[Federal Register: December 31, 2007 (Volume 72, Number 249)]
[Notices]
[Page 74385-74386]
[DOCID:fr31de07-103]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57001; File No. SR-NASDAQ-2007-099]

Self-Regulatory Organizations; the NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Establishing Fee for Registering and Transferring Registration of
Associated Persons

December 20, 2007.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on December 20, 2007, The NASDAQ Stock Market LLC (``Nasdaq''), filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II, and III below, which
Items have been prepared by Nasdaq. Pursuant to Section 19(b)(3)(A)(ii)
of the Act \3\ and Rule 19b-4(f)(2) thereunder,\4\ Nasdaq has
designated this proposal as establishing or changing a due, fee, or
other charge, which renders the proposed rule change effective upon
filing. 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.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    Nasdaq proposes to charge fees for individual registration and
transfer/re-licensing under Rule 7003(b). The proposed rule change is
effective upon filing.
    The text of the proposed rule change is below. Proposed new
language is underlined; proposed deletions are in brackets.
* * * * *
    (a) The following fees will be collected and retained by FINRA
[NASD] via the Web CRD registration system for the registration of
associated persons of Nasdaq members that are not also FINRA [NASD]
members:
    (1)-(6) No change.
    (b) The following fees will be collected via the Web CRD
registration system for the registration of associated persons of
Nasdaq members:
    (1) $55 for each initial Form U4 filed for the registration of a
representative or principal.
    (2) $55 for each registration U4 transfer or re-licensing of a
representative or principal.
* * * * *

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

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

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

1. Purpose
    Nasdaq proposes to revise Rule 7003 and begin charging fees for
registration and transfer/re-licensing of individuals. Currently,
Nasdaq is one of only a few self-regulatory organizations (``SROs'')
that charge membership application and renewal fees for firms, but does
not charge fees for registered representatives.
    Subsequent to the early 2006 transition of the Nasdaq Market Center
as a facility of the Financial Industry Regulatory Authority, Inc. (f/
k/a National Association of Securities Dealers, Inc.) to a facility of
a new SRO, Nasdaq decided to limit membership fees to firm application,
renewal, and trading rights charges. However, since then Nasdaq's
market share in trading New York Stock Exchange securities has
increased significantly and Nasdaq will also soon launch an options
exchange. Both of these events create additional regulation expense
that must be supported. Nasdaq believes that the new fees are warranted
to ensure that fees for registered representatives fund a portion of
the cost of regulating the Nasdaq market. Nasdaq believes that even
with the new fees, registered representatives that are Nasdaq members
will still generally pay less than or the same amount they pay to be
registered representatives in other SROs.\5\
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    \5\ See, http://www.finra.org/web/groups/reg_systems/documents/regulatory_systems/p005213.pdf
.

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    Nasdaq proposes to begin charging $55 for individual initial
registration and transfer/re-licensing on January 1, 2008.
2. Statutory Basis
    Nasdaq believes that the proposed rule change is consistent with
the provisions of Section 6 of the Act,\6\ in general, and with Section
6(b)(4) of the Act,\7\ in particular, in that it provides for the
equitable allocation of reasonable dues, fees and other charges among
members and issuers and other persons using any facility or system
which Nasdaq operates or controls. Nasdaq believes that the proposed
Nasdaq membership fees for individual registration and transfer/re-
licensing are a reasonable and equitable method of ensuring that
registered representative fees funds a portion of the cost of
regulating the Nasdaq market, and that the overall cost for registered
representatives that are Nasdaq members is reasonable as compared with
their cost of membership in other SROs.
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    \6\ 15 U.S.C. 78f.
    \7\ 15 U.S.C. 78f(b)(4).

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

    Nasdaq does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

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

    Written comments were neither solicited nor received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act \8\ and subparagraph (f)(2) of Rule 19b-4
thereunder.\9\ At any time within 60 days of the filing of the proposed
rule change, the Commission may summarily abrogate such rule change if
it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.
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    \8\ 15 U.S.C. 78s(b)(3)(a)(ii).
    \9\ 17 CFR 240.19b-4(f)(2).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-NASDAQ-2007-099 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2007-099. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments,

all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room on official
business days between the hours of 10 a.m. and 3 p.m. Copies of the
filing also will be available for inspection and copying at the
principal office of Nasdaq. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly.
    All submissions should refer to File Number SR-NASDAQ-2007-099 and
should be submitted on or before January 22, 2008.
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    \10\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-25354 Filed 12-28-07; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 149 (Friday, August 4, 2023)]
[Notices]
[Pages 51842-51844]
[FR Doc No: 2023-16645]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1434]

Waivers, Exceptions, and Exemptions From the Requirements of
Section 582 of the Federal Food, Drug, and Cosmetic Act Guidance for
Industry; Availability

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

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Waivers,
Exceptions, and Exemptions from the Requirements of section 582 of the
Federal Food, Drug, and Cosmetic Act.'' This guidance describes the
process an authorized trading partner or other stakeholder should use
to request a waiver, exception, or exemption from the requirements of
the Federal Food, Drug, and Cosmetic Act (FD&C Act) as well as the
factors FDA intends to consider when evaluating such requests from an
authorized trading partner or other stakeholder, and when determining
FDA-initiated exceptions and exemptions. Additionally, this guidance
describes the process the FDA intends to follow once every 2 years to
review and make determinations on the appropriateness of renewing a
previously approved waiver, exception, or exemption, where applicable.
This guidance finalizes the draft guidance of the same title issued on
May 9, 2018.

DATES: The announcement of the guidance is published in the Federal
Register on August 4, 2023.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-1434 for ``Waivers, Exceptions, and Exemptions from the
Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act
Guidance for Industry.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at

https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Lysette Deshields, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected]; or Anne Taylor, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Waivers, Exceptions, and Exemptions from the Requirements of
section 582 of the Federal Food, Drug, and Cosmetic Act.'' The Food
Drug and Cosmetic Act, as amended by the Drug Supply Chain Security Act
(DSCSA), outlines critical steps to enhance drug distribution security.
These steps will ultimately allow tracing of certain human finished
prescription drugs in an electronic, interoperable manner as they are
distributed within the United States. Section 582 of the FD&C Act (21
U.S.C. 360eee-1), as amended by the DSCSA, applies to manufacturers,
repackagers, wholesale distributors, and dispensers (collectively
referred to as ``trading partners'') who engage in transactions of
product, and outlines requirements related to product tracing,
verification, product identification, and authorized trading partners.
    Section 582(a)(3)(A) of the FD&C Act requires FDA to issue a
guidance that: (1) establishes a process by which an authorized
manufacturer, repackager, wholesale distributor, or dispenser may
request a waiver from any of the requirements set forth in section 582
of the FD&C Act, which the Secretary of HHS (Secretary) may grant if
the Secretary determines that such requirements would result in an
undue economic hardship or for emergency medical reasons, including a
public health emergency declaration pursuant to section 319 of the
Public Health Service Act; (2) establishes a process by which the
Secretary determines exceptions, and a process through which a
manufacturer or repackager may request such an exception, to the
requirements relating to product identifiers if a product is packaged
in a container too small or otherwise unable to accommodate a label
with sufficient space to bear the information required for compliance
with section 582 of the FD&C Act; and (3) establishes a process by
which the Secretary may determine other products or transactions that
shall be exempt from the requirements of section 582 of the FD&C Act.
    Additionally, section 582(a)(3)(B) of the FD&C Act requires the FDA
to issue guidance that includes a process describing how the FDA
intends to review and renew granted waivers, exceptions, and
exemptions.
    This guidance finalizes the draft guidance entitled ``Waivers,
Exceptions, and Exemptions from the Requirements of Section 582 of the
Federal Food, Drug, and Cosmetic Act'' issued on May 9, 2018 (83 FR
21297). FDA considered comments received on the draft guidance as the
guidance was finalized. Changes from the draft guidance to the final
guidance include: (1) recommending that a requestor submit a request
for a waiver, exception, or exemption to FDA electronically; (2)
recommending additional information a requestor should provide to FDA
in a request for waiver, exception, or exemption; (3) recommending that
recipients of a waiver, exception, or exemption notify the Agency of
any material change in circumstances that formed the basis for granting
the initial request for regulatory relief as soon as possible; (4)
recommending that recipients of a waiver, exception, or exemption
notify affected entities that a product and/or transaction is subject
to a waiver, exception, or exemption; (5) describing how an authorized
trading partner and other stakeholder may submit a request to FDA to
reconsider the scope of a waiver, exception, or exemption that has been
granted; (6) describing how an authorized trading partner and other
stakeholder may submit a request to FDA to reconsider and re-evaluate a
denied waiver, exception, or exemption request; and (7) recommending
that recipients of a waiver, exception, or exemption notify affected
entities upon termination of a waiver, exception, or exemption. 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
current thinking of FDA on ``Waivers, Exceptions, and Exemptions from
the Requirements of Section 582 of the Federal Food, Drug, and
Cosmetic.'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to

previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in ``Waivers, Exceptions, and Exemptions from the
Requirements of section 582 of the Federal Food, Drug, and Cosmetic
Act'' have been approved under OMB control number 0910-0806.

III. Electronic Access

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

    Dated: July 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16645 Filed 8-3-23; 8:45 am]
BILLING CODE 4164-01-P