Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Rules and Regulations 15163 

Government Publishing Office, 

Washington, DC 20402) and any other 

annual reports made to Congress on 

activities of the Commission as required 

by law; 

* * * * * 

■ 18. Amend § 4.11 by revising 

paragraphs (a)(1)(i)(A) and (F) to read as 

follows: 

§ 4.11 Disclosure requests. 

(a) Freedom of Information Act—(1) 

Initial requests—(i) Form and contents; 

time of receipt. (A) A request under the 

provisions of the Freedom of 

Information Act, 5 U.S.C. 552, as 

amended, for access to Commission 

records shall be in writing and 

transmitted by one of the following 

means: by mail to the following address: 

Freedom of Information Act Request, 

Office of the General Counsel, Federal 

Trade Commission, 600 Pennsylvania 

Avenue NW., Washington, DC 20580; by 

facsimile transmission to (202) 326– 

2477; by email message to the FOIA 

email account at foia@ftc.gov; or by the 

form located on the FTC’s FOIA Web 

site, https://www.ftc.gov/ftc/foia.htm. 

* * * * * 

(F) Failure to agree to pay fees. If a 

request does not include an agreement 

to pay fees, and if the requester is 

notified of the estimated costs pursuant 

to § 4.8(d)(3), the request will be 

deemed not to have been received until 

the requester agrees to pay such fees. If 

a requester declines to pay fees within 

20 calendar days and is not granted a fee 

waiver, the request will be denied. 

* * * * * 

■ 19. Amend § 4.13 by revising 

paragraph (m) to read as follows: 

§ 4.13 Privacy Act rules. 

* * * * * 

(m) Specific exemptions. (1) Pursuant 

to 5 U.S.C. 552a(j)(2), investigatory 

materials maintained by an agency 

component in connection with any 

activity relating to criminal law 

enforcement in the following systems of 

records are exempt from all subsections 

of 5 U.S.C. 552a, except (b), (c)(1) and 

(2), (e)(4)(A) through (F), (e)(6), (7), (9), 

(10), and (11), and (i), and from the 

provisions of this section, except as 

otherwise provided in 5 U.S.C. 

552a(j)(2): 

(i) I–7—Office of Inspector General 

Investigative Files—FTC. 

(ii) [Reserved] 

(2) Pursuant to 5 U.S.C. 552a(k)(2), 

investigatory materials compiled for law 

enforcement purposes in the following 

systems of records are exempt from 

subsections (c)(3), (d), (e)(1), (e)(4)(G), 

(H), and (I), and (f) of 5 U.S.C. 552a, and 

from the provisions of this section, 

except as otherwise provided in 5 U.S.C. 

552a(k)(2): 

(i) I–1—Nonpublic Investigational and 

Other Nonpublic Legal Program 

Records—FTC. 

(ii) I–2—Disciplinary Action 

Investigatory Files—FTC. 

(iii) I–4—Clearance Application and 

Response Files—FTC. 

(iv) I–5—Matter Management 

System—FTC. 

(v) I–7—Office of Inspector General 

Investigative Files—FTC. 

(vi) I–8—Stenographic Reporting 

Services Request System—FTC. 

(vii) II–3—Worker’s Compensation— 

FTC. 

(viii) II–6—Discrimination Complaint 

System—FTC. 

(ix) IV–1—Consumer Information 

System—FTC. 

(x) V–1—Freedom of Information Act 

Requests and Appeals—FTC. 

(xi) V–2—Privacy Act Requests and 

Appeals—FTC. 

(xii) VII–6—Document Management 

and Retrieval System—FTC. 

(3) Pursuant to 5 U.S.C. 552a(k)(5), 

investigatory materials compiled to 

determine suitability, eligibility, or 

qualifications for Federal civilian 

employment, military service, Federal 

contracts, or access to classified 

information, but only where disclosure 

would reveal the identity of a 

confidential source of information, in 

the following systems of records are 

exempt from subsections (c)(3), (d), 

(e)(1), (e)(4)(G), (H), and (I), and (f) of 5 

U.S.C. 552a, and from the provisions of 

this section, except as otherwise 

provided in 5 U.S.C. 552a(k)(5): 

(i) II–4—Employment ApplicationRelated Records—FTC. 

(ii) II–11—Personnel Security, 

Identity Management and Access 

Control Records System—FTC. 

By direction of the Commission. 

Janice Podoll Frankle, 

Acting Secretary. 

[FR Doc. 2015–06406 Filed 3–20–15; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 882 

[Docket No. FDA–2015–M–0619] 

Medical Devices; Neurological 

Devices; Classification of the Limited 

Output Transcutaneous Piezoelectric 

Stimulator for Skin Reactions 

Associated With Insect Bites 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA) is classifying the 

limited output transcutaneous 

piezoelectric stimulator for skin 

reactions associated with insect bites 

into class II (special controls). The 

special controls that will apply to the 

device are identified in this order and 

will be part of the codified language for 

the limited output transcutaneous 

piezoelectric stimulator for skin 

reactions associated with insect bites’ 

classification. 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 order is effective March 23, 

2015. The classification was applicable 

on November 7, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Michael Hoffman, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1434, Silver Spring, 

MD 20993–0002, 301–796–6476, 

michael.hoffman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

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

the Federal Food, Drug, and Cosmetic 

Act (the 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, to a predicate 

device that does not require premarket 

approval. The Agency determines 

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15164 Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Rules and Regulations 

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 (21 CFR part 807) of the regulations. 

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

amended by section 607 of the Food and 

Drug Administration Safety and 

Innovation Act (Pub. L. 112–144), 

provides two procedures by which a 

person may request FDA to classify a 

device under the criteria set forth in 

section 513(a)(1). Under the first 

procedure, the person submits a 

premarket notification under section 

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

has not previously been classified and, 

within 30 days of receiving an order 

classifying the device into class III 

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

the person requests a classification 

under section 513(f)(2). Under the 

second procedure, rather than first 

submitting a premarket notification 

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

and then a request for classification 

under the first procedure, the person 

determines that there is no legally 

marketed device upon which to base a 

determination of substantial 

equivalence and requests a classification 

under section 513(f)(2) of the FD&C Act. 

If the person submits a request to 

classify the device under this second 

procedure, FDA may decline to 

undertake the classification request if 

FDA identifies a legally marketed device 

that could provide a reasonable basis for 

review of substantial equivalence with 

the device or if FDA determines that the 

device submitted is not of ‘‘lowmoderate risk’’ or that general controls 

would be inadequate to control the risks 

and special controls to mitigate the risks 

cannot be developed. 

In response to a request to classify a 

device under either procedure provided 

by section 513(f)(2) of the FD&C Act, 

FDA will classify the device by written 

order within 120 days. This 

classification will be the initial 

classification of the device. 

On September 8, 2010, Ecobrands, 

Ltd., submitted a request for 

classification of the Zap-It! under 

section 513(f)(2) of the FD&C Act. 

Subsequently, on February 14, 2013, 

Tecnimed S.r.l., submitted a similar 

request for classification of the ZanzaClick, Mini-Click, and Disc-o-Click 

under section 513(f)(2) of the FD&C Act. 

Both manufacturers recommended that 

the devices be classified into class II 

(Refs. 1 and 2). 

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

the FD&C Act, FDA reviewed the 

requests in order to classify the devices 

under the criteria for classification set 

forth in section 513(a)(1). 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 requests, 

FDA determined that the devices can be 

classified into class II with the 

establishment of special controls. FDA 

believes these special controls, in 

addition to general controls, will 

provide reasonable assurance of the 

safety and effectiveness of the devices. 

Therefore, on November 7, 2014, FDA 

issued orders to both requestors 

classifying the devices into class II. FDA 

is codifying the classification of the 

devices by adding 21 CFR 882.5894. 

Following the effective date of this 

final classification order, any firm 

submitting a premarket notification 

(510(k)) for a limited output 

transcutaneous piezoelectric stimulator 

for skin reactions associated with insect 

bites will need to comply with the 

special controls named in this final 

order. The device is assigned the generic 

name limited output transcutaneous 

piezoelectric stimulator for skin 

reactions associated with insect bites, 

and it is identified as a device intended 

to alleviate skin reactions associated 

with insect bites via cutaneous, 

piezoelectric stimulation at the local site 

of the bite. 

FDA has identified the following risks 

to health associated specifically with 

this type of device, as well as the 

mitigation measures required to mitigate 

these risks in table 1. 

TABLE 1—LIMITED OUTPUT TRANSCUTANEOUS PIEZOELECTRIC STIMULATOR FOR SKIN REACTIONS ASSOCIATED WITH

INSECT BITES RISKS AND MITIGATION MEASURES

Identified risk Mitigation measure 

Cutaneous burns ........................................................................................................................ Characterization of Electrical Output Labeling. 

Adverse skin reactions ............................................................................................................... Biocompatibility Assessment. 

Damage to sensitive tissue (e.g., eyes, lips, inside mouth, open wounds) ............................... Labeling. 

Infection ...................................................................................................................................... Labeling. 

Burns and other injuries due to ignition of flammable substances which may be used in the 

same intended use environment (e.g., insect repellent).

Labeling. 

Interference with implanted devices and other patient care devices ......................................... Labeling. 

Failure to identify correct population and condition ................................................................... Labeling. 

Device failure .............................................................................................................................. Non-clinical (Bench) Testing Labeling. 

FDA believes that the following 

special controls, in combination with 

the general controls, address these risks 

to health and provide reasonable 

assurance of the safety and 

effectiveness: 

• Appropriate testing to characterize 

the electrical output specifications of 

the device (i.e., total charge delivered, 

maximum instantaneous output current, 

maximum instantaneous output voltage, 

pulse duration, charge density) must be 

conducted. 

• Mechanical bench testing must 

demonstrate that the device will 

withstand the labeled number duration 

of uses. 

• All elements of the device that may 

contact the patient must be assessed to 

be biocompatible. 

• Labeling must include: 

Æ Validated instructions which 

addresses the following: 

D Identification of areas of the body 

which are appropriate and not 

appropriate for contact with the device; 

D whether use of the device in 

conjunction with flammable materials 

(e.g., insect repellent) is appropriate; 

D use of the device on or near 

implanted devices; and 

D how to identify the correct type of 

skin condition. 

Æ Technical parameters of the device 

(maximum output voltage 

(instantaneous), maximum output 

current (instantaneous), and pulse 

duration). 

Æ Language to direct end users to 

contact the device manufacturer and 

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Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Rules and Regulations 15165 

MedWatch if they experience any 

adverse events with this device. 

Æ The anticipated number of device 

uses prior to failure. 

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 not necessary to provide reasonable 

assurance of the safety and effectiveness 

of the device. Therefore, this device 

type is exempt from premarket 

notification requirements. Persons who 

intend to market this type of device 

need not submit to FDA a premarket 

notification, prior to marketing the 

device, which contains information 

about the limited output transcutaneous 

piezoelectric stimulator for skin 

reactions associated with insect bites 

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. 

III. Paperwork Reduction Act of 1995 

This final order establishes special 

controls that refer 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 (OMB) under the Paperwork 

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

3520). The collections of information in 

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. 

IV. References 

The following references have 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, and are available 

electronically at http://

www.regulations.gov. 

1. DEN100024: De Novo Request per 513(f)(2) 

from Ecobrands, Ltd., dated September 8, 

2010. 

2. DEN130019: De Novo Request per 513(f)(2) 

from Tecnimed S.r.l., dated February 14, 

2013. 

List of Subjects in 21 CFR Part 882 

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 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. Add § 882.5894 to subpart F to read 

as follows: 

§ 882.5894 Limited output transcutaneous 

piezoelectric stimulator for skin reactions 

associated with insect bites. 

(a) Identification. A limited output 

transcutaneous piezoelectric stimulator 

for skin reactions associated with insect 

bites is a device intended to alleviate 

skin reactions associated with insect 

bites via cutaneous, piezoelectric 

stimulation at the local site of the bite. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) Appropriate testing to characterize 

the electrical output specifications of 

the device (i.e., total charge delivered, 

maximum instantaneous output current, 

maximum instantaneous output voltage, 

pulse duration, charge density) must be 

conducted. 

(2) Mechanical bench testing must 

demonstrate that the device will 

withstand the labeled number duration 

of uses. 

(3) All elements of the device that 

may contact the patient must be 

assessed to be biocompatible. 

(4) Labeling must include: 

(i) Validated instructions which 

addresses the following: 

(A) Identification of areas of the body 

which are appropriate and not 

appropriate for contact with the device. 

(B) Whether use of the device in 

conjunction with flammable materials 

(e.g., insect repellent) is appropriate. 

(C) Use of the device on or near 

implanted devices. 

(D) How to identify the correct type of 

skin condition. 

(ii) Technical parameters of the device 

(maximum output voltage 

(instantaneous), maximum output 

current (instantaneous), and pulse 

duration). 

(iii) Language to direct end users to 

contact the device manufacturer and 

MedWatch if they experience any 

adverse events with this device. 

(iv) The anticipated number of device 

uses prior to failure. 

Dated: March 17, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–06499 Filed 3–20–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF DEFENSE 

Department of the Navy 

32 CFR Part 706 

Certifications and Exemptions Under 

the International Regulations for 

Preventing Collisions at Sea, 1972 

AGENCY: Department of the Navy, DoD. 

ACTION: Final rule. 

SUMMARY: The Department of the Navy 

(DoN) is amending its certifications and 

exemptions under the International 

Regulations for Preventing Collisions at 

Sea, 1972, as amended (72 COLREGS), 

to reflect that the Deputy Assistant 

Judge Advocate General 

(DAJAG)(Admiralty and Maritime Law) 

has determined that USS JOHN 

WARNER (SSN 785) is a vessel of the 

Navy which, due to its special 

construction and purpose, cannot fully 

comply with certain provisions of the 72 

COLREGS without interfering with its 

special function as a naval ship. The 

intended effect of this rule is to warn 

mariners in waters where 72 COLREGS 

apply. 

DATES: This rule is effective March 23, 

2015 and is applicable beginning 

January 28, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Commander Theron R. Korsak, 

(Admiralty and Maritime Law), Office of 

the Judge Advocate General, Department 

of the Navy, 1322 Patterson Ave. SE., 

Suite 3000, Washington Navy Yard, DC 

20374–5066, telephone 202–685–5040. 

SUPPLEMENTARY INFORMATION: Pursuant 

to the authority granted in 33 U.S.C. 

1605, the DoN amends 32 CFR part 706. 

This amendment provides notice that 

the DAJAG (Admiralty and Maritime 

Law), under authority delegated by the 

Secretary of the Navy, has certified that 

USS JOHN WARNER (SSN 785) is a 

vessel of the Navy which, due to its 

special construction and purpose, 

cannot fully comply with the following 

specific provisions of 72 COLREGS 

without interfering with its special 

function as a naval ship: Annex I, 

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