[Federal Register Volume 83, Number 8 (Thursday, January 11, 2018)]
[Notices]
[Pages 1371-1373]
[FR Doc No: 2018-00359]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6826]

Anesthetic and Analgesic Drug Products Advisory Committee; Notice
of Meeting; Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice, establishment of a public docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Anesthetic and Analgesic Drug
Products Advisory Committee. The general function of the committee is
to provide advice and recommendations to FDA on regulatory issues. The
meeting will be open to the public. FDA is establishing a docket for
public comment on this document.

DATES: The meeting will be held on February 14, 2018, from 1:30 p.m. to
5 p.m., and February 15, 2018, from 8 a.m. to 5 p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Avenue, Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2017-N-6826. The docket will close on February
13, 2018. Submit either electronic or written comments on this public
meeting by February 13, 2018. Please note that late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before February 13, 2018. The https://www.regulations.gov
electronic filing

system will accept comments until midnight Eastern Time at the end of
February 13, 2018. Comments received by mail/hand delivery/courier (for
written/paper submissions) will be considered timely if they are
postmarked or the delivery service acceptance receipt is on or before
that date.
    Comments received on or before January 31, 2018, will be provided
to the committee. Comments received after that date will be taken into
consideration by FDA.
    You may submit comments 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-2017-N-6826 for ``Anesthetic and Analgesic Drug Products Advisory
Committee; Notice of Meeting; Establishment of a Public Docket; Request
for Comments.'' Received comments, those filed in a timely manner (see
ADDRESSES), 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.'' FDA 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 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 the 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.

FOR FURTHER INFORMATION CONTACT: Moon Hee V. Choi, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, Fax:<PHONE_NUMBER>, email: [email protected], or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area). A notice in the Federal Register about last
minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check FDA's website at
https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to
the appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The committee will discuss supplemental new drug
application (sNDA) 022496/S-009, for EXPAREL (bupivacaine liposomal
injectable suspension), submitted by Pacira Pharmaceuticals, Inc., to
produce local analgesia and as a nerve block to produce regional
analgesia.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's website after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
January 31, 2018. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. on February 15, 2018. Those
individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
January 23, 2018. Time allotted for each presentation may be limited.
If the number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons

regarding their request to speak by January 24, 2018.
    Persons attending FDA's advisory committee meetings are advised
that FDA is not responsible for providing access to electrical outlets.
    For press inquiries, please contact the Office of Media Affairs at
[email protected] or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Moon Hee V. Choi at least 7 days in advance of the meeting (See
FOR FURTHER INFORMATION CONTACT).
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: January 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00359 Filed 1-10-18; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: May 3, 2006 (Volume 71, Number 85)]
[Notices]
[Page 26132-26145]
[DOCID:fr03my06-114]

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

SECURITIES AND EXCHANGE COMMISSION

[Release Nos. 33-8681; 34-53737/April 28, 2006]

Order Making Fiscal Year 2007 Annual Adjustments to the Fee Rates
Applicable Under Section 6(b) of the Securities Act of 1933 and
Sections 13(e), 14(g), 31(b), and 31(c) of the Securities Exchange Act
of 1934

I. Background

    The Commission collects fees under various provisions of the
securities laws. Section 6(b) of the Securities Act of 1933
(``Securities Act'') requires the Commission to collect fees from
issuers on the registration of securities.\1\ Section 13(e) of the
Securities Exchange Act of 1934 (``Exchange Act'') requires the
Commission to collect fees on specified repurchases of securities.\2\
Section 14(g) of the Exchange Act requires the Commission to collect
fees on proxy solicitations and statements in corporate control
transactions.\3\ Finally, Sections 31(b) and (c) of the Exchange Act
require national securities exchanges and national securities
associations, respectively, to pay fees to the Commission on
transactions in specified securities.\4\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 77f(b).
    \2\ 15 U.S.C. 78m(e).
    \3\ 15 U.S.C. 78n(g).
    \4\ 15 U.S.C. 78ee(b) and (c). In addition, Section 31(d) of the
Exchange Act requires the Commission to collect assessments from
national securities exchanges and national securities associations
for round turn transactions on security futures. 15 U.S.C. 78ee(d).
---------------------------------------------------------------------------

    The Investor and Capital Markets Fee Relief Act (``Fee Relief
Act'') \5\ amended Section 6(b) of the Securities Act and Sections
13(e), 14(g), and 31 of the Exchange Act to require the Commission to
make annual adjustments to the fee rates applicable under these
sections for each of the fiscal years 2003 through 2011, and one final
adjustment to fix the fee rates under these sections for fiscal year
2012 and beyond.\6\
---------------------------------------------------------------------------

    \5\ Pub. L. 107-123, 115 Stat. 2390 (2002).
    \6\ See 15 U.S.C. 77f(b)(5), 77f(b)(6), 78m(e)(5), 78m(e)(6),
78n(g)(5), 78n(g)(6), 78ee(j)(1), and 78ee(j)(3). Section 31(j)(2)
of the Exchange Act, 15 U.S.C. 78ee(j)(2), also requires the
Commission, in specified circumstances, to make a mid-year
adjustment to the fee rates under Sections 31(b) and (c) of the
Exchange Act in fiscal years 2002 through 2011.
---------------------------------------------------------------------------

II. Fiscal Year 2007 Annual Adjustment to the Fee Rates Applicable
Under Section 6(b) of the Securities Act and Sections 13(e) and 14(g)
of the Exchange Act

    Section 6(b)(5) of the Securities Act requires the Commission to
make an annual adjustment to the fee rate applicable under Section 6(b)
of the Securities Act in each of the fiscal years 2003 through 2011.\7\
In those same fiscal years, Sections 13(e)(5) and 14(g)(5) of the
Exchange Act require the Commission to adjust the fee rates under
Sections 13(e) and 14(g) to a rate that is equal to the rate that is
applicable under Section 6(b). In other words, the annual adjustment to
the fee rate under Section 6(b) of the Securities Act also sets the
annual adjustment to the fee rates under Sections 13(e) and 14(g) of
the Exchange Act.
---------------------------------------------------------------------------

    \7\ The annual adjustments are designed to adjust the fee rate
in a given fiscal year so that, when applied to the aggregate
maximum offering price at which securities are proposed to be
offered for the fiscal year, it is reasonably likely to produce
total fee collections under Section 6(b) equal to the ``target
offsetting collection amount'' specified in Section 6(b)(11)(A) for
that fiscal year.
---------------------------------------------------------------------------

    Section 6(b)(5) sets forth the method for determining the annual
adjustment to the fee rate under Section 6(b) for fiscal year 2007.
Specifically, the Commission must adjust the fee rate under Section
6(b) to a ``rate that, when applied to the baseline estimate of the
aggregate maximum offering prices for [fiscal year 2007], is reasonably
likely to produce aggregate fee collections under [Section 6(b)] that
are equal to the target offsetting collection amount for [fiscal year
2007].'' That is, the adjusted rate is determined by dividing the
``target offsetting collection amount'' for fiscal year 2007 by the
``baseline estimate of the aggregate maximum offering prices'' for
fiscal year 2007.
    Section 6(b)(11)(A) specifies that the ``target offsetting
collection amount'' for fiscal year 2007 is $214,000,000.\8\ Section
6(b)(11)(B) defines the ``baseline estimate of the aggregate maximum
offering price'' for fiscal year 2007 as ``the baseline estimate of the
aggregate maximum offering price at which securities are proposed to be
offered pursuant to registration statements filed with the Commission
during [fiscal year 2007] as determined by the Commission, after
consultation with the Congressional Budget Office and the Office of
Management and Budget * * *.''
---------------------------------------------------------------------------

    \8\ Congress determined the target offsetting collection amounts
by applying reduced fee rates to the CBO's January 2001 projections
of the aggregate maximum offering prices for fiscal years 2002
through 2011. In any fiscal year through fiscal year 2011, the
annual adjustment mechanism will result in additional fee rate
reductions if the CBO's January 2001 projection of the aggregate
maximum offering prices for the fiscal year proves to be too low,
and fee rate increases if the CBO's January 2001 projection of the
aggregate maximum offering prices for the fiscal year proves to be
too high.
---------------------------------------------------------------------------

    To make the baseline estimate of the aggregate maximum offering
price for fiscal year 2007, the Commission is using the same
methodology it developed in consultation with the Congressional Budget
Office (``CBO'') and Office of Management and Budget (``OMB'') to
project aggregate offering price for purposes of the fiscal year 2006
annual adjustment. Using this methodology, the Commission determines
the ``baseline estimate of the aggregate maximum offering price'' for
fiscal year 2007 to be $6,974,885,248,909.\9\ Based on this estimate,
the Commission calculates the annual adjustment for fiscal 2007 to be
$30.70 per million. This adjusted fee rate applies to Section 6(b) of
the Securities Act, as well as to Sections 13(e) and 14(g) of the
Exchange Act.
---------------------------------------------------------------------------

    \9\ Appendix A explains how we determined the ``baseline
estimate of the aggregate maximum offering price'' for fiscal year
2007 using our methodology, and then shows the purely arithmetical
process of calculating the fiscal year 2007 annual adjustment based
on that estimate. The appendix includes the data used by the
Commission in making its ``baseline estimate of the aggregate
maximum offering price'' for fiscal year 2007.

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

III. Fiscal Year 2007 Annual Adjustment to the Fee Rates Applicable
Under Sections 31(b) and (c) of the Exchange Act

    Section 31(b) of the Exchange Act requires each national securities
exchange to pay the Commission a fee at a rate, as adjusted by our
order pursuant to Section 31(j)(2),\10\ which currently is $30.70 per
million of the aggregate dollar amount of sales of specified securities
transacted on the exchange. Similarly, Section 31(c) requires each
national securities association to pay the Commission a fee at the same
adjusted rate on the aggregate dollar amount of sales of specified
securities transacted by or through any member of the association
otherwise than on an exchange. Section 31(j)(1) requires the Commission
to make annual adjustments to the fee rates applicable under Sections
31(b) and (c) for each of the fiscal years 2003 through 2011.\11\
---------------------------------------------------------------------------

    \10\ Order Making Fiscal Year 2006 Annual Adjustments to the Fee
Rates Applicable under Section 6(b) of the Securities Act of 1933
and Sections 13(e), 14(g), 31(b) and 31(c) of the Securities
Exchange Act of 1934, Rel. No. 33-8572 (April 28, 2005), 70 FR 23271
(May 4, 2005).
    \11\ The annual adjustments, as well as the mid-year adjustments
required in specified circumstances under Section 31(j)(2) in fiscal
years 2002 through 2011, are designed to adjust the fee rates in a
given fiscal year so that, when applied to the aggregate dollar
volume of sales for the fiscal year, they are reasonably likely to
produce total fee collections under Section 31 equal to the ``target
offsetting collection amount'' specified in Section 31(l)(1) for
that fiscal year.
---------------------------------------------------------------------------

    Section 31(j)(1) specifies the method for determining the annual
adjustment for fiscal year 2007. Specifically, the Commission must
adjust the rates under Sections 31(b) and (c) to a ``uniform adjusted
rate that, when applied to the baseline estimate of the aggregate
dollar amount of sales for [fiscal year 2007], is reasonably likely to
produce aggregate fee collections under [Section 31] (including
assessments collected under [Section 31(d)]) that are equal to the
target offsetting collection amount for [fiscal year 2007].''
    Section 31 (l)(1) specifies that the ``target offsetting collection
amount'' for fiscal year 2007 is $881,000,000.\12\ Section 31(l)(2)
defines the ``baseline estimate of the aggregate dollar amount of
sales'' as ``the baseline estimate of the aggregate dollar amount of
sales of securities * * * to be transacted on each national securities
exchange and by or through any member of each national securities
association (otherwise than on a national securities exchange) during
[fiscal year 2007] as determined by the Commission, after consultation
with the Congressional Budget Office and the Office of Management and
Budget * * *.''
---------------------------------------------------------------------------

    \12\ Congress determined the target offsetting collection
amounts by applying reduced fee rates to the CBO's January 2001
projections of dollar volume for fiscal years 2002 through 2011. In
any fiscal year through fiscal year 2011, the annual and, in
specified circumstances, mid-year adjustment mechanisms will result
in additional fee rate reductions if the CBO's January 2001
projection of dollar volume for the fiscal year proves to be too
low, and fee rate increases if the CBO's January 2001 projection of
dollar volume for the fiscal year proves to be too high.
---------------------------------------------------------------------------

    To make the baseline estimate of the aggregate dollar amount of
sales for fiscal year 2007, the Commission is using the same
methodology it developed in consultation with the CBO and OMB to
project dollar volume for purposes of prior fee adjustments.\13\ Using
this methodology, the Commission calculates the baseline estimate of
the aggregate dollar amount of sales for fiscal year 2007 to be
$53,460,711,153,955. Based on this estimate, and an estimated
collection of $51,489 in assessments on security futures transactions
under Section 31(d) in fiscal year 2007, the uniform adjusted rate is
$15.30 per million.\14\
---------------------------------------------------------------------------

    \13\ Appendix B explains how we determined the ``baseline
estimate of the aggregate dollar amount of sales'' for fiscal year
2007 using our methodology, and then shows the purely arithmetical
process of calculating the fiscal year 2007 annual adjustment based
on that estimate. The appendix also includes the data used by the
Commission in making its ``baseline estimate of the aggregate dollar
amount of sales'' for fiscal year 2007.
    \14\ The calculation of the adjusted fee rate assumes that the
current fee rate of $30.70 per million will apply through October
31, 2006, due to the operation of the effective date provision
contained in Section 31(j)(4)(A) of the Exchange Act.
---------------------------------------------------------------------------

IV. Effective Dates of the Annual Adjustments

    Section 6(b)(8)(A) of the Securities Act provides that the fiscal
year 2007 annual adjustment to the fee rate applicable under Section
6(b) of the Securities Act shall take effect on the later of October 1,
2006, or five days after the date on which a regular appropriation to
the Commission for fiscal year 2007 is enacted.\15\ Section 13(e)(8)(A)
and 14(g)(8)(A) of the Exchange Act provide for the same effective date
for the annual adjustments to the fee rates applicable under Sections
13(e) and 14(g) of the Exchange Act.\16\
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 77f(b)(8)(A).
    \16\ 15 U.S.C. 78m(e)(8)(A) and 78n(g)(8)(A).
---------------------------------------------------------------------------

    Section 31(j)(4)(A) of the Exchange Act provides that the fiscal
year 2007 annual adjustments to the fee rates applicable under Sections
31(b) and (c) of the Exchange Act shall take effect on the later of
October 1, 2006, or 30 days after the date on which a regular
appropriation to the Commission for fiscal year 2007 is enacted.

V. Conclusion

    Accordingly, pursuant to Section 6(b) of the Securities Act and
Sections 13(e), 14(g), and 31 of the Exchange Act,\17\
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 77f(b), 78m(e), 78n(g), and 78ee(j).
---------------------------------------------------------------------------

    It is hereby ordered that the fee rates applicable under Section
6(b) of the Securities Act and Sections 13(e) and 14(g) of the Exchange
Act shall be $30.70 per million effective on the later of October 1,
2006, or five days after the date on which a regular appropriation to
the Commission for fiscal year 2007 is enacted; and
    It is further ordered that the fee rates applicable under Sections
31(b) and (c) of the Exchange Act shall be $15.30 per million effective
on the later of October 1, 2006, or 30 days after the date on which a
regular appropriation to the Commission for fiscal year 2007 is
enacted.

    By the Commission.
Nancy M. Morris,
Secretary.

Appendix A

    With the passage of the Investor and Capital Markets Relief Act,
Congress has, among other things, established a target amount of
monies to be collected from fees charged to issuers based on the
value of their registrations. This appendix provides the formula for
determining such fees, which the Commission adjusts annually.
Congress has mandated that the Commission determine these fees based
on the ``aggregate maximum offering prices,'' which measures the
aggregate dollar amount of securities registered with the Commission
over the course of the year. In order to maximize the likelihood
that the amount of monies targeted by Congress will be collected,
the fee rate must be set to reflect projected aggregate maximum
offering prices. As a percentage, the fee rate equals the ratio of
the target amounts of monies to the projected aggregate maximum
offering prices.
    For 2007, the Commission has estimated the aggregate maximum
offering prices by projecting forward the trend established in the
previous decade. More specifically, an ARIMA model was used to
forecast the value of the aggregate maximum offering prices for
months subsequent to March 2006, the last month for which the
Commission has data on the aggregate maximum offering prices.
    The following sections describe this process in detail.

A. Baseline Estimate of the Aggregate Maximum Offering Prices for
Fiscal Year 2007

    First, calculate the aggregate maximum offering prices (AMOP)
for each month in the sample (March 1996-March 2006). Next,
calculate the percentage change in the AMOP from month to month.
    Model the monthly percentage change in AMOP as a first order
moving average process. The moving average approach

allows one to model the effect that an exceptionally high (or low)
observation of AMOP tends to be followed by a more ``typical'' value
of AMOP.
    Use the estimated moving average model to forecast the monthly
percent change in AMOP. These percent changes can then be applied to
obtain forecasts of the total dollar value of registrations. The
following is a more formal (mathematical) description of the
procedure:
    1. Begin with the monthly data for AMOP. The sample spans ten
years, from March 1996 to March 2006.
    2. Divide each month's AMOP (column C) by the number of trading
days in that month (column B) to obtain the average daily AMOP
(AAMOP, column D).
    3. For each month t, the natural logarithm of AAMOP is reported
in column E.
    4. Calculate the change in log(AAMOP) from the previous month as
[Delta]t = log (AAMOPt) -
log(AAMOPt-1). This approximates the percentage change.
    5. Estimate the first order moving average model
[Delta];t = [alpha] + [beta]et-1 +
et, where et denotes the forecast error for
month t. The forecast error is simply the difference between the
one-month ahead forecast and the actual realization of
[Delta]t. The forecast error is expressed as
et = [Delta]t - [alpha] -
[beta]et-1. The model can be estimated using standard
commercially available software such as SAS or Eviews. Using least
squares, the estimated parameter values are [alpha] = 0.01095 and
[beta] = -0.78845.
    6. For the month of April 2006, forecast
[Delta]t = 4/06 = [alpha] + [beta]et = 3/06.
For all subsequent months, forecast [Delta]t = [alpha].
    7. Calculate forecasts of log(AAMOP). For example, the forecast
of log(AAMOP) for June 2006 is given by FLAAMOPt = 6/06 =
log(AAMOPt = 3/06) + [Delta]t = 4/06 +
[Delta]t = 5/06 + [Delta]t = 6/06.
    8. Under the assumption that et is normally
distributed, the n-step ahead forecast of AAMOP is given by
exp(FLAAMOPt + [sigma]n2/2), where
[sigma]n denotes the standard error of the n-step ahead
forecast.
    9. For June 2007, this gives a forecast AAMOP of $24.4 billion
(Column I), and a forecast AMOP of $537.2 billion (Column J).
    10. Iterate this process through September 2007 to obtain a
baseline estimate of the aggregate maximum offering prices for
fiscal year 2007 of $6,974,885,248,909.

B. Using the Forecasts From A To Calculate the New Fee Rate

    1. Using the data from Table A, estimate the aggregate maximum
offering prices between 10/1/06 and 9/30/07 to be
$6,974,885,248,909.
    2. The rate necessary to collect the target $214,000,000 in fee
revenues set by Congress is then calculated as: $214,000,000 /
$6,974,885,248,909 = 0.00003068 (or $30.70 per million).
BILLING CODE 8010-01-P

[GRAPHIC] [TIFF OMITTED] TN03MY06.008

[GRAPHIC] [TIFF OMITTED] TN03MY06.009

[GRAPHIC] [TIFF OMITTED] TN03MY06.010

[GRAPHIC] [TIFF OMITTED] TN03MY06.011

[GRAPHIC] [TIFF OMITTED] TN03MY06.012

[GRAPHIC] [TIFF OMITTED] TN03MY06.013

BILLING CODE 8010-01-C

Appendix B

    With the passage of the Investor and Capital Markets Relief Act,
Congress has, among other things, established a target amount of
monies to be collected from fees charged to investors based on the
value of their transactions. This appendix provides the formula for
determining such fees, which the Commission adjusts annually, and
may adjust semi-annually.\18\ In order to maximize the likelihood
that the amount of monies targeted by Congress will be collected,
the fee rate must be set to reflect projected dollar transaction
volume on the securities exchanges and certain over-the-counter
markets over the course of the year. As a percentage, the fee rate
equals the ratio of the target amounts of monies to the projected
dollar transaction volume.
---------------------------------------------------------------------------

    \18\ Congress requires that the Commission make a mid-year
adjustment to the fee rate if four months into the fiscal year it
determines that its forecasts of aggregate dollar volume are
reasonably likely to be off by 10% or more.
---------------------------------------------------------------------------

    For 2007, the Commission has estimated dollar transaction volume
by projecting forward the trend established in the previous decade.
More specifically, dollar transaction volume was forecasted for
months subsequent to March 2006, the last month for which the
Commission has data on transaction volume.
    The following sections describe this process in detail.

A. Baseline Estimate of the Aggregate Dollar Amount of Sales for
Fiscal Year 2007

    First, calculate the average daily dollar amount of sales (ADS)
for each month in the sample (March 1996-March 2006). The monthly
aggregate dollar amount of sales (exchange plus certain over-the-
counter markets) is presented in column C of Table B.
    Next, calculate the change in the natural logarithm of ADS from
month to month. The average monthly percentage growth of ADS over
the entire sample is 0.013 and the standard deviation 0.117.
Assuming the monthly percentage change in ADS follows a random walk,
calculating the expected monthly percentage growth rate for the full
sample is straightforward. The expected monthly percentage growth
rate of ADS is 2.0%.
    Now, use the expected monthly percentage growth rate to forecast
total dollar volume. For example, one can use the ADS for March 2006
($165,519,031,905) to forecast ADS for April 2006 ($168,860,299,166
= $165,519,031,905 x 1.020).\19\ Multiply by the number of trading
days in April 2006 (19) to obtain a forecast of the total dollar
volume for the month ($3,208,345,684,147). Repeat the method to
generate forecasts for subsequent months.
---------------------------------------------------------------------------

    \19\ The value 1.020 has been rounded. All computations are done
with the unrounded value.
---------------------------------------------------------------------------

    The forecasts for total dollar volume are in column G of Table
B. The following is a more formal (mathematical) description of the
procedure:
    1. Divide each month's total dollar volume (column C) by the
number of trading days in that month (column B) to obtain the
average daily dollar volume (ADS, column D).
    2. For each month t, calculate the change in ADS from the
previous month as [Delta] t = log (ADS t / ADS
t-1), where log (x) denotes the natural logarithm of x.
    3. Calculate the mean and standard deviation of the series
{[Delta] 1, [Delta] 2, . . . , [Delta]
120{time} . These are given by [mu] = 0.013 and [sigma] =
0.117, respectively.
    4. Assume that the natural logarithm of ADS follows a random
walk, so that [Delta] s and [Delta] t are
statistically independent for any two months s and t.
    5. Under the assumption that [Delta] t is normally
distributed, the expected value of ADS t /ADS
t-1 is given by exp ([mu] + [sigma] 2/2), or
on average ADS t = 1.020 x ADS t-1.
    6. For April 2006, this gives a forecast ADS of 1.020 x
$165,519,031,905 = $168,860,299,166. Multiply this figure by the 19
trading days in April 2006 to obtain a total dollar volume forecast
of $3,208,345,684,147.
    7. For May 2006, multiply the April 2006 ADS forecast by 1.020
to obtain a forecast ADS of $172,269,015,268. Multiply this figure
by the 22 trading days in May 2006 to obtain a total dollar volume
forecast of $3,789,918,335,894.
    8. Repeat this procedure for subsequent months.

B. Using the Forecasts From A to Calculate the New Fee Rate

    1. Use Table B to estimate fees collected for the period 10/1/06
through 10/31/06. The projected aggregate dollar amount of sales for
this period is $4,188,205,050,118. Projected fee collections at the
current fee rate of 0.0000307 are $128,577,895.
    2. Estimate the amount of assessments on securities futures
products collected during 10/1/06 and 9/30/07 to be $51,489 by
projecting a 2.0% monthly increase from a base of $3,342 in March
2006.
    3. Subtract the amounts $128,577,895 and $51,489 from the target
offsetting collection amount set by Congress of $881,000,000 leaving
$752,370,487 to be collected on dollar volume for the period 11/1/06
through 9/30/07.
    4. Use Table B to estimate dollar volume for the period 11/1/06
through 9/30/07. The estimate is $49,272,506,103,837. Finally,
compute the fee rate required to produce the additional $752,370,487
in revenue. This rate is $752,370,487 divided by $49,272,506,103,837
or 0.0000152696.
    5. Round the result to the seventh decimal point, yielding a
rate of .0000153 (or $15.30 per million).
BILLING CODE 8010-01-P

[GRAPHIC] [TIFF OMITTED] TN03MY06.014

[GRAPHIC] [TIFF OMITTED] TN03MY06.015

[GRAPHIC] [TIFF OMITTED] TN03MY06.016

[GRAPHIC] [TIFF OMITTED] TN03MY06.017

[FR Doc. 06-4192 Filed 5-1-06; 11:23 am]

BILLING CODE 8010-01-C


[Federal Register Volume 88, Number 130 (Monday, July 10, 2023)]
[Notices]
[Pages 43562-43565]
[FR Doc No: 2023-14445]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2022-0905; FRL-10798-02-OCSPP]

1,4-Dioxane; Draft Supplement to the TSCA Risk Evaluation;
Science Advisory Committee on Chemicals (SACC) Meeting; Notice of
Meeting and Request for Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA or ``Agency'') is
announcing the availability of and soliciting public comment on the
``2023 Draft Supplement to the 1,4-Dioxane Risk Evaluation'' prepared
under the Toxic Substances Control Act (TSCA) that is being submitted
to the Science Advisory Committee on Chemicals (SACC) for peer review.
The draft supplement is available for public review and comment and is
submitted to the SACC for peer review. The SACC will consider and
review the draft supplement at a 4-day virtual public meeting that was
previously announced in the Federal Register of March 23, 2023. The
virtual public meeting will be held on September 12-15, 2023, via a
webcast platform such as ``Zoomgov.com'' and audio teleconference.

DATES: The following is a chronological listing of the dates for the
specific activities that are described in more detail under
SUPPLEMENTARY INFORMATION.
    September 1, 2023--Deadline for submitting a request for special
accommodations to allow EPA time to process the request before the
meeting.
    September 8, 2023--Deadline for providing written comments on the
draft supplement.
    September 8, 2023--Deadline for registering to be listed on the
meeting agenda to make oral comments during the virtual meeting.
    September 15, 2023--Deadline for those not making oral comments to
register to receive the links to observe the meeting.

ADDRESSES:
    To comment: Submit written comments, identified by docket
identification (ID) number EPA-HQ-OPPT-2022-0905, through the Federal
eRulemaking Portal at https://www.regulations.gov. Follow the online
instructions for submitting comments. Do not electronically submit any
information you consider to be Confidential Business Information (CBI)

or other information whose disclosure is restricted by statute.
Copyrighted material will not be posted without explicit permission
from the copyright holder. Members of the public should also be aware
that personal information included in any written comments may be
posted on the internet at https://www.regulations.gov. Additional
information on commenting or visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.
    To register for the meeting: For information on how to register and
access the virtual public meeting, please refer to the SACC website at
https://www.epa.gov/tsca-peer-review. EPA intends to announce
registration instructions on the SACC website by mid-August of 2023.
You may also subscribe to the following listserv for alerts regarding
this and other SACC-related activities at https://public.govdelivery.com/accounts/USAEPAOPPT/subscriber/new?topic_id=USAEPAOPPT_101.
    To request special accommodations: For information on access or
services for individuals with disabilities, and to request
accommodation for a disability, please contact the Designated Federal
Official (DFO) listed under FOR FURTHER INFORMATION CONTACT.

FOR FURTHER INFORMATION CONTACT: The DFO, Dr. Alaa Kamel, Mission
Support Division (7602M), Office of Program Support, Office of Chemical
Safety and Pollution Prevention, Environmental Protection Agency;
telephone number:<PHONE_NUMBER> or SACC main office number: (202) 564-
8450; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. What action is the Agency taking?

    EPA is announcing the availability of and soliciting public comment
on the ``2023 Draft Supplement to the 1,4-Dioxane Risk Evaluation.''
EPA is also announcing a 4-day virtual public meeting on September 12-
15, 2023, for the SACC to consider and review the draft supplement.
This September 2023 meeting was previously announced in the Federal
Register of March 23, 2023 (88 FR 17566 (FRL-10798-01-OCSPP)). EPA will
be soliciting comments from the SACC on the methodologies utilized in
the 2023 Draft Supplement to the 1,4-Dioxane Risk Evaluation that have
not been previously peer reviewed. EPA is also releasing for public
comment an updated risk determination for 1,4-dioxane (see docket ID
No. EPA-HQ-OPPT-2016-0723). EPA is not soliciting comments from the
SACC on the risk determination for 1,4-dioxane.
    This document provides instructions for accessing the materials
provided to the SACC, submitting written comments, and registering to
provide oral comments and attend the virtual meeting.

B. What is the Agency's authority for taking this action?

    The SACC was established by EPA in 2016 in accordance with the
Toxic Substances Control Act (TSCA), 15 U.S.C. 2625(o), to provide
independent advice and expert consultation, at the request of the
Administrator, with respect to the scientific and technical aspects of
issues relating to the implementation of TSCA. The SACC operates in
accordance with the Federal Advisory Committee Act (FACA), 5 U.S.C. 10,
and supports activities under the TSCA, 15 U.S.C. 2601 et seq., the
Pollution Prevention Act (PPA), 42 U.S.C. 13101 et seq., and other
applicable statutes.

C. Does this action apply to me?

    This action is directed to the public in general. This action may,
however, be of interest to those involved in the manufacture,
processing, distribution, and disposal of chemical substances and
mixtures, and/or those interested in the assessment of risks involving
chemical substances and mixtures regulated under TSCA. Since other
entities may also be interested, the Agency has not attempted to
describe all the specific entities that may be affected by this action.

D. What should I consider as I submit my comments to EPA?

1. Submitting CBI
    Contact the DFO listed under FOR FURTHER INFORMATION CONTACT for
instructions before submitted CBI or other sensitive information. Do
not submit this information to EPA electronically (e.g., through
https://www.regulations.gov or email). Clearly mark the part or all of
the information that you claim to be CBI. For confidential information
in a disk or CD-ROM that you mail to EPA, mark the outside of the disk
or CD-ROM as CBI and then identify electronically within the disk or
CD-ROM the specific information that is claimed as CBI. In addition to
one complete version of the comment that includes information claimed
as CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for Preparing Your Comments
    When preparing and submitting your comments, see the commenting
tips at https://www.epa.gov/dockets/commenting-epa-dockets. See also
the instructions in Unit III.C.

II. Background

A. What is the purpose of the SACC?

    The SACC provides independent scientific advice and recommendations
to the EPA on the scientific and technical aspects of risk assessments,
methodologies, and pollution prevention measures and approaches for
chemicals regulated under TSCA. The SACC is comprised of experts in
toxicology; environmental risk assessment; exposure assessment; and
related sciences (e.g., synthetic biology, pharmacology, biotechnology,
nanotechnology, biochemistry, biostatistics, physiologically based
pharmacokinetic modeling (PBPK), computational toxicology,
epidemiology, environmental fate, and environmental engineering and
sustainability). The SACC currently consists of 19 members. When
needed, the committee will be assisted by ad hoc reviewers with
specific expertise in the topics under consideration.

B. Why did EPA develop these documents?

    TSCA requires EPA to conduct risk evaluations on prioritized
chemical substances and identifies the minimum components EPA must
include in all chemical substance risk evaluations. The purpose of
conducting risk evaluations is to determine whether a chemical
substance presents an unreasonable risk to human health or the
environment under the conditions of use. These evaluations include
assessing unreasonable risks to relevant potentially exposed or
susceptible subpopulations. As part of this process, EPA: (1)
integrates hazard and exposure assessments using the best available
science that is reasonably available to assure decisions are based on
the weight of the scientific evidence; and (2) conducts peer review for
risk evaluation approaches that have not been previously peer reviewed.
    1,4-Dioxane was one of the first 10 chemical substances undergoing
the TSCA risk evaluation process after passage of the Frank R.
Lautenberg Chemical Safety for the 21st Century Act, which amended TSCA
in 2016. 1,4-Dioxane is primarily used as a solvent in a variety of
commercial and

industrial applications such as the manufacture of other chemicals
(e.g., adhesives, sealants) or as a processing aid or laboratory
chemical. Although there are no direct consumer uses of 1,4-dioxane, it
is present as a byproduct in commercial and consumer products from
several manufacturing processes, including ethoxylation, sulfonation,
sulfation, and esterification.
    In the 2019 Draft Risk Evaluation for 1,4-Dioxane (see https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0238-0011), EPA reviewed
the exposures and hazards of 1,4-dioxane direct industrial and
commercial uses assessing risk from occupational exposures and surface
water exposures to environmental organisms. This assessment, which
included the physical and chemical properties, lifecycle information,
environmental fate and transport information, and hazard identification
and dose-response analysis was reviewed by the SACC. The Agency
considered the SACC feedback and is not seeking additional review at
this time as this information has not changed.
    In November of 2020, EPA released for public comment a Draft
Supplement to the 2019 Draft Risk Evaluation (see https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0238-0067). The November
2020 Draft Supplement assessed eight conditions of use (COUs) of 1,4-
dioxane as a byproduct in consumer products and general population
exposure from incidental contact with surface water. The Agency
determined that the additional analysis did not warrant SACC review.
    The 2019 Draft Risk Evaluation and 2020 Draft Supplement were both
incorporated into the final Risk Evaluation for 1,4-Dioxane released in
December 2020 (see https://www.epa.gov/sites/default/files/2020-12/documents/1._risk_evaluation_for_14-dioxane_casrn_123-91-1.pdf). After
its release, EPA determined an additional supplement to the final Risk
Evaluation for 1,4-Dioxane was needed to consider critical exposure
pathways not previously assessed. Specifically, the 2023 Draft
Supplement includes evaluation of additional conditions of use in which
1,4-dioxane is present as a byproduct in industrial processes and
commercial products and evaluates risks from general population
exposures to 1,4-dioxane released to ambient surface water and
groundwater, ambient air, and land. To evaluate these additional
exposure pathways, the Agency used new methods and novel applications
of existing methods. These new methods described below have not been
the subject of public comment or peer review for applications in TSCA
risk evaluations.
    In this 2023 Draft Supplement, EPA is relying on the physical and
chemical properties, lifecycle information, environmental fate and
transport information, and hazard identification and dose-response
analysis presented in the December 2020 final Risk Evaluation for 1,4-
Dioxane, thus, EPA is not seeking feedback on these topics. However,
EPA is seeking review of the methodologies listed below that have not
been previously peer reviewed and are utilized in this 2023 Draft
Supplement to the 1,4-Dioxane Risk Evaluation.
1. EPA Applied Monte Carlo Modeling in the Assessment of 1,4-Dioxane
Occupational Exposures and Environmental Releases
    The Agency has utilized Monte Carlo approaches in TSCA risk
evaluations previously for specific conditions of use; however, the
application of Monte Carlo methods in the ``2023 Draft Supplement to
the 1,4-Dioxane Risk Evaluation'' was expanded to capture additional
exposure and release models for additional conditions of use. The
expanded application of these methods incorporates randomness and
variability to improve the representativeness of the resulting model
outputs. This was done to further improve exposure and release
estimates and is in response to previous SACC review comments received
on the first 10 chemical risk evaluations conducted under amended TSCA.
2. EPA Assessed Hydraulic Fracturing as a Condition of Use
    This evaluation required consideration of new field operations data
that have not yet been considered in TSCA risk evaluations to estimate
occupational exposures and environmental releases from these
operations. EPA has developed a new generic exposure scenario for
hydraulic fracturing and applied it in the 2023 Draft Supplement along
with the Monte Carlo modeling to estimate a range of potential
releases.
3. EPA Assessed the Ambient Air Pathway To Determine Exposures and
Associated Risks to Fenceline Communities (a Subset of the General
Population)
    The Agency assessed general population exposures via the inhalation
route through both single- and multi-year analyses. The single-year
analysis utilized the Fenceline 1.0 methodology described in the ``EPA
Toxic Substances Control Act (TSCA) Screening Level Approach for
Assessing Ambient Air and Water Exposures to Fenceline Communities,''
previously peer reviewed by the SACC (see, EPA (2022). Peer Review of
the EPA TSCA Screening Level approach for Assessing Ambient Air and
Water Exposures to Fenceline Communities March 15-17, 2022. https://www.regulations.gov/docket/EPA-HQ-OPPT-2021-0415/document.) EPA
quantitatively characterized exposures and risks to communities in
proximity to multiple facilities releasing 1,4-dioxane to air.
4. EPA Assessed General Population Exposures via Drinking Water Sourced
From Groundwater and Surface Water
    Although the 2020 1,4-dioxane risk evaluation considered incidental
oral and dermal exposures to surface water, the 2020 analysis did not
consider drinking water exposures through sourcing of 1,4-dioxane
contained in surface water or groundwater.
a. Surface Water
     1,4-Dioxane concentrations in surface water reported in
the 2023 draft supplemental risk evaluation were modeled based on known
facility and publicly owned treatment works releases directly to
surface water. This methodology is generally consistent with what was
previously done to aquatic exposures and presented in the draft
Fenceline 1.0 methodology previously reviewed by the SACC. However,
this analysis was modified to include consideration of multiple years
of release data, as recommended by SACC, and integrated NHDPlus flow
networks and flows to modernize approaches previously utilized in TSCA
risk evaluations. This assessment is the first time the modified
approach has been employed in a TSCA risk evaluation
     1,4-Dioxane concentrations resulting from consumer and
commercial down-the-drain releases of 1,4-dioxane through publicly
owned treatment works to surface water were estimated. EPA used the
Stochastic Human Exposure and Dose Simulation Model (SHEDS) for high-
throughput (HT) (SHEDS-HT) model (see Environ. Sci. Technol. 2014, 48,
21, 12750-12759) predictions to estimate down-the-drain disposals
(Isaacs, 2014). SHEDS-HT was developed by EPA under the ExpoCast
program for evaluating chemicals based on the potential for
biologically relevant human exposure. This is the first TSCA risk
evaluation incorporating down-the-drain estimates based on SHEDS-HT
model predictions and is the first time the down-the-drain model has
been

used for one of the first 10 chemical risk evaluations conducted under
amended TSCA.
     1,4-Dioxane concentrations in surface water were modeled
based on multiple upstream sources, including releases from facilities
and publicly owned treatment works and down-the-drain releases. In
addition, EPA compared the modeled concentrations to drinking water
monitoring data for community water systems. This approach to
considering the contribution of multiple sources to drinking water
exposures is novel. EPA has not previously considered multiple sources
of releases when estimating exposure concentrations in surface water
for a chemical risk evaluation under TSCA.
b. Groundwater
     1,4-Dioxane concentrations in groundwater were modeled for
two disposal pathways by applying the Delisting Risk Assessment
Software (DRAS) model in a novel way. DRAS is a multi-pathways model
developed by the EPA that calculates the potential human health risks
associated with disposing of a specific facility's given waste stream
in a landfill or surface impoundment. (See U.S. EPA. (2020). Hazardous
Waste Delisting Risk Assessment Software Version 4. Lenexa, KS: EPA
Region 6. https://www.epa.gov/hw/hazardous-waste-delisting-risk-assessment-software-dras.) DRAS was specifically designed to address
the Criteria for Listing Hazardous Waste. The 2023 Draft Supplement to
the 1,4-Dioxane Risk Evaluation presents a novel application of this
model and the first application in a TSCA chemical risk evaluation.
Specifically, EPA compared the modeled concentrations to monitoring
data from groundwater contaminations around the nation to consider if
they are within a reasonable range.
    EPA is also seeking review of the overall synthesis of the results
of these novel methodologies and the integration of the results into
the 1,4-Dioxane Risk Evaluation. Feedback from this review will be
considered in the development of the final supplement to the 1,4-
dioxane risk evaluation. In addition, SACC reviewer feedback may help
refine EPA's methods for conducting release assessments and evaluating
general population exposures in risk evaluations of other chemicals
under TSCA.

III. Virtual Public Meeting of the SACC

A. What is the purpose of this public meeting?

    The purpose of the 4-day virtual public meeting is the SACC peer
review of the methodologies that have not been previously peer reviewed
and are utilized in the 2023 Draft Supplement. Feedback from this
review will be considered in the development of the final Supplement to
the Risk Evaluation for 1,4-Dioxane. In addition, SACC reviewer
feedback may help refine EPA's methods for conducting release
assessments and evaluating general population exposures in risk
evaluations of other chemicals under TSCA.
    EPA intends to provide a meeting agenda for each day of the
meeting, and as needed, may provide updated times for each day in the
meeting agenda that will be posted in the docket and on the SACC
website.

B. How can I access the documents submitted for review to the SACC?

    The 2023 Draft Supplement and related documents, including
background documents, related supporting materials, and draft charge
questions provided to the SACC, are available in the docket. As
additional background materials become available and are provided to
the SACC, EPA will include those additional background documents (e.g.,
SACC members and consultants participating in this meeting and the
meeting agenda) in the docket. All of these documents will be available
through https://www.regulations.gov (docket ID No. EPA-HQ-OPPT-2022-
0905) and through links on the SACC website at https://www.epa.gov/tsca-peer-review.
    After the public meeting, the SACC will prepare meeting minutes and
a final report document summarizing its recommendations to the EPA.
This document will also be available in the docket and the SACC
website.

C. How can I provide comments for the SACC's consideration?

    To ensure proper receipt of comments it is imperative that you
identify docket ID No. EPA-HQ-OPPT-2022-0905 in the subject line on the
first page of your comments and follow the instructions in Unit I.D.
and in this unit.
1. Written Comments
    The Agency encourages written comments for this meeting be
submitted by the deadlines set in the DATES section of this document
and following the instructions in this document.
2. Oral Comments
    The Agency encourages each individual or group wishing to make
brief oral comments to the SACC during the peer review virtual public
meeting to follow the registration instructions that will be announced
on the SACC website by mid-August of 2023. Oral comments before the
SACC during the peer review virtual public meeting are limited to 5
minutes. In addition, each speaker should submit a written copy of
their oral comments and any supporting materials (e.g., presentation
slides) to the DFO prior to the meeting for distribution to the SACC by
the DFO.

D. How can I participate in the virtual public meeting?

    The virtual public meeting will be held via a webcast platform such
as ``Zoomgov.com'' and audio teleconference. You must register online
to receive the webcast meeting link and audio teleconference
information. Please follow the registration instructions that will be
announced on the SACC website.
    Authority: 15 U.S.C. 2625(o); 5 U.S.C 10.

    Dated: July 3, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2023-14445 Filed 7-7-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 164 (Thursday, August 23, 2018)]
[Rules and Regulations]
[Pages 42594-42596]
[FR Doc No: 2018-18103]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2018-0188; FRL-9982-06--Region 7]

Approval of Nebraska Air Quality Implementation Plan; Particulate
Emissions; Limitations and Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve revisions to the State Implementation Plan (SIP)
submitted on July 14, 2014, by the State of Nebraska. This final action
will amend the SIP to include revisions to title 129 of the Nebraska
Administrative Code, chapter 20 ``Particulate Emissions; Limitations
and Standards''. The revisions make clear that the emission rates in
the rule apply to applicable sources except when a more stringent
Federal rule or limit in a construction permit exists. Other minor
administrative revisions are also being made. Approval of these
revisions will not impact air quality, ensures consistency between the
State and Federally approved rules, and ensures Federal enforceability
of the State's rules.

DATES: This final rule is effective on September 24, 2018.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R07-OAR-2018-0188. All documents in the docket are listed on
the https://www.regulations.gov website. Although listed in the index,
some information is not publicly available, i.e., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available through https://www.regulations.gov or please contact the person identified in the FOR
FURTHER INFORMATION CONTACT section for additional information.

FOR FURTHER INFORMATION CONTACT: Greg Crable, Environmental Protection
Agency, Air Planning and Development Branch, 11201 Renner Boulevard,
Lenexa, Kansas 66219 at<PHONE_NUMBER>, or by email at
[email protected].

SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' and
``our'' refer to EPA. This section provides additional information by
addressing the following:

I. What is being addressed in this document?
II. Have the requirements for approval of a SIP Revision been met?
III. EPA's Response to Comments.
IV. What action is EPA taking?
V. Incorporation by Reference.
VI. Statutory and Executive Order Reviews.

I. What is being addressed in this document?

    EPA is approving amendments to Nebraska's SIP to include revisions
to title 129 of the Nebraska Administrative Code, chapter 20,
``Particulate Emissions; Limitations and Standards'' submitted to EPA
on July 14, 2014. EPA proposed approval of the State's submission in
its action published in the Federal Register on June 5, 2018 at 83 FR
25975. The chapter 20 revisions provide clarity to the chapter. The
revisions to chapter 20, being addressed in this action, were submitted
as a part of a larger package, revising other title 129 chapters,
submitted at the same time as the July 14, 2014 submittal. On April 6,
2018, EPA took final action on two title 129 chapters, chapter 1
``Definitions'', and chapter 15 ``Operating Permit Modifications;
Reopening for Cause.'' In that final action, EPA stated it would take
action separately on chapter 20. See 83 FR 14762. EPA is now taking a
final action to approve revisions to chapter 20. The revisions to
chapter 20 are described below.
    Nebraska's Department of Environmental Quality (NDEQ)

approved the revision to the chapter title by removing,''(EXCEPTIONS
DUE TO BREAKDOWNS OR SCHEDULED MAINTENANCE: SEE CHAPTER 35)'' and
replacing it with a stand alone statement of exception that reads:
``For exceptions due to breakdowns or scheduled maintenance: see
Chapter 35--COMPLIANCE; EXCEPTIONS DUE TO STARTUP, SHUTDOWN, OR
MALFUNCTION.'' In addition, the submitted revision removes a footnote
to table 20-2, making it a stand alone section numbered 007 and
finally, the revision will add 008 clarifying that section 001 and 002
of chapter 20 applies unless a more stringent particulate matter
standard is specified in the underlying requirments of an applicable
Federal rule or is specified within a construction permit issued under
title 129.

II. Have the requirements for approval of a SIP Revision been met?

    The state submission has met the public notice requirements for SIP
submissions in accordance with 40 CFR 51.102. The submission also
satisfied the completeness criteria of 40 CFR part 51, appendix V. In
addition, as explained above, the revisions meet the substantive SIP
requirements of the CAA, including section 110 and implementing
regulations.

III. EPA's Response to Comments

    The public comment period on EPA's proposed rule opened on June 5,
2018, the date of its publication in the Federal Register, and closed
on July 5, 2018. During this period, EPA received four comments. After
reviewing the comments, the EPA has determined that the comments are
outside the scope of our proposed rule and fails to identify any
material issue necessitating a response. Accordingly, the EPA will not
provide a specific response to the comments. We note that the public
comments received on this rulemaking action are available for review by
the public and may be viewed by following the instructions for access
to docket materials as outlined in the ADDRESSES section of this
preamble.

IV. What action is EPA taking?

    EPA is taking final action to amend the Nebraska SIP, to include
revisions to title 129, chapter 20 as submitted by NDEQ on July 14,
2014.

V. Incorporation by Reference

    In this rule, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is finalizing the incorporation by reference of the Nebraska
Regulations described in the amendments to 40 CFR part 52 set forth
below. EPA has made, and will continue to make, these materials
generally available through www.regulations.gov and at the EPA Region 7
Office (please contact the person identified in the FOR FURTHER
INFORMATION CONTACT section of this preamble for more information).
    Therefore, these materials have been approved by EPA for inclusion
in the State implementation plan, have been incorporated by reference
by EPA into that plan, are fully Federally enforceable under sections
110 and 113 of the CAA as of the effective date of the final rulemaking
of EPA's approval, and will be incorporated by reference in the next
update to the SIP compilation.\1\
---------------------------------------------------------------------------

    \1\ 62 FR 27968 (May 22, 1997).
---------------------------------------------------------------------------

VI. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the CAA. Accordingly,
this action merely approves state law as meeting Federal requirements
and does not impose additional requirements beyond those imposed by
state law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866.
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by October 22, 2018. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: August 16, 2018.
James B. Gulliford,
Regional Administrator, Region 7.

    For the reasons stated in the preamble, EPA amends 40 CFR part 52
as set forth below:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

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

Subpart CC--Nebraska

0
2. Amend Sec.  52.1420(c) by revising the entry for citation ``129-20''
to read as follows:

Sec.  52.1420  Identification of plan.

* * * * *
    (c)* * *

                                        EPA-Approved Nebraska Regulations
----------------------------------------------------------------------------------------------------------------
                                                        State
    Nebraska citation               Title          effective date     EPA Approval date         Explanation
----------------------------------------------------------------------------------------------------------------
                                                STATE OF NEBRASKA
----------------------------------------------------------------------------------------------------------------
                                       Department of Environmental Quality
----------------------------------------------------------------------------------------------------------------
                                   Title 129--Nebraska Air Quality Regulations
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
129-20...................  Particulate Emissions;       5/13/2014  8/23/2018, [Insert      .....................
                            Limitations and                         Federal Register
                            Standards.                              citation].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-18103 Filed 8-22-18; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 57 (Friday, March 26, 2021)]
[Notices]
[Page 16270]
[FR Doc No: 2021-06241]

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

SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-428, OMB Control No. 3235-0478]

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

Extension:
    Rule 11a1-1(T)

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the existing
collection of information provided for in Rule 11a1-1(T) (17 CFR
240.11a1-1(T)), under the Securities Exchange Act of 1934 (15 U.S.C.
78a et seq.) (``Exchange Act''). The Commission plans to submit this
existing collection of information to the Office of Management and
Budget (``OMB'') for extension and approval.
    On January 27, 1976, the Commission adopted Rule 11a1-1(T)--
Transactions Yielding Priority, Parity, and Precedence (17 CFR
240.11a1-1(T)) under the Exchange Act (15 U.S.C. 78a et seq.) to exempt
certain transactions of exchange members for their own accounts that
would otherwise be prohibited under Section 11(a) of the Exchange Act.
The Rule provides that a member's proprietary order may be executed on
the exchange of which the trader is a member, if, among other things:
(1) The member discloses that a bid or offer for its account is for its
account to any member with whom such bid or offer is placed or to whom
it is communicated; (2) any such member through whom that bid or offer
is communicated discloses to others participating in effecting the
order that it is for the account of a member; and (3) immediately
before executing the order, a member (other than a specialist in such
security) presenting any order for the account of a member on the
exchange clearly announces or otherwise indicates to the specialist and
to other members then present that he is presenting an order for the
account of a member.
    Without these requirements, it would not be possible for the
Commission to monitor its mandate under the Exchange Act to promote
fair and orderly markets and ensure that exchange members have, as the
principle purpose of their exchange memberships, the conduct of a
public securities business.
    There are approximately 538 respondents that require an aggregate
total of approximately 15 hours per year to comply with this Rule. Each
of these approximately 538 respondents makes an estimated 20 annual
responses, for an aggregate of 10,760 responses per year. Each response
takes approximately 5 seconds to complete. Thus, the total compliance
burden per year is approximately 15 hours (10,760 x 5 seconds/60
seconds per minute/60 minutes per hour = 15 hours). The approximate
internal cost of compliance per hour is approximately $355, resulting
in a total internal cost of compliance of approximately $5,325 per year
(15 hours @ $355).
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information will
have practical utility; (b) the accuracy of the Commission's estimates
of the burden of the proposed collection of information; (c) ways to
enhance the quality, utility, and clarity of the information collected;
and (d) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    Please direct your written comments to: David Bottom, Director/
Chief Information Officer, Securities and Exchange Commission, c/o
Cynthia Roscoe, 100 F Street NE, Washington, DC 20549, or send an email
to<EMAIL_ADDRESS>
    Dated: March 22, 2021.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-06241 Filed 3-25-21; 8:45 am]
BILLING CODE 8011-01-P