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
Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Proposed Rules 48071 

change the rule based on your 

comments. 

Viewing Comments and Documents 

To view comments, as well as 

documents mentioned in this preamble 

as being available in the docket, go to 

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

‘‘read comments’’ box, which will then 

become highlighted in blue. In the 

‘‘Keyword’’ box insert ‘‘USCG–2011– 

0254’’ and click ‘‘Search.’’ Click the 

‘‘Open Docket Folder’’ in the ‘‘Actions’’ 

column. You may also visit the Docket 

Management Facility in Room W12–140 

on the ground floor of the Department 

of Transportation West Building, 1200 

New Jersey Avenue, SE., Washington, 

DC 20590, between 9 a.m. and 5 p.m., 

Monday through Friday, except Federal 

holidays. We have an agreement with 

the Department of Transportation to use 

the Docket Management Facility. 

Privacy Act 

Anyone can search the electronic 

form of comments received into any of 

our dockets by the name of the 

individual submitting the comment (or 

signing the comment, if submitted on 

behalf of an association, business, labor 

union, etc.). You may review a Privacy 

Act notice regarding our public dockets 

in the January 17, 2008, issue of the 

Federal Register (73 FR 3316). 

Public Meeting 

We do not now plan to hold a public 

meeting. But you may submit a request 

for one on or before September 7, 2011 

using one of the four methods specified 

under ADDRESSES. Please explain why 

you believe a public meeting would be 

beneficial. If we determine that one 

would aid this rulemaking, we will hold 

one at a time and place announced by 

a later notice in the Federal Register. 

Basis and Purpose 

The Zidell Waterfront Property is 

placing an engineered sediment cap 

over contaminated sediments adjacent 

to the west bank of the Willamette River 

between approximate river miles 13.5 

and 14.2 as part of an Oregon 

Department of Environmental Quality 

(DEQ) required remedial action. 

Geographically this location starts at 

approximately the West bank of the 

Marquam Bridge and continues 

southerly, along the west bank of the 

Willamette River to the North end of 

Ross Island. 

The engineered sediment cap is 

designed to be compatible with normal 

port operations, but could be damaged 

by other maritime activities including 

anchoring, dragging, dredging, 

grounding of large vessels, deployment 

of barge spuds, etc. Such damage could 

disrupt the function or impact the 

effectiveness of the cap to contain the 

underlying contaminated sediment and 

shoreline soil in these areas. As such, 

this RNA is necessary to help ensure the 

cap is protected and will do so by 

prohibiting certain maritime activities 

that could disturb or damage it. 

The engineered sediment cap will 

also reduce the depth of the water close 

to the west bank of the Willamette River 

and, as a result, may limit some vessels 

from using that area of the river. 

Discussion of Proposed Rule 

The proposed rule would create an 

RNA covering all waters adjacent to the 

Zidell Waterfront Property on the 

Willamette River extending from the 

west bank of the river out 200 to 400 

feet into the river depending on the 

exact location between approximate 

river mile 14.2 near the Ross Island 

Bridge and approximate river mile 13.5 

near the Marquam Bridge. 

Regulatory Analyses 

We developed this proposed rule after 

considering numerous statutes and 

executive orders related to rulemaking. 

Below we summarize our analyses 

based on 13 of these statutes or 

executive orders. 

Regulatory Planning and Review 

This proposed rule is not a significant 

regulatory action under section 3(f) of 

Executive Order 12866, Regulatory 

Planning and Review, and does not 

require an assessment of potential costs 

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

Order. The Office of Management and 

Budget has not reviewed it under that 

Order. The Coast Guard has made this 

determination based on the fact that the 

RNA is limited in size and will not limit 

vessels from transiting or using the 

waters covered, except for activities that 

may damage the engineered sediment 

cap. 

Small Entities 

Under the Regulatory Flexibility Act 

(5 U.S.C. 601–612), we have considered 

whether this proposed rule would have 

a significant economic impact on a 

substantial number of small entities. 

The term ‘‘small entities’’ comprises 

small businesses, not-for-profit 

organizations that are independently 

owned and operated and are not 

dominant in their fields, and 

governmental jurisdictions with 

populations of less than 50,000. 

The Coast Guard certifies under 5 

U.S.C. 605(b) that this proposed rule 

would not have a significant economic 

impact on a substantial number of small 

entities. This proposed rule would affect 

the following entities, some of which 

might be small entities: The owners or 

operators of vessels operating in the area 

covered by the RNA. The RNA would 

not have a significant economic impact 

on a substantial number of small 

entities, however, because the RNA is 

limited in size and will not limit vessels 

from transiting or using the waters 

covered, except for activities that may 

damage the engineered sediment cap. 

If you think that your business, 

organization, or governmental 

jurisdiction qualifies as a small entity 

and that this rule would have a 

significant economic impact on it, 

please submit a comment (see 

ADDRESSES) explaining why you think it 

qualifies and how and to what degree 

this rule would economically affect it. 

Assistance for Small Entities 

Under section 213(a) of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (Pub. L. 104–121), 

we want to assist small entities in 

understanding this proposed rule so that 

they can better evaluate its effects on 

them and participate in the rulemaking. 

If the rule would affect your small 

business, organization, or governmental 

jurisdiction and you have questions 

concerning its provisions or options for 

compliance, please contact MST1 Jaime 

Sayers, Waterways Management 

Division, Marine Safety Unit Portland, 

Coast Guard; telephone 503–240–9319, 

e-mail Jaime.A.Sayers@uscg.mil. The 

Coast Guard will not retaliate against 

small entities that question or complain 

about this proposed rule or any policy 

or action of the Coast Guard. 

Collection of Information 

This proposed rule would call for no 

new collection of information under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520.). 

Federalism 

A rule has implications for federalism 

under Executive Order 13132, 

Federalism, if it has a substantial direct 

effect on State or local governments and 

would either preempt State law or 

impose a substantial direct cost of 

compliance on them. We have analyzed 

this proposed rule under that Order and 

have determined that it does not have 

implications for federalism. 

Unfunded Mandates Reform Act 

The Unfunded Mandates Reform Act 

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

Federal agencies to assess the effects of 

their discretionary regulatory actions. In 

particular, the Act addresses actions 

that may result in the expenditure by a 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
48072 Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Proposed Rules 

State, local, or tribal government, in the 

aggregate, or by the private sector of 

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

more in any one year. Though this 

proposed rule would not result in such 

an expenditure, we do discuss the 

effects of this rule elsewhere in this 

preamble. 

Taking of Private Property 

This proposed rule would not cause a 

taking of private property or otherwise 

have taking implications under 

Executive Order 12630, Governmental 

Actions and Interference with 

Constitutionally Protected Property 

Rights. 

Civil Justice Reform 

This proposed rule meets applicable 

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

Executive Order 12988, Civil Justice 

Reform, to minimize litigation, 

eliminate ambiguity, and reduce 

burden. 

Protection of Children 

We have analyzed this proposed rule 

under Executive Order 13045, 

Protection of Children from 

Environmental Health Risks and Safety 

Risks. This rule is not an economically 

significant rule and would not create an 

environmental risk to health or risk to 

safety that might disproportionately 

affect children. 

Indian Tribal Governments 

This proposed rule does not have 

tribal implications under Executive 

Order 13175, Consultation and 

Coordination with Indian Tribal 

Governments, because it would not have 

a substantial direct effect on one or 

more Indian tribes, on the relationship 

between the Federal Government and 

Indian tribes, or on the distribution of 

power and responsibilities between the 

Federal Government and Indian tribes. 

Energy Effects 

We have analyzed this proposed rule 

under Executive Order 13211, Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use. We have 

determined that it is not a ‘‘significant 

energy action’’ under that order because 

it is not a ‘‘significant regulatory action’’ 

under Executive Order 12866 and is not 

likely to have a significant adverse effect 

on the supply, distribution, or use of 

energy. The Administrator of the Office 

of Information and Regulatory Affairs 

has not designated it as a significant 

energy action. Therefore, it does not 

require a Statement of Energy Effects 

under Executive Order 13211. 

Technical Standards 

The National Technology Transfer 

and Advancement Act (NTTAA) (15 

U.S.C. 272 note) directs agencies to use 

voluntary consensus standards in their 

regulatory activities unless the agency 

provides Congress, through the Office of 

Management and Budget, with an 

explanation of why using these 

standards would be inconsistent with 

applicable law or otherwise impractical. 

Voluntary consensus standards are 

technical standards (e.g., specifications 

of materials, performance, design, or 

operation; test methods; sampling 

procedures; and related management 

systems practices) that are developed or 

adopted by voluntary consensus 

standards bodies. 

This proposed rule does not use 

technical standards. Therefore, we did 

not consider the use of voluntary 

consensus standards. 

Environment 

We have analyzed this proposed rule 

under Department of Homeland 

Security Management Directive 023–01 

and Commandant Instruction 

M16475.lD, which guide the Coast 

Guard in complying with the National 

Environmental Policy Act of 1969 

(NEPA) (42 U.S.C. 4321–4370f), and 

have made a preliminary determination 

that this action is one of a category of 

actions that do not individually or 

cumulatively have a significant effect on 

the human environment. A preliminary 

environmental analysis checklist 

supporting this determination is 

available in the docket where indicated 

under ADDRESSES. This proposed rule 

involves the creation of a regulated 

navigation area. We seek any comments 

or information that may lead to the 

discovery of a significant environmental 

impact from this proposed rule. 

List of Subjects in 33 CFR Part 165 

Harbors, Marine safety, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, 

Waterways. 

For the reasons discussed in the 

preamble, the Coast Guard proposes to 

amend 33 CFR part 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

1. The authority citation for part 165 

continues to read as follows: 

Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. 

Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 

33 CFR 1.05–1(g), 6.04–1, 6.04–6, 160.5; Pub. 

L. 107–295, 116 Stat. 2064; Department of 

Homeland Security Delegation No. 0170.1. 

2. Add § 165.1337 to read as follows: 

§ 165.1337 Regulated Navigation Area, 

Zidell Waterfront Property, Willamette River, 

OR. 

(a) Regulated Navigation Area. The 

following area is a regulated navigation 

area: All waters within the area 

bounded by the following points: 

45°29′55.12′′ N/122°40′2.19′′ W; thence 

continuing to 45°29′55.14′′ N/ 

122°39′59.36′′ W; thence continuing to 

45°29′56.30′′ N/122°39′59.09′′ W; thence 

continuing to 45°29′57.51′′ N/ 

122°39′59.64′′ W; thence continuing to 

45°29′58.72′′ N/122°39′59.64′′ W; thence 

continuing to 45°30′0.52′′ N/ 

122°39′59.94′′ W; thence continuing to 

45°30′1.95′′ N/122°40′0.46′′ W; thence 

continuing to 45°30′3.44′′ N/ 

122°40′0.78′′ W; thence continuing to 

45°30′4.87′′ N/122°40′0.95′′ W; thence 

continuing to 45°30′7.33′′ N/ 

122°40′1.80′′ W; thence continuing to 

45°30′8.11′′ N/122°40′2.69′′ W; thence 

continuing to 45°30′8.83′′ N/ 

122°40′3.81′′ W; thence continuing to 

45°30′13.06′′ N/122°40′5.39′′ W; thence 

continuing to 45°30′15.30′′ N/ 

122°40′6.93′′ W; thence continuing to 

45°30′17.78′′ N/122°40′8.16′′ W; thence 

continuing to 45°30′20.53′′ N/ 

122°40′9.07′′ W; thence continuing to 

45°30′20.90′′ N/122° 40′11.52′′ W; 

thence continuing to 45°30′24.04′′ N/ 

122°40′12.53′′ W; thence continuing to 

45°30′23.79′′ N/122°40′14.87′′ W; thence 

continuing along the shoreline to 

45°29′55.12′′ N/122°40′2.19′′ W. 

Geographically the regulated 

navigation area covers all waters 

adjacent to the Zidell Waterfront 

Property on the Willamette River 

extending from the west bank of the 

river out 200 to 400 feet into the river 

depending on the exact location 

between approximate river mile 14.2 

near the Ross Island Bridge and 

approximate river mile 13.5 near the 

Marquam Bridge. 

(b) Regulations. All vessels are 

prohibited from anchoring, dragging, 

dredging, or trawling in the regulated 

navigation area established by this 

section. See 33 CFR part 165 subpart B 

for additional information and 

requirements. 

Dated: July 6, 2011. 

G.T. Blore, 

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

Thirteenth Coast Guard District. 

[FR Doc. 2011–19986 Filed 8–5–11; 8:45 am] 

BILLING CODE 9110–04–P 


emcdonald on DSK2BSOYB1PROD with PROPOSALS