[Federal Register: February 15, 2008 (Volume 73, Number 32)]
[Notices]
[Page 8913-8915]
[DOCID:fr15fe08-115]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57302; File No. SR-BSE-2008-08]

Self-Regulatory Organizations; Boston Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Expand, and Make Permanent, the $1 Strike Program

February 11, 2008.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on January 28, 2008, the Boston Stock Exchange, Inc. (``BSE'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been substantially prepared by the Exchange.
BSE filed the proposal pursuant to section 19(b)(3)(A) of the Act \3\
and Rule 19b-4(f)(6) thereunder,\4\ which renders the proposal
effective upon filing with the Commission. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the rules of the Boston Options
Exchange (``BOX'') to expand the $1 Strike Pilot Program (``Program'')
and request permanent approval of the Program. The text of the proposed
rule change is available at the Exchange, the Commission's Public
Reference Room, and http://www.bostonoptions.com.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of the proposed rule change is to expand the Program
and request permanent approval of the Program.\5\ Chapter IV, section 6
of the BOX rules establishes guidelines regarding the addition of
options series for trading on BOX. The Program currently allows the
Exchange to select a total of 5 individual stocks on which option
series may be listed at $1 strike price intervals. To be eligible for
selection into the Program, the underlying stock must close below $20
in its primary market on the previous trading day. If selected for the
Program, the Exchange may list strike prices at $1 intervals from $3 to
$20, but no $1 strike price may be listed that is greater than $5 from
the underlying stock's closing price in its primary market on the
previous day. The Exchange also may list $1 strikes on any other option
class designated by other securities exchanges that employ a similar $1
strikes program under their respective rules. The Exchange may not list
long-term option series (``LEAPS'') at $1 strike price intervals for
any class selected for the Program. The Exchange also is restricted
from listing any series that would result in strike prices being $0.50
apart.
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    \5\ BSE implemented the Program in February 2004 and extended it
four times through June 5, 2008. See Securities Exchange Act Release
Nos. 49292 (February 20, 2004), 69 FR 8993 (February 26, 2004) (SR-
BSE-2004-01) (adopting the Program); 49806 (June 4, 2004), 69 FR
32640 (June 10, 2004) (SR-BSE-2004-22) (extending the Program until
June 5, 2005); 51778 (June 2, 2005), 70 FR 33562 (June 8, 2005) (SR-
BSE-2005-18) (extending the Program until June 5, 2006); 53855 (May
24, 2006), 71 FR 30973 (May 31, 2006) (SR-BSE-2006-19) (extending
the Program until June 5, 2007); and 55684 (April 30, 2007), 72 FR
26188 (May 8, 2007) (SR-BSE-2007-17) (extending the Program until
June 5, 2008).
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    The Exchange proposes to expand the Program to allow it to select a
total of 10 individual stocks on which option series may be listed at
$1 strike price intervals. Additionally, the Exchange proposes to
expand the price range on which it may list $1 strikes, presently from
$3 to $20, to now include stocks priced from $3 to $50. The existing
restrictions on listing $1 strikes will continue, e.g., no $1 strike
price may be listed that is greater than $5 from the underlying stock's
closing price in its primary market on the previous day, and the
Exchange is restricted from listing any series that would result in
strike prices being $0.50 apart.
    As stated in the Commission notice initially establishing the
Program and in the subsequent extensions of the Program,\6\ the
Exchange believes that $1 strike price intervals provide investors with
greater flexibility in the trading of equity options that overlie lower
priced stocks by allowing investors to establish equity options
positions that are better tailored to meet their investment objectives.
The Exchange states that Participants representing customers have
requested that BSE seek to expand the Program, both in terms of the
number of classes which can be selected and the range in which $1
strikes may be listed.
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    \6\ See id.
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    With regard to the impact on systems capacities, the Exchange's
analysis of the Program shows that the impact on BSE's, OPRA's, and
market data vendors' respective automated systems has been minimal. In
a previously filed proposed rule change,\7\ the Exchange analyzed the
trading volume for all classes selected by BOX for the Program as a
percentage of overall trading volume for all classes on BOX during a
specific number of months. The Exchange concluded that the classes
selected for the Program represented on average 2.6% of all trading
volume on BOX. The Exchange represents that it

has sufficient capacity to handle an expansion of the Program, as
proposed.
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    \7\ See Securities Exchange Act Release No. 55684 (April 30,
2007), 72 FR 26188 (May 8, 2007) (SR-BSE-2007-17).
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    The Exchange believes that the Program has provided investors with
greater trading opportunities and flexibility and the ability to more
closely tailor their investment strategies and decisions to the
movement of the underlying security. Furthermore, the Exchange has not
detected any material proliferation of illiquid options series
resulting from the narrower strike price intervals. For these reasons,
BSE requests that the Program be approved on a permanent basis.
2. Statutory Basis
    The Exchange believes that the proposal is consistent with the
requirements of section 6(b) of the Act,\8\ in general, and section
6(b)(5) of the Act,\9\ in particular, in that it is designed to promote
just and equitable principles of trade and to protect investors and the
public interest.
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    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    The Exchange states that it has neither solicited nor received
written comments on the proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change: (1) Does not
significantly affect the protection of investors or the public
interest; (2) does not impose any significant burden on competition;
and (3) by its terms does not become operative for 30 days after the
date of this filing, or such shorter time as the Commission may
designate if consistent with the protection of investors and the public
interest, the proposed rule change has become effective pursuant to
section 19(b)(3)(A) of the Act \10\ and Rule 19b-4(f)(6)
thereunder.\11\
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    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to provide the Commission
with written notice of its intent to file the proposed rule change,
along with a brief description and text of the proposed rule change,
at least five business days prior to the date of filing of the
proposed rule change, or such shorter time as designated by the
Commission. The Exchange has fulfilled this requirement.
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    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative for 30 days after the date of filing. However,
Rule 19b-4(f)(6)(iii) permits the Commission to designate a shorter
time if such action is consistent with the protection of investors and
the public interest. The Exchange requests that the Commission waive
the 30-day operative delay so that the Exchange can immediately
implement these listing rules, as proposed, that are similar to those
implemented by other options exchanges \12\ and do not raise any novel
issues. In addition, the Exchange believes that the proposed rule
change is necessary to eliminate any confusion among members of
multiple exchanges regarding the Program and to allow the Exchange to
remain competitive. The Commission believes that waiving the 30-day
operative delay is consistent with the protection of investors and the
public interest because the proposed rule change will provide the
Exchange's members and customers with added flexibility in the trading
of equity options and promote, without undue delay, additional
competition in the market for such options.\13\ For these reasons, the
Commission designates the proposed rule change as operative upon
filing. The Commission expects the Exchange to continue to monitor for
options with little or no open interest and trading activity and to act
promptly to delist such options. In addition, the Commission expects
that BSE will continue to monitor the trading volume associated with
the additional options series listed as a result of this proposal and
the effect of these additional series on market fragmentation and on
the capacity of the Exchange's, OPRA's, and vendors' automated systems.
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    \12\ See Securities Exchange Act Release Nos. 57169 (January 18,
2008), 73 FR 4654 (January 25, 2008) (SR-ISE-2007-110); 57130
(January 10, 2008), 73 FR 3302 (January 17, 2008) (SR-NYSEArca-2008-
04); 57110 (January 8, 2008), 73 FR 2292 (January 14, 2008) (SR-
Amex-2007-141); 57111 (January 8, 2008), 73 FR 2297 (January 14,
2008) (SR-Phlx-2008-01); and 57049 (December 27, 2007), 73 FR 528
(January 3, 2008) (SR-CBOE-2007-125).
    \13\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-BSE-2008-08 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-BSE-2008-08. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-BSE-2008-08 and should be
submitted on or before March 7, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
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    \14\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E8-2852 Filed 2-14-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 151 (Tuesday, August 6, 2019)]
[Notices]
[Page 38324]
[FR Doc No: 2019-16716]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2019-47]

Petition for Exemption; Summary of Petition Received; The Boeing
Company

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Federal Aviation Regulations. The
purpose of this notice is to improve the public's awareness of, and
participation in, the FAA's exemption process. Neither publication of
this notice nor the inclusion or omission of information in the summary
is intended to affect the legal status of the petition or its final
disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before August 26, 2019.

ADDRESSES: Send comments identified by docket number FAA-2019-0571
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE, Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Deana Stedman, AIR-673, Federal
Aviation Administration, 2200 South 216th Street, Des Moines, WA 98198,
phone and fax<PHONE_NUMBER>, email<EMAIL_ADDRESS>or Alphonso
Pendergrass, ARM-200, Office of Rulemaking, Federal Aviation
Administration, 800 Independence Avenue SW, Washington, DC 20591, phone
202-267-4713, email<EMAIL_ADDRESS>    This notice is published pursuant to 14 CFR 11.85.

    Issued in Des Moines, Washington, on July 31, 2019.
Victor Wicklund,
Manager, Transport Standards Branch.

Petition for Exemption

    Docket No.: FAA-2019-0571.
    Petitioner: The Boeing Company.
    Section(s) of 14 CFR Affected: Sec.  25.1461.
    Description of Relief Sought: Boeing Defense Space and Security is
petitioning for an exemption of the affected section of 14 CFR to allow
revision of Supplemental Type Certificate (STC) No. ST00157MC for the
Model 767-2C military tanker airplane. The exemption would apply to the
ram air turbine on the wing aerial refueling pod and would apply to
military use only.

[FR Doc. 2019-16716 Filed 8-5-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: September 23, 2008 (Volume 73, Number 185)]
[Rules and Regulations]
[Page 54684-54686]
[DOCID:fr23se08-12]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2008-0914]
RIN 1625-AA00

Safety Zone; Milwaukee River Challenge, Milwaukee River,
Milwaukee, WI

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone on the
Milwaukee River, Milwaukee, WI. This zone is intended to restrict
vessels from a portion of the Milwaukee River during the Milwaukee
River Challenge on September 20, 2008. This temporary safety zone will
establish restrictions upon, and control the movement of, vessels in a
specified area immediately prior to, during, and immediately after the
regatta.

DATES: This regulation is effective from 9 a.m. to 5 p.m. on September
20, 2008.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2008-0914 and are available online
at www.regulations.gov. They are also available for inspection or
copying at two locations: 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, and U.S. Coast
Guard Sector Lake Michigan, 2420 South Lincoln Memorial Drive,
Milwaukee, Wisconsin 53207 between 9:30 a.m. and 2 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: MST2 Eric Vogel, Prevention
Department, Coast Guard Sector Lake Michigan, Milwaukee, WI at (414)
747-7154. 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 Procedures 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 immediate action is necessary to
ensure the safety of commercial and recreational vessels in the
vicinity of the regatta on the date and times this rule will be in
effect and delay would be contrary to the public interest. Under 5
U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for
making this rule effective less than 30 days after publication in the
Federal Register. 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 this rule would be
contrary to the public interest of ensuring the safety of spectators
and vessels during this event and immediate action is necessary to
prevent possible loss of life or property.

Background and Purpose

    This temporary zone is necessary to ensure the safety of vessels
and participants from the hazards associated with the operation of
rowing race boats in a confined waterway. Based on the potential vessel
traffic and the presence of small rowing vessels the Captain of the
Port Lake Michigan has determined that racing rowing boats in presence
of normal vessel traffic poses a significant risk to public safety and
property. The likely combination of rowing vessels operating near large
towing vessels and recreational vessels operating at high speeds could
result in collisions that may cause serious injuries or fatalities.
Establishing a safety zone to control vessel movement in the location
of the race course will help ensure the safety of persons and property
at this event and help minimize the associated risk.

Discussion of Rule

    A temporary safety zone is necessary to ensure safety of life on
the navigable waters immediately prior to, during, and immediately
after the Milwaukee River Challenge. This proposed rule will establish
restrictions upon and control the movement of vessels through a portion
of the Milwaukee River immediately prior to, during, and immediately
after the Milwaukee River Challenge.
    The Captain of the Port will cause notice of enforcement of the
regulation established by this section to be made by all appropriate
means to the affected segments of the public. Such means of
notification will include, but is not limited to, Broadcast Notice to
Mariners and Local Notice to Mariners. The Captain of the Port will
issue a Broadcast Notice to Mariners notifying the public when
enforcement of the regulation is terminated.

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.
    This expectation is based on the minimal time that vessels will be
restricted from the zone in an area where the Coast Guard expects
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 may be
small entities: The owners and operators of vessels intending to
transit or anchor in a portion of Milwaukee River between 9 a.m. to 5
p.m. on September 20, 2008.
    This safety zone will not have a significant economic impact on a
substantial number of small entities for the following reasons. This
rule will be in effect for only eight hours on September 20, 2008. In
the event that this temporary safety zone affects shipping, commercial
vessels may request permission from the Captain of the Port Lake
Michigan to transit through the safety zone. The Coast Guard will give
notice to the public via a Broadcast to Mariners that the regulation is
in effect.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small
entities in understanding the rule so that they could better evaluate
its effects on them and participate in the rulemaking process. Small
businesses may send comments on the actions of Federal employees who
enforce, or otherwise determine compliance with, Federal regulations to
the Small Business and Agriculture Regulatory Enforcement Ombudsman and
the Regional Small Business Regulatory Fairness Boards. The Ombudsman
evaluates these actions annually and rates each agency's responsiveness
to small business. If you wish to comment on actions by employees of
the Coast Guard, call 1-888-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 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 or more in any
one year. Though this rule would not result in

such expenditure, we do discuss the effects of this rule elsewhere in
this preamble.

Taking of Private Property

    This rule will not effect 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 concern 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 procedure; and related management
system 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 5100.1 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
under the Instruction that there are no factors in this case that would
limit the use of a categorical exclusion under section 2.B.2 of the
Instruction. Therefore, this rule is categorically excluded, under
figure 2-1, paragraph (34)(g), of the Instruction, from further
environmental documentation.
    A final ``Environmental Analysis Check List'' and ``Categorical
Exclusion Determination'' are available in the docket where indicated
under ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, and Waterways.

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. Chapter 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. A new temporary Sec.  165.T09-0914 is added as follows:

Sec.  165.T09-0914  Safety zone; Milwaukee River Challenge, Milwaukee
River, Milwaukee, WI.

    (a) Location. The following area is a temporary safety zone: All
waters of the Milwaukee River from the junction with the Menomonee
River at position 43[deg]01'55'' N, 087[deg]54'40'' W to the Humboldt
Avenue Bridge at position 43[deg]03'25'' N, 087[deg]53'53'' W. All
waters of the Menomonee River from the Twenty-fifth St. Bridge at
position 43[deg]01'58'' N, 087[deg]56'41'' W to the junction with the
Milwaukee River. (DATUM: NAD 83).
    (b) Effective period. This regulation is effective from 9 a.m. to 5
p.m. on September 20, 2008.
    (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 Lake
Michigan, 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 Lake Michigan 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 Lake Michigan 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. 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 Lake Michigan or his on-scene representative.

    Dated: August 27, 2008.
B.C. Jones,
Captain, U.S. Coast Guard, Captain of the Port Lake Michigan.
[FR Doc. E8-22128 Filed 9-22-08; 8:45 am]

BILLING CODE 4910-15-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

REGION III

1650 Arch Street

Philadelphia, Pennsylvania 19103

                 January 11, 2012

SUBJECT:

Technical Support Document - Adequacy Findings for the Motor Vehicle
Emissions Budgets in the Attainment Demonstration for the Delaware
Portion of the Philadelphia-Wilmington-New Jersey 1997 Fine Particulate
(PM2.5) National Ambient Air quality Standard (NAAQS) Nonattainment Area

FROM:	            /s/

Martin Kotsch,

Office of Air Program Planning (3AP30)

TO:

Administrative Record for the Adequacy Findings for the Motor Vehicle
Emissions Budgets in the Attainment Demonstration for the Delaware
Portion of the Philadelphia-Wilmington-New Jersey City 1997 PM2.5 NAAQS
Nonattainment Area

           /s/

THRU:	Cristina Fernandez, Associate Director,

Office of Air Program Planning (3AP30)

I.   Administrative Requirements for Making Adequacy Findings

We have followed the process for determining the adequacy of the
submitted State Implementation Plan (SIP) Motor Vehicle Emissions
Budgets (MVEBs) in accordance with the procedures listed in the January
2008 Conformity Regulations contained in 40 CFR part 93, 118(f)
“Adequacy review process for implementation plan submissions”.

On November 17, 2011, the Delaware Department of Natural Resources and
Environmental Control (DNREC) formally submitted a revised Attainment
Demonstration Plan for the 1997 PM2.5 NAAQS (hereafter the attainment
demonstration) for the Delaware Portion of the
Philadelphia-Wilmington-New Jersey PM2.5 Nonattainment Area as a SIP
revision.  These revisions are being proposed by DNREC under a procedure
called parallel processing, whereby EPA proposes rulemaking action
concurrent with the state's procedures for amending its SIP.  If the
proposed revisions are substantially changed in areas other than those
identified in this notice, EPA will evaluate those changes and may
publish another notice of proposed rulemaking.  If no substantial
changes are made other than those areas cited in this notice, EPA will
publish a Final Rulemaking Notice on the revisions.   Any final
rulemaking action by EPA will occur only after the SIP revisions have
been adopted by Delaware and submitted formally to EPA for incorporation
into the SIP.

EPA will be issuing its own Notice of Proposed Rule making for a 30-day
public comment period soliciting public comment as to the approvability
of the Pennsylvania SIP submission.  Concurrently with EPA’s Notice of
Proposed Rulemaking, a notice will be posted on EPA’s website at
http://www.epa.gov/otaq/stateresources/transconf/currsips.htm for the
purpose of opening EPA’s 30-day public comment period on the
adequacy/approvability of the budgets in the SIP revision.  That notice
will inform the public of the availability of the Pennsylvania SIP
revision on its own website.  EPA’s website notice will provide a link
to the address for the website where interested members of the public
could access the SIP revision. Following EPA’s public comment period,
responses to any comments received on the proposed mobile budgets in the
Delaware SIP will be addressed in an amendment to this Technical Support
Document (TSD).

Shown below in Table 1 are the 2 sets of budgets from the SIP submittal.

Table 1

The Budgets of the Delaware Portion of the Philadelphia-Wilmington-New
Jersey 1997 PM2.5 NAAQS Attainment Demonstration

Plan

Submittals

Milestone

Year

Mobile Vehicle Emissions Budget for Direct PM-Tons Per Year

Mobile Vehicle Emissions Budget for NOx-Tons Per Year

	Attainment Plan Demonstration	2009	      199	   6,273

II. Evaluation of the Adequacy of the MVEBs Budgets in the Attainment
Demonstration for the Delaware Portion of the
Philadelphia-Wilmington-New Jersey 1997 NAAQS PM2.5  Nonattainment Area
Submitted by DNREC on November 11 , 2011

In this TSD, we are evaluating the MVEBs associated with the 2009
attainment demonstration plan contained in the November 17, 2011 SIP
revision, for conformity purposes.  We are using the evaluation criteria
detailed in the Transportation Conformity Rule, 40 CFR part
93.102(b)(2)(v), 93.102(b)(2)(v), 93.102(b)(3), and part 93, 93.118(e)4
through 93.118(e)5.  The evaluation is presented in Table 2, below.

Table 2

Adequacy of the MVEBs Contained in the Attainment Demonstration for the
Delaware Portion of the Philadelphia-Wilmington-New Jersey 1997 NAAQS
PM2.5 Nonattainment Area

Transportation Conformity Rule

40 CFR Part 93, 93.118

Review Criteria

Was the Criterion Satisfied?   If Yes How was this Criteria Satisfied?

93.102(b)(2)(iv)	Have EPA and the State made a finding that NOx is an
insignificant contributor to the direct mobile PM emissions?	EPA and the
State have not made such a finding.

93.102(b)(2)(v)	Has EPA or State made a finding that VOCs, Sulfur Oxides
(SOx) or Ammonia (NH3) as precursors to be a significant contributor to
the mobile PM2.5 emissions?	Neither EPA or the State has made such a
finding.

93.102(b)(3)	Has the EPA or the State made a finding that re-entrained
road dust is a significant contributor to the PM mobile emissions?
Neither EPA or the State has made such a finding.

Sec. 93.118(e)(4)(i)	Was the submitted revised plan endorsed by the
Governor (or his or her designee) and subject to a State public hearing?

	Yes.  The submitted and attainment demonstration was endorsed and
submitted as a SIP revision by the Governor’s   designee, the
Secretary of the DNREC, a public hearing will be held.

Sec. 93.118(e)(4)(ii)	Before the attainment demonstration was submitted
to EPA, did consultation between federal, State and local agencies
occur; was full implementation plan documentation provided to EPA, and
was EPA’s stated concerns, if any, addressed?	Yes. Consultation has
occurred among all required federal, state and local agencies.

	Sec. 93.118(e)(4)(iii)	Was the motor vehicle emissions budget(s)
clearly identified and precisely quantified?	Yes, the budgets are
clearly identified on page 2 of the November 11, 2011 submittal
containing the revised attainment demonstration.

Sec. 93.118(e)(4)(iv)	Is the motor vehicle emissions budget(s), when
considered together with all other emission reductions, consistent with
applicable requirements for attainment demonstrations?

	EPA believes the budgets can be declared adequate because in
conjunction with the other emission reductions, they   demonstrate
attainment for 2010.

Sec. 93.118(e)(4)(v)

Is the motor vehicle emissions budget(s) consistent with and clearly
related to the emissions inventory and the control measures in the Plan?

EPA believes that the budgets are clearly related to the emissions
inventory and the control measures in the SIP submittal.

Sec. 93.118(e)(4)(vi)

Revisions to previously submitted attainment demonstrations:  explain
and document any changes to previously submitted budgets and control
measures; impacts on point and area source emissions; any changes to
established safety margins (see Sec. 93.101 for definition); and reasons
for the changes (including the basis for any changes related to emission
factors or estimates of vehicle miles traveled).

N/A

Sec. 93.118(e)(5)

Did they provide and we review public comments and the State’s
responses to those comments with the submitted control strategy SIP?

Any comments on the proposed mobile vehicle emissions budgets received
by the state after submission of the final SIP will be considered as
part of the overall final approvability of the SIP.

III. Findings - Based upon our review and evaluation of the MVEBs
contained in DNREC’s November 11, 2011 submittal of the attainment
plan for the Delaware 1997 PM2.5 NAAQS nonattainment area, we find the
said MVEBs adequate for conformity purposes subject to receipt of the
final SIP.

 PAGE  1


[Federal Register: October 17, 2008 (Volume 73, Number 202)]
[Notices]
[Page 61847-61848]
[DOCID:fr17oc08-68]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12585-002]

Golden Gate Energy Company; Notice of Intent To File License
Application, Filing of Draft Application, Request for Waivers of
Integrated Licensing Process Regulations Necessary for Expedited
Processing of a Hydrokinetic Pilot Project License Application, and
Soliciting Comments

October 10, 2008.
    a. Type of Filing: Notice of Intent to File a License Application
for an Original License for a Hydrokinetic Pilot Project.
    b. Project No.: 12585-002.
    c. Dated Filed: September 30, 2008.
    d. Submitted By: Golden Gate Energy Company.
    e. Name of Project: San Francisco Bay Tidal Energy Pilot Project.
    f. Location: Within San Francisco Bay, in San Francisco and Marin
Counties, California. The Proposed project site extends from beyond the
western side of the Golden Gate Bridge into the Bay and around Angel
and Alcatraz Islands before ending well short of the BART tunnel. No
federal lands are occupied by

the proposed project works or located within the proposed project
boundary.
    g. Filed Pursuant to: 18 CFR 5.3 of the Commission's regulations.
    h. Potential Applicant Contact: Mike Hoover, Golden Gate Energy
Company, 1785 Massachusetts Ave., NW., Suite 100, Washington, DC 20036;
(202) 494-9232.
    i. FERC Contact: Matt Buhyoff<PHONE_NUMBER>; or e-mail at
<EMAIL_ADDRESS>    j. Golden Gate Energy Company has filed with the Commission: (1) A
notice of intent to file an original hydrokinetic pilot project license
application and a draft license application with monitoring plan; (2) a
request for waivers of the integrated licensing process regulations
necessary for expedited processing of a hydrokinetic project pilot
license application; (3) a proposed process plan and schedule; (4) a
request to be designated as the non-federal representative for sections
7 of the Endangered Species Act consultation; and (5) a request to be
designated as the non-federal representative for section 106
consultation under the National Historic Preservation Act (collectively
the Pre-Filing materials).
    k. With this notice, we are soliciting comments on the Pre-Filing
materials from paragraph j above, including the draft license
application and monitoring plans. All comments should be sent to the
address above in paragraph h. In addition, all comments (original and
eight copies) must be filed with the Commission at the following
address: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426. All filings
with the Commission must include on the first page, the project name
(San Francisco Bay Tidal Energy Pilot Project) and number (P-12585-
002), and bear the heading ``Comments on the proposed San Francisco Bay
Tidal Energy Pilot Project.'' Any individual or entity interested in
submitting comments on the Pre-filing Materials must do so by October
30, 2008.
    Comments may be filed electronically via the Internet in lieu of
paper. The Commission strongly encourages electronic filings. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site (http://www.ferc.gov) under the ``e-filing'' link.
    l. This notice does not constitute the Commission's approval of
Golden Gate Energy Company's request to use the Pilot Project Licensing
Procedures. Upon its review of the project's overall characteristics
relative to the pilot project criteria, the draft application contents,
and any comments filed, the Commission may seek additional information
needed to continue processing the Pilot Project or reject the NOI,
draft application, and Golden Gate Energy Company's request for waiver/
process plan for an original hydrokinetic pilot project license.
    m. The proposed San Francisco Bay Tidal Energy Pilot Project would
be implemented in a four-phase deployment, including removal of
hydrokinetic electrical power generators and associated hardware in San
Francisco Bay, California. The final design of each phase would be
dependent upon results of the previous phase. In Phase 1, dependent
upon final design, the project would consist of: (1) A 51-foot-long
floating barge supporting; (2) up to three experimental hydrokinetic
units approximately 2-3 meters in diameter; and (3) appurtenant
facilities. Phase 2 would consist of: (1) An anchored jack-up barge
supporting; (2) hydrokinetic units approximately 5-7 meters in
diameter; and (3) appurtenant facilities. Phase 3 would consist of (1)
a 12kV transmission cable approximately 1.25 miles in total length.
Approximately 0.75 mile of the cable would be buried in the marine
environment and the remaining 0.5 mile of the cable would follow an
existing on shore right-of-way; and (2) appurtenant facilities. Phase 4
consists of project removal and site restoration. The applicant
estimates that the total average capacity of less than 1 megawatt.
    n. A copy of the draft application and all Pre-filing Materials are
available for review at the Commission in the Public Reference Room or
may be viewed on the Commission's Web site (http://www.ferc.gov), using
the ``eLibrary'' link. Enter the docket number, excluding the last
three digits in the docket number field to access the document. For
assistance, contact FERC Online Support at<EMAIL_ADDRESS>or toll free at 1-866-208-3676, of for TTY,<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the address in
paragraph h.
    o. Pre-filing process schedule. The pre-filing process will be
conducted pursuant to the following tentative schedule. Revisions to
the schedule may be made as appropriate.

------------------------------------------------------------------------
                Milestone                              Date
------------------------------------------------------------------------
Comments on Pre-filing Materials due....  Oct. 30, 2008.
Issuance of Meeting Notice (if            Nov. 14, 2008.
 appropriate).
Public Meeting/technical Conference (if   Dec. 12, 2008.
 appropriate).
Issuance of notice concluding Pre-filing  Dec. 29, 2008.
 process.
Issuance of ILP Waiver request            Dec. 29, 2008.
 determination.
------------------------------------------------------------------------

    p. Register online at http://ferc.gov/esubscribenow.htm to be
notified via e-mail of new filing and issuances related to this or
other pending projects. For assistance, contact FERC Online Support.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-24664 Filed 10-16-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 19 (Monday, January 30, 2023)]
[Notices]
[Pages 5888-5891]
[FR Doc No: 2023-01849]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0187]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Premarket Approval of Medical Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on information collection associated with
premarket approval of medical devices.

DATES: Submit either electronic or written comments on the collection
of information by March 31, 2023.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before March 31, 2023. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 31, 2023. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

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-2023-N-0187 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Premarket Approval of Medical
Devices.'' Received comments, those filed in a timely manner (see
ADDRESSES), 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>.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Premarket Approval of Medical Devices

OMB Control Number 0910-0231--Revision

    This information collection supports implementation of statutory
and regulatory requirements that govern premarket approval of medical
devices. Premarket approval (PMA) is the FDA process of scientific and
regulatory review to evaluate the safety and effectiveness of Class III
medical devices. Class III devices are those that support or sustain
human life, are of substantial importance in preventing impairment of
human health, or which present a potential, unreasonable risk of
illness or injury. Due to the level of risk associated with Class III
devices, FDA has determined that general and special controls alone are
insufficient to assure the safety and effectiveness of Class III
devices. Therefore, these devices require a premarket approval (PMA)
application under section 515 of the FD&C Act (21 U.S.C. 360e) in order
to obtain marketing approval. Please note that PMA requirements apply
differently to preamendments devices, postamendments devices, and
transitional class III devices and some Class III preamendment devices
may require a Class III 510(k). See the PMA Historical Background web
page at https://www.fda.gov/medical-devices/premarket-approval-pma/pma-historical-background for additional information. Section 515A of the
FD&C Act (21 U.S.C. 360e-1) governs pediatric uses of devices.
    The PMA is the most stringent type of device marketing application
required by FDA. Applicants must receive FDA approval of a PMA
application prior to marketing the device. PMA approval is based on a
determination that the PMA contains sufficient valid scientific
evidence to assure that the device is safe and effective for its
intended use(s). Respondents to the information collection are PMA
applicants, or persons who own the rights, or otherwise have authorized
access, to the data and other information to be submitted in support of
FDA approval. This person may be an individual, partnership,
corporation, association, scientific or academic establishment,
government agency or organizational unit, or other legal entity. The
applicant is often the inventor/developer and ultimately the
manufacturer. A Class III device that fails to meet PMA requirements is
considered to be

adulterated under section 501(f) of the FD&C Act (21 U.S.C. 351(f)) and
may not be marketed.
    FDA regulations in part 814 (21 CFR part 814) implement section 515
and 515A of the FD&C Act and establish procedures for the premarket
approval of medical devices intended for human use, including the
submission of information concerning use in pediatric patients.
Regulations in part 814, subpart A (Sec. Sec.  814.1 to 814.19) set
forth general provisions pertaining to the confidentiality of data and
information submitted to FDA in a PMA, research conducted outside the
United States, service of orders, and product development protocols.
Provisions in part 814, subparts B and C (Sec. Sec.  814.20 to 814.47)
establish format and content elements that must be included in an
application, explain submission and review schedules, and address the
withdrawal and temporary suspension of a PMA. Postapproval
requirements, including reports required under 21 CFR part 803 (medical
device reporting), are covered in regulations in part 814, subpart E
(Sec. Sec.  814.80 to 814.84). Burden attributable to information
collection associated with regulations in part 814, subpart H
(Sec. Sec.  814.100 to 814.126) pertaining to Humanitarian Use Devices
is currently approved in OMB control number 0910-0332.
    For operational efficiency, we are revising the information
collection to include burden that may be associated with
recommendations found in the Agency guidance document entitled,
``Providing Information about Pediatric Uses of Medical Devices'' (May
2014), currently approved in OMB control number 0910-0748. The guidance
document describes how to compile and submit the readily available
pediatric use information required under section 515A of the FD&C Act.
The guidance document is available for download from our website at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-information-about-pediatric-uses-medical-devices.
    Relatedly, we are revising the information collection to include
burden that may be associated with the submission of information on
pediatric use of medical devices under section 515A of the FD&C Act,
also currently approved in OMB control number 0910-0748. Section
515A(a) of the FD&C Act requires applicants who submit information to
include readily available information providing a description of any
pediatric subpopulations that suffer from the disease or condition that
the device is intended to treat, diagnose, or cure, and the number of
affected pediatric patients. This information allows FDA to track the
number of approved devices for which there is a pediatric subpopulation
that suffers from the disease or condition that the device is intended
to treat, diagnose, or cure and the review time for each such device
application.
    We are also revising the information collection to include burden
applicable to implementing requirements under section 402(j)(5)(B) of
the Public Health Service (PHS) Act (42 U.S.C. 282(j)(5)(b)), and set
forth in regulations at 42 CFR part 11 (see 81 FR 64981, September 21,
2016). Specifically, applications under sections 505, 515, or 520(m) of
the FD&C Act (21 U.S.C. 355, 360e, or 360j(m)), or under section 351 of
the PHS Act (42 U.S.C. 262), or submission of a report under section
510(k) of the FD&C Act, must be accompanied by a certification. Where
available, such certification must include the appropriate National
Clinical Trial numbers. We have developed Form FDA 3674
(``Certifications to Accompany Drug, Biological Product, and Medical
Device Applications/Submissions''), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/form-fda-3674-certifications-accompany-drug-biological-product-and-device-applicationssubmissions, for respondents to submit the requisite
information.
    Respondents can make single submissions in an electronic format
that includes eCopies, submissions submitted on CD, DVD, or flash drive
and mailed to FDA and eSubmissions, submissions created using an
electronic submission template (e.g., ``electronic Submission Template
and Resource'' (eSTAR)). Consistent with our authority in section
745A(b) of the FD&C Act (21 U.S.C. 379k-1(b)), and performance goals
found in our current Medical Device User Fee Amendments Commitment
Letter, we developed eSTAR for use through the Center for Devices and
Radiological Health Customer Collaboration Portal. We use eSTAR as a
tool to facilitate the preparation of submissions in electronic format
(available on FDA's website at https://www.fda.gov/medical-devices/how-study-and-market-your-device/voluntary-estar-program and identified as
Form FDA 4062 ``Electronic Submission Template and Resource (eSTAR)''
(for Non-In Vitro Diagnostic submissions) and form FDA 4078
``Electronic Submission Template and Resource (eSTAR)'' (for In Vitro
Diagnostic submissions)). We believe respondents' use of eSTAR will
significantly reduce burden attendant to application submissions by
providing a uniform format for requisite elements and by enhancing user
interface through the use of modernized technology.
    We estimate the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
     Activity/21 CFR or FD&C Act section         Number of     responses per   Total annual      Average  burden per  response (hours)      Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                     Premarket Approval Submissions (``traditional'' preparation; eCopy submission)
                                                 21 CFR Part 814, Premarket Approval of Medical Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
Subpart A--General:
    Research conducted outside the United                 20               1              20  2.........................................              40
     States (814.15(b)).
Subpart B--Premarket Approval Application
 (PMA):
    PMA application (814.20)................              40               1              40  654.6.....................................          26,184
    Information on clinical investigations                10               1              10  0.5 (30 minutes)..........................               5
     conducted outside the United States
     (814.20(b)(6)(ii)(C)).
    PMA amendments and resubmitted PMAs                1,356               1           1,356  167.......................................         226,452
     (814.37(a)-(c) and (e)).
    PMA supplements (814.39(a)).............             762               1             762  0.983 (59.11 minutes).....................          45,048
    Special PMA supplement--changes being                 75               1              75  6.........................................             450
     affected (814.39(d)).
    30-day notice (814.39(f))...............           1,181               1           1,181  16........................................          18,896
        Subtotal Parts A and B..............  ..............  ..............  ..............  ..........................................         317,075
Subpart C--FDA Action on a PMA:
    Panel of experts request (814.42 and                   1               1               1  30........................................              30
     515(c)(3) of the FD&C Act).

Subpart E--Postapproval Requirements:
    Postapproval requirements (814.82(a)(9))             121               1             121  135.......................................          16,335
    Periodic reports (814.84(b))............             764               1             764  10........................................           7,640
                                             -----------------------------------------------------------------------------------------------------------
        Total Subpart E.....................  ..............  ..............  ..............  ..........................................          24,005
--------------------------------------------------------------------------------------------------------------------------------------------------------
 42 CFR part 11, Clinical Trials Registration and Results Information Submission, subparts D and E; and FDA Guidance ``Form FDA 3674--Certifications To
                                        Accompany Drug, Biological Product, and Device Applications/Submissions''
--------------------------------------------------------------------------------------------------------------------------------------------------------
Certification to accompany PMA submissions                40               1              40  0.75 (45 minutes).........................              30
 (Form FDA 3674).
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                    FD&C Act section 515A Pediatric Uses of Devices:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pediatric information in a PMA, PDP, or PMA              944               1             944  2.10......................................            1984
 supplement.
Pediatric use information outside approved               800               1             800  0.5 (30 minutes)..........................             400
 indication.
                                             -----------------------------------------------------------------------------------------------------------
        Subtotal............................           1,744               1           1,744  ..........................................           2,384
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                          Premarket Approval Submissions (eSTAR preparation; eCopy submission):
--------------------------------------------------------------------------------------------------------------------------------------------------------
eSTAR setup.................................              30               1              30  0.08 (5 minutes)..........................               2
                                             -----------------------------------------------------------------------------------------------------------
            Total...........................  ..............  ..............  ..............  ..........................................         343,496
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our estimate is based on the annual rate of receipt of PMA
submissions, including PDPs and PMA supplements, for fiscal years 2019
through 2021 and our expectation of submissions to come in the next few
years. We also account for referrals of PMAs to a panel for review, as
provided for under Sec.  814.44(a). FDA may refer the PMA to a panel on
its own initiative, and will do so upon request of an applicant, unless
FDA determines that the application substantially duplicates
information previously reviewed by a panel. We have adjusted our
figures to reflect an overall decrease, which we attribute to
respondents' use of modernized submission technologies including eSTAR.
At the same time, we include in our estimate an initial burden
attributable to respondents who need to set up an eSTAR account for the
first time.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                      Average  burden
                      Activity/21 CFR section                           Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Maintenance of records (814.82(a)(5) and (a)(6))...................             552                1              552               17            9,384
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The regulations require the maintenance of records, which are used
to trace patients, and the organization and indexing of records into
identifiable files to ensure a device's continued safety and
effectiveness. These records are required of all applicants who have an
approved PMA. Currently there are 815 active PMAs that could be subject
to these requirements, based on FDA data, and approximately 33 new PMAs
are approved each year. We estimate our annual recordkeeping burden
based on an average of 552 PMA holders. The applicant determines which
records should be maintained during product development to document
and/or substantiate the device's safety and effectiveness. Records
required under 21 CFR part 820 may be relevant to a PMA review and may
be submitted as part of an application. In individual instances,
records may be required as conditions of approval to ensure the
device's continuing safety and effectiveness.
    Cumulatively, our adjustments reflect only a slight increase to the
estimated burden for the information collection.

    Dated: January 25, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-01849 Filed 1-27-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 120 (Wednesday, June 22, 2011)]
[Notices]
[Pages 36527-36528]
[FR Doc No: 2011-15526]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[ Project No. 349-150]

Alabama Power Company (Alabama Power); Notice of Application
Tendered for Filing With the Commission and Establishing Procedural
Schedule for Licensing and Deadline for Submission of Final Amendments

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: New Major License.
    b. Project No.: 349-150.
    c. Date Filed: June 8, 2011.
    d. Applicant: Alabama Power Company (Alabama Power).
    e. Name of Project: Martin Dam Hydroelectric Project.
    f. Location: The existing Martin Dam Project is located on the
Tallapoosa River in northeast Alabama, in Tallapoosa, Coosa, and Elmore
Counties, Alabama, near the cities of Alexander City and Dadeville,
Alabama. The project would occupy 1.36 acres of Federal lands.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Theodore J. McCullough, Senior Vice President
and Senior Production Officer, Alabama Power Company, 600 North 18th
Street, P.O. Box 2641, Birmingham, AL 35291, telephone<PHONE_NUMBER>;
James F. Crew, Manager, Hydro Services, Alabama Power Company, 600
North 18th Street, P.O. Box 2641, Birmingham, AL 35291, telephone (205)
257-4265.
    i. FERC Contact: Jennifer Adams,<PHONE_NUMBER> or
<EMAIL_ADDRESS>    j. This application is not ready for environmental analysis at this
time.
    k. The Project Description: Martin Dam is located at river mile
420.0 on the Tallapoosa River near the cities of Alexander City and
Dadeville, Alabama. Martin Dam impounds about 31 miles of the
Tallapoosa River, forming Martin Reservoir (or Lake Martin), a 40,000-
acre reservoir with (a) 700 miles of shoreline, (b) a gross storage
capacity of 1,622,000 acre-feet, and (c) active storage of 1,381,077
acre-feet at a 45.5-foot drawdown.
    The existing Martin Dam Project consists of: (1) A concrete gravity
dam and an earth dike section, totaling about 2,000 feet in length with
a maximum height of 168 feet, and includes (a) A 720-foot-long gated
spillway section with 20 vertical lift spillway gates, each measuring
30 feet wide by 16 feet high; (b) a 250-foot-long concrete gravity
intake structure, (c) a 255-foot-long concrete gravity non-overflow
section, and (d) an approximately 1,000-foot-long earth embankment; (2)
a reservoir with a surface area of 40,000 acres at the normal full pool
elevation of 491 feet mean sea level (msl); (3) headworks containing
four steel penstocks and 12 intake gates, each fitted with trash racks;
(4) a brick and concrete, steel-frame powerhouse, 307 feet long, 58
feet wide, and 99 feet high; (5) four vertical Francis turbines that
power four generating units with a total installed capacity of 182.5
MW; (6) two 450-foot-long transmission lines; and (7) appurtenant
facilities. The project generates about 33,000,000 megawatt-hours (MWh)
annually.
    The Martin Dam Project operates as a peaking project using a
multipurpose storage reservoir (Lake Martin), in which the water levels
fluctuate seasonally. Under its normal peaking operations, the project
operates between elevations 481 and 491 feet msl. Flows from the dam
vary from leakage during periods of non-generation to 17,900 cubic feet
per second (cfs) during generation. The Martin Dam Project typically
generates Monday through Friday for eight hours per day. Releases from
Martin Dam are made directly into Alabama Power's Yates and Thurlow
Hydroelectric Project (FERC Project No. 2407). The Thurlow Dam is
required to release a minimum flow of 1,200 cfs. Releases from Martin
Dam are often necessary to maintain the 1,200-cfs minimum flow
requirement.
    Alabama Power uses three guide curves for the Martin Dam Project:
(1) A flood control guide; (2) an operating guide; and (3) a drought
contingency curve. The flood control guide maximizes lake elevations
for flood control purposes. The operating guide limits fluctuations in
Lake Martin to water levels that stakeholders deemed acceptable during
the previous relicensing process for the Martin Dam Project. The area
between the flood control guide and operating guide represents the
range that Alabama Power operates the project under normal inflow
conditions.

    l. Locations of the Application: A copy of the application is
available for review at the Commission in the Public Reference Room or
may be viewed on the Commission's Web site at http://www.ferc.gov using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, contact FERC Online Support at<EMAIL_ADDRESS>or toll-free at 1-866-208-3676, or for TTY,<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the address in item
(h) above.
    m. You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via e-mail of new filings and
issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    n. Procedural Schedule:
    The application will be processed according to the following
preliminary Hydro Licensing Schedule. Revisions to the schedule may be
made as appropriate.

------------------------------------------------------------------------
                 Milestone                           Target date
------------------------------------------------------------------------
Notice of Acceptance/Notice of Ready for    August 7, 2011
 Environmental Analysis.
Filing of recommendations, preliminary      October 6, 2011.
 terms and conditions, and fishway
 prescriptions.
Commission issues Draft EIS...............  April 3, 2012.
Comments on Draft EIS.....................  June 2, 2012.
Modified Terms and Conditions.............  August 1, 2012.
Commission Issues Final EIS...............  October 30, 2012.
------------------------------------------------------------------------

    o. Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of the Notice
of Ready for Environmental Analysis.

    Dated: June 15, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-15526 Filed 6-21-11; 8:45 am]
BILLING CODE 6717-01-P