Federal Register / Vol. 76, No. 158 / Tuesday, August 16, 2011 / Rules and Regulations 50667 

PART 884—OBSTETRICAL AND 

GYNECOLOGICAL DEVICES 

■ 4. The authority citation for 21 CFR 

part 884 continues to read as follows: 

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

360j, 371. 

■ 5. Section 884.5330 is amended by 

revising paragraph (c) to read as follows: 

§ 884.5330 Female condom. 

* * * * * 

(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 November 

21, 2011, for any female condom that 

was in commercial distribution before 

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

November 21, 2011, been found to be 

substantially equivalent to any female 

condom that was in commercial 

distribution before May 28, 1976. Any 

other female condom shall have an 

approved PMA or declared completed 

PDP in effect before being placed in 

commercial distribution. 

Dated: August 10, 2011. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2011–20664 Filed 8–15–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2011–0708] 

RIN 1625–AA11 

Regulated Navigation Area; 

Portsmouth Naval Shipyard, 

Portsmouth, NH 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a regulated navigation area 

on the Piscataqua River near 

Portsmouth, NH. This temporary final 

rule places speed restrictions on all 

vessels transiting the navigable waters 

on the Piscataqua River, Portsmouth, 

NH near the Portsmouth Naval Shipyard 

between Henderson Point Light on 

Seavey Island and Badgers Island Buoy 

14. This rule is necessary to provide for 

the safety of life on the navigable waters 

during ongoing ship construction. 

DATES: This rule is effective from 

August 16, 2011 until 5 p.m. on 

September 5, 2011. This rule will be 

enforced with actual notice from 7 a.m. 

on August 5, 2011 until 5 p.m. on 

September 5, 2011. 

ADDRESSES: Documents indicated in this 

preamble as being available in the 

docket are part of docket USCG–2011– 

0708 and are available online by going 

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

USCG–2011–0708 in the ‘‘Keyword’’ 

box, and then clicking ‘‘Search.’’ They 

are also available for inspection or 

copying at the Docket Management 

Facility (M–30), U.S. Department of 

Transportation, West Building Ground 

Floor, Room W12–140, 1200 New Jersey 

Avenue, SE., Washington, DC 20590, 

between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this temporary 

rule, call or e-mail Lieutenant Junior 

Grade Terence Leahy, Waterways 

Management Division at Coast Guard 

Sector Northern New England, 

telephone 207–767–0398, e-mail 

Terence.O.Leahy@uscg.mil or 

Lieutenant Junior Grade Isaac Slavitt, 

Waterways Management Division at 

Coast Guard First District, telephone 

617–223–8385. If you have questions on 

viewing the docket, call Renee V. 

Wright, Program Manager, Docket 

Operations, telephone 202–366–9826. 

SUPPLEMENTARY INFORMATION: 

Regulatory Information 

The Coast Guard is issuing this 

temporary final rule without prior 

notice and opportunity to comment 

pursuant to authority under section 4(a) 

of the Administrative Procedure Act 

(APA) (5 U.S.C. 553(b)). This provision 

authorizes an agency to issue a rule 

without prior notice and opportunity to 

comment when the agency for good 

cause finds that those procedures are 

‘‘impracticable, unnecessary, or contrary 

to the public interest.’’ Under 5 U.S.C. 

553(b)(B), the Coast Guard finds that 

good cause exists for not publishing a 

notice of proposed rulemaking (NPRM) 

with respect to this rule because the 

Coast Guard was not notified of the 

need for this rule until 13 July 2011, and 

the Portsmouth Naval Facility will begin 

diving operations in this area within a 

short timeframe making publication of a 

NPRM and Final Rule impractical. This 

regulated navigation area is necessary to 

provide for the safety of the divers and 

others working in the area as wake from 

passing vessels could cause the ship to 

move erratically and unexpectedly, 

injuring the divers and their support 

crews. Not providing for the safety of 

the divers and others in the area is 

contrary to the public interest of 

creating a safe work environment. 

Under 5 U.S.C. 553(d)(3), the Coast 

Guard finds that good cause exists for 

making this rule effective less than 30 

days after publication in the Federal 

Register as immediate action is 

necessary to provide for the safety of 

divers and workers on the vessel. In 

addition to the reasons stated within 

this preamble, a delay in the effective 

date of this rule is contrary to the 

public’s interest in ensuring the ship 

construction project continues as 

scheduled. 

Basis and Purpose 

Under the Ports and Waterways Safety 

Act, the Coast Guard has the authority 

to establish RNAs in defined water areas 

that are determined to have hazardous 

conditions and in which vessel traffic 

can be regulated in the interest of safety. 

See 33 U.S.C. 1231 and Department of 

Homeland Security Delegation No. 

0170.1. 

As part of ongoing ship construction 

projects at the Portsmouth Naval 

Shipyard, divers will be working on the 

hull of a vessel for approximately four 

weeks beginning on August 5, 2011. 

Unexpected and uncontrolled 

movement of the vessel due to wake 

while divers are in the water creates a 

significant risk of serious injury or 

death. In order to ensure the safety of 

vessel workers such as divers during the 

period of ship construction work, the 

Coast Guard is creating a regulated 

navigation area to limit the speed, and 

thus wake, of all vessels operating in the 

vicinity of the shipyard. 

Discussion of Rule 

This action places speed restrictions 

on all vessels transiting the navigable 

waters on the Piscataqua River, 

Portsmouth, NH near the Portsmouth 

Naval Shipyard between Henderson 

Point Light on Seavey Island and 

Badgers Island Buoy 14 when necessary 

for the safety of navigation during 

periods of ship construction work. All 

vessels operating in this area shall 

proceed with caution; operate at no 

more than 5 knots and in a manner so 

as to produce no wake. Diving 

operations and other vessel construction 

may occur at any time, day or night. 

The Captain of the Port Sector 

Northern New England will cause notice 

of enforcement or suspension of 

enforcement of this regulated navigation 

area to be made by all appropriate 

means in order to affect the widest 

distribution among the affected 

segments of the public. Such means of 

notification will include, but is not 

limited to, Broadcast Notice to Mariners 


jlentini on DSK4TPTVN1PROD with RULES
50668 Federal Register / Vol. 76, No. 158 / Tuesday, August 16, 2011 / Rules and Regulations 

and Local Notice to Mariners. In 

addition, Captain of the Port Sector 

Northern New England maintains a 

telephone line that is staffed 24 hours a 

day, seven days a week. The public can 

obtain information concerning 

enforcement of the regulated navigation 

area by contacting Sector Northern New 

England Command Center at (207) 767– 

0303. 

Regulatory Analyses 

We developed this 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. 

Executive Order 12866 and Executive 

Order 13563 

This rule is not a significant 

regulatory action under section 3(f) of 

Executive Order 12866, Regulatory 

Planning and Review, as supplemented 

by Executive Order 13563, 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. 

Small Entities 

Under the Regulatory Flexibility Act 

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

whether this 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 rule will not have 

a significant economic impact on a 

substantial number of small entities. 

This rule will affect the following 

entities, some of which may be small 

entities: The owners or operators of 

vessels intending to transit the portion 

of the Piscataqua River affected by this 

rule between August 5, 2011 and 

September 5, 2011. 

This regulation may have some 

impact on the public, but the potential 

impact will be minimized for the 

following reasons: This rule allows 

vessels to continue to transit through 

the regulated area, but only at a reduced 

speed. The reduced speed area is 

relatively small (approximately 1 

nautical mile long) and will only be 

enforced when necessary to protect the 

safety of personnel at the Portsmouth 

Naval Shipyard. Further, the Coast 

Guard will advise mariners as to the 

enforcement of the regulated navigation 

area through broadcast and local notice 

to mariners thus allowing mariners to 

plan their transits accordingly. 

Assistance for Small Entities 

Under section 213(a) of the Small 

Business Regulatory Enforcement 

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

we offer to assist small entities in 

understanding the rule so that they can 

better evaluate its effects on them and 

participate in the rulemaking process. 

Small businesses may send comments 

on the actions of Federal employees 

who enforce, or otherwise determine 

compliance with, Federal regulations to 

the Small Business and Agriculture 

Regulatory Enforcement Ombudsman 

and the Regional Small Business 

Regulatory Fairness Boards. The 

Ombudsman evaluates these actions 

annually and rates each agency’s 

responsiveness to small business. If you 

wish to comment on actions by 

employees of the Coast Guard, call 

1–888–REG–FAIR (1–888–734–3247). 

The Coast Guard will not retaliate 

against small entities that question or 

complain about this rule or any policy 

or action of the Coast Guard. 

Collection of Information 

This rule calls 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 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 

State, local, or tribal government, in the 

aggregate, or by the private sector of 

$100,000,000 or more in any one year. 

Though this rule will not result in such 

an expenditure, we do discuss the 

effects of this rule elsewhere in this 

preamble. 

Taking of Private Property 

This rule will not effect 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 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 rule under 

Executive Order 13045, Protection of 

Children from Environmental Health 

Risks and Safety Risks. This rule is not 

an economically significant rule and 

does not create an environmental risk to 

health or risk to safety that may 

disproportionately affect children. 

Indian Tribal Governments 

This rule does not have tribal 

implications under Executive Order 

13175, Consultation and Coordination 

with Indian Tribal Governments, 

because it does 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 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 


jlentini on DSK4TPTVN1PROD with RULES
Federal Register / Vol. 76, No. 158 / Tuesday, August 16, 2011 / Rules and Regulations 50669 

systems practices) that are developed or 

adopted by voluntary consensus 

standards bodies. 

This rule does not use technical 

standards. Therefore, we did not 

consider the use of voluntary consensus 

standards. 

Environment 

We have analyzed this 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 concluded this action is one of a 

category of actions which do not 

individually or cumulatively have a 

significant effect on the human 

environment. This rule is categorically 

excluded, under figure 2–1, paragraph 

(34)(g), of the Instruction. This rule 

involves the establishing of a regulated 

navigation area and therefore falls 

within the categorical exclusion noted 

above. An environmental analysis 

checklist and a categorical exclusion 

determination are available in the 

docket where indicated under 

ADDRESSES. 

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 amends 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, 6.04–1, 6.04–6, 160.5; Public 

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

Homeland Security Delegation No. 0170.1. 

■ 2. Add § 165.T01–0708 to read as 

follows: 

§ 165.T01–0708 Regulated Navigation 

Area; Portsmouth Naval Base, Portsmouth, 

NH. 

(a) Location. The following area is a 

regulated navigation area: All navigable 

waters on the Piscataqua River, 

Portsmouth, NH and Kittery, ME near 

the Portsmouth Naval Shipyard between 

43°04′29.319′′ N, 070°44′10.189′′ W 

(Henderson Point Light 10, LLNR 8375) 

on Seavey Island and 43°04′51.951′′ N, 

070°45′21.518′′ W (Badgers Island Buoy 

14, LLNR 8405). 

(b) Regulations: (1) The general 

regulations contained in 33 CFR 165.10, 

165.11 and 165.13 apply. 

(2) In accordance with the general 

regulations, the following restrictions 

apply to all vessels operating within the 

regulated area noted above. 

(i) No vessel may operate in this 

regulated area at a speed in excess of 

five knots. 

(ii) All vessels must proceed through 

the area with caution and operate in 

such a manner as to produce no wake. 

(iii) Vessels operating within the 

regulated navigation area must comply 

with all directions given to them by the 

Captain of the Port Sector Northern New 

England or his on-scene representative. 

The ‘‘on-scene representative’’ of the 

Captain of the Port is any Coast Guard 

commissioned, warrant or petty officer 

who has been designated by the Captain 

of the Port to act on his behalf. The onscene representative may be on a Coast 

Guard vessel, State Marine Patrol vessel 

or other designated craft, or may be on 

shore and will communicate with 

vessels via VHF–FM radio or loudhailer. 

Members of the Coast Guard Auxiliary 

or Naval Harbor Security Patrol may be 

present to inform vessel operators of 

this regulation. 

(iv) For purposes of navigational 

safety, the Captain of the Port or onscene representative may authorize a 

deviation from this regulation. 

(c) Enforcement. (1) This regulated 

navigation area is enforceable 24 hours 

a day from August 5, 2011 until 

September 5, 2011. 

(2) Notice of suspension of 

enforcement: The Captain of the Port 

Sector Northern New England may 

temporarily suspend enforcement of the 

regulated navigation area. If 

enforcement of the zone is temporarily 

suspended, the Captain of the Port 

Sector Northern New England will 

cause a notice of the suspension of 

enforcement of this regulated navigation 

area to be made by all appropriate 

means to affect the widest publicity 

among the affected segments of the 

public. Such means of notification may 

also include but are not limited to, 

Broadcast Notice to Mariners or Local 

Notice to Mariners. Such notification 

will include the date and time that 

enforcement is suspended as well as the 

date and time that enforcement will 

resume. 

(3) Violations of this regulated 

navigation area should be reported to 

the Captain of the Port Sector Northern 

New England, at (207) 767–0303 or on 

VHF–Channel 16. Persons in violation 

of this regulated navigation area may be 

subject to civil and/or criminal 

penalties. 

Dated: August 5, 2011. 

Daniel A. Neptun, 

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

First Coast Guard District. 

[FR Doc. 2011–20770 Filed 8–15–11; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2009–0559] 

RIN 1625–AA00 

Safety Zones; Eleventh Coast Guard 

District Annual Fireworks Events 

AGENCY: Coast Guard, DHS. 

ACTION: Final rule. 

SUMMARY: The Coast Guard is amending 

multiple permanent safety zones to 

ensure public safety during annual 

firework displays at various locations in 

the Eleventh Coast Guard District. These 

amendments will standardize the safety 

zone language, update listed events, 

delete events that are no longer 

occurring, add new unlisted annual 

fireworks events to the regulations, and 

standardize the format for all tables in 

these four sections. When these safety 

zones are activated, and thus subject to 

enforcement, this rule would limit the 

movement of vessels within the 

established firework display area. 

DATES: This rule is effective September 

15, 2011. 

ADDRESSES: Comments and material 

received from the public, as well as 

documents mentioned in this preamble 

as being available in the docket, are part 

of docket USCG–2009–0559 and are 

available online by going to http:// 

www.regulations.gov, inserting USCG– 

2009–0559 in the ‘‘Keyword’’ box, and 

then clicking ‘‘Search.’’ This material is 

also available for inspection or copying 

at the Docket Management Facility (M– 

30), U.S. Department of Transportation, 

West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue, SE., 

Washington, DC 20590, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

e-mail Lieutenant Lucas Mancini, 

Eleventh Coast Guard District 

Prevention Division, Waterways 

Management Branch, Coast Guard; 

telephone 510–437–3801, e-mail 

Lucas.W.Mancini@uscg.mil. If you have 

questions on viewing or submitting 

material to the docket, call Renee V. 


jlentini on DSK4TPTVN1PROD with RULES