[Federal Register Volume 77, Number 171 (Tuesday, September 4, 2012)]
[Notices]
[Pages 53878-53880]
[FR Doc No: 2012-21657]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14447-000]

L.S. Starrett Company; Notice of Application Tendered for Filing
With the Commission and Soliciting Additional Study Requests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Exemption from Licensing.

    b. Project No.: P-14447-000.
    c. Date filed: August 15, 2012.
    d. Applicant: L.S. Starrett Company.
    e. Name of Project: Crescent Street Dam Hydroelectric Project.
    f. Location: On the Millers River, in the Town of Athol, Worcester
County, Massachusetts. The project would not occupy any federal lands.
    g. Filed Pursuant to: Public Utility Regulatory Policies Act of
1978, 16 U.S.C. 2705, 2708.
    h. Applicant Contact: Steve Walsh, L.S. Starrett Company, 121
Crescent Street, Athol, MA 01331;<PHONE_NUMBER> ext. 229.
    i. FERC Contact: Tom Dean,<PHONE_NUMBER> or<EMAIL_ADDRESS>    j. Cooperating agencies: Federal, state, local, and tribal agencies
with jurisdiction and/or special expertise with respect to
environmental issues that wish to cooperate in the preparation of the
environmental document should follow the instructions for filing such
requests described in item l below. Cooperating agencies should note
the Commission's policy that agencies that cooperate in the preparation
of the environmental document cannot also intervene. See, 94 FERC ]
61,076 (2001).
    k. Pursuant to section 4.32(b)(7) of 18 CFR of the Commission's
regulations, if any resource agency, Indian Tribe, or person believes
that an additional scientific study should be conducted in order to
form an adequate factual basis for a complete analysis of the
application on its merit, the resource agency, Indian Tribe, or person
must file a request for a study with the Commission not later than 60
days from the date of filing of the application, and serve a copy of
the request on the applicant.
    l. Deadline for filing additional study requests and requests for
cooperating agency status: October 15, 2012.
    All documents may be filed electronically via the Internet. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site 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_ADDRESS>or toll free at 1-866-208-3676,
or for TTY,<PHONE_NUMBER>. Although the Commission strongly encourages
electronic filing, documents may also be paper-filed. To paper-file,
mail an original and seven copies to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426.
    m. The application is not ready for environmental analysis at this
time.
    n. The existing project consists of: (1) A 28-foot-high, 127-foot-
long concrete and masonry dam with a 98-foot-long spillway topped with
a 3-foot-high bascule gate; (2) a 4.5-acre impoundment with a normal
water surface elevation of 541.3 feet National Geodetic Vertical Datum
of 1929; (3) generation facilities on the right side of the dam that
include: (a) An intake structure equipped with a 7-foot-high, 7-foot-
wide head gate and a 14-foot-high, 17.5-feet-wide trashrack with 1.25-
inch clear bar spacing; (b) a 25-foot-long, 7-foot-diameter penstock;
(c) a 44-foot-long, 28-foot-wide powerhouse containing a 250 kilowatt
(kW) turbine generating unit; (d) a 7-foot-diameter, 47-foot-long
bypass outlet conduit equipped with a 7-foot-high, 7-foot-wide gate;
(e) a 16-foot-wide, 4-foot-deep, 200-foot-long tailrace; and (f) three
180-foot-long, 600 volt transmission lines; (4) generation facilities
on the left side of the dam that include: (a) An 18-foot-long weir
equipped with a 6-foot-high, 6-foot-wide slide gate and a 12-foot-high,
13.5-foot-wide trashrack with \3/4\-inch clear bar spacing; (b) a 55-
foot-long, 6-foot-diameter penstock; (c) a 37-foot-long, 37-foot-wide
powerhouse containing a 198 kW turbine generating unit; (d) and a 14-
foot-wide, 9-foot-deep, 100-foot-long tailrace (e) six 900-foot-long,
600 volt transmission lines; and (f) appurtenant facilities. The
project would have an estimated annual generation of 1,729.2 megawatt-
hours.
    o. 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. A copy is also available for inspection and
reproduction at the address in item h above.
    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, contact FERC
Online Support.
    p. With this notice, we are initiating consultation with the
Massachusetts State Historic Preservation Officer (SHPO), as required
by section 106 of the National Historic Preservation Act and the
regulations of the Advisory Council on Historic Preservation, 36 CFR
800.4.
    q. With this notice, we are designating L.S. Starrett as the
Commission's non-federal representative for carrying out informal
consultation, pursuant to section 7 of the Endangered Species Act and
section 106 of the National Historic Preservation Act.
    r. Procedural schedule: The application will be processed according
to the following preliminary schedule. Revisions to the schedule will
be made as appropriate (e.g., if there are no deficiencies and/or
scoping is waived, the schedule would be shortened).

Issue Deficiency Letter.........................  October 2012.
Issue Notice of Acceptance......................  December 2012.
Issue Scoping Document..........................  January 2013.
Issue Notice ready for environmental analysis...  March 2013.
Issue Notice of the availability of the EA......  July 2013.

    Dated: August 27, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-21657 Filed 8-31-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 227 (Tuesday, November 25, 2014)]
[Notices]
[Pages 70256-70258]
[FR Doc No: 2014-27844]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-73646; File No. SR-BX-2014-056]

Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Clarify
Rule 7018(a) with Respect to Execution and Routing of Orders in
Securities Priced at $1 or More Per Share

November 19, 2014.
    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 November 12, 2014, NASDAQ OMX BX, Inc. (``BX'' or ``Exchange'')
filed with the Securities and Exchange Commission (``SEC'' or
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the Exchange. 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.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to make minor clarifying changes to Rule
7018(a) with respect to execution and routing of orders in securities
priced at $1 or more per share.
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaqomxbx.cchwallstreet.com, at the principal
office of the Exchange, and at the Commission's Public Reference Room.

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 make minor clarifying
changes concerning the use and definition of the term ``Consolidated
Volume'' provided in Rule 7018(a). Consolidated Volume is currently
defined as the total consolidated volume reported to all consolidated
transaction reporting plans by all exchanges and trade reporting
facilities during a month, excluding executed orders with a size of
less than one round lot.\3\ Consolidated Volume is used as a measure in
determining member firm liability for certain charges, and eligibility
for certain credits, for participation in BX. The Exchange compares a
member firm's equity transactions in BX to Consolidated Volume to
determine how impactful its particular order activity in BX is in
relation to overall equity market volume. The definition of
Consolidated Volume is currently provided under the QMM Tier 1
eligibility requirements of Rule 7018(a), although the term is used in
preceding portions of the rule. In an effort to make the rule clearer,
the Exchange is proposing to move the definition of Consolidated Volume
to the beginning of Rule 7018(a). The Exchange is also capitalizing the
term in certain fees and credits, which currently precede the
definition of Consolidated Volume under the rule, to make clear that
they reference the defined term. Lastly, the Exchange is proposing to
delete duplicative language from Rule 7018(a)(2) under the QMM Tier 1
eligibility requirements that concerns the exclusion of the day of the
annual Russell Investments Indexes. The Exchange notes that the
language is included in the definition of Consolidated Volume and is
therefore redundant.
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    \3\ For purposes of calculating Consolidated Volume and the
extent of a member's trading activity, expressed as a percentage of
or ratio to Consolidated Volume, the Exchange excludes the date of
the annual reconstitution of the Russell Investments Indexes from
both total Consolidated Volume and the member's trading activity.
---------------------------------------------------------------------------

    The Exchange is also proposing to clarify the definition of
Consolidated Volume. The current definition of Consolidated Volume does
not expressly state that it encompasses transactions in equity
securities only. As noted above, Consolidated Volume is used to
determine how impactful a member firm's order activity in BX is in
relation to overall equity market volume, thus allowing the Exchange to
consider the member firm's contribution to BX as compared to what
market participants provide to the larger equity markets. The Exchange
believes that adding language to make clear that the Consolidated
Volume includes only equities volume will serve to avoid possible
misinterpretation that the rule may include volume outside of the
equities markets. Accordingly, the Exchange is proposing to add
language to the definition of Consolidated Volume under Rule 7018(a) to
clarify that it applies only to equity securities.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6 of the Act,\4\ in general, and furthers the objectives
of Sections 6(b)(4) and 6(b)(5) of the Act,\5\ in particular, in that
it provides for the equitable allocation of reasonable dues, fees and
other charges among members and issuers and other persons using any
facility or system which the Exchange operates or controls, and is
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, to protect investors and the public interest; and are not
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers. Specifically, the proposed changes further these
objectives because they make the rule more clear, thereby helping avoid
potential investor confusion on how the credits and charges that use
the definition are applied. The Exchange notes that it is not changing
how the rule is applied in any way, and therefore the fees and credits
thereunder continue to be reasonable and equitably allocated among
member firms.
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    \4\ 15 U.S.C. 78f.
    \5\ 15 U.S.C. 78f(b)(4) and (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
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act, as amended.
Specifically, the proposed changes do not alter the meaning or
application of the fees and credits provided under Rule 7018(a), and
therefore do not affect competition in any respect.

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

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A)(ii) of the Act \6\ and Rule
19b-4(f)(6) \7\ thereunder.
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    \6\ 15 U.S.C. 78s(b)(3)(a)(ii).
    \7\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file 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 satisfied this requirement.
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    A proposed rule change filed under Rule 19b-4(f)(6) normally may
not become operative prior to 30 days after the date of filing.
However, Rule 19b-4(f)(6)(iii) \8\ 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 period to allow the
Exchange to immediately implement changes to rule language that will
serve to enhance the clarity concerning the application of fees
assessed and credits provided under the rule. The Commission believes
that the proposed rule change will enhance clarity and avoid possible
misinterpretation of the rule. For these reasons, the Commission
believes that the proposed rule change presents no novel issues and
that waiver of the 30-day operative delay is consistent with the
protection of investors and the public interest. Therefore, the
Commission designates the proposed rule change to be operative upon
filing.\9\
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    \8\ 17 CFR 240.19b-4(f)(6)(iii).
    \9\ For purposes only of waiving the operative delay for this
proposal, the Commission has considered the proposed rule's impact
on efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend 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.\10\
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    \10\ 15 U.S.C. 78s(b)(3)(C).
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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 email to<EMAIL_ADDRESS>Please include
File Number SR-BX-2014-056 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BX-2014-056. This file
number should be included on the subject line if email 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 Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 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-BX-2014-056 and should be
submitted on or before December 16, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-27844 Filed 11-24-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: April 21, 2010 (Volume 75, Number 76)]
[Notices]
[Page 20835]
[DOCID:fr21ap10-53]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings No. 1

April 08, 2010.

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP10-581-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Gulf South Pipeline Company submits Third Revised
Sheet 2502 to FERC Gas Tariff, Sixth Revised Volume 1.
    Filed Date: 04/05/2010.
    Accession Number: 20100405-0225.
    Comment Date: 5 p.m. Eastern Time on Monday, April 19, 2010.

    Docket Numbers: RP10-582-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Algonquin Gas Transmission, LLC submits Fourth Revised
Sheet 87 et al. to FERC Gas Tariff, Fifth Revised Volume 1 to be
effective 5/6/10.
    Filed Date: 04/06/2010.
    Accession Number: 20100406-0210.
    Comment Date: 5 p.m. Eastern Time on Monday, April 19, 2010.

    Docket Numbers: RP10-583-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Natural Gas Pipeline Company of American LLC submits
Third Revised Sheet 35C.03 to the FERC Gas Tariff, Seventh Revised
Volume 1.
    Filed Date: 04/07/2010.
    Accession Number: 20100407-0236.
    Comment Date: 5 p.m. Eastern Time on Monday, April 19, 2010.

    Docket Numbers: RP10-584-000.
    Applicants: Kern River Gas Transmission Company.
    Description: Kern River Gas Transmission Company submits Second
Revised Sheet 495-A et al. of its FERC Gas Tariff, Second Revised
Volume 1.
    Filed Date: 04/07/2010.
    Accession Number: 20100407-0239.
    Comment Date: 5 p.m. Eastern Time on Monday, April 19, 2010.

    Docket Numbers: RP10-585-000.
    Applicants: Maritimes & Northeast Pipeline, LLC.
    Description: Maritimes & Northeast Pipeline, LLC submits First
Revised Sheet 9P et al. of its FERC Gas Tariff, First Volume 1, to be
effective 5/7/2010.
    Filed Date: 04/07/2010.
    Accession Number: 20100407-0245.
    Comment Date: 5 p.m. Eastern Time on Monday, April 19, 2010.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-9131 Filed 4-20-10; 8:45 am]
BILLING CODE 6717-01-P


[ Email thread from Eldert Bontekoe to William Nickerson, OMB, dated 12/ 22/ 2003]

William:

Thanks for your quick review.

I am in the office today and tomorrow. I can be reached at 734 214 4442. I will give you a call later today.

The answers to your questions are below [ in italics]. We will correct all the edits that you suggested.

Eldert William_ Nickerson@ o mb. eop. gov 12/ 22/ 2003 11: 59 AM To: Eldert Bontekoe/ AA/ USEPA/ US@ EPA, Linda Hormes/ AA/ USEPA/ US@ EPA, Lori Stewart/ DC/ USEPA/ US@ EPA cc: Subject: emissions durability NPRM I wasn't sure which of you are in the office today, so I'm copying everyone to cover the bases. So don't worry, I haven't forgotten about you. I did some leisurely weekend reading and I just have a few minor points on the NPRM.

1. On pages 100 and 149 there seems to be an inconsistency on whether the temperature bins are 10 or 25 degrees.

The difference in temperature precision is deliberate. There are two different cycles which are being measured and the accuracy of the data collection should reflect that. On page 100 we are measuring the temperature of the catalyst during driving on the road cycle  the temperature measured will be between 20 C ( or whatever the ambient temperature is) up to about 900 950 C. Because of the wide range of temperatures a 25 C bin is appropriate. On the other hand, the temperatures measured in the discussion on page 149 is the catalyst temperature during the bench cycle. The bench cycle will vary only 90 C ( 800 to 890 at standard conditions), the precise measurement of this temperature is critical, a 25 C bin is too wide for this purpose, consequently we are proposing the 10 C bin discussed in that section.

2. We will fix the following:

page 93, " though" should be " through" page 106, " forth" should be " fourth" page 130, need a close quote on " significant regulatory action" page 133, section D should start a new paragraph 3. On page 118, the title for section IV does not reflect the content that follows We will also fix the headings as follows: Page 118 " IV. What are the economic and environmental impacts?" Page 121 " V. What are the opportunities for public participation?"

4. There is some odd formatting in the appendices for example, the text on page 188 above the SRC graph, and several places with partially or completely blank pages The formatting of the tables and the graphs change with each printer driver that is used. In the final version, we will assure that the graphs appear in the correct spot.

I am working toward concluding review today or tomorrow. Call me with any questions 202 395 7151.


[Federal Register Volume 79, Number 223 (Wednesday, November 19, 2014)]
[Notices]
[Pages 68953-68954]
[FR Doc No: 2014-27409]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

[Docket ID Number DOT-OST-2014-0031]

Agency Information Collection: Activity Under OMB Review: Report
of Financial and Operating Statistics for Large Certificated Air
Carriers

AGENCY: Office of the Assistant Secretary for Research and Technology
(OST-R), Bureau of Transportation Statistics (BTS), DOT.

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, Public
Law 104-13, the Bureau of Transportation Statistics invites the general
public, industry and other governmental parties to comment on the
continuing need for and usefulness of BTS collecting financial data
from large certificated air carriers. Large certificated air carriers
are carriers that operate aircraft with 61 seats or more, aircraft with
18,001 pounds of payload capacity or more, or operate international air
services.

DATES: Written comments should be submitted by January 20, 2015.

FOR FURTHER INFORMATION CONTACT: Jeff Gorham, Office of Airline
Information, RTS-42, Room E34, OST-R, BTS, 1200 New Jersey Avenue SE.,
Washington, DC 20590-0001, Telephone Number<PHONE_NUMBER>, Fax Number
(202) 366-3383 or EMAIL<EMAIL_ADDRESS>    Comments: Comments should identify the associated OMB approval
#2138-0013 and Docket ID Number DOT-OST-2014-0031. Persons wishing the
Department to acknowledge receipt of their comments must submit with
those comments a self-addressed stamped postcard on which the following
statement is made: Comments on OMB #2138-0013, Docket--DOT-OST-2014-
0031. The postcard will be date/time stamped and returned.

ADDRESSES: You may submit comments identified by DOT Docket ID Number
DOT-OST-2014-0031 by any of the following methods:
    Federal eRulemaking Portal: Go to http://www.regulations.gov.
Follow the online instructions for submitting comments.
    Mail: Docket Services: U.S. Department of Transportation, 1200 New
Jersey Avenue SE., West Building Ground Floor, Room W12-140,
Washington, DC 20590-0001.
    Hand Delivery or Courier: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., between 9 a.m. and 5 p.m. ET, Monday
through Friday, except Federal holidays.
    Fax:<PHONE_NUMBER>.
    Instructions: Identify docket number, DOT-OST-2014-0031, at the
beginning of your comments, and send two copies. To receive
confirmation that DOT received your comments, include a self-addressed
stamped postcard. Internet users may access all comments received by
DOT at http://www.regulations.gov. All comments are posted
electronically without charge or edits, including any personal
information provided.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78) or you may visit http://DocketInfo.dot.gov.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov. or the street
address listed above. Follow the online instructions for accessing the
dockets.

Electronic Access

    You may access comments received for this notice at http://www.regulations.gov, by searching docket DOT-OST-2014-0031.

SUPPLEMENTARY INFORMATION:
    OMB Approval No. 2138-0013.
    Title: Report of Financial and Operating Statistics for Large
Certificated Air Carriers.
    Form No.: BTS Form 41.
    Type Of Review: Extension of a currently approved collection.
    Respondents: Large certificated air carriers.
    Number of Respondents: 63.
    Estimated Time per Response: 4 hours per schedule, an average
carrier may submit 90 schedules in one year.
    Total Annual Burden: 22,680 hours.
    Needs and Uses: Program uses for Form 41 data are as follows:

Mail Rates

    The Department of Transportation sets and updates the international
and mainline Alaska mail rates based on carrier aircraft operating
expense, traffic and operational data. Form 41 cost data, especially
fuel costs, terminal expenses, and line haul expenses are used in
arriving at rate levels. DOT revises the established rates based on the
percentage of unit cost changes in the carriers' operations. These
updating procedures have resulted in the carriers receiving rates of
compensation that more closely parallel their costs of providing mail
service and contribute to the carriers' economic well-being.

Submission of U.S. Carrier Data to ICAO

    As a party to the Convention on International Civil Aviation, the
United States is obligated to provide the International Civil Aviation
Organization with financial and statistical data on operations of U.S.
air carriers. Over 99 percent of the data filed with ICAO is extracted
from the carriers' Form 41 reports.

Carrier Fitness

    Fitness determinations are made for both new entrants and
established U.S. domestic carriers proposing a substantial change in
operations. A portion of these applications consists of an operating
plan for the first year (14 CFR Part 204) and an associated projection
of revenues and expenses. The carrier's operating costs, included in
these projections, are compared against the cost data in Form 41 for a
carrier or carriers with the same aircraft type and similar operating
characteristics. Such a review validates the reasonableness of the
carrier's operating plan.
    Form 41 reports, particularly balance sheet reports and cash flow
statements play a major role in the identification of vulnerable
carriers. Data comparisons are made between current and past periods in
order to assess the current financial position of the carrier.
Financial trend lines are extended into the future to analyze the
continued viability of the carrier. DOT reviews three areas of a
carrier's operation: (1) The qualifications of its management team, (2)
its disposition to comply with laws and regulations, and (3) its
financial posture. DOT must determine whether or not a carrier has
sufficient financial resources to conduct its operations without
imposing undue risk on the traveling public. Moreover, once a carrier
is operating, DOT is required to monitor its continuing fitness.
    Senior DOT officials must be kept fully informed as to all current
and developing economic issues affecting the airline industry. In
preparing financial conditions reports or status reports on a
particular airline, financial

and traffic data are analyzed. Briefing papers may use the same
information.
    The Confidential Information Protection and Statistical Efficiency
Act of 2002 (44 U.S.C. 3501 note), requires a statistical agency to
clearly identify information it collects for non-statistical purposes.
BTS hereby notifies the respondents and the public that BTS uses the
information it collects under this OMB approval for non-statistical
purposes including, but not limited to, publication of both
Respondent's identity and its data, submission of the information to
agencies outside BTS for review, analysis and possible use in
regulatory and other administrative matters.

    Issued in Washington, DC, on November 14, 2014.
William Chadwick,
Director, Office of Airline Information, Office of the Assistant
Secretary for Research and Technology.
[FR Doc. 2014-27409 Filed 11-18-14; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register Volume 81, Number 38 (Friday, February 26, 2016)]
[Proposed Rules]
[Pages 9797-9798]
[FR Doc No: 2016-04197]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 98

[EPA-HQ-OAR-2015-0526; FRL-9942-95-OAR]
RIN 2060-AS60

2015 Revisions and Confidentiality Determinations for Data
Elements Under the Greenhouse Gas Reporting Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of proposed rulemaking; extension of public comment
period.

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

SUMMARY: The EPA is announcing an extension of the public comment
period for the proposed rule titled ``2015 Revisions and
Confidentiality Determinations for Data Elements under the Greenhouse
Gas Reporting Rule''. The public comment period for this proposal began
on January 29, 2016. This document announces the extension of the
deadline for public comments from February 29, 2016 to March 30, 2016.

DATES: Comment Due Date: The comment due date of February 29, 2016, for
the proposed rule published on January 15, 2016, at 81 FR 2536, is
extended to March 30, 2016.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2015-0526, to the Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or withdrawn. The
EPA may publish any comment received to its public docket. Do not
submit electronically any information you consider to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Multimedia submissions (audio, video,

etc.) must be accompanied by a written comment. The written comment is
considered the official comment and should include discussion of all
points you wish to make. The EPA will generally not consider comments
or comment contents located outside of the primary submission (i.e. on
the web, cloud, or other file sharing system). For additional
submission methods, the full EPA public comment policy, information
about CBI or multimedia submissions, and general guidance on making
effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Carole Cook, Climate Change Division,
Office of Atmospheric Programs (MC-6207J), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone
number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>For technical information, please go to the
Greenhouse Gas Reporting Program Web site, http://www.epa.gov/ghgreporting/index.html. To submit a question, select Help Center,
followed by ``Contact Us.''

SUPPLEMENTARY INFORMATION:

Worldwide Web (WWW)

    In addition to being available in the docket, an electronic copy of
today's proposal will also be available through the WWW. Following the
Administrator's signature, a copy of this action will be posted on the
EPA's Greenhouse Gas Reporting Rule Web site at http://www.epa.gov/ghgreporting.

Additional Information on Submitting Comments

    To expedite review of your comments by Agency staff, you are
encouraged to send a separate copy of your comments, in adition to the
copy you submit to the official docket, to Carole Cook, U.S. EPA,
Office of Atmospheric Program, Climate Change Division, Mail Code
6207A, Washington, DC 20460, telephone<PHONE_NUMBER>, email address:
<EMAIL_ADDRESS>
Background

    In this action, the EPA is providing notice that it is extending
the comment period on the proposed rule titled ``2015 Revisions and
Confidentiality Determinations for Data Elements under the Greenhouse
Gas Reporting Rule'', which was published on January 15, 2016 (81 FR
2536). The previous deadline for submitting public comment on that rule
was February 29, 2016. The EPA is extending that deadline to March 30,
2016. This extension will provide the general public additional time
for participation and comments.

List of Subjects in 40 CFR Part 98

    Environmental protection, Administrative practice and procedure,
Greenhouse gases, Reporting and recordkeeping requirements.

     Dated: February 22, 2016.
Sarah Dunham,
Director, Office of Atmospheric Programs.
[FR Doc. 2016-04197 Filed 2-25-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 35 (Friday, February 21, 2020)]
[Notices]
[Page 10212]
[FR Doc No: 2020-03453]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2019-0945]

Agency Information Collection Activities: Requests for Comments;
Clearance of a Renewed Approval of Information Collection: Bird/Other
Wildlife Strike Report

AGENCY: Federal Aviation Administration (FAA), DOT

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. The Federal Register Notice with a 60-day comment period
soliciting comments on the following collection of information was
published on November 25, 2019. The collection involves voluntary
reporting of bird/other wildlife strike information following a
wildlife strike incident with aircraft. This data becomes part of the
publicly available National Wildlife Strike Database. Strike reports
provide critical information that allows the FAA to determine high-risk
species, track national trends, evaluate the FAA's wildlife hazard
management program, and provide scientific foundation for regulatory
guidance. Additionally, this essential information allows engine and
airframe manufacturers to evaluate the effectiveness of aircraft
components. It also helps airports identify and mitigate hazardous
species and the location of wildlife attractants, affords a better
understanding of strike dynamics, and provides key metrics for an
airport to evaluate the effectiveness of its wildlife management
program.

DATES: Written comments should be submitted by March 23, 2020.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to the attention of the Desk Officer, Department of
Transportation/FAA, and sent via electronic mail to
<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>, or mailed to
the Office of Information and Regulatory Affairs, Office of Management
and Budget, Docket Library, Room 10102, 725 17th Street NW, Washington,
DC 20503.

FOR FURTHER INFORMATION CONTACT: John Weller by email at:
<EMAIL_ADDRESS>phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.
    OMB Control Number: 2120-0045.
    Title: Bird/Other Wildlife Strike Report.
    Form Numbers: FAA Form 5200-7.
    Type of Review: This review is for a renewal of an information
collection.
    Background: The Federal Register Notice with a 60-day comment
period soliciting comments on the following collection of information
was published on November 25, 2019 (84 FR 64948). 14 CFR 139.337,
Wildlife Hazard Management, requires the FAA to collect wildlife strike
data to develop standards and monitor hazards to aviation. Data
identify wildlife strike control requirements and provide in-service
data on aircraft component failure. Pilots, airport operations staff,
aircraft and airport maintenance personnel, air traffic controllers,
wildlife biologists, and anyone else having knowledge of a strike
report incidents to the FAA, primarily using the web version of FAA
Form 5200-7. The data becomes part of the publicly available National
Wildlife Strike Database used to enhance safety by airports, airlines,
engine and airframe manufacturers, and the FAA. Overall, the number of
strikes annually reported to the FAA has increased from 1,850 in 1990
to more than 16,000 in 2018.
    Respondents: Approximately 16,020 airport operations staff, pilots,
air traffic controllers, wildlife biologists, aircraft and airport
maintenance personnel, and others having knowledge of a strike.
    Frequency: Information is collected as needed.
    Estimated Average Burden per Response: 5 minutes.
    Estimated Total Annual Burden: 1,335 hours.

    Issued in Washington, DC, on February 14, 2020.
John Weller,
National Wildlife Biologist, Airport Safety and Operations Division,
Office of Airports Safety and Standards.
[FR Doc. 2020-03453 Filed 2-20-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 171 (Wednesday, September 6, 2023)]
[Proposed Rules]
[Pages 60904-60907]
[FR Doc No: 2023-18839]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2023-0017; Project Identifier AD-2022-01418-T]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Supplemental notice of proposed rulemaking (SNPRM).

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

SUMMARY: The FAA is revising a notice of proposed rulemaking (NPRM)
that applied to all The Boeing Company Model 757 airplanes. This action
revises the NPRM by adding inspections for airplanes modified to a
cargo configuration. The FAA is proposing this airworthiness directive
(AD) to address the unsafe condition on these products. Since these
actions would impose an additional burden over those in the NPRM, the
FAA is requesting comments on this SNPRM.

DATES: The FAA must receive comments on this SNPRM by October 23, 2023.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to regulations.gov. Follow
the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2023-0017; or in person at Docket Operations between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains the NPRM, this SNPRM, any comments received, and other
information. The street address for Docket Operations is listed above.
    Material Incorporated by Reference:
     For service information identified in this SNPRM, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600;
telephone<PHONE_NUMBER>; website myboeingfleet.com.
     You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available at
regulations.gov by searching for and locating Docket No. FAA-2023-0017.

FOR FURTHER INFORMATION CONTACT: Wayne Ha, Aviation Safety Engineer,
FAA, 3960 Paramount Boulevard, Lakewood, CA 90712; phone:<PHONE_NUMBER>;
email: [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2023-0017; Project Identifier
AD-2022-01418-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may again
revise this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
regulations.gov, including any personal information you provide. The
agency will also post a report summarizing each substantive verbal
contact received about this proposed AD.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this SNPRM contain
commercial or financial information that is customarily treated as
private, that you actually treat as private, and that is relevant or
responsive to this SNPRM, it is important that you clearly designate
the submitted comments as CBI. Please mark each page of your submission
containing CBI as ``PROPIN.'' The FAA will treat such marked
submissions as confidential under the FOIA, and they will not be placed
in the public docket of this SNPRM. Submissions containing CBI should
be sent to Wayne Ha, Aviation Safety Engineer, FAA, 3960 Paramount
Boulevard, Lakewood, CA 90712; phone:<PHONE_NUMBER>; email:
[email protected]. Any commentary that the FAA receives that is not
specifically designated as CBI will be placed in the public docket for
this rulemaking.

Background

    The FAA issued an NPRM to amend 14 CFR part 39 by adding an AD that
would apply to all The Boeing Company Model 757 airplanes. The NPRM
published in the Federal Register on January 26, 2023 (88 FR 4920). The
NPRM was prompted by the potential for cracks to start in hidden areas
underneath the scuff plates in the fuselage skin and bear strap of
certain doors. In the NPRM, the FAA stated that certain maintenance
inspections do not include a step to remove the scuff plates, which
contributes to the inability to find cracks before they become
critical. Cracks underneath the scuff plates in the fuselage skin and
bear strap, if not addressed, could adversely affect the structural
integrity of the airplane.

    In the NPRM, the FAA proposed to require a general visual
inspection or a maintenance records check for repairs in the areas
around the fuselage skin door cutout lower corners of certain doors.
The FAA also proposed applicable on-condition actions including
repetitive low frequency and high frequency eddy current inspections
for cracks in the skin or bear strap in the unrepaired areas, and crack
repair.

Actions Since the NPRM Was Issued

    Based on the comments the FAA received on the NPRM, the FAA is
proposing additional inspections for Model 757-200 series airplanes
that have been modified from a passenger configuration to a cargo
configuration under supplemental type certificate (STC) ST04242AT,
ST03562AT, or ST03952AT. As proposed in the NPRM, for Model 757-200
series airplanes with STC ST04242AT, ST03562AT, or ST03952AT, only the
No. 1, No. 2, and No. 4 passenger entry doors, and the No. 1, No. 2,
and No. 3 cargo doors, would have to be inspected. With this SNPRM, the
FAA is proposing that for those airplanes, the crew entry door and main
deck cargo door, as applicable, would also have to be inspected. This
change is more fully discussed under the Comments section.

Comments

    The FAA received comments from the Air Line Pilots Association,
International, Boeing, and United Airlines, who supported the NPRM
without change.
    The FAA also received comments from Aviation Partners Boeing, VT
Mobile Aerospace Engineering (VT MAE), and Federal Express (FedEx). The
following presents the comments received on the NPRM and the FAA's
response to each comment.

Effect of Winglets on Accomplishment of the Proposed Actions

    Aviation Partners Boeing stated that the installation of blended or
scimitar blended winglets per STC ST01518SE does not affect compliance
with the actions in the proposed AD.
    The FAA agrees with the commenter. The FAA has redesignated
paragraph (c) of the proposed AD (of the NPRM) as paragraph (c)(1) of
this proposed AD (of the SNPRM) and added paragraph (c)(2) to this
proposed AD to state that installation of STC ST01518SE does not affect
the ability to accomplish the actions required by this AD. Therefore,
for airplanes on which STC ST01518SE is installed, a ``change in
product'' alternative method of compliance (AMOC) approval request is
not necessary to comply with the requirements of 14 CFR 39.17.

Request To Change Required Inspections and Compliance Time for
Airplanes Modified per VT MAE STC ST04242AT

    VT MAE requested the FAA change the proposed inspections for
airplanes modified under STC ST04242AT from a passenger configuration
to a 15-pallet cargo configuration. VT MAE stated that under STC
ST04242AT, the No. 1 left hand side (LHS), No. 1 right hand side (RHS),
No. 4 LHS, and No. 4 RHS passenger entry doors have been plugged (re-
skinned). Thus, the commenter requested the FAA not require these
airplanes to be subject to the inspection of the No. 1 LHS, No. 1 RHS,
No. 4 LHS and No. 4 RHS passenger entry doors specified in Boeing Alert
Requirements Bulletin 757-53A0119 RB, dated October 12, 2022. In
addition, the commenter stated that under STC ST04242AT, the crew entry
door and the main deck cargo door surround cutout structure is similar
to that of Boeing Model 757-200 PF airplanes identified as Group 4 in
Boeing Alert Requirements Bulletin 757-53A0119 RB, dated October 12,
2022. As a result, VT MAE requested that these airplanes be required to
do the inspection of the crew entry door and main deck cargo door
(Table 4 and Table 5 of Boeing Alert Requirements Bulletin 757-53A0119
RB, dated October 12, 2022), that is specified for Group 4 airplanes.
    The FAA agrees that Model 757-200 series airplanes modified under
VT MAE STC ST04242AT should be subject to the same inspections as those
required for Model 757-200 PF series airplanes (Group 4 in the service
information), due to the similar design. The FAA has added paragraph
(g)(2) of this proposed AD to require these additional inspections. The
FAA disagrees with the request to omit the inspection of the passenger
doors because the commenter did not submit sufficient data to
substantiate an acceptable level of safety.
    VT MAE also requested the FAA change the proposed compliance time
to start after the airplane is converted from passenger to cargo
configuration for the inspection at the door cutout lower corners of
the crew entry door and the door cutout lower corners of main deck
cargo door. The commenter stated that the cutout structures are newly
installed during the freighter conversion.
    The FAA disagrees with the request to revise the compliance time
because the commenter did not submit sufficient data to substantiate an
acceptable level of safety. However, the FAA will consider requests for
approval of AMOCs and compliance times if sufficient data is submitted
to substantiate the changes would provide an acceptable level of
safety.

Request To Add Inspections and Change Compliance Time for Airplanes
Modified per VT MAE STC ST03562AT or ST03952AT

    FedEx and VT MAE requested the FAA add inspections for airplanes
modified from a passenger configuration to a cargo configuration. VT
MAE stated that under STCs ST03562AT and ST03952AT, the main deck cargo
door surround cutout structure is similar in design to Boeing Model
757-200 airplanes in a special freighter configuration under STC
ST00916WI-D (identified as Group 6 in Boeing Alert Requirements
Bulletin 757-53A0119 RB, dated October 12, 2022). Thus, VT MAE
requested that airplanes modified under STC ST03562AT or ST03952AT be
inspected as specified in Boeing Alert Requirements Bulletin 757-
53A0119 RB, dated October 12, 2022, including the inspection at the
door cutout lower corners of the main deck cargo door specified for
Group 6 in Table 5. FedEx made the same request regarding airplanes
modified under STC ST03562AT.
    The FAA agrees that Model 757-200 airplanes modified under VT MAE
STC ST03562AT or ST03952AT should be subject to the same inspections as
those required for Model 757-200 airplanes modified under STC
ST00916WI-D (Group 6 in the service information), due to the similar
design. The FAA has added paragraph (g)(3) of this proposed AD to
require these additional inspections.
    VT MAE and FedEx also requested the FAA change the proposed
compliance time to start after the airplane is converted from passenger
to cargo configuration for the inspection at the door cutout lower
corners of main deck cargo door. The commenters stated that the cutout
structure surrounding the main deck cargo doors are added during
passenger-to-cargo conversion, rather than when the airplanes are
manufactured.
    The FAA disagrees with the request to revise the compliance time
because the commenters did not submit sufficient data to substantiate
an acceptable level of safety. However, the FAA will consider requests
for approval of alternative compliance times as an AMOC if sufficient
data is submitted to substantiate the change would provide an
acceptable level of safety.

Request To Clarify Exceptions Paragraph

    FedEx requested the FAA clarify paragraph (h)(2) of the proposed AD
and provided suggested language.
    The FAA determined that the language provided by the commenter is
identical to the language in paragraph (h)(2) of the proposed AD.
However, the FAA has revised the language in paragraph (h)(2) of this
proposed AD to clarify which conditions the exception applies to.

FAA's Determination

    The FAA is issuing this SNPRM after determining the unsafe
condition described previously is likely to exist or develop in other
products of the same type design. Certain changes described above
expand the scope of the NPRM. As a result, it is necessary to reopen
the comment period to provide additional opportunity for the public to
comment on this SNPRM.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Boeing Alert Requirements Bulletin 757-53A0119 RB,
dated October 12, 2022. This service information specifies procedures
for either a general visual inspection or a maintenance records check
for repairs in the areas around the fuselage skin door cutout lower
corners of the No. 1, No. 2, and No. 4 passenger entry doors; crew
entry door; No. 1, No. 2, and No. 3 cargo doors; and main deck cargo
door; and applicable on-condition actions, including repetitive low
frequency and high frequency eddy current inspections for cracks in the
skin or bear strap in the unrepaired areas, and crack repair. This
service information is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in ADDRESSES.

Proposed AD Requirements in This SNPRM

    This proposed AD would require accomplishing the actions specified
in the service information already described, except for any
differences identified as exceptions in the regulatory text of this
proposed AD. For information on the procedures and compliance times,
see this service information at regulations.gov by searching for and
locating Docket No. FAA-2023-0017.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 482 airplanes of U.S. registry. The FAA estimates the following
costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
General visual inspection for repairs.  1 work-hour x $85 per                 $0             $85         $40,970
                                         hour = $85.
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary on-
condition actions that would be required based on the results of the
proposed inspection. The agency has no way of determining the number of
airplanes that might need these on-condition actions:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                 Action                           Labor cost            Parts cost         Cost per product
----------------------------------------------------------------------------------------------------------------
Inspections for cracks..................  Up to 27 work-hours x $85               $0  Up to $2,295 per
                                           per hour = Up to $2,295                     inspection cycle.
                                           per inspection cycle.
----------------------------------------------------------------------------------------------------------------

    The extent of cracking found during the on-condition inspection
could vary significantly from airplane to airplane. The FAA has no way
of determining the extent of cracking that may be found on each
airplane, the cost to repair the cracking on each airplane, or the
number of airplanes that may require repair.

Authority for This Rulemaking

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

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

The Boeing Company: Docket No. FAA-2023-0017; Project Identifier AD-
2022-01418-T.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by October 23, 2023.

(b) Affected ADs

    None.

(c) Applicability

    (1) This AD applies to all The Boeing Company Model 757-200, -
200PF, -200CB, and -300 series airplanes, certificated in any
category.
    (2) Installation of Supplemental Type Certificate (STC)
ST01518SE does not affect the ability to accomplish the actions
required by this AD. Therefore, for airplanes on which STC ST01518SE
is installed, a ``change in product'' alternative method of
compliance (AMOC) approval request is not necessary to comply with
the requirements of 14 CFR 39.17.

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Unsafe Condition

    This AD was prompted by the potential for cracks to start in
hidden areas underneath the scuff plates in the fuselage skin and
bear strap of certain doors. The FAA is issuing this AD to address
cracks caused by higher fatigue stresses at the fuselage skin door
cutout lower corners. This unsafe condition, if not addressed, could
adversely affect the structural integrity of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Required Actions

    (1) For all airplanes: Except as specified by paragraph (h) of
this AD, at the applicable times specified in the ``Compliance''
paragraph of Boeing Alert Requirements Bulletin 757-53A0119 RB,
dated October 12, 2022, do all applicable actions identified in, and
in accordance with, the Accomplishment Instructions of Boeing Alert
Requirements Bulletin 757-53A0119 RB, dated October 12, 2022.
    (2) For Model 757-200 series airplanes that have been modified
from a passenger to cargo configuration under VT Mobile Aerospace
Engineering (VT MAE) STC ST04242AT: Except as specified by paragraph
(h) of this AD, at the applicable times specified in Table 4 and
Table 5 of the ``Compliance'' paragraph of Boeing Alert Requirements
Bulletin 757-53A0119 RB, dated October 12, 2022, do all applicable
actions for Group 4 identified in, and in accordance with, Table 4
and Table 5 of the Accomplishment Instructions of Boeing Alert
Requirements Bulletin 757-53A0119 RB, dated October 12, 2022.
    (3) For Model 757-200 series airplanes that have been modified
from a passenger to cargo configuration under VT MAE STC ST03562AT
or ST03952AT: Except as specified by paragraph (h) of this AD, at
the applicable times specified in Table 5 of the ``Compliance''
paragraph of Boeing Alert Requirements Bulletin 757-53A0119 RB,
dated October 12, 2022, do all applicable actions for Group 6
identified in, and in accordance with, Table 5 of the Accomplishment
Instructions of Boeing Alert Requirements Bulletin 757-53A0119 RB,
dated October 12, 2022.
    Note 1 to paragraph (g): Guidance for accomplishing the actions
required by this AD can be found in Boeing Alert Service Bulletin
757-53A0119, dated October 12, 2022, which is referred to in Boeing
Alert Requirements Bulletin 757-53A0119 RB, dated October 12, 2022.

(h) Exceptions to Service Information Specifications

    (1) Where the Compliance Time columns of the tables in the
``Compliance'' paragraph of Boeing Alert Requirements Bulletin 757-
53A0119 RB, dated October 12, 2022, use the phrase ``the original
issue date of Requirements Bulletin 757-53A0119 RB,'' this AD
requires using ``the effective date of this AD.''
    (2) Where Boeing Alert Requirements Bulletin 757-53A0119RB,
dated October 12, 2022, specifies performing a general visual
inspection (GVI) or a maintenance records check for any existing
repair, if only a maintenance records check is accomplished with no
GVI, then any initial high frequency eddy current (HFEC) or low
frequency eddy current (LFEC) inspection with a compliance time of
before further flight must be done prior to the accumulation of
30,000 total flight cycles, or within 3,000 flight cycles after the
effective date of this AD, whichever occurs later.
    (3) Where Boeing Alert Requirements Bulletin 757-53A0119 RB,
dated October 12, 2022, specifies contacting Boeing for repair
instructions or for alternative inspections: This AD requires doing
the repair, or doing the alternative inspections and applicable on-
condition actions, before further flight using a method approved in
accordance with the procedures specified in paragraph (i) of this
AD.

(i) AMOCs

    (1) The Manager, AIR-520, Continued Operational Safety Branch,
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or
responsible Flight Standards Office, as appropriate. If sending
information directly to the manager of the Continued Operational
Safety Branch, send it to the attention of the person identified in
paragraph (j) of this AD. Information may be emailed to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the responsible Flight Standards Office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by The Boeing Company Organization Designation
Authorization (ODA) that has been authorized by the Manager, AIR-
520, Continued Operational Safety Branch, to make those findings. To
be approved, the repair method, modification deviation, or
alteration deviation must meet the certification basis of the
airplane, and the approval must specifically refer to this AD.

(j) Related Information

    (1) For more information about this AD, contact Wayne Ha,
Aviation Safety Engineer, FAA, 3960 Paramount Boulevard, Lakewood,
CA 90712; phone:<PHONE_NUMBER>; email: [email protected].
    (2) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (k)(3) and (4) of this AD.

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Boeing Alert Requirements Bulletin 757-53A0119 RB, dated
October 12, 2022.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-
5600; telephone<PHONE_NUMBER>; website myboeingfleet.com.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on August 23, 2023.
Victor Wicklund,
Deputy Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-18839 Filed 9-5-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 182 (Thursday, September 21, 2023)]
[Notices]
[Pages 65174-65177]
[FR Doc No: 2023-20452]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-3742]

Scientific Challenges and Opportunities To Advance the
Development of Individualized Cellular and Gene Therapies; Request for
Information

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for information and comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency), Center for
Biologics Evaluation and Research (CBER) is requesting information from
stakeholders regarding critical scientific

challenges and opportunities to advance the development of
individualized cellular and gene therapies (CGTs). FDA intends to
gather information and comments submitted in response to this request
for information (RFI) to inform potential planning of future town
halls, workshops, or discussion papers which could ultimately
facilitate the development of additional regulatory science tools,
standards, or guidance.

DATES: Either electronic or written comments on the notice must be
submitted by November 20, 2023.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 20, 2023. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received 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-3742 for ``Scientific Challenges and Opportunities To
Advance the Development of Individualized Cellular and Gene
Therapies.'' 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: Karen Fikes, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    Personalized medicine has often been described as the use of
individual characteristics, such as genetic markers or other measurable
traits, to guide disease prevention or treatment among existing
products (Ref. 1). An improved understanding of the molecular basis of
disease along with the availability of sensitive diagnostic tools has
led to the increasing opportunity to create individualized products
based upon such genetic markers or measurable traits. These
individualized therapies can now be developed for a single patient (or
a very small number of patients) based on designing or engineering a
product that specifically targets the mechanism underlying a patient's
(or small number of patients') illness (Ref. 2). The opportunities and
challenges associated with individualized therapies span the entire
development pathway; from robust and consistent manufacturing with
assurance of product quality, to nonclinical models and tools to
characterize safety and activity, to the generation, collection, and
assessment of clinical evidence from an individual patient (or a very
small number of patients) (Refs. 3 and 4). For the purposes of this
RFI, these types of products will be referred to as individualized
CGTs. Examples of these emerging areas of research include:
     Products designed for the same indication with the same
mode of action. For instance, a personalized vaccine for pancreatic
cancer that consists of autologous dendritic cells pulsed with patient-
specific neoantigen peptides (Ref. 5).
     Products designed for different indications with different
modes of action. For instance, two gene therapy vector products for
separate rare genetic neurological diseases, where both products
utilize the same vector backbone but contain different transgene
inserts.
    This RFI is specifically seeking input on the scientific challenges
and opportunities for individualized CGTs. The outcomes of this RFI are
meant to complement other ongoing and planned CBER town halls,
workshops, and discussion papers designed to educate and seek feedback
on a broad range of considerations for the development of

CGTs (Ref. 6). The purpose of this RFI is limited to planning purposes
only and should not be construed as a policy, a solicitation for
applications, or an obligation on the part of the government to provide
support for any ideas identified in response to it.

II. Request for Information and Comments

    FDA is requesting information regarding major scientific challenges
and opportunities to advance the development of individualized CGTs,
with a specific focus on the areas outlined below, including
manufacturing (e.g., product quality), nonclinical development (e.g.,
toxicology, proof of concept, biodistribution), clinical development
(e.g., assessing safety and efficacy), and additional questions to
consider (e.g., additional scientific needs, best practices,
opportunities for collaborations).

A. Manufacturing

    All CGTs, including individualized CGTs, need to be manufactured
with sufficient quality, purity, and potency to ensure that each batch
of the product has adequate safety and full potential to achieve the
intended therapeutic outcome. In the case of CGTs for rare diseases,
where a single batch of product may be sufficient to treat a small
number of patients diagnosed with the rare disease, it can be
challenging to develop a consistent manufacturing process and robust
control strategy for future batches of the product for additional
patients diagnosed with the same rare disease.
    Additionally, the manufacturing of some individualized CGTs may
need to be tailored to each patient, leading to high variability among
each batch of the individualized product. For example, autologous CAR-T
cell products are derived from a patient's own cells, and variability
in this starting material leads to variability in the drug product. It
can be challenging to understand and control the impact of this
variability on the safety and efficacy of the product. As additional
examples, a tumor neoantigen vaccine may be based on the genetic
sequence of the individual patient's tumor, and some genome editing
products may be customized to treat the individual patient's genetic
mutation. The tailored manufacturing processes needed for these types
of products can be difficult to standardize and can also result in
significant variability among batches.
     Given the challenges to develop consistent manufacturing
strategies for CGTs designed for a very small number of patients or an
individual patient, how can manufacturers leverage their prior
experience manufacturing one CGT to support subsequent development and
approval of another related, but distinct CGT (potential areas for
leveraging may include manufacturing process validation, control
strategy, assay validation, and drug product stability studies)?
     When the batch size of a CGT is very small, what are some
challenges and solutions regarding the volume of product (or number of
vials) needed for batch release testing, stability testing, retention
of reserve samples, and comparability studies?
     What are some challenges and solutions for individualized
CGTs that need to be tested and released rapidly, either because the
product has a very short shelf life or because the patient's clinical
status may be rapidly declining and treatment is urgently needed?
     For many individualized CGT products, each batch is
tailored to an individual patient (e.g., autologous CAR-T cells, tumor
neoantigen vaccines, certain genome editing products). For such
products, what are some challenges and solutions for assuring that each
batch has adequate potency to achieve the intended therapeutic effect?
     What are some challenges and solutions for individualized
genome editing products that aim to treat monogenic diseases for which
the target gene has different mutations in different patients?

B. Nonclinical Development

    There are several challenges in translating nonclinical data to
humans for individualized CGTs. Because the final investigational
product is unique to an individual or a small number of subjects, it
often is not possible to evaluate the final clinical product in
nonclinical studies. Additionally, many individualized CGTs target
antigens that are human-specific and thus lack relevant animal models
to inform safety and activity. An example includes T-Cell receptor-
engineered T cells that target a patient-specific neoantigen, or a
shared target in the context of an HLA allele specific to a small group
of human subjects. There are also opportunities and challenges to
utilizing prior knowledge from nonclinical studies of other approved or
investigational individualized CGTs that may be leveraged for a related
product under development for different populations or indications. An
example includes two or more gene therapy vector products for different
rare genetic diseases that utilize the same vector backbone while
containing different transgene inserts.
    With continued scientific advances in the CGT field, it is also
important to consider the use of computational approaches to support
nonclinical evaluation of individualized CGTs. Computational approaches
may present an opportunity to quickly and efficiently screen product
safety or activity, but may pose additional challenges in their
consistent use and validation.
     What nonclinical studies could be leveraged in support of
a related product using similar technologies? What nonclinical studies
are important to conduct with each final clinical product?
     What nonclinical development approaches could be
considered when there are no relevant animal models or animal models
are unable to replicate each individual disease/condition?
     For patient-specific products where evaluating each
individual product is infeasible or impractical, what is the role for
nonclinical studies conducted with representative product(s)?
     What are the opportunities and challenges with using
computational approaches to support nonclinical development?

C. Clinical Development

    Assessing efficacy can be a particular challenge in clinical
studies of individualized CGTs, particularly for rare diseases with
heterogeneous presentations. Randomized controlled designs are desired
for interpretability of results, but may be unfeasible or unethical for
various reasons in rare disease clinical trials. However, natural
history data may be limited and/or lack suitability to support outcome
assessments. Additional specific challenges in individuals or small
groups include development and interpretation of novel endpoints,
limitations in statistical analyses to understand treatment effects,
and determining appropriate study design and duration to assess
clinically meaningful benefit. An example may be a newly identified
specific genetic mutation associated with a unique phenotypic
presentation of disease, where only a few individuals with the specific
mutation have been identified, and the natural history of disease is
poorly understood. Adaptive, Bayesian, and other trial designs may
provide different opportunities or challenges, and the approach will
likely need to be considered on a case-by-case basis.
    Understanding clinical safety of individualized CGTs may also be
difficult and may depend on relevant

available data for similar products or other treatments for the
disorder or similar disorders.
     What are challenges and strategies/opportunities with
interpreting efficacy data from individual patients (including expanded
access) and small groups of patients? What opportunities are there in
leveraging prior and/or collective experiences?
     What strategies can be utilized to accumulate and
interpret safety data in personalized/individualized CGTs?
     For genetic disorders with clear genotype-phenotype
associations for disease manifestations or severity, what opportunities
are there for tailoring treatments and study design to specific
genotypes/phenotypes?

D. Additional Questions To Consider

     What additional major scientific challenges to advance the
development of individualized CGTs should be considered?
     What existing best practices or scientific approaches
should be leveraged to address any of these challenges? Are there
specific opportunities for collaborations to advance the development of
individualized CGTs?
     Are there specific areas where flexibility in regulatory
approaches would improve the feasibility of developing and
commercializing individualized CGTs?

III. References

    The following references are on display in the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.

1. President's Council of Advisors on Science and Technology,
``Priorities for Personalized Medicine,'' September 2008.
2. FDA, ``Focus Area: Individualized Therapeutics and Precision
Medicine,'' 2022. Available at https://www.fda.gov/science-research/focus-areas-regulatory-science-report/focus-area-individualized-therapeutics-and-precision-medicine.
3. Marks, P. and C. Witten, ``Toward a New Framework for the
Development of Individualized Therapies,'' Gene Therapy, 28:615-617,
2021.
4. FDA, ``Facilitating End-to-End Development of Individualized
Therapeutics'' (Public Workshop) (March 3, 2020). Available at
https://fda.yorkcast.com/webcast/Catalog/Mobile/FolderPresentation/6d6af3ca61754c3c869f7f556bbede9e21/4174764f-a52d-4503-893d-0b8bc35e1da7/b9c6ac08f3d040eba768ef43befb498f1d/.
5. Fritah, H., R. Rovelli, C.L. Chiang, and C.L. Kandalaft, ``The
Current Clinical Landscape of Personalized Cancer Vaccines,'' Cancer
Treatment Reviews, 106:102383, 2022.
6. FDA, ``OTP Events, Meetings, and Workshop,'' (2023). Available at
https://www.fda.gov/news-events/otp-events-meetings-and-workshops.

    Dated: September 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20452 Filed 9-20-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 108 (Monday, June 6, 2022)]
[Notices]
[Page 34321]
[FR Doc No: 2022-12022]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-536, OMB Control No. 3235-0596]

Submission for OMB Review; Comment Request; Extension: Rule 204A-
1

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (the ``Commission'') has submitted to the Office of
Management and Budget a request for extension of the previously
approved collection of information discussed below.
    The title for the collection of information is ``Rule 204A-1 (17
CFR 275.204A-1) under the Investment Advisers Act of 1940.'' (15 U.S.C.
80b-1 et seq.) Rule 204A-1 (the ``Code of Ethics Rule'') requires
investment advisers registered with the SEC to (i) set forth standards
of conduct expected of advisory personnel (including compliance with
the federal securities laws); (ii) safeguard material nonpublic
information about client transactions; and (iii) require the adviser's
``access persons'' to report their personal securities transactions,
including transactions in any mutual fund managed by the adviser. The
Code of Ethics Rule requires access persons to obtain the adviser's
approval before investing in an initial public offering (``IPO'') or
private placement. The Code of Ethics Rule also requires prompt
reporting, to the adviser's chief compliance officer or another person
designated in the code of ethics, of any violations of the code.
Finally, the Code of Ethics Rule requires the adviser to provide each
supervised person with a copy of the code of ethics and any amendments,
and require the supervised persons to acknowledge, in writing, their
receipt of these copies. The purposes of the information collection
requirements are to (i) ensure that advisers maintain codes of ethics
applicable to their supervised persons; (ii) provide advisers with
information about the personal securities transactions of their access
persons for purposes of monitoring such transactions; (iii) provide
advisory clients with information with which to evaluate advisers'
codes of ethics; and (iv) assist the Commission's examination staff in
assessing the adequacy of advisers' codes of ethics and assessing
personal trading activity by advisers' supervised persons.
    The respondents to this information collection are investment
advisers registered with the Commission. The Commission has estimated
that compliance with rule 204A-1 imposes a burden of approximately 87
hours per adviser annually based on an average adviser having 60 access
persons. Our latest data indicate that there were 14,705 advisers
registered with the Commission. Based on this figure, the Commission
estimates a total annual burden of 1,275,659 hours for this collection
of information.
    Rule 204A-1 does not require recordkeeping or record retention. The
collection of information requirements under the rule is mandatory. The
information collected pursuant to the rule is not filed with the
Commission, but rather takes the form of communications between
advisers and their supervised persons. Investment advisers use the
information collected to control and assess the personal trading
activities of their supervised persons. Responses to the reporting
requirements will be kept confidential to the extent each investment
adviser provides confidentiality under its particular practices and
procedures. An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid control number.
    The public may view background documentation for this information
collection at the following website: www.reginfo.gov. Find this
particular information collection by selecting ``Currently under 30-day
Review--Open for Public Comments'' or by using the search function.
Written comments and recommendations for the proposed information
collection should be sent within 30 days of publication of this notice
by July 6, 2022 to (i) [email protected] and
(ii) David Bottom, Director/Chief Information Officer, Securities and
Exchange Commission, c/o John Pezzullo, 100 F Street NE, Washington, DC
20549, or by sending an email to: [email protected].

    Dated: May 31, 2022.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-12022 Filed 6-3-22; 8:45 am]
BILLING CODE 8011-01-P