[Federal Register Volume 84, Number 108 (Wednesday, June 5, 2019)]
[Notices]
[Pages 26123-26125]
[FR Doc No: 2019-11658]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1588]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Exemptions From
Substantial Equivalence Requirements for Tobacco Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by July 5,
2019.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0684.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Exemptions From Substantial Equivalence Requirements for Tobacco
Products

OMB Control Number 0910-0684--Extension

    On June 22, 2009, the Family Smoking Prevention and Tobacco Control
Act (Tobacco Control Act) (Pub. L. 111-31) was signed into law. The
Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act
(FD&C Act) by adding a chapter granting FDA important authority to
regulate the manufacture, marketing, and distribution of tobacco
products to protect the public health generally and to reduce tobacco
use by minors.
    The FD&C Act, as amended by the Tobacco Control Act, requires that
before a new tobacco product may be introduced or delivered for
introduction into interstate commerce, the new tobacco product must
undergo premarket review by FDA. FDA must issue an order authorizing
the commercial distribution of the new tobacco product or find the
product exempt from the requirements of substantial equivalence under
section 910(a)(2)(A) of the FD&C Act, before the product may be
introduced into commercial distribution (section 910 of the FD&C Act
(21 U.S.C. 387j)).
    The Tobacco Control Act also gave FDA the authority to issue a
regulation deeming all other products that meet the statutory
definition of a tobacco product to be subject to Chapter IX of the FD&C
Act (section 901(b) (21 U.S.C. 387a(b))). On May 10, 2016, FDA issued
that rule, extending FDA's tobacco product authority to all products
that meet the definition of tobacco product in the law (except for
accessories of newly regulated tobacco products), including electronic
nicotine delivery systems, cigars, hookah, pipe tobacco, nicotine gels,
dissolvables that were not already subject to the FD&C Act, and other
tobacco products that may be developed in the future (81 FR 28974 at
28976, May 10, 2016) (``the final deeming rule'')).
    FDA has established a pathway for manufacturers to request
exemptions from the substantial equivalence requirements of the FD&C
Act in Sec.  [thinsp]1107.1 (21 CFR 1107.1) of the Agency's
regulations. As described in Sec.  [thinsp]1107.1(a), FDA may exempt
tobacco products that are modified by adding or deleting a tobacco
additive, or increasing or decreasing the quantity of an existing
tobacco additive, from the requirement of demonstrating substantial
equivalence if the Agency determines that: (1) The modification would
be a minor modification of a tobacco product that can be sold under the
FD&C Act; (2) a report demonstrating substantial equivalence is not
necessary to ensure that permitting the tobacco product to be marketed
would be appropriate for the protection of public health; and (3) an
exemption is otherwise appropriate.

    Section 1107.1(b) states that a request for exemption under section
905(j)(3) of the FD&C Act (21 U.S.C. 387e(j)(3)) may be made only by
the manufacturer of a legally marketed tobacco product for a minor
modification to that tobacco product and that the manufacturer must
submit the request and all information supporting it to FDA. The
request must be made in an electronic format that FDA can process,
review, and archive (or a written request must be made by the
manufacturer explaining in detail why the manufacturer cannot submit
the request in an electronic format and requesting an alternative means
of submission to the electronic format).
    An exemption request must contain: (1) The manufacturer's address
and contact information; (2) identification of the tobacco product(s);
(3) a detailed explanation of the purpose for the modification; (4) a
detailed description of the modification, including a statement as to
whether the modification involves adding or deleting a tobacco
additive, or increasing or decreasing the quantity of the existing
tobacco additive; (5) a detailed explanation of why the modification is
a minor modification of a tobacco product that can be sold under the
FD&C Act; (6) a detailed explanation of why a report under section
905(j)(1) of the FD&C Act intended to demonstrate substantial
equivalence is not necessary to ensure that permitting the tobacco
product to be marketed would be appropriate for protection of the
public health; (7) a certification (i.e., a signed statement by a
responsible official of the company) summarizing the supporting
evidence and providing the rationale for the official's determination
that the modification does not increase the tobacco product's appeal to
or use by minors, toxicity, addictiveness, or abuse liability; (8)
other information justifying an exemption; and (9) an environmental
assessment (EA) under part 25 (21 CFR part 25) prepared in accordance
with the requirements of Sec.  [thinsp]25.40.
    The National Environmental Policy Act of 1969 (NEPA) (42 U.S.C.
4321-4347) states national environmental objectives and imposes upon
each Federal Agency the duty to consider the environmental effects of
its actions. Section 102(2)(C) of NEPA requires the preparation of an
environmental impact statement for every major Federal action that will
significantly affect the quality of the human environment.
    FDA's NEPA regulations are contained in part 25. All applications
for exemption from substantial equivalence require the submission of an
EA. An EA provides information that is used to determine whether an FDA
action could result in a significant environmental impact. Section
25.40(a) and (c) specifies the content requirements for EAs for
nonexcluded actions.
    The information required by Sec.  [thinsp]1107.1(b) is submitted to
FDA so FDA can determine whether an exemption from substantial
equivalence to the product is appropriate for the protection of the
public health. Section 1107.1(c) states that FDA will review the
information submitted and determine whether to grant or deny an
exemption based on whether the criteria in section 905(j)(3) of the
FD&C Act are met. FDA may request additional information if necessary
to make a determination and may consider the exemption request
withdrawn if the information is not provided within the requested
timeframe.
    Section 905(j)(1)(A)(ii) of the FD&C Act states that if an
exemption has been requested and granted, a report must be submitted to
FDA that demonstrates that the tobacco product is modified within the
meaning of section 905(j)(3), the modifications are to a product that
is commercially marketed and in compliance with the requirements of the
FD&C Act, and all of the modifications are covered by exemptions
granted by the Secretary of Health and Human Services (the Secretary)
under section 905(j)(3).
    In the Federal Register of September 13, 2018 (83 FR 46501) FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Two PRA related comments were received,
which inquired about how FDA formulated the PRA estimates. In response
to the questions related to the PRA estimates, these estimates are
based on our experience. To date, the annual number of exemption
requests has been lower than the estimate of 812 respondents in this
notice (https://www.accessdata.fda.gov/scripts/fdatrack/view/track.cfm?program=ctp&id=%20CTP-OS-total-exemption-from-SE-since-Program-Inception), but the Agency expects that the number of exemption
requests could increase as applicants begin to submit such requests for
tobacco products subject to the final deeming rule. The estimated
number of respondents is intended to reflect that potential. As noted
in the comments, the exemption request is anticipated to take less time
than the other premarket applications, and FDA believes that 24 hours
average burden per response reflects the experience to date.
    Along with commenting on the PRA estimates, these comments also
state that the Agency should provide additional details on exemption
requests and develop categories of exemptions. FDA appreciates these
comments but notes that consideration of such new processes is outside
the scope of the present information collection. FDA will continue to
consider these comments as appropriate in future rulemakings.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                                                Average
                                     Number of       Number of     Total annual     burden per
   21 CFR section and activity      respondents    responses per     responses     response  (in    Total hours
                                                  respondent \2\                      hours)
----------------------------------------------------------------------------------------------------------------
     Sec.   1107.1(b) Optional Preparation of Tobacco Product Exemption From Substantial Equivalence Request
                        Including Sec.   25.40 Preparation of an Environmental Assessment
----------------------------------------------------------------------------------------------------------------
21 CFR 1107.1(b)--Preparation of             812               1             812              24          19,488
 tobacco product exemption from
 substantial equivalence request
 and 21 CFR 25.40--Preparation
 of an environmental assessment.
                                 -------------------------------------------------------------------------------
    Total Hours (Sec.             ..............  ..............  ..............  ..............          19,488
     1107.1(b)).................
----------------------------------------------------------------------------------------------------------------

      Sec.   1107.1(c) Preparation of Additional Information for Tobacco Product Exemption From Substantial
                                               Equivalence Request
----------------------------------------------------------------------------------------------------------------
21 CFR 1107.1(c)--Preparation of             244               1             244               3             732
 additional information for
 tobacco product exemption from
 substantial equivalence request
                                 -------------------------------------------------------------------------------
    Total Hours (Sec.             ..............  ..............  ..............  ..............             732
     1107.1(c)).................
----------------------------------------------------------------------------------------------------------------
 Section 905(j)(1)(A)(ii) of the FD&C Act: If exemption granted, report submitted to demonstrate tobacco product
is modified under section 905(j)(3), modifications are to a product that is commercially marketed and compliant,
              and modifications covered by exemptions granted by Secretary under section 905(j)(3)
----------------------------------------------------------------------------------------------------------------
Abbreviated report submitted to             1217               1            1217               3           3,651
 demonstrate tobacco product is
 modified under section
 905(j)(3), modifications are to
 a product that is commercially
 marketed and compliant, and
 modifications covered by
 exemptions granted by Secretary
 under section 905(j)(3)........
                                 -------------------------------------------------------------------------------
    Total Hours (section          ..............  ..............  ..............  ..............           3,651
     905(j)(1)(A)(ii)) of the
     FD&C Act...................
                                 -------------------------------------------------------------------------------
        Total Hours Exemptions    ..............  ..............  ..............  ..............          23,871
         From Substantial
         Equivalence
         Requirements...........
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA estimates that we will receive 812 exemption requests under
Sec.  1107.1(b) for 24 hours per response including EA for a total of
19,488 hours. Since an EA is required for each Sec.  1107.1(b)
(Optional Preparation of Tobacco Product Exemption From Substantial
Equivalence Request), the burden per response for EAs (12 hours) has
been combined with the 12 hours for an SE request for a total of 24
hours per response.
    FDA further estimates that we will receive 244 submissions
requiring additional information in support of the initial exemption
request, and it is expected that it will take an average of 3 hours to
prepare the additional information for a total of 732 hours.
    FDA estimates that 1,217 respondents will prepare 1,217 responses
and each response will take approximately 3 hours to prepare, as
required by section 905(j)(1)(A)(ii) of the FD&C Act, for a total of
3,651 hours.
    This collection of information requires a manufacturer to submit a
report at least 90 days prior to making an introduction or delivery for
introduction into interstate commerce for commercial distribution of a
tobacco product. Section 905(j)(1)(A)(ii) of the FD&C Act states that
if an exemption has been requested and granted, the manufacturer must
submit to FDA a report that demonstrates that the tobacco product is
modified within the meaning of section 905(j)(3), the modifications are
to a product that is commercially marketed and in compliance with the
requirements of the FD&C Act, and all the modifications are covered by
exemptions granted by the Secretary under section 905(j)(3). FDA
estimates the total hours for exemptions from Substantial Equivalence
Requirements will be 23,871 hours.
    FDA's estimates are based on full analysis of economic impacts and
information gathered from other FDA-regulated products. Based on a
review of the currently approved information collection, we have made
no adjustments to our burden estimate.

    Dated: May 30, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-11658 Filed 6-4-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 246 (Friday, December 23, 2022)]
[Rules and Regulations]
[Pages 78869-78871]
[FR Doc No: 2022-27801]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2022-0217]
RIN 1625-AA00

Safety Zone; Fireworks Display, Sea Otter Point, Port of Valdez,
AK

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone in the
navigable waters from the surface to seabed, within a 150 yard radius
of the fireworks launching point located at Sea

Otter Point in position 61[deg]07'22'' North and 146[deg]21'13'' West
in the vicinity of the mouth of the Small Boat Harbor, Port of Valdez,
Alaska, to limit access for the duration of the New Year's fireworks
display. The safety zone is needed to protect mariners and vessels from
potential hazards during the fireworks display.

DATES: This rule is effective from 9:50 p.m. through 10:45 p.m. on
December 31, 2022.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2022-0217 in the search box and click ``Search.'' Next, in the Document
Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email MST1 Christian R. Heming, Waterways Management Division,
U.S. Coast Guard;<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port Prince William Sound
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary 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 publishing an NPRM would be impracticable
and contrary to the public interest since immediate action is needed to
minimize potential danger to the public during the event. Any delay in
the effective date of this rule could prevent this community event from
occurring or present a safety risk to people and vessels in the
vicinity of the fireworks display. The Coast Guard will issue a
broadcast notice to mariners to advise mariners of the zone and on-
scene Coast Guard assets will provide notice to mariners.
    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. Delaying the effective date of
this rule could prevent this community event from occurring or present
a safety risk to people and vessels in the vicinity of the fireworks
display.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port Prince
William Sound (COTP) has determined that potential hazards associated
with the New Year's fireworks display will be a safety concern for
anyone within a 150-yard radius of the fireworks launch site at Sea
Otter Point. The safety zone is necessary to provide notice of the
hazards presented by the fireworks display in order to achieve the goal
of enhancing the safety of people and vessels attending the event in
the navigable waters in the vicinity of the fireworks launching site.

IV. Discussion of the Rule

    This rule establishes a safety zone from 9:50 p.m. through 10:45
p.m. on December 31, 2022. The safety zone will cover all navigable
waters within 150 yards of the locations where the fireworks will be
launched at Sea Otter Point. The duration of the zone is intended to
protect personnel, vessels, and the marine environment in these
navigable waters during the fireworks display. No vessel or person will
be permitted to enter the safety zone without obtaining permission from
the COTP or a designated representative.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, this
rule has not been reviewed by the Office of Management and Budget
(OMB).
    This regulatory action determination is based on the size,
location, duration, and time-of-day of the safety zone. The safety zone
would impact a small designated area of Port Valdez for a duration less
than 1 hour. Vessel traffic is rare and normally low for this time of
year at the Port of Valdez. Moreover, the Coast Guard would issue a
Broadcast Notice to Mariners via VHF-FM marine channel 16 about the
zone, and the rule would allow vessels to seek permission to enter the
zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. 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.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    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 rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    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.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the National Government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, 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.

E. 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.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that 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 involves a
safety zone lasting approximately one hour that will prohibit entry
within 150 yards of the launching site at Sea Otter Point, located near
the entrance of the Small Boat Harbor in Port of Valdez, AK. It is
categorically excluded from further review under paragraph L60(a) of
Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places or vessels.

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

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  46 U.S.C. 70034, 70051, 70124; 33 CFR 1.05-1, 6.04-
1, 6.04-6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.3.

0
2. Add Sec.  165.T17-0217 to read as follows:

Sec.  165.T17-0217   Safety Zone; Fireworks Display, Sea Otter Point,
Port of Valdez, AK.

    (a) Location. The following area is a safety zone: All navigable
waters, from the surface to the seabed, of Port Valdez within a 150-
yard radius from a position of 61[deg]07'22'' N and 146[deg]21'13'' W.
This includes the entrance to the Port Valdez small boat harbor.
    (b) Definitions. The following definition applies to this section:
``Designated representative'' means any commissioned, warrant, and
petty officer of the Coast Guard on board Coast Guard, Coast Guard
Auxiliary, and local, state, and federal law enforcement vessels who
have been authorized to act on the behalf of the Captain of the Port
Prince William Sound.
    (c) Regulations. (1) Under the general regulations contained in
subpart C of this part, entry into, transiting, or anchoring within
this safety zone is prohibited unless authorized by the Captain of the
Port Prince William Sound or his designated representative.
    (2) The safety zone is closed to all vessel traffic, except as may
be permitted by the Coast Guard Captain of the Port Prince William
Sound or his designated representative.
    (3) Upon being hailed by a U.S. Coast Guard vessel or designated
representative by siren, radio, flashing light or other means, the
operator of the vessel shall proceed as directed.
    (4) Persons desiring to enter the safety zone may request
permission from the Captain of the Port Prince William Sound via VHF
Channel 13 or via telephone at<PHONE_NUMBER>.
    (5) The Coast Guard will issue a broadcast notice to mariners to
advise mariners of the temporary safety zone and on-scene Coast Guard
representatives will provide notice to mariners during the event.
    (d) Enforcement period. This rule will be enforced from 9:50 p.m.
to 10:45 p.m. on December 31, 2022.

    Dated: December 12, 2022.
P.A. Drayer,
Commander, U.S. Coast Guard, Captain of the Port Prince William Sound.
[FR Doc. 2022-27801 Filed 12-22-22; 8:45 am]
BILLING CODE 9110-04-P


								January 24, 2006

Mr. Marco Gonzalez

Executive Secretary

Secretariat for the Montreal Protocol

P. O. Box 30552, Nairobi, Kenya

Dear Mr. Gonzalez:

	 In accordance with the Montreal Protocol, the United States is
submitting our 2008 nomination for a critical use exemption (CUE) for
methyl bromide.  The enclosed sector by sector nominations generally
follow the format set out in the Methyl Bromide Handbook, and include
supplemental information as appropriate.  We hope that this format
facilitates the review of the Technology and Economic Assessment Panel
and the Methyl Bromide Technical Options Committee (MBTOC).  The United
States is submitting these documents electronically, but would be
pleased to provide a hard copy upon request.  We will fax this signed
cover letter to you for your records.

We have appreciated the opportunity to meet with the MBTOC at their
recent meetings to discuss key issues and answer questions, and would
like to continue such discussions at their 2006 meetings.  We look
forward to working with you to answer any questions that may arise
during the review process.  Please contact me<EMAIL_ADDRESS>or
1-202-647-9799) should questions arise during consideration of this
submission.

Sincerely,

John E. Thompson

Division Director, Office of Environmental Policy

	  PAGE  2


[Federal Register: August 20, 2010 (Volume 75, Number 161)]
[Rules and Regulations]
[Page 51379-51381]
[DOCID:fr20au10-5]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2010-0746]
RIN 1625-AA00

Safety Zone; Celebrate Erie, Presque Isle Bay, Erie, PA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone on
Presque Isle Bay, Erie, PA for the Celebrate Erie fireworks. This zone
is intended to restrict vessels from a portion of Presque Isle Bay in
Erie, PA during the Celebrate Erie fireworks display, August 22, 2010.
This temporary safety zone is necessary to protect spectators and
vessels from the hazards associated with a firework display.

DATES: This rule is effective from 9:30 p.m. until 10:30 p.m. on August
22, 2010.

ADDRESSES: Documents indicated in this preamble as being available in
the docket, are part of docket USCG-2010-0746 and are available online
by going to http://www.regulations.gov, inserting USCG-2010-0746 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
temporary rule, call or e-mail MST2 Jessica Seguin, Marine Events
Coordinator, U.S. Coast Guard Sector Buffalo; telephone<PHONE_NUMBER>,
e-mail<EMAIL_ADDRESS>If you have questions on viewing the
docket, call Renee V. Wright, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

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.'' 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 it is contrary to the public interest to
delay the effective date of this rule. Delaying the effective date by
first publishing an NPRM would be contrary to the safety zone's
intended objectives because immediate action is needed to protect
persons and vessels against the hazards associated with a fireworks
display on navigable waters. Such hazards include premature
detonations, dangerous projectiles and falling or burning debris.
Accordingly, under 5 U.S.C. 553(b), the Coast Guard finds that good
cause exists for not publishing an NPRM.
    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. Due to the need for immediate
action, the restriction of vessel traffic is necessary to protect life,
property and the environment; therefore, a 30-day notice is
impracticable. Delaying the effective date would be contrary to the
safety zone's intended objectives of protecting persons and vessels
involved in the event, and enhancing public and maritime safety.

Background and Purpose

    This temporary safety zone is necessary to ensure the safety of
vessels and spectators from hazards associated with a fireworks
display. Based on accidents that have occurred in other Captain of the
Port zones, and the explosive hazards of fireworks, the Captain of the
Port Buffalo has determined that fireworks launched proximate to
watercraft pose a significant risk to public safety and property. The
likely combination of large numbers of recreation vessels, congested
waterways, darkness punctuated by bright flashes of light, alcohol use,
and debris falling into the water could easily result in serious
injuries or fatalities. Establishing a safety zone to control vessel
movement around the location of the launch platform will help ensure
the safety of persons and property at these events and help minimize
the associated risks.

Discussion of Rule

    A temporary safety zone is necessary to ensure the safety of
spectators and vessels during the setup, loading, and launching of a
fireworks display in conjunction with the Celebrate Erie Fireworks. The
fireworks display will occur on August 22, 2010 from 9:30 p.m. to 10:30
p.m. The safety zone will encompass all waters of Presque Isle Bay,
Erie, PA within a four hundred (400) foot radius from position
42[deg]08'19'' N, 80[deg]05'29'' W (DATUM: NAD 83).
    All persons and vessels shall comply with the instructions of the
Coast Guard Captain of the Port or the designated on-scene
representative. Entry into, transiting, or anchoring within the safety
zone is prohibited unless authorized by the Captain of the Port Buffalo
or his on-scene representative. The Captain of the Port or his on-scene
representative may be contacted via VHF Channel 16.

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.
    The Coast Guard determined that this rule is not a significant
regulatory action because of the minimal time that the area will be
restricted. Plus, vessels may still transit with the permission of the
Captain of the Port Buffalo or his designated on-scene representative.
The Coast Guard expects this area will have an insignificant adverse
impact to mariners from the zones activation.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities.
    This rule will affect the following entities, some of which might
be small entities: The owners or operators of vessels intending to
transit or anchor in a portion of Presque Isle Bay, Erie, PA on August
22, 2010 from 9:30 p.m. until 10:30 p.m.
    This safety zone will not have a significant economic impact on a
substantial number of small entities because of the minimal amount of
time in which the safety zone will be enforced. This safety zone will
only be enforced for 60 minutes in a low vessel traffic area. Vessel
traffic can pass safely around the zone. Before the effective period,
we will issue maritime advisories, which include a Local Notice to
Mariners and a 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 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 the establishment of a safety zone.
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 record
keeping requirements, Security measures, Waterways.

0
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

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1226, 1231; 46 U.S.C. Chapters 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5;
Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add a new temporary section 165.T09-0746 as follows:

Sec.  165.T09-0746  Safety zone; Celebrate Erie, Presque Isle Bay,
Erie, PA.

    (a) Location. The following area is a temporary safety zone: All
U.S. waters of Presque Isle Bay, Erie, PA within a 400 foot radius from
position 42[deg]08'19'' N, 80[deg]05'29'' W (DATUM: NAD 83).
    (b) Effective period. This zone will be effective and enforced from
9:30 p.m. until 10:30 p.m. on August 22, 2010.
    (c) Regulations.
    (1) In accordance with the general regulations in section 165.23 of
this part, entry into, transiting, or anchoring within this safety zone
is prohibited unless authorized by the Captain of the Port Buffalo, or
his on-scene representative.
    (2) This safety zone is closed to all vessel traffic, except as may
be permitted by the Captain of the Port Buffalo or his on-scene
representative.
    (3) 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 on-
scene representative of the Captain of the Port will be aboard either a
Coast Guard or Coast Guard Auxiliary vessel.
    (4) Vessel operators desiring to enter or operate within the safety
zone shall contact the Captain of the Port Buffalo or his on-scene
representative to obtain permission to do so. The Captain of the Port
or his on-scene representative may be contacted via VHF Channel 16.
    (5) Vessel operators given permission to enter or operate in the
safety zone must comply with all directions given to them by the
Captain of the Port Buffalo or his on-scene representative.

    Dated: August 5, 2010.
R.S. Burchell,
Captain, U.S. Coast Guard, Captain of the Port Buffalo.
[FR Doc. 2010-20633 Filed 8-19-10; 8:45 am]
BILLING CODE 9110-04-P