[Federal Register Volume 86, Number 158 (Thursday, August 19, 2021)]
[Notices]
[Pages 46744-46746]
[FR Doc No: 2021-17761]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-92663; File No. SR-NASDAQ-2021-061]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend Listing Rule 5910 To Modify the Application Fee for Companies
Listing Under IM-5101-2

August 13, 2021.
    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 August 3, 2021, 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 Listing Rule 5910 to modify the
application fee for companies listing under IM-5101-2 (companies whose
business plan is to complete one or more acquisitions) on the Nasdaq
Global Market.
    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/nasdaq/rules, 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
    Nasdaq proposes to revise the application fee payable by
Acquisition Companies listing on the Nasdaq Global Market to make it
the same as the application fee payable by Acquisition Companies
listing on the Nasdaq Capital Market, as described in more details
below.
    Historically, companies whose business plan is to complete an
initial public offering and engage in a merger or acquisition with one
or more unidentified companies within a specific period of time, as
described in IM-5101-2, (``Acquisition Companies'') would choose to
list on the Nasdaq Capital Market instead of the Nasdaq Global Market,
primarily because it had lower fees. Recently Nasdaq modified the Entry
and All-Inclusive Annual Listing Fees for Acquisition Companies listing
on the Nasdaq Global Market.\3\ As a result, the Entry and All-
Inclusive Annual Listing Fees for Global Market Acquisition Companies
are currently identical to the fees charged to Capital Market
Acquisition Companies.
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    \3\ Securities Exchange Act Release No. 92345 (July 7, 2021), 86
FR 36807 (July 13, 2021).
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    A company applying to list on Nasdaq is required to submit a non-
refundable initial application fee with its application, which is
subsequently credited towards the Entry Fee payable upon listing. A
company listing on the Global Market is required to submit a non-
refundable $25,000 initial application fee, whereas the application fee
on the Capital Market is $5,000.\4\
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    \4\ See Listing Rules 5910(a)(11) and 5920(a)(11).
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    Nasdaq proposes to revise the application fee for Acquisition
Companies listing on the Nasdaq Global Market to make it the same as
the application fee Acquisition companies pay on the Capital Market.
    Nasdaq has limited resources and charges companies applying to list
on Nasdaq an application fee to offset the cost of conducting its
regulatory review in connection with the initial listing of the
company. As explained above, the application fee is subsequently
credited towards the Entry Fee payable upon listing. In Nasdaq's
experience, conducting an initial listing review for an Acquisition
Company is less costly than conducting an initial listing review for
other types of companies for a number of reasons. Specifically, review
of an Acquisition Company's IPO application is generally much simpler

and quicker than an application of an operating company because an
Acquisition Company has no underlying operating business. For the same
reason, an Acquisition Company's SEC filings and IPO documentation are
much less detailed and its financial statements are simple and do not
have historical financials. An Acquisition Company's registration
statement does not have an operating business to describe and has no
risk factors related to an operating business. Further, Acquisition
Companies always qualify as Emerging Growth Companies under Section
2(a)(19) of the Securities Act, which results in scaled requirements
for narrative disclosure and financial reporting.
    Accordingly, Nasdaq believes it is appropriate to charge
Acquisition Companies listing on the Global Market a smaller
application fee than the fee applicable to operating companies. Nasdaq
notes that, as described above, the application fee is a part of the
Entry Fee, and therefore, the overall Entry Fee payable by an
Acquisition Company listing on Nasdaq remains unchanged under this
proposal. Accordingly, this proposal has no financial impact on the
level of listing fees collected from issuers that list on Nasdaq and
thus has no impact the Exchange's resource commitment to its regulatory
oversight of the listing process or its regulatory programs.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\5\ in general, and furthers the objectives of Sections
6(b)(4) and 6(b)(5) of the Act,\6\ in particular, in that it provides
for the equitable allocation of reasonable dues, fees and other charges
among members and issuers and other persons using any facility, and is
not designed to permit unfair discrimination between customers,
issuers, brokers, or dealers.
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    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(4) and (5).
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    As a preliminary matter, Nasdaq competes for listings with other
national securities exchanges and companies can easily choose to list
on, or transfer to, those alternative venues. As a result, the fees
Nasdaq can charge listed companies are constrained by the fees charged
by its competitors and Nasdaq cannot charge prices in a manner that
would be unreasonable, inequitable, or unfairly discriminatory.\7\
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    \7\ In that regard, Nasdaq notes that while the New York Stock
Exchange charges most companies an Initial Application Fee of
$25,000 in connection with applying to list an equity security,
Acquisition Companies are not subject to the Initial Application
Fee. See Sections 902.03 and 902.11 of the NYSE Listed Company
Manual.
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    The proposal is being implemented to avoid charging a higher
application fee to an Acquisition Company that is listing on the Nasdaq
Global Market over what such company is required to pay when applying
to list on the Capital Market. As a result of a recent rule change, the
Entry and All-Inclusive Annual Listing Fees for Global Market
Acquisition Companies are currently identical to the fees charged
Capital Market Acquisition Companies.\8\ This proposal would fully
equalize listing fees and the timing of paying such fees for
Acquisition Companies listing on the Capital and Global Markets. Nasdaq
believes it is equitable under Section 6(b)(4) of the Act \9\ to charge
Global Market Acquisition Companies the same application fee as Capital
Market Acquisition Companies given that they are treated the same, and
their applications are no more complicated, regardless of whether they
are applying to list on the Global or Capital Market.
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    \8\ Securities Exchange Act Release No. 92345 (July 7, 2021), 86
FR 36807 (July 13, 2021).
    \9\ 15 U.S.C. 78f(b)(4).
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    Moreover, the Exchange believes that it is not unfairly
discriminatory to charge Acquisition Companies application fee
different from the fee applicable to operating companies listing on the
Global Market, because Acquisition Companies differ in some important
respects from traditional operating companies and such differences make
it less costly for Nasdaq to conduct an initial listing review.
Specifically, an Acquisition Company's IPO process is generally much
simpler and quicker than a regular IPO because an Acquisition Company
has no underlying operating business. For the same reason, an
Acquisition Company's SEC filings and IPO documentation, including its
financial statements, are simple and do not have historical discussions
or financials. An Acquisition Company's registration statement does not
have an operating business to describe and has no risk factors related
to an operating business. Further, Acquisition Companies always qualify
as Emerging Growth Companies under Section 2(a)(19) of the Securities
Act which results in scaled requirements for narrative disclosure and
financial reporting. Therefore, Nasdaq believes that it is appropriate,
and not unfairly discriminatory, to charge lower application fee to
Global Market Acquisition Companies than application fee that are
charged to operating companies listed on the Nasdaq Global Market.
    For the foregoing reasons, the Exchange believes that the proposal
is consistent with the Act.

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.
    The proposed modified application fee will be applicable to all
similarly situated issuers on the same basis and will eliminate an
existing distinction between Acquisition Companies listing on the
Capital and Global Markets. The Exchange does not believe that the
proposed fees will have any meaningful effect on the competition among
issuers listed on the Exchange.
    The Exchange operates in a highly competitive market in which
issuers can readily choose to list new securities on other exchanges
and transfer listings to other exchanges if they deem fee levels at
those other venues to be more favorable. Because competitors are free
to modify their own fees in response, and because issuers may change
their listing venue, the Exchange does not believe its proposed fee
change can impose any burden on intermarket competition. In that
regard, Nasdaq notes that while the New York Stock Exchange charges
most companies an Initial Application Fee of $25,000 in connection with
applying to list an equity security, Acquisition Companies are not
subject to the Initial Application Fee.\10\
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    \10\ See Sections 902.03 and 902.11 of the NYSE Listed Company
Manual.
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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.\11\
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    \11\ 15 U.S.C. 78s(b)(3)(A)(ii).
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    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-2021-061 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-2021-061. 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 website (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 website 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. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NASDAQ-2021-061 and should be submitted
on or before September 9, 2021.
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    \12\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-17761 Filed 8-18-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 157 (Thursday, August 14, 2014)]
[Notices]
[Pages 47649-47650]
[FR Doc No: 2014-19267]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0092]

Guidance for Industry on Immunogenicity Assessment for
Therapeutic Protein Products; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the availability of a guidance for industry entitled
``Immunogenicity Assessment for Therapeutic Protein Products.''
Therapeutic protein products may elicit immune responses, which may
lead to serious or life-threatening adverse events for the patient or
loss of efficacy of the product. This guidance is intended to assist
manufacturers and clinical investigators in developing a risk-based
approach in both the nonclinical and clinical phases of product
development that will allow them to evaluate and reduce the likelihood
that the immunogenicity of the product will cause harm to patients.
This guidance finalizes the draft guidance issued in February 2013.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 2201, Silver Spring, MD 20993-0002; or the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Amy Rosenberg, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 2238, Silver Spring, MD 20892, 240-402-
9789; or Stephen Ripley, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Rockville, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Immunogenicity Assessment for Therapeutic Protein
Products.'' The purpose of this guidance is to assist

manufacturers and clinical investigators involved in the development of
therapeutic protein products for human use in evaluating and reducing
the risk of adverse events caused by immune responses to these
products. The guidance: (1) Outlines and recommends adoption of a risk-
based approach to evaluating and mitigating potential immune responses
to therapeutic protein products that may affect their safety and
efficacy, (2) describes various product- and patient-specific factors
that affect the immunogenicity of or immune responses to therapeutic
protein products and provides recommendations pertaining to each factor
that may reduce the likelihood that an immune response will be
generated to the product, (3) offers a series of recommendations for
risk mitigation in the clinical phase of development of therapeutic
protein products, (4) provides supplemental information on the
diagnosis and management of particular adverse consequences of immune
responses to therapeutic protein products, and (5) discusses briefly
the use of animal studies and the conduct of comparative immunogenicity
studies.
    In the Federal Register of February 11, 2013 (78 FR 9702), FDA
announced the availability of the draft guidance of the same title
dated February 2013. FDA received numerous comments on the draft
guidance, and those comments were considered as the guidance was
finalized. In addition, editorial changes were made to improve clarity.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on immunogenicity assessments for therapeutic
protein products. It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the requirements of the
applicable statutes and regulations.

II. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm; http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm; or
http://www.regulations.gov.

    Dated: August 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-19267 Filed 8-13-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: November 19, 2008 (Volume 73, Number 224)]
[Notices]
[Page 69626-69627]
[DOCID:fr19no08-70]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

November 13, 2008.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP08-632-001.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Gulf South Pipeline Co, LP submits Sub Second Revised
Sheet No. 2501 to FERC Gas Tariff, Sixth Revised Volume No. 1, to be
effective 11/1/08.
    Filed Date: 11/12/2008.
    Accession Number: 20081113-0103.
    Comment Date: 5 p.m. Eastern Time on Monday, November 24, 2008.

    Docket Numbers: RP09-64-000.
    Applicants: Northern Natural Gas Company.
    Description: Northern Natural Gas Company submits 14 Revised Sheet
No. 66B.01 et al. to FERC Gas Tariff, Fifth Revised Volume No. 1, to be
effective 12/13/08.
    Filed Date: 11/12/2008.
    Accession Number: 20081113-0108.
    Comment Date: 5 p.m. Eastern Time on Monday, November 24, 2008.

    Docket Numbers: RP09-65-000.
    Applicants: Gulfstream Natural Gas System, L.L.C.
    Description: Gulfstream Natural Gas System submits First Revised
Sheet No. 8.01a et al. to FERC Gas Tariff, Original Volume No. 1, to be
effective 12/12/08.
    Filed Date: 11/12/2008.
    Accession Number: 20081113-0107.
    Comment Date: 5 p.m. Eastern Time on Monday, November 24, 2008.

    Docket Numbers: RP09-66-000.
    Applicants: Texas Eastern Transmission LP.
    Description: Texas Eastern Transmission, LP submits First Revised
Sheet No. 981 et al. to FERC Gas Tariff, Seventh Revised Volume No. 1,
to be effective 12/12/08.
    Filed Date: 11/12/2008.
    Accession Number: 20081113-0106.
    Comment Date: 5 p.m. Eastern Time on Monday, November 24, 2008.

    Docket Numbers: RP09-67-000.
    Applicants: Texas Gas Transmission, LLC.
    Description: Texas Gas Transmission. LLC submits Original Sheet No.
70 et al. to FERC Gas Tariff, Second Revised Volume No. 1, to be
effective 11/1/08.
    Filed Date: 11/12/2008.
    Accession Number: 20081113-0105.
    Comment Date: 5 p.m. Eastern Time on Monday, November 24, 2008.

    Docket Numbers: RP09-68-000.
    Applicants: Wyoming Interstate Company, Ltd.
    Description: Wyoming Interstate Company, Ltd submits Tenth Revised
Sheet No. 1 to FERC Gas Tariff, Second Revised Volume No. 2, to be
effective 12/15/08.
    Filed Date: 11/12/2008.
    Accession Number: 20081113-0104.
    Comment Date: 5 p.m. Eastern Time on Monday, November 24, 2008.

    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 dockets(s). For assistance with any FERC Online
service, please e-mail<EMAIL_ADDRESS>or call (866) 208-
3676 (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E8-27402 Filed 11-18-08; 8:45 am]

BILLING CODE 6717-01-P


Comment Info: =================

General Comment: "A 75 day comment period is insufficient time for the vaping industry and the wider vaping community to comment on the proposed deeming regulations. I would respectfully request that the period for comment be extended to 180 days."  Requested by a person who smoked for 44 years and who is now smoke free for 9 months thanks to e cigarettes. I agree with sales not being available to minors but I believe the FDA needs to commit to doing more research rather than making decisions without extending time for comments and further research.