[Federal Register Volume 78, Number 175 (Tuesday, September 10, 2013)]
[Notices]
[Pages 55322-55325]
[FR Doc No: 2013-21930]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-70312; File No. SR-FINRA-2013-037]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing of a Proposed Rule Change To Amend
FINRA Rule 5131 (New Issue Allocations and Distributions)

September 4, 2013.
    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 August 23, 2013, Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been prepared by FINRA. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    FINRA is proposing to amend FINRA Rule 5131 (New Issue Allocations
and Distributions) to provide a limited exception to allow members to
rely on written representations from certain accounts to comply with
Rule 5131(b).
    The text of the proposed rule change is available on FINRA's Web
site at http://www.finra.org, at the principal office of FINRA 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, FINRA 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. FINRA 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
    FINRA Rule 5131 (New Issue Allocations and Distributions) (the
``Rule'') addresses abuses in the allocation and distribution of ``new
issues.'' \3\ Rule 5131(b) prohibits the practice of spinning, which
refers to an underwriter's allocation of new issue shares to executive
officers and directors of a company as an inducement to award the
underwriter with investment banking business, or as consideration for
investment banking business previously awarded (the ``spinning''
provision).
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    \3\ Rule 5131 provides that ``new issue'' shall have the same
meaning as in Rule 5130(i)(9).
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    Specifically, the spinning provision provides that no member or
person associated with a member may allocate shares of a new issue to
any account in which an executive officer or director of a public
company \4\ or a covered non-public company,\5\ or a person materially
supported \6\ by such executive officer or director, has a beneficial
interest: \7\
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    \4\ A ``public company'' is any company that is registered under
Section 12 of the Exchange Act or files periodic reports pursuant to
Section 15(d) thereof. See Rule 5131(e)(1).
    \5\ The Rule defines a ``covered non-public company'' as any
non-public company satisfying the following criteria: (i) Income of
at least $1 million in the last fiscal year or in two of the last
three fiscal years and shareholders' equity of at least $15 million;
(ii) shareholders' equity of at least $30 million and a two-year
operating history; or (iii) total assets and total revenue of at
least $75 million in the latest fiscal year or in two of the last
three fiscal years. See Rule 5131(e)(3).
    \6\ ``Material support'' means directly or indirectly providing
more than 25% of a person's income in the prior calendar year.
Persons living in the same household are deemed to be providing each
other with material support. See Rule 5131(e)(6).
    \7\ The Rule provides that the term ``beneficial interest''
shall have the same meaning as in Rule 5130(i)(1).
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     If the company is currently an investment banking services
\8\ client of the member or the member has received compensation from
the company for

investment banking services in the past 12 months;
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    \8\ ``Investment banking services'' include, without limitation,
acting as an underwriter, participating in a selling group in an
offering for the issuer or otherwise acting in furtherance of a
public offering of the issuer; acting as a financial adviser in a
merger, acquisition or other corporate reorganization; providing
venture capital, equity lines of credit, private investment, public
equity transactions (PIPEs) or similar investments or otherwise
acting in furtherance of a private offering of the issuer; or
serving as placement agent for the issuer. See Rule 5131(e)(5).
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     If the person responsible for making the allocation
decision knows or has reason to know that the member intends to
provide, or expects to be retained by the company for, investment
banking services within the next three months; or
     On the express or implied condition that such executive
officer or director, on behalf of the company, will retain the member
for the performance of future investment banking services.
    Rule 5131.02 (Annual Representation) provides that, for the
purposes of the spinning provision, a member may rely on a written
representation obtained within the prior 12 months from the beneficial
owner(s) of an account, or a person authorized to represent the
beneficial owner(s), as to whether such beneficial owner(s) is an
executive officer or director or person materially supported by an
executive officer or director and if so, the company on whose behalf
such executive officer or director serves. Therefore, to comply with
the spinning provision, firms typically issue questionnaires to their
customers to ascertain whether any of the persons covered by the
spinning provision have a beneficial interest in the account.\9\
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    \9\ The spinning provision currently addresses operational
burdens associated with some accounts with a large and diverse
ownership base where the potential for spinning is minimal through a
series of exemptions for purchasers such as mutual funds, insurance
company general accounts and various employee benefit plans. See
generally Rule 5130(c). Private funds, however, are not a category
of purchasers for which a general exemption exists.
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    Rule 5131(b)(2) provides a de minimis exception for new issue
allocations to any account in which the beneficial interests of
executive officers and directors of a company subject to the rule, and
persons materially supported by such executive officers and directors,
do not exceed in the aggregate 25% of such account. FINRA understands
that members (and their customers) have had difficulty obtaining,
tracking and aggregating information from funds regarding indirect
beneficial owners, such as participants in a fund of funds, for use in
determining an account's eligibility for the de minimis exception and
that this has resulted in compliance difficulties and restrictions,
including in situations where the ability of an underwriter to confer
any meaningful financial benefit to a particular investor by allocating
new issue shares to the account is impracticable.\10\
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    \10\ For example, members have noted that broker-dealers
normally do not know the identity of the beneficial owners of the
fund of funds invested in the account.
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    FINRA believes that certain funds, owing to several mitigating
factors including their size, lack of affiliation with the account
directly receiving the allocation and layered (and often opaque)
ownership structure, generally do not raise the concerns that the Rule
is designed to address. Moreover, where the potential profits from a
new issue allocation are spread across a large and diverse investor
base, it is unlikely that the proportional benefit to any particular
indirect investor would be of an amount that would further spinning
(i.e., indirect fund ownership can be an impractical and ineffective
means to receive any benefit from spinning). Therefore, FINRA is
proposing a limited exception to the spinning provision in the fund of
funds context that includes a set of conditions designed to ensure that
the important protections of the Rule continue to be preserved, while
offering meaningful relief for members and investors in situations
where spinning abuse is not likely.
    Specifically, FINRA is proposing to provide that members may rely
upon a written representation obtained within the prior 12 months from
a person authorized to represent an account that does not look through
to the indirect beneficial owners of a fund invested in the account,
that such fund:
     Is a ``private fund'' as defined in the Investment
Advisers Act of 1940; \11\
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    \11\ Section 202(a)(29) of the Investment Advisers Act of 1940
defines the term ``private fund'' as an issuer that would be an
investment company, as defined in Section 3 of the Investment
Company Act of 1940 (15 U.S.C. 80a-3) (``Investment Company Act''),
but for Section 3(c)(1) or 3(c)(7) of the Investment Company Act.
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     Is managed by an investment adviser;
     Has assets greater than $50 million;
     Owns less than 25% of the account and is not a fund in
which a single investor has a beneficial interest of 25% or more;
     Does not have a beneficial owner that also is a control
person of such fund's investment adviser;
     Is ``unaffiliated'' with the account in that the private
fund's investment adviser does not have a control person in common with
the account's investment adviser;\12\ and
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    \12\ A control person of an investment adviser is a person with
direct or indirect ``control'' over the investment adviser; as that
term is defined in Form ADV.
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     Was not formed for the specific purpose of investing in
the account.
    FINRA believes that these conditions are reasonable to assure that
a member's new issue allocation will not be in furtherance of spinning,
while reducing the compliance burdens associated with the Rule. In
addition, a member may rely upon a written representation by an account
as to the availability of this proposed exception unless it believes,
or has reason to believe, that such representation is inaccurate.
Members availing themselves of the new supplementary material must
maintain a copy of all records and information relating to whether an
account is eligible to receive an allocation of the new issue under the
spinning provision in its files for at least three years following the
member's allocation to that account.
    FINRA discussed with FINRA committees, industry groups and member
firms the logistical impracticalities, costs and other hurdles involved
in attempting to track beneficial ownership. The comments are described
in detail in Item 5 (sic) below. The proposal takes those discussions
into account.
    FINRA has considered various alternatives to the current approach,
including proposing an exception for all private funds meeting certain
asset thresholds, providing an interpretation to the existing de
minimis exception, or requiring alternative percentage caps for direct
and indirect beneficial ownership in the account. In considering these
and other alternatives, FINRA sought to balance preserving the
protections the Rule was designed to provide with limiting the scope of
the rule to situations that might reasonably result in the harms sought
to be addressed. FINRA also sought to avoid increasing complexity in
the Rule, with added compliance costs, where the concerns to be avoided
were remote.
    As a result, FINRA determined that a wholesale exception for
private funds was not appropriate.\13\ In addition, because a fund
indirectly invested in the account could consist of a single investor--
potentially including covered persons--FINRA believes that a limit to
both direct and indirect beneficial ownership is important in
preserving the efficacy of the spinning provision. The proposed rule
change is intended to balance the compliance concerns and burdens noted
by the industry with FINRA's goal of assuring that the Rule continues
to be designed to promote investor confidence and prevent fraudulent
and manipulative behaviors.
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    \13\ See supra note 9.
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    FINRA will announce the effective date of the proposed rule change
in a Regulatory Notice to be published no later than 60 days following
Commission approval. The effective date will be no later than 120 days
following Commission approval.

2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\14\ which requires, among
other things, that FINRA rules must be designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest. FINRA believes that the proposed exception and
required conditions will further these purposes by promoting capital
formation and aiding member compliance efforts, while maintaining
investor confidence in the capital markets.
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    \14\ 15 U.S.C. 78o-3(b)(6).
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    Specifically, the proposed condition that the fund be managed by an
investment adviser that is unaffiliated with the account's investment
adviser seeks to ensure the structural independence of the funds'
respective advisers. This requirement, in addition to the proviso that
the unaffiliated private fund must not have been formed for the
specific purpose of investing in the account, seeks to mitigate the
possibility of collusive conduct aimed at furthering spinning.
    In addition, the condition providing that the unaffiliated private
fund may not have any beneficial owners who also are control persons of
such fund's investment adviser seeks to eliminate the conflict that may
exist where an adviser also is an investor in the fund and, therefore,
may directly benefit from allocation decisions. The requirements
regarding the minimum size of the private fund (over $50 million) and
the percentage ownership thresholds (private fund must own less than
25% of the account and not be a fund in which a single investor has a
beneficial interest of 25% or more) seek to ensure that the
proportional benefit of any new issue allocation to a single indirect
beneficial owner would be insufficient to further spinning.

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

    FINRA 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 in that the proposed rule
provides an exception to Rule 5131(b) for funds of funds that face
special difficulties under the existing exemptions from the Rule, and
thus the proposed exemption tries to reduce differential impacts of the
Rule. FINRA also believes that it is reasonable to permit members to
rely on written representations from the account regarding compliance
with the conditions of the exception as a means of achieving compliance
with the purposes of the Rule without imposing layered tracking and
other requirements on members that could be costly and unduly hamper
the accounts' access to new issue shares.

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

    FINRA received four letters regarding the issues addressed by the
proposed rule change from three commenters,\15\ and engaged in
additional discussions with industry groups and market participants
regarding the operation of the spinning provision, the operation of the
existing de minimis exception and members' difficulty in identifying
indirect beneficial owners of an account. A list of the commenters is
attached as Exhibit 2a. Copies of the comment letters received are
attached as Exhibit 2b.
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    \15\ See Letters from Gregory J. Robbins, Senior Managing
Director and General Counsel, Mesirow Advanced Strategies, Inc., to
Gary L. Goldsholle, Vice President and Associate General Counsel,
Office of the General Counsel, FINRA, dated June 10, 2011
(``Mesirow''); Andrew Baker, Chief Executive Officer, Alternative
Investment Management Association, to Richard G. Ketchum, Chairman
and Chief Executive Officer, FINRA, dated August 3, 2011 (``AIMA'');
Stuart J. Kaswell, Executive Vice President and Managing Director
and General Counsel, Managed Funds Association, to Marc Menchel,
Executive Vice President and General Counsel, FINRA, dated August
19, 2011 (``MFA 1''); and Stuart J. Kaswell, Executive Vice
President and Managing Director and General Counsel, Managed Funds
Association, to Marc Menchel, Executive Vice President and General
Counsel, FINRA, dated October 4, 2011 (``MFA 2'').
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    Commenters sought either interpretive guidance regarding the
existing de minimis exception to increase its scope or a new amendment
to address difficulties in allocating to investment funds, particularly
in the fund of funds context. Commenters argued that investment funds
are not an effective tool for a broker-dealer to convey a meaningful
benefit to a particular covered person.\16\ One commenter stated that
the funds of funds it offers have investments in anywhere from 25 to 70
unaffiliated portfolio funds.\17\ The commenter further noted that
investors in a fund of funds, including any potential covered persons,
cannot direct which broker a portfolio fund uses or will use, and may
not know in which portfolio funds the fund of funds is invested.\18\
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    \16\ See AIMA, Mesirow, MFA 1 and MFA 2.
    \17\ See Mesirow.
    \18\ See Mesirow.
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    Commenters also discussed the logistical impracticalities and other
hurdles involved in attempting to track beneficial ownership.\19\ A
commenter stated that, as currently structured, the spinning provisions
potentially would require significant amounts of time and money to
implement.\20\ In addition, another commenter generally stated that
funds of funds may (and often do) have several hundred investors, each
of which themselves may have hundreds of beneficial owners; thus, the
operational hurdles and cost of obtaining the relevant representations
from all of the ultimate beneficial owners would be substantial.\21\
The commenter further stated that obtaining beneficial ownership
information is not always possible due to confidentiality and investor
privacy concerns.\22\
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    \19\ See e.g., AIMA, MFA 1 and MFA 2.
    \20\ See AIMA.
    \21\ See MFA 2.
    \22\ See MFA 1.
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    FINRA has carefully considered the comments received and has
considered the various alternatives suggested in crafting the current
proposal and believes that the proposed rule change strikes the
appropriate balance by simplifying the operation of the Rule while
maintaining the protections the spinning provision is designed to
provide, as discussed above.\23\
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    \23\ One commenter suggested, among other things, that the
existing 25% de minimis exception be interpreted to apply separately
to each public company or covered non-public company. However, the
rule clearly states that the calculation is to be applied in the
aggregate for all covered companies and the proposal would not
change that requirement. See AIMA.
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III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) by order approve or disapprove such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be 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-FINRA-2013-037 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-FINRA-2013-037. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference 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 such filing also will be available for
inspection and copying at the principal office of FINRA. 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-FINRA-2013-037 and should be
submitted on or before October 1, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\24\
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    \24\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-21930 Filed 9-9-13; 8:45 am]
BILLING CODE 8011-01-P


PART A OF THE SUPPORTING STATEMENT

1.	Identification of the Information Collection

1(a)	Title and Number of the Information Collection.

	“Aerospace Manufacturing and Rework Industry Information
Collection.”  This is a new information collection request (ICR).  The
EPA ICR number 2395.01, and the OMB Control number is 2060-NEW.

1(b)	Short Characterization.

	This information collection survey for aerospace manufacturing and
rework facilities was prepared by EPA’s Sector Policies and Programs
Division (SPPD) in the Office of Air Quality Planning and Standards
(OAQPS), and they are the intended users of the collected data.
Respondents are owners or operators of aerospace manufacturing and
rework facilities.  Aerospace manufacturing and rework was listed as a
source category under the Clean Air Act (CAA) on July 16, 1992 (57 FR
31576).  The CAA requires that a risk and technology review (RTR) be
conducted for this source category by September 1, 2003.  This
information collection will provide SPPD with the data necessary to
conduct the RTR.

	This survey was developed specifically for aerospace manufacturing and
rework facilities.  This information collection has been tailored to the
processes at aerospace facilities and uses an electronic submission
approach that will be less burdensome for both the facilities that must
respond and for EPA personnel who must compile the responses.
Respondents are asked to complete simple forms from available
information and no request is made to create or develop emission
estimates from information in the literature.

	Information is requested from approximately 1,000 aerospace
manufacturing and rework facilities on general facility information,
coatings and spray booth information, other process information (e.g.,
storage tanks, composite processing, etc.), emission control devices in
place and their basic design and operating features, quantity of air
emissions, pollution prevention programs at each facility, and
information regarding startup and shutdown events.  This information is
necessary for EPA to adequately characterize residual risk at these
facilities, to characterize emissions and control measures for
operations not currently regulated, and to develop standards for new and
existing aerospace facilities under section 112 of the CAA, if
appropriate.  The information will be collected from the electronic
completion of simple forms, which will be compiled to develop a computer
database.  The completed forms and the computer database will become
part of the rulemaking docket.

	EPA estimates that there will be roughly 1,000 survey respondents and
that they will incur a total burden of 227,700 hours at an estimated
cost of $10,965,834 as a result of this one-time collection.  The cost
to the Agency is estimated to be approximately $47,633.

2.	Need For and Use of the Collection

2(a)	Need/Authority for the Collection.

	The EPA is charged under section 112 of the CAA with developing
national emission standards for 189 listed HAP.  The Aerospace
Manufacturing and Rework Facilities Maximum Achievable Control
Technology (Aerospace MACT) standard (40 CFR 63, subpart GG), is a
National Emission Standard for Hazardous Air Pollutants (NESHAP)
developed under the authority of section 112(d) of the CAA.  EPA is
required to review each MACT standard and to revise them “as necessary
(taking into account developments in practices, processes and control
technologies)” no less frequently than every eight years.  These
reviews are commonly referred to as “technology reviews.”  In
addition, EPA is required to assess the risk remaining (residual risk)
after each MACT standard and promulgate more stringent standards if they
are necessary to protect public health.  Under EPA’s RTR program, EPA
is addressing these two requirements concurrently.  EPA is updating the
information they currently possess and filling identified data gaps in
that information in order to provide a thorough basis for the RTR
efforts.  The data collection effort will gather additional information
to allow comprehensive and technically sound analyses that will form the
basis for future rulemaking decisions.  The information is being
collected under the authority of section 114 of the CAA.

2(b)	Practical Utility/Users of the Data.

	The SPPD of the OAQPS uses the information gathered through the survey
form to conduct the RTR, on which future rulemaking decisions will be
based.

 3.	Nonduplication, Consultations and Other Collection Criteria

3(a)	Nonduplication.

	To the best of EPA’s knowledge, the data to be collected through this
survey is not available elsewhere.  A search of EPA’s ongoing
information collections revealed no duplication of information gathering
efforts, and the information that will be requested is not available
through other sources.

	In 1994, EPA surveyed aerospace manufacturing and rework facilities to
gather information to develop MACT standards for the aerospace industry.
 That survey was sent to a small portion of the industry and did not ask
for information about certain aerospace manufacturing operations and
emission source types.  The current survey does not duplicate the
previous survey.  Furthermore, in response to changes in market
conditions and regulatory requirements (such as the OSHA hexavalent
chromium exposure limit), EPA expects that many aerospace facilities
have changed their coatings, enclosed their spray booth operations and
reduced HAP content in solvents since 1994.  To the extent that some of
the questions in this survey are similar to those in the previous
survey, many of the answers that facilities will provide may have
changed in the intervening years.  Because the current survey will
collect different and updated information as compared to the previous
survey, the data collected in 1994 does not fulfill EPA’s current
needs, and the current survey is not duplicative of the previous survey.

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

	Pursuant to the Paperwork Reduction Act (PRA) (44 U.S. C 3501 et seq.),
the EPA notified the public through a Federal Register notice (see 75 FR
35454, 6/22/2010) of the Agency’s intent to submit the Aerospace
Industry Survey ICR to OMB.  The notice included a description of the
entities to be affected by the proposed survey, a brief explanation of
the need for the survey, identification of the statutory authority under
which the survey will be issued, and an estimate of burden to be
incurred by survey respondents.  Through the notice, the Agency
requested comments and suggestions regarding the survey and the
reduction of data collection burden.  A summary of the comments EPA
received and EPA’s responses are included as an attachment.

3(c)	Consultations.

	Under 5 CFR 1320.8(d)(1), OMB requires agencies to consult with
potential ICR respondents and data users about specific aspects of ICRs
before submitting an original or renewal ICR to OMB for review and
approval.  EPA sent out a letter providing potential respondents with a
list of the data elements that will be included in the survey and
requested feedback on these data elements via written communication or
by participation in a conference call with EPA.  This teleconference
meeting was held December 18, 2009, at the EPA facilities in Research
Triangle Park, NC.  The list of data elements is included as Attachment
2 to this supporting statement.  The letter was sent to relevant trade
organizations and to over 1,200 facilities believed to be aerospace
manufacturing or rework facilities.  No feedback, either written or at
the meeting, was provided by potential respondents directly relating to
the data elements of the survey.  Some facilities did respond to the
letter to inform EPA that they were not aerospace manufacturing and
rework facilities or were area sources.

3(d)	Effects of Less Frequent Collection.

	This survey is to be administered one time only.  If this survey is not
conducted, the specific data sought in this survey will not be available
for EPA’s use in decision making about the need for and scope of
potential residual risk rules for the aerospace industry.

3(e)	General Guidelines.

	This information collection complies with the guidelines in 5 CFR
1320.5(d)(2).

3(f)	Confidentiality.

	All 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 39999, September 8, 1978; 43
FR 42251, September 28, 1978; 44 FR 17674, March 23, 1979.)

3(g)	Sensitive Questions.

	This section is not applicable because this survey does not involve
matters of a sensitive nature.

4.	The Respondents and the Information Requested

4(a)	Respondents/NAICS Codes.

	Respondents associated with this information collection are owners or
operators of existing aerospace manufacturing and rework facilities.
The North American Industrial Classification Codes (NAICS) associated
with this industry are presented in Table 1.

Table 1.  North American Industrial Classification Codes for the
Aerospace Manufacturing and Rework Industry

NAICS Code	Description

	336411	Aircraft Manufacturing

336412	Aircraft Engine and Engine Parts Manufacturing

336413	Other Aircraft Parts and Auxiliary Equipment Manufacturing

336414	Guided Missile and Space Vehicle Manufacturing

336415	Guided Missile and Space Vehicle Propulsion Units and Propulsion
Units Parts Manufacturing

336419	Other Guided Missile and Space Vehicle Parts and Auxiliary
Equipment Manufacturing

481111	Scheduled Passenger Air Transportation

481112	Scheduled Freight Air Transportation

481211	Nonscheduled Chartered Passenger Air Transportation

481212	Nonscheduled Chartered Freight Air Transportation

481219	Other Nonscheduled Air Transportation

Approximately 1,000 aerospace manufacturing and rework facilities have
been identified to receive this survey.  EPA projects a total of about
1,000 responses under this ICR.

4(b)	Information Requested.

	4(b)(i)	Data items, including recordkeeping requirements.  A copy of
the survey and instructions are provided as Attachment 1.  There are no
recordkeeping requirements associated with this request.  Information is
requested from each respondent on general facility information, coating
and spray booth information, other processes (e.g., storage tanks, metal
finishing, etc.), air emissions from these booths and other processes,
and identification of capture and control devices.

	Part I (Introduction) provides guidance to the respondent and
highlights that no additional monitoring or testing is required to
respond to the request.  The introduction lists an EPA contact for
questions and provides the name and address to which the completed
survey should be mailed.  Instructions are also provided for submitting
the completed form electronically.  Finally, an outline of the
questionnaire form is provided.

	Part II (Instructions) provides instructions on how to complete each
form in the questionnaire.  There are general instructions and
instructions specific to each form.

	Form A-1 (Parent Company Information) asks for information about the
parent company, and size of the parent company, in order for EPA to
conduct an appropriate economic analysis for this category and evaluate
potential small entity impacts.

	  Form A-2 (Facility Information) is where the respondent (facility
contact person), company and facility are identified.  EPA will use this
information to ensure that its facility list is current and accurate, a
necessary component of achieving to represent the universe of sources in
any analyses.  Coordinates are requested, along with a typical operating
schedule for the facility.  In addition, questions are asked about the
products produced at the facility and if the facility is a major source
of HAP emissions.

	Form B-1 (Spray Booth Information) requests data for each spray booth
at the facility, including the type of booth, the location coordinates
of each booth, and the dimensions of each booth.  Information is also
requested on the type of particulate filter system used in the booth.
Control device information should also be provided.

	Form C-1 and C-2 (Coatings) are the same form except one requests the
information in English units and the other requests the information in
metric units.  Respondents do not have to fill out both forms, but can
fill out whichever one utilizes the data they have easily available.
Information is requested on the type of coating, including specialty
coatings and the HAP contained in each coating.  The forms also include
a section for the respondents to identify the spray booth that each
coating was applied in and the amount of coating that was applied.

	Form D-1 (Chemical Milling and Metal Finishing Operations) requests HAP
usage and emissions from chemical milling and metal finishing operations
at the facility.  Coordinates, dimensions and hours of operation are
requested for each tank.  Control device and work practice information
is also requested.

	Form E-1 (Blast Depainting/Cleaning Operations) is where the respondent
will report HAP emissions from blast depainting and cleaning operations
that use blasting methods.  In addition to emissions, coordinates,
dimensions and hours of operation are also requested.  Control device
and work practice information should also be recorded on this form.

	Form E-2 (Solvent Depainting Operations) is where the respondent will
report HAP emissions from depainting operations that use solvent
materials.  The same information is requested (e.g., emissions,
coordinates, control device) as in Form E-1.

	Form E-3 (Solvent Cleaning Operations) requests information on HAP
emissions from solvent cleaning operations such as hand-wipe cleaning of
aerospace components, cleaning of spray guns and cleaning of spray
booths.  In addition to HAP emissions, information is requested on
location coordinates, building dimensions, control devices and work
practices.

	Form E-4 (Solvent Cleaning Operations) requests information similar to
that requested on Form E-3, except that only cleaning operations subject
to the Halogenated Solvent Cleaning NESHAP (40 CFR 63, subpart T) should
be reported.  Even though halogenated solvent cleaning operations are
not subject to the aerospace NESHAP, the EPA is concerned that some
aerospace facilities may have mistakenly reported emissions from these
operations as emissions from operations subject to the aerospace NESHAP
in part reporting to state or local agencies.  In order to estimate the
residual risk accurately from each of these categories, the EPA is
attempting to first develop accurate emissions estimates.  The
respondents’ efforts to properly report halogenated solvent cleaning
operations on Form E-4 and not on Form E-3 will play an important role
in the EPA’s development of emissions estimates from these two
categories.

	Form F-1 and F-2 (Composite Processing Operations) are the same form
except one requests the information in English units and the other
requests the information in metric units.  Respondents do not have to
fill out both forms, but can fill out whichever one utilizes the data
they have easily available.  Information is requested on the type of
resins used in composite processing operations, the total volume of
resin used and information related to the spray booth used to apply the
resins.

	Form G-1 (Storage Tanks) is where the respondent will provide HAP
emissions from storage tanks used to store materials used in aerospace
manufacturing and rework operations.  The type of tank, the coordinates
of the tank, the dimensions of the tank, the HAP component of the
material in the tank and control device information are all requested.

	Form H-1 (Wastewater Treatment Operations) requests information on
wastewater treatment operations as they pertain to aerospace
manufacturing and rework operations.  The coordinates, dimensions, hours
of operation, HAP emissions and control device information are all
requested.

	Form I-1 (Startups and Shutdowns) provides examples of startup and
shutdown events that would be reported on this form.  Information on
this form is requested if it is readily available.  Additional testing
or data gathering is not required to complete this form for startup and
shutdown events.

	Forms J-1 to J-11 (Air Pollution Control Devices) provide a form for
each control device likely to be in use at aerospace manufacturing and
rework facilities.  If an air pollution control device is not in use at
the facility, the relevant form does not need to be filled out.  The
information requested for these forms should be readily available.  No
additional testing or data gathering is required in order to complete
these forms.

	Form K-1 (Air Pollution Control Device Costs) is where the respondent
will enter readily available information related to the cost of each air
pollution control device for which information was provided in Forms J-1
to J-11.

	4(b)(ii)	Respondent activities.  The survey will be sent to each
aerospace manufacturing and rework facility, who will be asked to
complete and return the survey instrument.  Completion of the survey
involves the following steps:

Reviewing instructions:  Respondents will need to read the instructions
for the survey;

Search data sources:  Respondents may need to consult records and review
facility information, in addition to gathering available data from
files, regarding coating usage, booth types, and other requested
information prior to completing the survey;

Complete and review the collection of information:  Respondents will
need to complete the survey and review their answers; and

Transmit or otherwise disclose the information:  Respondents will need
to return the completed survey to EPA.

The request does not require respondents to make measurements of
emissions or otherwise create information, and it relies on information
that should be readily available to the respondent.  Consequently, it is
consistent and compatible with existing reporting and recordkeeping
requirements because the survey asks only for this existing information.
 There is no need for respondents to develop or acquire technology or
systems to collect, process or disclose the information.

	Non-respondents will receive up to two reminder calls encouraging them
to participate.  If EPA decides to issue subpoenas because it does not
receive a sufficient response rate to accurately characterize the
industry, the initial non-respondents will need to review the subpoena,
as well as following the steps outlined above.

	This questionnaire asks for readily obtainable information, e.g.,
information known or easily accessible by technical, managerial or
supervisory employees of the facility who are responsible for
manufacturing, processing, technical services or marketing.  The
facility does not need to generate new information to complete the
survey.

	The collection will be a one-time event, and there will be no
requirement for respondents to maintain records to support their
responses.  However, EPA is suggesting that respondents keep a copy of
the completed questionnaire for their files in case the Agency contacts
them with any follow-up questions after reviewing their responses.

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

5(a)	Agency Activities.

	Agency activities associated with the information collection include
preparing the questionnaire, answering respondent questions about the
questionnaire, reviewing data submissions, addressing requests for
confidentiality and compiling the data into a database.

5(b)	Collection Methodology and Management.

	Data collection will be accomplished using an electronic survey tool.
Recipients of the letter announcing the survey’s availability will be
directed to an EPA web page to download the files.  The respondent will
be asked to complete and return the survey within a three-month
timeframe.  Respondents will be encouraged to complete an electronic
copy of the survey and upload it to the EPA web page, which reduces
transcription errors when EPA processes the responses.  Non-respondents
will receive up to two reminder calls encouraging them to participate.
The web page will also have instructions on how to submit data that is
CBI.

	A written survey is being used because some of the information EPA is
requesting may require the respondent to consult records or other
documents at the facility, which would be difficult to do during a
telephone survey given the type of information requested and the number
of potential respondents.  In addition, the written survey method will
allow the respondent to complete the survey at his or her convenience.
Electronic transmission of the empty and completed survey forms will
lead to more efficient data collection, both in terms of reducing
mailing costs and paper usage and reducing transcription errors.  The
survey has been designed to be easily compiled into a database upon
receipt of the completed survey files.

	For this information collection, the submissions will be monitored for
completeness, and follow-up calls will be made to maximize the response
rate.  Confidential information will be maintained in secure locations
as required by procedures for handling CBI.  Confidential Business
Information will not be entered into the computer database.  Public
access to non-CBI information will be provided through the rulemaking
docket, which will contain the survey responses and a copy of the
resulting database.

5(c)	Small Entity Flexibility.

	EPA has identified a list of roughly 1,000 U.S. facilities with
aerospace manufacture or rework operations.  Some of these manufacturers
are small businesses as defined by the Small Business Administration’s
size standards.  EPA considered collecting data from only a sample of
manufacturers, but determined that a census (a survey administered to
the entire population of aerospace manufacturing and rework facilities,
including small businesses) is appropriate.  A census will more
accurately characterize the industry.  EPA needs to include small
businesses in the survey so that it can better estimate potential small
business impacts in the event the Agency ultimately decides to proceed
with a regulatory action.

	In developing the information request, SPPD considered whether a
separate request or no request for information should be made to small
facilities.  A major consideration was that the burden of responding to
the questionnaire is not excessive for small facilities.  Because they
have fewer and simpler processes, smaller facilities will require less
time to prepare a response than larger facilities.  The information
requested from the smaller facilities should be readily available and no
requests are made to perform measurements or create information.

	Many of the aerospace manufacturing and rework facilities meet the
definition of small business (e.g., companies with fewer than 1,000 or
1,500 employees total at all facilities for facilities in NAICS 2-digit
code 33, and companies with less than $7 million in annual average
receipts for facilities in NAICS 2-digit code 48), and information from
small entities is important to this regulatory development.  The
information collected from small entities will improve the analyses that
must be performed to assess the economic impact of a potential MACT
standard on them.  A Regulatory Flexibility Analysis must be performed
under the Regulatory Flexibility Act of 1980 if a proposed regulation
will have a significant economic impact on a substantial number of small
entities.  The information from small entities will also assist in
addressing the requirements of the Small Business Regulatory Enforcement
Fairness Act of 1996.

	Although many of these small businesses are not likely to be major
sources of HAP emissions, information on emissions and the level of
control performance achieved is needed from all facilities in the
industry to determine with reasonable accuracy the “average emission
limitation achieved” by the top-performing 12 percent of sources.  The
coverage of small facilities is especially important if any are in this
top 12 percent.

	In addition, the best controlled sources may include some of the
smaller facilities, which would affect the determination of MACT for new
aerospace facilities.  Information on smaller facilities will aid in
determining if a facility size cutoff is warranted, and if so, which of
the smaller facilities should be exempt from the MACT standard.  The
information on small facilities will also provide insight into pollution
prevention measures that might be applicable to larger facilities.  Even
if the smaller facilities are not major sources, the information from
their responses to the survey will be useful in determining if they are
significant area sources that may warrant regulation.

5(d)	Collection Schedule.

	The proposed mailing date for the survey is October 29, 2010.  The
respondents are given three months to reply, with January 28, 2011 being
the anticipated date when all data is available for analysis by EPA.
The data will be used to develop residual risk standards, if warranted,
with proposal targeted for August 2011 and promulgation in June 2012.

6.	Estimating the Burden and Cost of the Collection

6(a)	Estimating Respondent Burden.

	EPA will request that all U.S. aerospace manufacturing and rework
facilities complete the questionnaire forms.  Each section of the
questionnaire is expected to be completed by technical and clerical
staff and reviewed by managerial staff.  Respondent activities include
reading the cover letter and downloading the forms, reading the
instructions, gathering data, manipulating data for entry into the
forms, entering data into the forms and uploading the forms.  The
exhibit reflects the assumption that technical and clerical staff will
devote their time to reading instructions, gathering information,
completing the questionnaire forms and transmitting the information;
managerial staff will devote their time to reading instructions and
reviewing questionnaire responses.

	Table 2 presents the average number of hours required for each task for
respondents of three sizes:  small, medium and large.  Due to the wide
range in sizes of aerospace facilities, it was necessary to estimate the
burden for each size of facility.  Based on the industry’s facility
size breakdown contained in the proposal Background Information Document
for the Aerospace NESHAP, it is assumed that 84 percent of the
respondents are small facilities, 14 percent are medium facilities and
two percent are large facilities.  There are approximately 1,000
respondents expected to complete the questionnaire.

	A typical small-size facility respondent is estimated to need an
average of 175 hours to complete the questionnaire, while a typical
medium-size facility respondent is estimated to need an average of 300
hours to complete the questionnaire and a typical large-size facility
respondent is estimated to need an average of 450 hours to complete the
questionnaire.  These burden estimates include technical, management and
clerical hours.  Table 3 presents the burden estimate for small-size
facilities, while Table 4 presents the burden estimate for medium-size
facilities and Table 5 presents the burden estimate for large-size
facilities.  These unit burden estimates are average values.  As with
any average, some respondents will be above the average and others will
be below.

6(b)	Estimating Respondent Costs.

	The information collection activities and estimated costs for all
respondents are presented in Tables 3, 4, and 5.  The costs are based on
hourly rates estimated as follows:  technical at $49.80/hr, management
at $62.08/hr and clerical at $24.79/hr.  For a typical small-size
facility respondent, the costs are estimated as $9,692 (175 hours),
while for a typical medium-size facility respondent the costs are
estimated as $16,615 (300 hours), and for a typical large-size facility
the costs are estimated as $24,922 (450 hours).  There are no capital or
operation and maintenance costs.  A summary of the burden and costs for
all respondents is presented in Table 6.

6(c)	Estimating Agency Burden and Cost.

	The costs the federal government would incur would be for preparing the
questionnaire, answering respondent questions about the questionnaire,
reviewing data submissions, addressing requests for confidentiality and
compiling the data into a database.  The burden estimate is presented in
Table 7 at the end of this supporting statement.  Hourly labor rates
were taken from the Office of Personnel Management Salary Table 2010-GS
(effective January 2010) and are as follows:  technical (GS-12, Step 5)
at $32.73/hour, management (GS-15, Step 5) at $54.10/hr, and clerical
(GS-5, Step 5) at $14.90/hr.  The total costs for the Agency are
estimated as $47,633.

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

	For small-size facilities, the total burden shown in Table 3 is
estimated as 7,350 management hours, 147,000 technical hours and 14,700
clerical hours at a cost of $8,141,301.  The total burden and costs are
based on 840 small-size aerospace facilities completing the survey.

	For medium-size facilities, the total burden shown in Table 4 is
estimated as 2,100 management hours, 42,000 technical hours and 4,200
clerical hours at a cost of $2,326,086.  The total burden and costs are
based on 140 medium-size aerospace facilities completing the survey.

	For large-size facilities, the total burden shown in Table 5 is
estimated as 450 management hours, 9,000 technical hours and 900
clerical hours at a cost of $498,447.  The total burden and costs are
based on 20 large-size aerospace facilities completing the survey.

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

	6(e)(i)	Respondent tally.  The total respondent burdens are given in
Table 6 and are estimated as 169,050 hours and $8,141,301 for small-size
respondents, 48,300 hours and $2,326,086 for medium-size respondents
and 10,350 hours and $498,447 for large-size respondents.  For all
respondents, the total burden is estimated as 227,700 hours and
$10,965,834.

	6(e)(ii)	The Agency tally.  The total Agency burden is given in Table 7
and is estimated as 1,483.5 hours and $47,633.

	6(e)(iii)Variations in the annual bottom line.  This section does not
apply since no significant variation is anticipated.

6(f)	Reasons for Change in Burden.

	This is a new information collection requesting information from
approximately 1,000 aerospace manufacturing and rework facilities
necessary for EPA to adequately characterize residual risk at these
facilities, to characterize emissions and control measures for
operations not currently regulated, and to develop standards for new and
existing aerospace facilities under section 112 of the CAA, if
appropriate.

6(g)	Burden Statement.

	 The annual public reporting and recordkeeping burden for this
collection of information is estimated to average 228 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 currently valid OMB control number.
The OMB control numbers for EPA’s regulations are listed in 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-OAR-2004-0450, which is available for online viewing at
HYPERLINK "http://www.regulations.gov"  www.regulations.gov , or in
person viewing at the Air Docket in the EPA Docket Center (EPA/DC), EPA
West, Room 3334, 1301 Constitution Avenue, NW, 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
Air Docket is<PHONE_NUMBER>.  An electronic version of the public
docket is available at www.regulations.gov.  This site can be used to
submit or view public comments, access the index listing of the contents
of the public 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 above.  Also,
you can send comments to the Office of Information and Regulatory
Affairs, Office of Management and Budget, 725 17th Street, NW,
Washington, D.C. 20503, Attention: Desk Officer for EPA.  Please include
the EPA Docket ID EPA-HQ-OAR-2004-0450and OMB Control Number 2060-NEW in
any correspondence.

TABLE 2.  ESTIMATED RESPONDENT BURDEN FOR THE AEROSPACE ICR

Task	Technical Labor Hours by Facility Size

	Small	Medium	Large

Read cover letter/download forms	0.75	0.75	0.75

Read instructions	1.50	1.50	1.50

Gather data	120.00	200.00	300.00

Manipulate data for entry into forms	48.25	85.25	127.25

Enter data into forms	4.00	12.00	20.00

Upload forms	0.50	0.50	0.50

TOTAL TECHNICAL LABOR HOURS	175	300	450

TABLE 3.  ANNUAL RESPONDENT BURDEN AND COST FOR SMALL FACILITIES

Burden Item	(A)

Person hours per respondenta	(B)

Number of respondents	(C)

Technical person hours

(C = A x B)	(D)

Management person hours (0.05 x C)	(E)

Clerical person hours (0.1 x C)	(F)

Costb ($)

Read cover letter/download forms	0.75	840	630	32	63	34,891

Read instructions	1.50	840	1,260	63	126	69,783

Gather data	120.00	840	100,800	5,040	10,080	5,582,606

Manipulate data for entry into forms	48.25	840	40,530	2,027	4,053
2,244,673

Enter data into forms	4.00	840	3,360	168	336	186,087

Upload forms	0.50	840	420	21	42	23,261

TOTAL LABOR BURDEN AND COST	175	n/a	147,000	7,350	14,700	8,141,301

a See values in Table 2.

 b Costs were taken from the Bureau of Labor Statistics, National
Compensation Survey, Employer Costs for Employee Compensation
Supplementary Tables December 2007.  Supplementary Table 2 – Employer
costs per hour worked for employee compensation and costs as a percent
of total compensation:  Private industry workers in manufacturing
industries, by occupational group, establishment size and bargaining
status.  December 2007.  Available on-line at   HYPERLINK
"http://www.bls.gov/ect"  http://www.bls.gov/ect .  The cost for
technical person hours is $49.80/hour, taken from the total compensation
value for the “professional and related” occupational group.  The
cost for management person hours is $62.08/hr, taken from the total
compensation value for the “management, business and financial”
occupational group.  The cost for clerical person hours is $24.79/hr,
taken from the total compensation value for the “office and
administrative support” occupational group.

TABLE 4.  ANNUAL RESPONDENT BURDEN AND COST FOR MEDIUM FACILITIES

Burden Item	(A)

Person hours per respondenta	(B)

Number of respondents	(C)

Technical person hours

(C = A x B)	(D)

Management person hours (0.05 x C)	(E)

Clerical person hours (0.1 x C)	(F)

Costb ($)

Read cover letter/download forms	0.75	140	105.0	5.3	10.5	5,815

Read instructions	1.50	140	210.0	10.5	21.0	11,630

Gather data	200.00	140	28,000.0	1,400.0	2,800.0	1,550,724

Manipulate data for entry into forms	85.25	140	11,935.0	596.8	1,193.5
660,996

Enter data into forms	12.00	140	1,680.0	84.0	168.0	93,043

Upload forms	0.50	140	70.0	3.5	7.0	3,877

TOTAL LABOR BURDEN AND COST	300	n/a	42,000	2,100	4,200	2,326,086

a See values in Table 2.

b Costs were taken from the Bureau of Labor Statistics, National
Compensation Survey, Employer Costs for Employee Compensation
Supplementary Tables December 2007.  Supplementary Table 2 – Employer
costs per hour worked for employee compensation and costs as a percent
of total compensation:  Private industry workers in manufacturing
industries, by occupational group, establishment size and bargaining
status.  December 2007.  Available on-line at   HYPERLINK
"http://www.bls.gov/ect"  http://www.bls.gov/ect .  The cost for
technical person hours is $49.80/hour, taken from the total compensation
value for the “professional and related” occupational group.  The
cost for management person hours is $62.08/hr, taken from the total
compensation value for the “management, business and financial”
occupational group.  The cost for clerical person hours is $24.79/hr,
taken from the total compensation value for the “office and
administrative support” occupational group.

TABLE 5.  ANNUAL RESPONDENT BURDEN AND COST FOR LARGE FACILITIES

Burden Item	(A)

Person hours per respondenta	(B)

Number of respondents	(C)

Technical person hours

(C = A x B)	(D)

Management person hours (0.05 x C)	(E)

Clerical person hours (0.1 x C)	(F)

Costb ($)

Read cover letter/download forms	0.75	20	15.0	0.8	1.5	830.75

Read instructions	1.50	20	30.0	1.5	3.0	1,661.49

Gather data	300.00	20	6,000.0	300.0	600.0	332,298.00

Manipulate data for entry into forms	127.25	20	2,545.0	127.3	254.5
140,949.74

Enter data into forms	20.00	20	400.0	20.0	40.0	22,153.20

Upload forms	0.50	20	10.0	0.5	1.0	553.83

TOTAL LABOR BURDEN AND COST	450	n/a	9000	450	900	498,447

a See values in Table 2.

b Costs were taken from the Bureau of Labor Statistics, National
Compensation Survey, Employer Costs for Employee Compensation
Supplementary Tables December 2007.  Supplementary Table 2 – Employer
costs per hour worked for employee compensation and costs as a percent
of total compensation:  Private industry workers in manufacturing
industries, by occupational group, establishment size and bargaining
status.  December 2007.  Available on-line at   HYPERLINK
"http://www.bls.gov/ect"  http://www.bls.gov/ect .  The cost for
technical person hours is $49.80/hour, taken from the total compensation
value for the “professional and related” occupational group.  The
cost for management person hours is $62.08/hr, taken from the total
compensation value for the “management, business and financial”
occupational group.  The cost for clerical person hours is $24.79/hr,
taken from the total compensation value for the “office and
administrative support” occupational group.

TABLE 6.  SUMMARY OF ESTIMATED RESPONDENT BURDEN FOR THE AEROSPACE ICR

	Value by Facility Size

	Small	Medium	Large

Total Number of Respondents	840	140	20

Total Labor Hours	169,050	48,300	10,350

Labor Hours Per Respondent	175	300	450

Total Labor Cost ($)	8,141,301	2,326,086	498,447

Labor Cost Per Respondent ($)	9,692	16,615	24,922

TABLE 7.  ANNUAL BURDEN AND COST FOR THE FEDERAL GOVERNMENT

Burden Item	(A)

EPA Hrs/Occurrence	(B)

Contractor Hrs/Occurrence	(C)

Number of Occurrences	(D)

Total EPA Hrs (AxC)	(E)

Total Contractor Hrs (BxC)	(F)

Total Hrs (D+E)c

Develop survey and industry mailing list	50.0	350.0	1	50.0	350.0	400.0

Distribute survey	40.0	0.0	1	40.0	0.0	40.0

Answer questionsa	0.1	0.25	200	20.0	50.0	70.0

Audit/review submissions	0.25	0.1	1000	250.0	100.0	350.0

Enter into database/QA check	0.0	0.3	1000	0.0	300.0	300.0

Analyze submissions and summarize results	0.0	80.0	1	0.0	80.0	80.0

Respond to requests for confidentialityb	0.3	0.2	100	30.0	20.0	50.0

TOTAL LABOR BURDEN AND COST	n/a	n/a	n/a	390.0	900.0	1,290.0

a It is assumed that questions will need to be answered for 20 percent
of the respondents.

b It is assumed that responses to requests for confidentiality will be
needed for 10 percent of the respondents.

c For the purposes of the cost calculations in this table, it is assumed
that EPA and Contractor hours for technical, management, and clerical
positions cost the same amount.

TABLE 7.  ANNUAL BURDEN AND COST FOR THE FEDERAL GOVERNMENT (cont.)

Burden Item	(G)

Technical person hours (=F) (GS12)	(H)

Management person hours (G x 0.05) (GS15)	(I)

Clerical person hours (G x 0.1) (GS5)	(J)

Costd ($)

Develop survey and industry mailing list	400.0	20.0	40.0	14,770.00

Distribute survey	40.0	2.0	4.0	1,477.00

Answer questionsa	70.0	3.5	7.0	2,584.75

Audit/review submissions	350.0	17.5	35.0	12,923.75

Enter into database/QA check	300.0	15.0	30.0	11,077.50

Analyze submissions and summarize results	80.0	4.0	8.0	2,954.00

Respond to requests for confidentialityb	50.0	2.5	5.0	1,846.25

TOTAL LABOR BURDEN AND COST	1,290.0	64.5	129.0	47,633.25

d Costs were taken from the U.S. Office of Personnel Management, Salary
Table 2010-GS, effective January 2010, available on-line at   HYPERLINK
"http://www.opm.gov/oca/10tables/html/gs_h.asp"
http://www.opm.gov/oca/10tables/html/gs_h.asp .  All hourly rates are
baseline values.  It was assumed that the technical person is a GS-12,
Step 5 employee with a rate of $32.73 per hour, that the management
person is a GS-15, Step 5 employee with a rate of $54.10 per hour, and
that the clerical person is a GS-5, Step 5 employee with a rate of
$14.90 per hour.

 PAGE

 PAGE   1


[Federal Register Volume 79, Number 187 (Friday, September 26, 2014)]
[Notices]
[Pages 58010-58012]
[FR Doc No: 2014-22908]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-73176; File No. SR-BYX-2014-021]

Self-Regulatory Organizations; BATS Y-Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change to Rules
11.9 and 11.13 of BATS Y-Exchange, Inc.

September 22, 2014.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on September 11, 2014, BATS Y-Exchange, Inc. (the ``Exchange'' or
``BYX'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The Exchange
has designated this proposal as a ``non-controversial'' proposed rule
change pursuant to Section 19(b)(3)(A) of the Act \3\ and Rule 19b-
4(f)(6)(iii) thereunder,\4\ which renders it effective upon filing with
the Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange filed a proposal to amend Rules 11.9 and 11.13 to add
an additional routing strategy.
    The text of the proposed rule change is available at the Exchange's
Web site at http://www.batstrading.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 parts of such
statements.

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

1. Purpose
    Earlier this year, the Exchange and its affiliate BATS Exchange,
Inc. (``BZX'') received approval to effect a merger (the ``Merger'') of
the Exchange's parent company, BATS Global Markets, Inc., with Direct
Edge Holdings LLC, the indirect parent of EDGX Exchange, Inc.
(``EDGX'') and EDGA Exchange, Inc. (``EDGA'', and together with BZX,
BYX and EDGX, the ``BGM Affiliated Exchanges'').\5\ In the context of
the Merger, the BGM Affiliated Exchanges are working to align certain
system functionality, retaining only intended differences between the
BGM Affiliated Exchanges. Thus, the proposal set forth below is
intended to add certain system functionality currently offered by EDGA
in order to provide a consistent technology offering for users of the
BGM Affiliated Exchanges.
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 71375 (January 23,
2014), 79 FR 4771 (January 29, 2014) (SR-BATS-2013-059; SR-BYX-2013-
039).
---------------------------------------------------------------------------

    The specific proposal set forth in more detail below would amend
Rule 11.13, which describes the Exchange's routing processes, to add
the RMPT routing strategy, specifically RMPT. Currently, Mid-Point Peg
Orders are not eligible for routing. As described in proposed Rule
11.13(a)(3)(J), however, RMPT is a routing option under which a Mid-
Point Peg Order checks the System \6\ for available shares and any
remaining shares are then sent to destinations on the System routing
table that support midpoint eligible orders. If any shares remain
unexecuted after routing, they are posted to the BATS Book \7\ as a
Mid-Point Peg Order, unless otherwise instructed \8\ by the User.\9\ As
mentioned above, orders routed pursuant to RMPT are only sent to those
destinations on the System routing table that support midpoint eligible
orders, which means that a destination is not

necessarily included in the RMPT routing strategy by virtue of
supporting midpoint eligible orders. Rather, a destination must be
included in the System routing table to be included in RMPT routing.
---------------------------------------------------------------------------

    \6\ System is defined in Rule 1.5(aa).
    \7\ BATS Book is defined in Rule 1.5(e).
    \8\ As set forth in Rule 11.13(a)(3), the term ``System routing
table'' refers to the proprietary process for determining the
specific trading venues to which the System routes orders and the
order in which it routes them.
    \9\ User is defined in Rule 1.5(cc).
---------------------------------------------------------------------------

    The Exchange is also proposing to amend Rule 11.9, which describes
the Exchange's order types, in order to allow for Mid-Point Peg Orders
\10\ to be routed pursuant to RMPT. As described above, Mid-Point Peg
Orders are not currently eligible for routing, so, in conjunction with
the proposed addition of the RMPT routing strategy, the Exchange is
also proposing to amend Rule 11.9(c)(9) to provide that Mid-Point Peg
Orders may be eligible for routing where the User elects to route the
order pursuant to the RMPT Routing Option defined in proposed Rule
11.13(a)(3)(J).
---------------------------------------------------------------------------

    \10\ Mid-Point Peg Order is defined in Rule 11.9(c)(9).
---------------------------------------------------------------------------

    The Exchange notes that the proposed rule text is based on the
current rules of EDGA \11\ and is different only to the extent
necessary to conform to the Exchange's current rules. The Exchange also
notes that the proposed implementation of the RMPT routing strategy is
substantively identical to the RMPT routing strategy offered by
EDGA.\12\
---------------------------------------------------------------------------

    \11\ See EDGA Rules 11.5(c)(7) and 11.9(b)(2)(t).
    \12\ See Exchange Act Release No. 66557 (March 9, 2012), 77 FR
15405 (March 15, 2012) (SR-EDGA-2012-006); EDGA Rules 11.5(c)(7) and
11.9(b)(2)(t).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule changes are consistent
with Section 6(b) of the Act \13\ and further the objectives of Section
6(b)(5) of the Act \14\ because they are 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, to
foster cooperation and coordination with persons engaged in
facilitating transactions in securities, and, in general, to protect
investors and the public interest. The proposed rule change also is
designed to support the principles of Section 11A(a)(1) \15\ of the Act
in that it seeks to assure fair competition among brokers and dealers
and among exchange markets. In particular, the proposed change to
introduce additional routing strategies and allow for the routing of
Mid-Point Peg Orders will provide market participants with greater
flexibility in routing orders consistent with Regulation NMS without
developing order routing strategies on their own.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78f(b).
    \14\ 15 U.S.C. 78f(b)(5).
    \15\ 15 U.S.C. 78k-1(a)(1).
---------------------------------------------------------------------------

    As noted above, the proposed rule changes to add functionality are
generally intended to add certain system functionality currently
offered by EDGA in order to provide a consistent technology offering
for the BGM Affiliated Exchanges, which the Exchange believes is
designed to remove impediments to and perfect the mechanism of a free
and open market and a national market system. Further to this point, a
consistent technology offering, in turn, will simplify the technology
implementation, changes and maintenance by Users of the Exchange that
are also participants on BYX, EDGA and/or EDGX. The proposed rule
changes would also provide Users with access to functionality that may
result in the efficient execution of such orders and will provide
additional flexibility as well as increased functionality to the
Exchange's System and its Users, further removing impediments to and
perfecting the mechanism of a free and open market and a national
market system. As explained elsewhere in this proposal, the proposed
RMPT routing option is similar to routing strategies on other market
centers, including EDGA.

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

    The Exchange 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. The Exchange
provides routing services in a highly competitive market in which
participants may avail themselves of a wide variety of routing options
offered by self-regulatory organizations, alternative trading systems,
other broker-dealers, market participants' own proprietary routing
systems, and service bureaus. In such an environment, system
enhancements such as the changes proposed in this rule filing do not
burden competition, because they can succeed in attracting order flow
to the Exchange only if they offer investors higher quality and better
value than services offered by others. The Exchange reiterates that the
proposed rule change is being proposed in the context of the technology
integration of the BGM Affiliated Exchanges. Thus, the Exchange
believes this proposed rule change is necessary to permit fair
competition among national securities exchanges. In addition, the
Exchange believes the proposed rule change will benefit Exchange
participants in that it is one of several changes necessary to achieve
a consistent technology offering by the BGM Affiliated Exchanges.

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

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

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

    Because the 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 prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act \16\ and Rule 19b-
4(f)(6)(iii) thereunder.\17\
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78s(b)(3)(A).
    \17\ 17 CFR 240.19b-4(f)(6)(iii). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the 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 asked the Commission to waive the 30-day operative
delay so that the proposal may become operative immediately upon
filing. The Exchange stated that waiver of this requirement would allow
the Exchange to continue to strive towards a complete integration of
the BGM Affiliated Exchanges, with gradual roll-outs of new
functionality to ensure stability of the System. The Exchange also
stated that its proposed variations of the RMPT routing strategy, which
it noted are directly based on the rules of EDGA, would benefit market
participants and their customers by allowing them greater flexibility
in their efforts to fill orders and minimize trading costs, and that
expected benefits to Exchange Users from the proposed rule change
should not be delayed. The Commission believes that the waiver of the
30-day operative delay is consistent with the protection of investors
and the public interest. Therefore, the Commission designates the
proposed rule change to be operative upon filing.\18\
---------------------------------------------------------------------------

    \18\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).

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

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \19\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

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-BYX-2014-021 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BYX-2014-021. 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 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
10:00 a.m. and 3:00 p.m. Copies of such filing will also 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-BYX-2014-021 and should be
submitted on or before October 17, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
---------------------------------------------------------------------------

    \20\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-22908 Filed 9-25-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 180 (Tuesday, September 17, 2019)]
[Notices]
[Pages 48936-48937]
[FR Doc No: 2019-20108]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]

Product-Specific Guidances; Draft and Revised Draft Guidances for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of additional draft and revised draft product-specific
guidances. The guidances provide product-specific recommendations on,
among other things, the design of bioequivalence (BE) studies to
support abbreviated new drug applications (ANDAs). In the Federal
Register of June 11, 2010, FDA announced the availability of a guidance
for industry entitled ``Bioequivalence Recommendations for Specific
Products'' that explained the process that would be used to make
product-specific guidances available to the public on FDA's website.
The guidances identified in this notice were developed using the
process described in that guidance.

DATES: Submit either electronic or written comments on the draft
guidances by November 18, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2007-D-0369 for ``Product-Specific Guidances; Draft and Revised
Draft Guidances for Industry.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available

for public viewing and posted on https://www.regulations.gov. Submit
both copies to the Dockets Management Staff. If you do not wish your
name and contact information to be made publicly available, you can
provide this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)). Submit written requests for single copies of the draft
guidances to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD
20993-0002. Send one self-addressed adhesive label to assist that
office in processing your requests. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance documents.

FOR FURTHER INFORMATION CONTACT: Wendy Good, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 4714, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products'' that explained
the process that would be used to make product-specific guidances
available to the public on FDA's website at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
    As described in that guidance, FDA adopted this process as a means
to develop and disseminate product-specific guidances and provide a
meaningful opportunity for the public to consider and comment on those
guidances. Under that process, draft guidances are posted on FDA's
website and announced periodically in the Federal Register. The public
is encouraged to submit comments on those recommendations within 60
days of their announcement in the Federal Register. FDA considers any
comments received and either publishes final guidances or publishes
revised draft guidances for comment. Guidances were last announced in
the Federal Register on May 16, 2019. This notice announces draft
product-specific guidances, either new or revised, that are posted on
FDA's website.

II. Drug Products for Which New Draft Product-Specific Guidances Are
Available

    FDA is announcing the availability of new draft product-specific
guidances for industry for drug products containing the following
active ingredients:

     Table 1--New Draft Product-Specific Guidances for Drug Products
------------------------------------------------------------------------

-------------------------------------------------------------------------
Acyclovir
Amantadine hydrochloride
Amoxicillin; Clavulanate potassium
Avatrombopag maleate
Baloxavir marboxil
Baricitinib
Benztropine mesylate
Chenodiol
Chlordiazepoxide hydrochloride
Chlorpheniramine maleate
Chlorpromazine hydrochloride
Chlorthalidone
Clemastine fumarate (multiple reference listed drugs)
Duvelisib
Fexofenadine hydrochloride
Fluorometholone acetate
Fluticasone propionate; Salmeterol xinafoate
Fostamatinib disodium
Glycopyrronium tosylate
Hydrogen peroxide
Hydroxyprogesterone caproate
Ibrutinib
Ketoprofen
Lamivudine; Tenofovir disoproxil fumarate
Levetiracetam
Lofexidine hydrochloride
Loteprednol etabonate (multiple reference listed drugs)
Lovastatin
Plazomicin sulfate
Sarecycline hydrochloride
Tecovirimat
Thioridazine hydrochloride
------------------------------------------------------------------------

III. Drug Products for Which Revised Draft Product-Specific Guidances
Are Available

    FDA is announcing the availability of revised draft product-
specific guidances for industry for drug products containing the
following active ingredients:

   Table 2--Revised Draft Product-Specific Guidances for Drug Products
------------------------------------------------------------------------

-------------------------------------------------------------------------
Acyclovir
Armodafinil
Bosutinib monohydrate
Budesonide
Chlorthalidone
Colesevelam hydrochloride
Dantrolene sodium
Diphenhydramine citrate; Ibuprofen
Duloxetine hydrochloride
Fingolimod hydrochloride
Mesalamine
Metronidazole (multiple reference listed drugs)
Plecanatide
Sucralfate
Tretinoin
------------------------------------------------------------------------

    For a complete history of previously published Federal Register
notices related to product-specific guidances, go to https://www.regulations.gov and enter Docket No. FDA-2007-D-0369.
    These draft guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). These draft guidances,
when finalized, will represent the current thinking of FDA on, among
other things, the product-specific design of BE studies to support
ANDAs. They do not establish any rights for any person and are not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
This guidance is not subject to Executive Order 12866.

IV. Electronic Access

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

    Dated: September 11, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-20108 Filed 9-16-19; 8:45 am]
 BILLING CODE 4164-01-P