[Federal Register Volume 88, Number 199 (Tuesday, October 17, 2023)]
[Notices]
[Pages 71576-71578]
[FR Doc No: 2023-22843]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-2016]

Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for
Methanol; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Policy for
Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol.'' This
guidance is intended to alert pharmaceutical manufacturers and
pharmacists in State-licensed pharmacies or Federal facilities who
engage in drug compounding to the potential public health hazard of
alcohol (ethyl alcohol or ethanol) or isopropyl alcohol contaminated
with or substituted with methanol. During the Coronavirus Disease 2019
(COVID-19) public health emergency (PHE), FDA became aware of reports
of fatal methanol poisoning of consumers who ingested alcohol-based
hand sanitizer products that were manufactured with methanol or
methanol-contaminated ethanol. FDA is concerned that other drug
products containing ethanol or isopropyl alcohol (pharmaceutical
alcohol), which are widely used active ingredients in a variety of drug
products, could be similarly vulnerable to methanol contamination. This
guidance replaces the guidance for industry entitled ``Policy for
Testing Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including
During the Public Health Emergency (COVID-19)'' published in January
2021.

DATES: The announcement of the guidance is published in the Federal
Register on October 17, 2023.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-D-2016 for ``Policy for Testing of Alcohol (Ethanol) and
Isopropyl Alcohol for Methanol.'' Received comments will be placed in
the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or to the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; or to
Policy and Regulations Staff, HFV-6, Center for Veterinary Medicine,
Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Francis Godwin, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4342, Silver Spring, MD 20993-0002, 301-
796-5362; or Anne Taylor, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993-0002,

240-402-7911; or Julie Bailey, Center for Veterinary Medicine (HFV-
140), Food and Drug Administration, 7500 Standish Pl., Rockville, MD
20855,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry
entitled ``Policy for Testing of Alcohol (Ethanol) and Isopropyl
Alcohol for Methanol.'' This guidance is intended to alert
pharmaceutical manufacturers and pharmacists in State-licensed
pharmacies or Federal facilities who engage in compounding to the
potential public health hazard of alcohol (ethyl alcohol or ethanol) or
isopropyl alcohol (collectively ``pharmaceutical alcohol'')
contaminated with or substituted with methanol. During the COVID-19
PHE, FDA became aware of reports of fatal methanol poisoning of
consumers who ingested alcohol-based hand sanitizer products that were
manufactured with methanol or methanol-contaminated ethanol. FDA is
concerned that other drug products containing pharmaceutical alcohol,
which are widely used active ingredients in a variety of drug products,
could be similarly vulnerable to methanol contamination.
    This guidance outlines a policy intended to help pharmaceutical
manufacturers and pharmacists in State-licensed pharmacies or Federal
facilities who engage in compounding avoid the use of pharmaceutical
alcohol that is contaminated with or substituted with methanol in drug
products. The policy outlined in the guidance includes, but is not
limited to: (1) performing a specific identity test that includes a
limit test for methanol on each container within each shipment of each
lot of pharmaceutical alcohol before the component is used in the
manufacture or preparation of drug products; (2) knowing the entities
in pharmaceutical manufacturers' supply chain for pharmaceutical
alcohol (i.e., knowing the identities and appropriately qualifying the
manufacturer of the pharmaceutical alcohol and any subsequent
distributor(s)); (3) ensuring that all personnel in pharmaceutical
manufacturing facilities (especially personnel directly responsible for
receipt, testing, and release of pharmaceutical alcohol) are made aware
of the importance of proper testing and the potential hazards if the
testing is not done; and (4) establishing finished-product test methods
to ensure that when testing for ethanol or isopropyl alcohol content
(assay), the method also distinguishes between the active ingredient
and methanol. The policy outlined in this guidance applies to
pharmaceutical alcohols used as an active or inactive ingredient in a
drug.
    This guidance replaces the guidance entitled ``Policy for Testing
Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During
the Public Health Emergency (COVID-19)'' posted in January 2021 and
announced in the Federal Register on February 23, 2021 (86 FR 10977)
(hereafter ``2021 COVID-19 Methanol Guidance''). FDA issued the
guidance to communicate its policy for the duration of the COVID-19 PHE
declared by the Secretary of Health and Human Services (HHS) on January
31, 2020, including any renewals made by the HHS Secretary in
accordance with section 319(a)(2) of the Public Health Service Act (42
U.S.C. 247d(a)(2)). As stated in the 2021 guidance, at such time when
the PHE was over, as declared by the HHS Secretary, FDA intended to
reassess the guidance. Furthermore, in the Federal Register of March
13, 2023 (88 FR 15417), FDA listed the guidance documents that will no
longer be effective with the expiration of the PHE declaration,
guidances that FDA was revising to continue in effect for 180 days
after the expiration of the PHE declaration to provide a period for
stakeholder transition and then would no longer be in effect, and
guidances that FDA was revising to continue in effect for 180 days
after the expiration of the PHE declaration during which time FDA
planned to further revise the guidances. The 2021 COVID-19 Methanol
Guidance is included in the latter category. Although the COVID-19 PHE
ended May 11, 2023, FDA has determined that the recommendations set
forth in the 2021 COVID-19 Methanol Guidance are applicable outside the
context of the COVID-19 PHE. FDA is, therefore, issuing this revised
final guidance, which will supersede the current guidance. In preparing
this guidance, FDA considered comments received regarding the 2021
guidance, as well as the Agency's experience with this matter during
the PHE. Updates to this guidance include removal of certain language
regarding the COVID-19 PHE, as well as removal of language related to
the three hand sanitizer guidance documents that have since been
withdrawn.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (Sec.  10.115 (21 CFR 10.115)) without initially
seeking prior comment because the Agency has determined that prior
public participation is not feasible or appropriate (see Sec.
10.115(g)(2) and section 701(h)(1)(C)(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 371(h)(1)(C)(i))). Specifically, we are not
seeking prior comment because, although the COVID-19 PHE has ended, the
use of hand sanitizers and other drug products containing
pharmaceutical alcohol remains widespread. Given the serious risks to
public health, including blindness and death, that can result from
methanol contamination, it is thus important to public health to
continue to apply the policy described in the guidance, which
encourages stringent and continued oversight of such products for the
possible presence of methanol.
    The guidance represents the current thinking of FDA on ``Policy for
Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol.'' It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in 21 CFR part 314 have been approved under OMB control number 0910-
0001; the collections of information in 21 CFR part 312 have been
approved under OMB control number 0910-0014; the collections of
information in 21 CFR part 601 have been approved under OMB control
number 0910-0338; and the collections of information in 21 CFR parts
210 and 211 have been approved under OMB control number 0910-0139.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: October 11, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22843 Filed 10-16-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 68 (Wednesday, April 9, 2014)]
[Notices]
[Page 19618]
[FR Doc No: 2014-07931]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1496]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Food and Drug
Administration Generic Rapid Response Surveys (Generic Clearance)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by May 9,
2014.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0500.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Food and Drug Administration Generic Rapid Response Surveys--(OMB
Control Number 0910-0500)--Extension

    Section 505 of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 355), requires that important safety information
relating to all human prescription drug products be made available to
FDA so that it can take appropriate action to protect the public health
when necessary. Section 702 of the FD&C Act (21 U.S.C. 372) authorizes
investigational powers to FDA for enforcement of the FD&C Act. Under
section 519 of the FD&C Act (21 U.S.C. 360i), FDA is authorized to
require manufacturers to report medical device-related deaths, serious
injuries, and malfunctions to FDA; to require user facilities to report
device-related deaths directly to FDA and to manufacturers; and to
report serious injuries to the manufacturer. Section 522 of the FD&C
Act (21 U.S.C. 360l) authorizes FDA to require manufacturers to conduct
postmarket surveillance of medical devices. Section 705(b) of the FD&C
Act (21 U.S.C. 375(b)) authorizes FDA to collect and disseminate
information regarding medical products or cosmetics in situations
involving imminent danger to health or gross deception of the consumer.
Section 903(d)(2) of the FD&C Act (21 U.S.C. 393(d)(2)) authorizes the
Commissioner of Food and Drugs to implement general powers (including
conducting research) to carry out effectively the mission of FDA. These
sections of the FD&C Act enable FDA to enhance consumer protection from
risks associated with medical products usage that are not foreseen or
apparent during the premarket notification and review process. FDA's
regulations governing application for Agency approval to market a new
drug (21 CFR part 314) and regulations governing biological products
(21 CFR part 600) implement these statutory provisions. Currently, FDA
monitors medical product related postmarket adverse events via both the
mandatory and voluntary MedWatch reporting systems using FDA Forms 3500
and 3500A (OMB control number 0910-0291) and the vaccine adverse event
reporting system.
    FDA is seeking OMB clearance to collect vital information via a
series of rapid response surveys. Participation in these surveys will
be voluntary. This request covers rapid response surveys for community
based health care professionals, general type medical facilities,
specialized medical facilities (those known for cardiac surgery,
obstetrics/gynecology services, pediatric services, etc.), other health
care professionals, patients, consumers, and risk managers working in
medical facilities. FDA will use the information gathered from these
surveys to quickly obtain vital information about medical product risks
and interventions to reduce risks so the Agency may take appropriate
public health or regulatory action including dissemination of this
information as necessary and appropriate.
    FDA projects six emergency risk related surveys per year with a
sample of between 50 and 10,000 respondents per survey. FDA also
projects a response time of 0.5 hours per response. These estimates are
based on the maximum sample size per questionnaire that FDA may be able
to obtain by working with health care professional organizations. The
annual number of surveys was determined by the maximum number of
surveys per year FDA has ever conducted under this collection.
    In the Federal Register of December 24, 2013 (78 FR 77686), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                  Number of
           Activity               Number of     responses per   Total annual     Average burden     Total hours
                                 respondents     respondent       responses       per response
----------------------------------------------------------------------------------------------------------------
FDA Rapid Response Survey....          10,000               6          60,000  0.5 (30 minutes).          30,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: March 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07931 Filed 4-8-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 78, Number 229 (Wednesday, November 27, 2013)]
[Notices]
[Page 71024]
[FR Doc No: 2013-28213]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Air Taxi and
Commercial Operator Airport Activity Survey

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection.

DATES: Written comments should be submitted by January 27, 2014.

ADDRESSES: Send comments to the FAA at the following address: Ms. Kathy
DePaepe, Room 126B, Federal Aviation Administration, AES-200, 6500 S.
MacArthur Blvd., Oklahoma City, OK 73169.

FOR FURTHER INFORMATION CONTACT: Kathy DePaepe at<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0067.
    Title: Air Taxi and Commercial Operator Airport Activity Survey.
    Form Numbers: FAA Form 1800-31.
    Type of Review: Renewal of an information collection.
    Background: Enplanement data collected from air taxi and commercial
operators are required for the calculation of air carrier airport
sponsor apportionments as specified by the Airport Improvement Program
(AIP), and 49 U.S.C. part A, Air Commerce Safety, and part B, Airport
Development and Noise. The data collected serves as the only source of
data for charter and nonscheduled passenger data by Part 135 operators
(air taxis). The data received on the form is then incorporated into
the Air Carrier Activity Information System which is used to determine
whether an airport is eligible for AIP funds and for calculating
primary airport sponsor apportionment as specified by Title 49 U.S.C.
The data collected on the form includes passenger enplanements by
carrier and by airport.
    Respondents: Approximately 300 Part 135 operators.
    Frequency: Information is collected annually.
    Estimated Average Burden per Response: 1.5 hours.
    Estimated Total Annual Burden: 450 hours.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including 1. Whether the proposed
collection of information is necessary for FAA's performance; 2. The
accuracy of the estimated burden; 3. Ways for FAA to enhance the
quality, utility and clarity of the information collection; and 4. Ways
that the burden could be minimized without reducing the quality of the
collected information. The agency will summarize and/or include your
comments in the request for OMB's clearance of this information
collection.

    Issued in Washington, DC on November 18, 2013.
Albert R. Spence,
FAA Assistant Information Collection Clearance Officer, IT Enterprises
Business Services Division, AES-200.
[FR Doc. 2013-28213 Filed 11-26-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 202 (Monday, October 20, 2014)]
[Notices]
[Pages 62612-62613]
[FR Doc No: 2014-24889]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #2

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

    Docket Numbers: EC15-9-000.
    Applicants: Duke Energy Progress, Inc.
    Description: Application for Authorization to Transfer
Jurisdictional Assets Under Section 203 of the Federal Power Act of
Duke Energy Progress, Inc.
    Filed Date: 10/10/14.
    Accession Number: 20141010-5155.
    Comments Due: 5 p.m. ET 10/31/14.

    Take notice that the Commission received the following exempt
wholesale generator filings:
    Docket Numbers: EG15-4-000.
    Applicants: Mesquite Creek Wind LLC.
    Description: Self-Certification of EG or FC of Mesquite Creek Wind
LLC.
    Filed Date: 10/10/14.
    Accession Number: 20141010-5090.
    Comments Due: 5 p.m. ET 10/31/14.

    Docket Numbers: EG15-5-000.
    Applicants: Sky Global Power One, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator of Sky Global Power One, LLC.
    Filed Date: 10/10/14.
    Accession Number: 20141010-5122.
    Comments Due: 5 p.m. ET 10/31/14.

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER14-2678-001.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Tariff Amendment per 35.17(b): 2014-10-10_SA 2684
Amended GRE-MP Ortman T-T IA to be effective 8/20/2014.
    Filed Date: 10/10/14.
    Accession Number: 20141010-5095.
    Comments Due: 5 p.m. ET 10/31/14.

    Docket Numbers: ER14-2894-001.
    Applicants: Bounce Energy NY, LLC.
    Description: Tariff Amendment per 35.17(b): Amendment to 128 to be
effective 10/10/2014.
    Filed Date: 10/10/14.
    Accession Number: 20141010-5000.
    Comments Due: 5 p.m. ET 10/31/14.

    Docket Numbers: ER14-2896-001.
    Applicants: Bounce Energy PA, LLC.
    Description: Tariff Amendment per 35.17(b): Amendment to 129 to be
effective 10/10/2014.
    Filed Date: 10/10/14.
    Accession Number: 20141010-5001.
    Comments Due: 5 p.m. ET 10/31/14.

    Docket Numbers: ER15-72-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): 1976R3
Kaw Valley Electric Cooperative, Inc. NITSA and NOA to be effective 8/
1/2014.
    Filed Date: 10/10/14.
    Accession Number: 20141010-5075.
    Comments Due: 5 p.m. ET 10/31/14.

    Docket Numbers: ER15-73-000.
    Applicants: California Independent System Operator Corporation.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): 2014-
10-10_SVP_MSSA to be effective 11/1/2014.
    Filed Date: 10/10/14.
    Accession Number: 20141010-5100.
    Comments Due: 5 p.m. ET 10/31/14.

    Docket Numbers: ER15-74-000.
    Applicants: Duke Energy Progress, Inc.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): DEP-
NCEMPA Wholesale PPA and Amendments to Rate Schedules to be effective
12/10/2014.

    Filed Date: 10/10/14.
    Accession Number: 20141010-5134.
    Comments Due: 5 p.m. ET 10/31/14.

    Docket Numbers: ER15-75-000.
    Applicants: PacifiCorp.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): Revised
Network Integration Transmission SAs (BAL-002) to be effective 10/1/
2014.
    Filed Date: 10/10/14.
    Accession Number: 20141010-5143.
    Comments Due: 5 p.m. ET 10/31/14.

    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: October 10, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-24889 Filed 10-17-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 129 (Thursday, July 5, 2012)]
[Notices]
[Pages 39773-39774]
[FR Doc No: 2012-16372]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67292; File No. SR-NASDAQ-2012-073]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Modify Its Excess Order Fee

June 28, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on June 25, 2012, The NASDAQ Stock Market LLC (``NASDAQ'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') a proposed rule change as described in Items I, II and
III below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    NASDAQ proposes to institute an excess order fee. [sic] NASDAQ will
implement the proposed change on July 2, 2012. The text of the proposed
rule change is available at http://nasdaq.cchwallstreet.com, at
NASDAQ's principal office, 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 self-regulatory organization
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 those statements may be examined at
the places specified in Item III below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

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

1. Purpose
    NASDAQ recently submitted a proposed rule change to introduce an
Excess Order Fee,\3\ aimed at reducing inefficient order entry
practices of certain market participants that place excessive burdens
on the systems of NASDAQ and its members and that may negatively impact
the usefulness and life cycle cost of market data. The fee is scheduled
to be implemented on July 2, 2012. In general, the determination of
whether to impose the fee on a particular market participant identifier
(``MPID'') is made by calculating the ratio between (i) entered orders,
weighted by the distance of the order from the national best bid or
offer (``NBBO''), and (ii) orders that execute in whole or in part. The
fee is imposed on MPIDs that have an ``Order Entry Ratio'' of more than
100.
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    \3\ Securities Exchange Act Release No. 66951 (May 9, 2012), 77
FR 28647 (May 15, 2012) (SR-NASDAQ-2012-055).
---------------------------------------------------------------------------

    Through this proposed rule change, the Exchange is modifying the
parameters of the fee slightly to provide that all calculations under
the rule establishing the fee will be based on orders received by
NASDAQ during regular market hours (generally, 9:30 a.m. to 4:00 p.m.)
\4\ and will exclude orders received at other times, even if they
execute during regular market hours. NASDAQ is making the change
because the concerns about inefficient order entry practices that have
prompted the fee are generally not present with regard to trading
activity outside of regular market hours, when volumes are light.
NASDAQ is also concerned that lower execution rates outside of regular
market hours may skew calculations under the rule, such that an MPID
that is considered acceptably efficient during regular market hours
would be required to pay a fee under the rule due to its activity
outside of regular market hours.
---------------------------------------------------------------------------

    \4\ Regular market hours may be different in some circumstances,
such as on the day after Thanksgiving, when regular market hours on
all exchanges traditionally end at 1:00 p.m.
---------------------------------------------------------------------------

2. Statutory Basis
    NASDAQ believes that the proposed rule change is consistent with
the provisions of Section 6 of the Act,\5\ in general, and with
Sections 6(b)(4) and 6(b)(5) of the Act,\6\ in particular, in that it
provides for the equitable allocation of reasonable dues, fees and
other charges among members and issuers and other persons using any
facility or system which NASDAQ operates or controls, and is not
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f.
    \6\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    As originally proposed and as modified by this proposed rule
change, NASDAQ believes that the Order Entry Fee is reasonable because
it is designed to achieve improvements in the quality of displayed
liquidity and market data that will benefit all market participants. In
addition, although the level of the fee may theoretically be very high,
the fee is reasonable because market participants may readily avoid the
fee by making improvements in their order entry practices that reduce
the number of orders they enter, bring the prices of their orders
closer to the NBBO, and/or increase the percentage of their orders that
execute. The proposed change to the fee is reasonable because it will
reduce the likelihood of the fee being imposed on an MPID that is
considered acceptably efficient during regular market hours, when the
impact of

inefficient trading on NASDAQ and other market participants is highest.
    For similar reasons, the fee is consistent with an equitable
allocation of fees, because although the fee may apply to only a small
number of market participants, the fee would be applied to them in
order to encourage better order entry practices that will benefit all
market participants. Ideally, the fee will be applied to no one,
because market participants will adjust their behavior in order to
avoid the fee. The proposed change will increase the likelihood that
the fee will not be imposed in unwarranted circumstances. Finally,
NASDAQ believes that the fee is not unfairly discriminatory. Although
the fee may apply to only a small number of market participants, it
will be imposed because of the negative externalities that such market
participants impose on others through inefficient order entry
practices. The proposed modification to the fee is not unfairly
discriminatory because although it will lessen the potential impact of
the fee on MPIDs that are active outside of regular market hours, this
change is rationally related to the fee's purpose of promoting
efficient trading practices in conditions where inefficiency may
negatively impact NASDAQ and other market participants.

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

    NASDAQ does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended. Specifically,
NASDAQ believes that the fee will constrain market participants from
pursuing certain inefficient and potentially abusive trading
strategies. To the extent that this change may be construed as a burden
on competition, NASDAQ believes that it is appropriate in order to
further the purposes of Section 6(b)(5) of the Act.\7\ The proposed
change will lessen any burden on competition by removing from
consideration orders entered outside of regular market hours, when
concerns about the impact of inefficient trading on NASDAQ and other
market participants are diminished.
---------------------------------------------------------------------------

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

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

    Written comments were neither solicited nor received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\8\ At any time within 60 days of the filing
of the proposed rule change, the Commission summarily may temporarily
suspend such rule change if it appears to the Commission that such
action is necessary or appropriate in the public interest, for the
protection of investors, or otherwise in furtherance of the purposes of
the Act. If the Commission takes such action, the Commission shall
institute proceedings to determine whether the proposed rule should be
approved or disapproved.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(a)(ii). [sic]
---------------------------------------------------------------------------

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-NASDAQ-2012-073 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NASDAQ-2012-073. 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 on
official business days between the hours of 10 a.m. and 3 p.m. Copies
of the filing also will be available for inspection and copying at the
principal offices of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NASDAQ-2012-073, and should be submitted on or before
July 26, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

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

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-16372 Filed 7-3-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 29 (Thursday, February 12, 2015)]
[Notices]
[Page 7865]
[FR Doc No: 2015-02926]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9922-16-OW]

Transfer of the California Safe Drinking Water Program From the
California Department of Public Health to the California State Water
Resources Control Board

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This document informs the public that the California Drinking
Water Program has been transferred from the California Department of
Public Health to the California State Water Resources Control Board.

DATES: This transfer became effective under California legislation on
July 1, 2014, and was certified to the EPA by the California Attorney
General on August 7, 2014.

FOR FURTHER INFORMATION CONTACT: Luis Garcia-Bakarich, Drinking Water
Management Section (WTR3-1); Environmental Protection Agency, Region 9,
75 Hawthorne Street, San Francisco, California 94105; telephone number:
(415) 972-3237; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Notice is hereby given that the State of
California enacted legislation (SB 861) that transfers to the
California State Water Resources Control Board the authority, duties,
powers, purposes, functions, responsibilities, and jurisdiction of the
California Department of Public Health for the purposes of the
administration of the California Safe Drinking Water Act programs
effective July 1, 2014.

Background

    The California Safe Drinking Water Act provides for the operation
of public water systems and imposes various duties and responsibilities
for the regulation and control of drinking water in the State of
California including enforcing provisions of the federal Safe Drinking
Water Act. The program transfer under SB 861 included all elements of
the approved regulatory program as well as administration of the
Drinking Water State Revolving Fund and the Environmental Laboratory
Accreditation Program. An interagency agreement between the California
State Water Resources Control Board and the California Department of
Public Health was established for assuring the availability of drinking
water laboratory services pursuant to 40 CFR 142.10 (b)(4).
    40 CFR 142.17(a)(1) requires the State to notify the Administrator
of the EPA of any State-initiated program changes and of any transfer
of all or part of its program from the approved State agency to another
State agency. On August 7, 2014, the California Attorney General
certified to the EPA that the ``[t]ransfer of California's authority to
carry out the Safe Drinking Water Program from the California
Department of Public Health to the California State Water Resources
Control Board has been effectuated by SB 861 (Stats. 2014, ch. 35,
Sec. Sec.  62, 63, 127, 182).'' The Attorney General's certification
confirmed that the laws and regulations of California to carry out the
Safe Drinking Water Program remain in effect, and further stated that
``[i]n accordance with the Safe Drinking Water Act as amended, and 40
CFR 142.12(c)(1)(iii), the statutes and regulations of the State of
California to carry out the Safe Drinking Water Act have been duly
adopted and are enforceable under California law and the California
State Constitution.''
    The Attorney General's certification further confirmed that the
California State Water Resources Control Board has regulatory and
enforcement authority over drinking water standards and water systems
under California Health and Safety Code section 116271.
    The State of California was first granted primary enforcement
responsibility for public water systems under section 1413 of the Safe
Drinking Water Act on June 2, 1978 (43 FR 25180, June 9, 1978).

    Dated: January 30, 2015.
Michael Montgomery,
 Acting Director, Water Division, EPA Region 9.
[FR Doc. 2015-02926 Filed 2-11-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: March 7, 2008 (Volume 73, Number 46)]
[Rules and Regulations]
[Page 12275-12276]
[DOCID:fr07mr08-10]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[EPA-HQ-OAR-2006-0406, FRL-8540-2]
RIN 2060-AM74

National Emission Standards for Hazardous Air Pollutants for
Source Categories: Gasoline Distribution Bulk Terminals, Bulk Plants,
and Pipeline Facilities; and Gasoline Dispensing Facilities; Correction

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule; correction.

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

SUMMARY: This action corrects certain text of the final rules entitled
``National Emission Standards for Hazardous Air Pollutants for Source
Categories: Gasoline Distribution Bulk Terminals, Bulk Plants, and
Pipeline Facilities; and Gasoline Dispensing Facilities.'' The final
rules were published in the Federal Register on January 10, 2008.

DATES: Effective Date: March 7, 2008.

FOR FURTHER INFORMATION CONTACT: Mr. Stephen Shedd, Office of Air
Quality Planning and Standards, Sector Policies and Programs Division,
Coatings and Chemicals Group (E143-01), EPA, Research Triangle Park, NC
27711, telephone:<PHONE_NUMBER>, facsimile number:<PHONE_NUMBER>, e-
mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. What Is the Background for the Corrections?

    On January 10, 2008 (73 FR 1916), EPA issued final rules in which
EPA promulgated national emission standards for hazardous air
pollutants for gasoline distribution bulk terminals, bulk plants, and
pipeline facilities and for gasoline dispensing facilities. EPA
subsequently determined that certain sections of the final rules
contained incorrect references to paragraphs within those and other
sections. This action corrects those technical errors.
    These corrections do not affect the substance of the final rules,
nor do they change the rights or obligations of any party. Rather, this
action merely corrects certain technical errors in the references in
the final rules. Thus, it is proper to issue these corrections to the
final rules without notice and comment. Section 553 of the
Administrative Procedure Act (APA), 5 U.S.C. 553(b)(B), provides that,
when an agency for good cause finds that notice and public procedure
are impracticable, unnecessary, or contrary to the public interest, the
agency may issue a rule without providing notice and an opportunity for
public comment. We have determined that there is good cause for making
this action final without prior proposal and opportunity for comment
because the changes to the final rules are minor technical corrections,
are noncontroversial, and do not substantively change the agency
actions taken in the final rules. Thus, notice and public procedure are
unnecessary. We find that this constitutes good cause under 5 U.S.C.
553(b)(B).

II. What Are the Corrections to the Final Rules (73 FR 1916)?

    This notice corrects the following errors. In adding four test
methods to 40 CFR 63.14 through Incorporation by Reference, we
incorrectly assigned new paragraph numbers to be added to 40 CFR 63.14
that were already in use. To correct this error, it is necessary to
change the paragraph numbers that we are assigning to the four test
methods being incorporated by reference. The test method added as Sec.
63.14(b)(63) should have been added as Sec.  63.14(b)(65) and the three
test methods added as Sec.  63.14(l)(1), (2), and (3) should have been
added as Sec.  63.14(m)(1), (2), and (3).
    EPA has also determined that the text of 40 CFR 63.11092 and 40 CFR
63.11095 of subpart BBBBBB and 40 CFR 63.11117 of subpart CCCCCC
contains incorrect references. In 40 CFR 63.11092 of subpart BBBBBB,
paragraph (a)(3) included a reference to conduct an initial performance
test within 180 days of the ``rule promulgation'' date. The rule
mistakenly referred to the ``promulgation'' date instead of the
``compliance'' date. Thus, the text ``rule promulgation'' will be
replaced with the text ``compliance date specified in Sec.  63.11083''.
Also, in 40 CFR 63.11092 of subpart BBBBBB, paragraph (b)(1)(i)(B)(1)
included a reference to ``(b)(1)(i)(B)(1)(i), (ii), and (iii) of this
section'' when the reference should be to ``(b)(1)(i)(B)(1)(i), (ii),
and (iii) of this section''. In 40 CFR 63.11095 of subpart BBBBBB,
paragraph (c) included a reference to ``(a)(3) and (b)(4) of this
section'' when the reference should be to ``(a)(3) and (b)(5) of this
section''. In subpart CCCCCC, 40 CFR 63.11117, paragraph (e) included a
reference to ``Sec.  63.11124(b)'' when the reference should be to
``Sec.  63.11124(a)''. In 40 CFR 63.11118, paragraph (c) included two
improper references to ``paragraphs (a) and (b)'' and ``Sec.
63.11116'' when the references should be to ``paragraph (b)'' and
``Sec.  63.11117'', respectively. Also, in 40 CFR 63.11124, paragraph
(a) refers to ``(a)(1) through (4) of this section'' but section (a)(4)
does not exist, so the text will be corrected to refer to ``(a)(1)
through (3) of this section''. Additionally, in 40 CFR 63.11124,
paragraph (a)(1)(iii) refers to ``(a), (b) and (c)(1) or paragraph
(c)(2) of Sec.  63.11117'' but, while paragraph (c) exists, paragraphs
(c)(1) and (c)(2) do not exist, so the text will be corrected to refer
to ``(a) through (c) of Sec.  63.11117''. In 40 CFR 63.11124, paragraph
(b)(1)(iii) refers to ``(a)

through (d) of Sec.  63.11118'' but paragraph (d) does not have options
for the owner or operator to choose from and therefore notification
information is not needed, so the text will be corrected to refer to
``(a) through (c) of Sec.  63.11118''.

III. Statutory and Executive Order Reviews

    Under Executive Order 12866, Regulatory Planning and Review (58 FR
51735, October 4, 1993), this action is not a ``significant regulatory
action'' and is, therefore, not subject to review by the Office of
Management and Budget (OMB). This action is a correction to certain
text in the final rules and is not a ``major rule'' as defined by 5
U.S.C. 804(2). The final rules themselves, however, were reviewed by
OMB. The corrections do not impose an information collection burden
under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C.
3501, et seq.). Because EPA has made a ``good cause'' finding that this
action is not subject to notice-and-comment requirements under the APA
or any other statute, it is not subject to the regulatory flexibility
provisions of the Regulatory Flexibility Act (5 U.S.C. 601, et seq.),
or to sections 202 and 205 of the Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104-4). In addition, this action does not
significantly or uniquely affect small governments or impose a
significant intergovernmental mandate, as described in sections 203 and
204 of the UMRA. This technical correction action also does not
significantly or uniquely affect the communities of tribal governments,
as specified in Executive Order 13175, Consultation and Coordination
with Indian Tribal Governments (65 FR 67249, November 9, 2000). The
corrections do not have substantial direct effects on the States, on
the relationship between the national government and the States, or on
the distribution of power and responsibilities among the various levels
of government, as specified in Executive Order 13132, Federalism (64 FR
43255, August 10, 1999). The corrections also are not subject to
Executive Order 13045, Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997) because the final
rules were determined not to be subject to this order and this action
does not significantly change the final rules.
    This technical correction action does not involve changes to the
technical standards related to test methods or monitoring methods;
thus, the requirements of section 12(d) of the National Technology
Transfer and Advancement Act of 1995 (15 U.S.C. 272) do not apply. The
corrections also do not involve special consideration of environmental
justice-related issues as required by Executive Order 12898, Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
    The corrections are not subject to Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001) because this action is
not a significant regulatory action under Executive Order 12866.
    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
final action and other required information to the United States
Senate, the United States House of Representatives, and the Comptroller
General of the United States prior to publication of this action in the
Federal Register. This action is not a ``major rule'' as defined by 5
U.S.C. 804(2). This correction is effective March 7, 2008.
    EPA's compliance with the above statutes and Executive Orders for
the underlying rule is discussed in the January 10, 2008 Federal
Register notice containing ``National Emission Standards for Hazardous
Air Pollutants for Source Categories: Gasoline Distribution Bulk
Terminals, Bulk Plants, and Pipeline Facilities; and Gasoline
Dispensing Facilities'' (73 FR 1916).

List of Subjects for 40 CFR Part 63

    Environmental protection, Administrative practice and procedures,
Air pollution control, Incorporations by reference, Intergovernmental
relations, Reporting and recordkeeping requirements.

    Dated: February 29, 2008.
Robert J. Meyers,
Principal Deputy Assistant Administrator.

0
For the reasons set out in the preamble, title 40, chapter I, part 63
of the Code of Federal Regulations is amended as follows:

PART 63--[AMENDED]

0
1. The authority citation for part 63 continues to read as follows:

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

Subpart A--[Amended]

Sec.  63.14  [Amended]

0
2. Section 63.14 is amended as follows:
0
a. By redesignating paragraph (b)(63) as paragraph (b)(65).
0
b. By redesignating paragraph (l) as paragraph (m).

Subpart BBBBBB--[Amended]

Sec.  63.11092  [Amended]

0
3. Section 63.11092 is amended as follows:
0
a. In paragraph (a)(3) by removing the words ``rule promulgation'' and
adding in their place the words ``compliance date specified in Sec.
63.11083''.
0
b. In paragraph (b)(1)(i)(B)(1) by removing the words
``(b)(1)(i)(B)(1)(i), (ii), and (iii) of this section.'' and adding in
their place the words ``(b)(1)(i)(B)(1)(i), (ii), and (iii) of this
section.''

Sec.  63.11095  [Amended]

0
4. Section 63.11095 is amended in paragraph (c) by removing the
citation ``(b)(4)'' and adding in its place ``(b)(5)''.

Subpart CCCCCC--[Amended]

Sec.  63.11117  [Amended]

0
5. In Sec.  63.11117, paragraph (e) is amended by removing the citation
``Sec.  63.11124(b)'' and adding in its place the citation ``Sec.
63.11124(a)''.

Sec.  63.11118  [Amended]

0
6. In Sec.  63.11118, paragraph (c) introductory text is amended by
removing the words ``paragraphs (a) and (b) of this section, but must
comply with the requirements in Sec.  63.11116.'' and adding in their
place the words ``paragraph (b) of this section, but must comply with
the requirements in Sec.  63.11117.''

Sec.  63.11124  [Amended]

0
7. Section 63.11124 is amended as follows:
0
a. In paragraph (a) introductory text is amended by removing the
citation ``(4)'' and adding in its place the citation ``(3)''.
0
b. In paragraph (a)(1)(iii) introductory text is amended by removing
the citation ``(a), (b) and (c)(1) or paragraph (c)(2)'' and adding in
its place the citation ``(a) through (c)''.
0
c. In paragraph (b)(1)(iii) introductory text is amended by removing
the citation ``(a) through (d)'' and adding in its place the citation
``(a) through (c)''.

[FR Doc. E8-4554 Filed 3-6-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 144 (Friday, July 28, 2023)]
[Notices]
[Pages 48833-48834]
[FR Doc No: 2023-15956]

=======================================================================
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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER23-2448-000]

Tunica Windpower LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Tunica Windpower LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is August 10, 2023.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members and others, access
publicly available information and navigate Commission processes. For
public inquiries and assistance with making filings such as
interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].

    Dated: July 21, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-15956 Filed 7-27-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 88 (Monday, May 7, 2012)]
[Notices]
[Pages 26812-26813]
[FR Doc No: 2012-10878]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66889; File No. SR-ISE-2012-22]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Designation of a Longer Period for Commission Action on
Proposed Rule Change To Add an Index Option Product for Trading on the
Exchange

May 1, 2012.
    On March 9, 2012, International Securities Exchange, LLC
(``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to list and trade options on the ISE Max SPY
index. The proposed rule change was published for comment in the
Federal Register on March 22,

2012.\3\ The Commission received three comment letters on this
proposal.\4\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 66614 (March 16,
2012), 77 FR 16883.
    \4\ See letters to Elizabeth M. Murphy, Secretary, Commission,
from Janet McGinness, EVP & Corporate Secretary, NYSE Euronext,
dated April 2, 2012; Kenneth M. Vittor, Executive Vice President and
General Counsel, McGraw-Hill Companies, Inc., dated April 11, 2012;
and Edward T. Tilly, President and Chief Operating Officer, Chicago
Board Options Exchange, Incorporated, dated April 13, 2012.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \5\ provides that within 45 days of the
publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day for this filing is May 6, 2012. The Commission is extending
this 45-day time period.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission finds it appropriate to designate a longer period
within which to take action on the proposed rule change so that it has
sufficient time to consider this proposed rule change, which would
allow the listing of a new option product, the comment letters that
have been submitted in connection with this proposed rule change, and
any response to the comment letters submitted by the Exchange.
    Accordingly, the Commission, pursuant to Section 19(b)(2) of the
Act,\6\ designates June 20, 2012 as the date by which the Commission
should either approve or disapprove, or institute proceedings to
determine whether to disapprove, the proposed rule change (File No. SR-
ISE-2012-22).
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(31).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-10878 Filed 5-4-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 9 (Wednesday, January 14, 2015)]
[Proposed Rules]
[Page 1855]
[FR Doc No: C1-2015-00205]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 112

[Docket No. FDA-2014-N-2244]
RIN 0910-AG35

Draft Environmental Impact Statement for the Proposed Rule,
Standards for Growing, Harvesting, Packing, and Holding of Produce for
Human Consumption; Notice for Public Meeting on Draft Environmental
Impact Statement

Correction

    FR proposed rule document 2015-00205 beginning on pages 1478 in the
issue of Monday, January 12, 2015, was never placed on public
inspection and was published in error. It should be removed.

[FR Doc. C1-2015-00205 Filed 1-12-15; 4:15 pm]
BILLING CODE 1505-01-D