[Federal Register Volume 82, Number 128 (Thursday, July 6, 2017)]
[Notices]
[Pages 31340-31341]
[FR Doc No: 2017-14255]

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DEPARTMENT OF HOMELAND SECURITY

U.S. Coast Guard

[Docket No. USCG-2017-0618]

National Boating Safety Advisory Council--Input To Support
Regulatory Reform of Coast Guard Regulations--New Task

AGENCY: U.S. Coast Guard, Department of Homeland Security.

ACTION: Notice of new task assignment for the National Boating Safety
Advisory Council (NBSAC); notice of teleconference meeting.

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SUMMARY: The U.S. Coast Guard is issuing a new task to the National
Boating Safety Advisory Council (NBSAC). The U.S. Coast Guard is asking
NBSAC to help the agency identify existing regulations, guidance, and
collections of information (that fall within the scope of the Council's
charter) for possible repeal, replacement, or modification. This
tasking is in response to the issuance of Executive Orders 13771,
``Reducing Regulation and Controlling Regulatory Costs; 13777,
``Enforcing the Regulatory Reform Agenda;'' and 13783, ``Promoting
Energy Independence and Economic Growth.'' The full Council is
scheduled to meet by teleconference on July 21, 2017, to discuss this
tasking. This teleconference will be open to the public. The U.S. Coast
Guard will consider NBSAC recommendations as part of the process of
identifying regulations, guidance, and collections of information to be
repealed, replaced, or modified pursuant to the three Executive Orders
discussed above.

DATES: The full Council is scheduled to meet by teleconference on July
21, 2017, from 11 a.m. to noon EST. Please note that this
teleconference may adjourn early if the Council has completed its
business.

ADDRESSES: To join the teleconference or to request special
accommodations, contact the individual listed in the FOR FURTHER
INFORMATION CONTACT section no later than 1 p.m. on July 14, 2017. The
number of teleconference lines is limited and will be available on a
first-come, first-served basis.
    Instructions: Submit comments on the task statement at any time,
including orally at the teleconference, but if you want Council members
to review your comments before the teleconference, please submit your
comments no later than July 14, 2017. You must include the words
``Department of Homeland Security'' and the docket number for this
action. Written comments may also be submitted using the Federal e-
Rulemaking Portal at http://www.regulations.gov. If you encounter
technical difficulties with comment submission, contact the individual
listed in the FOR FURTHER INFORMATION CONTACT section of this notice.
Comments received will be posted without alteration at http://www.regulations.gov, including any personal information provided. You
may review Regulations.gov's Privacy and Security Notice at https://www.regulations.gov/privacyNotice.
    Docket Search: For access to the docket or to read documents or
comments related to this notice, go to http://www.regulations.gov,
insert ``USCG-2017-0618'' in the Search box, press Enter, and then
click on the item you wish to view.

FOR FURTHER INFORMATION CONTACT: Mr. Jeff Ludwig, Alternate Designated
Federal Officer of the National Boating Safety Advisory Council,
telephone<PHONE_NUMBER>, or email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

New Task to the Council

    The U.S. Coast Guard is issuing a new task to NBSAC to provide
recommendations on whether existing regulations, guidance, and
information collections (that fall within the scope of the Council's
charter) should be

repealed, replaced, or modified. NBSAC will then provide advice and
recommendations on the assigned task and submit a final recommendation
report to the U.S. Coast Guard.

Background

    On January 30, 2017, President Trump issued Executive Order 13771,
``Reducing Regulation and Controlling Regulatory Costs.'' Under that
Executive Order, for every one new regulation issued, at least two
prior regulations must be identified for elimination, and the cost of
planned regulations must be prudently managed and controlled through a
budgeting process. On February 24, 2017, the President issued Executive
Order 13777, ``Enforcing the Regulatory Reform Agenda.'' That Executive
Order directs agencies to take specific steps to identify and alleviate
unnecessary regulatory burdens placed on the American people. On March
28, 2017, the President issued Executive Order 13783, ``Promoting
Energy Independence and Economic Growth.'' Executive Order 13783
promotes the clean and safe development of our Nation's vast energy
resources, while at the same time avoiding agency actions that
unnecessarily encumber energy production.
    When implementing the regulatory offsets required by Executive
Order 13771, each agency head is directed to prioritize, to the extent
permitted by law, those regulations that the agency's Regulatory Reform
Task Force identifies as outdated, unnecessary, or ineffective in
accordance with Executive Order 13777. As part of this process to
comply with all three Executive Orders, the U.S. Coast Guard is
reaching out through multiple avenues to interested individuals to
gather their input about what regulations, guidance, and information
collections, they believe may need to be repealed, replaced, or
modified. On June 8, 2017, the U.S. Coast Guard issued a general notice
in the Federal Register requesting comments from interested individuals
regarding their recommendations, 82 FR 26632. In addition to this
general solicitation, the U.S. Coast Guard also wants to leverage the
expertise of its Federal Advisory Committees and is issuing similar
tasks to each of its Committees. A detailed discussion of each of the
Executive orders and information on where U.S. Coast Guard regulations,
guidance, and information collections are found is in the June 8th
notice.

The Task

    NBSAC is tasked to:
    Provide input to the U.S. Coast Guard on all existing regulations,
guidance, and information collections that fall within the scope of the
Council's charter.
    1. One or more subcommittees/working groups, as needed, will be
established to work on this tasking in accordance with the Council
charter and bylaws. The subcommittee(s) shall terminate upon the
approval and submission of a final recommendation to the U.S. Coast
Guard from the parent Council.
    2. Review regulations, guidance, and information collections and
provide recommendations whether an existing rule, information
collection, or guidance should be repealed, replaced or modified. If
the Council recommends modification, please provide specific
recommendations for how the regulation, information collection, or
guidance should be modified. Recommendations should include an
explanation on how and to what extent repeal, replacement or
modification will reduce costs or burdens to industry and the extent to
which risks to health or safety would likely increase.
    a. Identify regulations, guidance, or information collections that
potentially impose the following types of burden on the industry:
    i. Regulations, guidance, or information collections imposing
administrative burdens on the industry.
    ii. Regulations, guidance, or information collections imposing
burdens in the development or use of domestically produced energy
resources. ``Burden,'' for the purposes of compliance with Executive
Order 13783, means ``to unnecessarily obstruct, delay, curtail, or
otherwise impose significant costs on the siting, permitting,
production, utilization, transmission, or delivery of energy
resources.''
    b. Identify regulations, guidance, or information collections that
potentially impose the following types of costs on the industry:
    i. Regulations, guidance, or information collections imposing costs
that are outdated (such as due to technological advancement), or are no
longer necessary.
    ii. Regulations, guidance, or information collections imposing
costs which are no longer enforced as written or which are ineffective.
    iii. Regulations, guidance, or information collections imposing
costs tied to reporting or recordkeeping requirements that impose
burdens that exceed benefits. Explain why the reporting or
recordkeeping requirement is overly burdensome, unnecessary, or how it
could be modified.
    c. Identify regulations, guidance, and information collections that
the Council believes have led to the elimination of jobs or inhibits
job creation within a particular industry.
    3. All regulations, guidance, and information collections, or parts
thereof, recommended by the Council should be described in sufficient
detail (by section, paragraph, sentence, clause, etc.) so that it can
readily be identified. Data (quantitative or qualitative) should be
provided to support and illustrate the impact, cost, or burden, as
applicable, for each recommendation. If the data is not readily
available, the Council should include information as to how such
information can be obtained either by the Council or directly by Coast
Guard.

Public Participation

    All meetings associated with this tasking, both full Council
meetings and subcommittee/working groups, are open to the public. A
public oral comment period will be held during the July 21, 2017,
teleconference. Public comments or questions will be taken at the
discretion of the Designated Federal Officer; commenters are requested
to limit their comments to 3 minutes. Please contact the individual
listed in the FOR FURTHER INFORMATION CONTACT section, to register as a
commenter. Subcommittee meetings held in association with this tasking
will be announced as they are scheduled through notices posted to
http://homeport.uscg.mil/NBSAC and uploaded as supporting documents in
the electronic docket for this action, [USCG-2017-0618], at
Regulations.gov.

J.F. Williams,
Captain, U.S. Coast Guard, Director of Inspections and Compliance.
[FR Doc. 2017-14255 Filed 7-5-17; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: November 26, 2008 (Volume 73, Number 229)]
[Notices]
[Page 72091-72093]
[DOCID:fr26no08-111]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-58980; File No. SR-CBOE-2008-61]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change To Clarify Exchange Rule 9.11 Relating to Confirmations to
Customers

November 19, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on November 10, 2008, Chicago Board Options Exchange, Incorporated
(``Exchange'' or ``CBOE''), filed with the Securities and Exchange
Commission (the ``Commission'') the proposed rule change as described
in Items I, II, and III below, which Items have been substantially
prepared by the Exchange. The Exchange filed the proposal as a ``non-
controversial'' proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \3\ and Rule 19b-4(f)(6) thereunder.\4\ 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)(iii).
    \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 Chicago Board Options Exchange, Incorporated (``CBOE'' or
``Exchange''), proposes to amend CBOE Rule 9.11--Confirmation to
Customers to clarify that written confirmations relating to options
transactions do not need to specify the exchange or exchanges on which
an option contract is executed. The text of the proposed rule change is
available on the Exchange's Web site (http://www.cboe.com/Legal), at
the Exchange's Office of the Secretary, and at the Commission.

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 self-regulatory organization
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 those statements may be examined at
the places specified in Item IV below and is set forth in sections (A),
(B), and (C) below.

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

1. Purpose
    The proposed amendment to Exchange Rule 9.11 clarifies that a
member organization is not required to disclose the market on which an
options transaction is executed on a written confirmation furnished to
a customer of a member organization. The member organization will
continue to furnish a written confirmation that contains a description
of each transaction in the option contracts, the underlying security
type, option expiration month, exercise price, number of option

contracts, premium, commissions, date of transaction and settlement
date, and shall indicate whether the transaction is a purchase or sale
and whether a principal or agency transaction. The confirmation shall
also by appropriate symbols distinguish between Exchange transactions
and other transactions in options contracts.
    Prior to August 1999, an options class was typically listed on only
one options exchange. In August 1999, the options exchanges began to
multiply-list options classes that were previously listed on only one
exchange. In October 1999, the Commission stated that it believed a
linkage among options markets would benefit investors by increasing
competition among markets (and market participants) to provide the best
execution of customer orders.\5\ Subsequently, the Commission directed
the options exchanges to act jointly in discussing, developing, and
submitting for Commission approval an intermarket linkage plan for
multiply-traded options. On July 28, 2000, the Commission approved the
Plan for the Purpose of Creating and Operating an Intermarket Options
Market Linkage (the ``Options Linkage Plan'' or ``Linkage Plan'')
submitted by the CBOE, the American Stock Exchange LLC (``Amex'') and
the International Securities Exchange, Inc.\6\ The Philadelphia Stock
Exchange, Inc., and the Pacific Stock Exchange agreed to participate in
the Options Linkage Plan in November 2000.\7\ As a result of the
introduction of multiply listed options and the implementation of the
Linkage Plan, the contracts in a customer options order could be
executed on more than one options exchange and the significance of the
options exchange or exchanges that execute a particular options
transaction has diminished significantly.
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    \5\ See Exchange Act Release No. 42029 (Oct. 19, 1999), 64 FR
57674 (Oct. 26, 1999).
    \6\ See Exchange Act Release No. 43086 (July 28, 2000), 65 FR
48023 (Aug. 4, 2000).
    \7\ See Exchange Act Release Nos. 43573 (Nov. 16, 2000), 65 FR
70850 (November 28, 2000) and 43574 (Nov. 16, 2000), 65 FR 70851
(Nov. 28, 2000) (approval order).
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    Under the duty of best execution, CBOE members are required to
exercise diligence to obtain the best price when routing customer
options orders for execution. The Exchange, as well as the other
members of the Options Self Regulatory Council (the ``OSRC''),\8\
believes that in light of the existing best execution and disclosure
requirements, the usefulness of including on an options confirmation
the name of the options exchange or exchanges on which an options
transaction was effected does not outweigh the operational difficulties
of capturing the information given the multiple trading of options and
the application of the Options Linkage Plan industry-wide.
Consequently, the proposal would amend Exchange Rule 9.11 to make clear
that written confirmations relating to options transactions are not
required to specify the options exchange or exchanges on which such
options contracts were executed.
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    \8\ The ORSC consists of the options exchanges and the Financial
Industry Regulatory Authority, Inc. (``FINRA'').
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    The Exchange has worked with the other members of the OSRC in
developing these proposed rule changes. Also, the Commission has
approved an Amex proposal to clarify that written confirmations
relating to options transactions are not required to specify the
options exchange or exchanges on which such options contracts are
executed.\9\ Each additional member of the OSRC is expected to
similarly file rule proposals to either delete the requirement that the
written options confirmation disclose the name of the options exchange
or exchanges on which the options transaction was executed, or clarify
that no such requirement exists.
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    \9\ See Exchange Act Release No. 58814 (Oct. 20, 2008), 73 FR
63527 (Oct. 24, 2008) (SR-Amex-2008-53).
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    The Exchange believes that with the expansion of multi-listing of
options and the introduction of new options exchanges, it has become
operationally inefficient to require the disclosure of the market
center on which an order was executed on the confirmation. As an
example, a customer may have a single option order containing numerous
option contracts executed on multiple exchanges. Under these
conditions, it would be inefficient for the member organization to be
required to identify the exchange symbol for each contract executed on
that customer's order.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6 of the Exchange Act \10\ in general, and furthers the
objectives of Section 6(b)(5) \11\ of the Act in particular in that it
is designed to promote just and equitable principles of trade,
facilitate transactions in securities, remove impediments to and
perfect the mechanisms of a free and open market and a national market
system, and, in general, to protect investors and the public interest
by clarifying the Exchange's options confirmation procedure rules to
better reflect the realities of the modern options market.
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    \10\ 15 U.S.C. 78f.
    \11\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    CBOE does not believe that the proposed rule change will impose any
burden on competition 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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    Because the forgoing rule change does not: (1) Significantly affect
the protection of investors or the public interest; (2) impose any
significant burden on competition; and (3) become operative for 30 days
after the date of this filing, or such shorter time as the Commission
may designate, it has become effective pursuant to Section 19(b)(3)(A)
of the Act \12\ and Rule 19b-4(f)(6) thereunder.\13\
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    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under 19b-4(f)(6) normally may not
become operative prior to 30 days after the date of filing.\14\
However, Rule 19b-4(f)(6)(iii) \15\ permits the Commission to designate
a shorter time if such action is consistent with the protection of
investors and the public interest. The Exchange has requested that the
Commission waive the 30-day operative delay.
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    \14\ 17 CFR 240.19b-4(f)(6)(iii).
    \15\ Id.
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    The proposed rule change is substantially similar to an Amex rule
that provides that written confirmations relating to options
transactions are not required to specify the options exchange or
exchanges on which such options were executed.\16\ The Exchange
believes that this proposed rule change does not raise any new, unique
or substantive issues from those raised in the approved Amex filing.
The Exchange also believes that acceleration of the operative date is
consistent with the protection of investors and the public
interest.\17\

Lastly, the Exchange provided 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 days prior to the
date of the filing of the proposed rule change as required by Rule 19b-
4(f)(6).
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    \16\ See supra note 9, and related text.
    \17\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the impact of the proposed rule on
efficiency, competition, and capital formation. 15 U.S.C. 78c(f).
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    At any time within 60 days of the filing of such 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-CBOE-2008-61 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CBOE-2008-61. 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 such filing also will be available for
inspection and copying at the principal office of the CBOE. 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-CBOE-2008-61 and should be
submitted on or before December 17, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
Florence E. Harmon,
Acting Secretary.
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    \18\ 17 CFR 200.30-3(a)(12).
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[FR Doc. E8-28140 Filed 11-25-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 167 (Wednesday, August 30, 2023)]
[Notices]
[Pages 59903-59904]
[FR Doc No: 2023-18640]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2146-275]

Alabama Power Company; Notice of Application Accepted for Filing
and Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Non-Capacity Amendment of License.
    b. Project No: P-2146-275.
    c. Date Filed: August 8, 2023.
    d. Applicant: Alabama Power Company (Alabama Power).
    e. Name of Project: Coosa River Project.
    f. Location: The project is located on the Coosa River, in Coosa,
Chilton, Talladega and Shelby counties, Alabama.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Alan L. Peeples, Alabama Power Company, 600
North 18th Street, P.O. Box 2641, Birmingham, AL 35291-8180, (205) 257-
1401.
    i. FERC Contact: Zeena Aljibury,<PHONE_NUMBER>,
[email protected].
    j. Deadline for filing comments, motions to intervene, and protests
is 30 days from the issuance date of this notice by the Commission.
    The Commission strongly encourages electronic filing. Please file
motions to intervene, protests, comments, or recommendations using the
Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000
characters, without prior registration, using the eComment system at
http://www.ferc.gov/docs-filing/ecomment.asp. You must include your
name and contact information at the end of your comments. For
assistance,

please contact FERC Online Support at [email protected], (866)
208-3676 (toll free), or<PHONE_NUMBER> (TTY). In lieu of electronic
filing, you may submit a paper copy. Submissions sent via the U.S.
Postal Service must be addressed to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street NE, Room 1A,
Washington, DC 20426. Submissions sent via any other carrier must be
addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 12225 Wilkins Avenue, Rockville, Maryland 20852. The first
page of any filing should include the docket number P-2146-275.
Comments emailed to Commission staff are not considered part of the
Commission record.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervenor files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency.
    k. Description of Request: Alabama Power requests approval to
modify Unit 1 at the Bouldin Development to address significant
maintenance needs and to improve power and efficiency. The proposed
scope of work for Unit 1 includes complete turbine replacement, wicket
gate replacement, wicket gate stem bushings installation, turbine, and
generator bearing upgrades, and related component replacement. Alabama
Power states the turbine replacement is not expected to result in an
increase to the total rated capacity or the maximum discharge of the
unit at rated conditions. Alabama Power notes that project operations
will not change, and refurbishment will not include any structural
changes to the project facilities. Furthermore, the intake structure
will not be modified, nor will there be any modifications to the
existing trash racks. Therefore, Alabama Power states that the current
approach velocity at the trash racks will remain the same.
    l. Locations of the Application: This filing may be viewed on the
Commission's website 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. You may also register
online at http://www.ferc.gov/docs-filing/esubscription.asp to be
notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
[email protected], for TTY, call<PHONE_NUMBER>. Agencies may
obtain copies of the application directly from the applicant.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214, respectively. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Documents: Any filing must (1) bear in all
capital letters the title ``COMMENTS'', ``PROTEST'', or ``MOTION TO
INTERVENE'' as applicable; (2) set forth in the heading the name of the
applicant and the project number of the application to which the filing
responds; (3) furnish the name, address, and telephone number of the
person commenting, protesting or intervening; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis. Any filing made by an intervenor must be accompanied
by proof of service on all persons listed in the service list prepared
by the Commission in this proceeding, in accordance with 18 CFR
385.2010.
    p. The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members and others, access
publicly available information and navigate Commission processes. For
public inquiries and assistance with making filings such as
interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].

    Dated: August 23, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-18640 Filed 8-29-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 119 (Wednesday, June 20, 2012)]
[Notices]
[Pages 37055-37058]
[FR Doc No: 2012-14990]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0656]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Secure Supply Chain
Pilot Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Fax written comments on the collection of information by July
20, 2012.

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

FOR FURTHER INFORMATION CONTACT:  Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.
PIFO-400W, Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance: ``Secure Supply Chain Pilot Program.''
    The Secure Supply Chain Pilot Program (SSCPP) is intended to assist
FDA in its efforts to prevent the importation of adulterated,
misbranded, or unapproved drugs by allowing the Agency to focus its
resources on imported drugs that fall outside the program and that may
pose such risks. Such a program would increase the likelihood of
expedited entry for specific finished drug products and APIs imported
into the United States that meet the criteria for selection under the
program.
    Title: Secure Supply Chain Pilot Program.
    Description of Respondents: Respondents to this collection of
information are sponsors and foreign manufacturers of finished drug
products and active pharmaceutical ingredients (APIs) intended for
human use.
    Burden Estimate: In the Federal Register of January 15, 2009 (74 FR
2605) (the January 2009 notice), FDA announced an opportunity for
sponsors and foreign manufacturers of finished drug products and APIs
intended for human use imported via a secure supply chain to apply to
participate in a voluntary SSCPP to be conducted by FDA's Center for
Drug Evaluation and Research (CDER) and Office of Regulatory Affairs
(ORA). The goal of the SSCPP is to allow FDA to determine the
practicality of developing a secure supply chain program. The
information obtained from this pilot program will assist FDA in its
determination. An SSCPP would assist the Agency in its efforts to
prevent the importation of adulterated, misbranded, or unapproved drugs
by allowing the Agency to focus its resources on imported drugs outside
the program that may pose such risks. Such a program would increase the
likelihood of expedited entry for specific finished drug products and
APIs imported into the United States that meet the criteria for
selection under the program. A limited number of applications that meet
criteria established by FDA will be selected by FDA based largely on
information submitted in the SSCPP application.
    Because there is information collection under the PRA associated
with the SSCPP, this Federal Register notice is being issued as part of
the process for OMB approval to collect this information. After OMB
approval, FDA will accept applications to participate in the program
and will select qualified applications. FDA will announce in the
Federal Register OMB's approval, the date that applications may be
submitted, and application submission procedures. FDA has considered
all PRA and Non-PRA comments received. This FR notice responds only to
the PRA-related comments.
    The information collection associated with the SSCPP consists of
the following:
    (1) Secure Supply Chain Pilot Program application form. Proposed
Form FDA 3676 will request the following: (a) Identification and
contact information for sponsors and foreign manufacturers wishing to
participate in the SSCPP; (b) information about each drug to be
imported; (c) logistical information associated with the importation
and a description of the process by which the drug will be brought into
the United States; and (d) a description of procedures that the
applicant will follow to remedy any deficiencies that FDA may identify
with the importation, including recall procedures. A draft of proposed
Form FDA 3676 may be obtained at http://www.fda.gov/cder/fedreg/fda-3676.pdf, or by calling<PHONE_NUMBER>. The SSCPP application form may
not be submitted to FDA until OMB has approved the information
collection associated with the SSCPP.
    (2) Changes to information contained in the SSCPP. If there are
changes to the information contained in the SSCPP application, then the
applicant would be expected to submit to FDA a modified application
detailing those changes and obtain FDA authorization before
implementing them.
    (3) FDA withdrawal of selection. If FDA withdraws its selection of
an application from participating in the SSCPP, the applicant would be
given an opportunity to provide information to FDA to show that the
program's criteria are met and participation should continue or be
resumed. FDA will consider and act on this information at its sole
discretion.
    (4) Recordkeeping requirements. Applicants will be expected to
maintain records that confirm the information provided in their SSCPP
applications and make these records available to FDA if requested.
While these records must be maintained for the duration of the
applicant's participation in the program, FDA requests that they be
maintained and be readily available when requested by FDA for a period
of at least 3 years after the pilot ends or the

applicant's participation in the pilot ends. In addition, regardless of
whether required by law, for each shipment of finished drug product or
API, applicants must maintain records that document the product's
movement through their secure supply chain from the point of
manufacture to the point of receipt by the ultimate consignee. These
records must be maintained for the duration of the applicant's
participation in the program and be readily available when requested by
FDA. FDA intends to accept applications from no more than 100 qualified
applicants and for no more than 5 drugs per applicant to participate in
the SSCPP. As indicated in Table 1 of this document, FDA estimates that
no more than 500 SSCPP application forms will be submitted by
approximately 100 applicants, and that it will take approximately 3.5
hours to complete and submit each application form to FDA. FDA
anticipates that approximately 5 applicants will need to submit a
modified SSCPP, and that each modified application will take
approximately 60 minutes to complete and submit to FDA (this estimate
includes the time for an applicant to also submit a copy of its Customs
Trade Partnership Against Terrorism (C-TPAT) application). FDA
anticipates that it will need to withdraw its selection of only one
SSCPP application, and that it will take approximately 1 hour for an
applicant to submit information in response. The reporting burden
estimated in Table 1 also includes the time for submitting the address
where records associated with the SSCPP will be kept, and for
submitting the FDA-assigned qualifier code and Affirmation of
Compliance code for each imported drug.
    As indicated in Table 2 of this document, FDA estimates that
approximately 500 records associated with the SSCPP will be kept by
approximately 100 applicants, and that each record will take about 60
minutes to maintain.
    Because FDA intends to continue the SSCPP for 2 years, these burden
estimates are for a one-time burden over a 2-year period.
    In the January 2009 notice, FDA requested public comment on the
proposed collection of information. We received comments from 11
different companies that pertained to the information collection
resulting from the SSCPP. A summary of the comments and FDA's response
are as follows:
    (1) Several comments stated that foreign manufacturers, with the
exception of manufactures in Canada and Mexico, are not eligible for
Customs Trade Partnership Against Terrorism (C-TPAT) program and
therefore would be unable to meet the criteria in the SSCPP.
    To clarify the C-TPAT program eligibility requirements, only
business entities who handle cargo that enter the United States are
eligible to be a member of the C-TPAT program. Foreign manufacturers,
with the exception of those located in Canada and Mexico, cannot apply
to be members of the C-TPAT program, but would be visited by the C-TPAT
program as part of the validation process for a C-TPAT partner. C-TPAT
partners must adhere to the security requirements and ensure that
requirements are met by their business partners throughout the
international supply chain. The January 2009 notice states that firms
identified in the SSCPP application must be either C-TPAT Tier II
certified or Tier II pending certification at the time the application
is submitted. After further review and discussion with the U.S. Customs
and Border Protection (CBP) about the C-TPAT program, FDA is revising
the C-TPAT criteria to permit firms to participate in the SSCPP if the
supply chain has been validated as Tier II or Tier III. Tier II
validated means that CBP has visited a site in the firm's supply chain
and has validated its security procedures as meeting the requirements
set forth by C-TPAT. Tier III means that a firm has exceeded C-TPAT's
security criteria and implemented their own best practices. FDA intends
to revise the SSCPP application to reflect the change in the criteria
from Tier II certified or Tier II pending to require validated as Tier
II or Tier III.
    (2) Several comments stated that the January 2009 notice does not
contain sufficient detail to determine how FDA will identify the
ultimate consignee for purposes of this pilot program, and that further
clarification is needed.
    The January 2009 notice specifically defines ``ultimate
consignee,'' for the purposes of the SSCPP, as ``[t]he party in the
United States, at the time of entry or release, to whom the overseas
shipper sold the imported merchandise. If at the time of entry the
imported merchandise has not been sold, then the Ultimate Consignee at
the time of entry or release is defined as the party in the United
States to whom the overseas shipper consigned the imported
merchandise.''
    (3) Several comments stated that clarification is needed regarding
the data that will be required for individual shipments by program
participants, the automated systems that will be used, and the
modifications participants must make to those systems for imported
drugs under the program.
    FDA will be using the current systems for receiving and reviewing
entry information. FDA will assign a unique identifier to each selected
SSCPP application, and the Broker/Customs--Broker/Filer will transmit
the identifier when filing entry for the product, which will enable FDA
to verify the drug product as being part of the SSCPP. Otherwise, the
FDA data requirements to submit a drug import entry will not change.
    (4) Several comments expressed concern that the SSCPP requires the
primary and secondary points of contact to respond directly to all
questions posed by FDA regarding an applicant's status in the SSCPP. In
addition, comments made suggest that FDA identify primary and secondary
points of contact, within the Agency, with whom the applicants can
raise concerns and discuss issues.
    The intent in the SSCPP is to identify appropriate individuals who
can obtain information to respond to Agency questions and requests for
information. Those contacts can obtain assistance within the firm and
then contact the Agency with the response. This will eliminate
contacting multiple people potentially within several firms to obtain a
response. FDA intends to identify primary and secondary points of
contact within the Agency and will publish this information in a
subsequent Federal Register notice.
    (5) Several comments stated that under the Primary and Secondary
contacts requirement on the SSCPP application, the term ``any
concerns'' is too broad and the scope should be limited to
``concerns.'' In addition, the comments suggested that the applicant
provide a corrective action plan ``if needed,'' but that this should
not be a necessary requirement.
    FDA will change ``any concerns'' to ``concerns'' with the
understanding that the Agency will raise concerns related to the SSCPP.
FDA believes a corrective action plan should be kept as a required
element for participation in this program.
    (6) Several comments request that prior notification be given to
applicants when an audit check analysis is performed.
    FDA does not agree with this position. Audits of the SSCPP will not
be announced in advance and will be administered in intervals chosen by
the agency.
    (7) Several comments stated that the Secure Supply Chain (SSC)
Affirmation of Compliance (A of C) code should be submitted in place of
(and not in addition to) the A of C codes currently transmitted during
entry processing.

    There will be one code for products subject to the SSCPP. This will
be an SSC A of C, which will be required at the time of entry and will
identify the drug product as being part of the SSCPP.
    (8) Several comments requested clarification as to whether multiple
dosage forms of a drug covered under a single new drug application
(NDA) are considered one SSCPP application.
    Each individual dosage form will require a separate application for
the SSCPP. One API used in multiple drug products' NDAs would require
the submission of one application.
    (9) Some comments requested clarification regarding the product
entry process when an application, which has been modified to reflect a
change in information, is under review by FDA for continued
participation in the program.
    The firm must notify FDA of the change before its implementation.
If the firm implements the change before FDA authorizes the change, FDA
will revert to the normal drug entry process for the product.
    (10) Several comments requested that the SSCPP criteria for use of
one port of entry be amended to allow for multiple ports of entry
because of changes associated with airline landing requirements.
    At this time, the Agency will not consider amending this
requirement. Any deviations from the applicant's SSC distribution
practices, as identified in the SSCPP application, would cause that
individual shipment to be screened under general import processing
procedure. Included in such deviations are changes to airline landings,
which would require a different port of arrival and entry from that
which is defined in a participant's SSCPP application.
    (11) Several comments suggested that selection for participation in
the pilot program should be based on the Agency's satisfaction that the
importer will not deviate from the details of its application and that
the importer will continue to abide by applicable regulations, and not
based on a regular examination of relevant records. The comments
suggested that there would be no benefit to regular examination but
that examinations of records on a random basis would ensure compliance.
    The Agency believes that the pilot is consistent with the approach
recommended by this comment. As part of this pilot program, the Agency
believes it is important to have the ability to examine records on a
random basis as determined by the Agency.
    (12) Several comments expressed concern with the manner in which
FDA will determine that an applicant should be withdrawn from the
SSCPP. Several comments further suggested that withdrawing an applicant
if they receive a ``Warning Letter citing violations of the act
relating to drug products'' (see the January 2009 notice) is too broad
because the Warning Letter may be unrelated to the products covered by
the SSCPP application or to imports in general. The comments suggested
narrowing the statement and making it specific to Warning Letters
related to the product covered by the application.
    FDA disagrees. The Agency intends to fully evaluate an applicant's
compliance status and associated risk posed by violations relating to
drug products.
    (13) Several comments stated that the SSCPP should be evaluated in
terms of FDA resource conservation, impact on consumer safety, economic
benefit to the trade community, and supply chain facilitation. Some
comments further suggested expanding the program to be account-based
(along the lines of a ``Qualified Trusted Importer Program'') rather
than product-based.
    FDA agrees with this comment with respect to evaluating the
program. Evaluation of the SSCPP will be based on several factors
including, but not limited to, those identified in the comment.
However, we have decided that this voluntary program should be product-
based at this time.
    (14) Several comments requested clarification on the question of
whether an API source is required to be disclosed for applicants
importing finished dosage form drug products in their SSCPP
applications.
    Yes, the SSCPP application (Section E, Details of Your Secure
Supply Chain) requests this information for both applicants importing
finished dosage form drug products and/or APIs.
    (15) Several comments suggested changing the language in Box 15,
Logistics, on the SSCPP application to read, ``U.S. Port(s) of Entry''
and in Box 16, Logistics, to read, ``U.S. Port(s) of Arrival (if
different from Port(s) of Entry).'' In addition, in Box 22, Other
Information, it was suggested that it is important for FDA to recognize
current normal transportation and trade compliance practice, because
some transportation records are kept at a foreign shipping location and
not in the United States.
    FDA disagrees with changing the language to allow for multiple
ports at this time; therefore, the pilot program will be limited to the
one port of entry and one port of arrival (if different) listed in the
application. In addition, the transportation records must be readily
available, regardless of where they are physically located. The Agency
will revise the SSCPP application form to clearly state that
transportation records may be located either in the United States or
outside the country, provided the records are made readily available to
FDA upon request.
    (16) Some comments asked whether the data collected during the
pilot program as described in Section D of the SSCPP application will
be shared with participants and the public, and if so, at what
frequency. In addition, the comments questioned how industry
participants in the program establish themselves as having best
practices for securing a supply chain.
    The Agency recognizes that at this time there is no industry-wide
standard for best practices to secure the drug supply chain. However,
there is a draft Good Importer Practices guidance document that was
issued in January of 2009 that may be of assistance. Although
participation in this pilot program will not establish a firm as having
those best practices, at the end of the SSCPP, FDA intends to make
summary information about the program publicly available. The Agency
does not intend to publicly disclose information submitted in Section D
of the SSCPP application that can be associated with a specific
individual or entity, unless doing so is required by law.
    FDA estimates the burden of this collection of information as
follows:

                                     Table 1--Estimated Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
    Secure Supply Chain Pilot        Number of     responses per       Total        burden per      Total hours
             Program                respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Secure Supply Chain application              100               5             500             3.5           1,750
 form...........................
Modified Secure Supply Chain                   5               1               5               1               5
 application form...............
Information submitted in                       1               1               1               1               1
 response to termination of
 participation..................
                                 -------------------------------------------------------------------------------

    Total.......................  ..............  ..............  ..............  ..............           1,756
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                                       Table 2--Estimated Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Number of                      Average  burden
         Secure Supply Chain Pilot Program             Number of       records per      Total annual         per          Total hours/   Total hours per
                                                     recordkeepers     recordkeeper       records       recordkeeping         week             year
--------------------------------------------------------------------------------------------------------------------------------------------------------
Secure Supply Chain Pilot Program Records.........             100                5              500                1              500           26,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital or operating costs associated with this recordkeeping.

    Dated: June 14, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-14990 Filed 6-19-12; 8:45 am]
BILLING CODE 4160-01-P