[Federal Register Volume 82, Number 20 (Wednesday, February 1, 2017)]
[Rules and Regulations]
[Page 8894]
[FR Doc No: 2017-02174]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1105

[Docket No. FDA-2016-N-1555]

Refuse To Accept Procedures for Premarket Tobacco Product
Submissions; Revised Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; delay of effective date.

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

SUMMARY: In accordance with the memorandum of January 20, 2017, from
the Assistant to the President and Chief of Staff, entitled
``Regulatory Freeze Pending Review,'' this action revises the effective
date of the final rule (``Refuse to Accept Procedures for Premarket
Tobacco Product Submissions'') published December 29, 2016, from
January 30, 2017, until March 21, 2017.

DATES: The effective date of the rule that published on December 29,
2016, at 81 FR 95863, is delayed until March 21, 2017.

FOR FURTHER INFORMATION CONTACT: Center for Tobacco Products, Food and
Drug Administration, 10903 New Hampshire Ave., Document Control Center,
Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On December 29, 2016, the Food and Drug
Administration (FDA or Agency) issued a final rule describing when FDA
will refuse to accept a tobacco product submission (or application)
because the application has not met a minimum threshold for
acceptability for FDA review (81 FR 95863). Under the rule, FDA will
refuse to accept a tobacco product submission, for example, that is not
in English, does not pertain to a tobacco product, or does not identify
the type of submission. The rule was published with an effective date
of January 30, 2017.
    FDA bases this action on the memorandum of January 20, 2017 (82 FR
8346), from the Assistant to the President and Chief of Staff, entitled
``Regulatory Freeze Pending Review.'' That memorandum directed the
heads of Executive Departments and Agencies to temporarily postpone for
60 days from the date of the memorandum the effective dates of all
regulations that had been published in the Federal Register but had not
yet taken effect, for the purpose of ``reviewing questions of fact,
law, and policy they raise.'' FDA, therefore, is revising the effective
date of the rule that published on December 29, 2016 (81 FR 95863), to
March 21, 2017.
    To the extent that 5 U.S.C. 553 applies to this action, it is
exempt from notice and comment because it constitutes a rule of
procedure under 5 U.S.C. 553(b)(A). Alternatively, the Agency's
implementation of this action without opportunity for public comment,
effective immediately upon publication today in the Federal Register,
is based on the good cause exceptions in 5 U.S.C. 553(b)(B) and (d)(3).
Seeking public comment is impracticable, unnecessary, and contrary to
the public interest. The temporary delay in the effective date until
March 21, 2017, is necessary to give Agency officials the opportunity
for further review and consideration of the new regulation, consistent
with the memorandum described previously. Given the imminence of the
effective date and the brief length of the extension of the effective
date, seeking prior public comment on this temporary delay would have
been impracticable, as well as contrary to the public interest in the
orderly promulgation and implementation of regulations.\1\ FDA also
believes that affected entities need to be informed as soon as possible
of the extension and its length in order to plan and adjust their
implementation process accordingly.
---------------------------------------------------------------------------

    \1\ In the event that this rule does not publish on or before
January 30, 2017, good cause similarly exists to stay the
effectiveness of the rule published December 29, 2016, and revise
its effective date until March 21, 2017.

    Dated: January 27, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-02174 Filed 1-30-17; 11:15 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 127 (Tuesday, July 2, 2019)]
[Notices]
[Pages 31641-31643]
[FR Doc No: 2019-14053]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-86203; File No. SR-BX-2019-021]

Self-Regulatory Organizations; Nasdaq BX, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Harmonize the
Exchange's By-Law Provisions Regarding the Size of the Exchange's Board
of Directors to Those of the Other Nasdaq, Inc.-Owned U.S. Exchanges

June 26, 2019.
    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 June 17, 2019, Nasdaq BX, Inc. (``BX'' 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.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    The Exchange proposes to harmonize the Exchange's By-Law provisions
regarding the size of the Exchange's Board of Directors (``Board'') to
those of the other Nasdaq, Inc.-owned U.S. exchanges, The Nasdaq Stock
Market LLC (``Nasdaq''), Nasdaq PHLX LLC (``Phlx''), Nasdaq ISE, LLC
(``ISE''), Nasdaq GEMX, LLC (``GEMX''), and Nasdaq MRX, LLC (``MRX'')
(together, ``Affiliated Exchanges'').
    The text of the proposed rule change is available on the Exchange's
website at http://nasdaqbx.cchwallstreet.com/, at the principal office
of the Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    The Exchange proposes to amend its By-Laws at Article IV, Section
4.2 \3\ to conform its provisions regarding the size of the Exchange's
Board to those of the Affiliated Exchanges.\4\
---------------------------------------------------------------------------

    \3\ In Exhibit 5, the references to ``Corporation'' mean the
Exchange.
    \4\ See Nasdaq Second Amended Limited Liability Company
Agreement (``Nasdaq LLC Agreement''), Section 9(a); Phlx Second
Amended Limited Liability Company Agreement (``Phlx LLC
Agreement''), Section 8(a); and ISE, GEMX, and MRX Limited Liability
Company Agreements, Section 9(a).
---------------------------------------------------------------------------

    By-Law Article IV contains provisions regarding the powers and
composition of the Board, which are generally aligned with similar
provisions in the Limited Liability Company (``LLC'') Agreements and
By-Laws of the Affiliated Exchanges. For instance, as is the case with
the Affiliated Exchanges, the composition of the Exchange's Board is
required to reflect a balance among Industry Directors,\5\ Member
Representative Directors,\6\ and Non-Industry Directors,\7\ including
Public Directors \8\ and Director representatives of issuers and
investors (``issuer representatives''). Specifically, the number of
Non-Industry Directors, including at least one Public Director and at
least one issuer representative, shall equal or exceed the sum of the
number of Industry Directors and Member Representative Directors. In
addition, at least 20% of the Directors shall be Member Representative
Directors.\9\
---------------------------------------------------------------------------

    \5\ ``Industry Director'' means a Director (excluding any two
officers of the Exchange, selected at the sole discretion of the
Board, amongst those officers who may be serving as Directors (the
``Staff Directors'')), who (i) is or has served in the prior three
years as an officer, director, or employee of a broker or dealer,
excluding an outside director or a director not engaged in the day-
to-day management of a broker or dealer; (ii) is an officer,
director (excluding an outside director), or employee of an entity
that owns more than ten percent of the equity of a broker or dealer,
and the broker or dealer accounts for more than five percent of the
gross revenues received by the consolidated entity; (iii) owns more
than five percent of the equity securities of any broker or dealer,
whose investments in brokers or dealers exceed ten percent of his or
her net worth, or whose ownership interest otherwise permits him or
her to be engaged in the day-to-day management of a broker or
dealer; (iv) provides professional services to brokers or dealers,
and such services constitute twenty percent or more of the
professional revenues received by the Director or twenty percent or
more of the gross revenues received by the Director's firm or
partnership; (v) provides professional services to a director,
officer, or employee of a broker, dealer, or corporation that owns
fifty percent or more of the voting stock of a broker or dealer, and
such services relate to the director's, officer's, or employee's
professional capacity and constitute twenty percent or more of the
professional revenues received by the Director or twenty percent or
more of the gross revenues received by the Director's firm or
partnership; or (vi) has a consulting or employment relationship
with or provides professional services to the Exchange or any
affiliate thereof or to FINRA or has had any such relationship or
provided any such services at any time within the prior three years.
See By-Law Article I(t).
    \6\ ``Member Representative Director'' means a Director who has
been elected by the stockholders after having been nominated by the
Member Nominating Committee or voted upon by Exchange Members
pursuant to the By-Laws (or elected by the stockholders without such
nomination or voting in the case of the Member Representative
Directors elected pursuant to Section 4.3(b)). A Member
Representative Director may, but is not required to be, an officer,
director, employee, or agent of an Exchange Member. See By-Law
Article I(x). Member Representative Directors are directors that
meet the fair representation requirement in Section 6(b)(3) of the
Act, which requires that the ``rules of the Exchange assure a fair
representation of its members in the selection of its directors and
administration of its affairs. . .''
    \7\ ``Non-Industry Director'' means a Director (excluding Staff
Directors) who is (i) a Public Director; (ii) an officer or employee
of an issuer of securities listed on the Exchange; or (iii) any
other individual who would not be an Industry Director. See By-Law
Article I(bb).
    \8\ ``Public Director'' means a Director who has no material
business relationship with a broker or dealer, the Exchange or its
affiliates, or FINRA. See By-Law Article I(gg).
    \9\ See By-Law Article IV, Section 4.3. The Affiliated Exchanges
have substantially similar board composition requirements, including
the requirement that at least 20% of the directors be Member
Representative Directors. In addition, the By-Laws of Nasdaq, ISE,
GEMX, and MRX each have an additional board composition requirement
of at least two issuer representatives if the board consists of ten
or more directors. See Nasdaq LLC Agreement, Section 9(a) and Nasdaq
By-Laws, Article III, Section 2(a); Phlx LLC Agreement, Section 8(a)
and Phlx By-Laws, Article III, Section 3-2(a); and ISE, GEMX, and
MRX LLC Agreements, Section 9(a) and ISE, GEMX, and MRX By-Laws,
Article III, Section 2(a).
---------------------------------------------------------------------------

    Furthermore, consistent with the Affiliated Exchanges, the
Exchange's By-Laws presently allow the stockholders \10\ to set the
exact number of Directors.\11\ Unlike the Affiliated

Exchanges, however, the Exchange's By-Laws require that the minimum
Board size be fixed at ten Directors.\12\ The Exchange now proposes to
remove the minimum threshold of ten Directors contained in the By-Laws
to align with the provisions in the LLC Agreements of the Affiliated
Exchanges. The Exchange does not seek to amend the Board's authority or
qualification requirements in the By-Laws other than to remove this
minimum threshold. As such, the current requirements that the number of
Non-Industry Directors (including at least one Public Director and at
least one issuer representative) equal or exceed the sum of the number
of Industry Directors and Member Representative Directors, and at least
20% of the Directors be Member Representative Directors, would continue
to apply.
---------------------------------------------------------------------------

    \10\ Nasdaq, Inc. is the sole stockholder of the Exchange.
    \11\ See By-Law Article IV, Section 4.2. See supra note 4.
    \12\ See By-Law Article IV, Section 4.2. Section 4.2 also
provides that no decrease in the number of Directors shall shorten
the term of any incumbent Director.
---------------------------------------------------------------------------

    The practical effect of the proposed rule change is to enable the
size of the Board to be set below ten members. The Exchange believes
that a Board consisting of less than ten members is sufficiently large
to effectively perform the Board's oversight responsibilities, and when
combined with the current Board composition requirements discussed
above, is consistent with the Act. Furthermore, as noted above, while
the Affiliated Exchanges have substantially similar provisions in their
respective LLC Agreements authorizing the sole member to determine the
number of directors, these LLC Agreement provisions do not have a
strict minimum threshold on Board size like BX.\13\ As such, the
proposed changes will further streamline the rules governing the
organization and administration across BX and the Affiliated Exchanges.
---------------------------------------------------------------------------

    \13\ See supra note 4.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\14\ in general, and furthers the objectives of Section
6(b)(1) of the Act,\15\ which requires that the Exchange to be so
organized so as to have the capacity to be able to carry out the
purposes of the Act and to comply, and to enforce compliance by its
members and persons associated with its members, with the provisions of
the Act, the rules and regulations thereunder, and the rules of the
Exchange; Section 6(b)(3) of the Act,\16\ which requires that the rules
of a national securities exchange assure the fair representation of its
members in the selection of its directors and administration of its
affairs, and provide that one or more directors shall be representative
of issuers and investors and not be associated with a member of the
exchange, broker, or dealer; and Section 6(b)(5) of the Act,\17\ in
that it is designed to promote just and equitable principles of trade,
to remove impediments to and perfect the mechanism of a free and open
market and a national market system, and, in general to protect
investors and the public interest. The proposed changes will eliminate
the requirement for a minimum of ten Directors on the Board currently
in Article IV, Section 4.2 of the Exchange's By-Laws. As discussed
above, the current Board composition requirements in the By-Laws remain
unchanged under this proposal, and the requirements that the number of
Non-Industry Directors (including at least one Public Director and at
least one issuer representative) equal or exceed the sum of the number
of Industry Directors and Member Representative Directors, and at least
20% of the Directors be Member Representative Directors, would continue
to apply. Accordingly, the Exchange believes that the proposed removal
of the minimum threshold will improve administrative efficiency and
effectiveness by operating with a smaller number of directors while
continuing to fulfill its statutory obligations regarding the fair
representation of members of the Exchange. In addition, the proposed
amendments will have the additional benefit of bringing the Exchange's
requirements on Board size into greater conformity with those of the
Affiliated Exchanges, which allow for discretion as to the size of
their boards, thereby creating more consistent standards among the
affiliated exchanges owned by Nasdaq, Inc.\18\ As such, the Exchange
believes that its proposal will bring greater consistency to its rules,
which is beneficial to both investors and the public interest.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78f(b).
    \15\ 15 U.S.C. 78f(b)(1).
    \16\ 15 U.S.C. 78f(b)(3).
    \17\ 15 U.S.C. 78f(b)(5).
    \18\ See supra note 4.
---------------------------------------------------------------------------

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. The proposed rule change
relates solely to the administration and governance of the Exchange and
will have no effect on the Exchange's business operations or
competitive position.

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

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \19\ and Rule 19b-
4(f)(6) thereunder.\20\
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78s(b)(3)(A).
    \20\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its 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.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \21\ normally
does not become operative prior to 30 days after the date of the
filing. However, Rule 19b-4(f)(6)(iii) \22\ permits the Commission to
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay. The Exchange states
that the annual meeting of the stockholder will take place in June 2019
to address the election of Directors as well as certain housekeeping
items, which has historically included setting the size of the Board.
The Exchange states that the waiver of the operative delay will allow
the Exchange to harmonize its rules across the Affiliated Exchanges in
a timely manner, thereby creating more consistent standards for the
administration and governance across the Nasdaq, Inc.-owned affiliated
exchanges. Accordingly, the Commission believes that waiver of the 30-
day operative delay is consistent with the protection of investors and
the public interest. Therefore, the Commission hereby waives the 30-day
operative delay and designates the

proposed rule change as operative upon filing.\23\
---------------------------------------------------------------------------

    \21\ 17 CFR 240.19b-4(f)(6).
    \22\ 17 CFR 240.19b-4(f)(6)(iii).
    \23\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-BX-2019-021 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-BX-2019-021. 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-BX-2019-021 and should be submitted on
or before July 23, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\24\
---------------------------------------------------------------------------

    \24\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-14053 Filed 7-1-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 152 (Monday, August 8, 2011)]
[Notices]
[Pages 48193-48195]
[FR Doc No: 2011-20008]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65020; File No. SR-NASDAQ-2011-099]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule To Amend
Fees Assessed for Use of NASDAQ Pre-Trade Risk Management

August 3, 2011.
    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 July 25, 2011, The NASDAQ Stock Market LLC (the ``Exchange''
or ``NASDAQ'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III, below, which Items have been prepared by NASDAQ. 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\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    NASDAQ is proposing to amend fees assessed for use of NASDAQ Pre-
trade Risk Management (``PRM'') and to make a minor technical
correction. NASDAQ will implement the amended fees effective August 1,
2011.
    The text of the proposed rule change is below. Proposed new
language is in italics; proposed deletions are in brackets.

7016. Nasdaq Risk Management

    (a) No change.
    (b) Users of NASDAQ Pre-trade Risk Management (``PRM'') will be
assessed [a charge of $100 per month per PRM-enabled port.] a monthly
fee based on the following table, and such fees will not exceed $25,000
per member firm, per month:

----------------------------------------------------------------------------------------------------------------
                                            Number of PRM-enabled
               Port tiers                           ports                            Monthly fee
----------------------------------------------------------------------------------------------------------------
Tier 1.................................  50 or more................  $400 per port, per month.
Tier 2.................................  20 to 49..................  500 per port, per month.
Tier 3.................................  5 to 19...................  550 per port, per month.
Tier 4.................................  1 to 4....................  600 per port, per month.
----------------------------------------------------------------------------------------------------------------

    (c) Users of PRM services specified below will be assessed the
following charges in addition to the applicable PRM-enabled port
charges:
    PRM Modules--[$500 per month per PRM Module] No charge
    Aggregate Total Checks--[$0.025 per each eligible side, capped at
$2,000 per month per PRM Module] No charge
    PRM Workstation Add-ons to an $100 per each PRM Workstation Add-on
per month [existing NASDAQ Workstation or beginning July 2006 (no
charge for

any PRM WeblinkACT 2.0 Workstation Add-ons in April, May and June 2008]
* * * * *

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

    In its filing with the Commission, NASDAQ 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. NASDAQ 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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    NASDAQ is proposing to amend the fees assessed users of NASDAQ Pre-
Trade Risk Management. PRM provides member firms with the ability to
set a wide range of parameters for orders to facilitate pre-trade
protection by creating a PRM module defined to represent checks
desired. Using PRM, firms can increase controls on their trading
activity and the trading activity of their clients and customers at the
order level, including the opportunity to prevent potentially erroneous
transactions. PRM validates orders entered on PRM-enabled ports prior
to allowing those orders into its matching engine and, using parameters
set by the subscriber, determines if the order should be sent for
fulfillment. If PRM rejects an order, it alerts the member firm and
provides it with clearly-defined reasons for the rejection.\3\ These
alerts are sent on Execution and Order/Message DROP copy lines/reports.
---------------------------------------------------------------------------

    \3\ For example, PRM provides a ``Fat Finger Check,'' which
allows a user to compare price instructions on incoming orders
against the current displayed size and price in the market. If the
order is not in line with the displayed price and size, the order
will be rejected before it can execute. Users can set order limits
at several levels to ensure that clearly erroneous orders never
execute.
---------------------------------------------------------------------------

    PRM users may choose to set PRM Order Checks, Aggregate Total
Checks within a PRM Module, and subscribe to PRM Workstation Add-ons to
[sic] an existing NASDAQ Workstation or WeblinkACT 2.0. PRM manages
risk by checking each order, before it is accepted into the system,
against certain parameters pre-specified by the user within a module,
such as maximum order size or value, order type restrictions, market
session restrictions (pre/post market), security restrictions,
including per-security limits, restricted stock list, and certain other
criteria. These checks are in addition to the Fat Finger Check, which
is available for all orders submitted through a RASH/FIX PRM-enabled
port.\4\ In order for a member firm to subscribe, at least one PRM
Module per market participant ID (``MPID'') is required, but a user may
have multiple PRM Module subscriptions per MPID, depending on the type
and number of ports designated as PRM ports.\5\ A PRM Module is created
to validate individual orders against pre-specified parameters.
Aggregate Total Checks allow users to limit overall daily trading
activity based on Buy, Sell, and/or Net trading limits. These daily
trading activity limits may be established at an aggregate limit and/or
security specific limit per PRM Module. Member firms may subscribe to
the PRM Workstation Add-on to [sic] an existing NASDAQ Workstation or
WeblinkACT 2.0 for a fee.
---------------------------------------------------------------------------

    \4\ Id.
    \5\ A member using FIX or Rash ports can configure its PRM
Module to pre-trade-manage a subscriber's order flow for a specified
MPID and PRM-enabled port, or for an account within an MPID. A
member using OUCH ports can configure its PRM Module to pre-trade-
manage a subscriber's order flow for a specified port.
---------------------------------------------------------------------------

    NASDAQ is proposing to change the means by which PRM fees are
assessed under Rules 7016(b) and (c). Currently, under Rule 7016(b)
subscribers pay a nominal fee of $100 per PRM-enabled port, and $500
per month, per PRM Module. Subscribers must subscribe to at least one
PRM Module, but often subscribe to more than one PRM Module so that
firm may monitor separate order flow sent through a single PRM-enabled
port. In addition, a separate fee for Aggregate Total Checks is
assessed at a rate of $.025 per each eligible side and is limited to a
total of $2,000 per module, per month. As such, combined fees for a
single PRM-enabled port often exceed the minimum fee of $600 per month.
    In lieu of assessing module-based and order-based fees under Rule
7016(c), NASDAQ is proposing to eliminate the fee for these two
services and increase the per-port fee assessed under Rule 7016(b). The
new monthly port-based fee is tiered, decreasing as the number of PRM-
enabled ports subscribed increase and the next tier is reached. NASDAQ
is also proposing to limit the fees assessed a member firm under the
new tiered fee structure to a total of $25,000 per month. Although
NASDAQ is proposing to eliminate the fees assessed for PRM Modules and
Aggregate Total Check, both services will continue to be available to
subscribers with no change to the service provided.
    NASDAQ believes that assessing PRM fees by port will simplify the
billing process and either result in no increase in fees as assessed
under the current rules, or more likely result in a fee decrease for
the majority of current subscribers. For example, a subscriber to a
single PRM-enabled port with a single PRM Module subscription would
incur the same fee under both the proposed PRM-enabled port fee and the
current fee regime--$600 per month. A subscriber to five PRM-enabled
ports with five PRM Modules would be assessed a fee of $3,000 per month
under the current rules, whereas the same subscriber would only pay
$2,750 per month under the proposed rules. A subscriber with five PRM-
enabled ports and a total of ten PRM Modules would pay $5,500 per month
under the current rules, yet only $2,750 per month under the proposed
fees. This analysis does not account for the additional savings that
subscribers to Aggregate Total Checks will realize under the proposed
new fees.
    Last, NASDAQ is deleting language concerning a fee holiday from PRM
Workstation Add-ons fees from the table under Rule 7016(c), since it
concerns a limited timeframe that has since expired.
2. Statutory Basis
    NASDAQ believes that the proposed rule change is consistent with
Section 6(b)(4) of the Act \6\ in that it provides for the equitable
allocation of reasonable dues, fees and other charges among members and
issuers and other persons using any facility or system which the NASDAQ
operates or controls, and it does not unfairly discriminate between
customers, issuers, brokers or dealers. The amended fee schedule
applies to all subscribers equally based on the number of ports
subscribed. The proposed amended fees provide a more efficient means of
billing, thus reducing administrative costs. The proposed changes may
also provide incentive for member firms to subscribe to the service and
utilize additional PRM features (i.e., Total Aggregate Checks) given
the elimination of transaction-based fee for Total Aggregate Checks,
the elimination of the monthly PRM Module fee, and the tiered PRM fee
structure with a $25,000 monthly fee cap, per member firm. The proposed
amended fees will continue to cover the costs associated with
separately offering the service,

responding to customer requests, configuring NASDAQ's systems,
programming to user specifications, and administering the service,
among other things, and may provide NASDAQ with a profit to the extent
costs are covered.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    NASDAQ also believes that the proposed rule change is consistent
with the provisions of Section 6(b)(5) of the Act \7\ because 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. PRM is designed to
assist member firms in avoiding entry of erroneous orders by screening
out those that exceed pre-determined limits, which otherwise may harm
both the member firm and the quality of the markets. As such, PRM is an
important compliance tool that members may use to help maintain the
regulatory integrity of the markets. NASDAQ believes that the
amendments to the fees assessed for PRM and its services may encourage
more member firms to subscribe to this useful compliance tool.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    NASDAQ does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended.

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

    Written comments were neither solicited nor 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 \8\ and subparagraph (f)(2) of Rule 19b-4
thereunder.\9\ At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(a)(ii).
    \9\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2011-099 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-NASDAQ-2011-099. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for Web site
viewing and printing in the Commission's Public Reference Room, 100 F
Street, NE., Washington, DC 20549, on official business days between
the hours of 10 a.m. and 3 p.m. Copies of the filing also will be
available for inspection and copying at the principal office of the
Exchange. 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-
NASDAQ-2011-099 and should be submitted on or before August 29, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-20008 Filed 8-5-11; 8:45 am]
BILLING CODE 8011-01-P


[Sporodex L / 2001 0304 / PLG] ~ PROTECTED ~ Acute Oral Infectivity and Toxicity Study /1 [Pseudozyma flocculosa / 2000 0680 / STF] DACO M4. 2. 2 / USEPA OPPTS 885.3050 Reviewer: Esther Seto , Date January 8, 2002 Peer Review: Ibrahim Barsoum, PhD Microbial Pesticides Branch Biopesticides and Pollution Prevention Division U. S. Environmental Protection Agency _______________

STUDY TYPE: Acute Oral Toxicity  Rat PMRA DATA CODE M4.2. 2 / USEPA OPPTS 885.3050 TEST MATERIAL (PURITY): Sporodex® (WP formulation)  1997 Formulation 5.6 5.8 x 10 8 Pseudozyma flocculosa colony forming units / mL SYNONYMS: Pseudozyma flocculosa [STF], Sporothrix flocculosa, Stephanoascus flocculosa CITATION: Descôteaux, Jean Paul. (September 9, 1996). "Report of an Acute Oral Toxicity / Infectivity Study of Sporodex® Administered by Gavage to Fisher 344 Rats." Institut Armand Frappier, Laval, Québec, Canada. Study Number 951890. In Life Study Dates: February 6 7, 1996  February 27 28, 1996. Unpublished.

SPONSOR: Plant Products Co., Ltd. 314 Orenda Road Brampton, Ontario Canada EXECUTIVE SUMMARY: In an acute oral toxicity study, groups of fasted, 6  7 week old Fisher 344 rats (12/ sex) were given a single oral dose of Sporodex WP in USP sterile water for injection at doses of 5.8 x 10 8 colony forming units (CFU) per animal for males and 5. 6 x 10 8 CFU per animal for females. The animals were then observed for a period of up to 21 days with interim scheduled sacrifices.

Oral LD50 Males > 5.8 x 10 8 CFU per animal. Females > 5.6 x 10 8 CFU per animal.

No mortalities occurred. Limit test.

Pseudozyma flocculosa is of LOW Toxicity based on theLD50 in female Fisher 344 rats. There were no clinical signs of toxicity and all of the animals gained weight during the study. No gross findings were observed at necropsy. No label comments are required.

This acute oral study is classified acceptable. This study satisfies the guideline requirement for an acute oral study (OPPTS 885.3050) in the rat.

COMPLIANCE: Signed and dated GLP, Quality Assurance, and Data Confidentiality statements were [Sporodex L / 2001 0304 / PLG] ~ PROTECTED ~ Acute Oral Infectivity and Toxicity Study /2 [Pseudozyma flocculosa / 2000 0680 / STF] DACO M4. 2. 2 / USEPA OPPTS 885.3050 provided. The study meets GLP standards with the following exceptions: 1) The purity and the characterization of the active ingredient and the stability of the test material was established by the sponsor's representative's laboratory and was not included in the compliance statement. 2) Some SOPs were used as drafts.

I. MATERIALS AND METHODS A. MATERIALS:

1. Test Material: Sporodex® Description: pinkish fine powder Lot/ Batch #: UK34 35 Purity: 3.5 x 10 8 colony forming units / g CAS #: n/ a The purity and the stability of the test substance was established and documented by the sponsor's representative (Dr. Richard Bélanger; Université Laval).

2. Sample Preparation: A solution of the test substance was prepared by dissolving 0. 5 g of Sporodex® in 100 mL of USP grade sterile water for injection (Abbott Laboratories, Montréal, Québec) and mixing in a blender for approximately 2 minutes. The solution was adjusted by weight per volume to establish the recommended dose of 1 x 10 8 CFU/ mL by the addition of sterile water and mixing with a stir bar.

Half of the solution was heat treated for approximately 20 minutes at 82 ± 2  C to render the active ingredient non viable and was used as killed test substance [TS( K)] to dose control group animals. The rest of the solution was used as viable test substance [TS( V)] to dose animals in the treatment groups.

Immediately before and after dosing, various dilutions of TS( K) and TS( V) were plated on yeast malt peptone dextrose agar (YMA) media (Quélab, Montréal, Québec), containing 0. 05 g/ L of chloramphenicol, to confirm their titres. The titre of the TS( V) preparation was 5. 6  5. 8 x 10 8 CFU/ g and the titre of the TS( K) preparation was 0 CFU/ g.

USP grade sterile water for injection (Abbott Laboratories, Montréal, Québec) was also used as a control.

3. Test animals: Species: Rat Strain: Fisher 344, substrain NHsd Age/ weight: animal receipt 4 5 weeksold males: 67.3  80.5 g (based on ten animals) females: 68.3  82.1 g (based on ten animals) at time of dosing 6 7 weeksold males: 111  129 g females: 100  109 g Source: Harlan Sprague Dawley Inc. Indianapolis, Indiana, USA [Sporodex L / 2001 0304 / PLG] ~ PROTECTED ~ Acute Oral Infectivity and Toxicity Study /3 [Pseudozyma flocculosa / 2000 0680 / STF] DACO M4. 2. 2 / USEPA OPPTS 885.3050 Housing: Rats were individually housed, in wire bar covered cages with beta chip bedding, throughout the acclimation and treatment periods. Diet: Prolab Rodent Chow 4018 (Charles River Laboratories, St Constant, Québec) was provided ad libitum for the first week of the acclimation period. For the remainder of the study, the rats received a diet of certified Rodent Diet 5002 (PMI Feeds Inc.) ad libitum. Water: Municipal tap water was provided ad libitum Environmental conditions: Temperature: Humidity: Air changes: Photoperiod: 21  24  C 19  54 % not reported 12 hrs dark / 12 hrs light Acclimation period: approximately two weeks B. STUDY DESIGN and METHODS:

1. In life dates  Start: February 6 7, 1996 End: February 27 28, 1996 2. Animal assignment and treatment  Animals were assigned, on the basis of body weight, to the test groups noted in Table 1. Individual body weights did not vary from the group mean body weight (by sex) by more than 20%. Following a 16 hour fast, rats were given a single dose of TS( V), TS( K) or USP grade sterile water by gavage then observed daily and weighed weekly until sacrifice. Necropsies were performed following sacrifice on the scheduled days.

TABLE 1. Doses, mortality/ animals treated Test Group Test Substance Dose Level Sacrifice Day Males Females Combined 1 TS( V)  :5.8 x 10 8 CFUin 1 mL  :5.6 x 10 8 CFUin 1 mL 0 0/ 4 0/ 4 0/ 8 2 TS( K)  : heat killed active ingredient equal to 5. 8 x 10 8 CFUin 1 mL  : heat killed active ingredient equal to 5. 6 x 10 8 CFUin 1 mL 0 0/ 4 0/ 4 0/ 8 3 TS( V)  :5.8 x 10 8 CFUin 1 mL  :5.6 x 10 8 CFUin 1 mL 7 0/ 4 0/ 4 0/ 8 4 TS( K)  : heat killed active ingredient equal to 5. 8 x 10 8 CFUin 1 mL  : heat killed active ingredient equal to 5. 6 x 10 8 CFUin 1 mL 7 0/ 4 0/ 4 0/ 8 5 TS( V)  :5.8 x 10 8 CFUin 1 mL  :5.6 x 10 8 CFUin 1 mL 21 0/ 4 0/ 4 0/ 8 6 TS( K)  : heat killed active ingredient equal to 5. 8 x 10 8 CFUin 1 mL  : heat killed active ingredient equal to 5. 6 x 10 8 CFUin 1 mL 21 0/ 4 0/ 4 0/ 8 [Sporodex L / 2001 0304 / PLG] ~ PROTECTED ~ Acute Oral Infectivity and Toxicity Study /4 [Pseudozyma flocculosa / 2000 0680 / STF] DACO M4. 2. 2 / USEPA OPPTS 885.3050 7 Control 1 mL of USP sterile water for injection 21 0/ 4 0/ 4 0/ 8 3. Clinical Observations  Cage side observations for mortality and moribundity were made at least once daily. Cage side observations also included examination of the general condition, appearance and demeanor of each rat, and observation of the animal's movement within the cage.

4. Body Weights  Body weights were measured upon receipt of the animals, on the day of randomization, prior to gavage and weekly thereafter. All body weight measurements were taken following an overnight fasting period.

5. Feed Consumption  Measurement of feed consumption began on the day of dosing and continued weekly thereafter.

6. Necropsy  Animals were sacrificed according to the schedule in Table 1. All test animals were fasted overnight prior to sacrifice. On the day of scheduled sacrifice, animals were weighed and anaesthetized using Ketamine/ Xylazine prior to blood collection by cardiac puncture. The necropsy included an examination of the external surface of the body, all orifices, cranial cavity, external surface of the brain, the thoracic, abdominal and pelvic cavities and the viscera. The following tissues were collected from each test animal for enumeration of the test substance: brain, lungs, liver, kidneys, stomach and small intestine (duodenum, jejunum, ileum), caecum, mesenteric lymph nodes, and spleen.

7. Sensitivity of Detection  Aliquots containing the viable test substance diluted to approximately 10 4 , 10 5 ,and10 6 viable units/ mL were placed into sterile bags (Seward Medical, England) and homogenized with either the lungs or caecums removed from 3 male and 3 female rats. Additional samples containing the test substance without the addition of animal tissues served as the untreated controls. The homogenized samples and the untreated controls were standardized for volume and plated on duplicate plates of YMA media supplemented with 0. 05 g/ L of chloramphenicol. After incubation at approximately 27  C for 36 ± 12 hours, the substance titres were determined by counting colonies. The sensitivity of detection was expressed as a factor of the percent recovery and the limit of detection observed.

8. Enumeration of Test Substance  Each organ, aseptically collected at the time of necropsy, was weighed and homogenized. Organ homogenates and blood samples were diluted, as necessary, with peptone water. A 100 µl aliquot was then plated on duplicate YMA agar supplemented with 0. 05 g/ L of chloramphenicol and incubated at approximately 27  C for 36 ± 12 hours. Only plates with counts of between 10  120 colonies were included for the determination of the number of CFU/ g of tissue or CFU/ mL of blood. The number of CFU/ g of organ was calculated as follows:

(mean plate count / 0. 1 g of organ homogenate)* weight of organ homogenate weight of organ.

9. Statistics  The analysis of variance (ANOVA) method was used to determine whether statistically significant differences in body weight and feed consumption existed between groups.

II. RESULTS AND DISCUSSION:

A. Mortality is given in Table 1. [Sporodex L / 2001 0304 / PLG] ~ PROTECTED ~ Acute Oral Infectivity and Toxicity Study /5 [Pseudozyma flocculosa / 2000 0680 / STF] DACO M4. 2. 2 / USEPA OPPTS 885.3050 The oral LD50 for males is greater than 5. 8 x 10 8 CFU per animal. females is greaterthan5.6 x 10 8 CFU per animal.

B. Clinical observations  There were no clinical signs of toxicity at any point of the study. All animals appeared normal in general condition, demeanor and movement.

C. Body Weight  All animals gained weight (see Table 2 for summary). No statistically significant difference in body weight or weight gain between TS( K), TS( V) and USP sterile water control groups was found. A significant statistical difference (P <0.001), however, was found between sexes for all groups including control groups and was, therefore, not considered treatment related.

TABLE 2. Rat body weight summary Test Substance Sex Body Weight (g)

Day 0 a Day 7 b Day 14 c Day 21 c TS( V) M 120 ± 9 150 ± 14 173 ± 8 197 ± 7 TS( K) M 121 ± 8 148 ± 12 165 ± 23 190 ± 26 USP sterile water M 122 ± 7 149 ± 9 175 ± 11 200 ± 11 TS( V) F 104 ± 4 121 ± 6 132 ± 4 143 ± 4 TS( K) F 105 ± 4 123 ± 4 129 ± 5 141 ± 5 USP sterile water F 105 ± 4 122 ± 7 131 ± 9 143 ± 10 a : each value represents the mean and standard deviation calculated on the basis of 12 animals for TS( V) and TS( K) treatment groups and on the basis of 4 animals for the USP sterile water group b : each value represents the mean and standard deviation calculated on the basis of 8 animlas for TS( V) and TS( K) treatment groups and on the basis of 4 animals for the UPS sterile water group c : each value represents the mean and standard deviation calculated on the basis of 4 animals for TS( V) and TS( K) treatment groups and on the basis of 4 animals for the UPS sterile water group D. Feed Consumption  No statistically significant difference in weekly feed consumption between TS( K), TS( V) and USP sterile water control groups was found. A significant statistical difference (P <0.001), however, was found between sexes for all groups including control groups and was, therefore, not considered treatment related.

E. Necropsy  There were no gross necropsy findings for any of the animals in the study.

F. Sensitivity of Detection  In the presence of lung and caecum tissue, the percentage recovery of the active ingredient was 61 91% and 54 83%, respectively. The sensitivity of detection in the lungs was established as 132 CFU/ mL. The sensitivity of detection in the caecum was established as 142 CFU/ mL. Assuming that the density of the organ homogenate was 1 g/ mL, the sensitivities of detection in the lungs and in the caecum could also be expressed as 132 CFU/ g and 142 CFU/ g, respectively.

G. Enumeration of the Test Substance  Pseudozyma flocculosa, at levels of 1000 and 160 (estimated [Sporodex L / 2001 0304 / PLG] ~ PROTECTED ~ Acute Oral Infectivity and Toxicity Study /6 [Pseudozyma flocculosa / 2000 0680 / STF] DACO M4. 2. 2 / USEPA OPPTS 885.3050 value) CFU/ g of tissue, was recovered from the stomach and small intestines of 2/ 4 male rats which were sacrificed one hour after administration of TS( V). Pseudozyma flocculosa was also recovered from the stomach and small intestines of 1/ 4 female rats sacrificed one hour after administration of TS( V) at a level of 780 CFU/ g of tissue. No Pseudozyma flocculosa was recovered by the seventh day post dosing in any of the animals or in any of the other collected organs or fluids.

H. Reviewer's Conclusions: According to U. S. EPA OPPTS 885.3050, the recommended test substance for an acute oral toxicity/ pathogenicity study is the TGAI. The test substance used in this study was a 1997 formulation of Sporodex WP (wettable powder). PMRA and EPA previously accepted the wettable powder end use product as the test substance. A change in the intended formulation of the end use product from a wettable powder to a liquid formulation (Sporodex L), however, triggered the need for a rationale for the test substance. The applicant requested a waiver from submitting a replacement acute oral study using the TGAI or the liquid formulation based on the fact that the new formulants found in Sporodex L are of food grade quality and that the levels of other formulants have been significantly reduced. The toxicity of the liquid formulation is, therefore, expected to be less than that of the wettable powder formulation that was tested. The waiver rationale is accepted.

The acute oral study is classified as acceptable. Based on the results of this study, Sporodex L and its active ingredient, P. flocculosa, is not considered toxic or pathogenic to male or female Fisher 344 rats. The detection of P. flocculosa in the stomachs and small intestines of some of the treated rats is consistent with the route of administration. Clearance of P. flocculosa appears to occur within seven days of dosing.

I. Deficiencies  The number of air changes and the organ weights were not reported. These deficiencies are not considered to have a significant impact on the interpretation of the study. Clearance was not established by examining the feces for the presence of P. flocculosa. This is not considered a deficiency since clearance, instead, was estimated by enumerating P. flocculosa from collected tissues, organs and fluids.


[Federal Register Volume 88, Number 104 (Wednesday, May 31, 2023)]
[Notices]
[Page 34878]
[FR Doc No: 2023-11506]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4635-DR; Docket ID FEMA-2023-0001]

Washington; Amendment No. 6 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Washington (FEMA-4635-DR), dated January 5, 2022, and
related determinations.

DATES: This change occurred on March 27, 2023.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Andrew P.
Meyer, of FEMA is appointed to act as the Federal Coordinating Officer
for this disaster.
    This action terminates the appointment of David R. Gervino as
Federal Coordinating Officer for this disaster.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2023-11506 Filed 5-30-23; 8:45 am]
BILLING CODE 9111-23-P


SUPPORTING STATEMENT

	ENVIRONMENTAL PROTECTION AGENCY

NESHAP for Off-Site Waste and Recovery Operations (40 CFR Part 63,
Subpart DD) (Renewal)

1.  Identification of the Information Collection

1(a)  Title of the Information Collection

NESHAP for Off-Site Waste and Recovery Operations (40 CFR Part 63,
Subpart DD) (Renewal),

EPA ICR Number 1717.07, OMB Control Number 2060-0313

1(b)  Short Characterization/Abstract

The National Emission Standards for Hazardous Air Pollutants (NESHAP)
for Off-Site Waste and Recovery Operations were proposed on October 13,
1994, and promulgated on July 1, 1996.  These standards apply to
hazardous air pollutant (HAP) emissions from selected facilities
involved in waste management and recovery operations that are not
subject to Federal air standards under other subparts in part 63, and
commencing construction, modification or reconstruction after the date
of proposal if the facility is a major source of HAP emissions, as
defined in general provisions to 40 CFR part 63.  In addition, subpart
DD cross-references control requirements to be applied to specific types
of affected sources: tanks-level 1; containers; surface impoundments;
individual drain systems; oil-water separators; organic water
separators; and loading, transfer, and storage systems.  This
information is being collected to assure compliance with 40 CFR part 63,
subpart DD.  Organic HAP emissions are the pollutants regulated under
this subpart.

Owners or operators of the affected facilities described must make
one-time-only notifications.  Owners or operators are also required to
maintain records of the occurrence and duration of any startup,
shutdown, or malfunction in the operation of an affected facility, or
any period during which the monitoring system is inoperative.
Semiannual reports of excess emissions, or reports certifying that no
exceedances have occurred, are required.  These notifications, reports,
and records are essential in determining compliance; and, in general,
are required of all sources subject to the NESHAP.

Any owner or operator subject to the provisions of this part shall
maintain a file of these measurements, and retain the file for at least
five years following the date of such measurements, maintenance reports,
and records.  All reports are sent to the delegated state or local
authority.  In the event that there is no such delegated authority, the
reports are sent directly to the United States Environmental Protection
Agency (EPA) regional office.

There is an annual average of 236 respondents that will be subject to
the regulations.  Due to the nature of the industry, it is estimated
that no additional sources will become subject to the standard over the
next three years.  This information is based on discussions with EPA
personnel knowledgeable about the off-site waste and recovery
operations.  The average annual cost to industry over the next three
years of this Information Collection Request (ICR) is estimated to be
$14,681,368.

The Office of Management and Budget (OMB) approved the currently active
ICR without any “Terms of Clearance.”

The burden to the “Affected Public” may be found below in Table 1:
Annual Respondent Burden and Cost - NESHAP for Off-Site Waste and
Recovery Operations (40 CFR part 63, subpart DD) (Renewal).  The burden
to the “Federal government” is attributed entirely to work performed
by Federal employees or government contractors.  This burden may be
found below in Table 2: Average Annual EPA Burden - NESHAP for Off-Site
and Waste Recovery Operations (40 CFR part 63, subpart DD) (Renewal).

2.  Need for and Use of the Collection

2(a)  Need/Authority for the Collection

The EPA is charged under section 112 of the Clean Air Act, as amended,
to establish standards of performance for each category or subcategory
of major sources and area sources of hazardous air pollutants.  These
standards are applicable to new or existing sources of HAP and shall
require the maximum degree of emission reduction.  In addition, section
114(a) states that the Administrator may require any owner or operator
subject to any requirement of this Act to:

(A) Establish and maintain such records; (B) make such reports;      (C)
install, use, and maintain such monitoring equipment, and use such audit
procedures, or methods; (D) sample such emissions (in accordance with
such procedures or methods, at such locations, at such intervals, during
such periods, and in such manner as the Administrator shall prescribe);
(E) keep records on control equipment parameters, production variables
or other indirect data when direct monitoring of emissions is
impractical; (F) submit compliance certifications in accordance with
Section 114(a)(3);   and (G) provide such other information as the
Administrator may reasonably require.

In the Administrator's judgment, HAP emissions from off-site waste and
recovery operations cause or contribute to air pollution that may
reasonably be anticipated to endanger public health or welfare.
Therefore, the NESHAP was promulgated for this source category at 40 CFR
part 63, subpart DD.

2(b)  Practical Utility/Users of the Data

The control of emissions of pollutants from off-site waste and recovery
operations requires not only the installation of properly designed
equipment, but also the operation and maintenance of that equipment.
Emissions of organic HAP from off-site waste and recovery operations are
the result of operation of the affected facilities.  The subject
standards are achieved by the reduction of organic HAP emissions using
control technology and/or leak detection and repair procedures.

The notifications required in the applicable regulations are used to
inform the Agency or delegated authority when a source becomes subject
to the requirements of the regulations.  The reviewing authority may
then inspect the source to check if the pollution control devices are
properly installed and operated, that leaks are being detected and
repaired, and that the regulations are being met.  The semiannual
reports are used for problem identification, as a check on source
operation and maintenance, and for compliance determinations.

The information generated by the monitoring, recordkeeping and reporting
requirement described in this ICR is used by the Agency to ensure that
facilities affected by the NESHAP continue to operate the control
equipment in compliance with the regulation.  Adequate monitoring,
recordkeeping, and reporting are necessary to ensure compliance with the
applicable regulations, as required by the Clean Air Act.  The
information collected from recordkeeping and reporting requirements is
also used for targeting inspections, and is of sufficient quality to be
used as evidence in court.

3.  Non-duplication, Consultations, and Other Collection Criteria

The requested recordkeeping and reporting are required under 40 CFR part
63, subpart DD.

3(a)  Non-duplication

If the subject standards have not been delegated, the information is
sent directly to the appropriate EPA regional office.  Otherwise, the
information is sent directly to the delegated state or local agency.  If
a state or local agency has adopted their own similar standards to
implement the Federal standards, a copy of the report submitted to the
state or local agency can be sent to the Administrator in lieu of the
report required by the Federal standards.  Therefore, no duplication
exists.

3(b)  Public Notice Required Prior to ICR Submission to OMB

An announcement of a public comment period for the renewal of this ICR
was published in the Federal Register (74 FR 38004) on July 30, 2009.
No comments were received on the burden published in the Federal
Register.

3(c)  Consultations

Over the next three years, an average of 236 facilities per year will be
subject to the standard, with no additional sources per year becoming
subject to the standard.  We have also determined that approximately 33
percent of the respondents are reporting electronically.  In estimating
the affected number of sources and the growth rate of off-site waste and
recovery operations facilities subject to this standard during a
previous renewal, we contacted the Solid Waste Association of North
America (SWANA) Ms. Shannon Crawford, at<PHONE_NUMBER>, and Chartwell
Information, Mr. Grant Ferrier,<PHONE_NUMBER>.  For this renewal, we
contacted Environmental Business International (formerly Chartwell
Information), Mr. Grant Ferrier,<PHONE_NUMBER>, who did not refute
current estimates.  We referenced the most recent ICR, and used other
resources to obtain the most recent data available.  We reviewed
information available from the Online Tracking Information System (OTIS)
which is the primary source of information regarding the number of
existing sources.  OTIS data was used in conjunction with industry
consultation to verify the number of sources and the industry growth
rate.

3(d)  Effects of Less Frequent Collection

Less frequent information collection would decrease the margin of
assurance that facilities are continuing to meet the standards.
Requirements for information gathering and recordkeeping are useful
techniques to ensure that good operation and maintenance practices are
applied and emission limitations are met.  If the information required
by these standards was collected less frequently, the likelihood of
detecting poor operation and maintenance of control equipment and
noncompliance would decrease.

3(e)  General Guidelines

None of these reporting or recordkeeping requirements violate any of the
regulations established by OMB at 5 CFR part 1320, section 1320.5.

These standards require affected facilities to maintain all records,
including reports and notifications for at least five years.  This is
consistent with the General Provisions as applied to the standards.  EPA
believes that the five-year records retention requirement is consistent
with the Part 70 permit program and the five-year statute of limitations
on which the permit program is based.  Also, the retention of records
for five years would allow EPA to establish the compliance history of a
source and any pattern of compliance for purposes of determining the
appropriate level of enforcement action.  Historically, EPA has found
that the most flagrant violators frequently have violations extending
beyond the five years.  EPA would be prevented from pursuing the worst
violators due to the destruction or nonexistence of records if records
were retained for less than five years.

3(f)  Confidentiality

The required information has been determined not to be confidential.
However, any information submitted to the Agency for which a claim of
confidentiality is made will be safeguarded according to the Agency
policies set forth in title 40, chapter 1, part 2, subpart B -
Confidentiality of Business Information (CBI) (see 40 CFR 2; 41 FR
36902, September 1, 1976; amended by 43 FR 40000, September 8, 1978; 43
FR 42251, September 20, 1978; 44 FR 17674, March 23, 1979).

3(g)  Sensitive Questions

None of the reporting or recordkeeping requirements contain sensitive
questions.

4.  The Respondents and the Information Requested

4(a)  Respondents/SIC Codes

The respondents to the recordkeeping and reporting requirements are
off-site waste and recovery operations that store, treat, recycle,
reprocess, or dispose of wastes containing organic chemical compounds.
The United States Standard Industrial Classification (SIC) codes, which
correspond to the North American Industry Classification System (NAICS)
codes, could be found in the following table:

Off-site Waste and Recovery Operations (40 CFR part 63, subpart DD)	SIC
Codes	NAICS Codes

Petrochemical Manufacturing	2869	325110

All Other Basic Inorganic Chemical Manufacturing	2869	325188

Cyclic Crude and Intermediate Manufacturing	2689	325192

Ethyl Alcohol Manufacturing	2689	325193

All Other Basic Organic Chemical Manufacturing	2689	325199

Industrial Gas Manufacturing	2689	325120

All Other Miscellaneous Chemical Product and Preparation Manufacturing
2689	325998

Plastic Materials and Resin Manufacturing	2821	325211

Explosives Manufacturing	2892	325920

Carbon Black Manufacturing	2816	325182

Inorganic Dye and Pigment Manufacturing	2816	325131

Semiconductor and Related Device Manufacturing	3674	334413

Petroleum Refineries	2911	324110

Aircraft Manufacturing	3721	336411

Aircraft (research and development not producing prototypes)	3721	541710

Other General Government Support	9199	921190

All Other Petroleum and Coal Products Manufacturing	3312	324199

Iron and Steel Mills	3312	331111

Rolled Steel Shape Manufacturing	3312	331221

4(b)  Information Requested

None of these reporting or recordkeeping requirements violate any of the
regulations established by OMB at 5 CFR part 1320, section 1320.5.

(i)  Data Items

All data in this ICR that is recorded and/or reported is required by
National Emission Standards for Hazardous Air Pollutants for Off-Site
Waste and Recovery Operations (40 CFR part 63, subpart DD).

A source must make the following reports:

Reports for 40 CFR part 63, subpart DD

Notification and application of construction/reconstruction	63.5(d)

Notification of initial startup	63.9(b)

Notification of initial performance test	63.7(b) and 63.9(e)

Rescheduled initial performance test	63.7(b)(2)

Demonstration of continuous monitoring system	63.9(g)

Compliance status	63.9(h)

Physical and operational change	63.10

Notification of performance tests	63.7(b), and 63.697(b)(1)

Performance test results	63.8(e)(5), and 63.697(b)(2)

Startup, shutdown, malfunction reports	63.697(b)(3)

Notification of tank floating roof inspection	63.686(b)(3)

Notification of oil/water separator floating roof inspection
63.687(d)(6)

Notification to tank refill	63.697(d)(1)

Notification of seal gap measurements	63.697(d)(2)

Reports

Initial performance test results	63.10(d)(2)

Opacity or visible emissions	63.10(d)(3)

Periodic startup, shutdown, malfunction reports	63.10(d)(5)(i)

Source status report	63.10(e)(3)

Excess emission reports	63.695(e)

Semiannual summary report	63.697(b)(4)

A source must keep the following records:

Recordkeeping for 40 CFR part 63, subpart DD

Startup, shutdown, malfunctions, periods where the continuous monitoring
system is inoperative.	63.10(b)(2)

All reports and notifications.	63.10(b)

Record of applicability.	63.10(b)(3)

Records of sources with continuous monitoring systems.	63.10(c)

Records of startup, shutdown, and malfunctions, and pollution control
system maintenance.	63.696(b)(1)

Records of applicability determinations.	63.696(b)(3)

Documentation of extension of tank emptying schedule.	63.696(c)

Records of results of seal gap measurements and description of repairs.
63.686(d)(3)

Record of sampling plan for determining volatile organic hazardous air
pollutant (VOHAP) concentration at point of treatment	63.694(c)

Record of sampling plan for determining maximum HAP vapor pressure in
tanks.	63.694(j)(2)(1)

Record of maximum HAP vapor pressure determinations for covered tanks
63.686(c)(5)

Records should be retained for 5 years.	63.10(b)(1)

Electronic Reporting

Currently, sources are using monitoring equipment that provides
parameter data in an automated way, e.g., leaks and spills of mercury.
Although personnel at the source still need to evaluate the data, this
type of monitoring equipment has significantly reduced the burden
associated with monitoring and recordkeeping.  In addition, some
regulatory agencies are setting up electronic reporting systems to allow
sources to report electronically which is reducing the reporting burden.
 However, electronic reporting systems are still not widely used by the
regulatory agencies.  It is estimated that approximately 33 percent of
the respondents use electronic reporting.

(ii)  Respondent Activities

Respondent Activities

Determine the VOHAP concentration for off-site material at the
point-of-delivery and for the treated off-site material streams at the
point-of-treatment.

Determine the required HAP mass removal rate, actual HAP mass removal,
HAP reduction efficiency and HAP bio-degradation efficiency.

Determine the maximum organic HAP vapor pressure of the off-site
material in tanks and the process vent stream flow rate and total HAP
concentration.

Write the notifications and reports listed above.

Enter information required to be recorded above.

Submit the required reports developing, acquiring, installing, and
utilizing technology and systems for the purpose of collecting,
validating, and verifying information.

Develop, acquire, install, and utilize technology and systems for the
purpose of processing and maintaining information.

Develop, acquire, install, and utilize technology and systems for the
purpose of disclosing and providing information.

Train personnel to be able to respond to a collection of information.

Adjust existing ways to comply with any previously applicable
instructions and requirements.

Transmit, or otherwise disclose the information.

 	Currently, sources are using monitoring equipment that provides
parameter data in an automated way, e.g., HAP vapor pressure.  Although
personnel at the source still need to evaluate the data, this type of
monitoring equipment has significantly reduced the burden associated
with monitoring and recordkeeping.

5.  The Information Collected: Agency Activities, Collection
Methodology, and Information Management

5(a)  Agency Activities

EPA conducts the following activities in connection with the
acquisition, analysis, storage, and distribution of the required
information.

Agency Activities

Observe initial performance tests and repeat performance tests if
necessary.

Review notifications and reports, including performance test reports,
excess emissions reports, startup, shutdown, malfunction plan, and
quality control plan for CMS required to be submitted by industry.

Audit facility records.

Input, analyze, and maintain data in the Air Facility System (AFS).

5(b)  Collection Methodology and Management

Following notification of startup, the reviewing authority might inspect
the source to determine whether the pollution control devices are
properly installed and operational.  Performance test reports are used
by the Agency to discern a source’s initial capability to comply with
the emission standard, and note the operating conditions under which
compliance was achieved.  Data and records maintained by the respondents
are tabulated and published for use in compliance and enforcement
programs.  The semiannual reports are used for problem identification,
as a check on source operation and maintenance, and for compliance
determinations.

Information contained in the reports is entered into the AFS which is
operated and maintained by the EPA Office of Compliance.  AFS is the EPA
database for the collection, maintenance, and retrieval of compliance
and annual emission inventory data for more than 100,000 industrial and
government-owned facilities.  EPA uses the AFS for tracking air
pollution compliance and enforcement by local and state regulatory
agencies, EPA regional offices and EPA headquarters.  EPA and its
delegated Authorities can edit, store, retrieve and analyze the data.

The records required by this regulation must be retained by the owner or
operator for five years.

5(c)  Small Entity Flexibility

A majority of the affected facilities are primarily small entities
(e.g., small businesses).  According to the Off-Site Waste and Recovery
Operations NESHAP: Economic Impact Analysis,. (EPA-452/R-96-011, June
1996), EPA specifically identified 388 firms that own 621 potentially
affected facilities.  These 388 firms include 110 small businesses that
own 112 facilities Therefore, this ICR assumes approximately 18 percent
of the total facilities are small businesses, or 42 of 236 respondents.

The impact on small entities was taken into consideration during the
development of the regulation.  Due to technical considerations
involving the process operations and the type of control equipment
employed, the recordkeeping and reporting requirements are the same for
both small and large entities.  The Agency considers these requirements
the minimum needed to ensure compliance and, therefore, cannot reduce
them further for small entities.

5(d)  Collection Schedule

The specific frequency for each information collection activity within
this request is shown below in Table 1: Annual Respondent Burden and
Cost - NESHAP for Off-Site Waste and Recovery Operations (40 CFR part
63, subpart DD) (Renewal).

6.  Estimating the Burden and Cost of the Collection

Table 1 documents the computation of individual burdens for the
recordkeeping and reporting requirements applicable to the industry for
the subpart included in this ICR.  The individual burdens are expressed
under standardized headings believed to be consistent with the concept
of burden under the Paperwork Reduction Act.  Wherever appropriate,
specific tasks and major assumptions have been identified.  Responses to
this information collection are mandatory.

The Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB Control Number.

6(a)  Estimating Respondent Burden

The average annual burden to industry over the next three years from
these recordkeeping and reporting requirements is estimated to be
155,212 (Total Labor Hours from Table 1).  These hours are based on
Agency studies and background documents from the development of the
regulation, Agency knowledge and experience with the NESHAP program, the
previously approved ICR, and any comments received.

6(b)  Estimating Respondent Costs

(i)  Estimating Labor Costs

This ICR uses the following labor rates:

Managerial	$114.49 ($54.52 + 110%)

Technical	$98.20 ($46.76 + 110%)

Clerical	$48.53 ($23.11 + 110%)

These rates are from the United States Department of Labor, Bureau of
Labor Statistics, September 2009, “Table 2. Civilian Workers, by
Occupational and Industry group.”  The rates are from column 1,
“Total compensation.”  The rates have been increased by 110 percent
to account for the benefit packages available to those employed by
private industry.

(ii)  Estimating Capital/Startup and Operation and Maintenance Costs

	The capital/startup costs are one-time costs when a facility becomes
subject to the standard.  Since this is based on no new sources over the
next three years, capital/startup costs associated with this ICR during
this period will be zero.  In addition, there is no significant
operation and maintenance costs associated with this ICR since sources
are not required to install continuous monitoring systems.  The only
operational cost that sources will incur is associated with photocopying
and postage which would be minimal based on a rate of $7.57 per
response.  There are approximately 708 responses per year (708 responses
x $7.57 = $5,359.56), for a total annual operation and maintenance (O&M)
cost of $5,360.

6(c)  Estimating Agency Burden and Cost

The only costs to the Agency are those costs associated with analysis of
the reported information.  The EPA compliance and enforcement program
includes activities such as the examination of records maintained by the
respondents, periodic inspection of sources of emissions, and the
publication and distribution of collected information.

The average annual Agency cost during the three years of the ICR is
estimated to be $106,353.

This cost is based on the average hourly labor rate as follows:

		Managerial	$62.27 (GS-13, Step 5, $38.92 + 60%)

		Technical	$46.21 (GS-12, Step 1, $28.88 + 60%)

		Clerical	$25.01 (GS-6, Step 3, $15.63 + 60%)

These rates are from the Office of Personnel Management (OPM), 2010
General Schedule, which excludes locality rates of pay.  The rates have
been increased by 60 percent to account for the benefit packages
available to government employees.  Details upon which this estimate is
based appear below in Table 2: Average Annual EPA Burden – NESHAP for
Off-Site Waste and Recovery Operations (40 CFR part 63, subpart DD)
(Renewal).

6(d)  Estimating the Respondent Universe and Total Burden and Costs

	Based on our research for this ICR, there are approximately 236
existing sources currently subject to the standard.  It is estimated
that no additional sources per year will become subject to the
regulation in the next three years.

	Number of respondents is calculated using the following table which
addresses the three years covered by this ICR.

Number of Respondents

Year	(A)

Number of New Respondents	(B)

Number of Existing Respondents	(C)

Number of Existing Respondents That Keep Records But Do Not Submit
Reports	(D)

Number of Existing Respondents That Are Also New Respondents	(E)

Number of Respondents

(E=A+B+C-D)

1	0	236	0	0	236

2	0	236	0	0	236

3	0	236	0	0	236

Average	0	236	0	0	236

To avoid double-counting respondents, column D is subtracted.  As shown
above, the average Number of Respondents over the three-year period of
this ICR is 236.

The total number of annual responses per year is calculated using the
following table:

Respondent Universe and Number of Responses Per Year

Regulation Citation	(A)

Average Number of New Respondents per Year	(B)

Number of Reports for New Sources	(C)

Number of Existing Respondents	(D)

Number of Reports for Existing Sources	(F)

Number of Respondents That Keep Records But Do Not Submit Reports	(E)

Total Annual Responses =

(AxB)+(CxD)+F

40 CFR part 63, subpart DD	0	0	236	3	0	708

The number of total respondents is 236.  This represents the number of
existing sources plus the number of new sources averaged over the
three-year period (i.e., the total of the number of new respondents over
the three-year period divided by three years).

The number of Total Annual Responses is 708.  This is the number in
column E of the Respondent Universe and Number of Responses per Year
table above.

The total annual labor costs are $14,681,368.  Details regarding these
estimates may be found below in Table 1: Annual Respondent Burden and
Cost - NESHAP for Off-Site Waste and Recovery Operations (40 CFR part
63, subpart DD) (Renewal).

6(e)  Bottom Line Burden Hours Burden Hours and Cost Tables

The detailed bottom line burden hours and cost calculations for the
respondents and the Agency are shown in Tables 1 and 2 (below),
respectively, and summarized below.

(i)  Respondent Tally

The total annual labor hours are 155,212.  Details regarding these
estimates may be found below in Table 1: Annual Respondent Burden and
Cost – NESHAP for Off-Site Waste and Recovery Operations (40 CFR part
63, subpart DD) (Renewal).  Furthermore, the annual public reporting and
recordkeeping burden for this collection of information is estimated to
average 219 hours per response.

The total annual capital/startup and O&M costs to the regulated entity
are $5,000 (rounded).  The cost calculations are detailed in Section
6(c)(ii), Estimating Capital/Startup and Operation and Maintenance
Costs.

(ii)  The Agency Tally

The average annual Agency burden and cost over next three years is
estimated to be 2,360 labor hours at a cost of $106,353.  See below
Table 2: Average Annual EPA Burden – NESHAP for Off-Site Waste and
Recovery Operations (40 CFR part 63, subpart DD) (Renewal).

6(f)  Reasons for Change in Burden

There is no change in the calculation methodology for labor hours in
this ICR compared to the previous ICR.  This is due to two
considerations: (1) the regulations have not changed over the past three
years and are not anticipated to change over the next three years; and
(2) the growth rate for the respondents is very low, negative or
non-existent.  There is, however, an apparent increase of 906 hours in
respondent labor hours, due to a math error in the previous ICR.

	Also, there is an increase in both Respondent and Agency costs
resulting from labor rate increases from 2003 to 2009.  In this ICR, the
labor burden and cost calculations in Tables 1 and 2 of this ICR were
expanded to include managerial and clerical labor rates, and the
previous ICR only provided a technical labor rate for 2003.  This ICR
has been updated to present the most recent available labor rates for
each of the three labor categories.

6(g)  Burden Statement

The annual public reporting and recordkeeping burden for this collection
of information is estimated to average 219 hours per response.  Burden
means the total time, effort, or financial resources expended by persons
to generate, maintain, retain, or disclose or provide information to or
for a Federal agency.  This includes the time needed to review
instructions; develop, acquire, install, and utilize technology and
systems for the purposes of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and
providing information; adjust the existing ways to comply with any
previously applicable instructions and requirements; train personnel to
be able to respond to a collection of information; search data sources;
complete and review the collection of information; and transmit or
otherwise disclose the information.

An agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a valid OMB
Control Number.  The OMB Control Numbers for EPA regulations are listed
at 40 CFR part 9 and 48 CFR chapter 15.

	To comment on the Agency's need for this information, the accuracy of
the provided burden estimates, and any suggested methods for minimizing
respondent burden, including the use of automated collection techniques,
EPA has established a public docket for this ICR under Docket ID Number
EPA-HQ-OECA-2009-0534. An electronic version of the public docket is
available at http://www.regulations.gov/ which may be used to obtain a
copy of the draft collection of information, submit or view public
comments, access the index listing of the contents of the docket, and to
access those documents in the public docket that are available
electronically.  When in the system, select “search,” then key in
the docket ID number identified in this document.  The documents are
also available for public viewing at the Enforcement and Compliance
Docket and Information Center in the EPA Docket Center (EPA/DC), EPA
West, Room 3334, 1301 Constitution Ave., N.W., Washington, D.C.  The EPA
Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal holidays.  The telephone number
for the Reading Room is<PHONE_NUMBER>, and the telephone number for the
docket center is<PHONE_NUMBER>.  Also, you can send comments to the
Office of Information and Regulatory Affairs, Office of Management and
Budget, 725 17th Street, N.W., Washington, D.C. 20503, Attention: Desk
Officer for EPA.  Please include the EPA Docket ID Number
EPA-HQ-OECA-2009-0534 and OMB Control Number 2060-0313 in any
correspondence.

Part B of the Supporting Statement

This part is not applicable because no statistical methods were used in
collecting this information.

     Table 1: Annual Respondent Burden and Cost - NESHAP for Off-Site
Waste and Recovery Operations (40 CFR Part 63, Subpart DD) (Renewal)

Assumptions:

a)	This ICR uses the following labor rates: Managerial $114.49 ($54.52 +
110%); Technical $98.20 ($46.76 + 110%); and Clerical $48.53 ($23.11 +
110%).  These rates are from the United States Department of Labor,
Bureau of Labor Statistics, September 2009, “Table 2. Civilian
workers, by Occupational and Industry group.”  The rates are from
column 1, "Total compensation."  The rates have been increased by 110
percent to account for the benefit packages available to those employed
by private industry.  This ICR assumes that Managerial hours are 5
percent of Technical hours, and Clerical hours are 10 percent of
Technical hours.

b)	This activity is performed once during the year following
promulgation of the rule.

c)	It is assumed that it will take four hours to read instructions.

d)	It is assumed that it will take eight hours to gather existing
information.

e)	It is assumed that there will be no new sources.

f)	The burden of one annual summary report was included in the burden
estimate for the semiannual report.

g)	It is assumed that at 50 percent of the facilities, the owner or
operator manages, for a fee, off-site materials received from other
generators.

h)	It is assumed that 50 percent of the owners or operators accept the
off-site material at another location and ship it to the facility for
storage, treatment, or disposal.

i)	It is assumed that 20 percent of 236 facilities will perform
monitoring/repair.

Table 2: Average Annual EPA Burden - NESHAP for Off-Site Waste and
Recovery Operations (40 CFR Part 63, Subpart DD) (Renewal)

Assumptions:

a)	This ICR uses the following labor rates: Managerial $62.27 (GS-13,
Step 5, $38.92 + 60%); Technical $46.21 (GS-12, Step 1, $28.88 + 60%);
and Clerical $25.01 (GS-6, Step 3, $15.63 + 60%).  These rates are from
the Office of Personnel Management (OPM), 2010 General Schedule, which
excludes locality rates of pay.  The rates have been increased by 60
percent to account for the benefit packages available to government
employees.  This ICR assumes that Clerical hours are 10 percent of
Technical hours and Managerial hours are 5 percent of Technical hours.

b)	There will be no travel expenses associated with this ICR since we
have assumed that no new sources will become subject to this rule over
the three year period of this ICR.

c)	It is assumed that there will be no new sources (respondents) over
the 3-year period of this Information Collection Request. new or
reconstructed turbines per year.

d)	It is assumed that it will take 16 hours to review each performance
test report.

e)	It is estimated that the number of facilities subject to the rule is
236.

f)	It is assumed that two reports will be submitted by each of the 236
facilities on an annual basis.

 PAGE

 PAGE   2

 PAGE