Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Rules and Regulations 16925 

comment period, we intend to publish 

a document in the Federal Register 

confirming the effective date within 30 

days after the comment period ends. 

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 this rule does not 

impose any significant costs, we certify 

that it 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. We do not expect 

this rule to result in any 1-year 

expenditure that would meet or exceed 

this amount. 

IV. Paperwork Reduction Act of 1995 

We have concluded that this direct 

final rule contains no collection of 

information. Therefore, clearance by the 

Office of Management and Budget under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520) is not required. 

V. Environmental Impact 

We have determined under 21 CFR 

25.33 that this direct final rule 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. 

VI. Federalism 

We have analyzed this direct final 

rule in accordance with the principles 

set forth in Executive Order 13132. We 

have determined that this direct final 

rule does not contain policies that have 

substantial direct effects on the States, 

on the relationship between the 

National Government and the States, or 

on the distribution of power and 

responsibilities among the various 

levels of government. Accordingly, we 

have concluded this direct final rule 

does not contain policies that have 

federalism implications as defined in 

the Executive order and, consequently, 

a federalism summary impact statement 

is not required. 

VII. Comments 

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. Identify comments with the 

docket number found in brackets in the 

heading of this document, and they may 

be accompanied by a supporting 

memorandum or brief. 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 20 

Confidential business information, 

Courts, Freedom of information, 

Government employees. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 20 is 

amended as follows: 

PART 20—PUBLIC INFORMATION 

■ 1. The authority citation for 21 CFR 

part 20 continues to read as follows: 

Authority: 5 U.S.C. 552; 18 U.S.C. 1905; 19 

U.S.C. 2531–2582; 21 U.S.C. 321–393, 1401– 

1403; 42 U.S.C. 241, 242, 242a, 242l, 242n, 

243, 262, 263, 263b–263n, 264, 265, 300u– 

300u–5, 300aa–1. 

■ 2. Amend § 20.108 as follows: 

■ a. Revise paragraph (b); 

■ b. Remove paragraph (c); 

■ c. Redesignate paragraph (d) as 

paragraph (c); 

■ d. Revise newly redesignated 

paragraph (c). 

The revisions and redesignations read 

as follows: 

§ 20.108 Agreements between the Food 

and Drug Administration and other 

departments, agencies, and organizations. 

* * * * * 

(b) All written agreements and 

memoranda of understanding between 

FDA and any entity, including, but not 

limited to other departments, Agencies, 

and organizations will be made 

available through the Food and Drug 

Administration Web site at http:// 

www.fda.gov once finalized. 

(c) Agreements and understandings 

signed by officials of FDA with respect 

to activities of the Office of Criminal 

Investigations are exempt from the 

requirements set forth in paragraph (b) 

of this section. Although such 

agreements and understandings will not 

be made available through the FDA Web 

site, these agreements will be available 

for disclosure in response to a request 

from the public after deletion of 

information that would disclose 

confidential investigative techniques or 

procedures, or information that would 

disclose guidelines for law enforcement 

investigations if such disclosure could 

reasonably be expected to risk 

circumvention of the law. 

Dated: March 16, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–6967 Filed 3–22–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 882 

[Docket No. FDA–2012–M–0206] 

Medical Devices; Neurological 

Devices; Classification of the Near 

Infrared Brain Hematoma Detector 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is classifying the 

Near Infrared (NIR) Brain Hematoma 

Detector into class II (special controls). 

The Agency is classifying the device 

into class II (special controls) in order 

to provide a reasonable assurance of 

safety and effectiveness of the device. 

DATES: This rule is effective April 23, 

2012. The classification is applicable 

beginning December 13, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Daryl Kaufman, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2426, Silver Spring, 

MD 20993–0002, 301–796–6467. 

SUPPLEMENTARY INFORMATION: 


srobinson on DSK4SPTVN1PROD with RULES
16926 Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Rules and Regulations 

I. Background 

In accordance with section 513(f)(1) of 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) (21 U.S.C. 360c(f)(1)), 

devices that were not in commercial 

distribution before May 28, 1976 (the 

date of enactment of the Medical Device 

Amendments of 1976), generally 

referred to as postamendments devices, 

are classified automatically by statute 

into class III without any FDA 

rulemaking process. These devices 

remain in class III and require 

premarket approval, unless and until 

the device is classified or reclassified 

into class I or II, or FDA issues an order 

finding the device to be substantially 

equivalent, in accordance with section 

513(i) of the FD&C Act (21 

U.S.C.360c(i)), to a predicate device that 

does not require premarket approval. 

The Agency determines whether new 

devices are substantially equivalent to 

predicate devices by means of 

premarket notification procedures in 

section 510(k) of the FD&C Act (21 

U.S.C. 360(k)) and part 807 of the 

regulations (21 CFR part 807). 

Section 513(f)(2) of the FD&C Act 

provides that any person who submits a 

premarket notification under section 

510(k) of the FD&C Act for a device that 

has not previously been classified may, 

within 30 days after receiving an order 

classifying the device into class III 

under section 513(f)(1) of the FD&C Act, 

request FDA to classify the device under 

the criteria set forth in section 513(a)(1) 

of the FD&C Act. FDA will, within 60 

days of receiving this request, classify 

the device by written order. This 

classification will be the initial 

classification of the device. Within 30 

days after the issuance of an order 

classifying the device, FDA must 

publish a notice in the Federal Register 

announcing this classification. 

In accordance with section 513(f)(1) of 

the FD&C Act, FDA issued an order on 

March 16, 2010, classifying the 

Infrascanner into class III, because it 

was not substantially equivalent to a 

device that was introduced or delivered 

for introduction into interstate 

commerce for commercial distribution 

before May 28, 1976, or a device which 

was subsequently reclassified into class 

I or class II. On April 8, 2010, InfraScan, 

Inc. submitted a petition requesting 

classification of the Infrascanner Model 

1000 under section 513(f)(2) of the 

FD&C Act. The manufacturer 

recommended that the device be 

classified into class II (Ref. 1). 

In accordance with section 513(f)(2) of 

the FD&C Act, FDA reviewed the 

petition in order to classify the device 

under the criteria for classification set 

forth in section 513(a)(1) of the FD&C 

Act. FDA classifies devices into class II 

if general controls by themselves are 

insufficient to provide reasonable 

assurance of safety and effectiveness, 

but there is sufficient information to 

establish special controls to provide 

reasonable assurance of the safety and 

effectiveness of the device for its 

intended use. After review of the 

information submitted in the petition, 

FDA determined that the device can be 

classified into class II with the 

establishment of special controls. FDA 

believes these special controls will 

provide reasonable assurance of the 

safety and effectiveness of the device. 

The device is assigned the generic 

name Near Infrared (NIR) Brain 

Hematoma Detector, and it is identified 

as a noninvasive device that employs 

near-infrared spectroscopy that is 

intended to be used to evaluate 

suspected brain hematomas. 

FDA has identified the following risks 

to health associated with this type of 

device and the measures required to 

mitigate these risks: 

Identified risk Mitigation measures 

Excessive laser power .............................................................................. Electrical safety and electromagnetic compatibility (EMC). 

Interference with other devices ................................................................ Electrical safety and EMC. 

Labeling. 

Unit (hardware) malfunction ..................................................................... Performance testing (nonclinical and clinical). 

Software verification, validation, and hazard analysis. 

Software malfunction ................................................................................ Software verification, validation, and hazard analysis. 

Operator errors ......................................................................................... Labeling. 

Training. 

Incorrect result (false positive and negative) ........................................... Labeling. 

Adverse tissue reaction ............................................................................ Biocompatibility. 

Battery failure (failure of device to operate) ............................................. Labeling. 

FDA believes that the following 

special controls address these risks to 

health and provide reasonable assurance 

of safety and effectiveness: (1) The sale, 

distribution, and use of this device are 

restricted to prescription use in 

accordance with 21 CFR 801.109; (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 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. 

Therefore, on December 13, 2011, FDA 

issued an order to the petitioner 

classifying the device into class II. FDA 

is codifying the classification of the 

device by adding § 882.1935. 

Following the effective date of this 

final classification rule, any firm 

submitting a 510(k) premarket 

notification for an NIR Brain Hematoma 

Detector will need to comply with the 

special controls named in the 

regulation. 

Section 510(m) of the FD&C Act 

provides that FDA may exempt a class 

II device from the premarket notification 

requirements under section 510(k) of the 

FD&C Act, if FDA determines that 

premarket notification is not necessary 

to provide reasonable assurance of the 

safety and effectiveness of the device. 

For this type of device, FDA has 

determined that premarket notification 

is necessary to provide reasonable 

assurance of the safety and effectiveness 

of the device. Therefore, this device 

type is not exempt from premarket 

notification requirements. Persons who 

intend to market this type of device 

must submit to FDA a premarket 

notification, prior to marketing the 

device, which contains information 

about the NIR Brain Hematoma Detector 

they intend to market. 

II. Environmental Impact 

The Agency has determined under 21 

CFR 25.34(b) 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. 


srobinson on DSK4SPTVN1PROD with RULES
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