[Federal Register Volume 87, Number 178 (Thursday, September 15, 2022)]
[Notices]
[Pages 56684-56686]
[FR Doc No: 2022-19943]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2110]

Anesthesiology and Respiratory Therapy Devices Panel of the
Medical Devices Advisory Committee; Notice of Meeting; Establishment of
a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

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

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

DATES: The meeting will be held virtually on November 1, 2022, from 9
a.m. to 6 p.m. eastern time.

ADDRESSES: Please note that due to the impact of the COVID-19 pandemic,
all meeting participants will be joining this advisory committee
meeting via an online teleconferencing platform. Answers to commonly
asked questions about FDA advisory committee meetings, including
information regarding special accommodations due to a disability, may
be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2022-N-2110. The docket will close on December
1, 2022. Either electronic or written comments on this public meeting
must be submitted by December 1, 2022. Please note that late, untimely
filed comments will not be considered. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. eastern
time at the end of December 1, 2022. Comments

received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
    Comments received on or before October 18, 2022, will be provided
to the committee. Comments received after that date will be taken into
consideration by FDA. In the event that the meeting is cancelled, FDA
will continue to evaluate any relevant applications or information, and
consider any comments submitted to the docket, as appropriate.
    You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2022-N-2110 for ``Anesthesiology and Respiratory Therapy Devices
Panel of the Medical Devices Advisory Committee; Notice of Meeting;
Establishment of a Public Docket; Request for Comments.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<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.'' FDA will review
this copy, including the claimed confidential information, in its
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify the information as ``confidential.'' Any
information marked as ``confidential'' will not be disclosed except in
accordance with 21 CFR 10.20 and other applicable disclosure law. For
more information about FDA's posting of comments to public dockets, see
80 FR 56469, September 18, 2015, or access the information at: https://www.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>.

FOR FURTHER INFORMATION CONTACT: Akinola Awojope, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5216, Silver Spring, MD 20993-0002, 301-
636-0512, [email protected], or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area). A notice in the Federal Register about last minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check the FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before the
meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing platform. The committee
will discuss ongoing concerns that pulse oximeters may be less accurate
in individuals with darker skin pigmentations. The committee will also
discuss factors that may affect pulse oximeter accuracy and
performance, the available evidence about the accuracy of pulse
oximeters, recommendations for patients and healthcare providers, and
the amount and type of data that should be provided by manufacturers to
assess pulse oximeter accuracy and to guide other regulatory actions as
needed.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available on FDA's website at
the time of or after the advisory committee meeting. Background
material and the link to the online teleconference meeting room will be
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the Docket (see
ADDRESSES) on or before October 18, 2022, will be provided to the
committee. Oral presentations from the public will be scheduled between
approximately 10:30 a.m. and 11:30 a.m. and 1 p.m. and 2 p.m. eastern
time. Those individuals interested in making formal oral presentations
should notify the contact person and submit a brief statement of the
general nature of the evidence or arguments they wish to present, the
names and addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on

or before October 12, 2022. Time allotted for each presentation may be
limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by October
14, 2022.
    For press inquiries, please contact the Office of Media Affairs at
[email protected] or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Ann Marie Williams, at [email protected] or 301-
796-5966, at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: September 9, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-19943 Filed 9-14-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: November 12, 2008 (Volume 73, Number 219)]
[Notices]
[Page 66888-66889]
[DOCID:fr12no08-76]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. DI09-2-000]

Alaska Power & Telephone Company; Notice of Declaration of
Intention and Soliciting Comments, Protests, and/or Motions To
Intervene

November 4, 2008.
    Take notice that the following application has been filed with the
Commission and is available for public inspection:
    a. Application Type: Declaration of Intention.
    b. Docket No: DI09-2-000.
    c. Date Filed: October 28, 2008.
    d. Applicant: Alaska Power & Telephone Company.
    e. Name of Project: Connelly Lake Hydroelectric Project.
    f. Location: The proposed Connelly Lake Hydroelectric Project will
be located on Connelly Lake, an unnamed stream, and the Chilkoot River,
near the towns of Haines and Skagway, Haines Borough, Alaska, affecting
T. 28 S, R. 57 E, secs. 22, 26, 27, 34, 35, and 36, and T. 29 S, R. 58
E, secs. 4, 5, 9, 10, 14, 15, 22, 23, 25, and 26, Copper River
Meridian.
    g. Filed Pursuant to: Section 23(b)(1) of the Federal Power Act, 16
U.S.C. 817(b).
    h. Applicant Contact: Glen D. Martin, Project Manager, 193 Otto
Street, P.O. Box 3222, Port Townsend, WA 98368, telephone: (360) 385-
1733, x122; Fax:<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>    i. FERC Contact: Any questions on this notice should be addressed
to Henry Ecton,<PHONE_NUMBER>, or E-mail address:
<EMAIL_ADDRESS>    j. Deadline for filing comments, protests, and/or motions: December
05, 2008.
    All documents (original and eight copies) should be filed with:
Secretary, Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. Comments, protests, and/or interventions may be
filed electronically via the Internet in lieu of paper. Any questions,
please contact the Secretary's Office. See, 18 CFR 385.2001(a)(1)(iii)
and the instructions on the Commission's Web site at http://
www.ferc.gov under the ``e-Filing'' link.
    Please include the docket number (DI09-2-000) on any comments,
protests, and/or motions filed.
    k. Description of Project: The proposed Connelly Lake Hydropower
Project will include: (1) A 48-foot-high, 100-foot-wide rock-filled
dam; (2) a lake with a storage capacity of 4,700 acre-feet; (3) a
6,188-foot-long, 30-inch-diameter penstock; (4) a 40-foot-wide, 60-
foot-long metal powerhouse containing one or two turbines, with an
installed capacity of 6,200 kW; (5) a tailrace emptying into the
Chilkoot River; and (6) appurtenant facilities. The proposed project
will not be connected to an interstate grid, and will not occupy any
tribal or federal lands.
    When a Declaration of Intention is filed with the Federal Energy
Regulatory Commission, the Federal Power Act requires the Commission to
investigate and determine if the interests of interstate or foreign
commerce would be affected by the project. The Commission also
determines whether or not the project: (1) Would be located on a
navigable waterway; (2) would occupy or affect public lands or
reservations of the United States; (3) would utilize surplus water or
water power from a government dam; or (4) if applicable, has involved
or would involve any construction subsequent to 1935 that may have
increased or would increase the project's head or generating capacity,
or have otherwise significantly modified the project's pre-1935 design
or operation.
    l. Locations of the Application: Copies of this filing are on file
with the Commission and are available for public inspection. This
filing may be viewed on the Web at http://www.ferc.gov using the
``eLibrary'' link, select ``Docket No.'' and follow the instructions.
For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll-free at<PHONE_NUMBER>, or TTY,
contact<PHONE_NUMBER>.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene--Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR
385.210,.211,.214. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a

party to the proceeding. Any comments, protests, or motions to
intervene must be received on or before the specified comment date for
the particular application.
    o. Filing and Service of Responsive Documents--Any filings must
bear in all capital letters the title ``COMMENTS'', ``PROTESTS'', AND/
OR ``MOTIONS TO INTERVENE'', as applicable, and the Docket Number of
the particular application to which the filing refers. A copy of any
motion to intervene must also be served upon each representative of the
Applicant specified in the particular application.
    p. Agency Comments--Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-26784 Filed 11-10-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: July 30, 2007 (Volume 72, Number 145)]
[Notices]
[Page 41561-41563]
[DOCID:fr30jy07-87]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56120; File No. SR-NASDAQ-2007-060]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
and Amendment No. 1 Thereto To Extend Nasdaq's Authority Under Its
Cease and Desist Pilot Program

Date: July 24, 2007.
    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 19, 2007, The NASDAQ Stock Market LLC (``Nasdaq'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I and II below, which Items have been
substantially prepared by Nasdaq. Nasdaq has filed the proposal as a
``non-controversial'' rule change pursuant to section 19(b)(3)(A) of
the

Act \3\ and Rule 19b-4(f)(6) thereunder,\4\ which renders the proposal
effective upon filing with the Commission. On July 20, 2007, Nasdaq
filed Amendment No. 1 to the proposed rule change. The Commission is
publishing this notice to solicit comments on the proposed rule change,
as amended, from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Nasdaq proposes a rule change to extend for a two-year period, to
June 23, 2009, Nasdaq's authority under its cease and desist pilot
program. At this time, Nasdaq is not proposing any substantive changes
to the rules covered by the pilot program. The text of the proposed
rule change is available at Nasdaq, the Commission's Public Reference
Room, and http://nasdaq.complinet.com.

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

    In its filing with the Commission, Nasdaq 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. Nasdaq 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
    In May 2003, the Commission approved, on a pilot basis, a rule
change that gave the National Association of Securities Dealers, Inc.
(``NASD'') the authority to issue temporary cease and desist orders and
made explicit NASD's ability to impose permanent cease and desist
orders as a remedy in disciplinary cases.\5\ When Nasdaq registered as
a national securities exchange, it also adopted a cease and desist
program. Because NASD is Nasdaq's regulatory services provider and
administers Nasdaq's disciplinary program under contract, Nasdaq
generally seeks to maintain comparability between its disciplinary
procedure rules and NASD's. NASD recently extended the above mentioned
pilot rule through June 23, 2009.\6\ Accordingly, Nasdaq is proposing a
comparable extension. Although Nasdaq has not had occasion to use the
authority to date, the pilot extension will ensure that the authority
remains available for the next two years. The authority under the rule
will expire after the additional two-year period unless the pilot
program is further extended or adopted on a permanent basis with
Commission approval. Nasdaq is also amending Nasdaq Rules 9556 and 9800
to delete erroneous cross-references.
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    \5\ See Securities Exchange Act Release No. 47925 (May 23,
2003), 68 FR 33548 (June 4, 2003) (SR-NASD-98-80).
    \6\ See Securities Exchange Act Release No. 55819 (May 25,
2007), 72 FR 30895 (June 4, 2007) (SR-NASD-2007-033).
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2. Statutory Basis
    Nasdaq believes that the proposed rule change is consistent with
the provisions of section 6 of the Act,\7\ in general, and with
sections 6(b)(5) and (6) of the Act,\8\ in particular, in that the
proposal is designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, and, in
general, to protect investors and the public interest, and is further
designed to provide that Nasdaq members, or persons associated with its
members, are appropriately disciplined for violations of any provisions
of the Act or Nasdaq rules. The extension of the pilot program is
consistent with Nasdaq's obligations under the Act, because cease and
desist orders are designed to stop violative conduct that is likely to
cause dissipation or conversion of assets or other significant harm to
investors.
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    \7\ 15 U.S.C. 78f.
    \8\ 15 U.S.C. 78f(b)(5) and (6).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    Nasdaq 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 on the proposed rule change were neither solicited
nor received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to section 19(b)(3)(A) of the Act \9\ and Rule 19b-
4(f)(6) thereunder.\10\ At any time within 60 days of the filing of the
proposed rule change, the Commission may summarily abrogate 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.
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    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(6).
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    Nasdaq has requested that the Commission waive the 5-day pre-filing
notice requirement and the 30-day operative delay of the proposal.
Nasdaq represents that such waivers will allow Nasdaq to implement the
proposed rule change prior to the time of the expiration of the current
pilot. The Commission believes that it is consistent with the
protection of investors and the public interest to waive the 5-day pre-
filing notice requirement and 30-day operative delay and make this
proposed rule change immediately effective.\11\ The Commission believes
that the waiver will allow Nasdaq to continue, without interruption,
the existing operation of the pilot until June 23, 2009.
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    \11\ For purposes only of waiving the 30-day operative delay of
this proposal, the Commission has considered the proposed rule's
impact on efficiency, competition, and capital formation. 15 U.S.C.
78c(f).
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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-NASDAQ-2007-060 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-NASDAQ-2007-060. 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, 100 F. Street, NE., Washington, DC
20549, on official business days between the hours of 10 a.m. and 3
p.m. Copies of such filing also will be available for inspection and
copying at the principal office of Nasdaq. 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-2007-060 and should be submitted
on or before August 20, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\12\
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    \12\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-14605 Filed 7-27-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 86, Number 31 (Thursday, February 18, 2021)]
[Notices]
[Page 10046]
[FR Doc No: 2021-03272]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No.15056-000]

Premium Energy Holdings, LLC; Notice of Preliminary Permit
Application Accepted for Filing and Soliciting Comments, Motions To
Intervene, and Competing Applications

    On November 19, 2020, Premium Energy Holdings, LLC, filed an
application for a preliminary permit, pursuant to section 4(f) of the
Federal Power Act (FPA), proposing to study the feasibility of the
Ashokan Pumped Storage Project to be located 14 miles west of the City
of Kingston in Ulster County, New York. The sole purpose of a
preliminary permit, if issued, is to grant the permit holder priority
to file a license application during the permit term. A preliminary
permit does not authorize the permit holder to perform any land-
disturbing activities or otherwise enter upon lands or waters owned by
others without the owners' express permission.
    The proposed project would consist of the following: (1) A new
2,618-foot-long, 212-foot-high roller-compacted concrete dam for the
upper reservoir for alternative 1 (Stony Clove Reservoir) with a
surface area of 245 acres and a storage capacity 22,496 acre-feet at a
surface elevation of 1,500 feet above mean sea level (msl); (2) a new
2,736-foot-long, 232-foot-high roller-compacted concrete dam for the
upper reservoir for alternative 2 (Woodland Reservoir) with a surface
area of 313 acres and a storage capacity 26,231 acre-feet at a surface
elevation of 1,210 feet msl; (3) a new 2,527-foot-long, 304-foot-high
roller-compacted concrete dam for the upper reservoir for alternative 3
(Wittenberg Reservoir) with a surface area of 226 acres and a storage
capacity 25,558 acre-feet at a surface elevation of 1,180 feet msl; (4)
the existing Ashokan Reservoir for the lower reservoir with a surface
area of 8,300 acres and a storage capacity of 382,358 acre-feet at a
surface elevation of 585 feet msl; (5) new 13.99-mile-long tunnels,
shafts, and penstocks for alternative 1 connecting the upper and lower
reservoirs; (6) new 11.58-mile-long tunnels, shafts, and penstocks for
alternative 2 connecting the upper and lower reservoirs; (7) new 3.81-
mile-long tunnels, shafts, and penstocks for alternative 3 connecting
the upper and lower reservoirs; (8) a new 500-foot-long, 125-foot-wide,
150-foot-high underground reinforced-concrete powerhouse containing
five turbine-generator units with a total rated capacity of 800
megawatts; (9) a 17.3-mile-long, 230-kilovolt new transmission line for
alternatives 1 and 2 from the proposed Ashokan switchyard to the
existing Hurley avenue substation; (10) a 12.9-mile-long, 230-kilovolt
new transmission line for alternative 3 from the proposed Ashokan
switchyard to the existing Hurley avenue substation; and (11)
appurtenant facilities. The proposed project would have a maximum
annual generation of 2,700 gigawatt-hours.
    Applicant Contact: Victor M. Rojas, Premium Energy Holdings, LLC,
355 South Lemon Avenue, Suite A, Walnut, CA 91789; phone:<PHONE_NUMBER>.
    FERC Contact: Woohee Choi; phone:<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, notices of intent, and competing
applications using the Commission's eFiling system at https://ferconline.ferc.gov/eFiling.aspx. Commenters can submit brief comments
up to 6,000 characters, without prior registration, using the eComment
system at https://ferconline.ferc.gov/QuickComment.aspx. You must
include your name and contact information at the end of your comments.
For assistance, please contact FERC Online Support. In lieu of
electronic filing, you may submit a paper copy. Submissions sent via
the U.S. Postal Service must be addressed to: Kimberly D. Bose,
Secretary, Federal Energy Regulatory Commission, 888 First Street NE,
Room 1A, Washington, DC 20426. Submissions sent via any other carrier
must be addressed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland 20852.
The first page of any filing should include docket number P-15056-000.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of the
Commission's website at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-15056) in the docket number field to access
the document. For assistance, contact FERC Online Support.

    Dated: February 11, 2021.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2021-03272 Filed 2-17-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 63 (Friday, April 1, 2016)]
[Notices]
[Pages 18861-18863]
[FR Doc No: 2016-07369]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0823]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Format and Content Requirements for Over-the-Counter
Drug Product Labeling

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the standardized format and
content requirements for the labeling of over-the-counter (OTC) drug
products.

DATES: Submit either electronic or written comments on the collection
of information by May 31, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2013-N-0823 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Format and Content Requirements
for Over-the-Counter Drug Product Labeling.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,

before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Format and Content Requirements for OTC Drug Product Labeling--21 CFR
Part 201 (OMB Control Number 0910-0340)--Extension

    In the Federal Register of March 17, 1999 (64 FR 13254) (the 1999
labeling final rule), we amended our regulations governing requirements
for human drug products to establish standardized format and content
requirements for the labeling of all marketed OTC drug products in part
201 (21 CFR part 201). The regulations in part 201 require OTC drug
product labeling to include uniform headings and subheadings, presented
in a standardized order, with minimum standards for type size and other
graphical features. Specifically, the 1999 labeling final rule added
new Sec.  201.66 to part 201. Section 201.66 sets content and format
requirements for the Drug Facts portion of labels on OTC drug products.
    On June 20, 2000 (65 FR 38191), we published a Federal Register
final rule that required all OTC drug products marketed under the OTC
monograph system to comply with the labeling requirements in Sec.
201.66 by May 16, 2005, or sooner (65 FR 38191 at 38193). Currently
marketed OTC drug products are already required to be in compliance
with these labeling requirements, and thus will incur no further burden
to comply with Drug Facts labeling requirements in Sec.  201.66.
Modifications of labeling already required to be in Drug Facts format
are usual and customary as part of routine redesign practice, and thus
do not create additional burden within the meaning of the PRA.
Therefore, the burden to comply with the labeling requirements in Sec.
201.66 is a one-time burden applicable only to new OTC drug products
introduced to the marketplace under new drug applications (NDAs),
abbreviated new drug applications (ANDAs), or an OTC drug monograph,
except for products in ``convenience size'' packages.\1\ New OTC drug
products must comply with the labeling requirements in Sec.  201.66 as
they are introduced to the marketplace.
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    \1\ In a final rule published in the Federal Register of April
5, 2002, the Agency delayed the compliance dates for the 1999
labeling final rule for all OTC drug products that: (1) Contain no
more than two doses of an OTC drug; and (2) because of their limited
available labeling space, would require more than 60 percent of the
total surface area available to bear labeling to meet the
requirements set forth in Sec.  201.66(d)(1) and (9) and, therefore,
qualify for the labeling modifications currently set forth in Sec.
201.66(d)(10) (67 FR 16304 at 16306). The Agency issued this delay
in order to develop additional rulemaking for these ``convenience
size'' products (December 12, 2006; 71 FR 74474). These products are
not currently subject to the requirements of Sec.  201.66. PRA
approval for any requirements to which they may be subject in the
future will be handled in a separate rulemaking.
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    Based on a March 1, 2010, estimate provided by the Consumer
Healthcare Products Association (75 FR 49495 at 49496, August 13,
2010), we estimated that approximately 900 new OTC drug product stock-
keeping units (SKUs) are introduced to the marketplace each year. We
estimated that these SKUs are marketed by 300 manufacturers. We
estimated that the preparation of labeling for new OTC drug products
would require 12 hours to prepare, complete, and review prior to
submitting the new labeling to us. Based on this estimate, the annual
reporting burden for this type of labeling is approximately 10,800
hours.
    All currently marketed sunscreen products are required to be in
compliance with the Drug Facts labeling requirements in Sec.  201.66,
and thus will incur no further burden under the information collection
provisions in the 1999 labeling final rule. However, a new OTC
sunscreen drug product, like any new OTC drug product, will be subject
to a one-time burden to comply with Drug Facts labeling requirements in
Sec.  201.66. We estimate that 60 new SKUs of OTC sunscreen drug
products would be marketed each year (77 FR 27234). We estimate that
these 60 SKUs would be marketed by 20 manufacturers. We estimate that
approximately 12 hours would be spent on each label, based on the most
recent estimate used for other OTC drug products to comply with the
1999 Drug Facts labeling final rule, including public comments received
on this estimate in 2010 that addressed sunscreens.
    In determining the burden for Sec.  201.66, it is also important to
consider exemptions or deferrals of the regulation allowed products
under Sec.  201.66(e). Since publication of the 1999 labeling final
rule, we have received only one request for exemption or deferral. One
response over a 10-year period equates to an annual frequency of
response equal to 0.1. In the 1999 labeling final rule, we estimated
that a request for deferral or exemption would require 24 hours to
complete (64 FR 13254 at 13276, March 17, 1999). We continue to
estimate that this type of response will require approximately 24
hours. Multiplying the annual frequency of response (0.1) by the number
of hour per response (24) gives a total response time for requesting
exemption of deferral equal to 3 hours.
    FDA estimates the burden of this collection of information as
follows:

                              Table 1--Estimated Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of
         21 CFR Section             Number of    disclosures per   Total annual   Average burden    Total hours
                                   respondents      respondent      disclosures   per disclosure
----------------------------------------------------------------------------------------------------------------
201.66(c) and (d) for new OTC               300                3             900              12          10,800
 drug products.................
201.66(c) and (d) for new OTC                20                3              60              12             720
 sunscreen products............
201.66(e)......................               1            0.125           0.125              24               3
                                --------------------------------------------------------------------------------
    Total......................  ..............  ...............  ..............  ..............          11,523
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: March 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-07369 Filed 3-31-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 215 (Monday, November 7, 2011)]
[Proposed Rules]
[Pages 68660-68661]
[FR Doc No: 2011-28676]

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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 76, No. 215 / Monday, November 7, 2011 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-0944; Directorate Identifier 2011-NE-11-AD]
RIN 2120-AA64

Airworthiness Directives; Pratt & Whitney Division (PW) PW4000
Series Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
PW4000 series turbofan engines. This proposed AD would require
replacing the fuel metering unit (FMU), part number (P/N) 50U150, at
the next shop visit after the effective date of this proposed AD. This
proposed AD was prompted by an engine overspeed event that occurred
during taxi and resulted in a high-pressure compressor (HPC) surge and
tailpipe fire. We are proposing this AD to prevent engine overspeed on
these engines, which could result in an uncontained engine failure and
damage to the airplane.

DATES: We must receive comments on this proposed AD by January 6, 2012.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Pratt & Whitney, 400 Main St., East Hartford, CT 06108, phone: (860)
565-8770. You may review copies of the referenced service information
at the FAA, Engine & Propeller Directorate, 12 New England Executive
Park, Burlington, MA 01803. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (phone:<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: James Gray, Aerospace Engineer, Engine
Certification Office, FAA, 12 New England Executive Park, Burlington,
MA 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2011-0944;
Directorate Identifier 2011-NE-11-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    We received a report of an engine overspeed during taxi, which
resulted in an HPC surge and tailpipe fire. Although the event was not
an uncontained engine failure, engine overspeed events compromise the
integrity of the rotor and can lead to an uncontained engine failure.
Our investigation concluded that the existing FMU is susceptible to a
single-point failure condition in which a complete or nearly complete
blockage of the FMU servo wash filter could occur. A blockage in the
FMU servo wash filter could result in insufficient hydraulic pressure
being available to properly control the FMU and actuator functions.
Inability to control the FMU and actuator functions, if not corrected,
could result in an engine overspeed and an uncontained engine failure
and damage to the airplane.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would require replacing the FMU, P/N 50U150, at
the next shop visit after the effective date of this proposed AD.

Costs of Compliance

    We estimate that this proposed AD affects 750 engines installed on
airplanes of U.S. registry. We also estimate that it would take about
3.2 work-hours per product to comply with this proposed AD. The average
labor rate is $85 per work-hour. Required parts would cost about
$10,698 per engine. Based on these figures, we estimate the cost of the
proposed AD on U.S. operators to be $8,227,500.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures

the Administrator finds necessary for safety in air commerce. This
regulation is within the scope of that authority because it addresses
an unsafe condition that is likely to exist or develop on products
identified in this rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect 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.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

    1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new
airworthiness directive (AD):

Pratt & Whitney Division (PW): Docket No. FAA-2011-0944; Directorate
Identifier 2011-NE-11-AD.

Comments Due Date

    (a) We must receive comments by January 6, 2012.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to all PW PW4050, PW4052, PW4056, PW4060,
PW4060A, PW4060C, PW4062, PW4062A, PW4152, PW4156, PW4156A, PW4158,
PW4160, PW4460, PW4462, and PW4650 turbofan engines, including
models with any dash number suffix.

Unsafe Condition

    (d) This AD was prompted by an engine overspeed event that
occurred during taxi and resulted in a high-pressure compressor
surge and tailpipe fire. We are issuing this AD to prevent engine
overspeed on these engines, which could result in an uncontained
engine failure and damage to the airplane.

Compliance

    (e) Comply with this AD within the compliance times specified,
unless already done.

Replacement of Fuel Metering Unit (FMU), Part Number (P/N) 50U150

    (f) At the next shop visit after the effective date of this AD,
remove FMU, P/N 50U150, and install an FMU that has been modified as
specified in paragraphs 2.A through 2.C of the Accomplishment
Instructions of PW Alert Service Bulletin PW4ENG A73-220, Revision
1, dated May 18, 2011.

Installation Prohibition

    (g) Three years from the effective date of this AD, do not
install FMU, P/N 50U150, onto any engine.

Definition of Shop Visit

    (h) For the purpose of this AD, a shop visit is when the engine
is inducted into the shop for any maintenance involving the
separation of pairs of major mating engine flanges (lettered
flanges). However, the separation of engine flanges solely for the
purposes of transporting the engine without subsequent engine
maintenance is not an engine shop visit.

Alternative Methods of Compliance (AMOCs)

    (i) The Manager, Engine Certification Office, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19.

Related Information

    (j) For more information about this AD, contact James Gray,
Aerospace Engineer, Engine Certification Office, FAA, 12 New England
Executive Park, Burlington, MA 01803; phone:<PHONE_NUMBER>; fax:
(781) 238-7199; email<EMAIL_ADDRESS>    (k) For service information identified in this AD, contact Pratt
& Whitney, 400 Main St., East Hartford, CT 06108; phone: (860) 565-
8770. You may review copies of the referenced service information at
the FAA, Engine & Propeller Directorate, 12 New England Executive
Park, Burlington, MA 01803. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.

    Issued in Burlington, Massachusetts, on October 31, 2011.
Peter A. White,
Manager, Engine & Propeller Directorate, Aircraft Certification
Service.
[FR Doc. 2011-28676 Filed 11-4-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: October 9, 2008 (Volume 73, Number 197)]
[Notices]
[Page 59706]
[DOCID:fr09oc08-160]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Rule on Passenger Facility Charge (PFC)
Application 08-08-C-00-SMF, To Impose and Use PFC Revenue at Sacramento
International Airport, Sacramento, CA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of Intent to Rule on Application.

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SUMMARY: The FAA proposes to rule and invites public comment on the
application to impose and use PFC revenue at Sacramento International
Airport, under the provisions of the Aviation Safety and Capacity
Expansion Act of 1990 (Title IX of the Omnibus Budget Reconciliation
Act of 1990) (Public Law 101-508) and Part 158 of the Federal Aviation
Regulations (14 CFR part 158).

DATES: Comments must be received on or before November 10, 2008.

ADDRESSES: Comments on this application may be mailed or delivered in
triplicate to the FAA at the following address: Federal Aviation
Administration, Airports Division, 15000 Aviation Blvd., Room 3012,
Lawndale, CA 90261, or San Francisco Airports District Office, 831
Mitten Road, Room 210, Burlingame, CA 94010. In addition, one copy of
any comments submitted to the FAA must be mailed or delivered to Mr. G.
Hardy Acree, Director of Airports, Sacramento County Airport System, at
the following address: 6900 Airport Boulevard, Sacramento, CA 95837.
Air carriers and foreign air carriers may submit copies of written
comments previously provided to the Sacramento County Airport System
under section 158.23 of Part 158.

FOR FURTHER INFORMATION CONTACT: T J Chen, Program Manager, San
Francisco Airports District Office, 831 Mitten Road, Room 210,
Burlingame, CA 94010, Telephone:<PHONE_NUMBER>, extension 625. The
application may be reviewed in person at this same location.

SUPPLEMENTARY INFORMATION: The FAA proposes to rule and invites public
comment on the application to impose and use PFC revenue at Sacramento
International Airport under the provisions of the 49 U.S.C. 40117 and
Part 158 of the Federal Aviation Regulations (14 CFR Part 158). On July
28, 2008, the application was found not substantially complete and the
public agency supplemented the application on September 11, 2008,
within the requirements of section 158.27 of Part 158. The FAA will
approve or disapprove the application, in whole or in part, no later
than January 9, 2009.
    The following is a brief overview of the impose and use application
No. 08-08-C-00-SMF:
    Proposed charge effective date: July 1, 2011.
    Proposed charge expiration date: October 1, 2030.
    Level of the proposed PFC: $4.50.
    Total estimated PFC revenue: $603,497,524.

Description of Proposed Project:

    Impose and use: Terminal Modernization Program (TMP)--This project
is a new landside Central Terminal B to replace the existing Terminal B
facilities. The new Central Terminal B will be connected via an
automated people mover to the 19 gate airside Concourse B. The new
Terminal B will be served by a dual level roadway system and a new
automobile parking garage. The TMP also includes construction of remote
public parking, a centralized receiving warehouse, landscaping,
demolition of existing facilities, and modification of Terminal A for
additional tenants and gates.
    Class or classes of air carriers which the public agency has
requested not be required to collect PFCs: None.
    Any person may inspect the application in person at the FAA office
listed above under FOR FURTHER INFORMATION CONTACT and at the FAA
Regional Airports Division located at: Federal Aviation Administration,
Airports Division, 15000 Aviation Blvd., Room 3012, Lawndale, CA 90261.
In addition, any person may, upon request, inspect the application,
notice and other documents germane to the application in person at the
Sacramento County Airport System.

    Issued in Lawndale, California, on September 24, 2008.
Mia Paredes Ratcliff,
Acting Manager, Airports Division Western-Pacific Region.
 [FR Doc. E8-23911 Filed 10-8-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 244 (Friday, December 18, 2020)]
[Rules and Regulations]
[Pages 82332-82333]
[FR Doc No: 2020-27750]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 101 and 102

[Docket No. FDA-2019-D-0892]

The Use of an Alternate Name for Potassium Chloride in Food
Labeling; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a final guidance for industry entitled ``The Use of an
Alternate Name for Potassium Chloride in Food Labeling.'' This guidance
explains our intent to exercise enforcement discretion for the
declaration of the name ``potassium salt,'' as an alternative to
``potassium chloride,'' in the ingredient statement on the labels of
foods that contain potassium chloride as an ingredient.

DATES: The announcement of the guidance is published in the Federal
Register on December 18, 2020.

ADDRESSES: You may submit either electronic or written comments on FDA
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-2019-D-0892 for ``The Use of an Alternate Name for Potassium
Chloride in Food Labeling.'' 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, 240-
402-7500.
     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.'' We will review
this copy, including the claimed confidential information, in our
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 draft guidance to
the Office of Nutrition and Food Labeling, Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740. Send two self-addressed adhesive labels to
assist that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Andrea Krause, Center for Food Safety
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry
entitled ``The Use of an Alternate Name for Potassium Chloride in Food
Labeling.'' We are issuing this guidance consistent with our good
guidance practices regulation (21 CFR 10.115). The guidance represents
the current thinking of FDA on this topic. 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.
    In the Federal Register of May 20, 2019 (84 FR 22749), we made
available a draft guidance for industry entitled ``The Use of an
Alternate Name for Potassium Chloride in Food Labeling'' (``draft
guidance''), which was intended to explain to food manufacturers our
intent to exercise enforcement discretion for the declaration of the
name ``potassium chloride salt'' in the ingredient statement on food
labels as an alternative to the common or usual name ``potassium
chloride.'' The draft guidance considered, in part, a NuTek Food
Science citizen petition requesting that we issue guidance recognizing
``potassium salt'' as an additional common or usual name for potassium
chloride (see Citizen Petition from NuTek Food Science, LLC, dated June
27, 2016, FDA-2016-P-1826-0001 at page 1). Additionally, we
specifically invited comment on how the use of the name ``potassium
chloride salt'' in the ingredient statement as an alternative to
``potassium chloride'' would improve consumer understanding of the
ingredient and what alternate names to ``potassium chloride salt''
would better promote consumer understanding of potassium chloride (84
FR 22749 at 22750 through 22751). We gave interested parties until July
19, 2019, to submit comments for us to consider before beginning work
on the final version of the guidance.
    In response to requests for more time to comment on the draft
guidance, we issued a notice in the Federal Register of July 10, 2019
(84 FR 32848) extending the comment period to September 17, 2019. We
received more than 70 comments on the draft guidance. Many comments
expressed concerns that declaration of the alternate name ``potassium
chloride salt'' would be confusing or would not achieve the public
health goal of reduced sodium consumption, as food manufacturers would
likely not use the alternate name. Food manufacturers, public health
and consumer advocacy groups provided comments and data supporting
``potassium salt'' as an alternate name to ``potassium chloride.''
    After careful review and consideration of the comments to the draft
guidance, some of which led us to further review of relevant published
literature, we have modified the final guidance. Changes to the
guidance include:
     Exercising enforcement discretion for declaration of
``potassium salt,'' rather than ``potassium chloride salt,'' in the
ingredient statement on food labels as an alternative to declaration of
the common or usual name ``potassium chloride;'' and
     Further explaining potassium chloride's technical role as
a partial substitute for sodium chloride in food manufacturing through
the inclusion of additional examples and references.
    As discussed in the final guidance, we have made these changes with
the following considerations in mind: Potential public health benefits
to the U.S. population from reduced sodium and increased potassium
intake, the recognition that potassium chloride can substitute for
sodium chloride in a variety of food manufacturing applications across
a number of food categories, and the unlikelihood that the alternate
name will mislead consumers.
    The guidance announced in this notice finalizes the draft guidance
dated May 2019.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 101 have been approved under OMB control
number 0910-0381.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous
sentence to find the most current version of the guidance.

    Dated: December 11, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-27750 Filed 12-17-20; 8:45 am]
BILLING CODE 4164-01-P


From:
Brenna M Harden<EMAIL_ADDRESS>Sent:
Tue, 27 Sep 2022 15:44:10
To:
"Jones; DonnaLee"<EMAIL_ADDRESS>"French; Chuck"<EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS>Cc:
Marion M Krchmar<EMAIL_ADDRESS>Fadi K Mourad<EMAIL_ADDRESS>Todd A Richards<EMAIL_ADDRESS>Laura J Harris<EMAIL_ADDRESS>Rob Sanch<EMAIL_ADDRESS>Ronald K Burnette<EMAIL_ADDRESS>'Knight, Jeffrey A.'<EMAIL_ADDRESS>Robert H Carlin<EMAIL_ADDRESS>David W Fanning Jr<EMAIL_ADDRESS>Subject:
Coke Oven Section 114 ICR Enclosure 1 - Part 3 of 7 (Section B for Qs 3, 4, 10, 16 & 24)

On June 29, 2022, DTE Vantage (DTE) received Section 114 of the Clean Air Act Information Collection Request (ICR) in relation to development of Risk and Technology Review of Coke Oven Facilities related to 40 CFR Part 63, Subpart CCCCC, Pushing Quenching and Battery Stacks. The ICR also included risk and technology review, testing, interior and fenceline monitoring, and other information collection activities related to potential new regulations for coke byproduct recovery plants (CBRP) in relation to 40 CFR Part 63, Subpart L, Coke Oven Batteries. DTE owns and operates EES Coke Battery, L.L.C. (EES Coke) located in River Rouge, MI.

The June 28, 2022 ICR requires Enclosure 1 to be submitted September 27, 2022 (as Part 3 of 7 of this submittal).

Regards,
Brenna Harden
DTE Vantage | EES Coke Battery, L.L.C., Senior Environmental Engineer
PO Box 18309, River Rouge, MI 48218o<PHONE_NUMBER> | m<PHONE_NUMBER>
dtevantage.com

<<Item10-2 LDAR Vol 2.pdf>>
<<Item 3 COKE OVEN BYPRODUCTS OVERALL PLANT FLOW.pdf>>
<<Item 4 CBRP Overview Map.pdf>>
<<Item 16 RY2021 TAB Report.pdf>>
<<Item 24 2 CAA-05-2017-0009 CAFO 1-31-2017.pdf>>
<<Item 24-1 EES Coke, L.L.C. - ACO.pdf>>
<<Item10-1 LDAR Vol 1.pdf>>


[Federal Register Volume 87, Number 234 (Wednesday, December 7, 2022)]
[Notices]
[Page 75052]
[FR Doc No: 2022-26565]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1262]

Notice of Approval of Product Under Voucher: Rare Pediatric
Disease Priority Review Voucher

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of approval of a product redeeming a priority review voucher.
The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the
Food and Drug Administration Safety and Innovation Act (FDASIA),
authorizes FDA to award priority review vouchers to sponsors of
approved rare pediatric disease product applications that meet certain
criteria. FDA is required to publish notice of the issuance of priority
review vouchers as well as the approval of products redeeming a
priority review voucher. FDA has determined that IMJUDO (tremelimumab),
approved October 23, 2022, meets the criteria for redeeming a priority
review voucher.

FOR FURTHER INFORMATION CONTACT: Cathryn Lee, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>, email:
[email protected].

SUPPLEMENTARY INFORMATION: FDA is announcing the approval of a product
redeeming a rare pediatric disease priority review voucher. Under
section 529 of the FD&C Act (21 U.S.C. 360ff), which was added by
FDASIA, FDA will report the issuance of rare pediatric disease priority
review vouchers and the approval of products for which a voucher was
redeemed. FDA has determined that IMJUDO (tremelimumab), approved
October 23, 2022, meets the redemption criteria.
    For further information about the Rare Pediatric Disease Priority
Review Voucher Program and for a link to the full text of section 529
of the FD&C Act, go to https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further
information about IMJUDO (tremelimumab), approved October 23, 2022, go
to the ``[email protected]'' website at https://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: December 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-26565 Filed 12-6-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: May 10, 2007 (Volume 72, Number 90)]
[Notices]
[Page 26617]
[DOCID:fr10my07-55]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-437-000]

Kern River Gas Transmission Company; Notice of Proposed Changes
in FERC Gas Tariff

May 4, 2007.
    Take notice that on May 1, 2007, Kern River Gas Transmission
Company (Kern River) tendered for filing as part of its FERC Gas
Tariff, Second Revised Volume No. 1, the tariff sheets listed on
Appendix A to the filing, to be effective June 1, 2007.
    Kern River states that it has served a copy of this filing upon its
customers and interested state regulatory commissions.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Sec.  154.210 of the Commission's regulations (18 CFR 154.210). Anyone
filing an intervention or protest must serve a copy of that document on
the Applicant. Anyone filing an intervention or protest on or before
the intervention or protest date need not serve motions to intervene or
protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-8982 Filed 5-9-07; 8:45 am]

BILLING CODE 6717-01-P