[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)]
[Notices]
[Pages 4434-4437]
[FR Doc No: 2017-00626]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-79764; File No. SR-DTC-2016-008]

Self-Regulatory Organizations; The Depository Trust Company;
Order Granting Approval of Proposed Rule Change Relating To Processing
of Transactions in Money Market Instruments

January 9, 2017.
    The Depository Trust Company (``DTC'') filed on September 23, 2016
with the Securities and Exchange Commission (``Commission'') proposed
rule change SR-DTC-2016-008 (``Proposed Rule Change'') pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4 thereunder.\2\ The Proposed Rule Change was published
for comment in the Federal Register on October 11, 2016.\3\ On,
November 18, 2016, the Commission extended to January 9, 2017 the date
by which it shall either approve, disapprove, or institute proceedings
to determine whether to approve or disapprove the Proposed Rule
Change.\4\ The Commission did not receive any comments on the Proposed
Rule Change. For the reasons discussed below, the Commission is
granting approval of the Proposed Rule Change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 34-79046 (October 5,
2016), 81 FR 70200 (October 11, 2016) (SR-DTC-2016-008)
(``Notice''). DTC also filed the Proposed Rule Change as an advance
notice with the Commission, pursuant to Section 806(e)(1) of the
Payment, Clearing, and Settlement Supervision Act of 2010 and Rule
19b-4(n)(1) under the Act. 12 U.S.C. 5465(e) and 17 CFR 240.19b-
4(n)(1), respectively. The advance notice was published in the
Federal Register on November 9, 2016. Securities Exchange Act
Release No. 79224 (November 3, 2016), 81 FR 78884 (November 9, 2016)
(SR-DTC-2016-802). The Commission did not receive any comments on
the advance notice.
    \4\ Securities Exchange Act Release No. 34-79351 (November 18,
2016), 81 FR 85295 (November 25, 2016) (SR-DTC-2016-008)
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I. Description of the Proposed Rule Change

    The Proposed Rule Change is a proposal by DTC to modify (i) the DTC
Rules, By-laws and Organization Certificate (``Rules''),\5\ (ii) the
DTC Settlement Service Guide (``Settlement Guide''),\6\ and (iii) the
DTC Distributions Service Guide (``Distributions Guide''),\7\ in order
to change the way in which DTC processes transactions in money market
instruments (``MMI''). The proposal would affect DTC's processing of
issuances of MMI securities as well as maturity presentments, income
presentments, principal presentments, and reorganization presentments
(collectively, ``presentments'' and with issuances of MMI securities,
``MMI Obligations'').
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    \5\ Available at http://www.dtcc.com/legal/rules-and-procedures.aspx.
    \6\ Available at http://www.dtcc.com/~/media/Files/Downloads/
legal/service-guides/Settlement.pdf.
    \7\ Available at http://www.dtcc.com/~/media/Files/Downloads/
legal/service-guides/
Distributions%20Service%20Guide%20FINAL%20November%202014.pdf.
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    Specifically, DTC proposes to: (i) With respect to delivery of MMI
securities, require purchasers of the securities (or their custodian,
if applicable) to acknowledge that they agree to receive the securities
via DTC's Receiver Authorized Delivery (``RAD'') system before DTC
processes the transaction; (ii) with respect to cash, require an
issuing and paying agent (``IPA'') of an MMI issuer to acknowledge its
funding obligations for MMI presentments before DTC processes the
transaction, except in limited circumstances where there are no funding
obligations; \8\ (iii) implement an enhanced process to check certain
MMI transactions against DTC's risk management controls (referred to as
``MMI Optimization''); (iv) eliminate the largest provisional net
credit risk management control; and (v) eliminate DTC's receive versus
payment net additions control, as described below. In addition, the
proposal would amend DTC's Distributions Guide to conform to the
proposed changes.
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    \8\ An affirmative MMI funding acknowledgement by the IPA would
not be required where the aggregate amount of an issuer's delivery
of MMI securities that have been approved in RAD exceeds the
aggregate amount of presentments because payment for those
securities would fully fund the presentments. In such a case, the
IPA would be deemed to have provided a funding acknowledgement and
DTC would process the transactions, subject to risk management
controls.
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A. Background

    Today, according to DTC, when an issuer issues MMI securities at
DTC, the IPA for that issuer sends issuance

instructions to DTC electronically, which results in crediting the
applicable MMI securities to the DTC account of the IPA. The MMI
securities are then delivered by DTC to the accounts of the applicable
DTC participants (``Participants'') that are purchasing the issuance,
typically as custodians for individual investors, in accordance with
their purchase amounts. The IPA's delivery instructions may be free of
payment or, most often, for payment (i.e., delivery versus payment or
``DVP''). Unlike deliveries free of payment, DVP transactions are
subject to DTC's risk management controls for both the IPA and the
receiving Participants, which means they are monitored for Net Debit
Cap and Collateral Monitor sufficiency.\9\
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    \9\ DVP transfers at DTC are structured so that the completion
of delivery of securities to a Participant in end-of-day settlement
is contingent on the receiving Participant satisfying its end-of-day
net settlement obligation, if any. The risk of Participant failure
to settle is managed through risk management controls that would
enable DTC to complete settlement despite the failure to settle of
the Participant, or affiliated family of Participants, with the
largest net settlement obligation. The two principal controls are
the Net Debit Cap and Collateral Monitor. The largest net settlement
obligation of a Participant or affiliated family of Participants
cannot exceed DTC liquidity resources, based on the Net Debit Cap,
and must be fully collateralized, based on the Collateral Monitor.
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    When MMI securities of a particular acronym \10\ mature, the
current presentment process involves DTC automatically sweeping the
matured positions from the applicable Participant accounts and debiting
the settlement account of the applicable IPA for the amount of the
matured position, with corresponding credits made to the settlement
accounts of the deliverers. Because presentments are currently
processed automatically at DTC, IPAs have the option to refuse to pay
(``RTP'') for maturing MMI Obligations to protect against the
possibility that an IPA may not be able to fund settlement because it
has not received funds from the relevant issuer. An IPA that refuses
payment for a presentment (i.e., refuses to make payment for the
delivery of matured MMI securities for which it is the designated IPA
and/or pay interest or dividend income on MMI securities for which it
is the designated IPA) must notify DTC of its RTP. An IPA may notify
DTC of an RTP until 3:00 p.m. ET on the date of the affected
presentment.
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    \10\ MMI of an issuer are designated by DTC using unique four-
character identifiers referred to as acronyms. An MMI issuer can
have multiple acronyms representing its securities. MMI transactions
and other functions relating to MMI are done on an ``acronym-by-
acronym'' basis.
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    Under the current Rules, the effect of an RTP is for DTC to reverse
all processed MMI security deliveries of that MMI acronym, including
issuances, related funds credits and debits, and presentments, which
means that the securities would fail to settle. This reversal of
processed (but not yet settled) transactions could override DTC's risk
management controls (i.e., Collateral Monitor and Net Debit Cap) and
could result in a Participant's account having, unexpectedly, a net
debit balance that exceeds its Net Debit Cap and/or having insufficient
collateral to secure its settlement obligations throughout the day.
Thus, RTPs can create uncertainty and pose systemic risk with respect
to a Participant's and, ultimately, DTC's ability to complete end-of-
day net funds settlement.
    Currently, to mitigate the risks associated with an RTP, the Rules
and the Settlement Guide provide for the Largest Provisional Net Credit
control (``LPNC Control''). Under the LPNC Control, DTC withholds from
each Participant's Net Debit Cap the two largest intraday net MMI
credits owed to that Participant. The MMI credits withheld are not
included in the calculation of the Participant's Collateral Monitor or
its net debit balance. This provides protection in the event that
processed (but not yet settled) MMI transactions are reversed by DTC as
a result of an RTP.\11\
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    \11\ See Securities Exchange Act Release No. 71888 (April 7,
2014), 79 FR 20285 (April 11, 2014) (SR-DTC-2014-02) (clarifying the
LPNC procedures in the Settlement Guide) and Securities Exchange Act
Release No. 68983 (February 25, 2013), 78 FR 13924 (March 1, 2013)
(SR-DTC-2012-10) (updating the Rules related to LPNC).
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    According to DTC, its Rules and procedures relating to settlement
processing for the MMI program \12\ were designed to limit credit,
liquidity, and operational risk for DTC and Participants. In connection
with ongoing efforts by DTC to evaluate the risk associated with the
processing of MMI Obligations, DTC has determined that the risks
presented by intra-day reversals of processed MMI Obligations should be
eliminated to prevent the possibility that a reversal could override
DTC's risk controls and heighten liquidity and settlement risk. DTC
also states that eliminating intra-day reversals of processed MMI
Obligations would enhance intra-day finality and allow for the
elimination of the LPNC Control, which creates intra-day blockage and
affects liquidity through the withholding of settlement credits.
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    \12\ The procedures applicable to MMI settlement processing are
set forth in the Settlement Guide. Supra note 6.
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B. Proposed Changes

    The proposal would eliminate provisions for intra-day reversals of
processed MMI Obligations based on an IPA's RTP or issuer insolvency of
which DTC becomes aware, as described below.
    Pursuant to the proposal, DTC would no longer automatically process
MMI Obligations. DTC's processing of MMI Obligations involves the
delivery of cash and/or securities. With respect to securities, DTC
would require purchasers of MMI issuances (or their custodian, if
applicable) to acknowledge in RAD that they agree to receive the MMI
securities before DTC processes the transaction. With respect to cash,
an IPA would make an MMI funding acknowledgment using a new DTC
platform designed to accept such acknowledgments. When an MMI funding
acknowledgement is received, DTC would attempt to process transactions
in the acronym(s) for which the MMI funding acknowledgment pertains.
    If the IPA has provided an MMI funding acknowledgment for the full
amount of presentments, then all transactions in that acronym would be
sent to the normal DTC processing system and tested against DTC's risk
management controls. If the IPA provides an MMI funding acknowledgement
for only partial funding of the presentments, then DTC would undertake
the proposed ``MMI Optimization'' process to determine whether risk
management controls would be satisfied by all deliverers and purchasers
of the acronym and determine whether all parties would maintain
adequate positions to complete the applicable transactions. However, as
long as the issuances that could satisfy deliverer and purchaser risk
controls for that MMI acronym are equal to or greater than the maturing
presentments of that acronym, the applicable transactions (i.e., those
that pass risk controls) could be processed without an IPA's funding
acknowledgement.
    If DTC does not receive the necessary acknowledgments from both the
IPA and purchasers for an acronym for which maturing MMI Obligations
are due on that day and/or DTC is aware, through ordinary business
channels, that the issuer of an acronym is insolvent (``Acronym Payment
Failure''), then DTC would not process transactions in the acronym.\13\
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    \13\ DTC would automatically consider an Acronym Payment Failure
that occurred due to an IPA's failure to provide timely MMI funding
acknowledgement (i.e., provide the acknowledgment by 3:00 p.m. ET)
as an RTP.
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    In the event of an Acronym Payment Failure, DTC would: (i) Prevent
further issuance and maturity activity for the acronym in DTC's system;
(ii) prevent

deliveries of MMI securities of the acronym and halt all activity in
that acronym; (iii) set the collateral value of the MMI securities in
the acronym to zero for purposes of calculating the Collateral Monitor
of any affected Participant; and (iv) notify Participants of the
Acronym Payment Failure via DTC's current notification process.
Notwithstanding the occurrence of an Acronym Payment Failure, the IPA
would remain liable for funding pursuant to any MMI funding
acknowledgment previously provided for that business day.
    A ``Temporary Acronym Payment Failure'' would occur when an IPA
notifies DTC that it temporarily refuses to pay income presentments,
and only income presentments, for an acronym, which typically would be
due to an issuer's inability to fund income presentments on that day. A
Temporary Acronym Payment Failure would only be initiated if there are
no maturity presentments, principal presentments, and/or reorganization
presentments on that business day. DTC would require the issuer and/or
IPA to resolve such a situation by the next business day.
    In the event of a Temporary Acronym Payment Failure, DTC would: (i)
Temporarily devalue to zero all of the issuer's MMI securities for
purposes of calculating the Collateral Monitor, unless and until the
IPA acknowledges funding with respect to the income payments on the
following business day; (ii) notify Participants of the delayed
payment; and (iii) block from DTC's systems all further issuances and
maturities by that issuer for the remainder of the business day on
which notification of the Temporary Payment Failure was received by
DTC. An IPA would not be able to avail itself of a Temporary Acronym
Payment Failure for the same acronym on consecutive business days.
    The Commission understands that the proposal would not: (i)
Decrease the total number and value of transactions that would pass
DTC's risk controls throughout the processing day; or (ii) increase the
volume of transactions that would fail to settle. The Commission also
understands that the proposal would reduce blockage caused by DTC. Non-
MMI transactions and fully funded MMI transactions would likely have a
reduction in blockage because of the elimination of the LPNC Control.
The elimination of the LPNC Control would no longer withhold billions
of dollars of settlement credits as it does today, thus permitting MMI
transactions subject to the LPNC Control to process earlier in the day.
Moreover, it is expected that the value and volume of MMI transactions
recycling due to failure to meet DTC's risk management controls during
the late morning and afternoon periods would be reduced, because of
such transactions being held outside of DTC's processing system while
they await the necessary acknowledgments.
    Similar to the LPNC Control, the RVPNA Control is used to prevent a
Participant from delivering free of value or undervalued any MMI
securities that were received for payment on the same day.\14\ For
example, under DTC's current rules, if Participant A delivers MMI
securities to Participant B for payment, and then Participant B
delivers the same MMI securities to Participant C free of payment
(subject to risk management controls), the delivery to Participant C is
final when the securities are credited to Participant C. DTC would,
therefore, be unable to reverse the delivery to Participant C and,
thus, DTC could not reverse the delivery from Participant B to
Participant A. The RVPNA Control protects DTC against being unable to
reverse such transactions of MMI Securities in the event of an RTP by
the IPA. Because DTC would no longer permit the reversal of processed
MMI transactions, DTC would no longer need the RVPNA Control.
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    \14\ For purposes of RVPNA, MMI securities are considered
undervalued if they are delivered for less than 10 percent below
market value.
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II. Discussion and Commission Findings

    Section 19(b)(2)(C) of the Act \15\ directs the Commission to
approve a proposed rule change of a self-regulatory organization if it
finds that such proposed rule change is consistent with the
requirements of the Act and rules and regulations thereunder applicable
to such organization. The Commission believes the Proposed Rule Change
is consistent with Section 17A(b)(3)(F) of the Act and Rule 17Ad-
22(d)(12) under the Act,\16\ as described in detail below.
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    \15\ 15 U.S.C. 78s(b)(2)(C).
    \16\ 15 U.S.C. 78q-1(b)(3)(F); 17 CFR 240.17Ad-22(d)(12).
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A. Consistency With Section 17A(b)(3)(F) of the Act

    Section 17A(b)(3)(F) of the Act requires, in part, that the rules
of a clearing agency be designed to promote the prompt and accurate
clearance and settlement of securities transactions and to protect
investors and the public interest.\17\
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    \17\ 15 U.S.C. 78q-1(b)(3)(F).
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    The Commission believes that the Proposed Rule Change is consistent
with promoting prompt and accurate clearance and settlement. First, as
described above, DTC automatically processes MMI transactions today but
permits RTPs in order to enable IPAs to protect against the possibility
that the IPA does not receive the necessary funds from the relevant
issuer. However, if DTC reverses processed (but not yet settled) MMI
transactions because of an RTP, the transactions would fail to settle
and the reversal could override DTC's risk management controls.
    The Proposed Rule Change would eliminate such reversals, failures,
and possible overrides because the proposal would require, before DTC
would process an MMI transaction, that (i) purchasers of MMI issuances
(or their custodian, if applicable) authorize delivery of the MMI
securities, and (ii) IPAs provide an MMI funding acknowledgement that
commits the IPA to the acknowledge funds. If DTC does not receive a RAD
authorization or MMI funding acknowledgement, as applicable, it would
not process the MMI transaction. However, if a RAD authorization or an
MMI funding acknowledgment is receive, DTC would no longer permit an
RTP for what was authorized or acknowledge, thus eliminating the risk
that the applicable MMI transaction would fail to settle or override
DTC's risk management controls due to an RTP. Although theses proposed
changes would establish new requirements before DTC would process such
MMI transactions, the Commission believes that the benefits of
eliminating the risk of a potential override of DTC's risk management
controls from an RTP supports such requirements.
    Second, the Proposed Rule Change would help ensure prompt and
accurate clearance and settlement securities by employing the proposed
MMI Optimization. MMI Optimization would, for MMI transactions that
await funding, continually test the net effect of transactions, across
multiple MMI issuers, on receiving and delivering Participants' risk
controls, and then process the transactions once the controls are met.
As such, MMI Optimization would help maximize processing and facilitate
more timely settlement of MMI transactions, thus reducing risks that
transactions may not settle.
    Third, the proposed removal of the LPNC and RVPNA Controls also
would further promote prompt clearance and settlement. As described
above, the LPNC Control currently withholds from each Participant the
two largest intraday net MMI credits out of all of the MMI credits owed
to that Participant in order to protect DTC from a Participant

breaching its Net Debit Cap or having insufficient collateral in the
event of a reversal caused by an RTP. However, withholding the credits
makes them unavailable to the Participant, which can cause blockage
(i.e., the failure of a transaction to process because of insufficient
liquidity) for the Participant. Meanwhile, the RVPNA Control limits a
Participant's ability to deliver MMI that the Participant is due to
receive that day. By preventing Participants from delivering certain
MMI securities, the RVPNA Control also can create blockage.
    Because DTC would no longer process MMI transactions without a
purchaser's RAD authorization and an IPA's MMI funding acknowledgement,
as applicable, RTPs and resulting intraday reversals no longer present
the risk that the LPNC and RVPNA Controls are meant to address. As
such, DTC would eliminate these controls. This change would make
available to Participants the intraday credits that were previously
withheld by those controls, which would decrease intraday liquidity
blockage for the Participant and enable DTC to process MMI transactions
earlier. Thus, Participants would have less exposure to intraday
reversals that increase liquidity and settlement risk and a more
complete view of their actual intraday net debit and credit balances.
    The Commission also believes that the Proposed Rule Change is
consistent with protecting investors and the public interest. As
described above, DTC would no longer automatically process MMI
presentments. Rather, DTC would require purchasers to authorize
delivery via RAD and IPAs to provide a funding acknowledgment before
processing MMI presentments, as applicable. Because these changes would
eliminate the risk of reversals due to an RTP, the changes would
mitigate the risk of a potential override of DTC's risk management
controls. Thus, the Proposed Rule Change would help protect investors
and the public interest by reducing DTC's exposure to potential
failures, promoting DTC's safety and soundness, and providing greater
assurance that transactions will settle despite a Participant default.
    Therefore, for the above reasons, the Commission believes that the
Proposed Rule Change will help promote the prompt and accurate
clearance and settlement of securities transactions and help protect
investors and the public interest, consistent with Section 17A(b)(3)(F)
of the Act, cited above.

B. Consistency With Rule 17Ad-22(d)(12)

    Rule 17Ad-22(d)(12) under the Act requires DTC to establish,
implement, maintain and enforce written policies and procedures
reasonably designed to ensure that final settlement occurs no later
than the end of the settlement day; and require that intraday or real-
time finality be provided where necessary to reduce risks.\18\ Through
this proposal, DTC would no longer process MMI transactions
automatically but, rather, would first require an IPA's funding
acknowledgment and a purchaser's RAD authorization, as applicable.
Where such acknowledgements and authorizations are provided, DTC would
no longer permit an RTP, thus eliminating the risk of an intraday
reversal of a processed MMI transaction. Additionally, the proposal
would eliminate the LPNC and RVPNA Controls, which would help eliminate
blockage caused by the LPNC Control's withholding of Participants' two
largest net credits for MMI transactions and the RVPNA Control's
restriction on delivering certain MMI securities. Each of these
proposed changes, both individually and collectively, would help ensure
that final settlement occurs at the end of the day. Therefore, the
Commission believes that the changes proposed in the Advance Notice are
consistent with Rule 17Ad-22(d)(12) under the Act.\19\
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    \18\ 17 CFR 240.17Ad-22(d)(12).
    \19\ Id.
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III. Conclusion

    On the basis of the foregoing, the Commission finds that the
Proposed Rule Change is consistent with the requirements of the Act and
in particular with the requirements of Section 17A of the Act \20\ and
the rules and regulations thereunder.
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    \20\ 15 U.S.C. 78q-1.
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    It is therefore ordered, pursuant to Section 19(b)(2) of the Act,
that proposed rule change SR-DTC-2016-008 be, and hereby is, Approved
as of the date of this order or the date of a notice by the Commission
authorizing DTC to implement DTC's advance notice proposal (SR-DTC-
2016-802) that is consistent with this Proposed Rule Change, whichever
is later.\21\
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    \21\ In approving the proposed rule change, the Commission
considered the proposals' impact on efficiency, competition, and
capital formation. 15 U.S.C. 78c(f).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\22\
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    \22\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-00626 Filed 1-12-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 128 (Thursday, July 6, 2017)]
[Rules and Regulations]
[Pages 31250-31252]
[FR Doc No: 2017-13950]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0125; Directorate Identifier 2016-NM-193-AD;
Amendment 39-18946; AD 2017-14-02]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc., Airplanes

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

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Bombardier, Inc., Model DHC-8-401 and DHC-8-402 airplanes. This AD was
prompted by a report that a pilot was unable to move the rudder pedal
due to an obstruction. This AD requires an inspection to determine if
wiring shrouds are present, and modifying the wiring shrouds if
necessary. We are issuing this AD to address the unsafe condition on
these products.

DATES: This AD is effective August 10, 2017.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of August 10,
2017.

ADDRESSES: For service information identified in this final rule,
contact Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt
Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>Internet
http://www.bombardier.com. 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<PHONE_NUMBER>. It is also available on the
Internet at http://www.regulations.gov by searching for and locating
Docket No. FAA-2017-0125.

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-2017-
0125; 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 street 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: Cesar Gomez, Aerospace Engineer,
Airframe and Mechanical Systems Branch, ANE-171, FAA, New York Aircraft
Certification Office (ACO), 1600 Stewart Avenue, Suite 410, Westbury,
NY 11590; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain Bombardier, Inc.,
Model DHC-8-401 and DHC-8-402 airplanes. The NPRM published in the
Federal Register on March 2, 2017 (82 FR 12301). The NPRM was prompted
by a report that a pilot was unable to move the rudder pedal due to an
obstruction. The NPRM proposed to require an inspection to determine if
wiring shrouds are present, and modifying the wiring shrouds if
necessary. We are issuing this AD to prevent an obstruction that could
prevent rudder pedal movement during critical phases of flight or
ground operations, potentially resulting in loss of control of the
airplane.
    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued Canadian AD CF-2016-27, dated
September 14, 2016 (referred to after this as the Mandatory Continuing
Airworthiness Information, or ``the MCAI''), to correct an unsafe
condition for certain Bombardier, Inc., Model DHC-8-401 and DHC-8-402
airplanes. The MCAI states:

    An operator reported that the flying pilot was unable to move
the rudder pedal due to an obstruction caused by the non-flying
pilot's foot. The shoe belonging to the non-flying pilot was placed
between the rudder pedal and the newly installed wiring shroud and
prevented rudder pedal movement. The wiring shroud was installed to
support the wire harnesses installed below the cockpit instrument
panel.
    If not corrected, this condition could prevent rudder movement
during critical phases of flight or ground operation, and result in
loss of control of the aeroplane.
    This [Canadian] AD was issued to re-work the wiring shrouds to
eliminate potential for obstruction.

    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-2017-
0125.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the NPRM and
the FAA's response to each comment.

Support for the NPRM

    The Air Line Pilots Association, International, stated that it
supports the NPRM.

Request To Refer to Updated Service Information and Provide Credit

    Horizon Air requested that we revise the proposed AD to refer to
the newest version of the service information, Bombardier Service
Bulletin 84-25-169, Revision B, dated February 17, 2017. Horizon Air
also asked that we provide credit for previous actions done using
Bombardier Service Bulletin 84-25-169, Revision A, dated April 25,
2016.
    We agree with the commenter's requests. We have determined that the
new service information does not require any additional actions for
airplanes modified using Revision A. We have revised this AD to refer
to Bombardier Service Bulletin 84-25-169, Revision B, dated February
17, 2017. We have also added paragraph (h) to this AD to provide credit
for previous actions and redesignated subsequent paragraphs
accordingly.

Request To Reference Only the Actions Required for Compliance

    Horizon Air requested that we revise the requirements of the
proposed AD to mandate only the actions in paragraph 3.B.,
``Procedure'' of the Accomplishment Instructions of Bombardier Service
Bulletin 84-25-169, Revision B, dated February 17, 2017, rather than
the entire Accomplishment Instructions. Horizon Air explained that
requiring the job set-up and close-out sections of the service
information restricts an operator's ability to perform other
maintenance at the same time as incorporating the service information.
    We agree with the commenter's request because it provides operators
additional flexibility, while still ensuring the unsafe condition is
corrected. We have revised paragraph (g) of this AD accordingly.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this AD with the changes described previously and minor editorial
changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of this AD.

Related Service Information Under 1 CFR Part 51

    We reviewed Bombardier Service Bulletin 84-25-169, Revision B,
dated February 17, 2017. This service information describes procedures
for an inspection to verify if wiring shrouds are installed, and
modification of any existing wiring shrouds. 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.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
               Action                         Labor cost            Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Inspection.........................  1 work-hour x $85 per hour               $0             $85          $6,970
                                      = $85.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary modifications
that would be required based on the results of the inspection. We have
no way of determining the number of aircraft that might need these
modifications:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                   Action                                 Labor cost                Parts cost        product
----------------------------------------------------------------------------------------------------------------
Modification of wiring shrouds.............  7 work-hours x $85 per hour = $595.             $71            $666
----------------------------------------------------------------------------------------------------------------

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 adding the following new airworthiness
directive (AD):

2017-14-02 Bombardier, Inc.: Amendment 39-18946; Docket No. FAA-
2017-0125; Directorate Identifier 2016-NM-193-AD.

(a) Effective Date

    This AD is effective August 10, 2017.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Bombardier, Inc., Model DHC-8-401 and DHC-8-
402 airplanes, certificated in any category, as identified in
Bombardier Service Bulletin 84-25-169, Revision B, dated February
17, 2017.

(d) Subject

    Air Transport Association (ATA) of America Code 25, Equipment/
furnishings.

(e) Reason

    This AD was prompted by a report that a pilot was unable to move
the rudder pedal due to an obstruction caused by the non-flying
pilot's foot. We are issuing this AD to prevent an obstruction that
could prevent rudder pedal movement during critical phases of flight
or ground operations, potentially resulting in loss of control of
the airplane.

(f) Compliance

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

(g) Inspection and Modification of Wiring Shrouds

    Within 6 months after the effective date of this AD, do a one-
time inspection to determine if wiring shrouds are installed, in
accordance with paragraph 3.B., ``Procedure,'' of the Accomplishment
Instructions of Bombardier Service Bulletin 84-25-169, Revision B,
dated February 17, 2017.
    (1) If the airplane does not have wiring shrouds installed, no
further action is required by this AD.
    (2) If the airplane has wiring shrouds installed, before further
flight, modify the wiring shrouds in accordance with paragraph 3.B.,
``Procedure,'' of the Accomplishment Instructions of Bombardier
Service Bulletin 84-25-169, Revision B, dated February 17, 2017.

    Note 1 to paragraph (g) of this AD:  Installation of wiring
shrouds was provided in Bombardier Modification Summary Package
(ModSum) IS4Q2500035-1, Revision A, dated July 26, 2011; Revision B,
dated October 10, 2013; Revision C, dated March 26, 2014; or
Revision D, dated February 26, 2016; or ModSum IS4Q2500035-2,
Revision A, dated July 26, 2011; Revision B, dated October 10, 2013;
Revision C, dated March 26, 2014; or Revision D, dated February 26,
2016.

(h) Credit for Previous Actions

    This paragraph provides credit for actions required by paragraph
(g) of this AD, if those actions were performed before the effective
date of this AD using Bombardier Service Bulletin 84-25-169,
Revision A, dated April 25, 2016.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office (ACO), ANE-170, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the ACO, send it to ATTN: Program
Manager, Continuing Operational Safety, FAA, New York ACO, 1600
Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-
7300; fax<PHONE_NUMBER>. 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: 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, New York ACO,
ANE-170, FAA; or Transport Canada Civil Aviation (TCCA); or
Bombardier, Inc.'s TCCA Design Approval Organization (DAO). If
approved by the DAO, the approval must include the DAO-authorized
signature.

(j) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) Canadian AD CF-2016-27, dated September 14, 2016, 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-2017-0125.
    (2) For more information about this AD, contact Cesar Gomez,
Aerospace Engineer, Airframe and Mechanical Systems Branch, ANE-171,
FAA, New York ACO, 1600 Stewart Avenue, Suite 410, Westbury, NY
11590; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.
    (3) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (k)(3) and (k)(4) of this AD.

(k) 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.
    (i) Bombardier Service Bulletin 84-25-169, Revision B, dated
February 17, 2017.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt
Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>Internet
http://www.bombardier.com.
    (4) 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.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on June 23, 2017.
Chris Spangenberg,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2017-13950 Filed 7-5-17; 8:45 am]
 BILLING CODE 4910-13-P


                                                         UNITED STATES ENVIRONMENTAL PROTECTION AGENCY                             WASHINGTON, D.C.  20460

 								 OFFICE OF POLICY

MEMORANDUM

SUBJECT:	Transmittal to Docket:  Summary of the March 15, 2011, Public Meeting in Atlanta, Georgia, regarding the Environmental Protection Agency's Implementation of Executive Order 13563:  Improving Regulation and Regulatory Review

FROM:	Stuart C. Miles-McLean 		Office of Regulatory Policy and Management

TO: 		Public Docket #EPA-HQ-OA-2011-0156:  Improving Regulations:  General                     As called for by President Obama in Executive Order 13563, "to facilitate the periodic review of existing significant regulations," the Environmental Protection Agency (EPA) is considering "how best to promote retrospective analysis of rules that may be outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them in accordance with what has been learned."                As part of its retrospective review of regulations, EPA convened public meetings around the country to gather input on how we might design the plan we will use to periodically review our regulations.  This Memo transmits to the docket a summary of the public meeting held on March 15, 2011, in Atlanta, Georgia.


[Federal Register: September 9, 2008 (Volume 73, Number 175)]
[Notices]
[Page 52338]
[DOCID:fr09se08-57]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL08-84-000]

Arkansas Electric Energy Consumers, Inc., Complainant, v. Entergy
Corporation, Entergy Services, Inc., Entergy Arkansas, Inc., Entergy
Gulf States, Louisiana, Inc., Entergy Louisiana, L.L.C., Entergy
Mississippi, Inc., Entergy New Orleans, Inc., Entergy Texas, Inc.,
Respondents; Notice of Complaint

August 25, 2008.
    Take notice that on August 25, 2008, Arkansas Electric Energy
Consumers, Inc. (Complainant) pursuant to sections 206 and 212 of the
Rules and Practice and Procedure, 18 CFR 385.206 and 385.212 and
sections 205 and 306 of the Federal Power Act, 16 U.S.C. 824(e) and
825(e), filed a formal complaint against Entergy Corporation; Entergy
Services, Inc.; Entergy Arkansas, Inc.; Entergy Gulf States Louisiana,
Inc.; Entergy Louisiana, L.L.C.; Entergy Mississippi, Inc.; Entergy New
Orleans, Inc.; and Entergy Texas, Inc. (Respondents), requesting that
the Commission review whether Entergy Corporation's decision to acquire
a combined cycle gas turbine generating plant located near Sterlington,
Louisiana, called the Ouachita Plant violates the Entergy System
Agreement and is otherwise just and reasonable as required by the
Federal Power Act. The Complainant also requests the Commission to
determine that the Ouachita Plant is an Entergy Arkansas resource
rather than an Entergy system resource.
    The Complainant states that a copy of the complaint has been served
on the contacts for the Respondents listed on the Commission's list of
Corporate Officials.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible online at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on September 15, 2008.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-20783 Filed 9-8-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 156 (Tuesday, August 15, 2017)]
[Notices]
[Pages 38733-38734]
[FR Doc No: 2017-17138]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81358; File No. 265-29]

Equity Market Structure Advisory Committee

AGENCY: Securities and Exchange Commission.

ACTION: Notice of Federal Advisory Committee Renewal.

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

SUMMARY: The Securities and Exchange Commission is publishing this
notice to announce that the Chairman of the Commission, with the
concurrence of the other Commissioners, has approved the renewal of the
Securities and Exchange Commission Equity Market Structure Advisory
Committee.

FOR FURTHER INFORMATION CONTACT: Arisa Kettig, Senior Special Counsel,
Division of Trading and Markets, Securities and Exchange Commission,
100 F Street NE., Washington, DC 20549,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In accordance with the requirements of the
Federal Advisory Committee Act, 5 U.S.C. App., the Commission is
publishing this notice that the Chairman of the Commission, with the
concurrence of the other Commissioners, has approved the renewal of the
Securities and Exchange Commission Equity Market Structure Advisory
Committee (the ``Committee''). The Chairman of the Commission affirms
that the renewal of the Committee is necessary and in the public
interest.
    The Committee's objective is to provide the Commission with diverse
perspectives on the structure and operations of the U.S. equities
markets, as well as advice and recommendations on matters related to
equity market structure.
    No more than seventeen voting members will be appointed to the
Committee, representing a cross-section of those directly affected by,
interested in, and/or qualified to provide advice to the Commission on
matters related to equity market structure. The Committee's membership
will continue to be balanced fairly in terms of points

of view represented and functions to be performed.
    The Charter provides that the duties of the Committee are to be
solely advisory. The Commission alone will make any determinations of
actions to be taken and policies to be expressed with respect to
matters within the Commission's jurisdiction as to which the Committee
provides advice or makes recommendations. The Committee will meet at
such intervals as are necessary to carry out its functions. The charter
contemplates that the full Committee will meet one time. Meetings of
subgroups or subcommittees of the full Committee may occur more
frequently.
    The Committee will terminate five months from the date it is
renewed or such earlier date as determined by the Commission unless,
before the expiration of that time period, it is renewed in accordance
with the Federal Advisory Committee Act. A copy of the charter for the
Committee has been filed with the Chairman of the Commission, the
Committee on Banking, Housing, and Urban Affairs of the United States
Senate, the Committee on Financial Services of the United States House
of Representatives, the Committee Management Secretariat of the General
Services Administration, and the Library of Congress. It also has been
posted on the Commission's Web site at www.sec.gov.

    By the Commission.

    Dated: August 9, 2017.
Brent J. Fields,
Secretary.
[FR Doc. 2017-17138 Filed 8-14-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 53 (Wednesday, March 19, 2014)]
[Notices]
[Pages 15327-15328]
[FR Doc No: 2014-06037]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC14-67-000.
    Applicants: Sabine Cogen, LP.
    Description: Application for Authorization for Disposition of

Jurisdictional Facilities and Request for Expedited Action of Sabine
Cogen, LP.
    Filed Date: 3/10/14.
    Accession Number: 20140310-5273.
    Comments Due: 5 p.m. ET 3/31/14.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER14-1136-001.
    Applicants: PJM Interconnection, L.L.C.
    Description: Errata to Resubmit Original Service Agreement No. 3741
to be effective 12/23/2013.
    Filed Date: 3/10/14.
    Accession Number: 20140310-5244.
    Comments Due: 5 p.m. ET 3/31/14.

    Docket Numbers: ER14-1176-001.
    Applicants: Southwest Power Pool, Inc.
    Description: 2655 Substitute Kansas Municipal Energy Agency NITSA
NOA to be effective 1/1/2014.
    Filed Date: 3/10/14.
    Accession Number: 20140310-5216.
    Comments Due: 5 p.m. ET 3/31/14.

    Docket Numbers: ER14-1461-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Revisions to the OATT Att DD re Capacity Resource
Incentives to be effective 5/10/2014.
    Filed Date: 3/10/14.
    Accession Number: 20140310-5257.
    Comments Due: 5 p.m. ET 3/31/14.

    Docket Numbers: ER14-1462-000.
    Applicants: Ohio Power Company.
    Description: Notice of Cancellation of Ohio Power Company First
Revised Rate Schedule No. 18.
    Filed Date: 3/11/14.
    Accession Number: 20140311-5009.
    Comments Due: 5 p.m. ET 4/1/14.

    Take notice that the Commission received the following electric
securities filings:

    Docket Numbers: ES14-21-001.
    Applicants: AEP Appalachian Transmission Company, Inc, AEP Indiana
Michigan Transmission Company, AEP Kentucky Transmission Company, Inc.,
AEP Southwestern Transmission Company, I,AEP West Virginia Transmission
Company, AEP Oklahoma Transmission Company, Inc.
    Description: Amended and Restated Application of AEP Appalachian
Transmission Company, Inc., et. al.
    Filed Date: 3/11/14.
    Accession Number: 20140311-5040.
    Comments Due: 5 p.m. ET 4/1/14.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: March 11, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-06037 Filed 3-18-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 154 (Thursday, August 9, 2018)]
[Notices]
[Pages 39448-39449]
[FR Doc No: 2018-17025]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-2614]

Dissolution Testing and Acceptance Criteria for Immediate-Release
Solid Oral Dosage Form Drug Products Containing High Solubility Drug
Substances; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled
``Dissolution Testing and Acceptance Criteria for Immediate-Release
Solid Oral Dosage Form Drug Products Containing High Solubility Drug
Substances.'' This guidance has been developed to provide manufacturers
with recommendations for submission of new drug applications (NDAs),
investigational new drug applications (INDs), or abbreviated new drug
applications (ANDAs), as appropriate, for orally administered
immediate-release (IR) drug products that contain highly soluble drug
substances. The guidance is intended to describe when a standard
release test and criteria may be used in lieu of extensive method
development and acceptance criteria-setting exercises.

DATES: The announcement of the guidance is published in the Federal
Register on August 9, 2018.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-2614 for ``Dissolution Testing and Acceptance Criteria for
Immediate-Release Solid Oral Dosage Form Drug Products Containing High
Solubility Drug Substances.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug

Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD
20993-0002. Send one self-addressed adhesive label to assist that
office in processing your requests. See the SUPPLEMENTARY INFORMATION
section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Richard Lostritto, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Avenue, Bldg. 51, Rm. 4132, Silver Spring, MD 20993, 301-796-
1697.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Dissolution Testing and Acceptance Criteria for Immediate-
Release Solid Oral Dosage Form Drug Products Containing High Solubility
Drug Substances.'' This guidance finalizes the draft guidance for
industry entitled ``Dissolution Testing and Specification Criteria for
Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutics
Classification System Class 1 and 3 Drugs'' (August 2015) (FR 80
46019), and the recommendations in this guidance clarify the
recommendations in the guidance for industry entitled ``Dissolution
Testing of Immediate Release Solid Oral Dosage Forms'' (August 1997)
(FR 62 44974) for high solubility drug substances in IR drug products
that meet the conditions described in section III of this guidance. For
drug substances that do not meet the conditions in this guidance,
sponsors/applicants should follow the recommendations provided in the
August 1997 guidance.
    The title of this guidance has been revised to better reflect its
focus on the solubility of the drug substance in the drug product.
Therefore, a direct reference to biopharmaceutics classification system
class 1 and class 3 is not necessary because permeability requirements
are not within the focus of this guidance.
    Drug absorption from a solid dosage form after oral administration
depends on the release of the drug substance from the drug product, the
dissolution or solubilization of the drug under physiological
conditions, and the permeation across the gastrointestinal membrane.
NDAs and ANDAs submitted to FDA contain bioavailability (BA) or
bioequivalence (BE) data and in vitro dissolution data that, together
with chemistry, manufacturing, and controls data, characterize the
quality and performance of the drug product. In vitro dissolution data
are generally obtained from: (1) Batches used in pivotal clinical and/
or BA/BE studies, (2) batches used as stability registration batches,
and (3) batches used in other human studies conducted during product
development. In general, knowledge about the solubility, permeability,
dissolution, and pharmacokinetics of a drug product is considered when
defining dissolution acceptance criteria for the drug approval process.
    Immediate-release solid oral dosage form drug products containing
high solubility drug substances are considered to be relatively low
risk regarding the impact of dissolution on in vivo performance,
provided the in vitro performance meets or exceeds the recommendations
discussed within this guidance. This guidance establishes standard
dissolution methodology and acceptance criteria that are appropriate
for highly soluble drug substances that are formulated in IR dosage
form. The availability of these standards will facilitate the rapid
development of dissolution methodology and related acceptance criteria
with no requirement to show discriminatory ability of the dissolution
method for these products during drug product development. In addition,
these standards will facilitate FDA's evaluation of the data submitted
in the application.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Dissolution Testing and Acceptance
Criteria for Immediate-Release Solid Oral Dosage Form Drug Products
Containing High Solubility Drug Substances.'' It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. This guidance is not subject to
Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR parts 312 and 314 have
been approved under OMB control numbers 0910-0014 and 0910-0001,
respectively.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: August 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17025 Filed 8-8-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: February 8, 2008 (Volume 73, Number 27)]
[Notices]
[Page 7628-7629]
[DOCID:fr08fe08-114]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket Number PHMSA-2007-28119; Notice No. 07-9]

Proposed Recommended Practices for Bulk Loading and Unloading of
Hazardous Materials in Transportation

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA).

ACTION: Notice; request for comments; extension of comment period.

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

SUMMARY: PHMSA is extending until March 14, 2008, the period for
interested persons to submit comments on the agency's January 4, 2008
notice concerning proposed recommended practices for bulk loading and
unloading of hazardous materials. The January 4, 2008 notice summarizes
incident data related to bulk loading and unloading operations;
discusses recommendations issued by the National Transportation Safety
Board and the Chemical Safety and Hazard Investigation Board; provides
an overview of current Federal regulations applicable to bulk loading
and unloading operations; summarizes the results of a public workshop
PHMSA hosted last year; and sets forth proposed recommended practices
for bulk loading and unloading operations. Based on information and
comments received, we plan to consider strategies for enhancing the
safety of bulk loading and unloading operations, including whether
additional regulatory requirements may be necessary.

DATES: Submit comments by March 14, 2008. To the extent possible, we
will consider comments received after this date and consider strategies
including additional regulatory requirements, as necessary.

ADDRESSES: You may submit comments identified by the docket number
PHMSA-2007-28119; Notice No. 07-9 by any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the instructions for submitting comments.
     Web Site: http://dms.dot.gov. Follow the instructions for

submitting comments on the DOT electronic docket site.
     Fax: 1-202-493-2251.
     Mail: Docket Operations, U.S. Department of
Transportation, West Building, Ground Floor, Room W12-140, Routing
Symbol M-30, 1200 New Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: To Docket Operations, Room W12-140 on the
ground floor of the West Building, 1200 New Jersey Avenue, SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Instructions: All submissions must include the agency name and
docket number for this notice at the beginning of the comment. Note
that all comments received will be posted without change to the docket
management system, including any personal information provided.
    Docket: For access to the dockets to read background documents or
comments received, go to http://www.regulations.gov or http://dms.dot.gov
 (until December 31, 2007) or DOT's Docket Operations Office
(see ADDRESSES).
    Privacy Act: Anyone is able to search the electronic form of any
written communications and comments received into any of our dockets by
the name of the individual submitting the document (or signing the
document, if submitted on behalf of an association, business, labor
union, etc.). You may review DOT's complete Privacy Act Statement in
the Federal Register published on April 11, 2000 (65 FR 19477) or you
may visit http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Rick Boyle, Office of Hazardous
Materials Technology,<PHONE_NUMBER> or Kurt Eichenlaub, Office of
Hazardous Materials Standards,<PHONE_NUMBER>, Pipeline and Hazardous
Materials Safety Administration.

SUPPLEMENTARY INFORMATION: On January 4, 2008, the Pipeline and
Hazardous Materials Safety Administration (PHMSA, we) published a
notice (No. 07-9) under Docket PHMSA-2007-28119 soliciting information
and comments on proposed recommended practices for loading and

unloading operations involving bulk packagings used to transport
hazardous materials.
    In the January 4, 2008 notice, we summarized incident data related
to bulk loading and unloading operations; discussed recommendations
issued by the National Transportation Safety Board and the Chemical
Safety and Hazard Investigation Board; provided an overview of current
Federal regulations applicable to bulk loading and unloading
operations; summarized the results of a public workshop we hosted last
year; and set forth proposed recommended practices for bulk loading and
unloading operations. The comment period for the notice was to end on
February 8, 2008.
    The American Trucking Association (ATA) requests an additional 30
days in which to submit comments to the notice. ATA states additional
time will allow its members to more fully understand and comment on the
potential impact of the proposed recommended practices to the trucking
industry. We agree that an extension of 30 days is in the public
interest and, accordingly, we are extending the closing date of the
comment period until March 14, 2008.

    Issued in Washington, DC on February 5, 2008.
Robert Richard,
Deputy Associate Administrator for Hazardous Materials Safety.
 [FR Doc. E8-2364 Filed 2-7-08; 8:45 am]

BILLING CODE 4910-60-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

REGION III

	1650 Arch Street

	Philadelphia, Pennsylvania  19103

DATE:	June 17, 2014

SUBJECT:	Technical Support Document for Allegheny County’s Adoption of
Control Techniques Guidelines for Offset Lithographic Printing and
Letterpress Printing; Flexible Package Printing; and Industrial Solvent
Cleaning Operations for Control of Volatile Organic Compound Emissions

			/s/

FROM:	Irene Shandruk, Physical Scientist

Office of Air Program Planning

TO:	File

			/s

THRU: 	Cristina Fernandez, Associate Director

Office of Air Program Planning

A.  BACKGROUND

Section 172(c)(1) of the Clean Air Act (CAA) provides that state
implementation plans (SIPs) for nonattainment areas must include
reasonably available control measures (RACM), including reasonably
available control technology (RACT), for sources of emissions.  Section
182(b)(2)(A) provides that for certain nonattainment areas, States must
revise their SIPs to include RACT for sources of volatile organic
compound (VOC) emissions covered by a control techniques guidelines
(CTG) document issued after November 15, 1990 and prior to the area’s
date of attainment.

The United States Environmental Protection Agency (EPA) defines RACT as
“the lowest emission limitation that a particular source is capable of
meeting by the application of control technology that is reasonably
available considering technological and economic feasibility.” (44 FR
53761, Sept. 17, 1979).  In subsequent Federal Register notices, EPA has
addressed how states can meet the RACT requirements of the CAA.

CTGs are intended to provide state and local air pollution control
authorities information that should assist them in determining RACT for
VOCs from various sources, including offset lithographic printing and
letterpress printing; flexible package printing; and industrial cleaning
solvents.  In developing these CTGs, EPA, among other things, evaluated
the sources of VOC emissions from the industry and the available control
approaches for addressing these emissions, including the costs of such
approaches.  Based on available information and data, EPA provides
recommendations for RACT for VOCs from offset lithographic printing and
letterpress printing; flexible package printing; and industrial cleaning
solvents.

In 1993, EPA published a draft CTG for offset lithographic printing. (58
FR 59261). After reviewing comments on the draft CTG and soliciting
additional information to help clarify those comments, EPA published an
alternative control techniques (ACT) document in June 1994 that provided
supplemental information for States to use in developing rules based on
RACT for offset lithographic printing.  In December 1978, EPA published
a CTG for graphic arts (rotogravure printing and flexographic printing)
that included flexible package printing.  In 1994, EPA developed an ACT
document for industrial cleaning solvents.  After reviewing the
1978/1993/1994 CTGs and ACTs for these industries, conducting a review
of currently existing state and local VOC emission reduction approaches
for these industries, and taking into account any information that has
become available since then, EPA developed new CTGs entitled Control
Techniques Guidelines for Offset Lithographic and Letterpress Printing
(Publication No. EPA 453/R-06-002; September 2006); Control Techniques
Guidelines for Flexible Package Printing (Publication No. EPA
453/R-06-003; September 2006); Control Techniques Guidelines for
Industrial Cleaning Solvents (Publication No. EPA 453/R-06-001;
September 2006).

The CTG recommendations may not apply to a particular situation based
upon the circumstances of a specific source.  Regardless of whether a
State chooses to implement the recommendations contained within the CTGs
through State rules, or to issue State rules that adopt different
approaches for RACT for VOCs for offset lithographic printing and
letterpress printing, flexible package printing, and industrial solvent
cleaning operations, States must submit their RACT rules to EPA for
review and approval as part of the SIP process.  EPA will evaluate the
rules and determine, through notice and comment rulemaking in the SIP
process, whether they meet the RACT requirements of the CAA and EPA’s
regulations.

Description of Offset Lithographic Printing and Letterpress Printing

Offset lithography is a planographic method of printing.  The term
“planographic” denotes that the printing and non-printing areas are
in the same plane on the surface of a thin metal lithographic plate.  To
maintain the distinction between the areas on the lithographic plate,
the image area is rendered oil receptive, and the non-image area is
rendered water receptive.

Offset lithography is an indirect printing method; that is, ink is not
transferred directly to a substrate.  Rather, ink is transferred from
the lithographic plate to a rubber-covered, intermediate “blanket”
cylinder and then transferred from the blanket cylinder to the
substrate.  The offset lithographic process is used for a broad range of
printing applications, including books, magazines, periodicals, labels
and wrappers, catalogs and directories, financial and legal

documents, business forms, advertising brochures, newspapers, newspaper
inserts, charts and maps, calendars, tickets and coupons, greeting
cards, and stamps.  There are two types of offset lithography
characterized by the method in which the substrate is fed to the press.
In sheet-fed printing, individual sheets of paper or other substrate are
fed to the press.  In web printing, continuous rolls of substrate
material are fed to the press and rewound or cut to size after printing.
 VOC emissions from offset lithographic printing result from the
evaporation of

components of the inks, fountain solutions, cleaning materials and other
miscellaneous materials such as varnishes, coatings and glues.

Letterpress inks are similar to offset lithographic inks.  They are
paste inks containing petroleum oils or vegetable oils.  Both sheet-fed
and web presses are used for letterpress printing.  Sheet-fed
letterpress presses use coldset inks.  Most web letterpress equipment
use coldset inks.  These letterpress inks are similar in composition and
behavior to sheet-fed and coldset web lithographic inks.  In sheet-fed
and coldest web letterpress printing, 95 percent of the petroleum ink
oils and essentially all of the vegetable oils are retained in the
substrate and dry ink film.  The remaining 5 percent of petroleum ink
oils is volatilized and emitted.  Because of the high level of ink oil
retention, emissions from sheet-fed and coldset web letterpress inks are
inherently very low.

There are three main sources of VOC emissions from offset lithographic
printing:

(1) evaporation of VOCs (petroleum ink oils) from the inks; (2)
evaporation of VOCs from

the fountain solution; and (3) evaporation of VOCs from the cleaning
materials.  There

are two main sources of VOC emissions from letterpress printing: (1)
evaporation of

VOCs (petroleum ink oils) from the inks, and (2) evaporation of VOCs
from the cleaning

materials.

Description of Flexible Package Printing

Flexible packaging refers to any package or part of a package, the shape
of which can be readily changed.  Flexible packaging includes, but is
not limited to, bags, pouches, liners, and wraps utilizing paper,
plastic, film, aluminum foil, metalized or coated paper or film, or any
combination of these materials.  Flexible package manufacturers are
sometimes referred to as "converters."  The word "converted" in this use
is an industry-specific term that refers to the fact that flexible
packaging materials start out as rolls of paper or foil, or beads of
plastic resin, and are "converted" into a package or roll of packaging
material.  Printing on flexible packaging is almost entirely conducted
by rotogravure and wide-web flexographic printing.

Printing, coating, and laminating may all be performed on or in-line
with a flexible package printing press; and these activities are
included in the source category. One portion of the flexible packaging
industry provides fully printed packaging materials (designated
"preformed specialty bags") to contract packagers.  Another portion
provides combination or laminated materials (designated converted wrap)
for printing and/or final packing by captive packaging operations.
Applying coatings is a major capability of flexible packaging
converters.  So, the same facilities may be used to manufacture
non-packaging materials such as gift wraps and hot stamp foils. The
industry makes a distinction between labels and wrappers, which are
package components, and a product that becomes the entire package and
should be called a flexible package.  Any printing of shrink-wrap labels
or wrappers conducted on or in-line with a flexible package printing
press is also considered to be included under the flexible packaging
source category.  Printing of self-adhesive labels would not be
considered flexible packaging.  Rigid packaging printing operations are
often co-located with flexible package printing operations.  Folding
cartons, some labels and wrappers, gift wraps, wall coverings, vinyl
products, decorative laminates, floor coverings, tissue products, and
miscellaneous specialty products are not considered flexible packaging.

There are two types of printing processes used by flexible package
printing facilities: (1) rotogravure printing; and (2) flexographic
printing.  And there are two main sources of VOC emissions from flexible
package printing for both rotogravure and flexographic: (1) evaporation
of VOC from inks, coatings, and adhesives, and (2) evaporation of VOCs
from cleaning materials.

There are two approaches to reducing VOC emissions from inks, coatings,
and adhesives used in the flexible package printing industry: (1)
adding/improving add-on controls, and (2) material reformulation or
substitution.  The first approach includes improving capture and/or
control systems or adding control systems where none are in use.
Capture and control can be addressed separately, although in many cases,
improved capture is achieved through an increase in the amount of air
handled and can necessitate up-grades to existing control devices.  The
second approach, focusing on pollution prevention, is to substitute low
VOC or VOC-free materials for materials (inks, coatings, and adhesives)
presently in use.

Description of Industrial Cleaning Solvent Operations

This category of consumer and commercial products includes the
industrial cleaning solvents used by many industries. It includes a
variety of products that are used to remove contaminants such as
adhesives, inks, paint, dirt, soil, oil, and grease.  Contaminants are
removed from parts, products, tools, machinery, equipment, vessels,
floors, walls, and other work production related work areas for a
variety of reasons including safety, operability, and to avoid product
contamination.  The cleaning solvents used in these (unit) operations
are, in many cases, generally available bulk solvents that are used for
a multitude of applications not limited to cleaning.  For example,
petroleum distillates may be used as a cleaning solvent, as a paint
thinner, or as an ingredient used in the manufacture of a coating, such
as paint. Because a portion of all solvents evaporate during use, such
solvent-based cleaning materials result in large amounts of emissions of
VOC.

Although the industrial cleaning solvent product category includes a
variety of different products with differing VOC contents, and although
these products are used in different ways by a wide range of industries,
there are several basic approaches to achieve VOC emission reductions.
First, the users of the products can control emissions through work
practices targeted at the activities and sources of emissions specific
to the user’s industry (e.g., keeping solvent containers covered,
properly storing and disposing of used shop towels and solvent, etc.).
Second, users can also reduce overall VOC emissions through solvent
substitution (e.g., use of low - VOC, no -VOC, or low -vapor pressure
solvents).  They can also reduce VOC emissions by using add-on controls,
modifying equipment, or upgrading to using a lower emitting cleaning
technology.

B.  STATE SUBMITTAL

On November 15, 2013, Pennsylvania Department of Environmental
Protection (PADEP) submitted to EPA a SIP revision concerning the
adoption of the EPA CTGs for offset lithographic printing and
letterpress printing; flexible package printing; and industrial cleaning
solvent operations in Allegheny County.  EPA develops CTGs as guidance
on control requirements for source categories.  States can follow the
CTGs or adopt more restrictive standards.  Allegheny County is adopting
EPA’s CTG standards for offset lithographic printing and letterpress
printing; flexible package printing; and industrial cleaning solvent
operations.  These regulations are contained in the Allegheny County
Health Department (ACHD) Rules and Regulations, Article XXI, Air
Pollution Control sections 2105.80, 2105.81, and 2105.82.  This SIP
revision also includes a revision to an existing regulation for graphic
arts systems in section 2105.11.  The revisions are summarized below.

I.  Offset Lithographic Printing and Letterpress Printing

This section applies to the owner or operator of an offset lithographic
printing and/or letterpress printing operation, where the total actual
VOC emissions from all offset lithographic printing and letterpress
printing operations are equal to or greater than 15 pounds (6.8
kilograms) per day or 2.7 (2,455 kilograms) per twelve month rolling
period.  Exceptions include heatset web offset lithographic printing
operations and heatset web letterpress printing operations, for which
this section only applies to those presses with potential to emit from
the dryer at least 25 tons (22,680 kilograms) of VOC per twelve month
rolling period.

This section establishes emission limits, recordkeeping and housekeeping
requirements, as well as exemptions.  Emission limits of VOCs from
offset lithographic printing and/or letterpress printing operations are
as follows:

The VOC content for heatset web offset lithographic printing contains
1.6 percent alcohol or less (by weight), on-press (as-applied) in the
fountain or 3.0 percent alcohol or less (by weight) on-press
(as-applied) in the fountain solution or 5.0 percent alcohol or less
on-press and no alcohol in the fountain solution.

The VOC content for sheet-fed offset lithographic printing contains 5.0
percent alcohol or less (by weight), in the fountain or 8.5 percent
alcohol or less on-press in the fountain solution or 5.0 percent alcohol
substitute or less on-press and no alcohol in the fountain solution.

The VOC content for cold web lithographic printing contains 5.0 percent
alcohol substitute or less on-press and no alcohol in the fountain
solution.

The overall weight of VOC emitted to the atmosphere is reduced through
the use of a chiller condenser or an oxidizer for heatset web offset
lithographic printing or heatset web letterpress printing if

The overall control efficiency for a chiller condenser shall be no less
than 90 percent; or

The overall control efficiency for an oxidizer shall be no less than 95
percent; or

VOC outlet concentration is reduced to less than 20 ppmv on a dry basis.

Use cleaning materials with a VOC composite vapor pressure less than 10
mm HG at 68 degrees F or cleaning materials containing less than 70
weight percent VOC.

A combination of the methods listed in Paragraphs 1 through 5.

II.  Flexible Package Printing

This section applies to the owner or operator of a flexible package
printing press, including rotogravure printing and flexographic
printing, where the total actual VOC emissions from all flexible package
printing press operations, including related cleaning activities, at the
facility are equal to or greater than 15 pounds (6.8 kilograms) per day
or 2.7 tons (2,455 kilograms) per twelve month rolling period.  The
limits from section 2105.11, Graphic Arts System, no longer apply to
flexible package printing presses.

This section emission limits, recordkeeping and housekeeping
requirements, as well as exemptions.  Emission limits of VOCs from
flexible package printing operations are as follows:

The overall control efficiency shall be no less than 80 percent.

The VOC content of materials (inks, coatings, and adhesives) used on a
single press shall not be greater than 0.8 pound (lb) VOC per lb solids
applied.

The VOC content of materials (inks, coatings, and adhesives) used on a
single press shall not be greater than 0.16 lb VOC per lb materials
applied.

III.  Industrial Solvent Cleaning Operations

This section applies to the owner or operator of a facility, where the
total actual VOC emissions from all of the industrial solvent cleaning
operations at the facility are equal to or greater than 15 pounds (6.8
kilograms) per day or 2.7 tons (2,455 kilograms) per twelve month
rolling period.  This regulation applies to any facility that employs
solvent materials in industrial solvent cleaning operations during the
production, repair, maintenance, or servicing of parts, products, tools,
machinery, equipment, or general work areas, and stores and/or disposes
of these solvent materials.  This section establishes emission limits
(Table 1), recordkeeping and housekeeping requirements, as well as
exemptions.

Table 1:  Emission Limits of VOCs for Industrial Solvent Cleaning
Operations

	VOC Content Limitation

Industrial Solvent Cleaning Operation	lbs VOC per gallon (gal)	Kilograms
(kg) VOC per / liter (l)

 Product cleaning during manufacturing process or surface preparation
for coating, adhesive, or ink application

General	0.42	0.050

Electrical apparatus components and electronic components	0.83	0.099

Medical devices and pharmaceuticals	6.7	0.80

Repair and maintenance cleaning

General	0.42	0.050

Electrical apparatus components and electronic components	0.83	0.099

Medical devices and pharmaceuticals

Tools, equipment and machinery	6.7	0.80

General work surfaces	5.0	0.60

Cleaning of coating or adhesive	0.42	0.050

Cleaning of ink application equipment

 General	0.42	0.050

Flexographic printing	0.42	0.050

 Gravure printing

Publication	0.83	0.099

Packaging	0.42	0.050

(d) Screen printing	4.2	0.50

(e) Ultraviolet ink and electron beam ink application equipment, except
screen printing	4.2	0.50

(f) Specialty flexographic printing	0.83	0.099

Cleaning of polyester resin application equipment not subject to 40 CFR
Part 63 Subpart WWWW	0.42	0.050

IV.  Additional Revision

In addition to adopting the CTGs discussed above, section 2105.11,
Graphic Arts Systems, is being amended and added to the Allegheny County
portion of the Pennsylvania SIP.  Paragraph f, Exempt Other, is being
added and reads as follows:  The owner or operator of a flexible package
printing press subject to section 2105.81, Control of VOC Emissions From
Flexible Package Printing, is no longer subject to all subparagraphs of
section 2105.11, Graphic Arts Systems, and shall be subject to all
subparagraphs of section 2105.81, Control of VOC Emissions from Flexible
Package Printing as of January 1, 2012.

C.  EPA EVALUATION AND RECOMMENDED AGENCY ACTION

Allegheny County has adopted the standards and requirements of the CTGs
for offset lithographic printing and letterpress printing, flexible
package printing, and industrial solvent cleaning operations, and is
amending the Pennsylvania SIP to reflect these amendments.  The maximum
benefit from these amendments will be provided during the ozone season
when VOCs readily combine with NOx to form ground-level ozone.
Therefore, this revision will help Pennsylvania attain and maintain the
NAAQS for ozone and EPA approval of the SIP revision is recommended.

 PAGE

 PAGE   7


[Federal Register: June 26, 2007 (Volume 72, Number 122)]
[Notices]
[Page 35045-35046]
[DOCID:fr26jn07-32]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER07-911-000]

RPL Holdings, Inc.; Notice of Issuance of Order

June 19, 2007.
    RPL Holding, Inc. (RPL) filed an application for market-based rate
authority, with an accompanying rate schedule. The proposed market-
based rate schedule provides for the sale of energy, capacity and
ancillary services at market-based rates. RPL also requested waivers of
various Commission regulations. In particular, RPL requested that the
Commission grant blanket approval under 18 CFR part 34 of all future
issuances of securities and assumptions of liability by RPL.
    On June 7, 2007, pursuant to delegated authority, the Director,

Division of Tariffs and Market Development--West, granted the requests
for blanket approval under part 34 (Director's Order). The Director's
Order also stated that the Commission would publish a separate notice
in the Federal Register establishing a period of time for the filing of
protests. Accordingly, any person desiring to be heard concerning the
blanket approvals of issuances of securities or assumptions of
liability by RPL should file a protest with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in
accordance with Rules 211 and 214 of the Commission's Rules of Practice
and Procedure. 18 CFR 385.211, 385.214 (2004).
    Notice is hereby given that the deadline for filing protests is
July 9, 2007.
    Absent a request to be heard in opposition to such blanket
approvals by the deadline above, RPL is authorized to issue securities
and assume obligations or liabilities as a guarantor, indorser, surety,
or otherwise in respect of any security of another person; provided
that such issuance or assumption is for some lawful object within the
corporate purposes of RPL, compatible with the public interest, and is
reasonably necessary or appropriate for such purposes.
    The Commission reserves the right to require a further showing that
neither public nor private interests will be adversely affected by
continued approvals of RPL's issuance of securities or assumptions of
liability.
    Copies of the full text of the Director's Order are available from
the Commission's Public Reference Room, 888 First Street, NE.,
Washington, DC 20426. The Order may also be viewed on the Commission's
Web site at http://www.ferc.gov, using the eLibrary link. Enter the

docket number excluding the last three digits in the docket number
filed to access the document. Comments, protests, and interventions may
be filed electronically via the Internet in lieu of paper. See, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-12306 Filed 6-25-07; 8:45 am]

BILLING CODE 6717-01-P


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me and to the future of the products i use that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. As a former combustible cigarette smoker of 21 years, I firmly believe that e-cigarettes have saved my life. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all I, and all the other people whose lives have been improved by this product, have the opportunity to provide their comments on this proposed regulation.