[Federal Register Volume 87, Number 223 (Monday, November 21, 2022)]
[Proposed Rules]
[Pages 70752-70753]
[FR Doc No: 2022-25310]

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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. 87, No. 223 / Monday, November 21, 2022 /
Proposed Rules

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 173

[Docket No. FDA-2022-F-2725]

Cargill, Inc.; Filing of Food Additive Petition

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Notification of petition.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that we have filed a petition, submitted by Cargill, Inc., proposing
that the food additive regulations be amended to provide for the safe
use of hydrogen peroxide (CAS Reg. No. 7722-84-1) as an antimicrobial
agent, oxidizing and reducing agent, and bleaching agent, and to remove
sulfur dioxide.

DATES: The food additive petition was filed on August 30, 2022. Either
electronic or written comments on the petitioner's environmental
assessment must be submitted by December 21, 2022.

ADDRESSES: You may submit comments as follows. 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 21, 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.

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-F-2725 for ``Cargill, Inc.; Filing of Food Additive
Petition.'' 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.'' 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>.

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

SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic
Act (section 409(b)(5) (21 U.S.C. 348(b)(5))), we are giving notice
that we have filed a food additive petition (FAP 2A4833), submitted by
Cargill, Inc., 15407 McGinty Rd., Wayzata, MN 55391. The petition
proposes to amend the food additive regulations in Sec.  173.356 (21
CFR 173.356) Hydrogen peroxide, to provide for the safe use of hydrogen
peroxide (CAS Reg. No. 7722-84-1) as an antimicrobial agent, oxidizing
and reducing agent, and bleaching agent, and to remove sulfur dioxide.
    We are reviewing the potential environmental impact of this
petition. To encourage public participation consistent with regulations
issued under the National Environmental Policy Act (40 CFR 1501.4(b)),
we are placing the

environmental assessment submitted with the petition that is the
subject of this notice on public display at the Dockets Management
Staff (see DATES and ADDRESSES) for public review and comment.
    We will also place on public display, at the Dockets Management
Staff and at https://www.regulations.gov, any amendments to, or
comments on, the petitioner's environmental assessment without further
announcement in the Federal Register. If, based on our review, we find
that an environmental impact statement is not required, and this
petition results in a regulation, we will publish the notice of
availability of our finding of no significant impact and the evidence
supporting that finding with the regulation in the Federal Register in
accordance with 21 CFR 25.51(b).

    Dated: November 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-25310 Filed 11-18-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 38 (Tuesday, February 28, 2017)]
[Notices]
[Pages 12148-12150]
[FR Doc No: 2017-03846]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-80088; File No. SR-NASDAQ-2017-017]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend the Exchange's Port-Related Fees at Rules 7015 and 7016(b) To
Eliminate Prorated Billing

February 22, 2017.
    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 February 9, 2017, The NASDAQ Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I, II, and III, below, which Items have been prepared by the
Exchange. The Commission is publishing this notice to solicit comments
on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the Exchange's port-related fees at
Rules 7015 and 7016(b) to eliminate prorated billing.
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaq.cchwallstreet.com, at the principal office of
the Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    The purpose of the proposed rule change \3\ is to harmonize the
billing practices for subscription to Nasdaq ports and other services
provided under Rules 7015 \4\ and 7016(b) \5\ with those of the
Nasdaq's Options Market (``NOM'') by no longer applying a prorated fee
for subscriptions that are effective other than the first of any given
month.\6\ The Exchange does not prorate NOM connectivity subscriptions;
thus, Options Participants \7\ are assessed a full month's fee for a
connectivity subscription if they direct the Exchange to make the
subscribed connectivity live on any day of the month, including the
last day thereof. The Exchange notes that the NASDAQ PHLX does not
prorate port connectivity under both [sic] its equity and options
rules.\8\
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    \3\ The Exchange initially filed the proposed pricing changes on
February 1, 2017 (SR-NASDAQ-2017-009). On February 9, 2017, the
Exchange withdrew that filing and submitted this filing.
    \4\ Rule 7015 is titled ``Ports and other Services'' and
provides the options for connecting to the Nasdaq equity market
together with the fees associated with such connectivity.
    \5\ Rule 7016(b) concerns the fees assessed for Pre-trade Risk
Management service ports. Pre-trade Risk Management provides Members
with the ability to set a wide range of parameters for orders to
facilitate pre-trade protection for FIX, Rash, OUCH and FLITE ports.
    \6\ See NOM Rules Chapter XV, Section 3(b).
    \7\ As defined by NOM Rules Chapter I, Section 1(a)(40).
    \8\ See Securities Exchange Act Release No. 78665 (August 24,
2016), 81 FR 59693 (August 30, 2016) (SR-PHLX-2016-85) (eliminating
prorated billing as applied to PSX ports under Access Services
Fees).

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

    Currently, connectivity on Nasdaq's equity market under Rules 7015
and 7016(b) is prorated based on the day that it is activated, with the
Nasdaq Member \9\ only fee liable for the remaining days of the partial
month. The Exchange has found that prorating billing has resulted in
complexity and increased costs associated with the billing process. As
a consequence, the Exchange is harmonizing the billing process with
that of the Exchange's Options market and is not permitting prorated
billing effective February 1, 2017.
---------------------------------------------------------------------------

    \9\ As defined by Rule 0120(i).
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2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\10\ in general, and furthers the objectives of
Sections 6(b)(4) and 6(b)(5) of the Act,\11\ in particular, in that it
provides for the equitable allocation of reasonable dues, fees and
other charges among members and issuers and other persons using any
facility, and is not designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
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    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(4) and (5).
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    The Exchange believes that elimination of prorated fees under Rules
7015 and 7016(b) is reasonable because it will reduce complexity and
costs associated with the billing process, and will harmonize it with
the process applied to Options Participants. As noted above, Members
are currently able to choose when they want a new connectivity
subscription to become effective and thus make the determination of
when they wish to become fee liable. Members will continue to choose
when they become fee liable under the proposed change, but now the
Exchange will assess the full month's fee regardless of when the port
is subscribed. Thus, Members must weigh whether subscription to a
service covered by the rules for less than a full month is worth the
full monthly fee.
    The Exchange believes that elimination of prorated fees under Rules
7015 and 7016(b) is an equitable allocation and is not unfairly
discriminatory because it will apply to all new subscribers to the
port-related services under Rules 7015 and 7016(b), who are free to
choose the date on which their subscription becomes active and thus fee
liable. Moreover, the Exchange believes the proposed change is an
equitable allocation and is not unfairly discriminatory because it will
harmonize the billing process with that of NOM. Thus, the Exchange will
apply the same process to both its Options Participants and Equities
Members.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. In terms of inter-market
competition, the Exchange notes that it operates in a highly
competitive market in which market participants can readily favor
competing venues if they deem fee levels at a particular venue to be
excessive, or rebate opportunities available at other venues to be more
favorable. In such an environment, the Exchange must continually adjust
its fees to remain competitive with other exchanges and with
alternative trading systems that have been exempted from compliance
with the statutory standards applicable to exchanges. Because
competitors are free to modify their own fees in response, and because
market participants may readily adjust their order routing practices,
the Exchange believes that the degree to which fee changes in this
market may impose any burden on competition is extremely limited.
    In this instance, although eliminating prorated fees for
subscriptions under the rules may result in an increase in fees for new
subscriptions to the extent a Member determines to subscribe to a
service under Rules 7015 or 7016(b) on a day other than the first day
of a given month, the Exchange notes that it is doing so to both
simplify the process and harmonize it with the process applied to the
Exchange's Options Participants. Moreover, Members may choose the day
on which such services become effective and may therefore choose the
first day of a month, which would result in no fee increase. Last, the
proposed change does not impose a burden on competition because the
Exchange's services are completely voluntary and subject to extensive
competition both from other exchanges and from off-exchange venues. In
sum, if the changes proposed herein are unattractive to market
participants, it is likely that the Exchange will lose market share as
a result. Accordingly, the Exchange does not believe that the proposed
changes will impair the ability of members or competing order execution
venues to maintain their competitive standing in the financial markets.

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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\12\
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    \12\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2017-017 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2017-017. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the

Commission and any person, other than those that may be withheld from
the public in accordance with the provisions of 5 U.S.C. 552, will be
available for Web site viewing and printing in the Commission's Public
Reference Room, 100 F Street NE., Washington, DC 20549, on official
business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of
the filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly.
    All submissions should refer to File Number SR-NASDAQ-2017-017 and
should be submitted on or before March 21, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
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Robert W. Errett,
Deputy Secretary.
[FR Doc. 2017-03846 Filed 2-27-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 189 (Thursday, September 29, 2016)]
[Notices]
[Pages 66960-66961]
[FR Doc No: 2016-23517]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL16-117-000]

Vote Solar Initiative, Montana Environmental Information Center
v. Montana Public Service Commission; Notice of Complaint

    Take notice that on September 19, 2016, pursuant to Rule 206 of the
Federal Energy Regulatory Commission's (Commission) Rules of Practice
and Procedure, 18 CFR 385.206, Vote Solar Initiative and Montana
Environmental Information Center (collectively, Vote Solar) filed a
formal complaint against Montana Public Service Commission (Respondent)
alleging that Respondent violated

section 210 of Public Utilities Regulatory Policies Act of 1978, 16
U.S.C. 824a-3, by suspending the standard rate for solar qualifying
facilities with a nameplate capacity between 100 kW and 3 MW, all as
more fully explained in the complaint.
    Vote Solar certifies that copies of the complaint were served on
the contacts for the Montana Public Service Commission, on contacts for
North Western Energy as listed on the Commission's list of Corporate
Officials, and on other persons who may be affected by the complaint.
    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. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainant.
    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 5 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 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>.
    Comment Date: 5:00 p.m. Eastern Time on October 11, 2016.

    Dated: September 22, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-23517 Filed 9-28-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 108 (Wednesday, June 5, 2019)]
[Notices]
[Pages 26121-26123]
[FR Doc No: 2019-11657]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0147]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
and Food and Drug Administration Staff; Section 905(j) Reports:
Demonstrating Substantial Equivalence for Tobacco Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Fax written comments on the collection of information by July 5,
2019.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0673.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Guidance for Industry and Food and Drug Administration Staff; Section
905(j) Reports: Demonstrating Substantial Equivalence for Tobacco
Products

OMB Control Number 0910-0673--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, among other things, a chapter granting FDA
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, generally
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 (section 910 of the FD&C Act).
    The Tobacco Control Act also gave FDA the authority to issue a
regulation deeming all other products that meet the statutory
definition of a tobacco product to be subject to chapter IX of the FD&C
Act (section 901(b) of the FD&C Act (21 U.S.C. 387a(b))). On May 10,
2016, FDA issued that 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 at 28976) (``the Deeming final rule'').
    The FD&C Act authorizes three premarket pathways for a new tobacco
product to legally enter the market. Submission of a section
905(j)(1)(A)(i) report intended to demonstrate substantial equivalence
and, in response, an order from the Agency finding that the new tobacco
product is substantially equivalent to a predicate tobacco product and
in compliance with the requirements of the FD&C Act, is one pathway.
Under section 905(j)(1)(A)(i) of the FD&C Act (21 U.S.C.
387e(j)(1)(A)(i)), a tobacco product manufacturer must show that a new
tobacco product is substantially equivalent, within the meaning of
section 910, to a tobacco product commercially marketed (other than for
test marketing) in the United States as of February 15, 2007, or to a
tobacco product that the Secretary of Health and Human Services has
previously determined, under subsection (a)(3) of section 910, is
substantially equivalent and that it is in compliance with the
requirements of the FD&C Act. The comparison product chosen by the
tobacco product manufacturer is referred to by FDA as the predicate
tobacco product.
    The guidance document associated with this collection of
information contains recommendations on preparing reports intended to
demonstrate substantial equivalence to a predicate tobacco product as
required under section 905(j)(1)(A)(i) of the FD&C Act. FDA's guidance
entitled ``Demonstrating the Substantial Equivalence of a New Tobacco
Product: Responses to Frequently Asked Questions'' (December 2016) may
be accessed at https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm. In that guidance, FDA recommends
that certain modifications might be addressed in a ``Product Quantity
Change Report,'' which is a more streamlined Substantial Equivalence
(SE) Report for certain modifications that should be easier for
manufacturers to prepare.
    In the Federal Register of September 6, 2018 (83 FR 45251), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received seven comments that were PRA
related. Commenters noted that the burden estimates seem low given
current experience and rounds of review by FDA, but that FDA could
reduce the current burden by increasing transparency in the SE process
by issuing a rulemaking related to SE. These comments concerned the
burdens related to the SE program and noted that lack of a rule related
to the SE pathway has contributed to that burden. In addition,
commenters stated that lack of clarity on the content of SE Reports,
including the lack of clarity regarding the information that might be
needed when a new tobacco product has ``same characteristics'' or
``different characteristics,'' contributes to that burden.
    We believe that recent activities undertaken by FDA will help
address these concerns and support maintaining the current estimates,
which are averages of burden across a number of years. Specifically, in
October 2018, FDA held a public workshop that provided industry
stakeholders with additional information on SE content and process
(https://www.fda.gov/TobaccoProducts/NewsEvents/ucm615443.htm). More
recently, FDA issued a notice of proposed rulemaking related to the
content and format of SE Reports (84 FR 12740, April 2, 2019), which
would establish the required content of SE Reports and explain FDA
review practices. This proposed rule also provides potential approaches
to addressing same characteristics and different characteristics, along
with examples, and considerations FDA may evaluate in determining
whether difference(s) in characteristics cause the new tobacco product
to raise different questions of public health. FDA is seeking comment
on that proposed rule.
    In addition, we note that several of the commenters are cigar
industry stakeholders who indicated that submissions may be higher for
cigar products than our current estimates reflect, and we acknowledge
that future collections may be further refined to reflect changes in
numbers of submissions due to more SE submissions for cigar products
related to the Deeming final rule.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
            Activity                 Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Full SE 905(j)(1)(A)(i) and                  683               1             683             300         204,900
 910(a).........................
Full SE 905(j)(1)(A)(i) and                  456               1             456              90          41,040
 910(a) Bundled.................
Product Quantity Change SE                   239               1             239              87          20,793
 Report.........................
Product Quantity Change Bundled              192               1             192              62          11,904
 SE Report......................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         278,637
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA's estimates are based on experience with SE Reports, initial
updated deemed registration and listing data, interactions with the
industry, and information related to other regulated products. The
estimated number of SE Reports is expected to increase from an annual
average of 979 to 1,570.
    When groups of full or product quantity change SE Reports have
identical content, they may be bundled; when a group of similar reports
are bundled, the subsequent bundled reports are expected to take less
time to prepare than the initial report.

    FDA has based these estimates on information it now has available
from interactions with the industry, information related to other
regulated products, and FDA expectations regarding the tobacco
industry's use of the section 905(j) pathway to market their products.
Table 1 describes the annual reporting burden as a result of the
implementation of the substantial equivalence requirements of sections
905(j)(1)(A)(i) and 910(a) of the FD&C Act for an SE application.
    FDA estimates that 683 respondents will prepare and submit 683
section 905(j)(1)(A)(i) SE Reports each year. In addition, anyone
submitting an SE Report is required to submit an environmental
assessment (EA) under 21 CFR 25.40. The burden for environmental
reports has been included in the burden per response for each type of
SE report. Based on FDA's experience with EAs for currently regulated
tobacco products, we expect industry to spend 80 hours to prepare an
environmental assessment for a SE Report. Thus, FDA estimates that it
will take a manufacturer approximately 300 hours per report to prepare
an SE Report and the EA for a new tobacco product, which is a total of
204,900 hours each year.
    In addition, we estimate receiving 456 Full SE Bundled Reports at
90 hours per submission for a total of 41,040 hours each year.
    FDA estimates that it will receive 239 Product Quantity Change SE
Reports each year and that it will take a manufacturer approximately 87
hours to prepare this report for a total of 20,793 hours. This includes
time to prepare the environmental assessment, which FDA believes will
take less time due to the typically more limited modification(s)
included in a Product Quantity Change SE Report. We estimate receiving
192 Product Quantity Change Bundled SE Reports each year at
approximately 62 hours per submission for a total of 11,904 hours; this
number excludes the time for the initial SE Report, which was
previously accounted for.
    Therefore, FDA estimates the annual burden for submission of SE
information will be 278,637 hours. This is an increase of 106,759 hours
from the currently approved burden. We attribute this increase to an
increase in the number of SE Reports we expect related to Deemed
products (e.g., based on the initial registration and listing
information).

    Dated: May 30, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-11657 Filed 6-4-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: September 22, 2010 (Volume 75, Number 183)]
[Notices]
[Page 57747-57748]
[DOCID:fr22se10-38]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings No. 1

September 10, 2010.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP10-1283-000.
    Applicants: WestGas InterState, Inc.
    Description: WestGas InterState, Inc. submits tariff filing per
154.203: 2010-09-08 WGI Compliance Baseline to be effective 9/8/2010.
    Filed Date: 09/08/2010.
    Accession Number: 20100908-5067.
    Comment Date: 5 p.m. Eastern Time on Monday, September 20, 2010.

    Docket Numbers: RP10-1284-000.
    Applicants: Pine Needle LNG Company, LLC.
    Description: Petition of Pine Needle LNG Company, LLC for Approval
of Stipulation and Agreement.
    Filed Date: 09/09/2010.
    Accession Number: 20100909-5141.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 21, 2010.

    Docket Numbers: RP10-1285-000.
    Applicants: Tennessee Gas Pipeline Company.
    Description: Tennessee Gas Pipeline Company submits tariff filing
per 154.204: NET Colonial Combination to be effective 10/9/2010.
    Filed Date: 09/09/2010.
    Accession Number: 20100909-5145.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 21, 2010.

    Docket Numbers: RP10-1286-000.
    Applicants: Quest Pipelines (KPC).
    Description: Quest Pipelines (KPC) submits tariff filing per
154.203: Quest Pipelines (KPC)--Baseline eTariff Filing to be effective
9/10/2010.
    Filed Date: 09/10/2010.
    Accession Number: 20100910-5036.
    Comment Date: 5 p.m. Eastern Time on Wednesday, September 22, 2010.

    Any person desiring to intervene or to protest in any of the above
proceedings 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) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. 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. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    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
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also 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>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-23593 Filed 9-21-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: March 15, 2007 (Volume 72, Number 50)]
[Notices]
[Page 12170]
[DOCID:fr15mr07-53]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-341-000]

Transcontinental Gas Pipe Line Corporation; Notice of Proposed
Changes in FERC Gas Tariff

March 9, 2007.
    Take notice that on March 6, 2007, Transcontinental Gas Pipe Line
Corporation (Transco) tendered for filing as part of its FERC Gas
Tariff, Third Revised Volume No. 1, First Revised Thirty-Second Revised
Sheet No. 28B and Second Substitute Thirty-Third Revised Sheet No. 28B,
to become effective February 9, 2007 and March 1, 2007, respectively.
    Transco states that copies of the filing are being mailed to
affected customers and interested state 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
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 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>.

Philis J. Posey,
Acting Secretary.
[FR Doc. E7-4720 Filed 3-14-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 105 (Tuesday, June 2, 2015)]
[Notices]
[Pages 31453-31454]
[FR Doc No: 2015-13317]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Environmental Impact Statement for Port Bienville Railroad
Project

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Notice of Intent (NOI) to prepare an Environmental Impact
Statement (EIS).

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

SUMMARY: The Federal Railroad Administration (FRA) is issuing this NOI
to advise the public that the Mississippi Department of Transportation
(MDOT) and Hancock County Port and Harbor Commission intend to prepare
an Environmental Impact Statement (EIS) pursuant to the National
Environmental Policy Act of 1969 (NEPA) to evaluate the impacts of
construction and operation of the Port Bienville Railroad Project
(Project). The EIS will evaluate route alternatives for freight rail
service from the Port Bienville Short Line Railroad in Hancock County,
Mississippi to Nicholson in Pearl River County, Mississippi.

DATES: FRA invites the public, governmental agencies, and all other
interested parties to comment on the scope of the EIS. All such
comments should be provided in writing, within thirty (30) days of the
publication of this notice, at the address listed below. Comments may
also be provided orally or in writing at the scoping meetings. Once
scheduled, scoping meeting dates, times and locations, in addition to
information about the EIS for the Port Bienville Railroad Project can
be found online https://www.fra.dot.gov/Page/P0214.

ADDRESSES: Written comments on the scope of the EIS may be mailed or
emailed within thirty (30) days of the publication of this notice to
Melissa Hatcher, Environmental Protection Specialist, Office of Program
Delivery, Federal Railroad Administration, 1200 New Jersey Avenue SE.,
MS-20, Washington, DC 20590 or<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Melissa Hatcher, Environmental
Protection Specialist, Office of Program Delivery, Federal Railroad
Administration, 1200 New Jersey Avenue SE., MS-20, Washington, DC
20590<EMAIL_ADDRESS>or Kim Thurman, MDOT, Environmental
Division, P.O. Box 1850, Jackson, MS 39215-1850,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The EIS will be prepared in accordance with
the NEPA and the Council on Environmental Quality (CEQ) regulations for
implementing NEPA and FRA's Procedures for Considering Environmental
Impacts (64 FR 28545, May 26, 1999) (Environmental Procedures). The EIS
will also address section 106 of the National Historic Preservation Act
(16 U.S.C. 470(f)), section 4(f) of the Department of Transportation
Act of 1966 (49 U.S.C. 303), E.O. 12898 and USDOT Order 5610.2(a) on
Environmental Justice, and other applicable Federal and state laws and
regulations. The EIS will:
     Present the Purpose and Need for the Proposed Action.
     Identify the reasonable alternatives that satisfy the
Purpose and Need for the Proposed Action.
     Establish the no-build or no-action alternative to serve
as a baseline for comparison.
     Describe the environment likely to be affected by the
Proposed Action.
     Describe the potential environmental impacts associated
with the reasonable alternatives and propose mitigation measures to
reduce significant impacts.
    FRA, in cooperation with MDOT, will prepare an EIS for the Project
proposed by MDOT and Hancock County Port and Harbor Commission. The
Proposed Action will connect the Port Bienville Short Line Railroad,
located at the Port Bienville Industrial Park, Hancock County, with the
Norfolk Southern Railroad, located in the vicinity of Nicholson in
Pearl River County, to provide the Port with access to dual Class 1
rail service. The Project is composed of approximately 24 miles of new
railroad line. Dual Class I rail access is proposed to enable Hancock
and Pearl River Counties and Stennis Space Center to attract new
industries to this region that require this level of rail services, and
encourage job creation and investment opportunities to help this area
recover from recent hurricane disasters that have significantly
affected local economies.
    The Project's new corridor may involve alteration and fill of
``Waters of the United States,'' as that term is used in the Clean
Water Act (33 U.S.C. 1251 et seq.), and thus, the EIS process will
involve the U.S. Army Corps of Engineers, which is expected to serve as
a cooperating agency. The Project's corridor is expected to cross
through the acoustical (noise) buffer zone of NASA's Stennis Space
Center.

Project Background

    In 2008, the Hancock County Port and Harbor Commission received a
$2.7 million grant from the U.S. Department of Commerce's Economic
Development Administration to improve the railway at the Port Bienville
Industrial Park. In 2013, a Feasibility Report was completed to
determine the feasibility of constructing and operating a new rail line
to connect the Port Bienville Short Line Railroad with the Norfolk
Southern mainline in Nichols. The study included the development of
reasonable alternative corridors; identification of the economic
benefits and opportunities associated with the Project; and the
recommendation as to the feasibility of the Project. Given the business
case for dual Class I rail services, the demands of the existing and
emerging business clusters in Hancock and Pearl River Counties, the
future benefits to Stennis Space Center, the existing industrial land
inventory, and the workforce and transportation assets supporting this
region, the construction of this new rail line was determined feasible.
    The Project would provide existing businesses access to dual Class
I rail service, improving transit time and reliability, and enabling
Hancock and Pearl River Counties and the Stennis Space Center to
attract new industries to the region. By improving the efficiency of
goods movement in the area by rail, the Project would also improve
regional air quality and reduce truck traffic on area roads and
highways.

Scoping and Public Involvement

    In accordance with NEPA, the FRA and MDOT invite comments and
suggestions regarding the scope of the EIS from all interested parties
to ensure that all issues are addressed, all reasonable alternatives
are considered, and any significant issues are identified. In
particular, FRA is interested in identifying areas of environmental
concern where there might be a potential for significant impacts.
Public agencies with jurisdiction are requested to advise FRA and MDOT
of the applicable permit and environmental review requirements of each
agency, and the scope and content of the environmental information that
is germane to the agency's statutory responsibilities in connection
with the Project. Federal agencies with jurisdiction by law or special
expertise with respect to potential environmental issues will be
requested to act as a Cooperating Agency in accordance with 40 CFR
1501.16.
    In coordination with FRA, MDOT will lead the outreach activities
beginning with scoping meetings (dates to be determined). Public
involvement initiatives including public meetings, access to a Web
site, and outreach will continue throughout the EIS process.
Opportunities for public participation will be announced through
mailings, notices, advertisements, press releases, and a FRA-hosted EIS
Web page, accessible at https://www.fra.dot.gov/Page/P0214. One or more
public hearings will be held after the Draft EIS is released and made
available for public and agency review. Public notice will be given for
the time and place of public hearings.
    Comments or questions concerning the Proposed Action and the scope
of the EIS are invited from all interested parties and should be
directed to the FRA at the address provided above.

    Authority: 42 U.S.C. 4321 et seq.

    Issued in Washington, DC, on May 26, 2015.
Corey W. Hill,
Director, Office of Program Delivery.
[FR Doc. 2015-13317 Filed 6-1-15; 8:45 am]
 BILLING CODE 4910-06-P