Part 117 

Bridges. 

For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 117 as follows: 

PART 117—DRAWBRIDGE 

OPERATION REGULATIONS 

■ 1. The authority citation for part 117 

continues to read as follows: 

Authority: 33 U.S.C. 499; 33 CFR 1.05–1; 

Department of Homeland Security Delegation 

No. 0170.1. 

■ 2. Revise § 117.955 (b) to read as 

follows: 

§ 117.955 Buffalo Bayou. 

* * * * * 

(b) The draw of the Union Pacific Rail 

Road Bridge, mile 3.1, need not be 

opened to the passage of vessels. 

Dated: March 10, 2011. 

Mary E. Landry, 

Rear Admiral, U.S. Coast Guard, Commander, 

Eighth Coast Guard District. 

[FR Doc. 2011–6876 Filed 3–22–11; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2011–0113] 

Drawbridge Operation Regulation; 

Pocomoke River, Snow Hill, MD 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of temporary deviation 

from regulations. 

SUMMARY: The Commander, Fifth Coast 

Guard District, has issued a temporary 

deviation from the regulations 

governing the operation of the S12 

Bridge across Pocomoke River, mile 

29.9, at Snow Hill, MD. The deviation 

restricts the operation of the draw span 

to facilitate the cleaning and painting of 

the bridge. 

DATES: This deviation is effective from 

7 a.m. on March 15, 2011 through 11:59 

p.m. on May 30, 2011. 

ADDRESSES: Documents mentioned in 

this preamble as being available in the 

docket are part of docket USCG–2011– 

0113 and are available online by going 

to http://www.regulations.gov, inserting 

USCG–2011–0113 in the ‘‘Keyword’’ box 

and then clicking ‘‘Search’’. They are 

also available for inspection or copying 

at the Docket Management Facility (M– 

30), U.S. Department of Transportation, 

West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue, SE., 

Washington, DC 20590, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

e-mail Mr. Waverly W. Gregory, Jr., 

Bridge Administrator, Fifth Coast Guard 

District; telephone 757–398–6222, email Waverly.W.Gregory@uscg.mil. If 

you have questions on viewing the 

docket, call Renee V. Wright, Program 

Manager, Docket Operations, telephone 

202–366–9826. 

SUPPLEMENTARY INFORMATION: The 

Maryland State Highway 

Administration (SHA), who owns and 

operates this single leaf bascule 

drawbridge, has requested a temporary 

deviation from the current operating 

schedule to facilitate the cleaning and 

painting of the structure. Under the 

regular operating schedule, the bridge 

opens on signal as required by 33 CFR 

117.569(c) if at least five hours advance 

notice is given. 

The S12 Bridge across Pocomoke 

River, mile 29.9 at Snow Hill MD, has 

a vertical clearance in the closed 

position of two feet above mean high 

water and five feet above mean low 

water. Under this temporary deviation, 

the contractor has requested to maintain 

the bridge in the closed position to 

vessels from 7 a.m. on March 15, 2011 

through 11:59 p.m. on May 30, 2011, to 

allow for the potential delays caused by 

anticipated seasonal weather patterns 

that will interfere with environmental 

conditions required for sandblasting and 

painting of the bridge. 

Bridge opening data supplied by SHA 

and reviewed by the Coast Guard 

revealed vessel openings of the draw 

span from March 2010 through May 

2010. Specifically, the drawbridge 

opened for vessels a total of 23, 13, and 

25 times during the months of March 

2010 through May 2010, respectively. 

We also contacted a nearby canoe shop 

owner who indicated that he can work 

around the restrictions. 

The Coast Guard has coordinated the 

restrictions with the local users of the 

waterway and will inform other users 

through our Local and Broadcast 

Notices to Mariners of the closure 

periods for the bridge so that vessels can 

arrange their transits to minimize any 

impact caused by the temporary 

deviation. There are no alternate routes 

for vessels transiting this section of the 

Pocomoke River and the drawbridge 

will be able to open in the event of an 

emergency. 


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