70730 Federal Register / Vol. 70, No. 225 / Wednesday, November 23, 2005 / Rules and Regulations 

designee, to decide whether a national 

emergency has developed or is 

developing in the importing country, 

whether the investigational new drug 

will be used solely for that national 

emergency, and whether prompt 

exportation of the investigational new 

drug is necessary. Persons who wish to 

obtain a determination from the 

Secretary should direct their requests to 

Secretary’s Operations Center, Office of 

Emergency Operations and Security 

Programs, Office of Public Health 

Emergency Preparedness, Office of the 

Secretary, Department of Health and 

Human Services, 200 Independence 

Ave. SW., Washington, DC 20201. 

Requests may be also be sent by FAX: 

202–619–7870 or by e-mail: 

HHS.SOC@hhs.gov. 

(B) Exportation may proceed without 

prior FDA authorization. 

(c) Limitations. Exportation under 

paragraph (b) of this section may not 

occur if: 

(1) For drugs exported under 

paragraph (b)(1) of this section, the IND 

pertaining to the clinical investigation is 

no longer in effect; 

(2) For drugs exported under 

paragraph (b)(2) of this section, the 

requirements in section 802(b)(1), (f), or 

(g) of the act are no longer met; 

(3) For drugs exported under 

paragraph (b)(3) of this section, the 

requirements in section 802(c), (f), or (g) 

of the act are no longer met; 

(4) For drugs exported under 

paragraph (b)(4) of this section, the 

conditions underlying the certification 

or the statements submitted under 

paragraph (b)(5) of this section are no 

longer met; or 

(5) For any investigational new drugs 

under this section, the drug no longer 

complies with the laws of the importing 

country. 

(d) Insulin and antibiotics. New 

insulin and antibiotic drug products 

may be exported for investigational use 

in accordance with section 801(e)(1) of 

the act without complying with this 

section. 

Dated: November 16, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–23120 Filed 11–22–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[COTP Jacksonville 05–154] 

RIN 1625–AA87 

Security Zone; St. John’s River, 

Jacksonville, FL to Ribault Bay 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary moving 

security zone around foreign naval 

submarines in transit within the area 

between 12 nautical miles seaward from 

the baseline at the mouth of the St. 

John’s River to Ribault Bay. The security 

zone includes all waters within 500 

yards in any direction of the submarine. 

This rule prohibits entry into the 

security zone without the permission of 

the Captain of the Port (COTP) 

Jacksonville or his designated 

representative. Persons or vessels that 

receive permission to enter the security 

zone must proceed at a minimum safe 

speed, must comply with all orders 

issued by the COTP or his designated 

representative, and must not proceed 

any closer than 100 yards, in any 

direction, to the submarine. This 

security zone is needed to ensure public 

safety and to prevent sabotage or 

terrorist acts against the submarine. 

DATES: This rule is effective from 8 a.m. 

on November 9, 2005, until 11:59 p.m. 

on December 1, 2005. 

ADDRESSES: Documents mentioned in 

this preamble as being available in the 

docket are part of docket [COTP 

Jacksonville 05–154] and are available 

for inspection and copying at Coast 

Guard Sector Jacksonville Prevention 

Department, 7820 Arlington 

Expressway, Suite 400, Jacksonville, 

Florida 32211, between 8 a.m. and 4 

p.m., Monday through Friday, except 

Federal holidays. 

FOR FURTHER INFORMATION CONTACT: 

Ensign Kira Peterson at Coast Guard 

Sector Jacksonville Prevention 

Department, Florida telephone: (904) 

232–2640, ext. 108. 

SUPPLEMENTARY INFORMATION: 

Regulatory Information 

We did not publish a notice of 

proposed rulemaking (NPRM) for this 

regulation. Under 5 U.S.C. 553(b)(B), the 

Coast Guard finds that good cause exists 

for not publishing a NRPM. Publishing 

a NPRM, which would incorporate a 

comment period before a final rule 

could be issued, and delay the rule’s 

effective date, is contrary to the public 

interest because immediate action is 

necessary to protect the public and 

waters of the United States. 

For the same reasons, 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. The 

Coast Guard will issue a broadcast 

notice to mariners and will place Coast 

Guard vessels in the vicinity of this 

zone to advise mariners of the 

restrictions. 

Background and Purpose 

This rule is needed to protect foreign 

navy submarines from damage or injury 

from sabotage or other subversive acts, 

accidents or other causes of a similar 

nature, or to secure the observance of 

rights and obligations of the United 

States. Although this rule is effective 

from 8 a.m. on November 9, 2005, until 

11:59 p.m. on December 1, 2005, the 

Coast Guard will only enforce this rule 

when a foreign navy submarine is 

transiting within the area between 12 

nautical miles seaward from the 

baseline at the mouth of the St. John’s 

River to Ribault Bay. Anchoring, 

mooring, or transiting within this zone 

is prohibited, unless authorized by the 

Captain of the Port, Jacksonville, 

Florida, or his designated 

representative. The temporary security 

zone encompasses all waters within 500 

yards around the foreign naval 

submarine. Vessels or persons 

authorized to enter the zone must 

proceed at a minimum safe speed, must 

comply with all orders issued by the 

COTP or his designated representative, 

and must not proceed any closer than 

100 yards, in any direction, to the 

submarine. 

Regulatory Evaluation 

This regulation 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 cost 

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

Order. The Office of Management and 

Budget has not reviewed it under the 

order. It is not ‘‘significant’’ under the 

regulatory policies and procedures of 

the Department of Homeland Security 

(DHS) because these regulations will 

only be in effect for a short period of 

time and the impact on routine 

navigation is expected to be minimal. 

Small Entities 

Under the Regulatory Flexibility Act 

(5 U.S.C. 601–612), we considered 

whether this rule would have a 

Federal Register / Vol. 70, No. 225 / Wednesday, November 23, 2005 / Rules and Regulations 70731 

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 field, 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 upon a 

substantial number of small entities 

because the regulation will only be 

enforced for a short period of time 

within a 22-day window, during vessel 

transits, and the impact on routine 

navigation is expected to be minimal. 

Vessels may still transit safely around 

the zone and, upon permission of the 

Captain of the Port or his designated 

representative, may transit at minimum 

safe speed through that portion of the 

security zone between 100 and 500 

yards from the submarine. 

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. If 

the rule will affect your small business, 

organization, or government jurisdiction 

and you have questions concerning its 

provisions or options for compliance, 

please contact the person listed under 

FOR FURTHER INFORMATION CONTACT for 

assistance in understanding this rule. 

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). 

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 my result in the expenditure by 

State, local, or tribal government, in the 

aggregate, or by the private sector of 

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

Although 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 affect 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 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 

Commandant Instruction M16475.lD, 

which guides the Coast Guard in 

complying with the National 

Environmental Policy Act of 1969 

(NEPA) (42 U.S.C. 4321–4370f), and 

have concluded that there are no factors 

in this case that would limit the use of 

a categorical exclusion under section 

2.B.2 of the Instruction. Therefore, this 

rule is categorically excluded, under 

figure 2–1, paragraph (34)(g), of the 

Instruction, from further environmental 

documentation. Under figure 2–1, 

paragraph (34)(g), of the Instruction, an 

‘‘Environmental Analysis Check List’’

and a ‘‘Categorical Exclusion 

Determination’’ are not required for this 

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 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; 50 U.S.C. 191, 195; 33 CFR 

70732 Federal Register / Vol. 70, No. 225 / Wednesday, November 23, 2005 / Rules and Regulations 

1.05–1(g), 6.04–1, 6.04–6, and 160.5; Pub. L. 

107–295, 116 Stat. 2064; Department of 

Homeland Security Delegation No. 0170.1. 

■ 2. A new temporary § 165.T07–154 is 

added to read as follows: 

§ 165.T07–154 Security Zone; St. John’s 

River, Jacksonville, FL to Ribault Bay. 

(a) Regulated area. The Coast Guard is 

establishing a temporary moving 

security zone for a foreign navy 

submarine within the area 12 nautical 

miles seaward from the baseline at the 

mouth of the St. John’s River to Ribault 

Bay. The temporary security zone 

encompasses all waters within 500 

yards in any direction around a foreign 

navy submarine transiting within the 

area between 12 nautical miles seaward 

of the sea buoy at the entrance to the St. 

John’s River to Ribault Bay. 

(b) Definitions. The following 

definitions apply to this section: 

Designated representatives means 

Coast Guard Patrol Commanders 

including Coast Guard coxswains, petty 

officers and other officers operating 

Coast Guard vessels, and Federal, State, 

and local officers designated by or 

assisting the Captain of the Port (COTP), 

Jacksonville, Florida, in the enforcement 

of the regulated navigation areas and 

security zones. 

Minimum Safe Speed means the 

speed at which a vessel proceeds when 

it is fully off plane, completely settled 

in the water and not creating excessive 

wake. Due to the different speeds at 

which vessels of different sizes and 

configurations may travel while in 

compliance with this definition, no 

specific speed is assigned to minimum 

safe speed. In no instance should 

minimum safe speed be interpreted as a 

speed less than that required for a 

particular vessel to maintain 

steerageway. A vessel is not proceeding 

at minimum safe speed if it is: 

(1) On a plane; 

(2) In the process of coming up onto 

or coming off a plane; or 

(3) Creating an excessive wake. 

(c) Regulations. In accordance with 

the general regulations in § 165.33 of 

this part, anchoring, mooring or 

transiting in this zone is prohibited 

unless authorized by the Coast Guard 

Captain of the Port Jacksonville, FL or 

his designated representative. Persons 

or vessels that receive permission to 

enter the security zone must proceed at 

a minimum safe speed, must comply 

with all orders issued by the COTP or 

his designated representative, and must 

not proceed any closer than 100 yards, 

in any direction, to the submarine. 

(d) Dates. This section is effective 

from 8 a.m. on November 9, 2005, until 

11:59 p.m. on December 1, 2005. 

Dated: November 9, 2005. 

David L. Lersch, 

Captain, U.S. Coast Guard, Captain of the 

Port Jacksonville. 

[FR Doc. 05–23236 Filed 11–22–05; 8:45 am] 

BILLING CODE 4910–15–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[COTP Western Alaska–04–003] 

RIN 1625–AA00 

Safety Zone; Bering Sea, Aleutian 

Islands, Unalaska Island, AK 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule; change of 

effective period. 

SUMMARY: The Coast Guard is extending 

the effective period of the safety zone in 

the Bering Sea, Unalaska Island, Alaska. 

The zone is needed to facilitate safe 

salvage operations related to the 

grounding of the merchant vessel (M/V) 

SELENDANG AYU. Entry of vessels or 

persons into this zone is prohibited 

unless specifically authorized by the 

Commander, Seventeenth Coast Guard 

District, the Coast Guard Captain of the 

Port, Western Alaska, or their on-scene 

representative. The intended effect of 

the proposed safety zone is to mitigate 

safety risks to salvage personnel. 

DATES: The effective period of 

§ 165.T17–010 is extended from 

November 30, 2005 through October 31, 

2006. 

ADDRESSES: Documents indicated in this 

preamble as being available in the 

docket are available for inspection and 

copying at Coast Guard Marine Safety 

Office Anchorage, 510 ‘‘L’’ Street, Suite 

100, Anchorage, AK 99501. Normal 

Office hours are 7:30 a.m. to 4 p.m., 

Monday through Friday, except Federal 

holidays. 

FOR FURTHER INFORMATION CONTACT: LT 

Meredith Gillman, Marine Safety Office 

Anchorage, at (907) 271–6700. 

SUPPLEMENTARY INFORMATION: 

Regulatory Information 

We did not publish a notice of 

proposed rulemaking (NPRM) for this 

regulation. Under 5 U.S.C. 553(b)(B), the 

Coast Guard finds that good cause exists 

for not publishing an NPRM and for 

making this regulation effective less 

than 30 days after its publication in the 

Federal Register. Any delay 

encountered in this regulation’s 

effective date would be contrary to 

public interest because immediate 

action is needed to prevent 

unauthorized vessel traffic from 

hindering salvage operations. 

The Coast Guard will terminate the 

zone when salvage operations are 

complete and the area adjacent to the 

grounded vessel is considered safe to 

vessel traffic. 

Background and Purpose 

The M/V SELENDANG AYU ran 

aground at a position of 53.634° N, 

167.125° W on December 9, 2004. The 

vessel then broke in half and discharged 

its fuel oil into the water. A marine 

salvor is removing sections of the wreck 

from the bow and stern sections of the 

grounded vessel, as well as from the 

adjacent shoreline. The safety zone is 

necessary to prevent unauthorized 

vessels from impeding salvage 

operations. 

Discussion of Rule 

The Unified Command, which is 

responding to the grounding of the M/ 

V Selendang Ayu, identified the safety 

zone in the area where subsequent 

salvage operations will be taking place. 

This area is defined by a circle centered 

at 53 degrees, 38 minutes North; 167 

degrees, 7 minutes, 20 seconds West 

with a radius of 750 yards. All 

coordinates reference Datum: NAD 

1983. 

Regulatory Evaluation 

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 cost 

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

Order. The Office of Management and 

Budget has not reviewed it under that 

Order. It is not significant under the 

regulatory policies and procedures of 

the Department of Homeland Security 

(DHS). The Coast Guard expects the 

economic impact of this rule to be so 

minimal that a full Regulatory 

Evaluation under paragraph 10(e) of the 

regulatory policies and procedures of 

DHS is unnecessary. 

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.