[Federal Register Volume 87, Number 71 (Wednesday, April 13, 2022)]
[Notices]
[Pages 21884-21885]
[FR Doc No: 2022-07823]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9715-01-R6]

Clean Air Act Operating Permit Program; Petitions for Objection
to State Operating Permit for ExxonMobil Corp, Baytown Chemical Plant,
Harris County, Texas

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of final Order on Petition for objection to Clean Air
Act title V operating permit.

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SUMMARY: The Environmental Protection Agency (EPA) Administrator signed
an Order dated March 18, 2022, granting in part and denying in part a
Petition dated September 30, 2020 from the Environmental Integrity
Project, Sierra Club, and Texas Campaign for the Environment. The
Petition requested that the EPA object to a Clean Air Act (CAA) title V
operating permit issued by the Texas Commission on

Environmental Quality (TCEQ) to ExxonMobil Corp. for its Baytown
Chemical Plant located in Harris County, Texas.

ADDRESSES: The EPA requests that you contact the individual listed in
the FOR FURTHER INFORMATION CONTACT section to view copies of the final
Order, the Petition, and other supporting information. Out of an
abundance of caution for members of the public and our staff, the EPA
Region 6 office is currently closed to the public to reduce the risk of
transmitting COVID-19. Please call or email the contact listed below if
you need alternative access to the final Order and Petition, which are
available electronically at: https://www.epa.gov/title-v-operating-permits/title-v-petition-database.

FOR FURTHER INFORMATION CONTACT: Aimee Wilson, EPA Region 6 Office, Air
Permits Section,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION: The CAA affords EPA a 45-day period to
review and object to, as appropriate, operating permits proposed by
state permitting authorities under title V of the CAA. Section
505(b)(2) of the CAA authorizes any person to petition the EPA
Administrator to object to a title V operating permit within 60 days
after the expiration of the EPA's 45-day review period if the EPA has
not objected on its own initiative. Petitions must be based only on
objections to the permit that were raised with reasonable specificity
during the public comment period provided by the state, unless the
petitioner demonstrates that it was impracticable to raise these issues
during the comment period or unless the grounds for the issue arose
after this period.
    The EPA received the Petition from the Environmental Integrity
Project, Sierra Club, and Texas Campaign for the Environment dated
September 30, 2020, requesting that the EPA object to the issuance of
operating permit no. O2269, issued by TCEQ to the Baytown Chemical
Plant in Harris County, Texas. The Petition claims the TCEQ Executive
Director failed to adjust ExxonMobil's Plantwide Applicability Limits
(PAL) for NOx and VOC downward to account for Harris County's recent
designation as a serious Ozone nonattainment area and the revised
proposed permit improperly incorporates a Major NSR permit by
reference, fails to assure compliance with the PAL, fails to establish
a compliance schedule for ExxonMobil to comply with its commitment to
obtain a SIP-approved Chapter 116, Subchapter B permit for units and
emissions authorized by state-only flexible permit No. 20211/PAL16,
improperly incorporates confidential permit terms, and fails to specify
monitoring, testing, and recordkeeping requirements sufficient to
assure compliance with applicable requirements for projects authorized
by permits by rule (PBR).
    On March 18, 2022, the EPA Administrator issued an Order granting
in part and denying in part the Petition. The Order explains the basis
for EPA's decision.

    Dated: April 4, 2022.
David Garcia,
Director, Air and Radiation Division, Region 6.
[FR Doc. 2022-07823 Filed 4-12-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: April 2, 2007 (Volume 72, Number 62)]
[Notices]
[Page 15747-15749]
[DOCID:fr02ap07-126]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55528; File No. SR-NYSE-2007-28]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing of Proposed Rule Change To Exempt Limited Partnerships
From Certain of Its Shareholder Approval Rules

March 26, 2007.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act''),\2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on March 9, 2007, New York Stock Exchange LLC (the ``NYSE''
or the ``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule changes as described in Items I, II,
and III below, which items have been substantially prepared by the
Exchange. The Commission is publishing this notice to solicit comments
on the proposed rule changes from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the Exchange's Listed Company Manual
(the ``Manual'') to exempt limited partnerships from the obligation to
obtain shareholder approval under the circumstances set forth in
Sections 312.03(b), (c), and (d) for the issuance of common stock and
securities convertible into or exchangeable for common stock.\4\
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    \4\ NYSE-listed limited partnerships would still be subject to
the Exchange's shareholder approval requirements for equity
compensation plans. See NYSE Listed Company Manual Sections 303A.08
and 312.03(a).
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    The text of the proposed rule change is available on the Exchange's
Web site at http://www.nyse.com, the Office of the Secretary, 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 NYSE 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 exempt limited partnerships from the
obligation to obtain shareholder approval under the circumstances set
forth in Manual Sections 312.03(b), (c), and (d) for the issuance of
common stock and securities convertible into or exchangeable for common
stock.\5\
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    \5\ See supra note 4.
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    Subject to certain exceptions specified therein, Manual Sections
312.03(b), (c), and (d) require listed issuers to obtain shareholder
approval prior to the issuance of common stock or securities
convertible into or exchangeable for common stock in any transaction or
series of related transactions in the following situations:

     Where the potential dilution exceeds either one percent
of the number of shares of common stock or one percent of the voting
power outstanding before the issuance to: (a) a director, officer or
substantial security holder of the company (each a ``Related
Party''); (b) a subsidiary, affiliate or other closely-related
person of a Related Party; or (c) any company or entity in which a
Related Party has a substantial direct or indirect interest.
     If the Related Party involved in a transaction covered
by the preceding bullet is classified as such solely because such
person is a substantial security holder, and if the issuance relates
to a sale of stock for cash at a price at least as great as each of
the book and market value of the issuer's common stock, then
shareholder approval will not be required unless the number of
shares of common stock to be issued, or unless the number of shares
of common stock into which the securities may be convertible or
exercisable, exceeds either five percent of the number of shares of
common stock or five percent of the voting power outstanding before
the issuance.
     If: (a) the common stock has, or will have upon
issuance, voting power equal to or in

excess of 20 percent of the voting power outstanding before the
issuance of such stock or of securities convertible into or
exercisable for common stock; or (b) the number of shares of common
stock to be issued is, or will be upon issuance, equal to or in
excess of 20 percent of the number of shares of common stock
outstanding before the issuance of the common stock or of securities
convertible into or exercisable for common stock.
     If the issuance will result in a change of control of
the issuer.

    The policy underlying these requirements is that shareholders
should have the right to vote on any issuance of common stock that is
materially dilutive of either their voting or economic interest in the
company. Nasdaq has similar shareholder approval requirements to those
of the NYSE. However, Nasdaq exempts limited partnerships (``LPs'')
from those requirements,\6\ which the Exchange believes has placed it
at a significant disadvantage in competing with Nasdaq for initial
public offerings and transfers of LPs. To be treated as a partnership
for federal tax purposes, an LP must ensure that 90% of its income is
derived from ``qualified sources,'' which generally refers only to
income derived from natural resource-related activities. Most listed
LPs are engaged in energy-related businesses. The typical business
model of LPs in the energy industry is to use their capital to acquire
assets (e.g., pipelines) that produce predictable revenue streams and
to commit in their partnership agreements to distribute most of their
profits to the LP's unit holders. These LPs acquire assets frequently
on an opportunistic basis and pay for them by issuing additional LP
units. The Exchange believes that the ability of an LP listed on Nasdaq
to issue additional LP units without the expense and uncertainty of
obtaining shareholder approval provides Nasdaq with a significant
advantage over the Exchange in attracting and retaining listings of
LPs.
---------------------------------------------------------------------------

    \6\ See Nasdaq Marketplace Rule 4360 (``Qualitative Listing
Requirements for Nasdaq Issuers That Are Limited Partnerships''),
which does not include the shareholder approval requirements found
in Nasdaq Marketplace Rule 4350 (``Qualitative Listing Requirements
for Nasdaq Issuers That Are Not Limited Partnerships''). See also
Securities Exchange Act Release No. 30811 (June 15, 1992); 57 FR
28542 (June 25, 1992) (SR-NASD-91-58) (approving the NASD's adoption
of non-quantitative listing standards for partnerships, which did
not include shareholder approval requirements). See also Securities
Exchange Act Release No. 34533 (August 15, 1994); 59 FR 43147
(August 22, 1994) (SR-NASD-93-3) (approving the NASD's adoption of
the predecessor rule to Rule 4360, which also did not include
shareholder approval requirements for listed limited partnerships).
---------------------------------------------------------------------------

    The Exchange believes that an analysis of the policies regarding
voting and economic dilution underpinning its shareholder approval
requirements demonstrates that it is appropriate to exempt LPs from
their application. Listed LPs generally provide very limited voting
rights to their unit holders. Typically, control of the LP resides with
the general partner (``GP'') and the LP's board is that of the GP. The
owner of the GP appoints the board and the common unit holders of the
LP have no voting rights with respect to the election of directors. LP
partnership agreements generally provide that LP unit holders can vote
only on a merger or dissolution of the LP or on any amendment to the
partnership agreement that is adverse to their interests. As such, the
Exchange believes that investors who buy LP units have no expectation
that they will be able to vote and, therefore, the policy that
shareholders should be able to vote on any stock issuances that are
materially dilutive of their voting power is of less relevance to LPs
than to regular corporations. Furthermore, because LP unit holders
generally do not have the right to elect directors, most LPs do not
hold annual meetings. Therefore, it would not be possible for an LP to
arrange for shareholder approval to be obtained in conjunction with an
annual meeting, as would be possible for a regular company. Rather, an
LP would have to call a special meeting every time it needed approval
of an issuance pursuant to the shareholder approval rules.
    The Exchange also believes that the economic dilution concerns
underpinning the shareholder approval rules are also less relevant in
the case of LPs. Listed LPs typically are required under their
partnership agreements to distribute almost all of their earnings to
their unit holders and specify a minimum quarterly distribution that
the LP is required to make. As such, LPs will only invest in new assets
if they know that those assets will be sufficiently accretive to
earnings to pay the minimum quarterly distribution required for the
additional units that are sold to raise the capital to pay for those
assets. A failure to pay the minimum quarterly distribution, or a
reduction in the actual distribution level historically paid, would
likely have a negative effect on the trading price of a listed LP,
imposing a market discipline on management to ensure that any
additional issuances will not be economically dilutive.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) \7\ of the
Act in general, and furthers the objectives of Section 6(b)(5),\8\ in
particular, in that it is designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in facilitating transactions in securities, and to
remove impediments to and perfect the mechanisms of a free and open
market and a national market system. The Exchange believes that the
proposed rule change will increase competition among listing markets
and will remove a competitive disadvantage the Exchange currently has
vis a vis Nasdaq and is therefore designed to perfect the mechanism of
a free and open market.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

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

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

    Written comments were neither solicited nor received.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission will:
    (A) By order approve such proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-NYSE-2007-28 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.
    All submissions should refer to File Number SR-NYSE-2007-28. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments,

all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of the NYSE. 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-NYSE-2007-28 and should be submitted on or before April
23, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-5964 Filed 3-30-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: December 8, 2009 (Volume 74, Number 234)]
[Notices]
[Page 64710]
[DOCID:fr08de09-47]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2009-0973]

Random Drug Testing Rate for Covered Crewmembers

AGENCY: Coast Guard, DHS.

ACTION: Notice of minimum random drug testing rate.

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SUMMARY: The Coast Guard has set the calendar year 2010 minimum random
drug testing rate at 50 percent of covered crewmembers.

DATES: The minimum random drug testing rate is effective January 1,
2010 through December 31, 2010. Marine employers must submit their 2009
Management Information System (MIS) reports no later than March 15,
2010.

ADDRESSES: Annual MIS reports may be submitted to Commandant (CG-545),
U.S. Coast Guard Headquarters, 2100 Second Street, SW., STOP 7581,
Washington, DC 20593-7581 or by electronic submission to the following
Internet address: http://homeport.uscg.mil/Drugtestreports.

FOR FURTHER INFORMATION CONTACT: For questions about this notice,
please contact Mr. Robert C. Schoening, Drug and Alcohol Program
Manager, Office of Investigations and Casualty Analysis (CG-545), U.S.
Coast Guard Headquarters, telephone<PHONE_NUMBER>. If you have questions
on viewing or submitting material to the docket, call Renee V. Wright,
Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under 46 CFR 16.230, the Coast Guard
requires marine employers to establish random drug testing programs for
covered crewmembers on inspected and uninspected vessels.
    Every marine employer is required by 46 CFR 16.500 to collect and
maintain a record of drug testing program data for each calendar year,
and submit this data by 15 March of the following year to the Coast
Guard in an annual MIS report. Marine employers may either submit their
own MIS reports or have a consortium or other employer representative
submit the data in a consolidated MIS report.
    The purpose of setting a minimum random drug testing rate is to
assist the Coast Guard in analyzing its current approach for deterring
and detecting illegal drug abuse in the maritime industry. The testing
rate for calendar year 2010 is 50 percent.
    The Coast Guard may lower this rate if, for two consecutive years,
the drug test positive rate is less than 1.0 percent, in accordance
with 46 CFR part 16.230(f)(2).
    Since 2008 MIS data indicates that the positive rate is greater
than one percent industry-wide (1.53 percent), the Coast Guard
announces that the minimum random drug testing rate will continue at 50
percent of covered employees for the period of January 1, 2010 through
December 31, 2010 in accordance with 46 CFR 16.230(e).
    Each year, the Coast Guard will publish a notice reporting the
results of random drug testing for the previous calendar year's MIS
data and the minimum annual percentage rate for random drug testing for
the next calendar year.

    Dated: November 20, 2009.
K.S. Cook,
Rear Admiral, United States Coast Guard, Director of Prevention Policy.
[FR Doc. E9-29127 Filed 12-7-09; 8:45 am]


[Federal Register Volume 81, Number 26 (Tuesday, February 9, 2016)]
[Notices]
[Pages 6854-6855]
[FR Doc No: 2016-02493]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG16-49-000.
    Applicants: Seward Generation, LLC.
    Description: Self-Certification of EG or FC of Seward Generation,
LLC.
    Filed Date: 2/2/16.
    Accession Number: 20160202-5243.
    Comments Due: 5 p.m. ET 2/23/16.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-1946-011; ER15-622-005; ER15-621-005; ER15-
463-005; ER15-2722-001; ER15-110-005; ER14-2871-006; ER14-2382-006;
ER14-1777-004; ER13-1586-007; ER13-1485-005; ER11-3861-011; ER11-2639-
007; ER10-3310-009; ER10-3299-008; ER10-3286-009; ER10-3253-005; ER10-
3251-006; ER10-3250-007; ER10-3249-007; ER10-3245-007; ER10-3244-008;
ER10-3243-008; ER10-3240-005; ER10-3239-005; ER10-3237-005; ER10-3233-
004; ER10-3232-003; ER10-3231-004; ER10-3230-005; ER10-1992-013.
    Applicants: Broad River Energy LLC, Victory Garden Phase IV, LLC,
TGP

Energy Management, LLC, Terra-Gen Energy Services, LLC, San Gorgonio
Westwinds II, LLC, Ridgetop Energy, LLC, Ridge Crest Wind Partners,
LLC, Pacific Crest Power, LLC, ON Wind Energy LLC, Oak Creek Wind
Power, LLC, Foote Creek IV, LLC, Foote Creek III, LLC, Foote Creek II,
LLC, Coso Geothermal Power Holdings, LLC, Chandler Wind Partners, LLC,
Cameron Ridge, LLC, Wheelabrator Westchester, L.P., Wheelabrator South
Broward Inc., Wheelabrator Shasta Energy Company Inc., Wheelabrator
Saugus Inc., Wheelabrator Ridge Energy Inc., Wheelabrator Portsmouth
Inc., Wheelabrator North Andover Inc., Wheelabrator Frackville Energy
Company Inc., Wheelabrator Falls Inc., Wheelabrator Bridgeport, L.P.,
Wheelabrator Baltimore, L.P., New Athens Generating Company, LLC,
Millennium Power Partners, L.P., New Harquahala Generating Company,
LLC, Empire Generating Co, LLC.
    Description: Supplement to October 1, 2015 Notice of Change in
Status of the ECP MBR Sellers.
    Filed Date: 12/31/15.
    Accession Number: 20151231-5407.
    Comments Due: 5 p.m. ET 2/24/16.

    Docket Numbers: ER10-2839-004.
    Applicants: Midland Cogeneration Venture Limited Partnership.
    Description: Supplement to June 30, 2015 Updated Market Power
Analysis of Midland Cogeneration Venture Limited Partnership.
    Filed Date: 1/29/16.
    Accession Number: 20160129-5524.
    Comments Due: 5 p.m. ET 2/19/16.

    Docket Numbers: ER15-2648-001.
    Applicants: PJM Interconnection, L.L.C.
    Description: Compliance filing: Compliance per Nov 3, 2015 Order
re: Fee Proposal Window Effective Date to be effective 2/16/2016.
    Filed Date: 2/2/16.
    Accession Number: 20160202-5254.
    Comments Due: 5 p.m. ET 2/23/16.

    Docket Numbers: ER16-498-000.
    Applicants: RE Mustang LLC, RE Mustang 3 LLC, RE Mustang 4 LLC, RE
Barren Ridge 1 LLC.
    Description: Clarification to December 10, 2015 and December 29,
2015 RE Mustang LLC, RE Mustang 3 LLC, RE Mustang 4 LLC and RE Barren
Ridge 1 LLC tariff filings.
    Filed Date: 2/2/16.
    Accession Number: 20160202-5256.
    Comments Due: 5 p.m. ET 2/12/16.

    Docket Numbers: ER16-872-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Section 205(d) Rate Filing: 2016-02-02_SA 2886
MidAmerican-MidAmerican GIA (J279) to be effective 2/3/2016.
    Filed Date: 2/2/16.
    Accession Number: 20160202-5197.
    Comments Due: 5 p.m. ET 2/23/16.

    Docket Numbers: ER16-873-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Section 205(d) Rate Filing: Revisions to OATT and OA
RE Demand Resource CBL to be effective 4/4/2016.
    Filed Date: 2/2/16.
    Accession Number: 20160202-5199.
    Comments Due: 5 p.m. ET 2/23/16.

    Docket Numbers: ER16-874-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Section 205(d) Rate Filing: Amendment to WMPA No.
4244, Queue No. Z1-081 to be effective 7/20/2015.
    Filed Date: 2/2/16.
    Accession Number: 20160202-5253.
    Comments Due: 5 p.m. ET 2/23/16.

    Docket Numbers: ER16-875-000.
    Applicants: Otter Tail Power Company.
    Description: Notice of Termination of Supplement Nos. 1 and 4 (as
supplemented) to Rate Schedule No. 171 of Otter Tail Power Company.
    Filed Date: 2/2/16.
    Accession Number: 20160202-5264.
    Comments Due: 5 p.m. ET 2/23/16.

    Docket Numbers: ER16-876-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Tariff Cancellation: Notice of Cancellation of WMPA SA
No. 2974, Queue No. W4-080 to be effective 2/3/2016.
    Filed Date: 2/3/16.
    Accession Number: 20160203-5054.
    Comments Due: 5 p.m. ET 2/24/16.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: February 3, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-02493 Filed 2-8-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 91 (Thursday, May 11, 2023)]
[Notices]
[Pages 30312-30313]
[FR Doc No: 2023-10052]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-P-2229]

Determination That Hydrochlorothiazide Oral Solution, 50
Milligrams per 5 Milliliters, Was Not Withdrawn From Sale for Reasons
of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) has
determined that hydrochlorothiazide oral solution, 50 milligrams (mg)/5
milliliters (mL), was not withdrawn from sale for reasons of safety or
effectiveness. This determination means that FDA will not begin
procedures to withdraw approval of abbreviated new drug applications
(ANDAs) that refer to this drug product, and it will allow FDA to
continue to approve ANDAs that refer to the product as long as they
meet relevant legal and regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Alaina Kupperman, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6215, Silver Spring, MD 20993-0002, 301-
796-2395, [email protected].

SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of
an ANDA to market a generic version of a previously approved drug
product. To obtain approval, the ANDA applicant must show, among other
things, that the generic drug product: (1) has the same active
ingredient(s), dosage form, route of administration, strength,
conditions of use, and (with certain exceptions) labeling as the listed
drug, which is a version of the drug that was previously approved, and
(2) is bioequivalent to the listed drug. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    Section 505(j)(7) of the FD&C Act requires FDA to publish a list of
all approved drugs. FDA publishes this list as part of the ``Approved
Drug Products With Therapeutic Equivalence Evaluations,'' which is
known generally as the ``Orange Book.'' Under FDA regulations, drugs
are removed from the list if the Agency withdraws or

suspends approval of the drug's NDA or ANDA for reasons of safety or
effectiveness or if FDA determines that the listed drug was withdrawn
from sale for reasons of safety or effectiveness (21 CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    Hydrochlorothiazide oral solution, 50 mg/5 mL, is the subject of
ANDA 088587, held by Roxane Laboratories Inc., and initially approved
on July 2, 1984. Hydrochlorothiazide is indicated for: (1) adjunctive
therapy in edema associated with congestive heart failure, hepatic
cirrhosis, and corticosteroid and estrogen therapy; (2) edema due to
various forms of renal dysfunction such as nephrotic syndrome, acute
glomerulonephritis, and chronic renal failure; and (3) the management
of hypertension either as the sole therapeutic agent or to enhance the
effectiveness of other antihypertensive drugs in the more severe form
of hypertension.
    In a letter dated August 4, 2008, Roxane Laboratories Inc.
requested withdrawal of ANDA 088587 for hydrochlorothiazide oral
solution. In the Federal Register issue of July 21, 2010 (75 FR 42455),
FDA announced that it was withdrawing approval of ANDA 088587,
effective August 20, 2010.
    Hyman, Phelps & McNamara, P.C. submitted a citizen petition dated
September 13, 2022 (Docket No. FDA-2022-P-2229), under 21 CFR 10.30,
requesting that the Agency determine whether hydrochlorothiazide oral
solution, 50 mg/5 mL, was withdrawn from sale for reasons of safety or
effectiveness.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that hydrochlorothiazide oral solution, 50 mg/5 mL,
was not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
this product was withdrawn for reasons of safety or effectiveness. We
have carefully reviewed our files for records concerning the withdrawal
of hydrochlorothiazide oral solution, 50 mg/5 mL, from sale. We have
also independently evaluated relevant literature and data for possible
postmarketing adverse events. We have reviewed the available evidence
and determined that this drug product was not withdrawn from sale for
reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list hydrochlorothiazide
oral solution, 50 mg/5 mL, in the ``Discontinued Drug Product List''
section of the Orange Book. The ``Discontinued Drug Product List''
delineates, among other items, drug products that have been
discontinued from marketing for reasons other than safety or
effectiveness. ANDAs that refer to this drug product may be approved by
the Agency as long as they meet all other legal and regulatory
requirements for the approval of ANDAs. If FDA determines that labeling
for this drug product should be revised to meet current standards, the
Agency will advise ANDA applicants to submit such labeling.

    Dated: May 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-10052 Filed 5-10-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 164 (Monday, August 24, 2020)]
[Notices]
[Pages 52166-52167]
[FR Doc No: 2020-18580]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

TIME AND DATE: 2:00 p.m. on Wednesday, August 26, 2020.

PLACE: The meeting will be held via remote means and/or at the
Commission's headquarters, 100 F Street NE, Washington, DC 20549.

STATUS: This meeting will be closed to the public.

MATTERS TO BE CONSIDERED: Commissioners, Counsel to the Commissioners,
the Secretary to the Commission, and recording secretaries will attend
the closed meeting. Certain staff members who have an interest in the
matters also may be present.
    In the event that the time, date, or location of this meeting
changes, an announcement of the change, along with the new time, date,
and/or place of the meeting will be posted on the Commission's website
at https://www.sec.gov.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (6), (7), (8), 9(B) and (10) and 17 CFR
200.402(a)(3), (a)(5), (a)(6), (a)(7), (a)(8), (a)(9)(ii) and (a)(10),
permit consideration of the scheduled matters at the closed meeting.
    The subject matter of the closed meeting will consist of the
following topic:
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings;
    Resolution of litigation claims; and
    Other matters relating to enforcement proceedings.

    At times, changes in Commission priorities require alterations in
the scheduling of meeting agenda items that may consist of
adjudicatory, examination, litigation, or regulatory matters.

CONTACT PERSON FOR MORE INFORMATION: For further information; please
contact Vanessa A. Countryman from the Office of the Secretary at (202)
551-5400.

    Dated: August 19, 2020.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2020-18580 Filed 8-20-20; 11:15 am]
BILLING CODE 8011-01-P