[Federal Register Volume 85, Number 19 (Wednesday, January 29, 2020)]
[Notices]
[Pages 5263-5267]
[FR Doc No: 2020-01520]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-88022; File No. SR-MRX-2020-02]

Self-Regulatory Organizations; Nasdaq MRX, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend MRX
Pricing Schedule

January 23, 2020.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on January 13, 2020, Nasdaq MRX, LLC (``MRX'' or ``Exchange'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend MRX's Pricing Schedule.
Specifically, the Exchange proposes to amend Options 7, Section 3,
titled ``Regular Order Fees and Rebates.''
    The text of the proposed rule change is available on the Exchange's
website at http://nasdaqmrx.cchwallstreet.com/, at the principal office
of the Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the

proposed rule change. The text of these statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant aspects of such statements.

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

1. Purpose
    MRX proposes to amend its Pricing Schedule at Options 7, Section 3,
titled ``Regular Order Fees and Rebates.'' There are two changes that
are proposed to Options 7, Section 3: (1) An amendment to the Tier 2
Market Maker Penny and Non-Penny Symbol Regular Order Fees in Table 1;
and (2) an amendment to the Qualifying Tier Thresholds in Table 3. Each
proposed amendment will be discussed below.
    The Exchange originally filed the proposed pricing changes on
January 2, 2020 (SR-MRX-2020-01). On January 13, 2020, the Exchange
withdrew that filing and submitted this filing.
Market Maker Fees
    Today, the Exchange assesses the following Penny Symbol Regular
Order Fees and Rebates within Table 1 of Options 7, Section 3:

                                                  Penny Symbols
----------------------------------------------------------------------------------------------------------------
                                                     Maker fee       Maker fee       Taker fee       Taker fee
               Market participant                     tier 1          tier 2          tier 1          tier 2
----------------------------------------------------------------------------------------------------------------
Market Maker \(1)\..............................           $0.20           $0.00     \(2)\ $0.50     \(2)\ $0.50
Non-Nasdaq MRX Market Maker (FarMM).............            0.47            0.47            0.50            0.50
Firm Proprietary/Broker-Dealer..................            0.47            0.47            0.50            0.50
Professional Customer...........................            0.47            0.47            0.50            0.50
Priority Customer...............................            0.00            0.00            0.00            0.00
----------------------------------------------------------------------------------------------------------------

    Today, the Exchange assesses the following Non-Penny Symbol Regular
Order Fees and Rebates within Table 1 of Options 7, Section 3:

                                                Non-Penny Symbols
----------------------------------------------------------------------------------------------------------------
                                                     Maker fee       Maker fee       Taker fee       Taker fee
               Market Participant                     tier 1          tier 2          tier 1          tier 2
----------------------------------------------------------------------------------------------------------------
Market Maker \(1)\..............................           $0.20           $0.00     \(2)\ $0.90     \(2)\ $0.90
Non-Nasdaq MRX Market Maker (FarMM).............            0.90            0.90            0.90            0.90
Firm Proprietary/Broker-Dealer..................            0.90            0.90            0.90            0.90
Professional Customer...........................            0.90            0.90            0.90            0.90
Priority Customer...............................            0.00            0.00            0.00            0.00
----------------------------------------------------------------------------------------------------------------

    Today, the Tier 2 Market Maker \3\ Fee for both Penny and Non-Penny
Symbols is currently $0.00 per contract. The Exchange proposes to
increase this fee from $0.00 to $0.10 per contract. The Exchange is not
proposing to amend other fees within Table 1 other than the Market
Maker fees. Non-Nasdaq Marker Makers (FarMM), Firm Proprietary/Broker-
Dealer and Professional Customers are assessed a fee of $0.47 per
contract for Penny Symbols and $0.90 per contract for Non-Penny
Symbols. Priority Customers do not pay any fees for transacting Penny
or Non-Penny Symbols on MRX. Also, the Exchange is continuing to offer
Market Makers the opportunity to reduce its Maker Fee if it qualifies
for Tier 2. The Market Maker Fee for Tier 1 remains at $0.20 for both
Penny and Non-Penny Pilot Symbols and is not being amended. The
Exchange believes its fees remain competitive and will continue to
attract order flow.
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    \3\ This fee also applies to Market Maker orders sent to the
Exchange by Electronic Access Members. See Options 7, Section 3 at
note 1 of the Pricing Schedule.
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    Tier 2
    Today the Exchange has two tiers as part of its Qualifying Tier
Thresholds in Table 3 of Options 7, Section 3 as follows:

                   Table 3--Qualifying Tier Thresholds
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                                               Total affiliated and/or
                   Tier                       appointed member ADV \4\
------------------------------------------------------------------------
Tier 1....................................  0-49,999.
Tier 2....................................  50,000 or more.
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    All market participants can qualify for Tiers 1 and 2, provided
they meet the requisite volume thresholds specified in Table 3 above.
The maker and taker fees for all market participants represented in
Table 1, displayed above, are dependent on qualifying for a particular
tier (either Tier 1 or Tier 2). With respect to these tiers, the
highest tier threshold attained applies retroactively in a given month
to all eligible traded contracts and applies to all eligible market
participants.\5\
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    \4\ Total Affiliated and/or Appointed Member ADV means all
average daily volume (``ADV'') executed on the Exchange in all
symbols and order types, including volume executed by Affiliated
Members and/or Appointed Members.
    \5\ The Exchange proposes to amend the word ``Tier'' in Table 3
of Options 7, Section 3 to ``Tiers.''
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    The Exchange proposes to amend the current Qualifying Tier
Thresholds by replacing the ADV thresholds with total industry
percentage thresholds. Specifically, a member would be eligible for
Tier 1 if it executes 0.00%-0.7499% of Customer Total Consolidated
Volume, and Tier 2 if it executes 0.75% or more of Customer Total
Consolidated Volume. The Exchange also proposes to note that for
purposes of measuring Total Affiliated and/or Appointed Member ADV,
Customer Total Consolidated Volume means the total volume cleared at
The Options Clearing Corporation in the Customer range in equity and
ETF options in that month. The Exchange

notes that these new volume tiers are more stringent.\6\ The Exchange
is proposing to effectively raise the volume requirements to align with
increasing member activity on MRX over time. While the proposed tiers
are more stringent, the proposed pricing is intended to continue to
reward members that bring order flow to the Exchange and thereby
increase liquidity and trading opportunities for all members. The Total
Affiliated Member ADV category includes all volume executed on the
Exchange in all symbols and order types, as is the case today.
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    \6\ For example, 0.75% of Customer Total Consolidated Volume is
approximately 115,000 contracts per day.
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    While the maker/taker fees will remain the same for Non-Nasdaq MRX
Market Maker orders, Firm Proprietary/Broker-Dealer orders, and
Professional Customer orders regardless of the tier achieved,\7\ the
proposed volume requirements will impact Market Makers that are
eligible to qualify for the lower Tier 2 maker fee.\8\ Nonetheless, the
Exchange believes that the proposed fee structure will remain
attractive to Market Makers as they will continue to be charged
substantially lower maker fees based on their contributions to the
market.
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    \7\ In particular, these market participants will continue to be
uniformly charged the same $0.47 per contract (Penny Symbols) and
$0.90 per contract (Non-Penny Symbols) maker fees for Tier 1 and
Tier 2. Priority Customer orders currently do not get charged any
maker/taker fees, which will not change under this proposal.
    \8\ Currently, Market Makers are charged maker fees of $0.20 per
contract for Tier 1 and $0.00 per contract for Tier 2. As proposed
above, the Tier 2 maker fee for Market Makers will be increased from
$0.00 to $0.10 per contract.
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2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\9\ in general, and furthers the objectives of Sections
6(b)(4) and 6(b)(5) of the Act,\10\ in particular, in that it provides
for the equitable allocation of reasonable dues, fees and other charges
among members and issuers and other persons using any facility, and is
not designed to permit unfair discrimination between customers,
issuers, brokers, or dealers.
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    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(4) and (5).
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Market Maker Fees
    The Exchange's proposal to increase the Tier 2 Market Maker Fee for
both Penny and Non-Penny Symbols from $0.00 to $0.10 per contract is
reasonable. While the Exchange is proposing to increase these fees for
Market Makers in Tier 2, it continues to remain competitive and will
continue to attract order flow. MRX is continuing to offer Market
Makers the opportunity to reduce the Penny and Non-Penny Symbol Market
Maker Fee if it qualifies for Tier 2 ($0.20 per contract as compared to
the proposed $0.10 per contract).\11\ This discount will reward Market
Makers that bring more order flow to the Exchange. Incentivizing Market
Makers to provide greater liquidity benefits all market participants
through the quality of order interaction.
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    \11\ The Market Maker Fee for Tier 1 remains at $0.20 for both
Penny and Non-Penny Pilot Symbols.
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    The Exchange's proposal to increase the Tier 2 Market Maker Fee for
both Penny and Non-Penny Symbols from $0.00 to $0.10 per contract is
equitable and not unfairly discriminatory. Market Makers would continue
to pay a lower fee as compared to fees for orders from other non-
Priority Customers. Non-Nasdaq Marker Makers (FarMM), Firm Proprietary/
Broker-Dealer and Professional Customers are assessed a fee of $0.47
per contract for Penny Symbols and $0.90 per contract for Non-Penny
Symbols. Market Makers add value to MRX through quoting obligations
\12\ and their commitment of capital, unlike other market participants,
and are therefore entitled to the lower fee. Priority Customers do not
pay any fees for transacting Penny or Non-Penny Symbols on MRX.
Priority Customer liquidity benefits all market participants by
providing more trading opportunities, which attracts Market Makers. An
increase in the activity of these market participants in turn
facilitates tighter spreads, which may cause an additional
corresponding increase in order flow from other market participants.
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    \12\ See Options 3, Section 5.
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Tier 2
    The Exchange's proposal to amend the current Qualifying Tier
Thresholds by amending Tier 1 from Total Affiliated and/or Appointed
Member ADV of 0-49,999 contracts to 0.00%-0.7499% of Customer Total
Consolidated Volume \13\ and amending Tier 2 from Total Affiliated and/
or Appointed Member ADV of 50,000 or more to 0.75% or more of Customer
Total Consolidated Volume is reasonable. The Exchange is proposing to
base Tiers 1 and 2 on a percentage of industry volume in recognition of
the fact that the volume executed by a member may rise or fall with
industry volume. A percentage of industry volume calculation allows the
Exchange's tiers to be calibrated to current market volumes rather than
requiring the same amount of volume regardless of market conditions.
While the amount of volume required by the proposed tiers may change in
any given month due to increases or decreases in industry volume, the
Exchange believes that the proposed tier requirements are set at
appropriate levels. While the proposed percentage of industry volume
tier requirements are more stringent than the current ADV
requirements,\14\ the Exchange is proposing to effectively raise the
volume thresholds for the Qualifying Tier Thresholds to align with
MRX's growth as a venue (and corresponding increased member activity)
over time. While the proposed tiers are more stringent, the maker/taker
tiered fee structure is intended to continue to reward members, and in
particular, Market Makers who will continue to get charged lower maker
fees, to bring more order flow to the Exchange and thereby increase
liquidity and trading opportunities for all members.
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    \13\ For purposes of measuring Total Affiliated and/or Appointed
Member ADV, Customer Total Consolidated Volume means the total
volume cleared at The Options Clearing Corporation in the Customer
range in equity and ETF options in that month. The Exchange notes
that these new volume tiers are more stringent.
    \14\ See supra note 6.
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    The Exchange's proposal to amend the current Qualifying Tier
Thresholds is equitable and not unfairly discriminatory. The proposed
tiers will be applied uniformly to all market participants.
Furthermore, the Exchange believes that the qualifying tier thresholds
are equitable and not unfairly discriminatory as all market
participants may qualify for a higher tier by executing the required
volume of contracts, either through the Member, its affiliates, or an
Appointed Member, as is the case today. As noted above, the proposed
volume requirements will primarily impact Market Makers that are
eligible to qualify for the lower Tier 2 maker fee \15\ while all other
market participants (other than Priority Customers that get the benefit
of free executions) will continue to be charged the same fees
regardless of the tier achieved.\16\ The Exchange, however, anticipates
minimal member impact with the proposed changes to Tier 1 and Tier 2 as
no members, including Market Makers, meet the current Tier 2 ADV
requirements and thus would not fall

out of the higher tier as a result of this change. While the proposal
effectively increases the volume requirements for Tier 1 and Tier 2,
Market Makers will continue to be charged substantially lower maker
fees than other non-Priority Customers for both tiers based on their
contribution to the market. The Exchange does not believe that
continuing to provide lower maker fees for Market Makers is unfairly
discriminatory as Market Makers are subject to additional requirements
and obligations (such as quoting requirements) that other market
participants are not.
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    \15\ Currently, Market Makers are charged maker fees of $0.20
per contract for Tier 1 and $0.00 per contract for Tier 2. As
proposed above, the Tier 2 maker fee for Market Makers will be
increased from $0.00 to $0.10 per contract.
    \16\ In particular, other non-Priority Customers will continue
to be uniformly charged the same $0.47 per contract (Penny Symbols)
and $0.90 per contract (Non-Penny Symbols) maker fees for Tier 1 and
Tier 2.
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act.
Inter-Market Competition
    The proposal does not impose an undue burden on inter-market
competition. The Exchange believes its proposal remains competitive
with other options markets and will offer market participants with
another choice of where to transact options. The Exchange notes that it
operates in a highly competitive market in which market participants
can readily favor competing venues if they deem fee levels at a
particular venue to be excessive, or rebate opportunities available at
other venues to be more favorable. In such an environment, the Exchange
must continually adjust its fees to remain competitive with other
exchanges that have been exempted from compliance with the statutory
standards applicable to exchanges. Because competitors are free to
modify their own fees in response, and because market participants may
readily adjust their order routing practices, the Exchange believes
that the degree to which fee changes in this market may impose any
burden on competition is extremely limited.
Intra-Market Competition
    The proposed fee do not impose an undue burden on intra-market
competition.
Market Maker Fees
    The Exchange's proposal to increase the Tier 2 Market Maker Fee for
both Penny and Non-Penny Symbols from $0.00 to $0.10 per contract does
not impose an undue burden on intra-market competition. Market Makers
would continue to pay a lower fee as compared to fees for orders from
other non-Priority Customers. Non-Nasdaq Marker Makers (FarMM), Firm
Proprietary/Broker-Dealer and Professional Customers are assessed a fee
of $0.47 per contract for Penny Symbols and $0.90 per contract for Non-
Penny Symbols. Makers add value to MRX through quoting obligations \17\
and their commitment of capital, unlike other market participants, and
are therefore entitled to the lower fee. Priority Customers do not pay
any fees for transacting Penny or Non-Penny Symbols on MRX. Priority
Customer liquidity benefits all market participants by providing more
trading opportunities, which attracts Market Makers. An increase in the
activity of these market participants in turn facilitates tighter
spreads, which may cause an additional corresponding increase in order
flow from other market participants.
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    \17\ See Options 3, Section 5.
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Tier 2
    The Exchange's proposal to amend the current Qualifying Tier
Thresholds does not impose an undue burden on intra-market competition.
The tiers will be applied uniformly to all market participants.
Furthermore, all market participants can qualify for a higher tier by
executing the required volume of contracts, either through the member,
its affiliates, or an appointed member, as is the case today. As noted
above, the proposed volume requirements will primarily impact Market
Makers that are eligible to qualify for the lower Tier 2 maker fee
while all other market participants (other than Priority Customers that
get the benefit of free executions) will continue to be charged the
same maker/taker fees regardless of the tier achieved. The Exchange,
however, anticipates minimal member impact with the proposed changes to
Tier 1 and Tier 2 as no members, including Market Makers, meet the
current Tier 2 ADV requirements and thus would not fall out of the
higher tier as a result of this change. Furthermore, while the proposal
effectively increases the volume requirements for Tier 1 and Tier 2,
Market Makers will continue to be charged substantially lower maker
fees than other non-Priority Customers for both tiers. For the
foregoing reasons, the Exchange does not believe that its proposal will
have an undue burden on intramarket competition.

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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act,\18\ and Rule 19b-4(f)(2) \19\ thereunder.
At any time within 60 days of the filing of the proposed rule change,
the Commission summarily may temporarily suspend such rule change if it
appears to the Commission that such action is: (i) Necessary or
appropriate in the public interest; (ii) for the protection of
investors; or (iii) otherwise in furtherance of the purposes of the
Act. If the Commission takes such action, the Commission shall
institute proceedings to determine whether the proposed rule should be
approved or disapproved.
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    \18\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \19\ 17 CFR 240.19b-4(f)(2).
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-MRX-2020-02 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-MRX-2020-02. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml.)
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the

proposed rule change between the Commission and any person, other than
those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for website viewing and
printing in the Commission's Public Reference Room, 100 F Street NE,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change. Persons submitting
comments are cautioned that we do not redact or edit personal
identifying information from comment submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-MRX-2020-02 and should be
submitted on or before February 19, 2020.
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    \20\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2020-01520 Filed 1-28-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 161 (Wednesday, August 19, 2020)]
[Notices]
[Pages 51036-51037]
[FR Doc No: 2020-17798]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-0276]

Compliance Policy for the Quantity of Bioavailability and
Bioequivalence Samples Retained Under 21 CFR 320.38(c); Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a final guidance for industry entitled ``Compliance
Policy for the Quantity of Bioavailability and Bioequivalence Samples
Retained Under 21 CFR 320.38(c).'' This guidance describes FDA's policy
concerning the conditions under which the Agency generally does not
intend to take regulatory action against an applicant or a contract
research organization (CRO) that retains less than the quantity of
reserve samples (that is, samples of the test article and reference
standard that were used in bioavailability (BA) or bioequivalence (BE)
testing) required in our regulations. FDA developed this guidance in
light of technological advances in FDA's ability to test retention
samples and in response to communications from applicants and CROs
requesting to retain a lower quantity of these reserve samples.

DATES: The announcement of the guidance is published in the Federal
Register on August 19, 2020.

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-2020-D-0276 for ``Compliance Policy for the Quantity of
Bioavailability and Bioequivalence Samples Retained Under 21 CFR
320.38(c).'' 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.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    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
Office of Communications, 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 two self-addressed adhesive labels to assist that
office in processing your requests. See the SUPPLEMENTARY INFORMATION
section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Melissa Mannion, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Compliance Policy for the Quantity of Bioavailability and
Bioequivalence Samples Retained Under 21 CFR 320.38(c).'' The Agency is
issuing this guidance consistent with good guidance practices (GGP)
regulations (21 CFR 10.115) and is implementing this guidance without
prior public comment because FDA has determined that prior public
participation is not feasible or appropriate as public comment would
not affect the specifications of FDA's testing of retention samples
(Sec.  10.115(g)(2)). FDA has made this determination under Sec.
10.115(g)(2) because, with technological advances, the reduced quantity
of reserve samples is now sufficient for FDA testing; this reduced
quantity will provide a less burdensome approach for applicants and
CROs but remains consistent with the Agency's mission to ensure public
health. Although this guidance

document is immediately in effect, it remains subject to comment in
accordance with FDA's GGP regulation and FDA will consider all comments
received and revise the guidance document as appropriate (Sec.
10.115(g)(3)).
    On November 8, 1990, we issued an interim rule that amended, in
relevant part, part 320 (21 CFR 320) by adding a requirement to retain
reserve samples of drug products (that is, samples of the drug products
that were used to conduct BA or BE studies) for a specified period and,
when specifically requested, to release the reserve samples to us. The
interim rule was intended to help ensure BE between generic drugs and
their reference listed drugs and to help us investigate possible fraud
in BA and BE testing. After consideration of public comments, we
published a final rule in the Federal Register on April 28, 1993 (58 FR
25918).
    In the final rule, 21 CFR 320.38 and 320.63 require a new drug
application or abbreviated new drug application applicant (or its CRO)
to retain reserve samples of the test article and reference standard
that were used in conducting any in vivo BA and in vivo or in vitro BE
study that supports the approval of an application or supplemental
application. Specifically, Sec.  320.38(c) requires these applicants
(or their CROs) to retain a quantity of the test article and reference
standard that were used in BA or BE testing that is at least five times
the amount of product required for release testing.
    Section 320.38(c) requires that reserve samples of the test article
and reference standard used in a BA or BE study are of a sufficient
quantity to perform five times all of the release tests required in the
application or supplemental application. Since the final rule was
issued in 1993, technological advances in our ability to test these
products have led to test methods that are less destructive and more
sensitive, allowing us to detect the identity and composition of the
test article and reference standard with smaller volumes of samples.
Consistent with these developments, FDA has received communications
from applicants and CROs requesting to retain a lower quantity of the
reserve samples.
    In light of these technological advances, this guidance discusses
the conditions under which we do not generally intend to take
regulatory action against an applicant or CRO that retains an
appropriate reduced quantity of reserve samples of the test article and
reference standard that were used in its BA or BE testing.
    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 ``Compliance Policy for the Quantity of
Bioavailability and Bioequivalence Samples Retained Under 21 CFR
320.38(c).'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The
collections of information in 21 CFR parts 312 and 314 have been
approved under OMB control numbers 0910-0014 and 0910-0001,
respectively. The collections of information in part 320 for
``Investigational New Drug Safety Reporting Requirements for Human Drug
and Biological Products and Safety Reporting Requirements for
Bioavailability and Bioequivalence Studies in Humans'' have been
approved under OMB control number 0910-0672. The recordkeeping
requirement for CGMP sample retention in 21 CFR 211.170 has been
approved under OMB control number 0910-0139.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov. Use the FDA
website listed in the previous sentence to find the most current
version of the guidance.

    Dated: August 10, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-17798 Filed 8-18-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 240 (Thursday, December 13, 2012)]
[Notices]
[Pages 74263-74265]
[FR Doc No: 2012-30045]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68380; File No. SR-NYSEMKT-2012-76]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and
Immediate Effectiveness of Proposed Rule Change Amending Exchange Rule
903 To Provide That the Exchange May Not List Short Term Option Series
Expirations That Coincide With the Expiration of Quarterly Option
Series on the Same Class

December 7, 2012.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on November 30, 2012, NYSE MKT LLC (the ``Exchange'' or
``NYSE MKT'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the self-regulatory
organization. The Exchange filed the proposal as a ``non-
controversial'' proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \4\ and Rule 19b-4(f)(6) thereunder,\5\
which renders the proposal effective upon receipt of this filing by the
Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C.78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
    \4\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \5\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Exchange Rule 903 to provide that
the Exchange may not list Short Term Option Series (``STOS'')
expirations that coincide with the expiration of Quarterly Option
Series on the same class. The text of the proposed rule change is
available on the Exchange's Web site at www.nyse.com, at the principal
office of the Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of,

and basis for, the proposed rule change and discussed any comments it
received on the proposed rule change. The text of those statements may
be examined at the places specified in Item IV below. The Exchange has
prepared summaries, set forth in sections A, B, and C below, of the
most significant parts of such statements.

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

1. Purpose
    The Exchange proposes to amend Exchange Rule 903 to provide that
the Exchange may not list Short Term Option Series (``STOS'')
expirations that coincide with the expiration of Quarterly option
series on the same class.
    Exchange Rule 903(h) currently provides that no STOS may expire in
the same week in which monthly or Quarterly option series on the same
class expire. When the STOS Program was originally established in 2006,
the Exchange could not list expirations in the same week as the monthly
expiration.\6\ Quarterly options series on the Exchange were
subsequently added in 2006.\7\ The Exchange, as part of the Quarterly
options series Rules, adopted a provision in Commentary .09 of 903 that
provided that the ``Exchange will not list a Short Term Options Series
on an options class whose expiration coincides with that of a Quarterly
Options Series on that same options class.'' \8\ In 2010, the Exchange
added to the Rule 903(h) that no STOS expirations could be added in the
same week as the Quarterly options series expiration.\9\
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release No. 52014 (July 12,
2005), 70 FR 41244 (July 18, 2005) (SR-Amex-2005-035).
    \7\ See Securities Exchange Act Release No. 54137 (July 12,
2006), 71 FR 41283 (July 20, 2006) (SR-Amex-2006-67).
    \8\ See id.
    \9\ See Securities Exchange Act Release No.62370 (June 23,
2010), 75 FR 37870 (June 30, 2010) (SR-NYSEAmex-2010-62).
---------------------------------------------------------------------------

    NYSE Arca Options Rule 6.4, Commentary .07, provides that no STOS
may expire in the same week in which monthly option series on the same
class expire or, in the case of Quarterly options series, on an
expiration that coincides with an expiration of Quarterly option series
on the same class.\10\ For example, if the Quarterly options series
would expire on a Monday, since Monday does not coincide (not the same
day) as Friday when STOS would normally expire, NYSE Arca Options and
other options exchanges could list a STOS expiration for that week. In
contrast, pursuant to current Exchange Rule 903(h), the Exchange could
not list STOS that expire on that Friday in the same week that
Quarterly options series expires on Monday.
---------------------------------------------------------------------------

    \10\ Other options exchanges have similar rules. See Chicago
Board Options Exchange, Incorporated Rule 5.5(d)(2); NASDAQ OMX PHLX
LLC Rule 1012, Commentary .11(b).
---------------------------------------------------------------------------

    The Exchange proposes to adopt the same language that is used for
NYSE Arca Options to ensure conformity between the options exchanges.
The proposed change would allow the Exchange to list STOS expirations
the same week as Quarterly option series, but not on a day that
coincides or is the same as the expiration of Quarterly option series
on the same class. The Exchange believes that the STOS Program has
provided investors with greater trading opportunities and flexibility
and the ability to more closely tailor their investment and risk
management strategies and decisions. The Exchange believes that this
proposal would eliminate inconsistencies in expirations between the
STOS Programs of two exchanges and help provide the investing public
and other market participants with additional opportunities to hedge
their investment, thus allowing these investors to better manage their
risk exposure.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Securities Exchange Act of 1934 (the ``Act''),\11\ in general, and
furthers the objectives of Section 6(b)(5),\12\ in particular, in that
it is designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in facilitating
transactions in securities, and to remove impediments to and perfect
the mechanism of a free and open market and a national market system.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The proposal is designed to promote just and equitable principles
of trade, to foster cooperation and coordination with persons engaged
in facilitating transactions in securities, and to remove impediments
to and perfect the mechanism of a free and open market and a national
market system by ensuring conformity between STOS Programs on competing
options exchanges.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

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

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

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

    Because the foregoing proposed rule change does not significantly
affect the protection of investors or the public interest, does not
impose any significant burden on competition, and, by its terms, does
not become operative for 30 days from the date on which it was filed,
or such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \13\ and Rule 19b-
4(f)(6) thereunder.\14\
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(3)(A).
    \14\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the Exchange to give the Commission written notice of the
Exchange's intent to file the proposed rule change, along with a
brief description and text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission. The
Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    The Exchange has requested that the Commission waive the 30-day
operative delay. The Commission believes that waiver of the operative
delay is consistent with the protection of investors and the public
interest because waiver of the operative delay will allow the Exchange
to clarify its own rules as well as list STOs on the same dates as
other exchanges without undue delay. Therefore, the Commission
designates the proposal operative upon filing.\15\
---------------------------------------------------------------------------

    \15\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEMKT-2012-76 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEMKT-2012-76. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Section, 100 F Street
NE., Washington, DC 20549. Copies of the filing will also be available
for inspection and copying at the NYSE's principal office and on its
Internet Web site at www.nyse.com. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NYSEMKT-2012-76 and should be submitted on or before
January 3, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-30045 Filed 12-12-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 6 (Thursday, January 9, 2020)]
[Notices]
[Pages 1173-1176]
[FR Doc No: 2020-00183]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2020-0002; Internal Agency Docket No. FEMA-B-2002]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice lists communities where the addition or
modification of Base Flood Elevations (BFEs), base flood depths,
Special Flood Hazard Area (SFHA) boundaries or zone designations, or
the regulatory floodway (hereinafter referred to as flood hazard
determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and
where applicable, in the supporting Flood Insurance Study (FIS)
reports, prepared by the Federal Emergency Management Agency (FEMA) for
each community, is appropriate because of new scientific or technical
data. The FIRM, and where applicable, portions of the FIS report, have
been revised to reflect these flood hazard determinations through
issuance of a Letter of Map Revision (LOMR), in accordance with Federal
Regulations. The LOMR will be used by insurance agents and others to
calculate appropriate flood insurance premium rates for new buildings
and the contents of those buildings. For rating purposes, the currently
effective community number is shown in the table below and must be used
for all new policies and renewals.

DATES: These flood hazard determinations will be finalized on the dates
listed in the table below and revise the FIRM panels and FIS report in
effect prior to this determination for the listed communities.
    From the date of the second publication of notification of these
changes in a newspaper of local circulation, any person has 90 days in
which to request through the community that the Deputy Associate
Administrator for Insurance and Mitigation reconsider the changes. The
flood hazard determination information may be changed during the 90-day
period.

ADDRESSES: The affected communities are listed in the table below.
Revised flood hazard information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at https://msc.fema.gov for
comparison.
    Submit comments and/or appeals to the Chief Executive Officer of
the community as listed in the table below.

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The specific flood hazard determinations are
not described for each community in this notice. However, the online
location and local community map repository address where the flood
hazard determination information is available for inspection is
provided.
    Any request for reconsideration of flood hazard determinations must
be submitted to the Chief Executive Officer of the community as listed
in the table below.
    The modifications are made pursuant to section 201 of the Flood
Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance
with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq.,
and with 44 CFR part 65.
    The FIRM and FIS report are the basis of the floodplain management
measures that the community is required either to

adopt or to show evidence of having in effect in order to qualify or
remain qualified for participation in the National Flood Insurance
Program (NFIP).
    These flood hazard determinations, together with the floodplain
management criteria required by 44 CFR 60.3, are the minimum that are
required. They should not be construed to mean that the community must
change any existing ordinances that are more stringent in their
floodplain management requirements. The community may at any time enact
stricter requirements of its own or pursuant to policies established by
other Federal, State, or regional entities. The flood hazard
determinations are in accordance with 44 CFR 65.4.
    The affected communities are listed in the following table. Flood
hazard determination information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at https://msc.fema.gov for
comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Chief executive officer of                                    Online location of letter of map                            Community
         State and county          Location and case No.             community               Community map repository                 revision                Date of modification       No.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
California:
    Los Angeles..................  City of Santa Clarita  The Honorable Marsha McLean,    City Hall Planning             https://msc.fema.gov/portal/        Apr. 6, 2020..........       060729
                                    (19-09-0909P).         Mayor, City of Santa Clarita,   Department, 23920 Valencia     advanceSearch.
                                                           City Hall, 23920 Valencia       Boulevard, Suite 300, Santa
                                                           Boulevard, Suite 300, Santa     Clarita, CA 91355.
                                                           Clarita, CA 91355.
    Nevada.......................  Unincorporated Areas   The Honorable Richard           Nevada County Eric W. Rood     https://msc.fema.gov/portal/        Apr. 6, 2020..........       060210
                                    of Nevada County (19-  Anderson, Chairman, Board of    Administrative Center, 950     advanceSearch.
                                    09-0859P).             Supervisors, Nevada County,     Maidu Avenue, Nevada City,
                                                           950 Maidu Avenue, Nevada        CA 95959.
                                                           City, CA 95959.
    Riverside....................  City of Lake Elsinore  The Honorable Steve Manos,      Engineering Department, 130    https://msc.fema.gov/portal/        Apr. 7, 2020..........       060636
                                    (19-09-1886P).         Mayor, City of Lake Elsinore,   South Main Street, Lake        advanceSearch.
                                                           City Hall, 130 South Main       Elsinore, CA 92530.
                                                           Street, Lake Elsinore, CA
                                                           92530.
    Riverside....................  Unincorporated Areas   The Honorable Kevin Jeffries,   Riverside County Flood         https://msc.fema.gov/portal/        Apr. 7, 2020..........       060245
                                    of Riverside County    Chairman, Board of              Control and Water              advanceSearch.
                                    (19-09-1886P).         Supervisors, Riverside          Conservation District, 1995
                                                           County, 4080 Lemon Street,      Market Street, Riverside, CA
                                                           5th Floor, Riverside, CA        92501.
                                                           92501.
    Sacramento...................  City of Elk Grove (19- The Honorable Steve Ly, Mayor,  Public Works Department, 8401  https://msc.fema.gov/portal/        Mar. 12, 2020.........       060767
                                    09-0908P).             City of Elk Grove, City Hall,   Laguna Palms Way, Elk Grove,   advanceSearch.
                                                           8401 Laguna Palms Way, Elk      CA 95758.
                                                           Grove, CA 95758.
    Sacramento...................  Unincorporated Areas   The Honorable Patrick Kennedy,  Sacramento County Department   https://msc.fema.gov/portal/        Mar. 23, 2020.........       060262
                                    of Sacramento County   Chairman, Board of              of Water Resources, 827 7th    advanceSearch.
                                    (18-09-1752P).         Supervisors, Sacramento         Street, Suite 301,
                                                           County, 700 H Street, Suite     Sacramento, CA 95814.
                                                           2450, Sacramento, CA 95814.
    San Diego....................  City of National City  The Honorable Alejandra Sotelo- City Hall, 1243 National City  https://msc.fema.gov/portal/        Apr. 6, 2020..........       060293
                                    (19-09-0359P).         Solis, Mayor, City of           Boulevard, National City, CA   advanceSearch.
                                                           National City, 1243 National    91950.
                                                           City Boulevard, National
                                                           City, CA 91950.
Florida:
    St. Johns....................  Unincorporated Areas   The Honorable Jeb S. Smith,     St. Johns County Permit        https://msc.fema.gov/portal/        Apr. 8, 2020..........       125147
                                    of St. Johns County    Chair, St. Johns County Board   Center, 4040 Lewis Speedway,   advanceSearch.
                                    (19-04-4728P).         of Commissioners, 500 San       St. Augustine, FL 32084.
                                                           Sebastian View, St.
                                                           Augustine, FL 32084.
    St. Johns....................  Unincorporated Areas   The Honorable Jeb S. Smith,     St. Johns County Permit        https://msc.fema.gov/portal/        Apr. 7, 2020..........       125147
                                    of St. Johns County    Chair, St. Johns County Board   Center, 4040 Lewis Speedway,   advanceSearch.
                                    (19-04-4958P).         of Commissioners, 500 San       St. Augustine, FL 32084.
                                                           Sebastian View, St.
                                                           Augustine, FL 32084.
Hawaii: Maui.....................  Maui County (19-09-    The Honorable Michael P.        County of Maui Planning        https://msc.fema.gov/portal/        Apr. 6, 2020..........       150003
                                    1599P).                Victorino, Mayor, County of     Department, One Main Plaza,    advanceSearch.
                                                           Maui, 200 South High Street,    2200 Main Street, Suite 315,
                                                           Kalana O Maui Building, 9th     Wailuku, HI 96793.
                                                           Floor, Wailuku, HI 96793.

Idaho:
    Ada..........................  City of Boise (19-10-  The Honorable David Bieter,     City Hall, 150 North Capitol   https://msc.fema.gov/portal/        Apr. 3, 2020..........       160002
                                    0196P).                Mayor, City of Boise, P.O.      Boulevard, Boise, ID 83702.    advanceSearch.
                                                           Box 500, Boise, ID 83702.
    Blaine.......................  Unincorporated Areas   The Honorable Jacob Greenberg,  Blaine County Planning &       https://msc.fema.gov/portal/        Apr. 9, 2020..........       165167
                                    of Blaine County (19-  Chairman, Blaine County         Zoning, 219 South 1st          advanceSearch.
                                    10-0919P).             Commissioners, Blaine County    Avenue, Suite 208, Hailey,
                                                           District Court, 219 South 1st   ID 83333.
                                                           Avenue, Suite 300, Hailey, ID
                                                           83333.
Illinois: DuPage.................  Village of Carol       The Honorable Frank Saverino,   Village Hall, 500 North Gary   https://msc.fema.gov/portal/        Apr. 6, 2020..........       170202
                                    Stream (19-05-         Mayor, Village of Carol         Avenue, Carol Stream, IL       advanceSearch.
                                    1848P).                Stream, 500 North Gary          60188.
                                                           Avenue, Carol Stream, IL
                                                           60188.
Indiana:
    Marion.......................  City of Indianapolis   The Honorable Joe Hogsett,      City Hall, 1200 Madison        https://msc.fema.gov/portal/        Apr. 8, 2020..........       180159
                                    (20-05-0050X).         Mayor, City of Indianapolis,    Avenue, Suite 100,             advanceSearch.
                                                           2501 City-County Building,      Indianapolis, IN 46225.
                                                           200 East Washington Street,
                                                           Indianapolis, IN 46204.
    Marion.......................  Town of Speedway (20-  Mr. Jacob Blasdel, Town         Town Hall, 1450 North          https://msc.fema.gov/portal/        Apr. 8, 2020..........       180162
                                    05-0050X).             Manager, Town of Speedway,      Lynhurst Drive, Speedway, IN   advanceSearch.
                                                           1450 North Lynhurst Drive,      46224.
                                                           Speedway, IN 46224.
Kansas: Johnson..................  City of Olathe (19-07- The Honorable Michael           City Hall, 100 East Sante Fe   https://msc.fema.gov/portal/        Apr. 9, 2020..........       200173
                                    0801P).                Copeland, Mayor, City of        Street, Olathe, KS 66051.      advanceSearch.
                                                           Olathe, 100 East Santa Fe
                                                           Street, Olathe, KS 66051.
Michigan: Macomb.................  Township of Macomb     The Honorable Janet Dunn,       Township Hall, 54111           https://msc.fema.gov/portal/        Apr. 1, 2020..........       260445
                                    (19-05-3918P).         Supervisor, Township of         Broughton Road, Macomb, MI     advanceSearch.
                                                           Macomb, 54111 Broughton Road,   48042.
                                                           Macomb, MI 48042.
Nevada:
    Washoe.......................  City of Reno (19-09-   The Honorable Hillary Schieve,  City Hall, 1 East 1st Street,  https://msc.fema.gov/portal/        Apr. 7, 2020..........       320020
                                    0823P).                Mayor, City of Reno, P.O. Box   Reno, NV 89501.                advanceSearch.
                                                           1900, Reno, NV 89505.
    Washoe.......................  City of Reno (19-09-   The Honorable Hillary Schieve,  City Hall, 1 East 1st Street,  https://msc.fema.gov/portal/        Apr. 6, 2020..........       320020
                                    1056P).                Mayor, City of Reno, P.O. Box   Reno, NV 89501.                advanceSearch.
                                                           1900, Reno, NV 89505.
    Washoe.......................  City of Reno (19-09-   The Honorable Hillary Schieve,  City Hall, 1 East 1st Street,  https://msc.fema.gov/portal/        Mar. 12, 2020.........       320020
                                    1298P).                Mayor, City of Reno, P.O. Box   Reno, NV 89501.                advanceSearch.
                                                           1900, Reno, NV 89505.
    Washoe.......................  Unincorporated Areas   The Honorable Vaughn Hartung,   Washoe County Administration   https://msc.fema.gov/portal/        Apr. 7, 2020..........       320019
                                    of Washoe County (19-  Chairman, Board of              Building, Department of        advanceSearch.
                                    09-0823P).             Commissioners, Washoe County,   Public Works, 1001 East 9th
                                                           1001 East 9th Street,           Street, Reno, NV 89512.
                                                           Building A, Reno, NV 89512.
    Washoe.......................  Unincorporated Areas   The Honorable Vaughn Hartung,   Washoe County Administration   https://msc.fema.gov/portal/        Mar. 31, 2020.........       320019
                                    of Washoe County (19-  Chairman, Board of              Building, Department of        advanceSearch.
                                    09-0887P).             Commissioners, Washoe County,   Public Works, 1001 East 9th
                                                           1001 East 9th Street,           Street, Reno, NV 89512.
                                                           Building A, Reno, NV 89512.
    Washoe.......................  Unincorporated Areas   The Honorable Vaughn Hartung,   Washoe County Administration   https://msc.fema.gov/portal/        Apr. 6, 2020..........       320019
                                    of Washoe County (19-  Chairman, Board of              Building, Department of        advanceSearch.
                                    09-1056P).             Commissioners, Washoe County,   Public Works, 1001 East 9th
                                                           1001 East 9th Street,           Street, Reno, NV 89512.
                                                           Building A, Reno, NV 89512.

    Washoe.......................  Unincorporated Areas   The Honorable Vaughn Hartung,   Washoe County Administration   https://msc.fema.gov/portal/        Mar. 12, 2020.........       320019
                                    of Washoe County (19-  Chairman, Board of              Building, Department of        advanceSearch.
                                    09-1298P).             Commissioners, Washoe County,   Public Works, 1001 East 9th
                                                           1001 East 9th Street,           Street, Reno, NV 89512.
                                                           Building A, Reno, NV 89512.
Ohio: Warren.....................  City of Lebanon (19-   The Honorable Amy Brewer,       City Hall, 50 South Broadway,  https://msc.fema.gov/portal/        Mar. 30, 2020.........       390557
                                    05-5135P).             Mayor, City of Lebanon, City    Lebanon, OH 45036.             advanceSearch.
                                                           Hall, 50 South Broadway,
                                                           Lebanon, OH 45036.
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[FR Doc. 2020-00183 Filed 1-8-20; 8:45 am]
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Ozone NAAQS Teleconference

8/19/2010

Andrea Drinkard/DC/USEPA/US@EPA, Anna Wood/DC/USEPA/US@EPA,
<EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS>Don
Zinger/DC/USEPA/US@EPA, Gautam Srinivasan/DC/USEPA/US@EPA,
<EMAIL_ADDRESS><EMAIL_ADDRESS>Jenny
Noonan/RTP/USEPA/US@EPA, John Hannon/DC/USEPA/US@EPA, Karen
Martin/RTP/USEPA/US@EPA, Kevin McLean/DC/USEPA/US@EPA, Lydia
Wegman/RTP/USEPA/US@EPA

Location: ARN 5400

EXTERNAL ATTENDEES

Allison D. Wood – Hunton and Williams

Lucinda Minton Langworthy – Hunton and Williams

David Kaplan – US DOJ

Harold Edward Pizzetta, III – Mississippi AG office

Jeffrey Bossert Clark – Kirkland and Ellis LLP


[Federal Register: October 16, 2009 (Volume 74, Number 199)]
[Notices]
[Page 53313]
[DOCID:fr16oc09-148]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Request Revision From the Office of
Management and Budget of a Currently Approved Information Collection
Activity, Request for Comments; Domestic and International Flight Plans

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: The FAA invites public comments about our intention to request
the Office of Management and Budget (OMB) to approve a current
information collection.
    Information is collected to provide services to aircraft inflight
and protection of persons/property on the ground.

DATES: Please submit comments by December 15, 2009.

FOR FURTHER INFORMATION CONTACT: Carla Mauney on<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Federal Aviation Administration (FAA)

    Title: Domestic and International Flight Plans.
    Type of Request: Extension without change of an approved
collection.
    OMB Control Number: 2120-0026.
    Forms(s): 7233-1, 7233-4.
    Affected Public: A total of 300,000 respondents.
    Frequency: The information is collected on occasion.
    Estimated Average Burden per Response: Approximately 1 minute per
response.
    Estimated Annual Burden Hours: An estimated 287,447 hours annually.
    Abstract: Title 49 U.S.C., paragraph 40103(b) authorizes
regulations governing the flight of aircraft. 14 CFR 91 prescribes
requirements for filing domestic and international flight plans.
Information is collected to provide services to aircraft in flight and
protection of persons/property on the ground.

ADDRESSES: Send comments to the FAA at the following address: Ms. Carla
Mauney, Room 712, Federal Aviation Administration, IT Enterprises
Business Services Division, AES-200, 800 Independence Ave., SW.,
Washington, DC 20591.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimates of the burden of
the proposed information collection; ways to enhance the quality,
utility and clarity of the information to be collected; and ways to
minimize the burden of the collection of information on respondents,
including the use of automated collection techniques or other forms of
information technology.

    Issued in Washington, DC on October 8, 2009.
Carla Mauney,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, AES-200.
[FR Doc. E9-24757 Filed 10-15-09; 8:45 am]

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[Federal Register Volume 81, Number 81 (Wednesday, April 27, 2016)]
[Proposed Rules]
[Pages 24743-24745]
[FR Doc No: 2016-09435]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-6123; Directorate Identifier 2016-CE-007-AD]
RIN 2120-AA64

Airworthiness Directives; Schempp-Hirth Flugzeugbau GmbH Gliders

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

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
Schempp-Hirth Flugzeugbau GmbH Models Discus-2a, Discus-2b, Discus-2c,
Discus 2cT, Ventus-2a, and Ventus-2b gliders. This proposed AD results
from mandatory continuing airworthiness information (MCAI) originated
by an aviation authority of another country to identify and correct an
unsafe condition on an aviation product. The MCAI describes the unsafe
condition as insufficient overlap of the airbrake panels. We are
issuing this proposed AD to require actions to address the unsafe
condition on these products.

DATES: We must receive comments on this proposed AD by June 13, 2016.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Schempp-Hirth Flugzeugbau GmbH, Krebenstrasse 25, 73230 Kirchheim/Teck,
Germany; telephone: +49 7021 7298-0; fax: +49 7021 7298-199; email:
<EMAIL_ADDRESS>Internet: http://www.schempp-hirth.com. You may
review this referenced service information at the FAA, Small Airplane
Directorate, 901 Locust, Kansas City, Missouri 64106. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.

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-2016-
6123; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Office (telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments
will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Jim Rutherford, Aerospace Engineer,
FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2016-6123;
Directorate Identifier 2016-CE-007-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued AD
No.: 2016-0027, dated February 9, 2016 (referred to after this as ``the
MCAI''), to correct an unsafe condition for the specified products. The
MCAI states:

    Operational experience shows that, under certain conditions, the
overlap between the two airbrake panels can be insufficient and the
panels can interlock.
    This condition, if not corrected, could lead to blockage of the
airbrakes, possibly resulting in reduced control of the (powered)
sailplane.
    To address this potential unsafe condition, Schempp-Hirth
Flugzeugbau GmbH issued TN 349-39, 360-29, 825-55 and 863-22 (single
document, hereafter referred to as `the TN' in this AD), to provide
inspection instructions to verify the correct overlap between the
two affected airbrake panels.
    For the reason described above, this AD requires a one-time
inspection of the overlap of the affected airbrake panels and,
depending on findings, accomplishment of applicable corrective
action(s).

    You may examine the MCAI on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
6123.

Related Service Information Under 1 CFR Part 51

    Schempp-Hirth Flugzeugbau GmbH has issued Technical Note No. 349-
39, 360-29, 825-55, 863-22; dated January 29, 2016 (published as a
single document), and Arbeitsanweisung (English translation: Working
instructions) for Technische Mitteilung Nr. (English translation:
Technical Note No.) 349-39, 360-29, 825-55, 863-22, Ausgabe (English
translation: Issue) 1, Datum (English translation: Dated) January 22,
2016. The service information describes procedures for inspection of
the overlap of the airbrake panels and, if necessary, replacement of
the airbrake panels. 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
of this NPRM.

FAA's Determination and Requirements of the Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with this State of Design Authority, they
have notified us of the unsafe condition described in the MCAI and
service information referenced above. We are proposing this AD because
we evaluated all information and determined the unsafe condition exists
and is likely to exist or develop on other products of the same type
design.

Costs of Compliance

    We estimate that this proposed AD will affect 86 products of U.S.
registry. We also estimate that it would take about 2 work-hours per
product to comply with the basic requirements of this proposed AD.
    Based on these figures, we estimate the cost of the proposed AD on
U.S. operators to be $14,620, or $170 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 4 work-hours and require parts

costing $100, for a cost of $440 per product. We have no way of
determining the number of products that may need these actions.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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 AD:

Schempp-Hirth Flugzeugbau GmbH: Docket No. FAA-2016-6123;
Directorate Identifier 2016-CE-007-AD.

(a) Comments Due Date

    We must receive comments by June 13, 2016.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the following Schempp-Hirth Flugzeugbau GmbH
model and serial number gliders, certificated in any category:
    (1) Model Discus-2a, serial numbers 1 through 253;
    (2) Model Discus-2b, serial numbers 1 through 255;
    (3) Model Discus-2c, serial numbers 1 through 61;
    (4) Model Discus 2cT, serial numbers 1 through 127;
    (5) Model Ventus-2a, serial numbers 1 through 178; and
    (6) Model Ventus-2b, serial numbers 1 through 175.

(d) Subject

    Air Transport Association of America (ATA) Code 27: Flight
Controls.

(e) Reason

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as insufficient
overlap of the airbrake panels. We are issuing this proposed AD to
require actions to address the unsafe condition on these products.
We are issuing this AD to prevent interlocking of the airbrake
panels, which could lead to blockage of the airbrakes and possible
loss of control.

 (f) Actions and Compliance

    Unless already done, do the following actions in paragraphs
(f)(1) and (f)(2) of this AD:
    (1) Within the next 40 days after the effective date of this AD,
inspect the overlap of the airbrake panels for a minimum overlap of
at least 3 millimeters following Action 1 in Schempp-Hirth
Flugzeugbau GmbH Technische Mitteilung Nr. (English translation:
Technical Note No.) 349-39, 360-29, 825-55, 863-22, dated January
29, 2016 (published as a single document); and Action 1 in the
associated Arbeitsanweisung (English translation: Working
instructions) for Technische Mitteilung Nr. (English translation:
Technical Note No.) 349-39, 360-29, 825-55, 863-22, Ausgabe (English
translation: issue) 1, Datum (English translation: dated) January
22, 2016.
    Note 1 to paragraph (f)(1) and (f)(2) of this AD: This service
information contains German to English translation. The EASA used
the English translation in referencing the document. For
enforceability purposes, we will refer to the Schempp-Hirth
Flugzeugbau GmbH service information as it appears on the document.
    (2) If, during the inspection required in paragraph (f)(1) of
this AD, the overlap on the airbrake panels is found to be less than
3 millimeters, before further flight, install eccentric bushings and
make adjustments following Action 2 in Schempp-Hirth Flugzeugbau
GmbH Technische Mitteilung Nr. (English translation: Technical Note
No.) 349-39, 360-29, 825-55, 863-22, dated January 29, 2016
(published as a single document); and Action 2 in the associated
Arbeitsanweisung (English translation: Working instructions) for
Technische Mitteilung Nr. (English translation: Technical Note No.)
349-39, 360-29, 825-55, 863-22, Ausgabe (English translation: issue)
1, Datum (English translation: dated) January 22, 2016.

(g) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Jim Rutherford, Aerospace Engineer, FAA, Small
Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Before using any approved AMOC on any
airplane to which the AMOC applies, notify your appropriate
principal inspector (PI) in the FAA Flight Standards District Office
(FSDO), or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

(h) Related Information

    Refer to MCAI European Aviation Safety Agency (EASA) AD No.:
2016-0027, dated February 9, 2016, for related information. You may
examine the MCAI on the Internet at http://www.regulations.gov by
searching for and locating Docket No. FAA-2016-6123. For service
information related to this AD, contact Schempp-Hirth Flugzeugbau
GmbH, Krebenstrasse 25, 73230 Kirchheim/Teck, Germany; telephone:
+49 7021 7298-0; fax: +49 7021 7298-199; email<EMAIL_ADDRESS>Internet: http://www.schempp-hirth.com. You may review
this referenced service information at the FAA, Small Airplane
Directorate, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call
(816) 329-4148.

    Issued in Kansas City, Missouri, on April 15, 2016.
Melvin Johnson,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-09435 Filed 4-26-16; 8:45 am]
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