Federal Register / Vol. 75, No. 188 / Wednesday, September 29, 2010 / Rules and Regulations 59963 

frequency different than that required 

under this paragraph. The sponsor may 

also propose and adopt a different 

reporting format or frequency if the 

change is agreed to in advance by the 

director of the FDA review division that 

has responsibility for review of the IND. 

(4) Investigations of marketed drugs. 

A sponsor of a clinical study of a drug 

marketed or approved in the United 

States that is conducted under an IND 

is required to submit IND safety reports 

for suspected adverse reactions that are 

observed in the clinical study, at 

domestic or foreign study sites. The 

sponsor must also submit safety 

information from the clinical study as 

prescribed by the postmarketing safety 

reporting requirements (e.g., §§ 310.305, 

314.80, and 600.80 of this chapter). 

(5) Reporting study endpoints. Study 

endpoints (e.g., mortality or major 

morbidity) must be reported to FDA by 

the sponsor as described in the protocol 

and ordinarily would not be reported 

under paragraph (c) of this section. 

However, if a serious and unexpected 

adverse event occurs for which there is 

evidence suggesting a causal 

relationship between the drug and the 

event (e.g., death from anaphylaxis), the 

event must be reported under 

§ 312.32(c)(1)(i) as a serious and 

unexpected suspected adverse reaction 

even if it is a component of the study 

endpoint (e.g., all-cause mortality). 

(d) Followup. (1) The sponsor must 

promptly investigate all safety 

information it receives. 

(2) Relevant followup information to 

an IND safety report must be submitted 

as soon as the information is available 

and must be identified as such, i.e., 

‘‘Followup IND Safety Report.’’ 

(3) If the results of a sponsor’s 

investigation show that an adverse event 

not initially determined to be reportable 

under paragraph (c) of this section is so 

reportable, the sponsor must report such 

suspected adverse reaction in an IND 

safety report as soon as possible, but in 

no case later than 15 calendar days after 

the determination is made. 

(e) Disclaimer. A safety report or other 

information submitted by a sponsor 

under this part (and any release by FDA 

of that report or information) does not 

necessarily reflect a conclusion by the 

sponsor or FDA that the report or 

information constitutes an admission 

that the drug caused or contributed to 

an adverse event. A sponsor need not 

admit, and may deny, that the report or 

information submitted by the sponsor 

constitutes an admission that the drug 

caused or contributed to an adverse 

event. 

■ 3. Section 312.64 is amended by 

revising paragraph (b) to read as follows: 

§ 312.64 Investigator reports. 

* * * * * 

(b) Safety reports. An investigator 

must immediately report to the sponsor 

any serious adverse event, whether or 

not considered drug related, including 

those listed in the protocol or 

investigator brochure and must include 

an assessment of whether there is a 

reasonable possibility that the drug 

caused the event. Study endpoints that 

are serious adverse events (e.g., allcause mortality) must be reported in 

accordance with the protocol unless 

there is evidence suggesting a causal 

relationship between the drug and the 

event (e.g., death from anaphylaxis). In 

that case, the investigator must 

immediately report the event to the 

sponsor. The investigator must record 

nonserious adverse events and report 

them to the sponsor according to the 

timetable for reporting specified in the 

protocol. 

* * * * * 

PART 320—BIOAVAILABILITY AND 

BIOEQUIVALENCE REQUIREMENTS 

■ 4. The authority citation for 21 CFR 

part 320 continues to read as follows: 

Authority: 21 U.S.C. 321, 351, 352, 355, 

371. 

■ 5. Section 320.31 is amended in 

paragraphs (d)(1) and (d)(2) by removing 

the word ‘‘shall’’ and by adding in its 

place the word ‘‘must,’’ and by removing 

‘‘and’’ at the end of paragraph (d)(1) and 

replacing ‘‘this chapter.’’ at the end of 

paragraph (d)(2) with ‘‘this chapter; 

and’’, and by adding paragraph (d)(3) to 

read as follows: 

§ 320.31 Applicability of requirements 

regarding an ‘‘Investigational New Drug 

Application.’’ 

* * * * * 

(d) * * * 

(3) The person conducting the study, 

including any contract research 

organization, must notify FDA and all 

participating investigators of any serious 

adverse event, as defined in § 312.32(a), 

observed during the conduct of the 

study as soon as possible but in no case 

later than 15 calendar days after 

becoming aware of its occurrence. Each 

report must be submitted on FDA Form 

3500A or in an electronic format that 

FDA can process, review, and archive. 

FDA will periodically issue guidance on 

how to provide the electronic 

submission (e.g., method of 

transmission, media, file formats, 

preparation and organization of files). 

Each report must bear prominent 

identification of its contents, i.e., 

‘‘bioavailability/bioequivalence safety 

report.’’ The person conducting the 

study, including any contract research 

organization, must also notify FDA of 

any fatal or life-threatening adverse 

event from the study as soon as possible 

but in no case later than 7 calendar days 

after becoming aware of its occurrence. 

Each notification under this paragraph 

must be submitted to the Director, 

Office of Generic Drugs in the Center for 

Drug Evaluation and Research at FDA. 

Relevant followup information to a 

bioavailability/bioequivalence safety 

report must be submitted as soon as the 

information is available and must be 

identified as such, i.e., ‘‘Followup 

bioavailability/bioequivalence safety 

report.’’ Upon request from FDA, the 

person conducting the study, including 

any contract research organization, must 

submit to FDA any additional data or 

information that the agency deems 

necessary, as soon as possible, but in no 

case later than 15 calendar days after 

receiving the request. 

Dated: September 23, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–24296 Filed 9–28–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2010–0620] 

RIN 1625–AA00 

Safety Zone: Monte Foundation 

Firework Display, Monterey, CA 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary safety zone in 

the navigable waters of Monterey Bay 

off the fishing pier of Seacliff State 

Beach, Santa Cruz, CA in support of the 

Monte Foundation Firework Display. 

This safety zone is established to ensure 

the safety of participants and spectators 

from the dangers associated with the 

pyrotechnics. Unauthorized persons and 

vessels are prohibited from entering 

into, transiting through, or remaining in 

the safety zone without permission from 

the Captain of the Port or her designated 

representative. 

DATES: This rule is effective from 7 a.m. 

through 9:30 p.m. on October 8, 2010. 

ADDRESSES: Documents indicated in this 

preamble as being available in the 

docket are part of docket USCG–2010– 

0620 and are available online by going 


erowe on DSK5CLS3C1PROD with RULES
59964 Federal Register / Vol. 75, No. 188 / Wednesday, September 29, 2010 / Rules and Regulations 

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

USCG–2010–0620 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 Ensign Liz Ellerson, 

U.S. Coast Guard Sector San Francisco; 

telephone 415–399–7436, e-mail D11- 

PF-MarineEvents@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 it 

would be impracticable to publish a 

notice of proposed rulemaking (NPRM) 

with respect to this rule because the 

event would occur before the 

rulemaking process would be 

completed. Because of the dangers 

posed by the pyrotechnics used in this 

fireworks display, the safety zone is 

necessary to provide for the safety of 

event participants, spectators, spectator 

craft, and other vessels transiting the 

event area. For the safety concerns 

noted, it is in the public interest to have 

these regulations in effect during the 

event. 

Basis and Purpose 

The Monte Foundation Firework 

Display is scheduled to take place on 

October 8, 2010, on the navigable waters 

of Seacliff State Beach, in Monterey Bay, 

off of Santa Cruz, CA. The fireworks 

display is meant for entertainment 

purposes. This safety zone is issued to 

establish a temporary restricted area on 

the waters surrounding the fireworks 

launch site during loading of the 

pyrotechnics, and during the fireworks 

display. This restricted area around the 

launch site is necessary to protect 

spectators, vessels, and other property 

from the hazards associated with the 

pyrotechnics on the fireworks barges. 

The Coast Guard has granted the event 

sponsor a marine event permit for the 

fireworks display. 

Discussion of Rule 

During the set up of the fireworks and 

until the start of the fireworks display, 

the temporary safety zone applies to the 

navigable waters around the fireworks 

site within a radius of 100 feet. From 

8:45 p.m. until 9:05 p.m., the area to 

which the temporary safety zone applies 

will increase in size to encompass the 

navigable waters around the fireworks 

site within a radius of 1,000 feet. 

The effect of the temporary safety 

zone will be to restrict navigation in the 

vicinity of the fireworks site while the 

fireworks are set up, and until the 

conclusion of the scheduled display. 

Except for persons or vessels authorized 

by the Coast Guard Patrol Commander, 

no person or vessel may enter or remain 

in the restricted area. These regulations 

are needed to keep spectators and 

vessels away from the immediate 

vicinity of the fireworks barge to ensure 

the safety of participants, spectators, 

and transiting vessels. 

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 and 

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. 

Although this rule restricts access to 

the waters encompassed by the safety 

zone, the effect of this rule will not be 

significant because the local waterway 

users will be notified via public 

Broadcast Notice to Mariners to ensure 

the safety zone will result in minimum 

impact. The entities most likely to be 

affected are pleasure craft engaged in 

recreational activities. 

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 may affect owners and 

operators of pleasure craft engaged in 

recreational activities and sightseeing. 

This rule will not have a significant 

economic impact on a substantial 

number of small entities for several 

reasons: (i) Vessel traffic can pass safely 

around the area, (ii) vessels engaged in 

recreational activities and sightseeing 

have ample space outside of the effected 

portion of the areas off San Francisco, 

CA to engage in these activities, (iii) this 

rule will encompass only a small 

portion of the waterway for a limited 

period of time, and (iv) the maritime 

public will be advised in advance of this 

safety zone via Broadcast Notice to 

Mariners. 

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 


erowe on DSK5CLS3C1PROD with RULES
Federal Register / Vol. 75, No. 188 / Wednesday, September 29, 2010 / Rules and Regulations 59965 

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 (adjusted for inflation) 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 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 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 

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 that 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 establishing, disestablishing, or 

changing Regulated Navigation Areas 

and security or safety zones. 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, and 

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 

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. Add § 165.T11–359 to read as 

follows: 

§ 165.T11–359 Safety zone; Monte 

Foundation Firework Display, Santa Cruz, 

CA 

(a) Location. This temporary safety 

zone is established for the waters of 

Seacliff State Beach, in Monterey Bay, 

off of Santa Cruz, CA. The fireworks 

launch site will be located in position 

36°58′11.20′′ N, 121°54′36.79′′ W (NAD 

83). From 7 a.m. through 8:44 p.m., and 

from 9:06 p.m. until 9:30 p.m. on 

October 8, 2010, the temporary safety 

zone applies to the navigable waters 

around the fireworks site within a 

radius of 100 feet. From 8:45 p.m. until 

9:05 p.m. the area to which the 

temporary safety zone applies will 

increase in size to encompass the 

navigable waters around the fireworks 

site within a radius of 1,000 feet. 

(b) Definitions. As used in this 

section, ‘‘designated representative’’ 

means a Coast Guard Patrol 

Commander, including a Coast Guard 

coxswain, petty officer, or other officer 

on a Coast Guard vessel or a Federal, 

State, or local officer designated by or 

assisting the Captain of the Port San 

Francisco (COTP) in the enforcement of 

the safety zone. 

(c) Regulations. (1) Under the general 

regulations in § 165.23 of this title, entry 

into, transiting, or anchoring within this 

safety zone is prohibited unless 

authorized by the COTP or the COTP’s 

designated representative. 

(2) The safety zone is closed to all 

vessel traffic, except as may be 

permitted by the COTP or a designated 

representative. 

(3) Vessel operators desiring to enter 

or operate within the safety zone must 

contact the COTP or a designated 

representative to obtain permission to 

do so. Vessel operators given permission 

to enter or operate in the safety zone 

must comply with all directions given to 

them by the COTP or the designated 

representative. Persons and vessels may 

request permission to enter the safety 

zone on VHF–16 or through the 24-hour 

Command Center at telephone 415–399– 

3547. 

(d) Effective period. This section is 

effective from 7 a.m. through 9:30 p.m. 

on October 8, 2010. 


erowe on DSK5CLS3C1PROD with RULES
59966 Federal Register / Vol. 75, No. 188 / Wednesday, September 29, 2010 / Rules and Regulations 

Dated: September 15, 2010. 

C.L. Stowe, 

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

Port San Francisco. 

[FR Doc. 2010–24364 Filed 9–28–10; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2010–0138] 

RIN 1625–AA00 

Safety Zone; New York Air Show at 

Jones Beach State Park, Wantagh, NY 

AGENCY: Coast Guard, DHS. 

ACTION: Final rule. 

SUMMARY: The Coast Guard is 

establishing a permanent safety zone for 

the annual New York Air Show at Jones 

Beach State Park in Wantagh, New York. 

This safety zone is necessary to provide 

for the safety of navigation and 

protection of the maritime public from 

the hazards inherent with an air show 

which consists of aircraft performing 

aerobatic maneuvers over the Atlantic 

Ocean off of Jones Beach State Park. 

DATES: This rule is effective October 29, 

2010. 

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–2010–0138 and are 

available online by going to http:// 

www.regulations.gov, inserting USCG– 

2010–0138 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: Petty Officer Joseph Graun, 

Prevention Department, USCG Sector 

Long Island Sound at 203–468–4459, email: Joseph.L.Graun@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 

On April 21, 2010, we published a 

notice of proposed rulemaking (NPRM) 

entitled: Safety Zone; New York Air 

Show at Jones Beach State Park, Atlantic 

Ocean off of Jones Beach, Wantagh, NY, 

in the Federal Register (75 FR 20802). 

We received no comments or requests 

for a public meeting on the proposed 

rule. 

Basis and Purpose 

The Air Show consists of aircraft 

performing aerobatics in close proximity 

to other aircraft over a specified area of 

the Atlantic Ocean off of Jones Beach 

State Park. The safety zone will provide 

for the safety of the maritime 

community and spectators viewing the 

Air Show from the water should an 

accident, such as a collision of aircraft, 

occur during the Show. 

Entry into this zone is prohibited 

unless authorized by the Captain of the 

Port Long Island Sound or by 

Designated On-scene Patrol Personnel. 

Any violation of the safety zone 

described herein is punishable by, 

among other things, civil and criminal 

penalties, in rem liability against the 

offending vessel, and the initiation of 

suspension or revocation proceedings 

against Coast Guard-issued merchant 

mariner credentials. 

Background 

The New York State Office of Parks, 

Recreation and Historic Preservation 

sponsors an annual air show at Jones 

Beach State Park during the week before 

Memorial Day. In the past the Coast 

Guard established temporary regulations 

for this event every year and was not 

previously published in the CFR. The 

Notice of Proposed Rulemaking process 

provided the opportunity for public 

comments to be voiced and eliminated 

the unnecessary burden of establishing 

temporary rules every year. 

Discussion of Comments and Changes 

During the Notice of Proposed 

Rulemaking process, the sponsor of the 

event informed the Coast Guard that the 

dates of the enforcement period needed 

to be changed. The original proposed 

dates for the safety zone were from May 

24, 2010 until May 30, 2010 allowing 

enforcement of the safety zone during 

the air show practice sessions. There 

will no longer be a practice session; 

therefore, the safety zone will only be 

needed during the main event on the 

Thursday through Sunday before 

Memorial Day in May. 

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. 

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 may affect the following 

entities, some of which may be small 

entities: The owners or operators of 

vessels intending to transit or anchor in 

those portions of the Atlantic Ocean off 

of Jones Beach State Park, Jones Beach, 

New York covered by the safety zone. 

This regulation may have some 

impact on the public, but the potential 

impact will be minimized for the 

following reasons: The zone would only 

be enforced for a temporary period each 

day over a four day period; and vessels 

may transit in all areas around the zone 

at all times. 

Assistance for Small Entities 

Under section 213(a) of the Small 

Business Regulatory Enforcement 

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

in the NPRM we offered to assist small 

entities in understanding the rule so 

that they could 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– 


erowe on DSK5CLS3C1PROD with RULES