[Federal Register Volume 77, Number 145 (Friday, July 27, 2012)]
[Proposed Rules]
[Pages 44204-44205]
[FR Doc No: 2012-18099]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2012-0272; FRL-9702-5]

Approval and Promulgation of Air Quality Implementation Plans;
Maryland; Control of Iron and Steel Production Installations; Sintering
Plants

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA proposes to approve revisions to the Maryland State
Implementation Plan (SIP) submitted by the Maryland Department of the
Environment (MDE) on June 30, 2009. The revisions amend the visible
emissions requirements of the Maryland SIP's regulation for the Control
of Iron and Steel Production Installations as they apply to sintering
plants. The sintering plant located at the Sparrows Point steelmaking
facility (Sparrows Point) is the only sintering plant located in the
State of Maryland, and therefore the only source affected by these SIP
revisions. The revisions exempt the sintering plant from the visible
emissions section of the regulation for the Control of Iron and Steel
Production Installations contingent upon the source's two wet
scrubbers, used to control emissions of particulate matter,
continuously monitoring compliance with specified pressure drop and
flow rate operating parameters. EPA is approving these revisions
because they provide for a continuous means of determining compliance
with the applicable SIP emission rate for particulate matter from the
sintering plant located at Sparrows Point, and because that emission
rate has been demonstrated to protect and maintain the National Ambient
Air Quality Standards (NAAQS) for PM10 (particulate matter
consisting of particles with an aerodynamic diameter less than or equal
to 10 micrometers). EPA is proposing to approve these revisions in
accordance with the requirements of the Clean Air Act (CAA). In the
Final Rules section of this Federal Register, EPA is approving the
State's SIP submittal as a direct final rule without prior proposal
because the Agency views this as a noncontroversial submittal and
anticipates no adverse comments. A detailed rationale for the approval
is set forth in the direct final rule. If no adverse comments are
received in response to this action, no further activity is
contemplated. If EPA receives adverse comments, the direct final rule
will be withdrawn and all public comments received will be addressed in
a subsequent final rule based on this proposed rule. EPA will not
institute a second comment period. Any parties interested in commenting
on this action should do so at this time.

DATES: Comments must be received in writing by August 27, 2012.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2012-0272 by one of the following methods:
    A. www.regulations.gov. Follow the on-line instructions for
submitting comments.
    B. Email<EMAIL_ADDRESS>    C. Mail: EPA-R03-OAR-2012-0272, Marcia L. Spink, Associate Director
for Policy & Science, Air Protection Division, U.S. Environmental
Protection Agency, Region III, 1650 Arch Street, Philadelphia,
Pennsylvania 19103.
    D. Hand Delivery: At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R03-OAR-
2012-0272. EPA's policy is that all comments received will be included
in the public docket without change, and may be made available online
at www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or email. The
www.regulations.gov Web site is an ``anonymous access'' system, which
means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through www.regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
Internet. If you submit an electronic

comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses.
    Docket: All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in www.regulations.gov or
in hard copy during normal business hours at the Air Protection
Division, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103. Copies of the State submittal
are available at the Maryland Department of the Environment, 1800
Washington Boulevard, Suite 705, Baltimore, Maryland 21230.

FOR FURTHER INFORMATION CONTACT: Marcia L. Spink, Associate Director
for Policy & Science, Air Protection Division<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: For further information, please see the
information provided in the direct final action, with the same title,
that is located in the ``Rules and Regulations'' section of this
Federal Register publication.

    Dated: July 10, 2012.
W.C. Early
Acting Regional Administrator, Region III.
[FR Doc. 2012-18099 Filed 7-26-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 134 (Friday, July 14, 2023)]
[Notices]
[Pages 45222-45223]
[FR Doc No: 2023-14917]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-2436]

Manufacturing Changes and Comparability for Human Cellular and
Gene Therapy Products; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft document entitled ``Manufacturing Changes
and Comparability for Human Cellular and Gene Therapy Products; Draft
Guidance for Industry.'' The management of manufacturing changes
presents many challenges for human cellular therapy or gene therapy
(CGT) products due to the complexity of these products. The draft
guidance provides sponsors of Investigational New Drug Applications
(INDs) and applicants of Biologics License Applications (BLAs) for CGT
products, with recommendations regarding product comparability and the
management of manufacturing changes for investigational and licensed
CGT products. The purpose of this draft guidance is to provide FDA's
current thinking on management and reporting of manufacturing changes
for CGT products based on a life-cycle approach, and comparability
studies to assess the effect of manufacturing changes on product
quality.

DATES: Submit either electronic or written comments on the draft
guidance by September 12, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-D-2436 for ``Manufacturing Changes and Comparability for Human
Cellular and Gene Therapy Products; Draft Guidance for Industry.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Office of Communication, Outreach and Development, Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist the office in
processing your requests. The draft guidance may also be obtained by
mail by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.

FOR FURTHER INFORMATION CONTACT: Phillip Kurs, 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

    FDA is announcing the availability of a draft document entitled
``Manufacturing Changes and Comparability for Human Cellular and Gene
Therapy Products; Draft Guidance for Industry.'' The management of
manufacturing changes presents many challenges for human CGT products
due to the complexity of these products. The draft guidance provides
sponsors of INDs and applicants who intend to submit or currently hold
BLAs for CGT products, with recommendations on product comparability
and the management of manufacturing changes for investigational and
licensed CGT products, considering the unique challenges that apply to
these products.

While existing guidances provide general principles and recommendations
regarding comparability studies and management of manufacturing changes
for biological products, they generally do not address specific CGT
product challenges. The purpose of this draft guidance is to provide
FDA's current thinking on: (1) management and reporting of
manufacturing changes for CGT products based on a life-cycle approach
and (2) comparability studies to assess the effect of manufacturing
changes on CGT product quality.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on
``Manufacturing Changes and Comparability for Human Cellular and Gene
Therapy Products.'' It does not establish any rights for any person and
is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 211 have been approved under OMB control
number 0910-0139; the collections of information in 21 CFR part 312
have been approved under OMB control number 0910-0014; and the
collections of information in 21 CFR 601.2 and 601.12 have been
approved under OMB control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or
https://www.regulations.gov.

    Dated: July 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-14917 Filed 7-13-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 34 (Friday, February 18, 2022)]
[Notices]
[Pages 9399-9403]
[FR Doc No: 2022-03495]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-94237; File No. SR-CboeEDGX-2022-005]

Self-Regulatory Organizations; Cboe EDGX Exchange, Inc.; Notice
of Filing and Immediate Effectiveness of a Proposed Rule Change To
Amend Its Fee Schedule

February 14, 2022.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on February 1, 2022, Cboe EDGX Exchange, Inc. (the ``Exchange'' or
``EDGX'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been 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

    Cboe EDGX Exchange, Inc. (the ``Exchange'' or ``EDGX'' or ``EDGX
Equities'') proposes to amend its Fee Schedule. The text of the
proposed rule change is provided in Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (http://markets.cboe.com/us/options/regulation/rule_filings/edgx/), at the Exchange's Office of the Secretary, 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 Exchange proposes to amend its Fee Schedule applicable to its
equities trading platform (``EDGX Equities'') as follows: (1) Adopt new
fee code ZO which will be applicable to retail orders that add
liquidity in the pre and post market; (2) update Remove Volume Tier 2,
the Retail Volume Tiers, and Retail Membership Program Volume Tiers to
add references to proposed fee code ZO; (3) modify the rebate
applicable to Add/Remove Volume Tiers 1 and 2; (4) modify the criteria
of Growth Tier 4; and (5) modify the criteria of the Remove Volume Tier
1. The Exchange proposes to implement these changes effective February
1, 2022.
    The Exchange first notes that it operates in a highly competitive
market in which market participants can readily direct order flow to
competing venues if they deem fee levels at a particular venue to be
excessive or incentives to be insufficient. More specifically, the
Exchange is only one of 16 registered equities exchanges, as well as a
number of alternative trading systems and other off-exchange venues
that do not have similar self-regulatory responsibilities under the
Exchange Act, to which market participants may direct their order flow.
Based on publicly available information,\3\ no single registered
equities exchange has more than 17% of the market share. Thus, in such
a low-concentrated and highly competitive market, no single equities
exchange possesses significant pricing power in the execution of order
flow. The Exchange in particular operates a ``Maker-Taker'' model
whereby it pays rebates to members that add liquidity and assesses fees
to those that remove liquidity. The Exchange's Fee Schedule sets forth
the standard rebates and rates applied per share for orders that
provide and remove liquidity, respectively. Currently, for orders in
securities priced at or above $1.00, the Exchange provides a standard
rebate of $0.00160 per share for orders that add liquidity and assesses
a fee of $0.0030 per share for orders that remove liquidity. For orders
in securities priced below $1.00, the Exchange provides a standard
rebate

of $0.00009 per share for orders that add liquidity and assesses a fee
of 0.30% of total dollar value for orders that remove liquidity.
Additionally, in response to the competitive environment, the Exchange
also offers tiered pricing which provides Members opportunities to
qualify for higher rebates or reduced fees where certain volume
criteria and thresholds are met. Tiered pricing provides an incremental
incentive for Members to strive for higher tier levels, which provides
increasingly higher benefits or discounts for satisfying increasingly
more stringent criteria.
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    \3\ See Cboe Global Markets, U.S. Equities Market Volume
Summary, Month-to-Date (January 24, 2022), available at https://markets.cboe.com/us/equities/market_statistics/.
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Proposed New Fee Code
    The Exchange proposes to adopt a new fee code in the Fee Code and
Associated Fees table of the Fee Schedule. Currently, all retail orders
that add liquidity yield fee code ``ZA'' and receive a rebate of
$0.0032 per share in securities priced at or above $1.00 and a rebate
of $0.00003 per share in securities priced below $1.00. The Exchange
now proposes to adopt fee code ``ZO'', which will be appended to retail
orders that add liquidity, but in the pre and post market. The Exchange
proposes to continue to assess the same fees and rebates as are
currently assessed today for retail orders that add liquidity (i.e.,
orders yielding fee code ZO would receive a rebate of $0.0032 per share
in securities priced at or above $1.00 and a rebate of $0.00003 per
share in securities priced below $1.00). The Exchange also proposes to
apply incentive tiers and programs that currently apply to orders
yielding ZA to orders that will now yield ZO and therefore append
footnotes 2 and 3 to ZO in the Fee Code and Associated Fees table.
Particularly, the Exchange proposes to modify the description and
criteria of the Retail Volume Tiers (provided under footnote 2 of the
Fee Schedule) and Retail Equities Membership Program Volume Tiers
(provided under footnote 3 of the Fee Schedule), so that orders
yielding both fee codes ZA and ZO are eligible for the respective tiers
and the Retail Order ADV criteria under each tier includes orders
yielding ZO in addition to ZA. Similarly, the Exchange proposes to
amend the second prong of Remove Volume Tier 2 to provide the Retail
Order ADV criteria will also include orders yielding ZO in addition to
ZA. Accordingly, retail orders that add liquidity in the pre or post
market will continue to be eligible for the same incentive programs
(and continue to be counted towards Retail Order ADV thresholds) as
they are today, albeit under a separate fee code (i.e., ZO instead of
ZA).
Modifications to Add/Remove Volume Tiers
    The Add Volume Tiers set forth in footnote 1 of the Fee Schedule
(Add/Remove Volume Tiers) provides Members an opportunity for
qualifying orders (i.e., orders yielding fee code B,\4\ V,\5\ Y,\6\ 3
\7\ or 4 \8\) to receive an enhanced rebate on their orders on orders
that add liquidity and meet certain volume criteria. Specifically, Add
Volume Tier 1 provides a rebate of $0.0023 per share to Members that
add an ADV \9\ greater than or equal to 0.20% of the TCV.\10\
Similarly, Add Volume Tier 2 provides a rebate of $0.0025 per share to
Members that add an ADV greater than or equal to 0.30% of the TCV. The
Exchange notes that the Add Volume Tiers are designed to encourage
Members that provide liquidity adding orders to the Exchange to
increase their order flow, which would benefit all Members by providing
greater execution opportunities on the Exchange.
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    \4\ Orders yielding Fee Code ``B'' are orders adding liquidity
to EDGX (Tape B).
    \5\ Orders yielding Fee Code ``V'' are orders adding liquidity
to EDGX (Tape A).
    \6\ Orders yielding Fee Code ``Y'' are orders adding liquidity
to EDGX (Tape C).
    \7\ Orders yielding Fee Code ``3'' are orders adding liquidity
to EDGX in the pre and post market (Tapes A or C).
    \8\ Orders yielding Fee Code ``4'' are orders adding liquidity
to EDGX in the pre and post market (Tape B).
    \9\ ``ADAV'' means average daily added volume calculated as the
number of shares added per day and ``ADV'' means average daily
volume calculated as the number of shares added to, removed from, or
routed by, the Exchange, or any combination or subset thereof, per
day. ADAV and ADV is calculated on a monthly basis
    \10\ ``TCV'' means total consolidated volume calculated as the
volume reported by all exchanges and trade reporting facilities to a
consolidated transaction reporting plan for the month for which the
fees apply.
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    Now the Exchange proposes to reduce the rebates provided under Add
Volume Tiers 1 and 2 to $0.0020 per share and $0.0023 per share,
respectively. While the Exchange is proposing no change to the criteria
of the Add Volume Tiers 1 and 2, the Exchange believes that the tier
will continue to incentivize increased order flow to the Exchange,
which may contribute to a deeper, more liquid market to the benefit of
all market participants by creating a more robust and well-balanced
market ecosystem. The Add Volume Tiers 1 and 2, as modified, continue
to be available to all Members and provide Members an opportunity to
receive an enhanced rebate, albeit a reduced rebate. The proposed
rebates are in line with similar rebates for liquidity adding programs
in place on other exchanges.\11\
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    \11\ E.g., the BZX Equities Add Volume Tiers provide rebates
ranging from $0.0020 per share up to $0.0031 per share. See BZX
Equities Fee Schedule, footnote 1.
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    The Growth Volume Tiers are also set forth under footnote 1 of the
Fee Schedule (Add/Remove Volume Tiers) and are designed to encourage
growth in order flow by providing specific criteria in which Members
must increase their relative liquidity each month over a predetermined
baseline. Growth Tier 4, for example, provides an opportunity for
qualifying orders (i.e., orders yielding fee code B, V, Y, 3 or 4) to
receive an enhanced rebate of $0.0034 per share to Members that (1) add
a Step-Up ADAV \12\ from October 2021 greater than or equal to 0.10% of
the TCV or Members that add a Step-Up ADAV from October 2021 equal to
or greater than 10 million shares; and (2) Members that have a total
remove ADV equal to or greater than 0.60% of TCV or Members that have a
total remove ADV greater than or equal to 60 million shares. The
Exchange now proposes to amend the criteria of Growth Tier 4 to provide
the rebate to (1) an MPID that adds a Step-Up ADAV from October 2021
equal to or greater than 10% of the TCV or an MPID adds a Step-Up ADAV
from October 2021 equal to or greater than 15 million shares (instead
of 10 million shares); and (2) an MPID that adds an ADV equal to or
greater than 0.30% of TCV or an MPID that adds an ADV equal to or
greater than 30 million shares (instead of 60 million shares).
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    \12\ ``Step-Up ADAV'' means ADAV in the relevant baseline month
subtracted from current ADAV.
---------------------------------------------------------------------------

    Lastly, the Remove Volume Tiers are also set forth under footnote 1
of the Fee Schedule (Add/Remove Volume Tiers) and provide Members an
opportunity for qualifying orders (i.e., orders yielding fee codes
BB,\13\ N \14\ and W \15\) to receive a reduced fee on their orders
that remove liquidity and meet certain volume criteria. Specifically,
the Remove Volume Tier 1 provides a reduced fee of $0.00275 in
securities at or above $1.00 and 0.28% of the total dollar value in
securities priced below $1.00 to (1) Members that add a Step-Up ADAV
from June 2021 equal to or greater than 0.10% of the TCV or Members
that add a Step-Up ADAV from June 2021 equal to or greater than 8
million shares; and (2) Members that have a total remove ADV equal to
or greater than 0.60% of the TCV. Now the Exchange proposes to modify
the criteria to adopt an alternative criteria to satisfy prong two.
Specifically, the

Exchange proposes to provide the reduced rebate to (1) Members that add
a Step-Up ADAV from June 2021 equal to or greater than 0.10% of the TCV
or Members that add a Step-Up ADAV from June 2021 equal to or greater
than 8 million shares; and (2) Members that have a total remove ADV
equal to or greater than 0.60% of the TCV, or, Members that have a
total remove ADV equal to or greater than 60 million shares. The
Exchange proposes no change to the current reduced fee applicable to
the Remove Volume Tier 1.
---------------------------------------------------------------------------

    \13\ Orders yielding Fee Code ``BB'' are orders removing
liquidity to EDGX (Tape (B)).
    \14\ Orders yielding Fee Code ``N'' are orders removing
liquidity to EDGX (Tape (C)).
    \15\ Orders yielding Fee Code ``W'' are orders removing
liquidity to EDGX (Tape (A)).
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2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the objectives of Section 6 of the Securities and Exchange Act of
1933 (the ``Act''),\16\ in general, and furthers the objectives of
Section 6(b)(4),\17\ in particular, as it is designed to provide for
the equitable allocation of reasonable dues, fees and other charges
among its Members and issuers and other persons using its facilities.
The Exchange also believes that the proposed rule change is consistent
with the objectives of Section 6(b)(5) \18\ requirements that the rules
of an exchange be 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, particularly, is not designed to permit unfair discrimination
between customers, issuers, brokers, or dealers. As described above,
the Exchange operates in a highly competitive market in which market
participants can readily direct order flow to competing venues if they
deem fee levels at a particular venue to be excessive or incentives to
be insufficient. The proposed rule changes reflect a competitive
pricing structure designed to incentivize market participants to direct
their order flow to the Exchange, which the Exchange believes would
enhance market quality to the benefit of all Members.
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    \16\ 15 U.S.C. 78f.
    \17\ 15 U.S.C. 78f(b)(4).
    \18\ 15 U.S.C. 78f.(b)(5).
---------------------------------------------------------------------------

    Regarding the proposed new fee code ZO appended to retail orders
adding liquidity in the pre and post market, the Exchange notes that
the competition for retail order flow is particularly intense,
especially as it relates to exchange versus off-exchange venues, as
prominent retail brokerages tend to route a majority of their limit
orders to off-exchange venues.\19\ Accordingly, competitive forces
compel the Exchange to use exchange transaction fees and credits,
particularly as they relate to competing for retail order flow, because
market participants can readily trade on competing venues if they deem
pricing levels at those other venues to be more favorable.
---------------------------------------------------------------------------

    \19\ See Securities Exchange Release No. 86375 (July 15, 2019),
84 FR 34960 (SRCboeEDGX-2019-045).
---------------------------------------------------------------------------

    The Exchange believes that its proposed change to adopt fee code ZO
is reasonable, equitable and not unfairly discriminatory. First, the
Exchange notes that the proposed standard rebates under fee code ZO are
the same as those currently applied to such orders under fee code ZA,
which fee code as discussed currently also applies to retail orders
that add liquidity, albeit during regular market hours. Further, the
proposed standard rebates are consistent with, and competitive with,
rebates for retail order flow on other equities exchanges, which
provide pricing incentives to retail orders in the form of lower fees
and/or higher rebates.\20\ Second, while the proposed rebates apply
only to retail orders, the Exchange does not believe this application
is discriminatory as the Exchange offers similar rebates or reduced
fees to non-retail order flow. The Exchange notes that, like all other
fee codes, ZO and the accompanying rebates will be automatically and
uniformly applied to all Members' qualifying orders as applicable. The
Exchange also believes it's reasonable, equitable and not unfairly
discriminatory to apply volume incentive tiers that currently apply to
orders yielding ZA to ZO and to clarify that Retail Order ADV will
include orders yielding either ZA or ZO as such changes apply to all
members and such tiers already apply to all retail orders that add
liquidity, including those that execute in the pre or post market
(i.e., there will be no substantive impact to orders yielding ZO with
respect to their inclusion in these programs).
---------------------------------------------------------------------------

    \20\ See e.g., BZX Equities Fee Schedule, Fee Code ZA, which
provides a rebate of $0.0032 per share to retail orders adding
liquidity.
---------------------------------------------------------------------------

    The Exchange believes its proposal to reduce the rebates applicable
to Add Volume Tiers 1 and 2 is reasonable because each tier continues
to be available to all Members and provides Members an opportunity to
receive an enhanced rebate, albeit a reduced enhanced rebate.
Similarly, the Exchange believes its proposal to amend the criteria of
the Growth Tier 4 is reasonable because the tier will be available to
all MPIDs and provides MPIDs an opportunity to receive an enhanced
rebate. The Exchange also believes its proposal to amend the criteria
of the Remove Volume Tier 1 is reasonable because it will provide an
additional opportunity for Members to reach the tier, will continue to
be available to all Members, and will provide Members an opportunity to
receive a reduced fee.
    The Exchange notes that relative volume-based incentives and
discounts have been widely adopted by exchanges, including the
Exchange, and are reasonable, equitable, and non-discriminatory because
they are open to all Members on an equal basis and provide additional
discounts that are reasonably related to (i) the value to an exchange's
market quality and (ii) associated with higher levels of market
activity, such as higher levels of liquidity provision and/or growth
patterns. The Exchange also believes that the proposed and existing
rebates and fees, as applicable, under Add Volume Tiers 1 and 2, Growth
Tier 4, and Remove Volume Tier 1 continue to be commensurate with the
existing and proposed criteria. That is, the rebates reasonably reflect
the difficulty in achieving the corresponding criteria as amended.
    The Exchange believes that the changes to the Add Volume Tiers 1
and 2, Growth Tier 4, and Remove Volume Tier 1, will benefit all market
participants by incentivizing continuous liquidity and, thus, deeper
more liquid markets as well as increased execution opportunities.
Particularly, the proposal is designed to incentivize liquidity, which
further contributes to a deeper, more liquid market and provide even
more execution opportunities for active market participants at improved
prices. This overall increase in activity deepens the Exchange's
liquidity pool, offers additional cost savings, supports the quality of
price discovery, promotes market transparency and improves market
quality, for all investors.
    The Exchange also believes that the proposed amendments to the Add
Volume Tiers 1 and 2, Growth Tier 4, and Remove Volume Tier 1 represent
an equitable allocation of rebates and are not unfairly discriminatory
because all Members or MPIDs are eligible for the tiers and would have
the opportunity to meet the tiers' criteria and would receive the
proposed rebate if such criteria is met. Without having a view of
activity on other markets and off-exchange venues, the Exchange has no

way of knowing whether this proposed rule change would definitely
result in any Members or MPIDs qualifying for the proposed tiers. While
the Exchange has no way of predicting with certainty how the proposed
tier will impact Member activity, the Exchange anticipates that at
least one MPID will be able to compete for and reach the proposed
criteria in Growth Tier 4 and Remove Volume Tier 1. The Exchange also
notes that proposed tiers will not adversely impact any Member's
ability to qualify for other reduced fee or enhanced rebate tiers.
Should a Member not meet the proposed criteria under any of the
proposed tiers, the Member will merely not receive that corresponding
enhanced rebate or reduced fee.
    As noted above, the Exchange operates in a highly competitive
market. The Exchange is only one of 16 equity venues to which market
participants may direct their order flow, and it represents a small
percentage of the overall market. It is also only one of several maker-
taker exchanges. Competing equity exchanges offer similar rates and
tiered pricing structures to that of the Exchange, including schedules
of rebates and fees that apply based upon members achieving certain
volume thresholds.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule changes will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. Rather, as discussed above, the
Exchange believes that the proposed changes would encourage the
submission of additional order flow to a public exchange, thereby
promoting market depth, execution incentives and enhanced execution
opportunities, as well as price discovery and transparency for all
Members. As a result, the Exchange believes that the proposed changes
further the Commission's goal in adopting Regulation NMS of fostering
competition among orders, which promotes ``more efficient pricing of
individual stocks for all types of orders, large and small.''
    The Exchange believes the proposed rule changes do not impose any
burden on intramarket competition that is not necessary or appropriate
in furtherance of the purposes of the Act. Particularly, the proposed
tier changes will apply to Members or MPIDs equally in that all Members
or MPIDs are eligible for each of the tiers, have a reasonable
opportunity to meet the tiers' criteria and will receive the enhanced
rebate or reduced fee on their qualifying orders if such criteria is
met. Further, the proposed Fee Code will similarly be available to all
Members equally. The Exchange does not believe the proposed changes
burdens competition, but rather, enhances competition as it is intended
to increase the competitiveness of EDGX by amending an existing pricing
incentive and adopting a pricing incentive in order to attract order
flow and incentivize participants to increase their participation on
the Exchange, providing for additional execution opportunities for
market participants and improved price transparency. Greater overall
order flow, trading opportunities, and pricing transparency benefits
all market participants on the Exchange by enhancing market quality and
continuing to encourage Members to send orders, thereby contributing
towards a robust and well-balanced market ecosystem.
    Next, the Exchange believes the proposed rule change does not
impose any burden on intermarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act. As previously
discussed, the Exchange operates in a highly competitive market.
Members have numerous alternative venues that they may participate on
and direct their order flow, including other equities exchanges, off-
exchange venues, and alternative trading systems. Additionally, the
Exchange represents a small percentage of the overall market. Based on
publicly available information, no single equities exchange has more
than 17% of the market share.\21\ Therefore, no exchange possesses
significant pricing power in the execution of order flow. Indeed,
participants can readily choose to send their orders to other exchange
and off-exchange venues if they deem fee levels at those other venues
to be more favorable. Moreover, the Commission has repeatedly expressed
its preference for competition over regulatory intervention in
determining prices, products, and services in the securities markets.
Specifically, in Regulation NMS, the Commission highlighted the
importance of market forces in determining prices and SRO revenues and,
also, recognized that current regulation of the market system ``has
been remarkably successful in promoting market competition in its
broader forms that are most important to investors and listed
companies.'' \22\ The fact that this market is competitive has also
long been recognized by the courts. In NetCoalition v. Securities and
Exchange Commission, the D.C. Circuit stated as follows: ``[n]o one
disputes that competition for order flow is `fierce.' . . . As the SEC
explained, `[i]n the U.S. national market system, buyers and sellers of
securities, and the broker-dealers that act as their order-routing
agents, have a wide range of choices of where to route orders for
execution'; [and] `no exchange can afford to take its market share
percentages for granted' because `no exchange possesses a monopoly,
regulatory or otherwise, in the execution of order flow from broker
dealers'. . . .''.\23\ Accordingly, the Exchange does not believe its
proposed fee change imposes any burden on competition that is not
necessary or appropriate in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \21\ Supra note 3.
    \22\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496, 37499 (June 29, 2005).
    \23\ NetCoalition v. SEC, 615 F.3d 525, 539 (D.C. Cir. 2010)
(quoting Securities Exchange Act Release No. 59039 (December 2,
2008), 73 FR 74770, 74782-83 (December 9, 2008) (SR-NYSEArca-2006-
21)).
---------------------------------------------------------------------------

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

    The Exchange neither solicited nor received comments on the
proposed rule change.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \24\ and paragraph (f) of Rule 19b-4 \25\
thereunder. 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. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.
---------------------------------------------------------------------------

    \24\ 15 U.S.C. 78s(b)(3)(A).
    \25\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

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 protected]. Please include
File Number SR-CboeEDGX-2022-005 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CboeEDGX-2022-005. 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 website (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 website 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. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-CboeEDGX-2022-005 and should be
submitted on or before March 11, 2022.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\26\
---------------------------------------------------------------------------

    \26\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-03495 Filed 2-17-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 142 (Wednesday, July 26, 2017)]
[Proposed Rules]
[Pages 34620-34622]
[FR Doc No: 2017-15707]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Chapter I

46 CFR Chapters I and III

49 CFR Chapter IV

[Docket No. USCG-2017-0662]

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

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

ACTION: Announcement of new task assignment for the Navigation Safety
Advisory Council (NAVSAC); teleconference meeting.

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

SUMMARY: The U.S. Coast Guard is issuing a new task to the Navigation
Safety Advisory Council (NAVSAC). The U.S. Coast Guard is asking NAVSAC
to help the agency identify existing regulations, guidance, and
collections of information (that fall within the scope of the Council's
charter) for possible repeal, replacement, or modification. This
tasking is in response to the issuance of Executive Orders 13771,
``Reducing Regulation and Controlling Regulatory Costs; 13777,
``Enforcing the Regulatory Reform Agenda;'' and 13783, ``Promoting
Energy Independence and Economic Growth.'' The full Council is
scheduled to meet by teleconference on August 16, 2017, to discuss this
tasking. This teleconference will be open to the public. The U.S. Coast
Guard will consider NAVSAC recommendations as part of the process of
identifying regulations, guidance, and collections of information to be
repealed, replaced, or modified pursuant to the three Executive Orders
discussed above.

DATES: The full Council is scheduled to meet by teleconference on
August 16, 2017, from 1 p.m. to 3 p.m. EDT. Please note that this
teleconference may adjourn early if the Council has completed its
business.

ADDRESSES: To join the teleconference or to request special
accommodations, contact the individual listed in the FOR FURTHER
INFORMATION CONTACT section no later than 1 p.m. on August 9, 2017. The
number of teleconference lines is limited and will be available on a
first-come, first-served basis.
    Instructions: Submit comments on the task statement at any time,
including orally at the teleconference, but if you want Council members
to review your

comments before the teleconference, please submit your comments no
later than August 9, 2017. You must include the words ``Department of
Homeland Security'' and the docket number for this action. Written
comments may also be submitted using the Federal e-Rulemaking Portal at
http://www.regulations.gov. If you encounter technical difficulties
with comment submission, contact the individual listed in the FOR
FURTHER INFORMATION CONTACT section of this notice. Comments received
will be posted without alteration at http://www.regulations.gov,
including any personal information provided. You may review
Regulations.gov's Privacy and Security Notice at https://www.regulations.gov/privacyNotice.
    Docket Search: For access to the docket or to read documents or
comments related to this notice, go to http://www.regulations.gov,
insert ``USCG-2017-0662'' in the Search box, press Enter, and then
click on the item you wish to view.

FOR FURTHER INFORMATION CONTACT: Mr. George Detweiler, Alternate
Designated Federal Officer of the Navigation Safety Advisory Council,
telephone<PHONE_NUMBER>, or email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

New Task to the Council

    The U.S. Coast Guard is issuing a new task to NAVSAC to provide
recommendations on whether existing regulations, guidance, and
information collections (that fall within the scope of the Council's
charter) should be repealed, replaced, or modified. NAVSAC will then
provide advice and recommendations on the assigned task and submit a
final recommendation report to the U.S. Coast Guard.

Background

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

The Task

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

Public Participation

    All meetings associated with this tasking, both full Council
meetings and subcommittee/working groups, are open to the public. A
public oral comment period will be held during the August

16, 2017, teleconference. Public comments or questions will be taken at
the discretion of the Designated Federal Officer; commenters are
requested to limit their comments to 3 minutes. Please contact the
individual listed in the FOR FURTHER INFORMATION CONTACT section, to
register as a commenter. Subcommittee meetings held in association with
this tasking will be announced as they are scheduled through notices
posted to http://homeport.uscg.mil/navsac and uploaded as supporting
documents in the electronic docket for this action, [USCG-2017-0662],
at Regulations.gov.

Michael D. Emerson,
Director, Marine Transportation Systems.
[FR Doc. 2017-15707 Filed 7-25-17; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: July 29, 2008 (Volume 73, Number 146)]
[Notices]
[Page 43937-43940]
[DOCID:fr29jy08-61]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0389]

Food and Drug Administration Amendments Act of 2007; Prohibition
Against Food to Which Drugs or Biological Products Have Been Added;
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is requesting comments
relevant to the implementation of section 912 of the Food and Drug
Administration Amendments Act of 2007 (FDAAA). Section 912 of FDAAA
establishes section 301(ll) in the Federal Food, Drug, and Cosmetic Act
(the act), which prohibits the interstate shipment of certain foods to
which an approved drug or a licensed biological product has been added.
Section 301(ll) also prohibits the interstate shipment of foods
containing an added drug or a biological product that has been the
subject of substantial clinical investigations, the existence of which
has been made public. FDA requests that interested persons submit data,
information, and comments that will help provide a context for the
agency's decisions on implementation of this provision. To encourage
responsive comments, FDA is including a series of questions for
interested persons to consider in preparing comments.

DATES: Submit written or electronic comments by October 27, 2008.

ADDRESSES: Submit written comments, data, and other information to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Catherine L. Copp, Center for Food
Safety and Applied Nutrition (HFS-4), Food and Drug Administration,
301-436-1589, e-mail: catherine.copp@ fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    On September 27, 2007, the Food and Drug Administration Amendments
Act of 2007 (Public Law 110-85) (FDAAA) was enacted. Section 912 of
FDAAA establishes section 301(ll) in the Federal Food, Drug, and
Cosmetic Act (the act), 21 U.S.C. 331(ll), which adds the following
prohibited act to section 301.21 U.S.C. 331:
    The introduction or delivery for introduction into interstate
commerce of any food to which has been added a drug approved under
section 505, a biological product licensed under section 351 of the
Public Health Service Act, or a drug or a biological product for which
substantial clinical investigations have been instituted and for which
the existence of such investigations has been made public, unless--
    (1) such drug or such biological product was marketed infood
before any approval of the drug under section 505, beforelicensure
of the biological product under such section 351, andbefore any
substantial clinical

investigations involving thedrug or the biological product have been
instituted;(2) the Secretary, in the Secretary's discretion,
hasissued a regulation, after notice and comment, approving the
useof such drug or such biological product in the food;(3) the use
of the drug or the biological product in thefood is to enhance the
safety of the food to which the drug orthe biological product is
added or applied and not to haveindependent biological or
therapeutic effects on humans, and theuse is in conformity with--
    (A) a regulation issued under section 409prescribing conditions
of safe use in food;(B) a regulation listing or affirming
conditionsunder which the use of the drug or the biologicalproduct
in food is generally recognized as safe;(C) the conditions of use
identified in anotification to the Secretary of a claim of
exemptionfrom the premarket approval requirements for foodadditives
based on the notifier's determination that theuse of the drug or the
biological product in food isgenerally recognized as safe, provided
that theSecretary has not questioned the general recognition
ofsafety determination in a letter to the notifier;(D) a food
contact substance notification that iseffective under section
409(h); or(E) such drug or biological product had beenmarketed for
smoking cessation prior to the date of theenactment of the Food and
Drug Administration AmendmentsAct of 2007; or
    (4) the drug is a new animal drug whose use is not unsafeunder
section 512.
    Section 301(ll) makes it a prohibited act to ship in interstate
commerce certain foods to which an approved drug or a licensed
biological product has been added. Section 301(ll) also prohibits the
interstate shipment of certain foods containing an added drug or a
biological product that has been the subject of substantial clinical
investigations, the existence of which has been made public. Under the
act, persons who commit a prohibited act may be enjoined, 21 U.S.C.
332, or prosecuted criminally, 21 U.S.C. 333. In addition, a food which
may not, under the provisions of section 301(ll), be introduced or
delivered for introduction into interstate commerce, is subject to
seizure and forfeiture, 21 U.S.C. 334, and under 21 U.S.C. 381, a food
offered for import into the United States that appears to be prohibited
from introduction or delivery for introduction into interstate commerce
under section 301(ll) is subject to refusal of admission.
    The language of section 301(ll) has a number of parallels to, as
well as significant differences from, the language of a similar
provision in section 201(ff)(3)(B) (21 U.S.C. 321(ff)(3)(B)), which is
part of the act's definition of ``dietary supplement.'' Although there
is legislative history of FDAAA, including a report from the House
committee with jurisdiction (H. Rep. No. 225, 110th Cong., 2d Sess.
(2007)), section 301(ll) is not addressed in that legislative history.
    The Secretary of Health and Human Services has delegated to the
Commissioner of Food and Drugs the principal responsibility for
administering the act. As the administering agency, it is FDA's
responsibility generally to implement amendments to the act, including
the amendments made by section 912 of FDAAA.
    Section 301(ll) presents a number of questions of statutory
interpretation for FDA to consider. The scope of the agency's
discretion to interpret section 301(ll) is defined by the Supreme
Court's decision in Chevron U.S.A., Inc. v. Natural Resources Defense
Council, Inc., 467 U.S. 837 (1984). Under Chevron, if the language of a
statute makes Congressional intent on a particular question clear and
unambiguous, the agency charged with administering the statute must
give effect to that intent. Chevron, 467 U.S. at 842-43. If the statute
is silent or ambiguous on the question, however, the agency is
permitted to give the statute a reasonable construction, Chevron, 467
U.S. at 844-845, and that construction is entitled to deference.
Chevron, 467 U.S. at 844.

II. Questions Presented

    FDA believes that a fuller understanding of the impact of various
interpretations of section 301(ll) would be beneficial as the agency
considers how to implement this new provision. Accordingly, FDA is
requesting that interested persons submit data, information, and other
comments regarding possible approaches to implementation. To guide
those submissions and responses, the agency has prepared the following
questions. FDA suggests that, in preparing responses to this request
for comments, interested persons consider the following:

A. Food

    Section 301(ll) prohibits the introduction or delivery for
introduction into interstate commerce of certain ``food.'' Under
section 201(f), ``food'' means articles used for food or drink for man
or other animals, chewing gum, and articles used for components of such
articles. Food includes human food, including infant formula, medical
foods, and dietary supplements; food contact substances, including food
packaging; and animal feed, including pet food and feed ingredients.
Consistent with the broad definition of ``food'' in section 201(f), FDA
seeks information about the impact of section 301(ll) on food in all
its forms, including food ingredients, categories of food, and finished
food products.
    1. What types or categories of food would likely be subject to the
prohibition of section 301(ll)? What types or categories are likely to
be unaffected by section 301(ll)? If possible, please provide specific
examples of these foods.
    2. What is the likely impact of applying section 301(ll) to infant
formula? Are there substances used or potentially used in infant
formula that would be prohibited from such use by section 301(ll)?
    3. What is the likely impact of applying section 301(ll) to dietary
supplements? Are there substances used or potentially used in or as
dietary supplements that would be prohibited from such use by section
301(ll)? What would be the advantages and disadvantages of applying
both section 301(ll) and section 201(ff)(3)(B) to dietary supplements?
Would such an approach lead to more effective regulation or less
effective regulation of these products, and why?
    4. What is the likely impact of applying section 301(ll) to animal
feed? Are there substances used or potentially used in animal feed,
including pet food and feed ingredients, that would be prohibited from
such use by section 301(ll)?
    5. What is the likely impact of interpreting ``food'' in section
301(ll) to include food contact substances, including packaging
components that meet the definition of a food additive? Are there
substances used or potentially used in food packaging or other food
contact substances that would be prohibited from such use by section
301(ll)?

B. Previously Marketed Foods Now Barred from Interstate Commerce

    Section 301(ll) identifies a category of foods that can no longer
be introduced or delivered for introduction into interstate commerce
although these foods were allowed in interstate commerce before the
enactment of FDAAA. Specifically, if a food contains a substance that
is an approved drug, that is a licensed biological product, or that has
been the subject of substantial clinical investigations that have been
made public, and if the substance was added to the food to have an
independent biological or therapeutic effect on the person consuming
it, rather than to enhance the safety of the food, the food is now
barred from interstate commerce if any substantial clinical
investigations of the substance were instituted, or the drug was
approved or

the biologic was licensed, prior to the first marketing of the
substance in food. FDA seeks information on foods in this category that
were legally marketed prior to the enactment of FDAAA but that are now
barred from interstate commerce.
    1. How many and what types of foods would be affected? What would
be the impact on businesses that produce and sell these foods?
    2. What would be the impact on consumers who currently use the
products?
    3. If possible, please provide specific examples of affected foods.

C. Drug

    Section 301(ll) prohibits the introduction or delivery for
introduction into interstate commerce of food to which has been added a
``drug approved under section 505.''
    Implementing section 301(ll)'s restrictions on adding approved
drugs to food will require FDA to consider how the identity of a
``drug'' is to be determined for purposes of section 301(ll).
    1. What would be the impact of deeming two substances to be
identical if they are chemically identical?
    2. Are there approved drugs that cannot be identified by their
chemical structure? If so, what would be a scientifically accurate and
technically feasible way for FDA to determine the identity of the
``drug approved under section 505'' or ``drug * * * for which
substantial clinical investigations have been instituted'' and consider
whether that drug was marketed in food before the drug's approval by
FDA or before the initiation of the substantial clinical
investigations? Which drugs or classes of drugs cannot be identified by
their chemical structure?

D. Biological Product

    Section 301(ll) prohibits the introduction or delivery for
introduction into interstate commerce of food to which has been added a
``biological product licensed under section 351 of the Public Health
Service Act.'' Under section 351(i) of the Public Health Service Act
(PHS Act) (42 U.S.C. 262(i)), a ``biological product'' means ``a virus,
therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or
derivative, allergenic product, or analogous product, or arsphenamine
or derivative of arsphenamine (or any other trivalent organic arsenic
compound), applicable to the prevention, treatment, or cure of a
disease or condition of human beings.''
     What are the special concerns, if any, related to
determining whether a biological product that is added to food has
previously been licensed under section 351 of the PHS Act?

E. Clinical Investigations

    Section 301(ll) prohibits the introduction or delivery for
introduction into interstate commerce of food to which has been added a
``drug'' or a ``biological product'' for which ``substantial clinical
investigations have been instituted'' and for which ``the existence of
such investigations has been made public,'' unless the drug or the
biological product was ``marketed in food * * * before any substantial
clinical investigations involving the drug or the biological product
have been instituted.''
    1. What is the likely impact of interpreting ``clinical
investigations'' to refer exclusively to studies in humans?
    2. What is the likely impact of interpreting the existence of
substantial clinical investigations of a substance in humans to prevent
the addition of such substance to animal feed, including pet food and
feed ingredients?
    3. What factors should FDA consider in deciding whether clinical
investigations of a substance are ``substantial?''
    4. What factors should FDA consider in determining whether
substantial clinical investigations ``involv[ed] the drug or the
biological product?''
    5. Could this provision operate as a disincentive to conduct
clinical studies of substances intended for use in products to be
marketed as conventional foods or dietary supplements? If so, is there
an approach to implementation that could minimize or eliminate this
disincentive?
    6. To the extent that this provision discourages clinical
investigations of substances added to food and the public disclosure of
such investigations, what is the likely impact of this provision on so-
called self-determinations of the general recognition of safety (GRAS)
of substances added to food?

F. Marketed

    Under section 301(ll)(1), a food containing an approved drug or a
licensed biological product may be shipped in interstate commerce if
the drug or the biological product was ``marketed in food'' prior to
the approval of the drug, the licensing of the biological product, or
the initiation of substantial clinical investigations of the drug or
biological product. Section 201(ff) contains a similar provision.
Section 201(ff) uses the phrase ``marketed as a dietary supplement or
as a food,'' however, while section 301(ll) uses the phrase ``marketed
in food.'' In the context of section 201(ff), FDA has evaluated whether
a substance has been ``marketed'' within the meaning of that provision
by considering: (1) Whether the substance itself has been sold or
offered for sale, either as a finished product or as an ingredient; (2)
for substances that are not sold separately but are components present
in a marketed product, whether the component itself was marketed to
prospective purchasers through, e.g., labeling or advertising for the
product that made claims about the component or otherwise highlighted
its presence. See Pharmanex v. Shalala, 2001 WL 741419, at *4 & n.5 (D.
Utah March 30, 2001).
    1. What would be the likely impact of interpreting the term
``marketed'' the same way in section 301(ll) as in section 201(ff)?
What could be the regulatory significance, if any, of the differing
phrases ``marketed in food'' (section 301(ll)) and ``marketed as a
dietary supplement or as a food'' (section 201(ff))?
    2. What could be the significance, if any, of the marketing in food
of an approved drug or a licensed biological product outside the United
States?
    3. What factors should be considered the indicia of being
``marketed in food?'' What types of evidence should FDA consider in
deciding whether a substance has been ``marketed in food?''

G. Enhance The Safety of The Food Supply

    Section 301(ll)(3) provides an exception to the prohibition of
adding a drug or biological product to a food if use of the drug or
biological product is ``to enhance the safety of the food * * * and not
to have independent biological or therapeutic effects on humans.''
    1. What factors should FDA consider in determining whether the use
of a substance in food is to ``enhance the safety of the food'' within
the meaning of section 301(ll)?
    2. What would be the likely impact of each of the following
possible interpretations of what kinds of uses ``enhance the safety of
the food?''
     The addition of a substance to a food enhances the safety
of the food only if such addition reduces a risk not inherent in the
food itself, such as the risk of microbial or other contamination.
     The addition of a substance to a food enhances the safety
of the food if such addition reduces either a risk inherent to the food
itself, such as inherent toxicity or a risk that derives from the
nutritional content of the food (e.g., high saturated fat content), or
a risk not inherent in the food itself, such as the risk of microbial
or other contamination.

H. Independent biological or therapeutic effects on humans

    As noted, section 301(ll)(3) provides an exception to the
prohibition of adding a drug or biological product to a food if use of
the drug or biological product is ``to enhance the safety of the food *
* * and not to have independent biological or therapeutic effects on
humans.''
    1. What factors should FDA consider in determining whether the use
of a substance in food is to have a ``biological'' effect on humans?
    2. What factors should FDA consider in determining whether the use
of a substance in food is to have a biological effect on humans that is
``independent?''
    3. What factors should FDA consider in determining whether the use
of a substance in food is to have a ``therapeutic'' effect on humans?
    4. What factors should FDA consider in determining whether the use
of a substance in food is to have a therapeutic impact on humans that
is ``independent?''

I. In the Secretary's Discretion

    Section 301(ll)(2) permits the addition of a drug or biological
product to a food ``if the Secretary, in the Secretary's discretion,
has issued a regulation after notice and comment, approving the use * *
* in food.'' As noted, the Secretary has delegated his authority under
the act to the Commissioner of Food and Drugs.
    1. What factors should the Commissioner consider in exercising his
discretion under section 301(ll)(2)?
    2. What should be the impact, if any, on the exercise of the
Commissioner's discretion where use of the drug or biological product
in food has been the subject of another statutory or administrative
process (e.g., a food contact substance notification that is effective
under section 409(h))?

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

    Dated: July 22, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-17356 Filed 7-28-08; 8:45 am]

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[Federal Register Volume 77, Number 75 (Wednesday, April 18, 2012)]
[Proposed Rules]
[Pages 23166-23169]
[FR Doc No: 2012-9267]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0413; Directorate Identifier 2011-NM-257-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
The Boeing Company Model DC-10-10, DC-10-10F, DC-10-15, DC-10-30, DC-
10-30F (KC-10A and KDC-10), DC-10-40, DC-10-40F, MD-10-10F, MD-10-30F,
MD-11, and MD-11F airplanes. This proposed AD was prompted by fuel
system reviews conducted by the manufacturer. This proposed AD would
require adding design features to detect electrical faults, to detect a
pump running in an empty fuel tank, and to ensure that a fuel pump's
operation is not affected by certain conditions. We are proposing this
AD to reduce the potential of ignition sources inside fuel tanks,
which, in combination with flammable fuel vapors, could result in fuel
tank explosions and consequent loss of the airplane.

DATES: We must receive comments on this proposed AD by June 4, 2012.

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 http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

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

FOR FURTHER INFORMATION CONTACT: Serj Harutunian, Aerospace Engineer,
Propulsion Branch, ANM-140L, FAA, Los Angeles Aircraft Certification
Office (ACO), 3960 Paramount Boulevard, Lakewood, California 90712-
4137; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2012-0413;
Directorate Identifier 2011-NM-257-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The FAA has examined the underlying safety issues involved in fuel
tank explosions on several large transport airplanes, including the
adequacy of existing regulations, the service history of airplanes
subject to those regulations, and existing maintenance practices for
fuel tank systems. As a result of those findings, we issued a
regulation titled ``Transport Airplane Fuel Tank System Design Review,
Flammability Reduction and Maintenance and Inspection Requirements''
(66 FR 23086, May 7, 2001). In addition to new airworthiness standards
for transport airplanes and new maintenance requirements, this rule
included Special Federal Aviation Regulation No. 88 (``SFAR 88,''
Amendment 21-78, and subsequent Amendments 21-82 and 21-83).
    Among other actions, SFAR 88 (66 FR 23086, May 7, 2001) requires
certain type design (i.e., type certificate (TC) and supplemental type
certificate (STC)) holders to substantiate that their fuel tank systems
can prevent ignition sources in the fuel tanks. This requirement
applies to type design holders for large turbine-powered transport
airplanes and for subsequent modifications to those airplanes. It
requires them to perform design reviews and to develop design changes
and maintenance procedures if their designs do not meet the new fuel
tank safety standards. As explained in the preamble to the rule, we
intended to adopt airworthiness directives to mandate any changes found
necessary to address unsafe conditions identified as a result of these
reviews.
    In evaluating these design reviews, we have established four
criteria intended to define the unsafe conditions associated with fuel
tank systems that require corrective actions. The percentage of
operating time during which fuel tanks are exposed to flammable
conditions is one of these criteria. The other three criteria address
the failure types under evaluation: single failures, single failures in
combination with a latent condition(s), and in-service failure
experience. For all four criteria, the evaluations included
consideration of previous actions taken that may mitigate the need for
further action.
    We have determined that the actions identified in this proposed AD
are necessary to reduce the potential of ignition sources inside fuel
tanks, which, in combination with flammable fuel vapors, could result
in fuel tank explosions and consequent loss of the airplane.
    A fuel pump may cause an ignition source in a fuel tank when it has
internal electrical faults, or when the pump overheats due to prolonged
dry running in an empty fuel tank. Electrical faults inside fuel pumps
may cause arcing and burn through the pump housing into an empty fuel
tank. If a pump is not shut off in a timely manner when the tank is
emptied, the dry-running pump may cause excessive heat and become an
ignition source inside the tank.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would prohibit operation of an affected airplane
as of 60 months after the effective date of the AD, unless the
following design features and requirements have been approved by the
FAA and installed on the airplane.
     A protective device for each electrically powered fuel
pump that will detect electrical faults and shut off the pump
automatically when such faults are detected.
     Additional design features that will detect any fuel pump
running in an empty fuel tank, notify the flight crew, and
automatically shut off each pump within a specified time if not
manually shut off by the flight crew.
     Revisions of the airplane flight manual to include
procedures for manual pump shutoff.
     Means to ensure the detection of a fuel pump running in an
empty tank that has previously been shut off.

Costs of Compliance

    We estimate that this proposed AD affects 180 airplanes of U.S.
registry. We estimate the following costs to comply with this proposed
AD, based on the costs of similar STC installations:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
               Action                        Labor cost           Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
Installing design features..........  65 work-hours x $85 per         $55,000          $60,525      $10,894,500
                                       hour = $5,525.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

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

Regulatory Findings

    We 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) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new
airworthiness directive (AD):

The Boeing Company: Docket No. FAA-2012-0413; Directorate Identifier
2011-NM-257-AD.

(a) Comments Due Date

    We must receive comments by June 4, 2012.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all The Boeing Company Model DC-10-10, DC-10-
10F, DC-10-15, DC-10-30, DC-10-30F (KC-10A and KDC-10), DC-10-40,
DC-10-40F, MD-10-10F, MD-10-30F, MD-11, and MD-11F airplanes;
certificated in any category.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 28, Fuel.

(e) Unsafe Condition

    This AD was prompted by fuel system reviews conducted by the
manufacturer. We are issuing this AD to reduce the potential of
ignition sources inside fuel tanks, which, in combination with
flammable fuel vapors, could result in fuel tank explosions and
consequent loss of the airplane.

(f) Compliance

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

(g) Criteria for Operation

    As of 60 months after the effective date of this AD, no person
may operate any airplane affected by this AD unless an amended type
certificate or supplemental type certificate that incorporates the
design features and requirements described in paragraphs (g)(1)
through (g)(4) of this AD has been approved by the Manager, Los
Angeles Aircraft Certification Office (ACO), FAA, and those design
features are installed on the airplane to meet the criteria
specified in 14 CFR Section 25.981(a) and (d), at amendment level
25-125.
    (1) For all airplanes: Each electrically powered fuel pump
installed in any fuel tank that normally empties during flight--such
as center wing tanks, auxiliary fuel tanks, and tail tanks--must
have a protective device installed to detect electrical faults that
can cause arcing and burn through of the fuel pump housing and pump
electrical connector. The same device must shut off the pump by
automatically removing electrical power from the pump when such
faults are detected. When a fuel pump is shut off resulting from
detection of an electrical fault, the device must stay latched off,
until the fault is cleared through maintenance action and the pump
is verified safe for operation.
    (2) For airplanes with a 2-person flight crew: Additional design
features, if not originally installed by the airplane manufacturer,
must be installed to meet 3 criteria: to detect a running fuel pump
in a tank that is normally emptied during flight, to provide an
indication to the flight crew that the tank is empty, and to
automatically shut off that fuel pump. The prospective pump
indication and shutoff system must automatically shut off each pump
in case the flight crew does not shut off a pump running dry in an
empty tank within 60 seconds after each fuel tank is emptied. The
airplane flight manual supplement (AFMS) must be revised to include
flight crew manual pump shutoff procedures in the Normal Operating
Procedures section of the AFMS.
    (3) For airplanes with a 3-person flight crew: Additional design
features, if not originally installed by the airplane manufacturer,
must be installed to detect when a fuel pump in a tank that is
normally emptied during flight is running in an empty fuel tank, and
provide an indication to the flight crew that the tank is empty. The
flight engineer must manually shut off each pump running dry in an
empty tank within 60 seconds after the tank is emptied. The
Limitations section of the AFMS must be revised to specify that this
pump shutoff must be done by the flight engineer.
    (4) For all airplanes: The empty-tank shutoff system design must
preclude the undetected running of a fuel pump in an empty tank
after the pump is commanded off automatically or manually.

(h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Los Angeles Aircraft Certification Office
(ACO), 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
local Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in the Related Information
section of this AD.

    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(i) Related Information

    For more information about this AD, contact Serj Harutunian,
Aerospace Engineer, Propulsion Branch, ANM-140L, FAA, Los Angeles
ACO, 3960 Paramount Boulevard, Lakewood, California 90712-4137;
phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
    Issued in Renton, Washington, on April 6, 2012.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-9267 Filed 4-17-12; 8:45 am]
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