Federal Register / Vol. 74, No. 117 / Friday, June 19, 2009 / Proposed Rules 29151 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2009–0461] 

RIN 1625–AA00 

Safety Zones; Annual Events 

Requiring Safety Zones in the Captain 

of the Port Buffalo Zone 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Coast Guard proposes 

establishment of safety zones for annual 

events in the Captain of the Port Buffalo 

Zone. This proposed rule adds events 

not previously published in Coast Guard 

regulations. These safety zones are 

necessary to protect spectators, 

participants, and vessels from the 

hazards associated with fireworks 

displays or other events. 

DATES: Comments and related materials 

must reach the Coast Guard on or before 

July 20, 2009. 

ADDRESSES: You may submit comments 

identified by Coast Guard docket 

number USCG–2009–0461 to the Docket 

Management Facility at the U.S. 

Department of Transportation. To avoid 

duplication, please use only one of the 

following methods: 

(1) Federal eRulemaking Port: 

http://www.regulations.gov. 

(2) Fax: 202–493–2251 

(3) Mail: Docket Management Facility 

(M–30), U.S. Department of 

Transportation, West Building Ground 

Floor, Room W12–140, 1200 New Jersey 

Avenue, SE., Washington, DC 20590– 

0001. 

(4) Hand delivery: Room W12–140 on 

the Ground Floor of the West Building, 

1200 New Jersey Avenue, SE., 

Washington, DC 20590, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. The telephone 

number is 202–366–9329. 

To avoid duplication, please use only 

one of these four methods. See the 

‘‘Public Participation and Request for 

Comments’’ portion of the 

SUPPLEMENTARY INFORMATION section 

below for instructions on submitting 

comments. 

FOR FURTHER INFORMATION CONTACT: LT 

Brian Sadler, Waterways Management 

Division Chief, Sector Buffalo, 1 

Fuhrmann Blvd., Buffalo, NY 14203; 

telephone 716–843–9573, e-mail 

Brian.L.Sadler@USCG.MIL. If you have 

questions on viewing or submitting 

material to the docket, call Renee V. 

Wright, Program Manager, Docket 

Operations, telephone 202–366–9826. 

SUPPLEMENTARY INFORMATION: 

Public Participation and Request for 

Comments 

We encourage you to participate in 

this rulemaking by submitting 

comments and related materials. All 

comments received will be posted, 

without change, to http:// 

www.regulations.gov and will include 

any personal information you have 

provided. 

Submitting Comments 

If you submit a comment, please 

include the docket number for this 

rulemaking (USCG–2009–0461), 

indicate the specific section of this 

document to which each comment 

applies, and give the reason for each 

suggestion or recommendation. You 

may submit your comments and 

material online (via http:// 

www.regulations.gov) or by fax, mail, or 

hand delivery, but please use only one 

of these means. If you submit a 

comment online via http:// 

www.regulations.gov, it will be 

considered received by the Coast Guard 

when you successfully transmit the 

comment. If you fax, hand deliver, or 

mail your comment, it will be 

considered as having been received by 

the Coast Guard when it is received at 

the Docket Management Facility. We 

recommend that you include your name 

and a mailing address, an e-mail 

address, or a telephone number in the 

body of your document so that we can 

contact you if we have questions 

regarding your submission. 

To submit your comment online, go to 

http://www.regulations.gov, select the 

Advanced Docket Search option on the 

right side of the screen, insert ‘‘USCG– 

2009–0461’’ in the Docket ID box, press 

Enter, and then click on the balloon 

shape in the Actions column. If you 

submit your comments by mail or hand 

delivery, submit them in an unbound 

format, no larger than 81⁄2 by 11 inches, 

suitable for copying and electronic 

filing. If you submit comments by mail 

and would like to know that they 

reached the Facility, please enclose a 

stamped, self-addressed postcard or 

envelope. We will consider all 

comments and material received during 

the comment period and may change 

the rule based on your comments. 

Viewing Comments and Documents 

To view comments, as well as 

documents mentioned in this preamble 

as being available in the docket, go to 

http://www.regulations.gov, select the 

Advanced Docket Search option on the 

right side of the screen, insert USCG– 

2009–0461 in the Docket ID box, press 

Enter, and then click on the item in the 

Docket ID column. You may also visit 

the Docket Management Facility in 

Room W12–140 on the ground floor of 

the Department of Transportation West 

Building, 1200 New Jersey Avenue, SE., 

Washington, DC 20590, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. We have an 

agreement with the Department of 

Transportation to use the Docket 

Management Facility. 

Privacy Act 

Anyone can search the electronic 

form of comments received into any of 

our dockets by the name of the 

individual submitting the comment (or 

signing the comment, if submitted on 

behalf of an association, business, labor 

union, etc.). You may review a Privacy 

Act notice regarding our public dockets 

in the January 17, 2008 issue of the 

Federal Register (73 FR 3316). 

Public Meeting 

We do not now plan to hold a public 

meeting. But you may submit a request 

for one using one of the four methods 

specified under ADDRESSES. Please 

explain why you believe a public 

meeting would be beneficial. If we 

determine that one would aid this 

rulemaking, we will hold one at a time 

and place announced by a later notice 

in the Federal Register. 

Background and Purpose 

We propose these safety zones to 

control vessel traffic within the 

immediate location of the fireworks 

launching area during annual fireworks 

displays. 

The Coast Guard is now proposing to 

add 6 permanent safety zones in 33 CFR 

165.939. Establishing permanent safety 

zones provides better notice than 

promulgating temporary rules annually, 

and decreases the amount of paperwork 

required for these events. The Coast 

Guard has not previously received 

notice of any impact caused by safety 

zones created for these events. 

These safety zones are necessary to 

protect vessels and people from the 

hazards associated with fireworks 

displays or other events. Such hazards 

include obstructions to the waterway 

that may cause marine casualties and 

the explosive danger of fireworks and 

debris falling into the water that may 

cause death or serious bodily harm. 

Discussion of Proposed Rule 

The proposed rule and associated 

safety zones are necessary to ensure the 

safety of vessels and people during 


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29152 Federal Register / Vol. 74, No. 117 / Friday, June 19, 2009 / Proposed Rules 

annual firework events in the Captain of 

the Port Buffalo area of responsibility 

that may pose a hazard to the public. 

The proposed safety zones will be 

enforced only immediately before, 

during, and after events that pose 

hazard to the public, and only upon 

notice by the Captain of the Port. 

The Captain of the Port Buffalo will 

notify the public that the zones in this 

proposal are or will be enforced by all 

appropriate means to the affected 

segments of the public including 

publication in the Federal Register as 

practicable, in accordance with 33 CFR 

165.7(a). Such means of notification 

may also include, but are not limited to 

Broadcast Notice to Mariners or Local 

Notice to Mariners. The Captain of the 

Port will issue a Broadcast Notice to 

Mariners notifying the public when 

enforcement of the safety zone 

established by this section is cancelled. 

All persons and vessels shall comply 

with the instructions of the Coast Guard 

Captain of the Port Buffalo or the 

designated representative. Entry into, 

transiting, or anchoring within the 

safety zone is prohibited unless 

authorized by the Captain of the Port 

Buffalo Zone, or his designated 

representative. The Captain of the Port 

Buffalo Zone or his designated 

representative may be contacted via 

VHF Channel 16. 

Regulatory Analyses 

We developed this proposed rule after 

considering numerous statutes and 

executive orders related to rulemaking. 

Below we summarize our analyses 

based on 13 of these statutes or 

executive orders. 

Regulatory Planning and Review 

This proposed rule is not a significant 

regulatory action under section 3(f) of 

Executive Order 12866, Regulatory 

Planning and Review, and does not 

require an assessment of potential costs 

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

Order. The Office of Management and 

Budget has not reviewed it under that 

Order. 

We expect the economic impact of 

this proposed rule to be so minimal that 

a full Regulatory Evaluation is 

unnecessary. The Coast Guard’s use of 

these safety zones will be periodic, of 

short duration, and designed to 

minimize the impact on navigable 

waters. These safety zones will only be 

enforced immediately before, during, 

and after the time the events occur. 

Furthermore, these safety zones have 

been designed to allow vessels to transit 

unrestricted to portions of the 

waterways not affected by the safety 

zones. The Coast Guard expects 

insignificant adverse impact to mariners 

from the activation of these safety zones. 

Small Entities 

Under the Regulatory Flexibility Act 

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

whether this proposed rule would have 

a significant economic impact on a 

substantial number of small entities. 

The term ‘‘small entities’’ comprises 

small businesses, not-for-profit 

organizations that are independently 

owned and operated and are not 

dominant in their fields, and 

governmental jurisdictions with 

populations of less than 50,000. 

The Coast Guard certifies under 5 

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

would not have a significant economic 

impact on a substantial number of small 

entities. 

This proposed rule would affect the 

following entities, some of which might 

be small entities: The owners or 

operators of vessels intending to transit 

or anchor in the areas designated as 

safety zones during the dates and times 

the safety zones are being enforced. 

These safety zones would not have a 

significant economic impact on a 

substantial number of small entities for 

the following reasons: This proposed 

rule would be in effect for short periods 

of time, and only once per year, per 

zone. The safety zones have been 

designed to allow traffic to pass safely 

around the zone whenever possible and 

vessels will be allowed to pass through 

the zones with the permission of the 

Captain of the Port. 

If you think that your business, 

organization, or governmental 

jurisdiction qualifies as a small entity 

and that this proposed rule would have 

a significant economic impact on it, 

please submit a comment (see 

ADDRESSES) explaining why you think it 

qualifies and how and to what degree 

this proposed rule would economically 

affect it. 

Assistance for Small Entities 

Under section 213(a) of the Small 

Business Regulatory Enforcement 

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

we want to assist small entities in 

understanding this proposed rule so that 

they can better evaluate its effects on 

them and participate in the rulemaking. 

If the proposed rule would affect your 

small business, organization, or 

governmental jurisdiction and you have 

questions concerning its provisions or 

options for compliance, please contact 

CDR Joseph Boudrow, Prevention Dept. 

Chief, Sector Buffalo, 1 Fuhrmann 

Blvd., Buffalo, NY 14203; telephone 

716–843–9572, e-mail 

Joseph.A.Boudrow@uscg.mil. The Coast 

Guard will not retaliate against small 

entities that question or complain about 

this proposed rule or any policy or 

action of the Coast Guard. 

Collection of Information 

This proposed rule 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 proposed rule under that Order and 

have determined that it does not have 

implications for federalism. 

Unfunded Mandates Reform Act 

The Unfunded Mandates Reform Act 

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

Federal agencies to assess the effects of 

their discretionary regulatory actions. In 

particular, the Act addresses actions 

that may result in the expenditure by a 

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 proposed rule will not 

result in such expenditure, we 

nevertheless discuss its effects 

elsewhere in this preamble. 

Taking of Private Property 

This proposed rule will not affect the 

taking of private property or otherwise 

have taking implications under 

Executive Order 12630, Governmental 

Actions and Interference with 

Constitutionally Protected Property 

Rights. 

Civil Justice Reform 

This proposed rule meets applicable 

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

Executive Order 12988, Civil Justice 

Reform, to minimize litigation, 

eliminate ambiguity, and reduce 

burden. 

Protection of Children 

We have analyzed this proposed rule 

under Executive Order 13045, 

Protection of Children from 

Environmental Health Risks and Safety 

Risks. This proposed 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 proposed rule does not have 

tribal implications under Executive 


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Federal Register / Vol. 74, No. 117 / Friday, June 19, 2009 / Proposed Rules 29153 

Order 13175, Consultation and 

Coordination with Indian Tribal 

Governments, because it would not have 

a substantial direct effect on one or 

more Indian tribes, on the relationship 

between the Federal Government and 

Indian tribes, or on the distribution of 

power and responsibilities between the 

Federal Government and Indian tribes. 

Energy Effects 

We have analyzed this proposed rule 

under Executive Order 13211, Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use. We have 

determined that it is not a ‘‘significant 

energy action’’ under that order because 

it is not a ‘‘significant regulatory action’’ 

under Executive Order 12866 and is not 

likely to have a significant adverse effect 

on the supply, distribution, or use of 

energy. The Administrator of the Office 

of Information and Regulatory Affairs 

has not designated it as a significant 

energy action. Therefore, it does not 

require a Statement of Energy Effects 

under Executive Order 13211. 

Technical Standards 

The National Technology Transfer 

and Advancement Act (NTTAA) (15 

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

voluntary consensus standards in their 

regulatory activities unless the agency 

provides Congress, through the Office of 

Management and Budget, with an 

explanation of why using these 

standards would be inconsistent with 

applicable law or otherwise impractical. 

Voluntary consensus standards are 

technical standards (e.g., specifications 

of materials, performance, design, or 

operation; test methods; sampling 

procedures; and related management 

systems practices) that are developed or 

adopted by voluntary consensus 

standards bodies. 

This proposed rule does not use 

technical standards. Therefore, we did 

not consider the use of voluntary 

consensus standards. 

Environment 

We have analyzed this proposed rule 

under Department of Homeland 

Security Management Directive 023–01 

and Commandant Instruction 

M16475.1D, which guide the Coast 

Guard in complying with the National 

Environmental Policy Act of 1969 

(NEPA) (42 U.S.C. 4321–4370f), and 

have made a preliminary determination 

that this action is one of a category of 

actions which do not individually or 

cumulatively have a significant effect on 

the human environment. A preliminary 

environmental analysis checklist 

supporting this determination is 

available in the docket where indicated 

under ADDRESSES. This proposed rule 

involves the establishment of safety 

zones and as such should be 

categorically excluded, under figure 

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

from further environmental 

documentation. 

We seek any comments or information 

that may lead to the discovery of a 

significant environmental impact from 

this proposed rule. 

List of Subjects in 33 CFR Part 165 

Harbors, Marine Safety, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, 

Waterways. 

For the reasons discussed in the 

preamble, the Coast Guard proposes to 

amend 33 CFR part 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

1. The authority citation for part 165 

continues to read as follows: 

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

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

33 CFR 1.05–1, 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. In § 165.939 revise paragraph (a) 

introductory text and add paragraphs 

(a)(27) through (32) to read as follows: 

§ 165.939 Safety Zones; Annual Fireworks 

Events in the Captain of the Port Buffalo 

Zone. 

(a) Safety Zones: 

* * * * * 

(27) Independence Celebration 

Fireworks, Lake Ontario, Oswego 

Harbor, Oswego, NY—(i) Location. All 

waters of Lake Ontario at within an 800- 

foot radius of position 43°28′05′′ N, 

076°31′01′′ W; in Oswego Harbor, 

Oswego, NY. (DATUM: NAD 83). 

(ii) Enforcement date. One day in the 

first week of July. 

(28) Rochester Harborfest, Lake 

Ontario at the Genesee River, Rochester, 

NY—(i) Location. All waters of Lake 

Ontario at Genesee River, within a 500- 

foot radius of position 43°15′21′′ N, 

077°36′19′′ W; in Rochester, NY. 

[DATUM: NAD 83]. Located on the 

Ontario Beach West pier. 

(ii) Enforcement date. One weekend 

after Fathers Day weekend in June. 

(29) A Salute to Our Hero’s, Lake 

Ontario, Hamlin, NY—(i) Location. All 

waters of Lake Ontario within a 300-foot 

radius of position 43°16′27′′ N, 

076°58′27′′ W; off Hamlin Beach State 

Park Area 1. (DATUM: NAD 83). 

(ii) Enforcement date. One day in the 

first week of July. 

(30) Olcott NY Fireworks, Lake 

Ontario, Olcott, NY—(i) Location. All 

waters of Lake Ontario within a 600-foot 

radius of position 43°20′24′′ N, 

078°43′09′′ W; located on the West 

Federal Pier in Olcott, NY. (DATUM: 

NAD 83). 

(ii) Enforcement date. One day in the 

first week of July. 

(31) Erie Summer Festival of the Arts, 

Lake Erie, Presque Isle Bay, Erie, PA— 

(i) Location. All waters of Lake Erie, 

Presque Isle Bay within a 420-foot 

radius of position 42°07′45′′ N, 

080°06′20′′ W; in Erie, PA (DATUM: 

NAD 83). 

(ii) Enforcement date. One day in the 

last week of June. 

(32) Mercyhurst College ‘‘Old Fashion 

4th of July,’’ Lake Erie, Presque Isle Bay, 

Erie, PA—(i) Location. All waters of 

Lake Erie, Presque Isle Bay 1,000 feet 

NW of the Chestnut Street Boat Launch 

in a 400-foot radius of position 

42°08′41′′ N, 080°06′40′′ W; in Erie, PA. 

(DATUM: NAD 83). 

(ii) Enforcement date. One day in the 

first week of July. 

Dated: June 4, 2009. 

R.S. Burchell, 

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

Port Buffalo. 

[FR Doc. E9–14381 Filed 6–18–09; 8:45 am] 

BILLING CODE 4910–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 8 

RIN 0930–AA14 

Opioid Drugs in Maintenance and 

Detoxification Treatment of Opiate 

Addiction; Buprenorphine and 

Buprenorphine Combination; 

Approved Opioid Treatment 

Medications Use 

AGENCY: Substance Abuse and Mental 

Health Services Administration 

(SAMHSA), Department of Health and 

Human Services. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: This proposed rule amends 

the Federal opioid treatment program 

regulations by modifying the dispensing 

requirements for buprenorphine and 

buprenorphine combination products 

approved by FDA for opioid 

dependence and used in federally 

certified and registered opioid treatment 

programs. Opioid treatment programs 

that use these products in the treatment 

of opioid dependence will adhere to all 

other Federal treatment standards 

established for methadone. 


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