Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Rules and Regulations 16927 

III. Analysis of Impacts 

FDA has examined the impacts of the 

final rule under Executive Order 12866, 

Executive Order 13563, the Regulatory 

Flexibility Act (5 U.S.C. 601–612), and 

the Unfunded Mandates Reform Act of 

1995 (Pub. L. 104–4). Executive Orders 

12866 and 13563 direct 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 final rule is 

not a significant regulatory action under 

Executive Order 12866. 

The Regulatory Flexibility Act 

requires Agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because reclassification of this 

device from class III to class II will 

relieve manufacturers of the device of 

the cost of complying with the 

premarket approval requirements of 

section 515 of the FD&C Act (21 U.S.C. 

360e), and may permit small potential 

competitors to enter the marketplace by 

lowering their costs, the Agency 

certifies 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 $136 

million, using the most current (2010) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this final rule to result in any 1-year 

expenditure that would meet or exceed 

this amount. 

IV. 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 from or in 

addition to’’ certain Federal 

requirements applicable to devices. 21 

U.S.C. 360k; see Medtronic, Inc., v. 

Lohr, 518 U.S. 470 (1996), and Riegel v. 

Medtronic, Inc., 552 U.S. 312 (2008). 

The special controls established by this 

final rule create ‘‘requirements’’ under 

21 U.S.C. 360(k). 

V. Paperwork Reduction Act of 1995 

This final rule establishes special 

controls that refer to currently approved 

collections of information found in 

other FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

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

3520). The collections of information in 

21 CFR part 807, subpart E regarding 

premarket notification submissions have 

been approved under OMB control 

number 0910–0120, and the collections 

of information in 21 CFR part 801 

regarding labeling have been approved 

under OMB control number 0910–0485. 

VI. Reference 

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 InfraScan, Inc., April 8, 2010. 

List of Subjects in 21 CFR Part 882 

Medical devices, Neurological 

devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 882 is 

amended as follows: 

PART 882—NEUROLOGICAL DEVICES 

■ 1. The authority citation for 21 CFR 

part 882 continues to read as follows: 

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

360j, 371. 

■ 2. Section 882.1935 is added to 

subpart B to read as follows: 

§ 882.1935 Near Infrared (NIR) Brain 

Hematoma Detector. 

(a) Identification. A Near Infrared 

(NIR) Brain Hematoma Detector is a 

noninvasive device that employs nearinfrared spectroscopy that is intended to 

be used to evaluate suspected brain 

hematomas. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) The sale, distribution, and use of 

this device are restricted to prescription 

use in accordance with § 801.109 of this 

chapter; 

(2) The labeling must include specific 

instructions and the clinical training 

needed for the safe use of this device; 

(3) Appropriate analysis/testing 

should validate electromagnetic 

compatibility (EMC), electrical safety, 

and battery characteristics; 

(4) Performance data should validate 

accuracy and precision and safety 

features; 

(5) Any elements of the device that 

may contact the patient should be 

demonstrated to be biocompatible; and, 

(6) Appropriate software verification, 

validation, and hazard analysis should 

be performed. 

Dated: March 16, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–6975 Filed 3–22–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2012–0132] 

Drawbridge Operation Regulation; 

Willamette River, Portland, OR 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of temporary deviation 

from regulations. 

SUMMARY: The Commander, Thirteenth 

Coast Guard District, has issued a 

temporary deviation from the regulation 

governing the operation of the 

Broadway Bridge across the Willamette 

River, mile 11.7, at Portland, OR. This 

deviation is necessary to accommodate 

the Race for the Roses event scheduled 

for April 1, 2012. This deviation allows 

the bridge to remain in the closed 

position to allow safe movement of 

event participants. 

DATES: This deviation is effective from 

6:30 a.m. on April 1, 2012 through 

7:30 a.m. April 1, 2012. 

ADDRESSES: Documents mentioned in 

this preamble as being available in the 

docket are part of docket USCG–2012– 

0132 and are available online by going 

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

USCG–2012–0132 in the ‘‘Keyword’’ 

box and then clicking ‘‘Search’’. They 

are also available for inspection or 


srobinson on DSK4SPTVN1PROD with RULES
16928 Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Rules and Regulations 

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 

email the Bridge Administrator, Coast 

Guard Thirteenth District; telephone 

206–220–7282 email 

randall.d.overton@uscg.mil. If you have 

questions on viewing the docket, call 

Renee V. Wright, Program Manager, 

Docket Operations, telephone 202–366– 

9826. 

SUPPLEMENTARY INFORMATION: 

Multnomah County has requested that 

the Broadway Bascule Bridge remain 

closed to vessel traffic to facilitate safe, 

uninterrupted roadway passage of 

participants of the Race for the Roses 

event. The Broadway Bridge crosses the 

Willamette River at mile 11.7 and 

provides 90 feet of vertical clearance 

above Columbia River Datum 0.0 while 

in the closed position. Vessels which do 

not require a bridge opening may 

continue to transit beneath the bridge 

during this closure period. Under 

normal conditions this bridge operates 

in accordance with 33 CFR 117.897(c) 

which allows for the bridge to remain 

closed between 7 a.m. and 9 a.m. and 

4 p.m. and 6 p.m. Monday through 

Friday and also requires advance 

notification when a bridge opening is 

needed. This deviation period is from 

6:30 a.m. on April 1, 2012 through 

7:30 a.m. April 1, 2012. The deviation 

allows the bascule span of the Broadway 

Bridge across the Willamette River, mile 

11.7, to remain in the closed position 

and need not open for maritime traffic 

for one hour from 6:30 a.m. through 7:30 

a.m. on April 1, 2012. The bridge shall 

operate in accordance to 33 CFR 

117.897 at all other times. Waterway 

usage on this stretch of the Willamette 

River includes vessels ranging from 

commercial tug and barge to small 

pleasure craft. Mariners will be notified 

and kept informed of the bridge’s 

operational status via the Coast Guard 

Notice to Mariners publication and 

Broadcast Notice to Mariners as 

appropriate. The draw span will be 

required to open, if needed, for vessels 

engaged in emergency response 

operations during this closure period. 

In accordance with 33 CFR 117.35(e), 

the drawbridge must return to its regular 

operating schedule immediately at the 

end of the designated time period. This 

deviation from the operating regulations 

is authorized under 33 CFR 117.35. 

Dated: February 22, 2012. 

Randall D. Overton, 

Bridge Administrator. 

[FR Doc. 2012–6984 Filed 3–22–12; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2012–0078] 

Drawbridge Operation Regulation; 

Miami River, Miami, FL 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of temporary deviation 

from regulation; request for comments. 

SUMMARY: The Commander, Seventh 

Coast Guard District, has issued a 

temporary deviation from the regulation 

governing the operation of the N.W. 

12th Avenue Bridge across the Miami 

River, mile 2.1, in Miami, Florida. This 

deviation will test a change to the 

drawbridge operation schedule to 

determine whether a permanent change 

to the schedule is needed. The test 

deviation is necessary to determine 

whether possible vehicle traffic 

congestion during Miami Marlins home 

baseball games poses a safety concern. 

This 90 day test deviation will allow the 

N.W. 12th Avenue Bridge to remain 

closed to navigation for a short period 

prior to the start of Miami Marlins home 

baseball games. Tugs and tugs with 

tows, public vessels of the United 

States, and vessels in distress shall be 

passed at any time. 

DATES: This deviation is effective from 

6:46 p.m. on April 4, 2012 through 

7:30 p.m. on July 3, 2012. 

Comments and related material must 

be received by the Coast Guard on or 

before August 1, 2012. Requests for 

public meetings must be received by the 

Coast Guard on or before May 15, 2012. 

ADDRESSES: You may submit comments 

identified by docket number USCG– 

2012–0078 using any one of the 

following methods: 

(1) Federal eRulemaking Portal: 

http://www.regulations.gov. 

(2) Fax: (202) 493–2251. 

(3) Mail: 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– 

0001. 

(4) Hand delivery: Same as mail 

address above, between 9 a.m. and 

5 p.m., Monday through Friday, except 

Federal holidays. The telephone number 

is (202) 366–9329. 

To avoid duplication, please use only 

one of these four methods. See the 

‘‘Public Participation and Request for 

Comments’’ portion of the 

SUPPLEMENTARY INFORMATION section 

below for instructions on submitting 

comments. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

email Michael Lieberum, Seventh 

District Bridge Branch, Coast Guard; 

telephone (305) 415–6744, email 

Michael.B.Lieberum@uscg.mil. If you 

have questions on viewing or submitting 

material to the docket, call Renee V. 

Wright, Program Manager, Docket 

Operations, telephone (202) 366–9826. 

SUPPLEMENTARY INFORMATION: 

Public Participation and Request for 

Comments 

We encourage you to participate in 

this rulemaking by submitting 

comments and related materials. All 

comments received will be posted, 

without change, to http:// 

www.regulations.gov and will include 

any personal information you have 

provided. 

Submitting Comments 

If you submit a comment, please 

include the docket number for this 

rulemaking (USCG–2012–0078), 

indicate the specific section of this 

document to which each comment 

applies, and provide a reason for each 

suggestion or recommendation. You 

may submit your comments and 

material online (http:// 

www.regulations.gov), or by fax, mail or 

hand delivery, but please use only one 

of these means. If you submit a 

comment online via http:// 

www.regulations.gov, it will be 

considered received by the Coast Guard 

when you successfully transmit the 

comment. If you fax, hand deliver, or 

mail your comment, it will be 

considered as having been received by 

the Coast Guard when it is received at 

the Docket Management Facility. We 

recommend that you include your name 

and a mailing address, an email address, 

or a phone number in the body of your 

document so that we can contact you if 

we have questions regarding your 

submission. 

To submit your comment online, go to 

http://www.regulations.gov, click on the 

‘‘submit a comment’’ box, which will 

then become highlighted in blue. In the 

‘‘Keyword’’ box insert ‘‘USCG–2012– 

0078,’’ click ‘‘Search,’’ and then click on 

the balloon shape in the ‘‘Actions’’ 

column. If you submit your comments 


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