[Federal Register: August 25, 2008 (Volume 73, Number 165)]
[Rules and Regulations]
[Page 49941-49943]
[DOCID:fr25au08-5]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16, 610, 640, 812, 814, 822, and 860

[Docket No. FDA-2008-N-0423]

FDA Regulations; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending a
regulatory hearing process regulation to correct an inaccurate
citation, and regulations pertaining to biological products to correct
two typographical errors. FDA is also amending certain medical device
regulations to include references to and mailing address information
for the Center for Biologics Evaluation and Research (CBER), Center for
Drug Evaluation and Research (CDER), and Center for Devices and
Radiological Health (CDRH). This action is being taken to ensure the
accuracy of FDA's regulations.

DATES: This rule is effective August 25, 2008.

FOR FURTHER INFORMATION CONTACT: Denise S[aacute]nchez, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is amending 21 CFR 16.1 to correct an inaccurate citation and
is amending 21 CFR 610.51 and 21 CFR 640.53 to correct typographical
errors.
    FDA is also amending its medical device regulations in 21 CFR 812,
814, and 860 to include references to and mailing addresses for CBER
and CDER, and 21 CFR 822.8 to correct an inadvertent omission of the
mailing address for CDRH. Submissions regarding a medical device must
be sent to the address of the appropriate center that has regulatory
responsibility for the medical device. Therefore, FDA is updating these
regulations to include address information for all appropriate centers.
    Publication of this document constitutes final action under the
Administrative Procedures Act (5 U.S.C. 553). FDA has determined that
notice and public comment are unnecessary because this amendment to the
regulations provides only technical changes to correct an inaccurate
citation and typographical errors, and to update mailing addresses and
other information, and is nonsubstantive.

List of Subjects

21 CFR Part 16

    Administrative practice and procedure.

21 CFR Part 610

    Biologics, Labeling, Reporting and recordkeeping requirements.

21 CFR Part 640

    Blood, Labeling, Reporting and recordkeeping requirements.

21 CFR Part 812

    Health records, Medical devices, Medical research, Reporting and
recordkeeping requirements.

21 CFR Part 814

    Administrative practice and procedure, Confidential business
information, Medical devices, Medical research, Reporting and
recordkeeping requirements.

21 CFR Part 822

    Medical devices, Reporting and recordkeeping requirements.

21 CFR Part 860

    Administrative practice and procedure, Medical devices.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act, and Public
Health Service Act, and under authority delegated to the Commissioner
of Food and Drugs, 21 CFR parts 16, 610, 640, 812, 814, 822, and 860
are amended as follows:

PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

0
1. The authority citation for 21 CFR part 16 continues to read as
follows:

    Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394,
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.

Sec.  16.1  [Amended]

0
2. Section 16.1 is amended in paragraph (b)(2), by removing ``Sec.
1270.15(e)'' and adding in its place ``Sec.  1270.43(e)''.

PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS

0
3. The authority citation for 21 CFR part 610 continues to read as
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c,
360d, 360h, 360i, 371, 372, 374, 381; 42 U.S.C. 216, 262, 263, 263a,
264.

Sec.  610.53  [Amended]

0
4. Section 610.53 is amended in paragraph (c) in the table, under
column A, by removing the words ``Cryoprecipitated AFH'' and adding in
their place ``Cryoprecipitated AHF.''

PART 640--ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS

0
5. The authority citation for 21 CFR part 640 continues to read as
follows:

    Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371; 42
U.S.C. 216, 262, 263, 263a, 264.

Sec.  640.51  [Amended]

0
6. Section 640.51 is amended in paragraph (b) by removing the word
``Plasmaphersis'' and adding in its place ``Plasmapheresis.''

PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS

0
7. The authority citation for 21 CFR part 812 continues to read as
follows:

    Authority: 21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f,
360h-360j, 371, 372, 374, 379e, 381, 382, 383; 42 U.S.C. 216, 241,
262, 263b-263n.

0
8. Section 812.20 is amended by revising paragraph (d) to read as
follows:

Sec.  812.20  Application.

* * * * *
    (d) Information previously submitted. Information previously
submitted to the Center for Devices and Radiological Health, the Center
for Biologics Evaluation and Research, or the Center for Drug
Evaluation and Research, as applicable, in accordance with this chapter
ordinarily need not be resubmitted, but may be incorporated by
reference.

PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES

0
9. The authority citation for 21 CFR part 814 continues to read as
follows:

    Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372,
373, 374, 375, 379, 379e, 381.

0
10. Section 814.42 is amended by revising the fourth sentence of
paragraph (d)(2) to read as follows:

Sec.  814.42  Filing a PMA.

* * * * *
    (d) * * *
    (2) * * * If FDA does not reverse its decision not to file the PMA,
the applicant may request reconsideration of the decision from the
Director of the Center for Devices and Radiological Health, the
Director of the Center for Biologics Evaluation and Research, or the
Director of the Center for Drug Evaluation and Research, as applicable.
* * *
* * * * *

0
11. Section 814.100 is amended by revising paragraph (c)(2) to read as
follows:

Sec.  814.100  Purpose and scope.

* * * * *
    (c) * * *
    (2) Submitting an HDE to the Office of Device Evaluation (ODE),
Center for Devices and Radiological Health (CDRH), the Center for
Biologics Evaluation and Research (CBER), or the Center for Drug
Evaluation and Research (CDER), as applicable.
* * * * *

0
12. Section 814.104 is amended by revising paragraph (d) to read as
follows:

Sec.  814.104  Original applications.

* * * * *
    (d) Address for submissions and correspondence. Copies of all
original HDEs amendments and supplements, as well as any correspondence
relating to an HDE, must be sent or delivered to the following:
    (1) For devices regulated by the Center for Devices and
Radiological Health, send this information to the Document Mail Center
(HFZ-401), Office of Device Evaluation, Center for Devices and
Radiological Health, Food and Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850.
    (2) For devices regulated by the Center for Biologics Evaluation
and Research, send this information to the Document Control Center
(HFM-99), Center for Biologics Evaluation and Research, Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448.
    (3) For devices regulated by the Center for Drug Evaluation and
Research, send this information to the Central Document Control Room,
Center for Drug Evaluation and Research, Food and Drug Administration,
5901-B Ammendale Rd., Beltsville, MD 20705-1266.

PART 822--POSTMARKET SURVEILLANCE

0
13. The authority citation for 21 CFR part 822 continues to read as
follows:

    Authority: 21 U.S.C. 331, 352, 360i, 360l, 371, 374.

0
14. Section 822.8 is amended by adding a sentence after the first
sentence to read as follows:

Sec.  822.8  When, where, and how must I submit my postmarket
surveillance plan?

    * * * For devices regulated by the Center for Devices and
Radiological Health, send three copies of your submission to the
Postmarket Surveillance Document Center (HFZ-541), Epidemiology Branch,
Center for Devices and Radiological Health, Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850-3229. * * *

PART 860--MEDICAL DEVICE CLASSIFICATION PROCEDURES

0
15. The authority citation for 21 CFR part 860 continues to read as
follows:

    Authority: 21 U.S.C. 360c, 360d, 360e, 360i, 360j, 371, 374.

0
16. Section 860.7 is amended by revising paragraph (g)(4) to read as
follows:

Sec.  860.7  Determination of safety and effectiveness.

* * * * *
    (g) * * *
    (4) Required information that has been submitted previously to the
Center for Devices and Radiological Health, the Center for Biologics
Evaluation and Research, or the Center for Drug Evaluation and
Research, as applicable, need not be resubmitted, but may be
incorporated by reference.

0
17. Section 860.123 is amended by revising paragraph (b)(1) to read as
follows:

Sec.  860.123  Reclassification petition: Content and form.

* * * * *
    (b) * * *
    (1) For devices regulated by the Center for Devices and
Radiological Health, addressed to the Food and Drug Administration,
Center for Devices and Radiological Health, Regulations Staff

(HFZ-215), 1350 Piccard Dr., Rockville, MD 20857; for devices regulated
by the Center for Biologics Evaluation and Research, addressed to the
Document Control Center (HFM-99), Center for Biologics Evaluation and
Research, Food and Drug Administration, 1401 Rockville Pike, suite
200N, Rockville, MD 20852-1448; for devices regulated by the Center for
Drug Evaluation and Research, addressed to the Central Document Control
Room, Center for Drug Evaluation and Research, Food and Drug
Administration, 5901-B Ammendale Rd., Beltsville, MD 20705-1266, as
applicable.
* * * * *

    Dated: August 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-19654 Filed 8-22-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register: June 30, 2008 (Volume 73, Number 126)]
[Notices]
[Page 36885-36886]
[DOCID:fr30jn08-95]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1768-DR]

Wisconsin; Amendment No. 3 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Wisconsin (FEMA-1768-DR), dated June 14, 2008, and
related determinations.

EFFECTIVE DATE: June 19, 2008.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Wisconsin is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the catastrophe declared a major disaster by the President in his
declaration of June 14, 2008.

    Fond du Lac, Iowa, and Marquette Counties for Individual
Assistance.

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

R. David Paulison,
Administrator, Federal Emergency Management Agency.
[FR Doc. E8-14746 Filed 6-27-08; 8:45 am]

BILLING CODE 9110-10-P


[Federal Register Volume 84, Number 32 (Friday, February 15, 2019)]
[Notices]
[Pages 4594-4597]
[FR Doc No: 2019-02450]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85090; File No. PCAOB-2019-01]

Public Company Accounting Oversight Board; Notice of Filing of
and Immediate Effectiveness of Proposed Bylaw and Rule Amendments To
Provide That the Board's Appointment and Removal of Hearing Officers
Are Subject to Commission Approval

February 11, 2019.
    Pursuant to Section 107(b) of the Sarbanes-Oxley Act of 2002 (the
``Act''), 15 U.S.C. 7217(b), notice is hereby given that on January 29,
2019, the Public Company Accounting Oversight Board (the ``Board'' or
the ``PCAOB'') filed with the Securities and Exchange Commission (the
``SEC'' or the ``Commission'') the proposed amendments described in
items I and II below, which items have been prepared by the Board. The
Commission is publishing this notice to solicit comments on the
proposed amendments from interested persons.

I. Board's Statement of the Terms of Substance of the Proposed
Amendments

    On December 20, 2018, the Board adopted amendments to its bylaws
and rules (collectively, the ``proposed amendments'') to provide that
the PCAOB's appointment and removal of PCAOB hearing officers are
subject to Commission approval and to make related clarifying and
conforming changes to the PCAOB's rules. Specifically, the Board is
amending Article VI of its bylaws and PCAOB Rules 1001(h)(i), 5200, and
5402. The proposed amendments are concerned

solely with the administration of the PCAOB in that they relate to the
employment relationship between the Board and its hearing officers, its
interaction with the Commission in the Commission's performance of
oversight of the PCAOB, and the clarification of the delegations of
authority by the Board to PCAOB hearing officers.
    The text of the proposed amendments appears in the Board's SEC Form
19b-4 filing and is available on the Board's website at https://pcaobus.org/Rulemaking/Pages/Docket045 and at the Commission's Public
Reference Room.

II. Board's Statement of the Purpose of, and Statutory Basis for, the
Proposed Amendments

    In its filing with the Commission, the Board included statements
concerning the purpose of, and basis for, the proposed amendments and
stated that the amendments are concerned solely with the administration
of the PCAOB. The text of these statements may be examined at the
places specified in Item IV below. The Board has prepared summaries,
set forth in sections A, B, and C below, of the most significant
aspects of such statements.

A. Board's Statement of the Purpose of, and Statutory Basis for, the
Proposed Amendments

1. Purpose
    The Board's duties under the Act include acting on registration
applications of public accounting firms that prepare audit reports for
issuers, brokers, or dealers,\1\ and conducting disciplinary
proceedings concerning, and imposing appropriate sanctions where
justified upon, registered public accounting firms and their associated
persons.\2\ In carrying out these duties, the Board may direct that a
PCAOB hearing officer preside over a disciplinary or other
proceeding.\3\ The Board's authority to do so derives from Section
101(f)(4) of the Act, permitting the Board, subject to Commission
oversight under Section 107 of the Act, ``to appoint such employees,
accountants, attorneys, and other agents as may be necessary or
appropriate, and to determine their qualifications, define their
duties, and fix their salaries or other compensation.'' Section
101(g)(2) of the Act further authorizes that ``[t]he rules of the Board
shall, subject to the approval of the Commission . . . permit, as the
Board determines necessary and appropriate, delegation by the Board of
any of its functions to an . . . employee of the Board, . . . including
functions with respect to hearing, determining, ordering, certifying,
reporting, or otherwise acting as to any matter.'' In 2004, the
Commission approved the Board's proposed rules relating to
investigations and adjudications, authorizing creation of the PCAOB's
hearing officer position.\4\
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    \1\ The PCAOB has oversight authority with respect to audits of
brokers and dealers that are registered with the SEC. See Sections
110(3) and (4) of the Act, 15 U.S.C. 7220(3) and (4).
    \2\ See, e.g., Sections 101(c)(1) & (4), 102(c), 105(a) &
(c)(1)-(3) of the Act, 15 U.S.C. 7211(c)(1) & (4), 7212(c), 7215(a)
& (c)(1)-(3).
    \3\ See, e.g., Sections 101(f)(4) and 101(g)(2) of the Act, 15
U.S.C. 7211(f)(4) & (g)(2); PCAOB Rules 5200 (Commencement of
Disciplinary Proceedings), 5500 (Commencement of Hearing on
Disapproval of a Registration Application).
    \4\ See Order Approving Proposed Rules Relating to
Investigations and Adjudications, SEC Rel. No. 34-49704, 2004 WL
1439833 (May 14, 2004).
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    On June 21, 2018, the U.S. Supreme Court held in Lucia v. SEC that
SEC Administrative Law Judges (ALJs) are inferior officers under the
Appointments Clause of the U.S. Constitution and that accordingly SEC
ALJs are required to be appointed by ``the President, a court of law,
or a head of department,'' such as the Commission.\5\ Since the Lucia
decision, the Commission has taken various actions, including issuance
of an order reiterating its November 30, 2017 approval of the prior
appointments of its ALJs by its staff as the Commission's own under the
Constitution.\6\ In light of the Lucia litigation, other federal
government agencies have taken similar measures as to their ALJs or
like officials, also out of an abundance of caution and for avoidance
of doubt.\7\
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    \5\ 138 S. Ct. 2044, 2050-51 (2018).
    \6\ See In re Pending Administrative Proceedings, SEC Rel. No.
34-83907, 2018 WL 4003609, *1 (Aug. 22, 2018).
    \7\ See, e.g., USITC, The Appointment of the Commission's
Administrative Law Judges for Section 337 Investigations, 83 FR
45,678-01 (Sept. 10, 2018); FMSHRC, Ratification Notice (Apr. 3,
2018), available at www.fmshrc.gov/about/news/ commission-
ratification-notice; FDIC, Resolution of Board of Directors (July
19, 2018), available at https://www.fdic.gov/news/board/2018-07-19-085152.pdf; CFTC, Ratification and Reconsideration Order, In re
Pending Administrative Proceedings, 2018 WL 1966116 (Apr. 6, 2018);
Letter from Sec'y R. Alexander Acosta, Dep't of Labor, to Hon. Paul
R. Almanza, Admin. Law Judge, Dep't of Labor (Dec. 21, 2017),
available at https://www.oalj.dol.gov/PUBLIC/FOIA/Frequently_Requested_Records/ALJ_Appointments/Secretarys_Ratification_of_ALJ_Appointments_12_21_2017.pdf; FTC,
P130500 Federal Trade Commission Minute: Ratification of Appointment
of Administrative Law Judge and Chief Administrative Law Judge
(Sept. 11, 2015), attached as Ex. A to FTC, Order Denying Respondent
LabMD, Inc.'s Motion to Dismiss, In re LabMD Inc., No. 9357 (Sept.
14, 2015), available at https://www.ftc.gov/system/files/documents/cases/150914labmdmotion.pdf.
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    The Lucia case did not involve a challenge to PCAOB hearing
officers, only to SEC ALJs. Nor has any court, the Commission, or the
Board adjudicated whether a PCAOB hearing officer is, like an SEC ALJ,
an inferior officer under the Appointments Clause.\8\ Indeed, there are
a number of differences between the position of an SEC ALJ and the
position of a PCAOB hearing officer.\9\
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    \8\ An attempt was made to challenge the constitutionality of a
PCAOB hearing officer's appointment in Kabani v. SEC, but the court
held that the argument had not been timely raised and was forfeited.
733 F. App'x 918, 2018 WL 3828524, *1 (9th Cir. Aug. 13, 2018).
    \9\ For example, an SEC ALJ may administer oaths and
affirmations; issue, revoke, quash, or modify subpoenas; issue
protective orders; and punish contemptuous conduct; a PCAOB hearing
officer does not have that authority. Compare 17 CFR 200.14(a)(1) &
(2), 200.111(b), 180(a), 232(e), 322 with PCAOB Rules 5103, 5105,
5200(b)(1), 5424.
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    Nevertheless, out of an abundance of caution and to eliminate any
uncertainty about the status of PCAOB hearing officers that might
distract from the PCAOB's mission, including its important registration
and disciplinary functions, the Board is adopting certain amendments to
its bylaws and rules. These amendments modify the PCAOB's processes to
appoint and remove its hearing officers to provide that such
appointments and removals shall be subject to the approval of the
Commission, a head of department under the Appointments Clause.
    The amendments to Article VI of the Board's bylaws and PCAOB Rule
1001(h)(i), the language of which rule is changed to cross-reference
the bylaw amendment, specify that the PCAOB's appointment and removal
of any PCAOB hearing officer are subject to Commission approval. These
changes are consistent with the Commission's broad authority to oversee
the Board under Section 107 of the Act, see Sections 101(c) & (f) and
107 of the Act, 15 U.S.C. 7211(c) & (f), 7217, and the Commission's
authority to ``appoint . . . officers, attorneys, economists,
examiners, and other employees'' under Section 4(b) of the Securities
Exchange Act of 1934 (``Exchange Act''), 15 U.S.C. 78d(b).
    As contemplated by these amendments, when the PCAOB's Governing
Board, as defined by the bylaws,\10\ has reached a decision on the
appointment or removal of any PCAOB hearing officer, that decision
shall be

submitted to the Commission for consideration. The proposed appointment
or removal of a hearing officer by the PCAOB cannot be effectuated
until Commission approval has been given. The Commission's approval of
a PCAOB hearing officer's appointment will result in the hearing
officer being appointed in the manner of an inferior officer for
purposes of the Appointments Clause.\11\
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    \10\ See Articles IV and VI of the PCAOB's bylaws (stating that
``[t]he Governing Board shall consist of those persons appointed
thereto by the Securities and Exchange Commission, pursuant to
Section 101 of the Act'' and that ``[t]he Chairman of the Governing
Board . . . shall also be the President and Chief Executive Officer
of the Corporation''). In Free Enterprise Fund v. PCAOB, 561 U.S.
477, 510 (2010), the Supreme Court held that PCAOB Governing Board
members are inferior officers under the Appointments Clause.
    \11\ See Free Enterprise Fund, 561 U.S. at 512 n.13 (noting
examples of precedents in which ``[w]e have previously found that
the department head's approval [of the appointment of personnel]
satisfies the Appointments Clause'').
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    The Board is also adopting certain clarifying and conforming
amendments to its adjudications rules in light of the rule changes
discussed above. Specifically, the Board is adding a new subsection to
Rule 5200 to summarize the framework within which the hearing officer
functions under the Act and the Board's rules. That new subsection
explains that all proceedings shall be presided over by the Board,
which is the entity empowered to act on registration applications and
to conduct disciplinary proceedings.\12\ Alternatively, the Board may
order that the proceedings be conducted in the first instance by a
hearing officer to whom the Board has, under certain conditions,
delegated adjudicatory responsibilities.\13\ The new subsection makes
even more explicit the manner in which current PCAOB rules, such as
Rules 5200(b)(10), 5201(d)(2), 5204(b), and 5445, situate the hearing
officer within PCAOB adjudication processes.\14\
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    \12\ See, e.g., Sections 101(c)(1) & (4) of the Act, 15 U.S.C.
7211(c)(1) & (4) (``the Board shall . . . register public accounting
firms . . . [and] conduct . . . disciplinary proceedings . . .'')
(emphasis added).
    \13\ See Section 101(g)(2) of the Act, 15 U.S.C. 7211(g)(2)
(permitting, under specified conditions, ``delegation by the Board
of any of its functions to an . . . employee of the Board . . . ,
including functions with respect to hearing, determining, ordering,
certifying, reporting, or otherwise acting as to any matter'').
    \14\ The provision is also analogous to SEC Rule of Practice
110, 17 CFR 201.110.
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    Additionally, the amendments make clarifying and conforming edits
to the heading of current PCAOB Rule 5200(b) and to the heading and
text of PCAOB Rule 5402(b). Specifically, the words ``appointment'' and
``appoint'' in these current rules are replaced with ``assignment'' and
``assign,'' and current Rule 5200(b) is renumbered Rule 5200(c) and
cross-referenced to new Rule 5200(b). These changes avoid any confusion
between the actions of the Board and the Commission in appointing, and
approving the appointment of, a hearing officer, and the PCAOB
Secretary's ministerial act of assigning a specific hearing officer to
a specific proceeding pursuant to a Board order.
    The above-described, targeted amendments seek to dispel any legal
uncertainty arising from Lucia about the PCAOB hearing officer, who, as
noted, may be tasked with presiding over a disciplinary or other
proceeding. This will facilitate and make more efficient the Board's
performance of its duties under the Act to take ``[a]ction on
[a]pplications'' for the ``regist[ration] [of] public accounting firms
that prepare audit reports for issuers, brokers, and dealers''; to
``conduct . . . disciplinary proceedings concerning, and impose
appropriate sanctions where justified upon, registered public
accounting firms and associated persons of such firms''; and to
``enforce compliance with th[e] Act, the rules of the Board,
professional standards, and the securities laws relating to the
preparation and issuance of audit reports and the obligations and
liabilities of accountants with respect thereto, by registered public
accounting firms and associated persons thereof.'' \15\ These functions
are part of the Board's responsibility ``to oversee the audit of
companies that are subject to the securities laws, and related matters,
in order to protect the interests of investors and further the public
interest in the preparation of informative, accurate, and independent
audit reports.'' \16\
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    \15\ See, e.g., Sections 101(c)(1), (4) & (6), 102(c), 105(a) &
(c)(1)-(3) of the Act, 15 U.S.C. 7211(c)(1), (4) & (6), 7212(c),
7215(a) & (c)(1)-(3).
    \16\ See Section 101(a) of the Act, 15 U.S.C. 7211(a).
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    Moreover, additional benefits will flow from the amendments because
the Appointments Clause serves an important public purpose. The Supreme
Court has described the Clause's requirements as ``among the
significant structural safeguards of the constitutional scheme,''
``designed to preserve political accountability relative to important
government assignments.'' \17\ The Board has chosen to remedy the
uncertainty caused by Lucia by conforming the appointment and removal
of its hearing officers to those requirements. Thus, the Appointments
Clause's benefits and protections are explicitly extended to
respondents in PCAOB proceedings, and to the public more broadly.
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    \17\ Edmond v. United States, 520 U.S. 651, 659, 663 (1997).
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2. Statutory Basis
    The statutory basis for the proposed amendments is Title I of the
Act. Specifically, Section 101(f)(2) of the Act empowers the Board,
subject to Commission oversight under Section 107 of the Act, ``to
conduct its operations and maintain offices, and to exercise all other
rights and powers authorized by this Act.'' Section 101(f)(4), as
discussed, empowers the Board, subject to Commission oversight under
Section 107 of the Act, to appoint personnel. Section 101(g)(1) directs
the Board, ``subject to the approval of the Commission . . . [to]
provide for the operation and administration of the Board, the exercise
of its authority, and the performance of its responsibilities under
th[e] Act.'' And Section 101(g)(2), as discussed, permits the Board,
``subject to the approval of the Commission,'' to delegate its hearing
functions within the PCAOB. Furthermore, the amendments directly relate
to statutory duties of the Board and purposes for its establishment
that are discussed above.

B. Board's Statement on Burden on Competition

    Not applicable. The proposed amendments are concerned solely with
the administration of the PCAOB, as discussed in Item I above.

C. Board's Statement on Comments on the Proposed Amendments Received
From Members, Participants or Others

    Written comments were neither solicited nor received. The proposed
amendments are concerned solely with the administration of the PCAOB,
as discussed in Item I above.

III. Date of Effectiveness of the Proposed Amendments and Timing for
Commission

    The foregoing proposed amendments have become effective pursuant to
Section 19(b)(3)(A) of the Securities Exchange Act of 1934 \18\ and
paragraph (f)(3) of Rule 19b-4 thereunder.\19\ At any time within 60
days of the filing of the proposed amendments, the Commission summarily
may temporarily suspend such amendments 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
Act.
---------------------------------------------------------------------------

    \18\ 15 U.S.C. 78s(b)(3)(A).
    \19\ 17 CFR 240.19b-4(f)(3).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed
amendments are consistent with the requirements of Title I of 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/pcaob.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
PCAOB-2019-01 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 PCAOB-2019-01. This file number should
be included on the subject line if email is used. To help the
Commission process and review your comments more efficiently, please
use only one method. The Commission will post all comments on the
Commission's internet website (http://www.sec.gov/rules/pcaob.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed amendments that are filed with
the Commission, and all written communications relating to the proposed
amendments between the Commission and any person, other than those that
may be withheld from the public in accordance with the provisions of 5
U.S.C. 552, will be available for website viewing and printing in the
Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549-1090, 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 PCAOB. All
comments received will be posted without change. Persons submitting
comments are cautioned that we do not redact or edit personal
identifying information from comment submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to PCAOB-2019-01 and should be submitted on or
before March 8, 2019.

    For the Commission, by the Office of the Chief Accountant,
pursuant to delegated authority.\20\
---------------------------------------------------------------------------

    \20\ 17 CFR 200.30-11(b)(2).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-02450 Filed 2-14-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 53 (Thursday, March 19, 2015)]
[Notices]
[Pages 14419-14421]
[FR Doc No: 2015-06263]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74505; File No. SR-ISEGemini-2015-06]

Self-Regulatory Organizations; ISE Gemini, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend the
Schedule of Fees

March 13, 2015.
    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 March 2, 2015, ISE Gemini, LLC (the ``Exchange'' or ``ISE
Gemini'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change, as described in Items I, II,
and III below, which items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    ISE Gemini proposes to amend the Schedule of Fees as described in
more detail below. The text of the proposed rule change is available on
the Exchange's Internet Web site at http://www.ise.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 self-regulatory organization has prepared summaries,
set forth in Sections A, B and C below, of the most significant aspects
of such statements.

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

1. Purpose
    The Exchange proposes to amend the Schedule of Fees to increase
Priority Customer \3\ rebates in Penny Symbols \4\ and SPY as well as
related fees for non-Priority Customer orders trading against Priority
Customer orders in these symbols.
---------------------------------------------------------------------------

    \3\ A ``Priority Customer'' is a person or entity that is not a
broker/dealer in securities, and does not place more than 390 orders
in listed options per day on average during a calendar month for its
own beneficial account(s), as defined in Rule 100(a)(37A).
    \4\ ``Penny Symbols'' are options overlying all symbols listed
on ISE Gemini that are in the Penny Pilot Program.
---------------------------------------------------------------------------

    Currently, Priority Customer orders that add liquidity on ISE
Gemini are provided a maker rebate in Penny Symbols and SPY of $0.25
per contract for Tier 1,\5\ $0.40 per contract for Tier 2, $0.46 per
contract for Tier 3, $0.48 per contract for Tier 4, and $0.50 per
contract for Tier 5. In order to incentivize members to bring their
Priority Customer orders to ISE Gemini, the Exchange now proposes to
provide higher maker rebates to members that achieve Tier 3 or higher.
In particular, the Exchange proposes to increase the

Priority Customer rebate in Penny Symbols and SPY to $0.48 per contract
for Tier 3, $0.50 per contract for Tier 4, and $0.52 per contract for
Tier 5.
---------------------------------------------------------------------------

    \5\ This rebate is $0.32 per contract for members that execute a
Priority Customer Maker ADV of 5,000 to 19,999 contracts in a given
month.
---------------------------------------------------------------------------

    Market Maker,\6\ Non-ISE Gemini Market Maker,\7\ Firm Proprietary
\8\/Broker-Dealer,\9\ and Professional Customer \10\ (i.e. non-Priority
Customer) orders currently pay a taker fee of $0.49 per contract,
subject to a discount to $0.48 per contract for Market Makers that
achieve the highest tier. In connection with the increased Priority
Customer rebates described above, the Exchange further proposes to
charge non-Priority Customer orders a taker fee of $0.50 per contract
when trading against a Priority Customer order.\11\
---------------------------------------------------------------------------

    \6\ The term Market Maker refers to ``Competitive Market
Makers'' and ``Primary Market Makers'' collectively. See Rule
100(a)(25).
    \7\ A ``Non-ISE Gemini Market Maker'' is a market maker as
defined in Section 3(a)(38) of the Securities Exchange Act of 1934,
as amended, registered in the same options class on another options
exchange.
    \8\ A ``Firm Proprietary'' order is an order submitted by a
member for its own proprietary account.
    \9\ A ``Broker-Dealer'' order is an order submitted by a member
for a broker-dealer account that is not its own proprietary account.
    \10\ A ``Professional Customer'' is a person or entity that is
not a broker/dealer and is not a Priority Customer.
    \11\ The Exchange notes that there will be no Tier 5 Market
Maker discount when trading against a Priority Customer.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Act,\12\ in general, and
Section 6(b)(4) of the Act,\13\ in particular, in that it is designed
to provide for the equitable allocation of reasonable dues, fees, and
other charges among its members and other persons using its facilities.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f.
    \13\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Exchange believes that it is reasonable and equitable to
increase the rebates offered to Priority Customer orders in Penny
Symbols and SPY, as the proposed change is designed to attract
additional Priority Customer volume to the Exchange. The Exchange
already provides enhanced rebates for Priority Customer orders, and
believes that further increasing the rebates will incentivize members
to send additional Priority Customer order flow to ISE Gemini, creating
additional liquidity to the benefit of all members that trade on the
Exchange. The Exchange further believes that it is reasonable and
equitable to increase the fee charged to non-Priority Customers that
trade against a Priority Customer order as this change is designed to
offset the enhanced rebates offered to incentivize the other side of
the trade. As explained above, the Exchange believes that all members
will benefit from the additional liquidity created by the higher
Priority Customer rebates. Furthermore, the proposed taker fee for non-
Priority Customer orders trading against a Priority Customer is within
the range of fees charged by other options exchanges, including the BOX
Options Exchange (``BOX''), which charges as much as $0.59 per contract
for non-customer orders in penny pilot symbols that trade against a
public customer.\14\
---------------------------------------------------------------------------

    \14\ See BOX Fee Schedule, Section 1, Exchange Fees, A. Non-
Auction Transactions.
---------------------------------------------------------------------------

    In addition, while the Exchange is increasing Priority Customer
rebates as well as corresponding fees for non-Priority Customers
trading against Priority Customer orders, the Exchange does not believe
that these proposed changes are unfairly discriminatory. As has
historically been the case, Priority Customer orders remain entitled to
more favorable fees and rebates than other market participants in order
to encourage this order flow. A Priority Customer is by definition not
a broker or dealer in securities, and does not place more than 390
orders in listed options per day on average during a calendar month for
its own beneficial account(s). This limitation does not apply to
participants whose behavior is substantially similar to that of market
professionals, including Professional Customers, who will generally
submit a higher number of orders (many of which do not result in
executions) than Priority Customers.

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

    In accordance with Section 6(b)(8) of the Act,\15\ the Exchange
does not believe that the proposed rule change will impose any burden
on intermarket or intramarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act. The proposed
changes to fees and rebates in Penny Symbols and SPY are designed to
attract additional order flow to the Exchange. The Exchange believes
that the proposed fees and rebates are competitive with fees and
rebates offered to orders executed on other options exchanges. The
Exchange operates in a highly competitive market in which market
participants can readily direct their order flow to competing venues.
In such an environment, the Exchange must continually review, and
consider adjusting, its fees and rebates to remain competitive with
other exchanges. For the reasons described above, the Exchange believes
that the proposed fee changes reflect this competitive environment.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78f(b)(8).
---------------------------------------------------------------------------

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act,\16\ and subparagraph (f)(2) of Rule 19b-4
thereunder,\17\ because it establishes a due, fee, or other charge
imposed by ISE Gemini.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \17\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    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 to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-ISEGemini-2015-06 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-ISEGemini-2015-06. 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 also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-ISEGemini-2015-06, and should be submitted on or before
April 9, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
---------------------------------------------------------------------------

    \18\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2015-06263 Filed 3-18-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 28 (Friday, February 10, 2023)]
[Rules and Regulations]
[Pages 8771-8773]
[FR Doc No: 2023-02648]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2022-0155; FRL-10503-02-R4]

Air Plan Approval; Tennessee; Packaging Corporation of America
Nitrogen Oxides SIP Call Alternative Monitoring

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is conditionally
approving revisions to the Tennessee State Implementation Plan (SIP)
submitted by the State of Tennessee, through the Tennessee Department
of Environment and Conservation (TDEC), through a letter dated June 29,
2021. This revision establishes alternative monitoring, recordkeeping,
and reporting requirements under the Nitrogen Oxides (NOX)
SIP Call. EPA is finalizing action to conditionally approve these
changes pursuant to the Clean Air Act (CAA or Act).

DATES: This rule is effective March 13, 2023.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2022-0155. All documents in the docket
are listed on the regulations.gov website. Although listed in the
index, some information may not be publicly available, i.e.,
Confidential Business Information 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 either electronically through www.regulations.gov or in hard
copy at the Air Regulatory Management Section, Air Planning and
Implementation Branch, Air and Radiation Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia
30303-8960. EPA requests that, if at all possible, you contact the
person listed in the FOR FURTHER INFORMATION CONTACT section to
schedule your inspection. The Regional Office's official hours of
business are Monday through Friday 8:30 a.m. to 4:30 p.m., excluding
Federal holidays.

FOR FURTHER INFORMATION CONTACT: Steven Scofield, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air and
Radiation Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street SW, Atlanta, Georgia 30303-8960. The telephone number is
(404) 562-9034. Mr. Scofield can also be reached via electronic mail at
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Packaging Company of America (PCA) petitioned TDEC to adopt revised
permit conditions applicable to PCA's Highway 57, Counce, Tennessee
facility (PCA Counce Mill) with an alternative monitoring option for
this large non-EGU, along with corresponding revised recordkeeping and
reporting conditions. This petition resulted in the issuance of the
permit for PCA Counce Mill included as part of TDEC's SIP submittal.
The changes allow PCA Counce Mill to address the NOX SIP
Call's requirements for enforceable limits on ozone season
NOX mass emissions through non-Part 75 alternative
monitoring and reporting methodologies. The June 29, 2021, source-
specific SIP revision submitted by TDEC contains the permit provisions
that TDEC modified to specifically address the alternative monitoring
provisions allowed under the NOX SIP Call. TDEC requests
conditional approval of those provisions into the SIP.
    Through a notice of proposed rulemaking (NPRM) published on
December 23, 2022 (87 FR 78892), EPA proposed to conditionally approve
the June 10, 2021, changes to Tennessee Air Pollution Control Board
operating permit No. 078563 contained in TDEC's June 29, 2021
submittal. TDEC requests that this approval be conditioned on
Tennessee's commitment to modify the provisions at Tennessee Air
Pollution Control Regulation (TAPCR) 1200-03-27.12(11) to specify
allowable non-Part 75 permissible alternative monitoring and reporting
methodologies for large industrial non-EGUs subject to the
NOX SIP Call, such as the alternative monitoring and
reporting provisions in permit No. 078563. The details of Tennessee's
submission, as well as the background and EPA's rationale for
conditionally approving the changes, are described in more detail in
the December 23, 2022, NPRM. Comments on the December 23, 2022, NPRM
were due on or before January 23, 2023. No comments were received on
the December 23, 2022, NPRM, adverse or otherwise.

II. Incorporation by Reference

    In this document, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, and as discussed in Section III of this preamble, EPA is
finalizing the incorporation by reference of Tennessee Air Pollution
Control Board operating permit No. 078563 for PCA Counce Mill, state
effective on June 10, 2021, into the Tennessee SIP. EPA has made, and
will continue to make, these materials generally available through
www.regulations.gov and at the EPA Region 4 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 SIP, 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\ See 62 FR 27968 (May 22, 1997).
---------------------------------------------------------------------------

III. Final Action

    EPA is taking final action to conditionally approve Tennessee Air
Pollution Control Board operating permit No. 078563 for PCA Counce
Mill, state effective June 10, 2021, for incorporation into the
Tennessee SIP. These changes were submitted by Tennessee on June 29,
2021. As discussed in more detail in the December 23, 2022 NPRM, these
changes to Tennessee's SIP are approved subject to the condition that
Tennessee meets its commitment to submit a SIP revision modifying the
provisions of TAPCR 1200-03-27.12(11) to specify permissible non-Part
75 alternative monitoring and reporting methodologies, as allowed under
40 CFR 51.121(i)(1) and (4), by 12 months from the date of this final
approval. If the State fails to submit this revision on or before 12
months from the date of final approval of this action, the conditional
approval will become a disapproval pursuant to CAA section 110(k)(4).

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. See 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. This action merely
conditionally 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);
     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 CAA; 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).
    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 as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it impose substantial direct
costs on tribal governments or preempt tribal law.
    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 CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by April 11, 2023. 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) of the CAA.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Reporting and
recordkeeping requirements.

    Dated: February 2, 2023.
Daniel Blackman,
Regional Administrator, Region 4.

    For the reasons stated in the preamble, EPA amends 40 CFR part 52
as follows:

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 RR--Tennessee

0
2. Section 52.2219 is added to read as follows:

Sec.  52.2219  Conditional approval.

    (a) Tennessee submitted a source-specific SIP revision to EPA on
June 29, 2021, regarding the Packaging Company of America's Highway 57,
Counce, Tennessee facility, along with a commitment to modify the
provisions at Tennessee Air Pollution Control Regulation 1200-03-
27.12(11) to specify allowable non-Part 75 permissible alternative
monitoring and reporting methodologies for large industrial non-EGUs
subject to the NOX SIP Call. EPA conditionally approved the
June 29, 2021, SIP revision in an action published in the Federal
Register on February 10, 2023. If Tennessee fails to meet its
commitment by February 12, 2024, the conditional approval will become a
disapproval on February 12, 2024.
    (b) [Reserved]

0
3. In Sec.  52.2220(d), amend the table by adding an entry for
``Packaging Corporation of America--Counce Mill'' at the end of the
table to read as follows:

Sec.  52.2220  Identification of plan.

* * * * *
    (d) * * *

                               EPA-Approved Tennessee Source-Specific Requirements
----------------------------------------------------------------------------------------------------------------
                                                   State
       Name of source           Permit No.    effective date     EPA approval date            Explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
    Packaging Corporation of          078563       6/10/2021  2/10/2023, [Insert      Conditional approval based
         America--Counce Mill                                  citation of             on TDEC's commitment to
                                                               publication].           modify the provisions at
                                                                                TAPCR 1200-03-27.12(11)
                                                                                to specify allowable non-
                                                                                Part 75 permissible
                                                                                alternative monitoring
                                                                                and reporting
                                                                                methodologies for large
                                                                                industrial non-EGUs
                                                                                subject to the NOX SIP
                                                                                Call.
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2023-02648 Filed 2-9-23; 8:45 am]
BILLING CODE 6560-50-P


% Food exposure
% Once daily oral exposure, dose from cpfs SS F13_49 foodonly exp distribution.csv 30th percentile
% Female adult, Body weight set to 72.9 kg
% Cecilia Tan
% August 24, 2015

prepare @clear @all
% Setting model parameters
start @NoCallback
use human_parameters_MRP
use preg_female_parameters

BWSW=1;		% Set to 1 if BWT is provided
BWST=72.9;	% Initial BW in kg
PREG=0;
TSTOP= 1008; 	% Exposure duration in hrs (350 days)

%Single daily oral exposure
DT = xlsRead("Food.xls", "30p", "A1:A43"); % Dosing Times
DORAL=xlsRead("Food.xls", "30p", "B1:B43"); % Dose in ug/kg
prepare time rbcce cv urinetcpy
start@nocallback

mytable = [_time _rbcce _urinetcpy _cv*350.6]; %conc unit = ug/L
save mytable @file='food_30.txt' @format=ascii


[Federal Register: April 6, 2009 (Volume 74, Number 64)]
[Notices]
[Page 15588-15589]
[DOCID:fr06ap09-155]

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

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA 2009-0001-N-7]

Proposed Agency Information Collection Activities; Comment
Request

AGENCY: Federal Railroad Administration, DOT.

ACTION: Notice.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995 and its
implementing regulations, the Federal Railroad Administration (FRA)
hereby announces that it is seeking renewal of the following currently
approved information collection activities. Before submitting these
information collection requirements for clearance by the Office of
Management and Budget (OMB), FRA is soliciting public comment on
specific aspects of the activities identified below.

DATES: Comments must be received no later than June 5, 2009.

ADDRESSES: Submit written comments on any or all of the following
proposed activities by mail to either: Mr. Robert Brogan, Office of
Safety, Planning and Evaluation Division, RRS-21, Federal Railroad
Administration, 1200 New Jersey Ave., SE., Mail Stop 17, Washington, DC
20590, or Ms. Nakia Jackson, Office of Information Technology, RAD-20,
Federal Railroad Administration, 1200 New Jersey Ave., SE., Mail Stop
35, Washington, DC 20590. Commenters requesting FRA to acknowledge
receipt of their respective comments must include a self-addressed
stamped postcard stating, ``Comments on OMB control number --------.''
Alternatively, comments may be transmitted via facsimile to (202) 493-
6216 or<PHONE_NUMBER>, or via e-mail to Mr. Brogan at
<EMAIL_ADDRESS>or to Ms. Jackson at<EMAIL_ADDRESS>
Please refer to the assigned OMB control number in any correspondence
submitted. FRA will summarize comments received in response to this
notice in a subsequent notice and include them in its information
collection submission to OMB for approval.

FOR FURTHER INFORMATION CONTACT: Mr. Robert Brogan, Office of Planning
and Evaluation Division, RRS-21, Federal Railroad Administration, 1200
New Jersey Ave., SE., Mail Stop 17, Washington, DC 20590 (telephone:
(202) 493-6292) or Ms. Nakia Jackson, Office of Information Technology,
RAD-20, Federal Railroad Administration, 1200 New Jersey Ave., SE.,
Mail Stop 35, Washington, DC 20590 (telephone:<PHONE_NUMBER>). (These
telephone numbers are not toll-free.)

SUPPLEMENTARY INFORMATION: The Paperwork Reduction Act of 1995 (PRA),
Public Law No. 104-13, 2, 109 Stat. 163 (1995) (codified as revised at
44 U.S.C. 3501-3520), and its implementing regulations, 5 CFR Part
1320, require Federal agencies to provide 60-days notice to the public
for comment on information collection activities before seeking
approval for reinstatement or renewal by OMB. 44 U.S.C. 3506(c)(2)(A);
5 CFR 1320.8(d)(1), 1320.10(e)(1), 1320.12(a). Specifically, FRA
invites interested respondents to comment on the following summary of
proposed information collection activities regarding (i) whether the
information collection activities are necessary for FRA to properly
execute its functions, including whether the activities will have
practical utility; (ii) the accuracy of FRA's estimates of the burden
of the information collection activities, including the validity of the
methodology and assumptions used to determine the estimates; (iii) ways
for FRA to enhance the quality, utility, and clarity of the information
being collected; and (iv) ways for FRA to minimize the burden of
information collection activities on the public by automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology (e.g., permitting electronic

submission of responses). See 44 U.S.C. 3506(c)(2)(A)(I)-(iv); 5 CFR
1320.8(d)(1)(I)-(iv). FRA believes that soliciting public comment will
promote its efforts to reduce the administrative and paperwork burdens
associated with the collection of information mandated by Federal
regulations. In summary, FRA reasons that comments received will
advance three objectives: (i) Reduce reporting burdens; (ii) ensure
that it organizes information collection requirements in a ``user
friendly'' format to improve the use of such information; and (iii)
accurately assess the resources expended to retrieve and produce
information requested. See 44 U.S.C. 3501.
    Below are brief summaries of three currently approved information
collection activities that FRA will submit for clearance by OMB as
required under the PRA:

    Title: Stencilling Reporting Mark on Freight Cars.
    OMB Control Number: 2130-0520.
    Abstract: Title 49, Section 215.301 of the Code of Federal
Regulations, sets forth certain requirements that must be followed by
railroad carriers and private car owners relative to identification
marks on railroad equipment. FRA, railroads, and the public refer to
the stencilling to identify freight cars.
    Form Number(s): N/A.
    Affected Public: Businesses.
    Frequency of Submission: On occasion.
    Respondent Universe: 718 railroads.
    Total Estimated Responses: 20,000 cars stencilled.
    Total Estimated Annual Burden: 15,000 hours.
    Status: Regular review.

    OMB Control Number: 2130-0523.
    Title: Rear-End Marking Devices.
    Type of Request: Extension of a currently approved collection.
    Affected Public: Businesses.
    Form Number(s): N/A.
    Abstract: The collection of information is set forth under 49 CFR
Part 221 which requires railroads to furnish a detailed description of
the type of marking device to be used for the trailing end of rear cars
in order to ensure rear cars meet minimum standards for visibility and
display. Railroads are required to furnish a certification that the
device has been tested in accordance with current ``Guidelines For
Testing of Rear End Marking Devices.'' Additionally, railroads are
required to furnish detailed test records which include the testing
organizations, description of tests, number of samples tested, and the
test results in order to demonstrate compliance with the performance
standard.
    Respondent Universe: 718 railroads.
    Frequency of Submission: On occasion.
    Total Estimated Responses: 4.
    Total Estimated Annual Burden: 8 hours.
    Status: Regular review.

    Title: Locomotive Certification (Noise Compliance Regulations).
    OMB Control Number: 2130-0527.
    Type of Request: Extension of a currently approved collection.
    Affected Public: Businesses.
    Form Number(s): N/A.
    Abstract: Part 210 of title 49 of the United States Code of Federal
Regulations (CFR) pertains to FRA's noise enforcement procedures, which
encompass rail yard noise source standards published by the
Environmental Protection Agency (EPA). EPA has the authority to set
these standards under the Noise Control Act of 1972. The information
collected by FRA under Part 210 is necessary to ensure compliance with
EPA noise standards for new locomotives.

Respondent Universe: 2 Locomotive Manufacturers

    Frequency of Submission: On occasion.

----------------------------------------------------------------------------------------------------------------
                                                            Total annual       Average time per    Total annual
           CFR section             Respondent universe       responses             response        burden hours
----------------------------------------------------------------------------------------------------------------
210.27--New Loco. Certification--  2 Locomotive Manuf.  40 requests........  30 minutes.........              20
 Requests for Information.
--Identification of Locomotives..  2 Locomotive Manuf.  790 badges/plates..  30 minutes.........             395
210.31--Operation Standards--      2 Locomotive Manuf.  790 recorded         3 hours............           2,370
 Measurement of Loco Noise                               measurements.
 Emissions.
----------------------------------------------------------------------------------------------------------------

    Total Estimated Responses: 1,620.
    Total Estimated Annual Burden: 2,785 hours.
    Status: Regular review.
    Pursuant to 44 U.S.C. 3507(a) and 5 CFR 1320.5(b),
1320.8(b)(3)(vi), FRA informs all interested parties that it may not
conduct or sponsor, and a respondent is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number.

    Authority: 44 U.S.C. 3501-3520.

    Issued in Washington, DC on March 31, 2009.
Kimberly Orben,
Director, Office of Financial Management, Federal Railroad
Administration.
[FR Doc. E9-7655 Filed 4-3-09; 8:45 am]

BILLING CODE 4910-06-P