[Federal Register: April 3, 2008 (Volume 73, Number 65)]
[Proposed Rules]
[Page 18225-18229]
[DOCID:fr03ap08-23]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2008-0219]
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.

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SUMMARY: The Coast Guard proposes establishment of safety zones for
annual events in the Captain of the Port Buffalo zone. This proposed
rule consolidates current regulations establishing safety zones for
annual fireworks events in the former Captain of the Port Cleveland
Zone and the former Captain of the Port Buffalo Zone. In addition, it
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 May 5, 2008.

ADDRESSES: You may submit comments identified by Coast Guard docket
number USCG-2008-0219 to the Docket Management Facility at the U.S.
Department of Transportation. To avoid duplication, please use only one
of the following methods:
    (1) Online: http://www.regulations.gov.
    (2) 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.
    (3) 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<PHONE_NUMBER>.
    (4) Fax:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: CDR Joseph Boudrow, U.S. Coast Guard
Sector Buffalo;<PHONE_NUMBER>.

I. 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. We have an agreement with the
Department of Transportation (DOT) to use the Docket Management
Facility. Please see DOT's ``Privacy Act'' paragraph below.

A. Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2008-0219), indicate the specific section of this
document to which each comment applies, and give the reason for each
comment. We recommend that you include your name, mailing address, and
an e-mail address or other contact information in the body of your
document to ensure that you can be identified as the submitter. This
also allows us to contact you in the event further information is
needed or if there are questions. For example, if we cannot read your
submission due to technical difficulties and you cannot be contacted;
your submission may not be considered. You may submit your comments and
material by electronic means, mail, fax, or delivery to the Docket
Management Facility at the address under ADDRESSES; but please submit
your comments and material by only one means. If you submit them by
mail or delivery, submit them in an unbound format, no larger than 8\1/
2\ by 11 inches, suitable for copying and electronic filing. If you
submit them 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. We may change this proposed rule in view of them.

B. 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 at
any time, click on ``Search for Dockets,'' and enter the docket number
for this rulemaking (USCG-2008-0219) in the Docket ID box, and click
enter. You may also visit the Docket Management Facility in Room W12-
140 on the ground floor of the DOT West Building, 1200 New Jersey
Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

C. Privacy Act

    Anyone can search the electronic form of all 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 the Department of
Transportation's Privacy Act Statement in the Federal Register
published on April 11, 2000 (65 FR 19477), or you may visit http://
DocketsInfo.dot.gov.

SUPPLEMENTARY INFORMATION:

Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for a meeting by writing to Commander, Coast Guard Sector
Buffalo, at the address under ADDRESSES explaining why one 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

    On July 22, 2005, the Coast Guard consolidated the Captain of the
Port Cleveland zone and the Captain of the Port Buffalo zone into one
zone re-defining the Captain of the Port Buffalo zone. This proposed
rule will consolidate the regulations found in 33 CFR 165.202, Safety
Zones; Annual Fireworks Events in the Captain of the Port Cleveland
Zone, the regulations found in 33 CFR 165.914, Safety Zones; Annual
Fireworks Events in the Captain of the Port Buffalo Zone so that all
the annual fireworks events in the current Captain of the Port Buffalo
Zone are found in one CFR section. In addition this proposal adds
events not previously published in the CFR.
    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 annual firework events
in the Captain of the Port Buffalo area of responsibility that may pose
a hazard to the public. This proposal consolidates the events listed in
Sec. Sec.  165.202 and 165.914 into a new section 165.939. This new
section unites all the annual Firework events in the recently
consolidated COTP Buffalo zone into one section of the CFR. In
addition, there are several events that are added and some events that
have been deleted in this new section.
    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 or the designated representative. Entry
into, transiting, or anchoring within the safety zone is prohibited
unless authorized by the Captain of the Port Buffalo, or his designated
representative. The Captain of the Port or his designated
representative may be contacted via VHF Channel 16.

Regulatory Evaluation

    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 of operators of vessels
intending to transit or anchor in the areas designated as safety zones
in subparagraphs (1) through (28) 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 Department, Coast Guard Sector Buffalo, Buffalo,
NY, at<PHONE_NUMBER>. 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 effect 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

    The Coast Guard recognizes the treaty rights of Native American
Tribes. Moreover, the Coast Guard is committed to working with Tribal
Governments to implement local policies and to mitigate tribal
concerns. We have determined that these safety zones and fishing rights
protection need not be incompatible. We have also determined that this
proposed 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. Nevertheless, Indian Tribes that
have questions concerning the provisions of this proposed rule or
options for compliance are encouraged to contact the point of contact
listed under FOR FURTHER INFORMATION CONTACT.

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 Commandant Instruction
M16475.lD which guides the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have made a preliminary determination that this section is not likely
to have a significant effect on the human environment.
    A preliminary ``Environmental Analysis Check List'' supporting this
preliminary determination is 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, and 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; 50
U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Public
Law 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

    2. Add Sec.  165.939 to read as follows:

Sec.  165.939  Safety Zones; Annual Fireworks Events in the Captain of
the Port Buffalo Zone.

    (a) Safety Zones. The following areas are designated Safety zones
and are listed geographically from New York to Ohio.
    (1) Boldt Castle 4th of July Fireworks, Heart Island, NY.
    (i) Location. All waters of the St. Lawrence River within a 500-
foot radius of the land position: 44[deg]20'39'' N, 075[deg]55'16'' W;
at Heart Island, NY. (DATUM: NAD 83).
    (ii) Enforcement date. This section is effective from 9pm to 10pm
on July 4 of each year.
    (2) Clayton Chamber of Commerce Fireworks, Calumet Island, NY.
    (i) Location. All waters of the St. Lawrence River within a 500-
foot radius of land position: 44[deg]15'05'' N, 076[deg]05'35'' W; in
Calumet Island Harbor, NY. (DATUM: NAD 83).
    (ii) Enforcement date. This section is effective from 9 p.m. to 10
p.m. on July 1 of each year.
    (3) French Festival Fireworks, Cape Vincent, NY.
    (i) Location. All waters of the St. Lawrence River within a 500-
foot radius of land position: 44[deg]07'53'' N, 076[deg]20'02'' W.
(DATUM: NAD 83).
    (ii) Enforcement date. This section is effective from 9:30 p.m. to
10:30 p.m. on the first or second weekend of July each year.
    (4) Brewerton Fireworks, Brewerton, NY.
    (i) Location. All waters of Lake Oneida within a 500-foot radius of
barge position: 43[deg]14'15'' N, 076[deg]08'03'' W; in Brewerton, NY.
(DATUM: NAD 83).
    (ii) Enforcement date. This section is effective from 9:30 p.m. to
10:30 p.m. on the first weekend of July each year.
    (5) Celebrate Baldwinsville Fireworks, Baldwinsville, NY.
    (i) Location. All waters of the Seneca River within a 500-foot
radius of land position: 43[deg]09'21'' N, 076[deg]20'01'' W. (DATUM:
NAD 83).
    (ii) Enforcement date. This section is effective from 9:30 p.m. to
10 p.m. on the third weekend of September each year.
    (6) Island Festival Fireworks Display, Baldwinsville, NY.
    (i) Location. All waters of the Seneca River within a 500-foot
radius of land position: 43[deg]09'25'' N, 076[deg]20'21'' W; in
Baldwinsville, NY. (DATUM: NAD 83).
    (ii) Enforcement date. This section is effective from 10 p.m. to
10:30 p.m. on the first weekend of July each year.
    (7) Seneca River Days, Baldwinsville, NY.
    (i) Location. All waters of the Seneca River within a 500-foot
radius of land position: 43[deg]09'25'' N, 076[deg]20'21'' W; in
Baldwinsville, NY. (DATUM: NAD 83).
    (ii) Enforcement date. This section is effective from 9:30 p.m. to
10:30 p.m. on the first weekend of July each year.
    (8) Oswego Harborfest, Oswego, NY.
    (i) Location. All waters of Lake Ontario within a 1,000 foot radius
of barge position: 43[deg]28'10'' N, 076[deg]31'04'' W; in Oswego, NY.
(DATUM: NAD 83).
    (ii) Enforcement Date. This section is effective from 9 p.m. to 10
p.m. on the last Saturday in July each year.
    (9) Village Fireworks, Sodus Point, NY.
    (i) Location. All waters of Sodus Bay within a 500-foot radius of
land position: 43[deg]16'27'' N, 076[deg]58'27'' W; in Sodus Point, NY.
(DATUM: NAD 83).
    (ii) Enforcement date. This section is effective from 10 p.m. to
10:30 p.m. on the first Saturday in July each year.
    (10) City of Syracuse Fireworks Celebration, Syracuse, NY.
    (i) Location. All waters of Onondaga Lake within a 350-foot radius
of land position: 43[deg]03'37'' N, 076[deg]09'59'' W; in Syracuse, NY.
(DATUM: NAD 83).
    (ii) Enforcement Date. This section is effective from 9:30 p.m, to
10:30 p.m. on the last weekend in June each year.
    (11) Tom Graves Memorial Fireworks, Port Bay, NY.
    (i) Location. All waters of Port Bay within a 500-foot radius of
barge position: 43[deg]17'46'' N, 076[deg]50'02'' W; in Port Bay, NY.
(DATUM: NAD 83).
    (ii) Enforcement date. This section is effective from 10 p.m. to
10:30 p.m. on the first weekend in July each year.
    (12) Rochester Harbor and Carousel Festival, Rochester, NY.
    (i) Location. All waters of Lake Ontario within a 500-foot radius
of land position: 43[deg]15'21'' N, 077[deg]36'19'' W in Rochester, NY.
(DATUM: NAD 83).
    (ii) Enforcement date. This section is effective from 8 p.m. to 10
p.m. on June 24th of each year.

    (13) North Tonawanda Fireworks Display, Tonawanda, NY.
    (i) Location. All waters of the East Niagara River within a 500-
foot radius of a barge located at position: 43[deg]01'12'' N,
078[deg]53'36'' W; in North Tonawanda, NY. (DATUM: NAD 83).
    (ii) Enforcement date. This section is effective from 9:45 p.m. to
10:15 p.m. on July 4th of each year.
    (14) Tonawanda's Canal Fest Fireworks, Tonawanda, NY.
    (i) Location. All waters of the East Niagara River within a 500-
foot radius of barge position: 43[deg]01'12'' N, 078[deg]53'36'' W; in
Tonawanda, NY. (DATUM: NAD 83).
    (ii) Enforcement date. This section is effective from 9:30 p.m. to
10:30 p.m. on the fourth Sunday in July each year.
    (15) Celebrate Erie Fireworks, Erie, PA.
    (i) Location. All waters of Presque Isle Bay within an 800-foot
radius of land position: 42[deg]08'19'' N, 080[deg]05'29'' W; at the
end of Dobbins Landing Pier, Erie, PA. (DATUM: NAD 83).
    (ii) Enforcement date. This section is effective from 9:45 p.m. to
10:30 p.m. on the third weekend in August each year.
    (16) Ashtabula Area Fireworks, Walnut Beach, Ashtabula, OH.
    (i) Location. All waters of Lake Erie and Ashtabula Harbor within a
300-yard radius of land position: 41[deg]54.167' N, 080[deg]48.416' W;
in Ashtabula, OH. (DATUM: NAD 83).
    (ii) Enforcement date. This section is effective from 9:45 p.m. to
11 p.m. on the second weekend in July each year.
    (17) Fairport Harbor Mardi Gras, Fairport Harbor, OH.
    (i) Location. All waters of Fairport Harbor and Lake Erie within a
300-yard radius of land position: 41[deg]45.500' N, 081[deg]16.300' W;
east of the harbor entrance at Fairport Harbor Beach, OH. (DATUM: NAD
83).
    (ii) Enforcement date. This section is effective from 9:45 p.m. to
11 p.m. on the first Saturday of July each year.
    (18) Lake County Perchfest Fireworks, Fairport, OH.
    (i) Location. All waters of Fairport Harbor and Lake Erie within a
300-yard radius of land position: 41[deg]45.500' N, 081[deg]16.300' W;
in Fairport, OH. (DATUM: NAD 83).
    (ii) Enforcement date. This section is effective from 9:45 p.m. to
11 p.m. on the second weekend in September each year.
    (19) Mentor Harbor Yacht Club Fireworks, Mentor Harbor, OH.
    (i) Location. All waters of Lake Erie and Mentor Harbor within a
200-yard radius of 41[deg]43.200' N, 081[deg]21.400' W (west of the
harbor entrance); in Mentor Harbor, OH. (DATUM: NAD 83).
    (ii) Enforcement date. This section is effective from 9:45 p.m. to
11 p.m. on the first weekend in July each year.
    (20) Browns Football Halftime Fireworks, Cleveland, OH.
    (i) Location. All navigable waters of Cleveland Harbor and Lake
Erie beginning in approximate land position: 41[deg]30.823' N,
081[deg]41.620' W (the northwest corner of Burke Lakefront Airport);
continuing northwest to 41[deg]31.176' N, 081[deg]41.884' W; then
southwest to 41[deg]30.810' N, 081[deg]42.515' W; then southeast to
41[deg]30.450' N, 081[deg]42.222' W (the northwest corner of dock 28 at
the Cleveland Port Authority) then northeast back to the starting point
at 41[deg]30.823' N, 081[deg]41.620' W. (DATUM: NAD 83).
    (ii) Enforcement date. This section is effective on a Sunday during
the second or third Cleveland Brown's home game each year.
    (21) City of Cleveland 4th of July Fireworks, Cleveland, OH.
    (i) Location. All navigable waters of Cleveland Harbor and Lake
Erie within a 400-yard radius of Main Entrance Light 5 (LLNR 4180) at
position: 41[deg]30.23' N, 081[deg]42.7' W; in Cleveland, OH (DATUM:
NAD 83).
    (ii) Enforcement date. This section is effective from 9:45 p.m. to
11 p.m. on the first weekend in July each year.
    (22) Dollar Bank Jamboree Fireworks Display, Cleveland, OH.
    (i) Location. All navigable waters of Cleveland Harbor and Lake
Erie beginning at land position: 41[deg]30.823' N, 081[deg]41.620' W
(the northwest corner of Burke Lakefront Airport); continuing northwest
to 41[deg]31.176' N, 081[deg]41.884' W; then southwest to
41[deg]30.810' N, 081[deg]42.515' W; then southeast to 41[deg]30.450'
N, 081[deg]42.222' W (the northwest corner of dock 28 at the Cleveland
Port Authority) then northeast back to the starting point at
41[deg]30.823' N, 081[deg]41.620' W. (DATUM: NAD 83).
    (ii) Enforcement date. This section is effective from 9:45 p.m. to
11 p.m. on the first weekend in July each year.
    (23) Lakewood City Fireworks Display, Lakewood,OH.
    (i) Location. All waters of Lake Erie within a 200-yard radius of
land position: 41[deg]29.755' N, 081[deg]47.780' W (off of Lakewood
Park); in Lakewood, OH. (DATUM: NAD 83).
    (ii) Enforcement date. This section is effective from 9:45 p.m. to
11 p.m. on the first weekend in July each year.
    (24) Cleveland Yachting Club Fireworks Display, Rocky River, OH.
    (i) Location. All waters of the Rocky River and Lake Erie within a
200-yard radius of land position 41[deg]29.428' N, 081[deg]50.309' W
(DATUM: NAD 83) at Sunset Point on the western side of the mouth of the
Rocky River in Cleveland, OH.
    (ii) Enforcement date. This section is effective from 9:45 p.m. to
11 p.m. on the third weekend in July each year.
    (25) Lorain 4th of July Celebration Fireworks Display, Lorain, OH.
    (i) Location. All waters of Lorain Harbor within a 300-yard radius
of land position 41[deg]28.591' N, 082[deg]10.855' W (DATUM: NAD 83),
east of the harbor entrance on the end of the break wall near Spitzer's
Marina.
    (ii) Enforcement date. This section is effective from 9:45 p.m. to
11 p.m. on the first weekend in July each year.
    (26) Lorain Port Fest Fireworks Display, Lorain, OH.
    (i) Location. All waters of Lorain Harbor within a 250-yard radius
of land position: 41[deg]28.040' N, 082[deg]10.365' W; in Lorain, OH
(DATUM: NAD 83).
    (ii) Enforcement date. This section is effective from 9:45 p.m. to
11 p.m. on the third weekend in July each year.
    (b) Definitions. The following definitions apply to this section:
    (1) Designated Representative means any Coast Guard commissioned,
warrant, or petty officer designated by the Captain of the Port Buffalo
to monitor a safety zone, permit entry into the zone, give legally
enforceable orders to persons or vessels within the zones, and take
other actions authorized by the Captain of the Port.
    (2) Public vessel means vessels owned, chartered, or operated by
the United States, or by a State or political subdivision thereof.
    (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 designated representative.
    (2)(i) These safety zones are closed to all vessel traffic, except
as may be permitted by the Captain of the Port Buffalo or his
designated representative.
    (ii) All persons and vessels must comply with the instructions of
the Coast Guard Captain of the Port or his designated representative.
    (iii) Upon being hailed by the U.S. Coast Guard by siren, radio,
flashing light or other means, the operator of a vessel shall proceed
as directed.
    (3)(i) All vessels must obtain permission from the Captain of the
Port Buffalo or his designated representative to enter, move within, or
exit the safety zone established in this section when this safety zone
is enforced.
    (ii) Vessels and persons granted permission to enter the safety
zone must obey all lawful orders or directions of

the Captain of the Port or a designated representative.
    (iii) While within a safety zone, all vessels must operate at the
minimum speed necessary to maintain a safe course.
    (d) Exemption. Public vessels, as defined in paragraph (b) of this
section, are exempt from the requirements in this section.
    (e) Waiver. For any vessel, the Captain of the Port Buffalo or his
designated representative may waive any of the requirements of this
section, upon finding that operational conditions or other
circumstances are such that application of this section is unnecessary
or impractical for the purposes of public or environmental safety.
    (f) Notification. The Captain of the Port Buffalo will notify the
public that 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.

Sec.  165.202  [Removed and Reserved]

    3. Remove and reserve Sec.  165.202.

Sec.  165.914  [Removed and Reserved]

    4. Remove and reserve Sec.  165.914.

    Dated: March 25, 2008.
S.J. Ferguson,
Captain, U.S. Coast Guard, Captain of the Port Buffalo.
[FR Doc. E8-6896 Filed 4-2-08; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register: November 14, 2008 (Volume 73, Number 221)]
[Proposed Rules]
[Page 67429-67433]
[DOCID:fr14no08-37]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-1210; Directorate Identifier 2008-CE-047-AD]
RIN 2120-AA64

Airworthiness Directives; Avidyne Corporation Primary Flight
Displays (Part Numbers 700-00006-000, -001, -002, -003, and -100)

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice of proposed rulemaking (NPRM).

-----------------------------------------------------------------------

SUMMARY: We propose to supersede Airworthiness Directive (AD) 2008-06-
28 R1, which applies to certain Avidyne Corporation (Avidyne) Primary
Flight Displays (PFDs) (part numbers (P/Ns) 700-00006-000, -001, -002,
-003, and -100) that are installed on airplanes. AD 2008-06-28 R1
currently requires you to do a check of the maintenance records and
inspection of the PFD (if necessary) to determine if an affected serial
number PFD is installed and incorporate (if necessary) operational
limitations. Since we issued AD 2008-06-28 R1, Avidyne developed a
factory service procedure that will correct the problems on these
Avidyne PFDs and also factory serviced certain serial number PFDs.
Consequently, this proposed AD would retain the actions from AD 2008-
06-28 R1 until the affected PFD is factory serviced; add the actions of
a label or marking check, an air data system performance verification
test, and (if necessary) replacement of the PFD and factory servicing
of the failed PFD; and reduce the serial number applicability from that
of AD 2008-06-28 R1. We are proposing this AD to prevent certain
conditions from existing when PFDs display incorrect attitude,
altitude, and airspeed information. This could result in airspeed/
altitude mismanagement or spatial disorientation of the pilot with
consequent loss of airplane control, inadequate traffic separation, or
controlled flight into terrain.

DATES: We must receive comments on this proposed AD by January 13,
2009.

ADDRESSES: Use one of the following addresses to comment on this
proposed AD:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, 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 service information identified in this proposed AD, contact
Avidyne Corporation, 55 Old Bedford Road, Lincoln, MA 01773; telephone:
(781) 402-7400; fax:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Solomon Hecht, Aerospace Engineer,
ANE-150, Boston Aircraft Certification Office, 12 New England Executive
Park, Burlington, Massachusetts 01803, phone:<PHONE_NUMBER>, fax:
(781) 238-7170.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments regarding this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include the docket number, ``FAA-
2008-1210; Directorate Identifier 2008-CE-047-AD'' at the beginning of
your comments. We specifically invite comments on the overall
regulatory, economic, environmental, and energy aspects of the proposed
AD. We will consider all comments received by the closing date and may
amend the proposed AD in light of those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive concerning this proposed AD.

Discussion

    Several field reports of PFDs displaying incorrect altitude and
airspeed information caused us to issue AD 2008-06-28, Amendment 39-
15440 (73 FR 15862, March 26, 2008). AD 2008-06-28 required the
following on Avidyne PFDs (P/Ns 700-00006-000, -001, -002, -003, and -
100) that are installed on airplanes:
     Checking of the maintenance records and inspection of the
PFD (if necessary) to determine if an affected serial number PFD is
installed; and
     If an affected serial number PFD is installed,
incorporating information that limits operation when certain conditions
for the PFD or backup instruments exist.
    An incorrect serial number (SN) listed in AD 2008-06-28 caused us
to issue AD 2008-06-28 R1, Amendment 39-15468 (73 FR 19963, April 14,
2008). AD 2008-06-28 R1 corrects the incorrect SN and retains the
actions of AD-2008-06-28.
    Since we issued AD 2008-06-28 R1, Avidyne has prepared a factory
service procedure that will correct the possible incorrect altitude and
airspeed information displayed on these Avidyne PFDs and received
approval for a corresponding alternative method of compliance (AMOC) to
modify certain serial number PFDs at the factory, eliminating the
unsafe condition in these units.
    This proposed AD retains the actions from AD 2008-06-28 R1 until
the factory servicing is done. This proposed AD would require you to
inspect for a label marked ``Deviation 08-19A'' on the exterior of the
PFD near the TSO label or a ``MOD 52'' marking; if the label or mark is
not present, do the PFD air data system performance verification test;
if the PFD passes the test, remove the operational limitations
requirement; or if the PFD does not pass the test, remove the PFD, have
the PFD factory serviced, install a PFD that has passed the air data
system verification test or has been factory serviced (PFD bears a
label marked ``Deviation 08-19A'' on the exterior of the PFD near the
TSO label; or a ``MOD 52'' marking); and

remove the operational limitations requirement. This proposed AD also
reduces the serial number applicability from that of AD 2008-06-28 R1
due to Avidyne modifying PFDs at the factory.
    This condition, if not corrected, could result in airspeed/altitude
mismanagement or spatial disorientation of the pilot with consequent
loss of airplane control, inadequate traffic separation, or controlled
flight into terrain.

Relevant Service Information

    We have reviewed Avidyne Service Bulletin No. 601-00006-096,
Revision 1, dated July 14, 2008.
    The service information describes procedures for:
     Identifying possible Avidyne PFDs by serial number;
     Identifying PFDs that have already been serviced;
     Doing Avidyne PFD air data system performance verification
test procedures; and
     Having any Avidyne PFD that has not passed the air data
system verification test or has not been factory serviced (PFD does not
bears a label marked ``Deviation 08-19A'' on the exterior of the PFD
near the TSO label; or a ``MOD 52'' marking) serviced.

FAA's Determination and Requirements of the Proposed AD

    We are proposing this AD because we evaluated all information and
determined the unsafe condition described previously is likely to exist
or develop on other products of the same type design. This proposed AD
would supersede AD 2008-06-28 R1 with a new AD that would retain the
actions from AD 2008-06-28 R1 until the affected PFD is factory
serviced; add the actions of a label or marking check, an air data
system performance verification test, and (if necessary) replacement of
the PFD and factory servicing of the failed PFD; and reduce the serial
number applicability from that of AD 2008-06-28 R1. This proposed AD
would require you to use the service information described previously
to perform these actions.

Differences Between This Proposed AD and the Service Information

    The proposed AD includes terminating action for the requirement of
AD 2008-06-28 R1 to incorporate information that limits operation when
certain conditions for the PFD or backup instruments exist. The
requirements of this proposed AD, if adopted as a final rule, would
take precedence over the provisions in the service information.

Costs of Compliance

    We estimate that this proposed AD would affect 384 airplanes in the
U.S. registry.
    We estimate the following costs to do the proposed serial number
determination:

----------------------------------------------------------------------------------------------------------------
                                                                                Total cost  per   Total cost  on
                  Labor cost                              Parts cost                airplane     U.S.  operators
----------------------------------------------------------------------------------------------------------------
1 work-hour x $80 per hour = $80.............  Not applicable.................             $80          $30,720
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary test and
replacement that would be required based on the results of the proposed
test. We have no way of determining the number of airplanes that may
need this test and replacement:

------------------------------------------------------------------------
                                                         Total cost  per
            Labor cost                  Parts cost           airplane
------------------------------------------------------------------------
4 work-hours x $80 per hour =      Not applicable......            $320
 $320.
------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, Section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We have determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have 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.
    For the reasons discussed above, I certify that the proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

Examining the AD Docket

    You may examine the AD docket that contains the proposed AD, the
regulatory evaluation, any comments received, and other information on
the Internet at http://www.regulations.gov; or in person at the Docket
Management Facility between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The Docket Office (telephone<PHONE_NUMBER>)
is located at the street address stated in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator,

the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

    1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by removing Airworthiness Directive
(AD) 2008-06-28 R1, Amendment 39-15468 (73 FR 19963, April 14, 2008),
and adding the following new AD:

Avidyne Corporation: Docket No. FAA-2008-1210; Directorate
Identifier 2008-CE-047-AD.

Comments Due Date

    (a) We must receive comments on this airworthiness directive
(AD) action by January 13, 2009.

Affected ADs

    (b) This AD supersedes AD 2008-06-28 R1, Amendment 39-15440.

Applicability

    (c) This AD applies to Avidyne Corporation (Avidyne) Primary
Flight Displays (PFDs) (part numbers (P/Ns) 700-00006-000, 700-
00006-001, 700-00006-002, 700-00006-003, and 700-00006-100 with any
serial number listed in Avidyne Service Bulletin No. 601-00006-096,
Revision 1, dated July 14, 2008) that are installed on, but not
limited to the airplanes below that are certificated in any
category. Paragraph (d) of this AD gives procedures to determine if
an affected serial number is installed.
    (1) Adam Aircraft Model A500;
    (2) Cessna Aircraft Company Model 441 (STEC Alliant Supplemental
Type Certificate (STC) No. SA09547AC-D incorporated);
    (3) Cessna Aircraft Company Models LC42-550FG and LC41-550FG
(Columbia Aircraft Manufacturing and The Lancair Company previously
held the type certificate for these airplanes);
    (4) Cirrus Design Corporation Models SR20 and SR22;
    (5) Diamond Aircraft Industries GmbH Model DA 40;
    (6) Hawker Beechcraft Corporation Model E90 (STEC Alliant STC
No. SA09545AC-D incorporated);
    (7) Hawker Beechcraft Corporation Model 200 series (STEC Alliant
STC No. SA09543AC-D incorporated); and
    (8) Piper Aircraft, Inc. Models PA-28-161, PA-28-181, PA-28R-
201, PA-32R-301 (HP), PA-32R-301T, PA-32-301FT, PA-32-301XTC, PA-34-
220T, PA-44-180, PA-46-350P, PA-46R-350T, and PA-46-500TP.
    (d) If you have one of the affected part number PFDs installed
on your airplane, you must be able to positively show that it is not
one of the affected serial numbers or comply with paragraph (f), all
subparagraphs, as applicable in this AD. You must follow the actions
in the paragraphs below to determine what actions of paragraph (f)
apply. Under 14 CFR 43.7, the owner/operator holding at least a
private pilot certificate is allowed to do the check in paragraph
(d)(1) of this AD. All other actions must be done by a certificated
mechanic, unless noted differently.
    (1) Do a logbook check of aircraft records (previously referred
to in AD 2008-06-28 R1 as ``maintenance records'') to determine if
any PFD (P/Ns 700-00006-000, 700-00006-001, 700-00006-002, 700-
00006-003, or 700-00006-100) with any affected serial number listed
in Avidyne Service Bulletin No. 601-00006-096, Revision 1, dated
July 14, 2008, is installed.
    (i) If, as a result of the logbook check, you positively
identify that the PFD installed does not have a serial number
affected by this AD, then only paragraph (f)(5) of this AD applies
to you.
    (ii) If, as a result of the logbook check, you cannot positively
identify the serial number of the PFD, do the visual inspection
required in paragraph (d)(2) of this AD.
    (iii) If, as a result of the logbook check, you find any PFD
installed with an affected serial number, do the actions required by
paragraph (f) of this AD, including all subparagraphs as applicable.
    (2) If, as a result of the above logbook check, you cannot
positively identify the serial number of the PFD, visually inspect
any PFD (P/Ns 700-00006-000, 700-00006-001, 700-00006-002, 700-
00006-003, or 700-00006-100) for any affected serial number listed
in Avidyne Service Bulletin No. 601-00006-096, Revision 1, dated
July 14, 2008.
    (i) If, as a result of this visual inspection, you positively
identify that the PFD installed does not have a serial number
affected by this AD, then only paragraph (f)(5) of this AD applies
to you.
    (ii) If, as a result of this visual inspection, you identify
that the PDF installed does have a serial number affected by this
AD, do the actions required in paragraph (f) of this AD, including
all subparagraphs as applicable.

Unsafe Condition

    (e) This AD results from several field reports of Avidyne PFDs
displaying incorrect altitude and airspeed information and Avidyne
preparing a factory service procedure that will correct the possible
incorrect altitude and airspeed information displayed. We are
issuing this AD to prevent certain conditions from existing when
PFDs display incorrect attitude, altitude, and airspeed information.
This could result in airspeed/altitude mismanagement or spatial
disorientation of the pilot with consequent loss of airplane
control, inadequate traffic separation, or controlled flight into
terrain.

Compliance

    (f) To address this problem, you must do the following, unless
already done:

------------------------------------------------------------------------
           Actions                 Compliance            Procedures
------------------------------------------------------------------------
(1) Incorporate the           Prior to further      Under 14 CFR 43.7,
 operational limitations       flight after the      the owner/operator
 below by doing whichever of   effective date of     holding at least a
 the following applies:        this AD.              private pilot
(i) For airplanes with an                            certificate is
 airplane flight manual                              allowed to insert
 (AFM), pilot's operating                            the information
 handbook (POH), or airplane                         into the AFM, POH,
 flight manual supplement                            AFMS, or
 (AFMS), incorporate the                             maintenance records
 language in the Appendix of                         as required in
 this AD into the                                    paragraph (f)(1)(i)
 Limitations section of the                          or (f)(1)(ii)(A) of
 AFM, POH, or AFMS.                                  this AD and
(ii) For airplanes without                           fabricate the
 an AFM, POH, or AFMS, do                            placard required in
 the following:.                                     paragraph
(A) Incorporate the language                         (f)(1)(ii)(B) of
 in the Appendix of this AD                          this AD. Make an
 into your aircraft                                  entry into the
 maintenance records; and.                           aircraft records
(B) Fabricate a placard                              showing compliance
 (using at least 1/8-inch                            with these portions
 letters) with the following                         of the AD in
 words and install the                               accordance with 14
 placard on the instrument                           CFR 43.9.
 panel within the pilot's
 clear view: ``THIS AD AND
 SUPERSEDED AD 2008-06-28 R1
 CONTAIN LIMITATIONS
 REGARDING AVIDYNE PRIMARY
 FLIGHT DISPLAYS (PFD) AND
 REQUIRED INCORPORATION OF
 THESE LIMITATIONS INTO THE
 AIRCRAFT RECORDS. YOU MUST
 FOLLOW THESE LIMITATIONS.''.
------------------------------------------------------------------------
(2) Inspect for a label       Within the next 15    Follow Avidyne
 marked ``Deviation 08-19A''   days after the        Service Bulletin
 on the exterior of the PFD    effective date of     No. 601-00006-096,
 near the TSO label or a       this AD.              Revision 1, dated
 ``MOD 52'' marking.                                 July 14, 2008.
(i) If the label marked
 ``Deviation 08-19A'' or
 ``MOD 52'' marking is
 present, then the factory
 servicing required by
 paragraph (f)(4) of this AD
 is incorporated. Remove the
 limitations required by
 paragraph (f)(1) of this AD
 and AD 2008-06-28 R1.
 Except for the actions of
 paragraph (f)(5) of this
 AD, no further action is
 required by this AD..
(ii) If the label or mark is
 not present, do the PFD air
 data system performance
 verification test in
 Section 3.3 of the
 referenced service
 bulletin..
------------------------------------------------------------------------
(3) If the PFD passes the     Within the next 15    Follow Avidyne
 test required in paragraph    days after the        Service Bulletin
 (f)(2)(ii) of this AD,        effective date of     No. 601-00006-096,
 remove the limitations        this AD.              Revision 1, dated
 required by paragraph                               July 14, 2008.
 (f)(1) of this AD and AD
 2008-06-28 R1. Except for
 the actions of paragraph
 (f)(5) of this AD, no
 further action is required
 by this AD.
------------------------------------------------------------------------
(4) If the PFD does not pass  Within the next 15    Follow Avidyne
 the test required in          hours TIS after the   Service Bulletin
 paragraph (f)(1)(ii) of       effective date of     No. 601-00006-096,
 this AD, do the following:    this AD.              Revision 1, dated
(i) Remove the PFD, have the                         July 14, 2008.
 PFD factory serviced, and
 install a PFD that has
 passed the air data system
 verification test or has
 been factory serviced (PFD
 bears a label marked
 ``Deviation 08-19A'' on the
 exterior of the PFD near
 the TSO label or a ``MOD
 52'' marking);.
(ii) Remove the limitations
 required by paragraph
 (f)(1) of this AD and AD
 2008-06-28 R1; and.
(iii) Except for the actions
 of paragraph (f)(5) of this
 AD, no further action is
 required by this AD..
------------------------------------------------------------------------

(5) Do not install any PFD    As of the effective   Not applicable.
 (P/Ns 700-00006-000, 700-     date of this AD.
 00006-001, 700-00006-002,
 700-00006-003, or 700-00006-
 100) with any affected
 serial number listed in
 Avidyne Service Bulletin
 No. 601-00006-096, Revision
 1, dated July 14, 2008,
 unless it has passed the
 air data system
 verification test or has
 been factory serviced (PFD
 bears a label marked
 ``Deviation 08-19A'' on the
 exterior of the PFD near
 the TSO label or a ``MOD
 52'' marking).
------------------------------------------------------------------------

Alternative Methods of Compliance (AMOCs)

    (g) The Manager, Boston Aircraft Certification Office, FAA, has
the authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. Send information to ATTN: Solomon
Hecht, Aerospace Engineer, ANE-150, Boston Aircraft Certification
Office, 12 New England Executive Park, Burlington, Massachusetts
01803, phone:<PHONE_NUMBER>, fax:<PHONE_NUMBER>. Before using any
approved AMOC on any airplane to which the AMOC applies, notify your
appropriate principal inspector (PI) in the FAA Flight Standards
District Office (FSDO), or lacking a PI, your local FSDO.
    (h) AMOCs approved for AD 2008-06-28 R1 are approved for this
AD.

Related Information

    (i) To get copies of the service information referenced in this
AD, contact Avidyne Corporation, 55 Old Bedford Road, Lincoln, MA
01773; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>. To view the
AD docket, go to U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, or on the Internet at
http://www.regulations.gov.

Appendix to Docket No. FAA-2008-1210 Limitations Regarding Avidyne
Primary Flight Displays (PFDs)

    Before conducting flight operations, pilots must review and be
familiar with the Crosscheck Monitor section of the Avidyne Primary
Flight Display Pilot's Guide and all limitations contained in the
aircraft operating handbook.
    As a normal practice, all pilots should be vigilant in
conducting proper preflight and in-flight checks of instrument
accuracy, including:
     Preflight check of the accuracy of both the primary and
backup altimeter against known airfield elevation and against each
other.
     Verification of airspeed indications consistent with
prevailing conditions at startup, during taxi, and prior to takeoff.
     ``Airspeed alive'' check and reasonable indications
during takeoff roll.
     Maintenance of current altimeter setting in both
primary and backup altimeters.
     Cross-check of primary and backup altimeters at each
change of altimeter setting and prior to entering instrument
meteorological conditions (IMC).
     Cross-check of primary and backup altimeters and
validation against other available data, such as glideslope
intercept altitude, prior to conducting any instrument approach.
     Periodic cross-checks of primary and backup airspeed
indicators, preferably in combination with altimeter cross-checks.
    For flight operations under instrument flight rules (IFR) or in
conditions in which visual reference to the horizon cannot be
reliably maintained (that is IMC, night operations, flight
operations over water, in haze or smoke) and the pilot has reasons
to suspect that any source (PFD or back-up instruments) of attitude,
airspeed, or altitude is not functioning properly, flight under IFR
or in these conditions must not be initiated (when condition is
determined on the ground) and further flight under IFR or in these
conditions is prohibited until equipment is serviced and functioning
properly.
    Operation of aircraft not equipped with operating backup (or
standby) attitude, altimeter, and airspeed indicators that are
located where they are readily visible to the pilot is prohibited.
    Pilots must frequently scan and crosscheck flight instruments to
make sure the information depicted on the PFD correlates and agrees
with the information depicted on the backup instruments.

    Issued in Kansas City, Missouri, on November 7, 2008.
James E. Jackson,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E8-27082 Filed 11-13-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 218 (Tuesday, November 10, 2020)]
[Notices]
[Pages 71656-71658]
[FR Doc No: 2020-24943]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-4792]

Regulatory Considerations for Microneedling Products; Guidance
for Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Regulatory
Considerations for Microneedling Products.'' This guidance is being
issued to assist industry in understanding when a microneedling product
is a device as defined in the Federal Food, Drug, and Cosmetic Act
(FD&C Act). This document also provides information on the regulatory
pathway to market for microneedling devices for aesthetic use.

DATES: The announcement of the guidance is published in the Federal
Register on November 10, 2020.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-D-4792 for ``Regulatory Considerations for Microneedling
Products.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.

     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Regulatory Considerations for Microneedling Products'' to the Office
of the Center Director, Guidance and Policy Development, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your request.

FOR FURTHER INFORMATION CONTACT: Kimberly Ferlin, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4522, Silver Spring, MD 20993-0002, 240-
402-1834.

SUPPLEMENTARY INFORMATION:

I. Background

    ``Microneedling products'' is a generic term that encompasses
instruments with common technological features that include an array of
needles, ``micro-protrusion'' tips, or pins, which can be blunt or
sharp, and of varying lengths. This document discusses when a
microneedling product is a device as defined under section 201(h) of
the FD&C Act (21 U.S.C. 321(h)), and is, therefore, subject to the
device requirements under the FD&C Act and its implementing
regulations.\1\ This guidance also provides clarity on the regulatory
pathway to market for microneedling devices for aesthetic use,
resulting in more transparency and predictability to firms and
stakeholders, which may translate into more efficient device
development and patient access to such devices. The scope of this
guidance document does not include microneedling combination products,
acupuncture needles, hypodermic needles or other needles for injection,
tattoo machine needles, needle probes that emit any type of energy
(e.g., radio-frequency needles) or deliver any type of energy to a
patient (e.g., LASER, ultrasound), or dermabrasion devices. FDA
considered comments received on the draft guidance that appeared in the
Federal Register of September 15, 2017 (82 FR 43383). FDA revised the
guidance as appropriate in response to the comments. Further, the
guidance was revised to account for a De Novo request that was granted
since issuance of the draft, which classified microneedling devices for
aesthetic use into class II subject to premarket notification
requirements under section 510(k) of the FD&C Act ((21 U.S.C. 360(k))
and special controls. The classification is codified at 21 CFR
878.4430.
---------------------------------------------------------------------------

    \1\ On September 23, 2020, FDA published a proposed rule to
amend its intended use regulations for medical products (21 CFR
201.128 and 801.4) to better reflect the Agency's current practices
in evaluating whether a product is intended for use as a drug or
device. As described in the proposed rule, FDA's longstanding
position is that, in evaluating a product's intended use, any
relevant source of evidence may be considered, including a variety
of direct and circumstantial evidence. 85 FR 59718, 59721 (Sept. 23,
2020).
---------------------------------------------------------------------------

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Regulatory Considerations for
Microneedling Products.'' It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov and
at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to download an electronic copy of
``Regulatory Considerations for Microneedling Products'' may send an
email request to<EMAIL_ADDRESS>to receive an electronic
copy of the document. Please use the document number 1500036 to
identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in the following FDA regulations and guidance have been
approved by OMB as listed in the following table:

------------------------------------------------------------------------
                                                            OMB control
21 CFR part; guidance; or FDA form          Topic               No.
------------------------------------------------------------------------
807, subpart E....................  Premarket                  0910-0120
                                     notification.

``De Novo Classification Process    De Novo                    0910-0844
 (Evaluation of Automatic Class      classification
 III Designation)''.                 process.
``Requests for Feedback on Medical  Q-submissions.......       0910-0756
 Device Submissions: The Pre-
 Submission Program and Meetings
 with Food and Drug Administration
 Staff''.
800, 801, and 809.................  Medical Device             0910-0485
                                     Labeling
                                     Regulations.
------------------------------------------------------------------------

    Dated: November 5, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-24943 Filed 11-9-20; 8:45 am]
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[Federal Register Volume 79, Number 113 (Thursday, June 12, 2014)]
[Notices]
[Pages 33759-33760]
[FR Doc No: 2014-13758]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1504]

Independent Assessment of the Process for the Review of Device
Submissions; Final Comprehensive Findings and Recommendations and First
Implementation Plan; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
entitled ``Independent Assessment of the Process for the Review of
Device Submissions; Final Comprehensive Findings and Recommendations
and First Implementation Plan'' that appeared in the Federal Register
of May 29, 2014 (79 FR 30853). The document announced Booz Allen
Hamilton's final comprehensive findings and recommendations submitted
as part of their independent assessment of the process for the review
of medical device submissions as well as FDA's first implementation
plan based on Booz Allen Hamilton's high priority recommendations
issued December 11, 2013. The notice was issued earlier than intended.
The documents will be available on June 11, 2014, as required by the
Medical Device User Fee Amendments of 2012 (MDUFA) III Performance
Goals and Procedures Commitment Letter.

FOR FURTHER INFORMATION CONTACT: Amber Sligar, Office of Planning, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3291,
Silver Spring, MD 20993-0002,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Federal Register of Thursday, May 29,
2014, in FR Doc. 2014-12403, on pages 30853-30854, the following
correction is made:
    The notice implied that Booz Allen Hamilton's final comprehensive
findings and recommendations and FDA's first implementation plan are
available as of May 29, 2014. In fact, the

documents will be available Wednesday, June 11, 2014, at the following
Web site: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MDUFAIII/ucm314036.htm.

    Dated: June 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13758 Filed 6-11-14; 8:45 am]
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