Federal Register / Vol. 74, No. 202 / Wednesday, October 21, 2009 / Rules and Regulations 53885 

Budget (OMB) under the Paperwork 

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

3520) (the PRA). The collections of 

information in part 807, subpart E, 

regarding premarket notification 

submissions, have been approved under 

OMB Control No. 0910–0120. The 

collections of information in 21 CFR 

part 801 and 21 CFR 809.10, regarding 

labeling, have been approved under 

OMB Control No. 0910–0485. The 

collections of information in 21 CFR 

part 820 have been approved under 

OMB Control No. 0910–0073. 

VI. 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. 

1. Petition from XDx, Inc., dated August 

15, 2008. 

2. Order classifying XDx AlloMap Test, 

dated August 26, 2008. 

List of Subjects in 21 CFR Part 862 

Medical devices. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 862 is 

amended as follows: 

PART 862—CLINICAL CHEMISTRY 

AND CLINICAL TOXICOLOGY 

DEVICES 

■ 1. The authority citation for 21 CFR 

part 862 continues to read as follows: 

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

360j, 371. 

■ 2. Section 862.1163 is added to 

subpart B to read as follows: 

§ 862.1163 Cardiac allograft gene 

expression profiling test system. 

(a) Identification. A cardiac allograft 

gene expression profiling test system is 

a device that measures the ribonucleic 

acid (RNA) expression level of multiple 

genes and combines this information to 

yield a signature (pattern, classifier, 

index, score) to aid in the identification 

of a low probability of acute cellular 

rejection (ACR) in heart transplant 

recipients with stable allograft function. 

(b) Classification. Class II (special 

controls). The special control is FDA’s 

guidance document entitled ‘‘Class II 

Special Controls Guidance Document: 

Cardiac Allograft Gene Expression 

Profiling Test Systems.’’ See § 862.1(d) 

for the availability of this guidance 

document. 

Dated: October 9, 2009. 

Jeffrey Shuren, 

Acting Director, Center for Devices and 

Radiological Health. 

[FR Doc. E9–25315 Filed 10–20–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2009–0895] 

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 temporary final rule is 

effective from 7 a.m. on October 21, 

2009, until 5 p.m. on November 15, 

2009. This temporary final rule is 

enforceable with actual notice by Coast 

Guard personnel beginning October 15, 

2009. 

ADDRESSES: Documents indicated in this 

preamble as being available in the 

docket are part of docket USCG–2009– 

0895 and are available online by going 

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

USCG–2009–0895 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 

final rule, call Lieutenant Junior Grade 

Laura van der Pol, Waterways 

Management Division Chief, U.S. Coast 

Guard Sector Northern New England, 

telephone 207–741–5421, e-mail 

laura.k.vanderpol1@uscg.mil. 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 

Portsmouth Naval Facility will be 

beginning diving operations in this area 

within a short timeframe thus making 

publication of a NPRM and Final Rule 

impractical. Further, 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 as well 

as to minimize the risk to commercial 

vessels and recreational boaters who 

transit the area. 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. 

Background and Purpose 

As part of ongoing ship construction 

projects at the Portsmouth Naval 

Shipyard, vessels are being launched, 

creating a period of particular 

sensitivity to the personnel and 

equipment involved. Specifically, divers 

will be working on the hull of a vessel 

for approximately four weeks beginning 

on October 15, 2009. Underwater work 

includes the removal and installation of 

heavy equipment. Unexpected and 

uncontrolled movement of the vessel 

while divers are in the water creates a 

significant risk of serious injury or 

death. Additionally, loading operations 


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53886 Federal Register / Vol. 74, No. 202 / Wednesday, October 21, 2009 / Rules and Regulations 

onto ships that are severely constrained 

by their draft could also be adversely 

affected by unexpected and 

uncontrolled movement. Wake 

produced from vessels operating in the 

vicinity of the Portsmouth Naval 

Shipyard could cause unexpected and 

uncontrolled movement of the vessels in 

the shipyard. In order to minimize such 

unexpected and uncontrolled movement 

during the timeframe that divers will be 

operating and vessel loading conducted, 

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 regulated navigation area 

encompasses all the navigable waters on 

the Piscataqua River in Portsmouth, NH 

near the Portsmouth Naval Shipyard 

between Henderson Point Light 10 

(LLNR 8375; 43–04–29.319N, 070–44– 

10.189W) on Seavey Island and Badgers 

Island Buoy 14 (LLNR 8405; 43–04– 

51.951N, 070–45–21.518W). 

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 may occur at any time, at day 

or night, during the effective period of 

the rule; however, the regulated 

navigation area will only be enforced 

during times when divers are 

conducting underwater operations and 

during vessel loading operations. 

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 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 and Local Notice to 

Mariners. The Captain of the Port will 

issue a Broadcast Notice to Mariners 

notifying the public when enforcement 

of the regulated navigation area is 

suspended. 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. 

Regulatory Planning and Review 

This 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. 

We expect the economic impact of 

this rule to be minimal because this 

regulated navigation area only requires 

vessels to reduce speed through a small 

section of the Piscataqua River therefore 

only causing a small delay to a vessel’s 

transit. Further, the regulation is only 

enforced when a vessel’s wake would 

cause undue risk to life and safety of 

personnel at the Portsmouth Naval 

Shipyard. The regulation period is for 

approximately one month. 

Small Entities 

Under the Regulatory Flexibility Act 

(RFA) (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 October 15, 2009 and 

November 15, 2009. This regulated 

navigation area will not have a 

significant economic impact on a 

substantial number of small entities 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) 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 

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 


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Federal Register / Vol. 74, No. 202 / Wednesday, October 21, 2009 / Rules and Regulations 53887 

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 

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 that this action is one 

of the 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 will be 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, and 160.5; 

Public Law 107–295, 116 Stat. 2064; 

Department of Homeland Security Delegation 

No. 0170.1. 

■ 2. Add § 165.T01–0895 to read as 

follows: 

§ 165.T01–0895 Regulated Navigation 

Area; Piscataqua River, Portsmouth, NH. 

(a) Description of the regulated 

navigation area (RNA): All navigable 

waters on the Piscataqua River, 

Portsmouth, NH and Kittery, ME near 

the Portsmouth Naval Shipyard between 

Henderson Point Light 10 (LLNR 8375; 

43–04–29.319N, 070–44–10.189W) on 

Seavey Island and Badgers Island Buoy 

14 (LLNR 8405; 43–04–51.951N, 070– 

45–21.518W). 

(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 restrictions contained in 

paragraphs (b)(2)(i) through (b)(2)(iv) of 

this section 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 October 15, 2009 until 

November 15, 2009. 

(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 effect 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: October 13, 2009. 

Joseph L. Nimmich, 

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

First Coast Guard District. 

[FR Doc. E9–25263 Filed 10–20–09; 8:45 am] 

BILLING CODE 4910–15–P 


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