[Federal Register Volume 88, Number 241 (Monday, December 18, 2023)]
[Notices]
[Pages 87476-87480]
[FR Doc No: 2023-27675]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-99147; File No. SR-CboeBZX-2023-099]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Amend
the Fee Schedule Applicable to Members and Non-Members of the Exchange
Pursuant to BZX Rules 15.1(a) and (c) in Order To Adopt a New Tier
Under Footnote 13 (Tape B Volume and Quoting) Specific to Single-Stock
Exchange Traded Funds (``Single-Stock ETFs'')

December 12, 2023.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on December 1, 2023, Cboe BZX Exchange, Inc. (the ``Exchange'' or
``BZX'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The Exchange
filed the proposal as a ``non-controversial'' proposed rule change
pursuant to Section 19(b)(3)(A)(iii) of the Act \3\ and Rule 19b-
4(f)(6) thereunder.\4\ The Commission is publishing this notice to

solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Cboe BZX Exchange, Inc. (``BZX'' or the ``Exchange'') is filing
with the Securities and Exchange Commission (``Commission'' or ``SEC'')
a proposed rule change to amend the Fee Schedule applicable to Members
and non-members of the Exchange pursuant to BZX Rules 15.1(a) and (c)
in order to adopt a new Tier under footnote 13 (Tape B Volume and
Quoting) specific to Single-Stock Exchange Traded Funds (``Single-Stock
ETFs''). 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/equities/regulation/rule_filings/bzx/), 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 (``BZX Equities'') to adopt a new Tier under
footnote 13 (Tape B Volume and Quoting) specific to Single-Stock
ETFs.\5\ The Exchange proposes to implement these amendments to its fee
schedule December 1, 2023.
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    \5\ Single-Stock ETFs are investment products that pay positive
or negative multiples of the market performance of the single
underlying security.
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    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,\6\ 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 credits 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.\7\ For
orders in securities priced below $1.00, the Exchange does not provide
a rebate or assess a fee for orders that add liquidity and assesses a
fee of 0.30% of total dollar value for orders that remove liquidity.\8\
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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    \6\ See Cboe Global Markets, U.S. Equities Market Volume
Summary, Month-to-Date (July 31, 2023), available at https://www.cboe.com/us/equities/market_statistics/.
    \7\ See BZX Equities Fee Schedule, Standard Rates.
    \8\ Id.
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    Now, the Exchange proposes to adopt a new pricing Tier under
footnote 13 of the Fee Schedule. Specifically, for orders yielding fee
code B,\9\ the Exchange proposes to adopt LEP Tier 1 under footnote 13
of the Fee Schedule.\10\ The Exchange is proposing that a Member \11\
will qualify for the LEP Tier 1 where the Member is enrolled in a
minimum of five LEP Securities \12\ for which it meets certain required
criteria (the ``Required Criteria''). A Member must be enrolled in at
least the minimum number of LEP Securities for which it meets the
Required Criteria every day in a trading month in order to be eligible
for the proposed rebate. As proposed, the Exchange would count an LEP
Security toward the minimum number of LEP Securities requirement where
the Member meets the Required Criteria for at least 75% of the trading
days in a particular month. As noted above, these proposed requirements
are very similar to the existing LMP Tiers under footnote 13.
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    \9\ Fee code B is appended to displayed orders that add
liquidity to BZX in Tape B securities.
    \10\ The existing tiers under footnote 13 were added in a fee
filing adopting a similar structure related to LMP securities on the
Exchange. See Securities Exchange Act No. 78338 (July 15, 2016) 81
FR 47458 (July 21, 2016) (SR-BatsBZX-2016-041) (Notice of Filing and
Immediate Effectiveness of a Proposed Rule Change Related to Fees
for Use of Bats BZX Exchange, Inc.).
    \11\ See Exchange Rule 1.5(n).
    \12\ As discussed further below, the Exchange proposes to adopt
the term ``LEP Securities'', which means a list of Single-Stock
ETFs, including options-based ETFs in a single underlying equity
security, for which the Exchange wants to incentivize Members to
provide enhanced market quality. The Exchange will not remove a
security from the list of LEP Securities without 30 days prior
notice.
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    To qualify for proposed LEP Tier 1 a Member must be enrolled in at
least five BZX-listed LEP Securities and meet the following Required
Criteria,:
    (1) The Member has an NBBO Time \13\ of equal or greater than 20%;
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    \13\ ``NBBO Time'' means the average of the percentage of time
during regular trading hours during which the Member maintains at
least 100 shares at each of the NBB and NBO.
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    (2) Member has bids and offers with a ``Notional Depth'' \14\ of
$75,000 on each side for at least 90% of the trading day; and
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    \14\ As discussed further below, the Exchange proposes to adopt
a new definition for ``Notional Depth'' which means the notional
value of bids of at least 100 shares that are within $0.05 of the
BZX NBB and offers of at least 100 shares that are within $0.05 of
the BZX NBO.
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    (3) The difference in the NBBO spread of each LEP Security is less
than 0.50% for at least 95% of the trading day.
    The Required Criteria for each LEP Security will each be evaluated
separately, and the Member does not need to meet the Required Criteria
for all applicable LEP Securities on the same 75% of trading days. For
example, in a month with 22 trading days, a Member would be eligible
for Tier 1 where the Member met the Required Criteria in five LEP
Securities in the first 11 trading days of the month and met the
Required Criteria for a different set of five LEP Securities in the
second 11 trading days of the month.
    Members that meet proposed LEP Tier 1 would receive a rebate of
$0.0025 per share. In the event that a Member would receive a higher
rebate under a different Tier set forth in the Fee Schedule, the

Member would be entitled to the higher of the two rebates. As noted
above, the Exchange also proposes to adopt two new definitions to the
Fee Schedule. First, the Exchange proposes to adopt the term Notional
Depth which will mean the notional value of bids of at least 100 shares
that are within $0.05 of the NBB or offers of at least 100 shares that
are within $0.05 of the NBO. Second, the Exchange proposes to adopt the
term ``LEP Securities'' which will a list of Single-Stock ETFs,
including options-based ETFs in a single underlying equity security,
for which the Exchange wants to incentivize Members to provide enhanced
market quality.
    All Members will be eligible to enroll in LEP Securities, there
will be no limit to the number of LEP Securities in which a Member may
enroll, and there will be no limit to the number of Members that can
enroll in each LEP Security.\15\ All Members enrolled in LMP Securities
will be eligible for the rebate where the Member meets the Tape B
Quoting LMP Tier 1 requirements. Such LEP Securities will include all
Cboe-listed Single-Stock ETFs for which the Exchange wants to
incentivize Members to provide enhanced market quality. The Exchange
will not remove a security from the list of LEP Securities without 30
days prior notice.
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    \15\ The Exchange anticipates that the initial list of LMP
Securities will include at least nine ETPs. A current list of LEP
Securities will be available on www.cboe.com, which will be updated
as new securities are added to the list of LEP Securities. All Cboe-
listed LEP Securities will be enrolled in the program immediately
upon listing on the Exchange.
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    The Exchange also proposes to make a conforming change to the
existing Tiers under footnote 13 of the Fee Schedule. Specifically, the
Exchange proposes to rename existing Tiers 1 and 2 under footnote 13
``LMP Tier 1'' and ``LMP Tier 2'', respectively.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\16\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \17\ 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. Additionally,
the Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \18\ requirement that the rules of an exchange not be
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers as well as Section 6(b)(4) \19\ as it is designed
to provide for the equitable allocation of reasonable dues, fees and
other charges among its Members and other persons using its facilities.
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    \16\ 15 U.S.C. 78f(b).
    \17\ 15 U.S.C. 78f(b)(5).
    \18\ Id.
    \19\ 15 U.S.C. 78f(b)(4).
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    The proposed rule reflects a competitive pricing structure designed
to incent market participants to direct their order flow to the
Exchange and enhance market quality in LEP Securities and Tape B
securities. The Exchange 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. The Exchange believes that the proposed LEP Tier represents
an equitable allocation of rebates and are not unfairly discriminatory
because all Members are eligible for such LEP Tier and would have the
opportunity to meet the LEP Tier's criteria and would receive the
proposed rebate if such criteria is met. Further, the proposed rebates
are commensurate with the proposed criteria. That is, the rebates
reasonably reflect the difficulty in achieving the applicable criteria
as proposed. 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 qualifying
for the proposed LEP Tier. While the Exchange has no way of predicting
with certainty how the proposed LEP Tier will impact Member activity,
the Exchange reasonably expects four Members to compete for and reach
the proposed LEP Tier. The Exchange also notes that proposed Tier/
rebate 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 the proposed LEP Tier, the Member will
merely not receive that corresponding rebate.
    The Exchange believes that the proposed new LEP Tier is reasonable
in that they will enhance market quality on the Exchange in two ways:
(i) by incentivizing Members to meet certain quoting standards in LEP
Securities designed to narrow spreads, increase size at the inside, and
increase liquidity depth; and (ii) providing a rebate for all of a
qualifying Member's orders that add liquidity in LEP Securities will
incentivize Members to increase their participation on the Exchange in
LEP Securities. Furthermore, the Exchange believes it is appropriate to
incentivize Members to meet the Required Criteria in LEP Securities as
such securities poses an enhanced risk to Members providing liquidity
in those securities. Therefore, the proposal offers an incentive to
Members providing liquidity in LEP Securities.
    The Exchange believes that such incentives will promote price
discovery and market quality in such securities and, further, that the
tightened spreads and increased liquidity from the proposal will
benefit all investors by deepening the Exchange's liquidity pool,
offering additional flexibility for all investors to enjoy cost
savings, supporting the quality of price discovery, enhancing quoting
competition across exchanges, promoting market transparency, and
improving investor protection. Accordingly, the Exchange believes that
the proposal is reasonable, equitably allocated, and non-discriminatory
because it would apply uniformly to all Members and is consistent with
the overall goals of enhancing market quality.
    The Exchange notes that the proposed pricing structure is not
dissimilar from volume-based rebates and fees (``Volume Tiers'') that
have been widely adopted by exchanges, including the Exchange, and are
equitable and not unfairly discriminatory because they are open to all
Members on an equal basis and provide higher rebates and lower fees
that are reasonably related to the value to an exchange's market
quality. Much like Volume Tiers are generally designed to incentivize
higher levels of liquidity provision and/or growth patterns on the
Exchange, the proposal is designed to incentivize enhanced market
quality on the Exchange through tighter spreads, greater size at the
inside, and greater quoting depth in LEP Securities by offering a
rebate in LEP Securities. Such rebates will simultaneously incentivize
higher levels of liquidity provision in all LEP Securities.
Accordingly, the Exchange believes that the proposal will act to
enhance liquidity and competition across exchanges in LEP Securities on
the Exchange by providing a rebate reasonably related to such enhanced

market quality to the benefit of all investors, thereby promoting the
principles discussed in Section 6(b)(5) of the Act.\20\
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    \20\ 15 U.S.C. 78f(b)(5).
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    The Exchange also believes that the proposed definitions and name
changes to existing Tiers under footnote 13 are reasonable, fair and
equitable and non-discriminatory because it is designed to make sure
that the fee schedule is as clear and easily understandable as
possible.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. Particularly, the proposed
LEP Tier is available to all Members equally in that all Members are
eligible for the proposed LEP Tier, have a reasonable opportunity to
meet the LEP Tier's criteria and will receive the corresponding rebate
if such criteria is met. Additionally, the proposed LEP Tier is
designed to attract additional order flow to the Exchange. The Exchange
believes that the proposed LEP Tier criteria would incentivize market
participants to direct liquidity adding displayed order flow to the
Exchange, bringing with it 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 15 other equities exchanges and
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% \21\ of the market share. 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.
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    \21\ Supra note 6.
    \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)).
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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

    Because the foregoing proposed rule change does not: (i)
significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, the proposed rule
change has become effective pursuant to Section 19(b)(3)(A) of the Act
\24\ and Rule 19b-4(f)(6) \25\ thereunder.
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    \24\ 15 U.S.C. 78s(b)(3)(A).
    \25\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under Rule 19b-4(f)(6) \26\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\27\ the Commission
may designate a shorter time of such action is consistent with the
protection of investor and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposed
rule change may become operative upon filing. The Exchange states that
waiving the operative delay would allow market participants to realize
the benefits of the proposal immediately and that such waiver is
consistent with the protection of investors and the public interest
because it would promote enhanced market quality and serve as an
additional safeguard against extreme price dislocation. Based on the
foregoing, the Commission believes that waiving the 30-day operative
delay is consistent with the protection of investors and the public
interest. Therefore, the Commission hereby waives the operative delay
and designates the proposal operative upon filing.\28\
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    \26\ 17 CFR 240.19b-4(f)(6).
    \27\ 17 CFR 240.19b-4(f)(6)(iii).
    \28\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission 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.

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 (https://www.sec.gov/rules/sro.shtml); or

     Send an email to [email protected]. Please include
file number SR-CboeBZX-2023-099 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-CboeBZX-2023-099. 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 (https://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
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. Do not
include personal identifiable information in submissions; you should
submit only information that you wish to make available publicly. We
may redact in part or withhold entirely from publication submitted
material that is obscene or subject to copyright protection. All
submissions should refer to file number SR-CboeBZX-2023-099 and should
be submitted on or before January 8, 2024.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\29\
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    \29\ 17 CFR 200.30-3(a)(12), (59).
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Christina Z. Milnor,
Assistant Secretary.
[FR Doc. 2023-27675 Filed 12-15-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 100 (Thursday, May 25, 2017)]
[Rules and Regulations]
[Pages 24035-24039]
[FR Doc No: 2017-10266]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-8428; Directorate Identifier 2014-NM-032-AD;
Amendment 39-18898; AD 2017-10-24]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

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

ACTION: Final rule.

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SUMMARY: We are superseding Airworthiness Directive (AD) 2011-17-

09 for all Airbus Model A330-200, -200 Freighter, and -300 series
airplanes; and AD 2012-25-12 for all Airbus Model A330-200 and -300
series airplanes. AD 2011-17-09 required revisions to certain operator
maintenance documents to include new inspections. AD 2012-25-12
required replacing certain main landing gear (MLG) bogie beams before
reaching new reduced life limits. This new AD requires revising the
maintenance or inspection program, as applicable, to incorporate new,
more restrictive, or revised instructions and/or airworthiness
limitation requirements. This AD was prompted by revisions to certain
airworthiness limitation item (ALI) documents, which specify more
restrictive instructions and/or airworthiness limitations. We are
issuing this AD to address the unsafe condition on these products.

DATES: This AD is effective June 29, 2017.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of June 29,
2017.
    The Director of the Federal Register approved the incorporation by
reference of a certain other publication listed in this AD as of
January 30, 2013 (77 FR 75825, December 26, 2012).
    The Director of the Federal Register approved the incorporation by
reference of a certain other publication listed in this AD as of
September 30, 2011 (76 FR 53305, August 26, 2011).

ADDRESSES: For Airbus service information identified in this final
rule, contact Airbus SAS--Airworthiness Office--EAL, 1 Rond Point
Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36
96; fax +33 5 61 93 45 80; email<EMAIL_ADDRESS>
Internet http://www.airbus.com.
    For Messier-Bugatti-Dowty service information identified in this
final rule, contact Messier-Bugatti USA, One Carbon Way, Walton, KY
41094; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>    You may view this referenced service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call 425-
227-1221. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
8428.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
8428; 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 AD, the regulatory evaluation, any comments received, and
other information. The address for the Docket Office (telephone 800-
647-5527) is Docket Management Facility, U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Vladimir Ulyanov, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a supplemental notice of proposed rulemaking (SNPRM) to
amend 14 CFR part 39 to supersede AD 2011-17-09, Amendment 39-16773 (76
FR 53305, August 26, 2011) (``AD 2011-17-09''); and AD 2012-25-12,
Amendment 39-17293 (77 FR 75825, December 26, 2012) (``AD 2012-25-
12''). AD 2011-17-09 applied to all Airbus Model A330-200, -200
Freighter, and -300 series airplanes. AD 2012-25-12 applied to all
Airbus Model A330-200 and -300 series airplanes. The SNPRM published in
the Federal Register on December 16, 2016 (81 FR 91062). We preceded
the SNPRM with a notice of proposed rulemaking (NPRM) that published in
the Federal Register on January 13, 2016 (81 FR 1570). The NPRM was
prompted by a determination that more restrictive instructions and/or
airworthiness limitations should be incorporated into the maintenance
or inspection program, as applicable. The NPRM proposed to require
revising the maintenance or inspection program, as applicable, to
incorporate new or revised airworthiness limitation requirements. The
SNPRM proposed to require revising the maintenance or inspection
program, as applicable, to incorporate more restrictive instructions
and/or airworthiness limitations that the manufacturer has recently
issued. We are issuing this AD to detect and correct fatigue cracking,
accidental damage, or corrosion in principal structural elements, and
possible failure of certain life limited parts, which could result in
reduced structural integrity of the airplane.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive, 2014-0009, dated January 8, 2014 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for all Airbus Model
A330-200, -200 Freighter, and -300 series airplanes; and Model A340-
200, -300, -500, and -600 series airplanes. The MCAI states:

    The airworthiness limitations for Airbus aeroplanes are
currently published in Airworthiness Limitations Section (ALS)
documents.
    The instructions and airworthiness limitations applicable to the
Safe Life Airworthiness Limitation Items (SL ALI) are given in
Airbus A330 ALS Part 1 and A340 ALS Part 1, which are approved by
EASA.
    The revision 07 of Airbus A330 and A340 ALS Part 1 introduces
more restrictive instructions and/or airworthiness limitations.
Failure to comply with this revision could result in an unsafe
condition.
    For the reason described above, this [EASA] AD retains the
requirements of EASA AD 2012-0179, which is superseded, and requires
accomplishment of the actions specified in Airbus A330 or A340 ALS
Part 1 revision 07.
    In addition, this [EASA] AD also supersedes EASA AD 2011-0122-E
and EASA AD 2011-0212, whose requirements have been transferred into
Airbus A330 and A340 ALS Part 1 revision 07.

    The unsafe condition is fatigue cracking, accidental damage, or
corrosion in certain principal structural elements, and possible
failure of certain life limited parts, which could result in reduced
structural integrity of the airplane. You may examine the MCAI in the
AD docket on the Internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2015-8428.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the SNPRM or on the determination
of the cost to the public.

Conclusion

    We reviewed the available data and determined that air safety and
the public interest require adopting this AD as proposed except for
minor editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
SNPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the SNPRM.

Related Service Information Under 1 CFR Part 51

    Airbus has issued Airbus A330 ALS Part 1, SL-ALI, Revision 08,
dated April 11, 2016. Messier-Bugatti-Dowty has issued Service Letter
A33-34 A20, Revision 7, including Appendixes A through F, dated July
20, 2012. This service information describes SL-ALI for the landing
gear. This service information is distinct since it was issued by two
different manufacturers for different purposes.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 82 airplanes of U.S. registry.
    The actions that are required by AD 2011-17-09, and retained in
this AD, take about 1 work-hour per product, at an average labor rate
of $85 per work-hour. Based on these figures, the estimated cost of the
actions that are required by AD 2011-17-09 is $85 per product.
    The actions that are required by AD 2012-25-12, and retained in
this AD, take about 16 work-hours, at an average labor rate of $85 per
work-hour, with required parts cost of about $255,000 per MLG bogie
beam. Based on these figures, the estimated cost of the actions that
are required by AD 2012-25-12 is up to $256,360 per MLG bogie beam.
    We also estimate that it would take about 1 work-hour per product
to comply with the basic requirements of this AD. The average labor
rate is $85 per work-hour. Based on these figures, we estimate the cost
of this AD on U.S. operators to be $6,970, or $85 per product.

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 AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government. For the
reasons discussed above, I certify that this AD:
    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.

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2.The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2011-17-09, Amendment 39-16773 (76 FR 53305, August 26, 2011); and AD
2012-25-12, Amendment 39-17293 (77 FR 75825, December 26, 2012); and
adding the following new AD:

2017-10-24 Airbus: Amendment 39-18898; Docket No. FAA-2015-8428;
Directorate Identifier 2014-NM-032-AD.

(a) Effective Date

    This AD is effective June 29, 2017.

(b) Affected ADs

    This AD replaces AD 2011-17-09, Amendment 39-16773 (76 FR 53305,
August 26, 2011) (``AD 2011-17-09''); and AD 2012-25-12, Amendment
39-17293 (77 FR 75825, December 26, 2012) (``AD 2012-25-12'').

(c) Applicability

    This AD applies to the Airbus airplanes identified in paragraphs
(c)(1), (c)(2), and (c)(3) of this AD, certificated in any category,
with an original certificate of airworthiness or original export
certificate of airworthiness issued on or before April 11, 2016.
    (1) Airbus Model A330-201, -202, -203, -223, and -243 airplanes.
    (2) Airbus Model A330-223F and -243F airplanes.
    (3) Airbus Model A330-301, -302, -303, -321, -322, -323, -341, -
342, and -343 airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 05, Periodic
inspections.

(e) Reason

    This AD was prompted by revisions to certain airworthiness
limitation item documents, which specify more restrictive
instructions and/or airworthiness limitations. We are issuing this
AD to detect and correct fatigue cracking, accidental damage, or
corrosion in principal structural elements, and possible failure of
certain life limited parts, which could result in reduced structural
integrity of the airplane.

(f) Compliance

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

(g) Retained Maintenance Program Revision, With New Terminating Action

    This paragraph restates the requirements of paragraph (h) of AD
2011-17-09, with new terminating action. Within 3 months after
September 30, 2011 (the effective date of AD 2011-17-09): Revise the
maintenance program by incorporating Airbus A330 Airworthiness
Limitations Section (ALS) Part 1, Safe Life Airworthiness Limitation
Items (SL-ALI), Revision 05, dated July 29, 2010. Comply with all
ALIs in Airbus A330 ALS Part 1, SL-ALI, Revision 05, dated July 29,
2010, at the times specified therein. Accomplishing the actions
specified in paragraph (k) of this AD terminates the requirements of
this paragraph.

(h) Retained Limitation of No Alternative Intervals or Limits, With
Additional Exception

    This paragraph restates the requirements of paragraph (i) of AD
2011-17-09, with additional exception. Except as provided by
paragraphs (k) and (m)(1) of this AD, after accomplishment of the
actions specified in paragraph (g) of this AD, no alternatives to
the maintenance tasks, intervals, or limitations specified in
paragraph (g) of this AD may be used.

(i) Retained Bogie Beam Replacement, With Specific Delegation Approval
Language, New Terminating Action, and New Service Information

    This paragraph restates the requirements of paragraph (g) of AD
2012-25-12, with specific delegation approval language and
terminating action and new service information. For airplanes
identified in paragraphs (c)(1) and (c)(3) of this AD: At the

later of the times specified in paragraphs (i)(1) and (i)(2) of this
AD, replace all main landing gear (MLG) bogie beams having part
number (P/N) 201485300, 201485301, 201272302, 201272304, 201272306,
or 201272307, except those that have serial number (S/N) S2A, S2B,
or S2C, as identified in Messier-Dowty Service Letter A33-34 A20,
Revision 5, including Appendixes A through F, dated July 31, 2009;
or Messier-Bugatti-Dowty Service Letter A33-34 A20, Revision 7,
including Appendixes A through F, dated July 20, 2012; with a new or
serviceable part, using a method approved by the Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA;
or the European Aviation Safety Agency (EASA); or Airbus's EASA
Design Organization Approval (DOA). As of the effective date of this
AD, the applicable MLG bogie beams specified in this paragraph must
be replaced using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or EASA; or
Airbus's EASA DOA. Accomplishing the actions specified in paragraph
(k) of this AD terminates the requirements of this paragraph.
    (1) At the applicable time specified in paragraphs (i)(1)(i),
(i)(1)(ii), and (i)(1)(iii) of this AD.
    (i) For Model A330-201, -202, -203, -223, -243 series airplanes,
weight variant (WV)02x, WV05x (except WV058), and WV06x series:
Before the accumulation of a life limit of 50,000 landings or 72,300
total flight hours, whichever occurs first from the first
installation of a MLG bogie beam on the airplane.
    (ii) For Model A330-201, -202, -203, -223, -243 WV058 series
airplanes: Before the accumulation of a life limit of 50,000
landings or 57,900 total flight hours, whichever occurs first from
the first installation of a MLG bogie beam on the airplane.
    (iii) For Model A330-301, -302, -303, -321, -322, -323, -341, -
342, -343 series airplanes, WV00x, WV01x, WV02x, and WV05x series:
Before the accumulation of a life limit of 46,000 landings or 75,000
total flight hours, whichever occurs first from the first
installation of a MLG bogie beam on the airplane.
    (2) Within 6 months after January 30, 2013 (the effective date
of AD 2012-25-12).

(j) Retained Parts Installation Limitation, With New Terminating Action

    This paragraph restates the requirements of paragraph (h) of AD
2012-25-12, with new terminating action. For airplanes identified in
paragraphs (c)(1) and (c)(3) of this AD, as of January 30, 2013 (the
effective date of AD 2012-25-12), a MLG bogie beam having any part
number identified in paragraph (i) of this AD may be installed on an
airplane, provided its life has not exceeded the life limit
specified in paragraphs (i)(1)(i), (i)(1)(ii), and (i)(1)(iii) of
this AD, and it is replaced with a new or serviceable part before
reaching the life limit specified in paragraphs (i)(1)(i),
(i)(1)(ii), and (i)(1)(iii) of this AD. Accomplishing the actions
specified in paragraph (k) of this AD terminates the requirements of
this paragraph.

(k) New Maintenance or Inspection Program Revision

    Within 3 months after the effective date of this AD: Revise the
maintenance or inspection program, as applicable, by incorporating
the information in Airbus A330 ALS Part 1, SL-ALI, Revision 08,
dated April 11, 2016. The initial compliance times for the actions
specified in Airbus A330 ALS Part 1, SL-ALI, Revision 08, dated
April 11, 2016, are at the times specified in Airbus A330 ALS Part
1, SL-ALI, Revision 08, dated April 11, 2016, or within 3 months
after the effective date of this AD, whichever occurs later.
Accomplishing the actions specified in this paragraph terminates the
requirements specified in paragraphs (g) through (j) of this AD.

(l) New Limitation of No Alternative Actions or Intervals

    After the maintenance or inspection program, as applicable, has
been revised, as required by paragraph (k) of this AD, no
alternative actions (e.g., inspections) or intervals may be used
unless the actions or intervals are approved as an alternative
method of compliance (AMOC) in accordance with the procedures
specified in paragraph (m)(1) of this AD.

(m) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, 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 International Branch, send it to the
attention of the person identified in paragraph (n)(2) of this AD.
Information may be emailed to<EMAIL_ADDRESS>
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.
    (2) Contacting the Manufacturer: As of the effective date of
this AD, for any requirement in this AD to obtain corrective actions
from a manufacturer, the action must be accomplished using a method
approved by the Manager, International Branch, ANM-116, Transport
Airplane Directorate, FAA; or EASA; or Airbus's EASA DOA. If
approved by the DOA, the approval must include the DOA-authorized
signature.

(n) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA Airworthiness Directive 2014-0009, dated January 8,
2014, for related information. This MCAI may be found in the AD
docket on the Internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2015-8428.
    (2) For more information about this AD, contact Vladimir
Ulyanov, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
WA 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

(o) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (3) The following service information was approved for IBR on
June 29, 2017.
    (i) Airbus A330 Airworthiness Limitations Section Part 1, Safe
Life Airworthiness Limitation Items, Revision 08, dated April 11,
2016.
    (ii) Messier-Bugatti-Dowty Service Letter A33-34 A20, Revision
7, including Appendixes A through F, dated July 20, 2012.
    (4) The following service information was approved for IBR on
January 30, 2013 (77 FR 75825, December 26, 2012).
    (i) Messier-Dowty Service Letter A33-34 A20, Revision 5,
including Appendixes A through F, dated July 31, 2009.
    (ii) Reserved.
    (5) The following service information was approved for IBR on
September 30, 2011 (76 FR 53305, August 26, 2011).
    (i) Airbus A330 Airworthiness Limitations Section, Part 1, Safe
Life Airworthiness Limitation Items, Revision 05, dated July 29,
2010. The revision level of this document is indicated only on the
title page and in the Record of Revisions; the revision date of this
document is not indicated on the title page of this document.
    (ii) Reserved.
    (6) For Airbus service information identified in this AD,
contact Airbus SAS--Airworthiness Office--EAL, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96;
fax +33 5 61 93 45 80; email<EMAIL_ADDRESS>
Internet http://www.airbus.com.
    (7) For Messier-Bugatti-Dowty service information identified in
this AD, contact Messier-Bugatti USA, One Carbon Way, Walton, KY
41094; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>    (8) You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (9) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on May 10, 2017.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2017-10266 Filed 5-24-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 199 (Monday, October 15, 2018)]
[Rules and Regulations]
[Pages 51837-51838]
[FR Doc No: 2018-22347]

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

Coast Guard

33 CFR Part 117

[Docket No. USCG-2018-0894]

Drawbridge Operation Regulation; Sacramento River, Sacramento, CA

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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

SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Tower Drawbridge across the
Sacramento River, mile 59.0, at Sacramento, CA. The deviation is
necessary to allow the local community to participate in the Be the
Gift 5K walk/run. This deviation allows the bridge to remain in the
closed-to-

navigation position during the deviation period.

DATES: This deviation is effective from 8 a.m. through 10 a.m. on
October 20, 2018.

ADDRESSES: The docket for this deviation, USCG-2018-0894, is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH.'' Click on Open Docket Folder on the line
associated with this deviation.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Carl T. Hausner, Chief, Bridge
Section, Eleventh Coast Guard District; telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION: The California Department of Transportation
has requested a temporary change to the operation of the Tower
Drawbridge, mile 59.0, over the Sacramento River, at Sacramento, CA.
The drawbridge navigation span provides a vertical clearance of 30 feet
above Mean High Water in the closed-to-navigation position. The draw
operates as required by 33 CFR 117.189(a). Navigation on the waterway
is commercial and recreational.
    The drawspan will be secured in the closed-to-navigation position
from 8 a.m. to 10 a.m. on October 20, 2018, to allow the community to
participate in the Be the Gift 5K walk/run. This temporary deviation
has been coordinated with the waterway users. No objections to the
proposed temporary deviation were raised.
    Vessels able to pass through the bridge in the closed position may
do so at anytime. The bridge will be able to open for emergencies and
there is no immediate alternate route for vessels to pass. The Coast
Guard will also inform the users of the waterway through our Local and
Broadcast Notices to Mariners of the change in operating schedule for
the bridge so that vessel operators can arrange their transits to
minimize any impact caused by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: September 27, 2018.
Carl T. Hausner,
District Bridge Chief, Eleventh Coast Guard District.
[FR Doc. 2018-22347 Filed 10-12-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 22 (Thursday, February 1, 2018)]
[Proposed Rules]
[Pages 4614-4617]
[FR Doc No: 2018-01853]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R08-0AR-2017-0753; FRL-9973-45-Region 8]

Approval and Promulgation of Air Quality Implementation Plans;
State of Colorado; Revisions to the Transportation Conformity
Consultation Process

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a State Implementation Plan (SIP) revision submitted by
Colorado on May 16, 2017. The May 16, 2017 SIP revision addresses minor
changes and typographical corrections to the transportation conformity
requirements of Colorado's Regulation Number 10 ``Criteria for Analysis
of Conformity.'' These actions are being taken under section 110 of the
Clean Air Act.

DATES: Written comments must be received on or before March 5, 2018.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R08-
OAR-2017-0753 at https://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from www.regulations.gov. The EPA may publish any
comment received to the public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information, the disclosure of which is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e., on the web,

cloud, or other file sharing system). For additional submission
methods, the full EPA public comment policy, information about CBI or
multimedia submissions, and general guidance on making effective
comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Tim Russ, Air Program, U.S.
Environmental Protection Agency, Region 8, Mailcode 8P-AR, 1595 Wynkoop
Street, Denver, Colorado 80202-1129,<PHONE_NUMBER>, or
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

What should I consider as I prepare my comments for the EPA?

    a. Submitting CBI. Do not submit CBI to the EPA through
www.regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to the EPA, mark the outside of the disk or CD ROM
as CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    b. Tips for Preparing Your Comments. When submitting comments,
remember to:
    1. Identify the rulemaking by docket number and other identifying
information (subject heading, Federal Register date and page number).
    2. Follow directions--The agency may ask you to respond to specific
questions or organize comments by referencing a Code of Federal
Regulations (CFR) part or section number.
    3. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    4. Describe any assumptions and provide any technical information
and/or data that you used.
    5. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    6. Provide specific examples to illustrate your concerns, and
suggest alternatives.
    7. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    8. Make sure to submit your comments by the comment period deadline
identified.

II. Background

    The EPA is proposing approval of minor revisions to Colorado's
Regulation Number 10 which is entitled ``Criteria for Analysis of
Conformity'' (hereafter, ``Regulation No. 10''). We note the most
recent prior SIP revisions to Regulation No. 10, that we approved,
occurred on March 4, 2014 (79 FR 12079).
    The purpose of Regulation No. 10 is to address the transportation
conformity SIP requirements of section 176(c) of the Clean Air Act
(CAA) and 40 CFR 51.390(b). In addition, Regulation No. 10 also
addresses the following transportation conformity SIP element
requirements; 40 CFR 93.105 which formalizes the consultation
procedures; 40 CFR 93.122(a)(4)(ii) which addresses written commitments
to control measures that are not included in a Metropolitan Planning
Organization's (MPOs) transportation plan and transportation
improvement program that must be obtained prior to a conformity
determination; and 40 CFR 93.125(c) which addresses written commitments
to mitigation measures that must be obtained prior to a project-level
conformity determination.\1\
---------------------------------------------------------------------------

    \1\ A conformity SIP includes a state's specific criteria and
procedures for certain aspects of the transportation conformity
process consistent with the federal conformity rule. A conformity
SIP does not contain motor vehicle emissions budgets, emissions
inventories, air quality demonstrations, or control measures. See
EPA's Guidance for Developing Transportation Conformity State
Implementation Plans (SIPs) for further background: https://nepis.epa.gov/Exe/ZyPDF.cgi/P1002W5B.PDF?Dockey=P1002W5B.PDF.
---------------------------------------------------------------------------

III. What was the State's process to submit a SIP revision to the EPA?

    Section 110(k) of the CAA addresses our actions on submissions of
revisions to a SIP. The CAA requires states to observe certain
procedural requirements in developing SIP revisions for submittal to
the EPA. Section 110(a)(2) of the CAA requires that each SIP revision
be adopted after reasonable notice and public hearing. This must occur
prior to the revision being submitted by a state.
    For the May 16, 2017 revisions to Regulation No. 10, the Colorado
Air Quality Control Commission (AQCC) held a public hearing for those
revisions on February 18, 2016. There were no public comments. The AQCC
adopted the revisions to Regulation No. 10 directly after the hearing.
This SIP revision became state effective on March 30, 2016 and was
submitted by Dr. Larry Wolk, Executive Director of the Colorado
Department of Public Health and Environment (CDPHE), and on behalf of
the Governor, to the EPA on May 16, 2017.
    We have evaluated the State's May 16, 2017 submittal for Regulation
No. 10 and have determined that the State met the requirements for
reasonable notice and public hearing under section 110(a)(2) of the
CAA. By operation of law under section 110(k)(1)(B) of the CAA, the
State's May 16, 2017 submittal was deemed complete by the EPA on
November 25, 2017.

IV. EPA's Evaluation of the State's May 16, 2017 Submittal

    The EPA has reviewed the revisions to Regulation No. 10 that were
submitted by the State on May 16, 2017 and we are proposing to approve
these revisions. We reviewed the State's submittal to assure
consistency with the transportation conformity requirements in 40 CFR
51.390(b), that establish the requirements for conformity consultation
SIPs and to the transportation conformity requirements in 40 CFR
93.105, 93.122(a)(4)(ii) and 93.125(c).2 3 We also consulted
our document ``Guidance for Developing Transportation Conformity State
Implementation Plans (SIPs),'' EPA-420-B-09-001, dated January 2009.\4\
---------------------------------------------------------------------------

    \2\ ``40 CFR 93 Transportation Conformity Rule PM2.5
and PM10 Amendments; Final Rule,'' March 24, 2010, 75 FR
14260.
    \3\ ``40 CFR 93 Transportation Conformity Rule Restructuring
Amendments; Final Rule,'' March 14, 2012, 77 FR 14979.
    \4\ See: http://www.epa.gov/otaq/stateresources/transconf/policy/420b09001.pdf
---------------------------------------------------------------------------

    Our review regarding the revisions to Regulation No. 10 included
the following:
    (a) The Title to Regulation No. 10. The revisions to the title
included typographic changes to the title such as capitalization, use
of lower case letters to remove capitalization of particular words and
inclusion of a sentence regarding the editor's notes at the end of the
regulation. Except for the addition of the sentence regarding the
editor's notes, we otherwise note that only typographic changes were
performed and no words or terms were added or deleted.
    (b) Section II. ``Definitions.'' The EPA has reviewed and finds
acceptable the revisions and clarifications that the state made to the
definition of ``Routine Conformity Determination.'' These revisions to
Regulation No. 10 were designed to streamline the transportation
conformity process by allowing the CDPHE to provide concurrence for a
wider range of routine

transportation conformity determinations without the need for a public
hearing before the AQCC. This change to the routine conformity
determination definition will reduce the burden on the AQCC, the CDPHE
and transportation MPOs while continuing to ensure that air quality
transportation conformity requirements are met. In addition, we note
that the changes also include the provision that notwithstanding this
general definition, the CDPHE or the AQCC may, at its discretion,
request that any transportation conformity determination be reviewed by
the AQCC. The EPA notes that such a review may also include a public
hearing before the AQCC.
    (c) Typographical corrections were made to the following sections:
Section II, definition of Review Team; Section III, subsections
III.A.2, III.A.3, III.B.1.a, III.C.1.b.(2), III.C.1.g and III.F.3.
    (d) Section VI. ``Statements of Basis, Specific Statutory
Authority, and Purpose.'' The EPA notes that the changes to this
section VI in the State's regulation merely provide information for the
State regarding the SIP revision and are not necessary for an
approvable Transportation Conformity Consultation SIP element whose
purpose is to meet the requirements of CAA section 176(c)(4)(E) and 40
CFR 51.390. Therefore, the EPA is not taking any action on this
section.

V. Summary of the EPA's Proposed Action

    For the reasons discussed in section IV above, and under CAA
section 110(k)(3), the EPA is proposing to approve the Regulation No.
10 revisions to Section II to the definition of ``Routine Conformity
Determination.'' In addition, we are proposing approval of the
typographic corrections to the Regulation No. 10 title, to Section II
and to the Section III subsections III.A.2, III.A.3, III.B.1.a,
III.C.1.b.(2), III.C.1.g and III.F.3.
    The EPA notes that revisions were also made to Colorado's
Regulation No. 10, section VI ``Statements of Basis, Specific Statutory
Authority, and Purpose''; however, the EPA is not taking any action on
the revisions to this section. The revisions to section VI are only
informational in nature for the State and do not require federal
approval into the SIP.

VI. Consideration of Section 110(1) of the Clean Air Act

    Under section 110(l) of the CAA, the EPA cannot approve a SIP
revision if the revision would interfere with any applicable
requirements concerning attainment and Reasonable Further Progress
toward attainment of the National Ambient Air Quality Standards
(NAAQS), or any other applicable requirement of the CAA. The EPA
proposes to determine that the portions of Regulation No. 10 that we
are acting on are consistent with the applicable requirements of the
CAA. Furthermore, these portions do not relax any previously approved
SIP provision; thus they do not otherwise interfere with attainment and
maintenance of the NAAQS. In addition, section 110(l) of the CAA
requires that each revision to an implementation plan submitted by a
state shall be adopted by the state after reasonable notice and
opportunity for public hearing. On February 18, 2016, the AQCC held a
public hearing and the AQCC adopted the revisions to Regulation No. 10
directly after the hearing. This SIP revision became state effective on
March 30, 2016. Therefore, the CAA section 110(l) requirements are
satisfied.

VII. Incorporation by Reference

    In this rule, the EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by
reference the approval of portions of Regulation No. 10 as submitted by
the State of Colorado and as discussed above in section IV of this
preamble. The EPA has made, and will continue to make, these materials
generally available through www.regulations.gov and at the EPA Region 8
Office (please contact the person identified in the FOR FURTHER
INFORMATION CONTACT section of this preamble for more information).

VIII. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this proposed action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, and Volatile Organic Compounds.

    Authority: 42 U.S.C. 7401 et seq.

    Dated: January 24, 2018.
Debra H. Thomas,
Acting Regional Administrator, Region 8.
[FR Doc. 2018-01853 Filed 1-31-18; 8:45 am]
 BILLING CODE 6560-50-P


XX.  Comments on Product Complaints (Final Subpart O)

A.  Organization of Final Subpart O

     In the 2003 CGMP Proposal, the requirements for consumer complaints
were set forth in § 111.95.  As shown in table 16, we are reorganizing
proposed § 111.95 into three provisions in a new subpart (Subpart O
– Product Complaints).  Table 16 lists the sections in final subpart O
and identifies the provisions that form the basis for the final rule.

Table 16. - Derivation of Sections in Final Subpart O

Final Rule	2003 CGMP Proposal

 § 111.553 What Are the Requirements Under this Subpart for Written
Procedures?	N/A

§ 111.560 What requirements Apply to the Review and Investigation of a
Product complaint? 	§ 111.95(a), (b), (c), and (d)

§ 111.570 Under this Subpart,
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楶楳湯൳††吠敨映湩污爠汵㩥

●	Includes changes that reflect the final rule applies to persons who
manufacture, package, label, or hold dietary supplements unless subject
to an exclusion in § 111.1.

● 	Uses the term “product complaint” rather than “consumer
complaint,” and the definition of “product complaint” does not
include an explanation about the types of complaints that may or may not
be covered by the CGMP regulations.  The definition does, however,
include examples of product complaints.

2.  Changes After Considering Comments

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●	A qualified person investigates any product complaint that involves
a possible failure of a dietary supplement to meet any requirements of
part 111, without an intermediate step of having the quality control
personnelunit first determine whether the complaint should be
investigated;

●	The qQuality control personnelunit reviews and approves all
decisions made by athe qualified person about whether to investigate a
product complaint and the findings and follow-up action of any
investigation performed rather than conduct the investigation and follow
up itself; and

●	The review and investigation of the product complaint extends to all
relevant batches and records, without identifying specific records, and
specific batches, that must be included in the review and investigation.

C.  General Comments on Proposed § 111.95

(Final Subpart O)

     (Comment 314) Some comments express general support for the
proposed procedures for consumer complaints.  Other comments request
proposed § 111.95 be deleted.  Most of these comments point out that
we had announced the development of CFSAN’s Adverse Event Reporting
System (CAERS) for reporting to FDA adverse events attributed to food
products and suggest that this new system would be the appropriate
mechanism for handling complaints about dietary supplements.

     (Response)  We disagree with these comments.  Because the problem
giving rise to the complaint may be associated with a failure in
manufacturing, packaging, labeling, or holding, it is CGMP for a firm
that receives a product complaint to review it and investigate, if
necessary, regardless of whether we are notified about the complaint.
An important goal of the firm’s review and investigation is to
determine whether there is a problem with the production and process
control system for the manufacture, packaging, labeling, or holding of
the dietary supplement.  That goal would not be achieved merely by
notifying us.  A firm subject to any of the requirements of this final
rule, whether such firm is a manufacturer, packager, labeler, or holder,
is responsible for the requirements in subpart O for a product complaint
it receives.

     (Comment 315)  Some comments assert that the proposed requirements
for consumer complaints do not go far enough and urge that any final
rule require any complaints that involve an adverse event be referred to
us.  The comments stress accurate reporting of adverse events is
essential to long-term evaluations of a product’s safety.

     (Response)  Mandatory reporting requirements to us regarding
adverse events related to dietary supplements are outside the scope of
this rulemaking.  This final rule addresses the internal processes and
controls that persons who manufacture, package, label, or hold dietary
supplements must follow.  Mandatory reporting to FDA of serious adverse
events, however, is now required as a result of the enactment of the
“Dietary Supplement and Non-Prescription Drug Consumer Protection
Act” (Pub. L. 109-462) signed into law on December 22, 2006.  The new
law requires manufacturers, packers, or distributors of such products to
submit reports to FDA about serious adverse events involving such
products based on specific information that they receive from the
public.  Serious adverse events are defined in the law as those events
that result in death, a life-threatening situation, an inpatient
hospitalization, a persistent or significant disability or incapacity,
or a congenital anomaly or birth defect or one that requires medical or
surgical intervention to prevent such serious outcomes (based on
reasonable medical judgment).

	As discussed in the preamble to the 2003 CGMP Proposal (68 FR 12157 at
12217), however, we continue to strongly recommend that firms that
receive such product complaints, that are not “serious adverse
events,” notify us about any illness or injury, because, for example,
we may have additional expertise or data that may be helpful in
investigating the complaint or determining whether the problem applies
to more than one product.  In light of the requirement in the final rule
to establish and follow written procedures for handling product
complaints, we encourage you to include our recommendations in the
written procedures that you develop for handling product complaints (see
discussion of final § 111.553 in this section).

     (Comment 316) Some comments raise questions about who would be
subject to the proposed requirements regarding consumer complaints.
Some comments state the section should apply only to manufacturers of
dietary supplements, not to manufacturers of dietary ingredients.  Other
comments are concerned that distributors who merely put their label on
the finished product may be held responsible for keeping records of
adverse events caused by failures to follow CGMPs during the manufacture
of the supplements.

     (Response) The final rule only applies to persons who manufacture,
package, label, or hold a dietary supplement.  We discuss the scope of
this final rule in detail in section VI.

     In most cases, the person who receives a product complaint from a
consumer will be the manufacturer, packager, or distributor of the
dietary supplement.  A distributor (also a “holder” under this final
rule) who receives a product complaint must review and investigate that
complaint to determine whether the complaint relates to a failure of the
processes under the control of the distributor, such as conditions of
temperature, humidity, and light that could affect the identity, purity,
strength, or composition of the dietary supplement.  If the distributor
concludes the problem is unrelated to any process under the control of
the distributor, the distributor should contact the manufacturer.  Under
the final rule, any person in the manufacturing chain who receives a
product complaint - regardless of the source - must comply with the
requirements in this subpart O.

     (Comment 317) One comment suggests proposed § 111.95, which
describes requirements for consumer complaints, could be combined with
proposed § 111.85 which describes requirements for returned dietary
supplements.

     (Response) We decline to adopt this suggestion.  In this final
rule, we are incorporating the requirements for returned dietary
supplements into a distinct subpart (final subpart N) that sets forth
requirements for returned dietary supplements. The procedures described
in final subpart O, which relate solely to the handling of product
complaints rather than returned dietary supplement products, are quite
different from those described in final subpart N, which addresses the
handling, review, and possible reprocessing of returned product.

     (Comment 318) Some comments assert the proposed requirements for
complaints are different from those for food CGMPs.

     (Response) We are making no changes to the requirements after
considering these comments.  We responded to similar comments asserting
that certain aspects of the proposed regulations are different from
those for other food CGMP requirements in section V.

D.  What Are the Requirements under this Subpart

for Written Procedures?

(Final § 111.553)

     We received many comments which recommended written procedures for
various provisions.  We address the need for written procedures
generally in section IV.  We also respond to individual comments on
specific provisions in the same section.

Final § 111.553 requires that you establish and follow written
procedures to fulfill the requirements of this subpart O.   Under final
§ 111.570(b)(1) we require you to make and keep records of such
procedures.  Such records would be required to be made available to us
under the requirements in subpart P.

	We encourage you to include in your written procedures the
recommendation made in the 2003 CGMP Proposal for you to consult with a
health care provider if you receive complaints that involve serious
illness or injury.  and for you to notify us about complaints of illness
or injury associated with the quality of the dietary supplementEven if
the complaints are not required to be submitted to FDA under the newly
enacted “Dietary Supplement and Non-Prescription Drug Consumer
Protection Act” (Pub. L. 109-462), we encourage your company to notify
us about the product complaints.  nder this newly enacted law, which
requires reporting to FDA of “serious adverse events,”
Mmanufacturers and distributors should be aware that this newly enacted
law, which requires reporting to FDA of “serious adverse events,”
contains the new mandatory provisions that require record retention of
adverse event reports that are separate from the requirements in this
CGMP final rule concerning product complaints.

E.  What Requirements Apply to the Review and Investigation of a Product
Complaint?

(Final § 111.560)

1.  Final § 111.560(a)(1)

     Final § 111.560(a)(1) requires a qualified person to review all
product complaints to determine whether the product complaint involves a
possible failure of a dietary supplement to meet any of its
specifications, or any other requirements of part 111, including those
specifications and other requirements that, if not met, may result in a
risk of illness or injury.  Final § 111.560(a)(1) derives from
proposed § 111.95(a).

     We did not receive comments specific to proposed § 111.95(a).

2.  Final § 111.560(a)(2), (b), and (c)

     Final § 111.560(a)(2) requires a qualified person to investigate
any product complaint that involves a possible failure of a dietary
supplement to meet any of its specifications, or any other requirements
of part 111, including those specifications and other requirements that,
if not met, may result in a risk of illness or injury.  Final
§ 111.560(b) requires that the quality control personnel unit review
and approve decisions by the qualified person about whether or not to
investigate a product complaint and the findings and follow-up action of
any investigation performed.  Final § 111.560(c) requires that the
review and investigation extend to all relevant batches and records.

     (Comment 319) Some comments characterize the requirements of
proposed § 111.95 as a confusing and difficult scheme to review,
investigate, and resolve customer complaints.  These comments state the
2003 CGMP Proposal would require extensive human resources,
recordkeeping, and decision-making.

     (Response)  We disagree that the 2003 CGMP Proposal would require
extensive human resources, recordkeeping, or decision making.  The
comments provided no rationale for such assertions.  The 2003 CGMP
Proposal sets forth basic steps, i.e., review, evaluation, and
follow-up, that one would need to take to appropriately address a
product complaint.  For those product complaints for which there is a
reasonable possibility of a relationship to an adverse event, the 2003
CGMP Proposal would require that an investigation be done by the quality
control unit because we believe such an event would need more careful
review and follow-up.

	To address the comments that found proposed § 111.90 confusing, we
have made the following changes in the final rule to simplify the
procedures for handling product complaints:

●	Replaced the proposed procedure in which a qualified person
determines whether a complaint should be investigated by the quality
control unit with a procedure in which a qualified person investigates
any product complaint that involves a possible failure of a dietary
supplement to meet any require敭瑮⁳景瀠牡⁴ㄱ⸱

●	Require an oversight function by the quality control personnelunit
for the review and evaluation of product complaints, but not require
that the quality control personnelunit do any investigations on its own.
 This is consistent with other changes that we are making in response to
comments that requested that the quality control unit focus on reviewing
tasks performed by others rather than on performing the tasks itself.

●	Refer to “any product complaint that involves a possible failure
of a dietary supplement to meet any of its specifications, or any other
requirements of this part [part 111], including those specifications and
other requirements that, if not met, may result in a risk of illness or
injury” rather than to “a reasonable possibility of a relationship
between the quality of a dietary supplement and an adverse event.”
This is consistent with changes that we are making to the definition of
the term “product complaint” in final § 111.3 (see section VI).

●	Continue to require that the review and investigation of the product
complaint extend to all relevant batches and records but simplify the
language of the requirement by removing the details – i.e., that the
investigation must include the batch records associated with the dietary
supplement involved in the consumer complaint and not specifying that
the investigation must extend to other batches of dietary supplement.
Rather, we require that the investigation must extend to all relevant
batches and records.

     The final rule provides firms flexibility on how to use its human
resources.  Nothing in subpart O would preclude a qualified person
amongwithin the designated quality control personnelunit to be
designated to from actually reviewing product complaints and conducting
investigations of any product complaint.  If an individual is so
designated and  the quality control unit conducts the investigation,
reviews and approves the findings, and conducts follow up actions of any
investigation performed, final § 111.560(b) would not apply.

    (Comment 320) Some comments object to the requirement in proposed §
111.95(c) that consumer complaints are to be investigated only when
there may be a relationship between product quality and an adverse
event.  These comments suggest this provision be extended to any
possible relationship between dietary supplements and adverse events,
including those that might be independent of whether the product is
produced under CGMPs.  These comments consider there should be
consistent procedures for handling product complaints, regardless of
whether the complaints relate to product quality.

     (Response) The action requested in these comments is outside the
scope of this rule, which specifically addresses CGMP requirements to
ensure the quality of the dietary supplement product.  However, we
encourage firms to investigate all product complaints in a consistent
way, regardless of whether the complaints relate to the quality of the
dietary supplement.

     (Comment 321) Some comments request clarification of statements
made or terms used in the preamble to the 2003 CGMP Proposal regarding
the handling of product complaints.  In the  preamble discussion of
proposed § 111.95(c), we stated a consumer complaint about adverse
effects “after consuming several dietary supplements” is worthy of
quality control unit investigation.  One comment asks about the meaning
of “several” and whether this example means that a manufacturer is
responsible for consumers who take more than the recommended dosage.

     (Response) In our discussion of proposed § 111.95(c) we addressed
a situation where a consumer had symptoms on more than one occasion
rather than a situation where a consumer took more than the recommended
dosage.  However, firms must investigate any complaint of illness or
injury even if a consumer reports that he/she has consumed more than the
amount recommended on the product label to determine if the complaint is
related to CGMP.

F.  Under this Subpart, What Records must You Make and Keep?  (Final
§ 111.570)

1.  Final § 111.570(a)

     Final § 111.570(a) requires you to make and keep the records
required under subpart O in accordance with subpart P.  Final
§ 111.570(a) derives from proposed § 111.95(f)(2) with changes
associated with the reorganization.

     We did not receive comments specific to proposed § 111.95(f)(2).

2.  Final § 111.570(b)(1)

     As discussed in § 111.570(b)(1) the final rule includes a new
requirement, final § 111.553, which requires written procedures for
fulfilling the requirements of subpart O.  Those written procedures are
records.  Another new provision, final § 111.570(b)(1), requires you
to make and keep a record of the written procedures for fulfilling the
requirements of subpart O.

3.  Final § 111.570(b)(2)

     Final § 111.570(b)(2) requires you to make and keep a written
record of every product complaint that is related to CGMP.  Final
§ 111.570(b)(2) derives from proposed § 111.95(e) which would
require that you

. . . make and keep a written record of every consumer complaint that is
related to good manufacturing practices.  For the purposes of the
regulations in this part, a consumer complaint about product quality may
or may not include concerns about a possible hazard to health.  However,
a consumer complaint does not include an adverse event, illness, or
injury related to the safety of a particular dietary ingredient
independent of whether the product is produced under good manufacturing
practices.

	As a revision for consistency with the definition of “product
complaint” in final § 111.3, final § 111.570(b)(2) does not
include the two full sentences from proposed § 111.95(e), as quoted
above.

4.  Final § 111.570(b)(2)(i)

     Final § 111.570(b)(2)(i) requires that the person who performs
the requirements of subpart O, at the time of performance, document and
record the performance.  Final § 111.570(b)(2)(i) is similar to
proposed § 111.95(f)(1) with changes associated with the
reorganization.

5.  Final § 111.570(b)(2)(ii)

     Final § 111.570(b)(2)(ii) requires that the written record of the
product complaint include: (1) The name and description of the dietary
supplement; (2) the batch, lot, or control number of the dietary
supplement, if available; (3) the date the complaint was received and
the name, address or telephone number of the complainant, if available;
(4) the nature of the complaint including, if known, how the product was
used; (5) the reply to the complainant, if any; and (6) findings of the
investigation and follow-up action taken when an investigation is
performed.  Final § 111.570(b)(2) is similar to proposed
§ 111.95(e)(1) through (e)(6) and includes a change we are making
after considering comments to proposed § 111.95(e)(4) (discussed
below) which would have required that the consumer complaint written
record include “The nature of the complaint including how the consumer
used the product.”  On our own initiative, we also made a change to
include the date the complaint was received.

     (Comment 322) One comment notes proposed § 111.95(e)(4) would
require the written record of consumer complaints to include “how the
consumer used the product.”  The comment notes this information may
not always be available and suggests the words “where known” should
be added.

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     (Comment 323) Some comments request clarification of statements
made or terms used in the preamble to the 2003 CGMP Proposal regarding
the handling of product complaints.  In our discussion of proposed
§ 111.95(e) we recommended that consumer complaints and investigations
be reported to us when consumption of a dietary supplement may be
related to “a serious adverse event.”  Some comments note that
“serious” is not defined.

     (Response) The term “serious adverse event” is widely used in
the industries we regulate.  Our current forms for reporting “serious
adverse events” via the MedWatch program do not define the term, but
instead list outcomes that were attributed to an adverse event.  These
outcomes include death, life-threatening, hospitalization (initial or
prolonged), disability, congenital anomaly, required intervention to
prevent (a serious adverse event), permanent impairment/damage, and
“other.”  As discussed in this section, however, there is a new
statutory requirement for mandatory reporting to FDA of serious adverse
events enacted in the “Dietary Supplement and Non-Prescription Drug
Consumer Protection Act” (Pub. L. 109-462).  The new law does define
“serious adverse events” as those events that result in death, a
life-threatening situation, an inpatient hospitalization, a persistent
or significant disability or incapacity, or a congenital anomaly or
birth defect or one that requires medical or surgical intervention to
prevent such serious outcomes (based on reasonable medical judgment).
The law also has specific provisions for how these serious adverse
events are to be submitted to FDA and record retention for records
relating to these and other adverse event reports.  We anticipate
issuing guidance on implementation of the new statutory provisions.  We
encourage firms who are unsure as to whether the nature of a reported
adverse event should be merits reporteding to FDA to contact us for
assistance.

FDA-Internal-Confidential-Deliberative

Final Subpart O 9-28-05, 6-26-06, 3-30-07, 5-04-07

Page   PAGE  920