48062 Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Proposed Rules 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR part 812 have 

been approved under OMB control 

number 0910–0078; the collections of 

information in 21 CFR part 807, subpart 

E have been approved under OMB 

control number 0910–0120; the 

collections of information in 21 CFR 

part 814, subpart B have been approved 

under OMB control number 0910–0231; 

and the collections of information under 

21 CFR part 801 have been approved 

under OMB control number 0910–0485. 

XI. Proposed Effective Date 

FDA is proposing that any final rule 

based on this proposal become effective 

on the date of its publication in the 

Federal Register or at a later date if 

stated in the final rule. 

XII. 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. 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. 

XIII. 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. (FDA has verified the 

Web site address, but FDA is not 

responsible for any subsequent changes 

to the Web site after this document 

publishes in the Federal Register.) 

1. Geiger, Dale R, ‘‘FY 2003 and 2004 Unit 

Costs for the Process of Medical Device 

Review,’’ September 2005, http://www.

fda.gov/downloads/MedicalDevices/

DeviceRegulationandGuidance/

Overview/MedicalDeviceUserFeeand

ModernizationActMDUFMA/umc109216. 

2. U.S. Department of Commerce, Bureau of 

Economic Analysis, National Income and 

Product Accounts Table 1.1.9, http:// 

www.bea.gov/national/nipaweb/ 

SelectTable.asp, accessed March 25, 

2011. 

List of Subjects in 21 CFR Part 870 

Medical devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, it is proposed that 

21 CFR part 870 be amended as follows: 

PART 870—CARDIOVASCULAR 

DEVICES 

1. The authority citation for 21 CFR 

part 870 continues to read as follows: 

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

360j, 371. 

2. Section 870.3680 is amended by 

revising paragraph (c) to read as follows: 

§ 870.3680 Cardiovascular permanent or 

temporary pacemaker electrode. 

* * * * * 

(c) Date PMA or notice of completion 

of PDP is required. A PMA or notice of 

completion of a PDP is required to be 

filed with the Food and Drug 

Administration on or before [A DATE 

WILL BE ADDED 90 DAYS AFTER 

DATE OF PUBLICATION OF A 

FUTURE FINAL RULE IN THE 

FEDERAL REGISTER], for any 

permanent pacemaker electrode that 

was in commercial distribution before 

May 28, 1976, or that has, on or before 

[A DATE WILL BE ADDED 90 DAYS 

AFTER DATE OF PUBLICATION OF A 

FUTURE FINAL RULE IN THE 

FEDERAL REGISTER], been found to be 

substantially equivalent to any 

permanent pacemaker electrode that 

was in commercial distribution before 

May 28, 1976. Any other permanent 

pacemaker electrode shall have an 

approved PMA or declared completed 

PDP in effect before being placed in 

commercial distribution. 

Dated: August 2, 2011. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2011–19959 Filed 8–5–11; 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–2011–N–0504] 

Effective Date of Requirement for 

Premarket Approval for Cranial 

Electrotherapy Stimulator 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is proposing to 

require the filing of a premarket 

approval application (PMA) or a notice 

of completion of a product development 

protocol (PDP) for the Cranial 

Electrotherapy Stimulator. The Agency 

is also summarizing its proposed 

findings regarding the degree of risk of 

illness or injury designed to be 

eliminated or reduced by requiring this 

device to meet the statute’s approval 

requirements and the benefits to the 

public from the use of the device. In 

addition, FDA is announcing the 

opportunity for interested persons to 

request that the Agency change the 

classification of the cranial 

electrotherapy stimulator based on new 

information. This action implements 

certain statutory requirements. 

DATES: Submit either electronic or 

written comments by November 7, 2011. 

Submit requests for a change in 

classification by August 23, 2011. FDA 

intends that, if a final rule based on this 

proposed rule is issued, anyone who 

wishes to continue to market the device 

will need to submit a PMA within 90 

days of the effective date of the final 

rule. Please see section XII of this 

document for the effective date of any 

final rule that may publish based on this 

proposal. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2011–N– 

0504 by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following ways: 

• 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–2011–N–0504 for this 

rulemaking. 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. 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Proposed Rules 48063 

FOR FURTHER INFORMATION CONTACT: 

Timothy Marjenin, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 2258, Silver Spring, 

MD 20993–0002, 301–796–6502, e-mail: 

timothy.marjenin@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background—Regulatory Authorities 

The Federal Food, Drug, and Cosmetic 

Act (the FD&C Act), as amended by the 

Medical Device Amendments of 1976 

(the 1976 amendments) (Pub. L. 94– 

295), the Safe Medical Devices Act of 

1990 (SMDA) (Pub. L. 101–629), and the 

Food and Drug Administration 

Modernization Act of 1997 (FDAMA) 

(Pub. L. 105–115), the Medical Device 

User Fee and Modernization Act of 2002 

(MDUFMA) (Pub. L. 107–250), the 

Medical Devices Technical Corrections 

Act (Pub. L. 108–214), and the Food and 

Drug Administration Amendments Act 

of 2007 (Pub. L. 110–85), among other 

amendments, establish a comprehensive 

system for the regulation of medical 

devices intended for human use. 

Section 513 of the FD&C Act (21 U.S.C. 

360c) established three categories 

(classes) of devices, reflecting the 

regulatory controls needed to provide 

reasonable assurance of their safety and 

effectiveness. The three categories of 

devices are class I (general controls), 

class II (special controls), and class III 

(premarket approval). 

Under section 513 of the FD&C Act, 

devices that were in commercial 

distribution before the enactment of the 

1976 amendments, May 28, 1976 

(generally referred to as preamendments 

devices), are classified after FDA has: (1) 

Received a recommendation from a 

device classification panel (an FDA 

advisory committee); (2) published the 

panel’s recommendation for comment, 

along with a proposed regulation 

classifying the device; and (3) published 

a final regulation classifying the device. 

FDA has classified most 

preamendments devices under these 

procedures. 

Devices that were not in commercial 

distribution prior to May 28, 1976 

(generally referred to as 

postamendments devices) are 

automatically classified by section 

513(f) of the FD&C Act into class III 

without any FDA rulemaking process. 

Those devices remain in class III and 

require premarket approval unless, and 

until, the device is 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 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 21 CFR part 807. 

A preamendments device that has 

been classified into class III may be 

marketed by means of premarket 

notification procedures (510(k) process) 

without submission of a PMA) until 

FDA issues a final regulation under 

section 515(b) of the FD&C Act (21 

U.S.C. 360e(b)) requiring premarket 

approval. Section 515(b)(1) of the FD&C 

Act establishes the requirement that a 

preamendments device that FDA has 

classified into class III is subject to 

premarket approval. A preamendments 

class III device may be commercially 

distributed without an approved PMA 

or a notice of completion of a PDP until 

90 days after FDA issues a final rule 

requiring premarket approval for the 

device, or 30 months after final 

classification of the device under 

section 513 of the FD&C Act, whichever 

is later. Also, a preamendments device 

subject to the rulemaking procedure 

under section 515(b) of the FD&C Act is 

not required to have an approved 

investigational device exemption (IDE) 

(see part 812 (21 CFR part 812)) 

contemporaneous with its interstate 

distribution until the date identified by 

FDA in the final rule requiring the 

submission of a PMA for the device. At 

that time, an IDE is required only if a 

PMA has not been submitted or a PDP 

completed. 

Section 515(b)(2)(A) of the FD&C Act 

provides that a proceeding to issue a 

final rule to require premarket approval 

shall be initiated by publication of a 

notice of proposed rulemaking 

containing: (1) The regulation; (2) 

proposed findings with respect to the 

degree of risk of illness or injury 

designed to be eliminated or reduced by 

requiring the device to have an 

approved PMA or a declared completed 

PDP and the benefit to the public from 

the use of the device; (3) an opportunity 

for the submission of comments on the 

proposed rule and the proposed 

findings; and (4) an opportunity to 

request a change in the classification of 

the device based on new information 

relevant to the classification of the 

device. 

Section 515(b)(2)(B) of the FD&C Act 

provides that if FDA receives a request 

for a change in the classification of the 

device within 15 days of the publication 

of the notice, FDA shall, within 60 days 

of the publication of the notice, consult 

with the appropriate FDA advisory 

committee and publish a notice denying 

the request for change in reclassification 

or announcing its intent to initiate a 

proceeding to reclassify the device 

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

Section 515(b)(3) of the FD&C Act 

provides that FDA shall, after the close 

of the comment period on the proposed 

rule and consideration of any comments 

received, issue a final rule to require 

premarket approval or publish a 

document terminating the proceeding 

together with the reasons for such 

termination. If FDA terminates the 

proceeding, FDA is required to initiate 

reclassification of the device under 

section 513(e) of the FD&C Act, unless 

the reason for termination is that the 

device is a banned device under section 

516 of the FD&C Act (21 U.S.C. 360f). 

When a proposed rule to require 

premarket approval for a 

preamendments device is finalized, 

section 501(f)(2)(B) of the FD&C Act (21 

U.S.C. 351(f)(2)(B)) requires that a PMA 

or notice of completion of a PDP for any 

such device be filed within 90 days of 

the date of issuance of the final rule or 

30 months after the final classification 

of the device under section 513 of the 

FD&C Act, whichever is later. If a PMA 

or notice of completion of a PDP is not 

filed by the later of the two dates, 

commercial distribution of the device is 

required to cease since the device would 

be deemed adulterated under section 

501(f) of the FD&C Act. 

The device may, however, be 

distributed for investigational use if the 

manufacturer, importer, or other 

sponsor of the device complies with the 

IDE regulations. If a PMA or notice of 

completion of a PDP is not filed by the 

later of the two dates, and the device 

does not comply with IDE regulations, 

the device is deemed to be adulterated 

within the meaning of section 

501(f)(1)(A) of the FD&C Act, and 

subject to seizure and condemnation 

under section 304 of the FD&C Act (21 

U.S.C. 334) if its distribution continues. 

Shipment of devices in interstate 

commerce will be subject to injunction 

under section 302 of the FD&C Act (21 

U.S.C. 332), and the individuals 

responsible for such shipment will be 

subject to prosecution under section 303 

of the FD&C Act (21 U.S.C. 333). In the 

past, FDA has requested that 

manufacturers take action to prevent the 

further use of devices for which no PMA 

or PDP has been filed and may 

determine that such a request is 

appropriate for the cranial 

electrotherapy stimulator. 

The FD&C Act does not permit an 

extension of the 90-day period after 

issuance of a final rule within which an 

application or a notice is required to be 

filed. The House Report on the 1976 

amendments states that: ‘‘[t]he thirty 

month grace period afforded after 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
48064 Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Proposed Rules 

classification of a device into class III 

* * * is sufficient time for 

manufacturers and importers to develop 

the data and conduct the investigations 

necessary to support an application for 

premarket approval (H. Rept. 94–853, 

94th Cong., 2d sess. 42 (1976)).’’ 

The SMDA added section 515(i) to the 

FD&C Act requiring FDA to review the 

classification of preamendments class III 

devices for which no final rule requiring 

the submission of PMAs has been 

issued, and to determine whether or not 

each device should be reclassified into 

class I or class II or remain in class III. 

For devices remaining in class III, the 

SMDA directed FDA to develop a 

schedule for issuing regulations to 

require premarket approval. The SMDA 

does not, however, prevent FDA from 

proceeding immediately to rulemaking 

under section 515(b) of the FD&C Act on 

specific devices, in the interest of public 

health, independent of the procedures 

of section 515(i). Proceeding directly to 

rulemaking under section 515(b) of the 

FD&C Act is consistent with Congress’ 

objective in enacting section 515(i), i.e., 

that preamendments class III devices for 

which PMAs have not been previously 

required either be reclassified to class I 

or class II or be subject to the 

requirements of premarket approval. 

Moreover, in this proposal, interested 

persons are being offered the 

opportunity to request reclassification of 

the cranial electrotherapy stimulator. 

II. Dates New Requirements Apply 

In accordance with section 515(b) of 

the FD&C Act, FDA is proposing to 

require that a PMA or a notice of 

completion of a PDP be filed with the 

Agency for the cranial electrotherapy 

stimulator within 90 days after issuance 

of any final rule based on this proposal. 

An applicant whose device was legally 

in commercial distribution before May 

28, 1976, or whose device has been 

found to be substantially equivalent to 

such a device, will be permitted to 

continue marketing such class III 

devices during FDA’s review of the 

PMA or notice of completion of the 

PDP. FDA intends to review any PMA 

for the device within 180 days, and any 

notice of completion of a PDP for the 

device within 90 days of the date of 

filing. FDA cautions that under section 

515(d)(1)(B)(i) of the FD&C Act, the 

Agency may not enter into an agreement 

to extend the review period for a PMA 

beyond 180 days unless the Agency 

finds that ‘‘the continued availability of 

the device is necessary for the public 

health.’’ 

FDA intends that under § 812.2(d), the 

preamble to any final rule based on this 

proposal will state that, as of the date on 

which the filing of a PMA or a notice 

of completion of a PDP is required to be 

filed, the exemptions from the 

requirements of the IDE regulations for 

preamendments class III devices in 

§ 812.2(c)(1) and (c)(2) will cease to 

apply to any device that is: (1) Not 

legally on the market on or before that 

date or (2) legally on the market on or 

before that date but for which a PMA or 

notice of completion of a PDP is not 

filed by that date, or for which PMA 

approval has been denied or withdrawn. 

If a PMA or notice of completion of 

a PDP for the cranial electrotherapy 

stimulator is not filed with FDA within 

90 days after the date of issuance of any 

final rule requiring premarket approval 

for the device, commercial distribution 

of the device must cease. The device 

may be distributed for investigational 

use only if the requirements of the IDE 

regulations are met. The requirements 

for significant risk devices include 

submitting an IDE application to FDA 

for its review and approval. An 

approved IDE is required to be in effect 

before an investigation of the device 

may be initiated or continued under 

§ 812.30. FDA, therefore, cautions that 

IDE applications should be submitted to 

FDA at least 30 days before the end of 

the 90-day period after the issuance of 

the final rule to avoid interrupting 

investigations. 

III. Proposed Findings With Respect to 

Risks and Benefits 

As required by section 515(b) of the 

FD&C Act, FDA is publishing its 

proposed findings regarding: (1) The 

degree of risk of illness or injury 

designed to be eliminated or reduced by 

requiring that the cranial electrotherapy 

stimulator have an approved PMA or a 

declared completed PDP and (2) the 

benefits to the public from the use of the 

cranial electrotherapy stimulator. 

These findings are based on the 

reports and recommendations of the 

advisory committee (panel) for the 

classification of this device along with 

information submitted in response to 

the 515(i) Order, (74 FR 16214, April 9, 

2009), and any additional information 

that FDA has encountered. Additional 

information regarding the risks as well 

as classification associated with this 

device type can be found in the 

following documents published in the 

Federal Register on these dates: 

November 28, 1974 (43 FR 55716), 

September 4, 1979 (44 FR 51770), 

January 6, 1989 (54 FR 550), August 31, 

1993 (58 FR 45865), August 24, 1995 (60 

FR 43967), November 22, 1996 (61 FR 

59448), January 28, 1997 (62 FR 4023), 

and June 4, 1997 (62 FR 30456 and 62 

FR 30600). 

IV. Devices Subject to This Proposal 

Cranial electrotherapy stimulator (21 

CFR 882.5800) 

A. Identification 

A cranial electrotheraphy stimulator 

is a device that applies electrical current 

to a patient’s head to treat insomnia, 

depression, or anxiety. 

B. Summary of Data 

The Neurological Devices Panel that 

discussed original classification for the 

cranial electrotherapy stimulator (CES) 

device in 1977 and 1978 ultimately 

recommended that the device be 

classified into class III because 

satisfactory device effectiveness had not 

been demonstrated. The panel 

considered information from the 

National Research Council, which 

reviewed 88 published studies on CES 

and concluded that the device has not 

been shown to be effective in treating 

any of the conditions for which it was 

prescribed. In addition, the panel 

indicated that it was not possible to 

establish an adequate performance 

standard for CES because the 

characteristics of the electrical current 

necessary for potential effectiveness 

were not known. The panel believed 

that general controls would not provide 

sufficient control over these 

characteristics, and that the device 

presented a potential unreasonable risk 

of illness or injury to the patient if the 

practitioner relied on the device, and it 

was ineffective in treating the patient’s 

illness. Therefore, the panel 

recommended that premarket approval 

was necessary to assure the safety and 

effectiveness of CES devices. 

In support of a subsequent proposed 

rule in 1993 for classification of CES 

into class III, FDA performed a literature 

review and identified additional studies 

that had been performed for CES. After 

a review of the scientific literature, FDA 

concluded that the effectiveness of CES 

had still not been established by 

adequate scientific evidence. 

FDA has performed a literature search 

for studies of CES published after the 

1993 proposed rule (January 1, 1993, to 

present). Many studies were excluded 

from further review because they were 

conducted on very specific populations 

(e.g., alcoholics or other types of 

substance abuse), and therefore were not 

representative of the general population 

suffering from insomnia, anxiety, or 

depression. Six studies were identified 

for further review (Refs. 1 through 6). 

FDA also identified two relevant metaanalyses (Refs. 7 and 8). 

The Bystritsky et al. study (Ref. 1) was 

conducted open-label, and on only 12 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Proposed Rules 48065 

subjects. The study involved 

observational baseline versus posttreatment without a control and 

therefore provided insufficient evidence 

of safety and effectiveness. The 

Heffernan study (Ref. 2) concludes that 

a single CES treatment may have 

physiologic effects; however, no 

outcomes of anxiety, depression or 

insomnia were measured and the study 

was conducted on only 20 subjects. The 

Overcash study (Ref. 3) was a 

retrospective study design and used an 

anxiety rating scale that was not 

validated. The Voris study (Ref. 4) 

analyzed only a subgroup of 

‘‘psychiatric subjects’’ which included 

many types of anxiety disorders as well 

as non-anxiety psychiatric disorders. 

The subgroup represents a 

diagnostically heterogeneous group. The 

subgroup analysis was not pre-specified 

and the number of subjects per 

subgroup was not specified. The Hyun 

study (Ref. 5) was a randomized 

controlled trial of 60 subjects. However, 

the indication under investigation was 

preoperative anxiety, which may not be 

indicative of an Axis I anxiety disorder. 

Moreover, the outcome measure, a 5- 

point Likert scale rating of anxiety, was 

not a standardized validated rating 

instrument. The Winick study (Ref. 6), 

which was a randomized controlled trial 

of 33 subjects with anxiety prior to 

dental procedures and utilized a 7-point 

Likert scale, suffers from the same 

limitations as the Hyun study. 

The O’Conner meta-analysis (Ref. 7) 

examined the effect of CES on reduction 

of primary and secondary withdrawal 

symptoms among various chemically 

dependent populations. The results of 

this analysis do not relate to the 

question of safety and effectiveness 

since the labeled indications for CES 

currently include insomnia, depression, 

or anxiety, and not withdrawal 

symptoms of chemical dependence. The 

Klawansky meta-analysis (Ref. 8) was 

based on an examination of literature on 

CES versus sham treatment. Although 

the analysis showed CES to be more 

effective than sham for anxiety, the 

study populations showed great 

heterogeneity of diagnostic categories 

(e.g., in many cases anxiety was not the 

primary diagnosis, but rather one of a 

number of symptomatic outcome 

measures collected during a trial). 

Therefore, it is unclear whether the 

finding can be generalized to support 

the effectiveness of CES in 

homogeneous populations of 

individuals suffering from anxiety, 

depression, or insomnia. Also, many of 

the studies evaluated in the Klawansky 

meta-analysis involved insufficient 

blinding. 

FDA has concluded from a review of 

the scientific literature and the 

information provided in the 515(i) call 

for information (74 FR 16214) that the 

effectiveness of CES has not been 

established by adequate scientific 

evidence and the Agency continues to 

agree with the panel’s recommendation. 

C. Risks to Health 

• Worsening of the condition being 

treated—If the device is not effective 

and the patient is not treated in a 

conventional manner, the patient’s 

psychological condition may worsen. 

• Skin irritation—The electrodes or 

the conductive cream used with the 

electrodes may cause skin irritation. 

• Headaches—Reported cases of 

adverse effects of CES devices include 

headaches following treatment with 

electrical stimulation. 

• Potential risk of seizure—electrical 

stimulation of the brain may result in 

seizures, particularly in patients with a 

history of seizure. 

• Blurred vision—placement of 

electrodes over the eyes may cause 

blurred vision. 

• Potential adverse effects from 

electrical stimulation of the brain—The 

physiological effects associated with 

electrical stimulation of the brain by 

these devices have not been studied 

systematically; therefore, adverse effects 

which may be caused by these electrical 

stimuli remain unknown. 

V. PMA Requirements 

A PMA for the cranial electrotherapy 

simulator must include the information 

required by section 515(c)(1) of the 

FD&C Act. Such a PMA should also 

include a detailed discussion of the 

risks identified previously, as well as a 

discussion of the effectiveness of the 

device for which premarket approval is 

sought. In addition, a PMA must 

include all data and information on: (1) 

Any risks known, or that should be 

reasonably known, to the applicant that 

have not been identified in this 

document; (2) the effectiveness of the 

device that is the subject of the 

application; and (3) full reports of all 

preclinical and clinical information 

from investigations on the safety and 

effectiveness of the device for which 

premarket approval is sought. 

A PMA must include valid scientific 

evidence to demonstrate reasonable 

assurance of the safety and effectiveness 

of the device for its intended use (see 

§ 860.7(c)(2)). Valid scientific evidence 

is ‘‘evidence from well-controlled 

investigations, partially controlled 

studies, studies and objective trials 

without matched controls, welldocumented case histories conducted by 

qualified experts, and reports of 

significant human experience with a 

marketed device, from which it can 

fairly and responsibly be concluded by 

qualified experts that there is reasonable 

assurance of the safety and effectiveness 

of a device under its conditions of use. 

* * * Isolated case reports, random 

experience, reports lacking sufficient 

details to permit scientific evaluation, 

and unsubstantiated opinions are not 

regarded as valid scientific evidence to 

show safety or effectiveness. * * *’’ (21 

CFR 860.7(c)(2)). 

VI. PDP Requirements 

A PDP for the cranial electrotherapy 

stimulator may be submitted in lieu of 

a PMA, and must follow the procedures 

outlined in section 515(f) of the FD&C 

Act. A PDP must provide: (1) A 

description of the device, (2) preclinical 

trial information (if any), (3) clinical 

trial information (if any), (4) a 

description of the manufacturing and 

processing of the device, (5) the labeling 

of the device, and (6) all other relevant 

information about the device. In 

addition, the PDP must include progress 

reports and records of the trials 

conducted under the protocol on the 

safety and effectiveness of the device. 

VII. Opportunity To Request a Change 

in Classification 

Before requiring the filing of a PMA 

or notice of completion of a PDP for a 

device, FDA is required by section 

515(b)(2)(A)(i) through (b)(2)(A)(iv) of 

the FD&C Act and § 860.132 to provide 

an opportunity for interested persons to 

request a change in the classification of 

the device based on new information 

relevant to the classification. Any 

proceeding to reclassify the device will 

be under the authority of section 513(e) 

of the FD&C Act. 

A request for a change in the 

classification of these devices is to be in 

the form of a reclassification petition 

containing the information required by 

§ 860.123, including new information 

relevant to the classification of the 

device. 

The Agency advises that to ensure 

timely filing of any such petition, any 

request should be submitted to the 

Division of Dockets Management (see 

ADDRESSES) and not to the address 

provided in § 860.123(b)(1). If a timely 

request for a change in the classification 

of these devices is submitted, the 

Agency will, within 60 days after 

receipt of the petition, and after 

consultation with the appropriate FDA 

resources, publish an order in the 

Federal Register that either denies the 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
48066 Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Proposed Rules 

request or gives notice of its intent to 

initiate a change in the classification of 

the device in accordance with section 

513(e) of the FD&C Act and 21 CFR 

860.130 of the regulations. 

VIII. Environmental Impact 

The Agency has determined under 21 

CFR 25.30(h) 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. 

IX. Analysis of Impacts 

FDA has examined the impacts of the 

proposed 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 proposed rule is not a 

significant 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. The Agency proposes to certify 

that the rule would 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 proposed rule to result in any oneyear expenditure that would meet or 

exceed this amount. 

A. Benefits of the Proposed Rule 

The proposed requirement for PMAs 

or PDPs for CES would generate social 

benefits equal to the value of the 

information generated by the safety and 

effectiveness tests that CES producers 

would be required to conduct under the 

proposed call for PMAs or PDPs. 

Provided first to FDA, this information 

would eventually assist physicians, 

patients and insurance providers in 

making more informed decisions about 

CES. 

There is reason to believe that current 

decisions about CES use are based on 

incomplete information. In their 1995 

meta-analysis of CES research, 

Klawansky et al. (Ref. 8) find that most 

CES studies in the literature are beset 

with weaknesses, such as small sample 

size, incomplete statistical reporting, 

and potential bias from authors who 

have commercial interests in CES 

products. Klawansky and coauthors also 

express concern that only three of the 18 

studies they examined were truly 

double-blinded, and patient blinding 

may have been insufficient in some 

cases due to the difficulty of mimicking 

in sham treatment the sensation 

produced by CES. More recent literature 

indicates that there is still much 

uncertainty about the safety and 

effectiveness of CES. 

If consumers, up until now, have been 

overestimating the safety and 

effectiveness of CES devices, then 

demand for these products would 

decrease as a result of the call for PMAs 

or PDPs, and consumers would 

purchase fewer CES devices and 

services than under the previous 

process whereby CES devices were 

cleared under the 510(k) process. For all 

the units purchased under the 510(k) 

clearance process that would not be 

purchased under the PMA or PDP 

approval process, society is currently 

incurring a cost equal to the difference 

between the producer’s cost of 

producing that unit and the dollar value 

of the health benefit experienced by the 

consumer. The avoidance of this cost 

represents the per-unit benefit to society 

of the proposed requirement for PMAs 

or PDPs; summing over all currentlymarketed units yields society’s total 

benefit. This sum is bounded above by 

current consumer expenditure on CES 

devices (further discussion of this point 

appears in the Technical Appendix in 

section IX.D of this document). 

Consumer expenditure on CES can be 

approximated by finding total producer 

revenue (this is only an approximation 

because any applicable taxes drive a 

wedge between expenditure and 

revenue). FDA estimates that there are 

approximately 11 producers currently 

marketing CES devices. Six of these 

producers appear in FDA’s Data 

universal numbering system database, 

with sales revenue for the six ranging 

from $100,000 to $1.2 million per year. 

Manta.com (Ref. 9) reports sales revenue 

of less than $0.5 million for one of the 

producers not appearing in Data 

universal numbering system. (It appears 

that few CES producers market non-CES 

goods or services, so most of the firms’ 

revenue can be attributed to CES sales.) 

The average annual sales revenue of the 

7 producers for whom we have data is 

$515,000. Assuming that this average 

equals the CES industry’s overall 

average yields an estimate of annual 

CES producer revenue of 11 × 

$515,000=$5.67 million. As mentioned 

previously, in the case where additional 

safety and effectiveness information 

decreases demand, this revenue total 

provides an upper bound on the 

estimated benefit to society of requiring 

PMAs or PDPs for CES devices. 

If the additional testing associated 

with class III PMA or PDP were to reveal 

that CES devices are safer and more 

effective than consumers currently 

believe, then demand for these products 

would increase. In this case, consumers 

currently purchase too few rather than 

too many CES devices as a result of 

incomplete information, and the benefit 

of the requirement for PMAs or PDPs 

would come from the increased use and 

associated health benefits of the devices. 

As discussed in the Technical Appendix 

in section IX.D of this document, FDA 

cannot in this case estimate a bound on 

the total social benefit of requiring 

PMAs or PDPs. FDA requests comment 

on this issue and on all methods and 

results of our benefits estimation. 

B. Costs of the Proposed Rule 

Under the proposed rule, FDA would 

require producers in this industry to 

obtain PMA or establish a PDP before 

marketing new products. Currently, a 

CES producer receives clearance to 

market by submitting a 510(k). 

Therefore, the rule-induced cost per 

new product would be the difference 

between the cost of preparing and 

submitting a PMA application (which 

we assume to be approximately the 

same with PDP as with traditional PMA) 

and the cost of preparing and submitting 

a 510(k) application. Blozan and Tucker 

(Ref. 10) estimate the cost of an average 

510(k) at $500; since the mean number 

of pages for the 510(k) submissions in 

their sample is 24, the estimated cost 

per page is $21, or $36 after adjusting 

for inflation (Ref. 11). FDA records 

indicate that, recently, the one or two 

cranial electrotherapy stimulator 510(k) 

submissions received per year have 

consisted of several hundred pages 

each. Assuming an average of 300 pages 

per submission and a cost per page of 

$36 yields an average cost of preparing 

and submitting a 510(k) of $11,000. FDA 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Proposed Rules 48067 

has estimated an upper bound on the 

cost of PMA at approximately 

$1,000,000 (see, for example, 73 FR 

7498 at 7501, February 8, 2008); this 

yields a difference of $989,000 between 

the costs of PMA and 510(k) 

preparation. Multiplying this cost 

difference by the recent average of 1.5 

new CES submissions per year yields an 

annual rule-induced cost equal to $1.48 

million. Additionally, producers of CES 

products that are already on the market 

would need to submit PMA 

applications, costing approximately $1 

million each. FDA believes that there 

are approximately 13 such products, so 

there would be a rule-induced upfront 

cost of $13 million. 

These cost estimates are only correct 

if no producers would be dissuaded 

from introducing new products or 

seeking approval for currently-marketed 

products by the cost of submitting a 

PMA application or by changes in the 

possibility that FDA grants approval. In 

cases where producers are dissuaded 

from entering or attempting to stay in 

the market, the cost to industry of the 

proposed rule would be the foregone 

expected profit on the withdrawn or 

withheld CES devices, which is 

necessarily less than the cost of PMA 

submission (otherwise, the producers in 

question would not be dissuaded from 

seeking PMA); the $13 million upfront 

and $1.48 million annual estimates 

mentioned previously thus provide 

upper bounds on the submission-related 

cost that would be borne by industry. 

Excluded from these totals is the welfare 

loss that would be borne by consumers 

who would, in the absence of the 

proposed rule, use the CES devices that 

would be withdrawn or withheld from 

the market as a result of the call for 

PMAs or PDPs. Due to the lack of 

sufficient market data, we cannot 

quantify these consumers’ welfare loss. 

FDA requests comment on this issue 

and on all methods and results of our 

cost estimation. 

In addition to the cost to industry of 

preparing and submitting PMAs or 

PDPs, the proposed rule would impose 

review costs on FDA. Geiger (Ref. 12) 

estimated that, for devices reviewed by 

FDA’s Center for Devices and 

Radiological Health in 2003 and 2004, 

review costs were $563,000 per PMA 

and $13,400 per 510(k). Updated for 

inflation (with Ref. 11) to 2010 dollars, 

these review costs become $653,000 per 

PMA and $15,500 per 510(k). Thus, the 

proposed rule’s review-related costs are 

expected to equal $8.49 million (= 13 × 

$653,000) upfront and $956,000 (= 1.5 × 

[$653,000 ¥$15,500]) per subsequent 

year. A portion of this total will be paid 

by industry in the form of user fees, 

with the remainder coming from general 

revenues. The CES manufacturers 

currently registered with FDA have 

annual revenues well under $100 

million, so they would likely be eligible 

for small business user fees, which are 

currently set at $59,705 for a premarket 

application (PMA or PDP) and $2,174 

for a 510(k) submission (75 FR 45641 at 

45643). Thus, user fees would likely 

cover $776,000 (= 13 × $59,705) of 

upfront and $86,000 (= 1.5 × [$59,705 

¥$2,174]) of subsequent annual ruleinduced review costs. Because annual 

revenues for CES manufacturers are also 

below $30 million, CES manufacturers 

submitting first premarket applications 

may qualify for user fee waivers; such 

cases would increase the portion of FDA 

review costs coming from general 

revenues above the current estimates of 

$7.71 million upfront and $870,000 per 

subsequent year and decrease the 

anticipated rule-induced change in user 

fee collections. 

Table 1 of this document displays all 

quantified benefits and costs of the 

proposed rule. We reiterate that most of 

our estimates represent extreme upper 

bounds. For both benefits and costs, the 

likely effects of the rule would be much 

smaller than the estimates appearing in 

table 1. 

TABLE 1—ESTIMATED UPPER BOUNDS OF BENEFITS AND COSTS

[$ thousands] 

3% Discount rate 7% Discount rate 

Annual Present value Annual Present value 

Ongoing Benefit: 

Better-Informed Consumer Decisions ...................................................... 5,665 48,324 5,665 39,789 

Benefits: Ten-Year Total .......................................................................... ........................ 48,324 ........................ 39,789 

Upfront Costs: 

Industry PMA or PDP Preparation ........................................................... 13,000 13,000 13,000 13,000 

User Fees ................................................................................................. 776 776 776 776 

FDA Review, Net of User Fees ................................................................ 7,710 7,710 7,710 7,710 

Ongoing Costs: 

Industry PMA or PDP Preparation ........................................................... 1,484 12,656 1,484 10,421 

User Fees ................................................................................................. 86 736 86 606 

FDA Review, Net of User Fees ................................................................ 870 4,945 870 4,072 

Costs: Ten-Year Total 1 ................................................................................... ........................ 39,823 ........................ 36,584 

1 Costs borne by consumers (in the form of welfare loss) are not estimated. 

C. Impact on Small Entities 

The Regulatory Flexibility Act 

requires Agencies to prepare an initial 

regulatory flexibility analysis if a 

proposed rule would have a significant 

effect on a substantial number of small 

businesses, non-profit organizations, 

local jurisdictions or other entities. Even 

though the producers of CES devices do 

tend to be small, only a very few entities 

participate in this market. FDA 

estimates that there are approximately 

11 producers currently marketing CES 

devices; there may also be a handful of 

affiliated businesses that would be 

affected by the requirement for PMAs or 

PDPs. Therefore, FDA tentatively 

concludes that this proposed rule would 

not have a significant economic impact 

on a substantial number of small 

entities. We request comment on this 

issue. 

D. Technical Appendix 

The supply-demand diagrams of 

figure 1 of this document illustrate the 

changes in the market for CES devices 

and services that would occur if the 

additional testing associated with class 

III pre-market approval were to reveal 

that CES devices are less safe and 

effective than consumers currently 

believe. In Panel A, the benefit of 

proposed requirement for PMAs or PDPs 

is represented by the shaded area below 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
48068 Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Proposed Rules 

the current market supply curve, above 

the better-informed, post-call for PMA 

demand curve (Demand1) and between 

the old and new quantities purchased 

(determined by the intersections of the 

pre- and post-call for PMAs or PDPs 

demand curves with the current supply 

curve or the vertical axis). A similar 

shaded benefit area appears in Panel B, 

but in that case, there is an offsetting 

loss (shown as the shaded triangle 

between the pre- and post-call for PMAs 

or PDPs supply curves) caused by CES 

producers passing on some costs related 

to PMAs and PDPs to consumers and 

consumers therefore purchasing even 

fewer CES devices or services than new 

information indicates they should. The 

overall benefit of the rule in Panel B is 

the difference between the areas of the 

Benefit and Loss triangles. In both 

panels of Figure 1, total CES spending 

by consumers, equal to the revenue 

collected by CES producers and shown 

as the rectangle LMNO, provides an 

upper bound on the amount of the 

shaded rule-induced social benefit. 

While total spending/revenue always 

provides an overestimate of the social 

benefit, the amount of the overestimation may range from moderate, as 

in Panel A (the case in which CES 

products disappear from the market), to 

extreme, as in Panel B (the case in 

which there is continued use of at least 

some CES products). 

If the additional testing associated 

with class III marketing approval 

increases consumers’ confidence in the 

safety and effectiveness of CES devices, 

then demand for these products would 

increase, as depicted in figure 2 of this 

document. In this case, consumers 

currently purchase too few rather than 

too many CES devices and services as a 

result of incomplete information. The 

benefit to society of providing 

information can, as in Panel A of figure 

1, be depicted graphically as the area 

between the pre-call for PMA or PDP 

supply curve and the post-call for PMA 

or PDP demand curve, and between the 

old and new quantities consumed 

(determined by the intersections of the 

pre- and post-call for PMA or PDP 

demand curves with the pre- and postcall for PMA or PDP supply curves), but 

because the revenue rectangle LMNO 

does not contain the shaded benefit 

area, FDA cannot in this case estimate 

a bound on the total social benefit. 


emcdonald on DSK2BSOYB1PROD with PROPOSALSEP08AU11.171</GPH>
Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Proposed Rules 48069 

X. Federalism 

FDA has analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. FDA 

has determined that the proposed rule, 

if finalized, would not contain policies 

that would 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, the Agency tentatively 

concludes that the proposed 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. 

XI. Paperwork Reduction Act of 1995 

This proposed rule refers to currently 

approved collections of information 

found in 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 812 have been approved 

under OMB control number 0910–0078; 

the collections of information in 21 CFR 

part 814, subpart B, have been approved 

under OMB control number 0910–0231; 

and the collections of information under 

21 CFR part 801 have been approved 

under OMB control number 0910–0485. 

XII. Proposed Effective Date 

FDA is proposing that any final rule 

based on this proposal become effective 

on the date of its publication in the 

Federal Register or at a later date if 

stated in the final rule. 

XIII. 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. 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. 

XIV. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES), 

and may be seen by interested persons 

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

through Friday. (FDA has verified the 

Web site addresses, but we are not 

responsible for any subsequent changes 

to the Web sites after this document 

publishes in the Federal Register.) 

1. Bystritsky A, L. Kerwin, J. Feusner, ‘‘A 

Pilot Study of Cranial Electrotherapy 

Stimulation for Generalized Anxiety 

Disorder,’’ Journal of Clinical Psychiatry, 

69(3): 412–417, 2008. 

2. Heffernan, Michael, ‘‘The Effect of a Single 

Cranial Electrotherapy Stimulation on 

Multiple Stress Measures,’’ The 

Townsend Letter for Doctors and 

Patients, 147: 60–64, 1995. 

3. Overcash, Stephen J., ‘‘Cranial 

Electrotherapy Stimulation in Patients 

Suffering From Acute Anxiety 

Disorders,’’ American Journal of 

Electromedicine, 16(1): 49–51, 1999. 

4. Voris, Marshall D, ‘‘An Investigation of the 

Effectiveness of Cranial Electrotherapy 

Stimulation in the Treatment of Anxiety 

Disorders Among Outpatient Psychiatric 

Patients, Impulse Control Parolees and 

Pedophiles,’’ Manuscript submitted for 

publication. Delos Mind/Body Institute, 

Dallas and Corpus Christi, TX: 1–19, 

1995. 

5. Hyun J.K., Y.K. Woon, S.L. Yoon, et al., 

‘‘The Effect of Cranial Electrotherapy 

Stimulation on Preoperative Anxiety and 

Hemodynamic Responses.’’ Korean 

Journal of Anesthesiology, 55: 657–61, 

2008. 

6. Winick, R.L., ‘‘Cranial Electrotherapy 

Stimulation (CES): A Safe and Effective 

Low Cost Means of Anxiety Control in a 

Dental Practice,’’ General Dentistry, 

47(1): 50–55, 1999. 

7. O’Connor M.E., F. Bianco, R. Nicholson, 

‘‘Meta-analysis of Cranial 

Electrostimulation (CES) in Relation to 

the Primary and Secondary Symptoms of 

Substance Withdrawal,’’ Presented at the 

12th annual meeting of the 

Bioelectromagnetics Society, June 14, 

1991. 

8. Klawansky S., A. Yeung, C. Berkey, et al., 

‘‘Meta-analysis of Randomized 

Controlled Trials of Cranial 

Electrostimulation,’’ The Journal of 

Nervous and Mental Disease, 183(7): 

478–485, 1995. 


emcdonald on DSK2BSOYB1PROD with PROPOSALSEP08AU11.172</GPH>
48070 Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Proposed Rules 

9. Manta: Vital Info on Small Businesses, 

http://www.manta.com, accessed June 

11, 2010. 

10. Blozan, Carl F. and Steven A. Tucker, 

‘‘Premarket Notifications: The First 

24,000,’’ Medical Device & Diagnostic 

Industry: 59–69, January 1986. 

11. U.S. Department of Commerce, Bureau of 

Economic Analysis, 2010, National 

Income and Product Accounts Table 

1.1.9., http://www.bea.gov/national/

nipaweb/SelectTable.asp, accessed 

March 25, 2011. 

12. Geiger, Dale R. FY 2003 and 2004 Unit 

Costs for the Process of Medical Device 

Review, http://www.fda.gov/downloads/

MedicalDevices/DeviceRegulationand

Guidance/Overview/MedicalDeviceUser

FeeandModernizationActMDUFMA/

ucm109216.pdf, accessed September 

2005. 

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, it is proposed that 

21 CFR part 882 be 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 882.5800 is amended by 

revising paragraph (c) to read as follows: 

§ 882.5800 Cranial electrotherapy 

stimulator. 

* * * * * 

(c) Date PMA or notice of completion 

of PDP is required. A PMA or notice of 

completion of a PDP is required to be 

filed with the Food and Drug 

Administration on or before [A DATE 

WILL BE ADDED 90 DAYS AFTER 

DATE OF PUBLICATION OF A 

FUTURE FINAL RULE IN THE 

FEDERAL REGISTER], for any cranial 

electrotherapy stimulator device that 

was in commercial distribution before 

May 28, 1976, or that has, on or before 

[A DATE WILL BE ADDED 90 DAYS 

AFTER DATE OF PUBLICATION OF A 

FUTURE FINAL RULE IN THE 

FEDERAL REGISTER], been found to be 

substantially equivalent to any cranial 

electrotherapy stimulator device that 

was in commercial distribution before 

May 28, 1976. Any other cranial 

electrotherapy stimulator device shall 

have an approved PMA or declared 

completed PDP in effect before being 

placed in commercial distribution. 

Dated: August 2, 2011. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2011–19957 Filed 8–5–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2011–0254] 

RIN 1625–AA11 

Regulated Navigation Area, Zidell 

Waterfront Property, Willamette River, 

OR 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Coast Guard proposes the 

establishment of a Regulated Navigation 

Area (RNA) at the Zidell Waterfront 

Property located on the Willamette 

River in Portland, Oregon. This RNA is 

necessary to preserve the integrity of an 

engineered sediment cap as part of an 

Oregon Department of Environmental 

Quality (DEQ) required remedial action. 

This proposed RNA will do so by 

prohibiting activities that could disturb 

or damage the engineered sediment cap. 

DATES: Comments and related material 

must be received by the Coast Guard on 

or before November 7, 2011. 

ADDRESSES: You may submit comments 

identified by docket number USCG– 

2011–0254 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 proposed 

rule, call or e-mail MST1 Jaime Sayers, 

Waterways Management Division, 

Marine Safety Unit Portland, Coast 

Guard; telephone 503–240–9319, e-mail 

Jaime.a.Sayers@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–2011–0254), 

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 (via 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 e-mail 

address, or a telephone 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 

‘‘Document Type’’ drop down menu 

select ‘‘Proposed Rule’’ and insert 

‘‘USCG–2011–0254’’ in the ‘‘Keyword’’ 

box. Click ‘‘Search’’ then click on the 

balloon shape in the ‘‘Actions’’ column. 

If you submit your comments by mail or 

hand delivery, submit them in an 

unbound format, no larger than 81⁄2; by 

11 inches, suitable for copying and 

electronic filing. If you submit 

comments by mail and would like to 

know that they reached the Facility, 

please enclose a stamped, self-addressed 

postcard or envelope. We will consider 

all comments and material received 

during the comment period and may 


emcdonald on DSK2BSOYB1PROD with PROPOSALS