[Federal Register Volume 77, Number 147 (Tuesday, July 31, 2012)]
[Notices]
[Pages 45347-45348]
[FR Doc No: 2012-18608]

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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: EC12-120-000.
    Applicants: Pacific Wind, LLC, Pacific Wind Lessee, LLC.
    Description: Supplemental information regarding Application of
Pacific Wind, LLC and Pacific Wind Lessee, LLC.
    Filed Date: 7/23/12.
    Accession Number: 20120723-5060.
    Comments Due: 5 p.m. ET 8/2/12.

    Docket Numbers: EC12-123-000.
    Applicants: Public Power, LLC, Regional Energy Holdings, Inc.
    Description: Application under Section 203 of the Federal Power Act
of Public Power, LLC, et al.
    Filed Date: 7/20/12.
    Accession Number: 20120720-5179.
    Comments Due: 5 p.m. ET 8/10/12.

    Docket Numbers: EC12-123-000.
    Applicants: Public Power, LLC, Regional Energy Holdings, Inc.
    Description: Erratum to July 20, 2012 Application for Order under
Section 203 of the FPA of Regional Energy Holdings, Inc. and Public
Power, LLC.
    Filed Date: 7/23/12.
    Accession Number: 20120723-5061.
    Comments Due: 5 p.m. ET 8/10/12.

    Docket Numbers: EC12-124-000.
    Applicants: The Detroit Edison Company.
    Description: FPA Section 203 Application of The Detroit Edison
Company.
    Filed Date: 7/23/12.
    Accession Number: 20120723-5115.
    Comments Due: 5 p.m. ET 8/13/12.

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

    Docket Numbers: ER12-2287-000.
    Applicants: Southern California Edison Company.
    Description: Notice of Cancellation of Letter Agreement with Alta
Windpower Development, LLC to be effective 12/30/2011.
    Filed Date: 7/23/12.
    Accession Number: 20120723-5065.
    Comments Due: 5 p.m. ET 8/13/12.

    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: July 23, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-18608 Filed 7-30-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 175 (Tuesday, September 12, 2017)]
[Notices]
[Page 42806]
[FR Doc No: 2017-19246]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER17-2427-000]

Hudson Energy Services, 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 Hudson Energy Services, 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 September 26, 2017.
    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 should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic 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
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For TTY,
call<PHONE_NUMBER>.

    Dated: September 6, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-19246 Filed 9-11-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: March 13, 2007 (Volume 72, Number 48)]
[Notices]
[Page 11353-11354]
[DOCID:fr13mr07-48]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 67-113]

Southern California Edison Company; Notice of Application and
Amended Preliminary Draft Environmental Assessment Tendered for Filing
With the Commission, and Establishing Procedual Schedule for Licensing
and Deadline for Submission of Final Amendments

March 7, 2007.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: New License for Major Project-Existing Dam.
    b. Project No.: P-67-113.
    c. Date Filed: February 23, 2007.
    d. Applicant: Southern California Edison Company.
    e. Name of Project: Big Creek Nos. 2A, 8 and Eastwood Power Station
Hydroelectric Power Project.
    f. Location: The Big Creek Nos. 2A, 8 and Eastwood Hydroelectric
Project is located in Fresno County, California near the town of Shaver
Lake within the South Fork San Joaquin River, Big Creek, and Stevenson
Creek watersheds. The project affects 2,143.25 acres of Federal lands.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791 (a)-825(r).
    h. Applicant Contact: Russ W. Krieger, Vice President, Power
Production, Southern California Edison Company, 300 North Lone Hill
Ave., San Dimas, California 91773. Phone:<PHONE_NUMBER>.
    i. FERC Contact: Jim Fargo,<PHONE_NUMBER>, or e-mail:
<EMAIL_ADDRESS>
    j. Cooperating Agencies: We are asking Federal, State, local, and
tribal agencies with jurisdiction and/or special expertise with respect
to environmental issues to cooperate with us in the preparation of the
environmental document. Agencies who would like to request cooperating
status should follow the instructions for filing comments described in
item k below. Agencies granted cooperating status will be precluded
from being an intervenor in this proceeding consistent with the
Commission's regulations.
    k. Deadline for requests for cooperating agency status: 60 days
from the date of this notice. All documents (original and eight copies)
should be filed with: Philis J. Posey, Acting Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426.
Comments may be filed electronically via the Internet in lieu of paper;
see 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site (http://www.ferc.gov) under the ``e-Filing'' link. After

logging into the e-Filing system, select ``Comment on Filing'' from the
Filing Type Selection screen and continue with the filing and process.
The Commission strongly encourages electronic filing.
    l. Status: This application has not been accepted for filing. We
are not soliciting motions to intervene, protests, or final terms and
conditions at this time.
    m. Description of Project: The existing Big Creek Nos. 2A, 8 and
Eastwood Power Station Hydroelectric Power Project consists of two
powerhouses and an underground power station; two major dams and
reservoirs; five moderate-sized dams forming two forebays and three
small diversion pools; eight small diversions; six water conveyance
systems; and one transmission line. The project would have an average
annual generation of 1,125,429 megawatt-hours.
     Powerhouses and powerstation (i) Big Creek Powerhouse No.
2A with two turbine/generator units and a total dependable operating
capacity of about 98.5 MW; (ii) Powerhouse No. 8 with two turbine/
generator units and a dependable operating capacity of about 64.5 MW;
and (iii) Eastwood Power Station, with one turbine/pump/generator unit
and a dependable operating capacity of about 207 MW.
     Major dams and reservoirs (i) Shaver Dam, forming Shaver
Lake, which has a usable storage capacity of about 135,568 ac-ft, at an
elevation of about 5,370 ft above mean sea level (msl); and (ii)
Florence Dam, forming Florence Lake, which has a usable storage
capacity of about 64,406 ac-ft, at an elevation of about 7,327 ft above
msl.
     Moderate-sized dams, forebays and diversion pools (i)
Balsam Forebay, with a usable storage capacity of about 1,547 ac-ft, at
an elevation of about 6,670 ft above msl; (ii) Dam 5 Impoundment

(Powerhouse 8 Forebay), with a usable storage capacity of 49 ac-ft, at
an elevation of about 2,943 ft above msl; (iii) Pitman Diversion Pool,
with a usable capacity of about 1 ac-ft, at an elevation of about 6,900
ft above msl; (iv) Bear Diversion Pool, with a usable capacity of about
103 ac-ft, at an elevation of about 7,350 ft above msl; and (v) Mono
Diversion Pool, with a usable capacity of about 47 ac-ft, at an
elevation of about 7,350 ft above msl.
     Small diversions (i) Hooper Creek Diversion, with a usable
capacity of about 3 ac-ft, at an elevation of about 7,505 ft above msl;
(ii) Bolsillo Creek Diversion, with a usable capacity of less than 1
ac-ft, at an elevation of about 7,535 ft above msl; (iii) Chinquapin
Creek Diversion, with a usable capacity of less than 1 ac-ft, at an
elevation of about 7,629 ft above msl; (iv) Camp 62 Creek Diversion,
with a usable capacity of less than 1 ac-ft, at an elevation of about
7,307 ft above msl.
     Water conveyance systems (i) Ward Tunnel, about 12.8 miles
long, conveys water from Florence Lake to Huntington Lake (Huntington
Lake is a component of FERC Project No. 2175) and has a conveyance
capacity of about 1,760 cubic feet per second (cfs). The tunnel
receives water from Florence Lake, Mono Creek, Bear Creek, the small
tributaries discussed above, and the East and West Forks of Camp 61
Creek (via Portal Forebay, a component of the Portal Project, (FERC
Project No. 2174); (ii) Mono-Bear Siphon, about 1.6 miles of flowline
from Mono Diversion and 1.4 miles of flowline and tunnel from Bear
Creek Diversion connect at the Mono-Bear Wye and continues for about
2.6 miles through a combined flowline/siphon, conveys water from the
Mono and Bear diversions to Ward Tunnel. The Mono Tunnel and Bear
Tunnel have conveyance capacities of 450 cfs each and the combined
flowline/siphon has a conveyance capacity of about 650 cfs; (iii)
Huntington-Pitman-Shaver Conduit, also known as Tunnel No. 7, conveys
water from Huntington Lake and the Pitman Creek Diversion to Shaver
Lake through either North Fork Stevenson Creek or through Balsam
Forebay and the Eastwood Power Station. Tunnel No. 7 is about 5.4 miles
long and terminates at Gate No. 2 tunnel outlet located on North Fork
Stevenson Creek upstream of Shaver Lake. The Balsam Diversion Tunnel is
about 1.1 miles long and branches off Tunnel No. 7 about 1,200 ft
upstream of the Gate No. 2 outlet, connecting to Balsam Forebay; (iv)
Eastwood Power Station and Tailrace Tunnels, which convey water from
Balsam Forebay through the Eastwood Power Station to Shaver Lake. The
Eastwood Power Station Tunnel is about 1 mile long. The Tailrace Tunnel
is about 1.4 miles long. The conveyance capacity of the tunnels is
about 2,500 cfs. (v) Tunnel No. 5, about 2.6 miles long, conveys water
from Shaver Lake to Big Creek Powerhouse No. 2A and has a conveyance
capacity of about 650 cfs. (vi) Tunnel No. 8, about 1 mile long,
conveys water from the Dam No. 5 Impoundment just downstream of
Powerhouse 2/2A to Powerhouse No. 8, has a conveyance capacity of about
1,173 cfs.
     Transmission line (i) Eastwood Power Station--Big Creek 1
Transmission Line, which connects Eastwood Power Station to a non-
Project switchyard at Big Creek Powerhouse No. 1. This transmission
line is about 4.7 miles long, and is a 220kV line.
    n. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''

link. Enter the docket number excluding the three digits in the docket
number field to access the document. For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>or toll free at (866)
208-3676, or for TTY, contact<PHONE_NUMBER>. A copy is also available
for inspection and reproduction at the address in item h above.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp
 to be notified via e-mail of new filings and

issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    o. With this notice, we are initiating consultation with the
California State Historic Preservation Officer (SHPO), as required by
section 106, National Historic Preservation Act, and the regulations of
the Advisory Council on Historic Preservation, 36 CFR 800.4.
    p. Procedural schedule and final amendments: The application will
be processed according to the following Hydro Licensing Schedule.
Revisions to the schedule will be made if the Commission determines it
necessary to do so:

------------------------------------------------------------------------
             Milestone                          Tentative date
------------------------------------------------------------------------
Issue Acceptance/Deficiency Letter   June 2007.
 and request Additional
 Information, if needed.
Notice asking for final terms and    September 2007.
 conditions.
Notice of the availability of the    March 2008.
 draft EIS.
Notice of the availability of the    September 2008.
 final EIS.
------------------------------------------------------------------------

    Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of the notice
soliciting final terms and conditions.

Philis J. Posey,
Acting Secretary.
[FR Doc. E7-4480 Filed 3-12-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 93 (Friday, May 13, 2022)]
[Notices]
[Page 29413]
[FR Doc No: 2022-10261]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-94876; File No. SR-PEARL-2022-12]

Self-Regulatory Organizations; MIAX PEARL LLC; Notice of
Withdrawal of Proposed Rule Change To Amend the MIAX PEARL Options Fee
Schedule To Increase the Monthly Fees for MIAX Express Network Full
Service Port

May 9, 2022.
    On April 1, 2022, MIAX PEARL LLC (``MIAX Pearl'' or ``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
amend the MIAX Pearl Options Fee Schedule to increase the monthly fees
for the MIAX Express Network Full Service (``MEO'') Ports.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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    The proposed rule change was immediately effective upon filing with
the Commission pursuant to Section 19(b)(3)(A) of the Act.\3\ On April
20, 2022, the proposed rule change was published for comment in the
Federal Register and, pursuant to Section 19(b)(3)(C) of the Act,\4\
the Commission: (1) Temporarily suspended the proposed rule change; and
(2) instituted proceedings under Section 19(b)(2)(B) of the Act \5\ to
determine whether to approve or disapprove the proposed rule change.\6\
On May 2, 2022, the Exchange withdrew the proposed rule change (SR-
PEARL-2022-12).
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    \3\ 15 U.S.C. 78s(b)(3)(A). A proposed rule change may take
effect upon filing with the Commission if it is designated by the
exchange as ``establishing or changing a due, fee, or other charge
imposed by the self-regulatory organization on any person, whether
or not the person is a member of the self-regulatory organization.''
15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 15 U.S.C. 78s(b)(3)(C).
    \5\ 15 U.S.C. 78s(b)(2)(B).
    \6\ See Securities Exchange Act Release No. 94722 (April 14,
2022), 87 FR 23660.
    \7\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-10261 Filed 5-12-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: June 22, 2006 (Volume 71, Number 120)]
[Notices]
[Page 35883-35884]
[DOCID:fr22jn06-63]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-390-000]

Vector Pipeline L.P.; Notice of Proposed Changes in FERC Gas
Tariff

June 15, 2006.
    Take notice that on June 12, 2006, Vector Pipeline L.P. (Vector),
tendered for filing as part of its FERC Gas Tariff, Original Volume No.
1, the following tariff sheets with an effective date of July 12, 2006:

Sixth Revised Sheet No. 3.
Third Revised Sheet No. 163.

    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
section 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 online 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>.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-9811 Filed 6-21-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 38 (Friday, February 25, 2022)]
[Notices]
[Pages 10797-10800]
[FR Doc No: 2022-03992]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1588]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Exemptions From Substantial Equivalence Requirements
for Tobacco Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(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 exemptions from substantial equivalence
requirements for tobacco products.

DATES: Submit either electronic or written comments on the collection
of information by April 26, 2022.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 26, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 26, 2022. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

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-2013-N-1588 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Exemptions From Substantial
Equivalence Requirements for Tobacco Products.'' 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, 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.'' 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>.

FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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.

Exemptions From Substantial Equivalence Requirements for Tobacco
Products

OMB Control Number 0910-0684--Extension

    On June 22, 2009, the Family Smoking Prevention and Tobacco Control
Act (Tobacco Control Act) (Pub. L. 111-31) was signed into law. The
Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act
(FD&C Act) by adding a chapter granting FDA important authority to
regulate the manufacture, marketing, and distribution of tobacco
products to protect the public health generally and to reduce tobacco
use by minors.
    The FD&C Act, as amended by the Tobacco Control Act, requires that
before a new tobacco product may be introduced or delivered for
introduction into interstate commerce, the new tobacco product must
undergo

premarket review by FDA. FDA must issue an order authorizing the
commercial distribution of the new tobacco product or find the product
exempt from the requirements of substantial equivalence under section
910(a)(2)(A) of the FD&C Act (21 U.S.C. 387j(a)(2)(A)), before the
product may be introduced into commercial distribution.
    On May 10, 2016, FDA issued a rule extending FDA's tobacco product
authority to all products that meet the definition of tobacco product
in the law (except for accessories of newly regulated tobacco
products), including electronic nicotine delivery systems, cigars,
hookah, pipe tobacco, nicotine gels, dissolvables that were not already
subject to the FD&C Act, and other tobacco products that may be
developed in the future (81 FR 28974) (``the final deeming rule'').
    FDA has established a pathway for manufacturers to request
exemptions from the substantial equivalence requirements of the FD&C
Act in Sec.  1107.1 (21 CFR 1107.1) of the Agency's regulations. As
described in Sec.  1107.1(a), FDA may exempt tobacco products that are
modified by adding or deleting a tobacco additive, or increasing or
decreasing the quantity of an existing tobacco additive, from the
requirement of demonstrating substantial equivalence if the Agency
determines that: (1) The modification would be a minor modification of
a tobacco product that can be sold under the FD&C Act; (2) a report
demonstrating substantial equivalence is not necessary to ensure that
permitting the tobacco product to be marketed would be appropriate for
the protection of public health; and (3) an exemption is otherwise
appropriate.
    Section 1107.1(b) states that a request for exemption under section
905(j)(3) of the FD&C Act (21 U.S.C. 387e(j)(3)) may be made only by
the manufacturer of a legally marketed tobacco product for a minor
modification to that tobacco product and that the manufacturer must
submit the request and all information supporting it to FDA. The
request must be made in an electronic format that FDA can process,
review, and archive (or a written request must be made by the
manufacturer explaining in detail why the manufacturer cannot submit
the request in an electronic format and requesting an alternative means
of submission to the electronic format).
    An exemption request must contain: (1) The manufacturer's address
and contact information; (2) identification of the tobacco product(s);
(3) a detailed explanation of the purpose for the modification; (4) a
detailed description of the modification, including a statement as to
whether the modification involves adding or deleting a tobacco
additive, or increasing or decreasing the quantity of the existing
tobacco additive; (5) a detailed explanation of why the modification is
a minor modification of a tobacco product that can be sold under the
FD&C Act; (6) a detailed explanation of why a report under section
905(j)(1) of the FD&C Act intended to demonstrate substantial
equivalence is not necessary to ensure that permitting the tobacco
product to be marketed would be appropriate for protection of the
public health; (7) a certification (i.e., a signed statement by a
responsible official of the company) summarizing the supporting
evidence and providing the rationale for the official's determination
that the modification does not increase the tobacco product's appeal to
or use by minors, toxicity, addictiveness, or abuse liability; (8)
other information justifying an exemption; and (9) an environmental
assessment (EA) under part 25 (21 CFR part 25) prepared in accordance
with the requirements of Sec.  25.40 (21 CFR 25.40).
    The National Environmental Policy Act of 1969 (NEPA) (42 U.S.C.
4321-4347) states national environmental objectives and imposes upon
each Federal Agency the duty to consider the environmental effects of
its actions. Section 102(2)(C) of NEPA requires the preparation of an
environmental impact statement for every major Federal action that will
significantly affect the quality of the human environment.
    The FDA NEPA regulations are contained in part 25. All applications
for exemption from substantial equivalence require the submission of an
EA. An EA provides information that is used to determine whether an FDA
action could result in a significant environmental impact. Section
25.40(a) and (c) specifies the content requirements for EAs for non-
excluded actions.
    The information required by Sec.  1107.1(b) is submitted to FDA so
FDA can determine whether an exemption from substantial equivalence to
the product is appropriate for the protection of the public health.
Section 1107.1(c) states that FDA will review the information submitted
and determine whether to grant or deny an exemption based on whether
the criteria in section 905(j)(3) of the FD&C Act are met. FDA may
request additional information if necessary, to make a determination
and may consider the exemption request withdrawn if the information is
not provided within the requested timeframe.
    This collection of information requires a manufacturer to submit a
report at least 90 days prior to making an introduction or delivery for
introduction into interstate commerce for commercial distribution of a
tobacco product. Section 905(j)(1)(A)(ii) of the FD&C Act states that
if an exemption has been requested and granted, the manufacturer must
submit to FDA a report that demonstrates that the tobacco product is
modified within the meaning of section 905(j)(3), the modifications are
to a product that is commercially marketed and in compliance with the
requirements of the FD&C Act, and all the modifications are covered by
exemptions granted by the Secretary under section 905(j)(3).
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                                                Average
                                     Number of       Number of     Total annual     burden per
   21 CFR section and activity      respondents    responses per     responses     response (in     Total hours
                                                  respondent \2\                      hours)
----------------------------------------------------------------------------------------------------------------
     Sec.   1107.1(b) Optional Preparation of Tobacco Product Exemption From Substantial Equivalence Request
                        Including Sec.   25.40 Preparation of an Environmental Assessment
----------------------------------------------------------------------------------------------------------------
Sec.   1107.1(b)--Preparation of             812               1             812              24          19,488
 tobacco product exemption from
 substantial equivalence request
 and Sec.   25.40--Preparation
 of an environmental assessment.
                                 -------------------------------------------------------------------------------
    Total Hours (Sec.             ..............  ..............  ..............  ..............          19,488
     1107.1(b)).................
----------------------------------------------------------------------------------------------------------------

      Sec.   1107.1(c) Preparation of Additional Information for Tobacco Product Exemption From Substantial
                                               Equivalence Request
----------------------------------------------------------------------------------------------------------------
Sec.   1107.1(c)--Preparation of             150               1             150               3             450
 additional information for
 tobacco product exemption from
 substantial equivalence request
                                 -------------------------------------------------------------------------------
    Total Hours (Sec.             ..............  ..............  ..............  ..............             450
     1107.1(c)).................
----------------------------------------------------------------------------------------------------------------
 Section 905(j)(1)(A)(ii) of the FD&C Act: If exemption granted, report submitted to demonstrate tobacco product
is modified under section 905(j)(3), modifications are to a product that is commercially marketed and compliant,
              and modifications covered by exemptions granted by Secretary under section 905(j)(3)
----------------------------------------------------------------------------------------------------------------
Abbreviated report submitted to            1,217               1           1,217               2           2,434
 demonstrate tobacco product is
 modified under section
 905(j)(3), modifications are to
 a product that is commercially
 marketed and compliant, and
 modifications covered by
 exemptions granted by Secretary
 under section 905(j)(3)........
                                 -------------------------------------------------------------------------------
    Total Hours (section          ..............  ..............  ..............  ..............           2,434
     905(j)(1)(A)(ii)) of the
     FD&C Act...................
                                 -------------------------------------------------------------------------------
    Total Hours Exemptions From   ..............  ..............  ..............  ..............          22,372
     Substantial Equivalence
     Requirements...............
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA estimates that we will receive 812 exemption requests under
Sec.  1107.1(b) for 24 hours per response including EA for a total of
19,488 hours. Since an EA is required for each Sec.  1107.1(b)
(Optional Preparation of Tobacco Product Exemption From Substantial
Equivalence Request), the burden per response for EAs (12 hours) has
been combined with the 12 hours for an SE request for a total of 24
hours per response.
    FDA further estimates that we will receive 150 submissions
requiring additional information in support of the initial exemption
request, and it is expected that it will take an average of 3 hours to
prepare the additional information for a total of 450 hours.
    FDA estimates that 1,217 respondents will prepare 1,217 responses
and each response will take approximately 2 hours to prepare, as
required by section 905(j)(1)(A)(ii) of the FD&C Act, for a total of
2,434 hours.
    Our estimated burden for the information collection reflects an
overall decrease of 1,499 hours and 94 respondents. The estimates
reflect a decrease of 1,217 hours to account for a reduction in average
response time for preparing an abbreviated report. FDA provides a
recommended format for applicants in the exemption order letter that
significantly reduces the burden hours for preparing the abbreviated
report. The estimates also reflect a decrease of 94 responses for
submissions requiring additional information in support of the initial
exemption request, which resulted in a decrease of 282 hours. We
attribute this adjustment to the number of submissions we received over
the last few years. Therefore, FDA now estimates the burden for
exemptions from substantial equivalence requirements is 22,372 hours.

    Dated: February 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-03992 Filed 2-24-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 240 (Friday, December 17, 2021)]
[Notices]
[Pages 71703-71704]
[FR Doc No: 2021-27350]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. -2021-0015]

Petition for Exemption; Summary of Petition Received; CASS
Professional Services Corp.

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice.

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

SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Federal Aviation Regulations. The
purpose of this notice is to improve the public's awareness of, and
participation in, the FAA's exemption process. Neither publication of
this notice nor the inclusion nor omission of information in the
summary is intended to affect the legal status of the petition or its
final disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before January 6, 2022.

ADDRESSES: Send comments identified by docket number FAA-2021-0798
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow

the online instructions for sending your comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation, 1200 New Jersey Avenue SE, Room W12-140,
West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE,
Washington, DC 20590-0001, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Tiffany Jackson,<PHONE_NUMBER>, Office
of Rulemaking, Federal Aviation Administration, 800 Independence Avenue
SW, Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC.
Caitlin Locke,
Acting Executive Deputy Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2021-0798.
    Petitioner: CASS Professional Services Corp. (CPS).
    Section(s) of 14 CFR Affected: Sec. Sec.  61.57(a)(3) and 61.58(g).
    Description of Relief Sought: CASS Professional Services is
petitioning for relief from Sec. Sec.  61.57(a)(3) and 61.58(g) to
utilize Boeing KC-135 simulators not approved in accordance with part
142, operated by a United States Air Force contractor, for the purposes
of meeting the currency and evaluation requirements in accordance with
part 61 for their B-707 pilots.

[FR Doc. 2021-27350 Filed 12-16-21; 8:45 am]
BILLING CODE 4910-13-P