[Federal Register Volume 84, Number 91 (Friday, May 10, 2019)]
[Notices]
[Pages 20636-20637]
[FR Doc No: 2019-09676]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-2478]

Recommendations for Reducing the Risk of Transfusion-Transmitted
Babesiosis; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration is announcing the
availability of a final guidance entitled ``Recommendations for
Reducing the Risk of Transfusion-Transmitted Babesiosis.'' The final
guidance document notifies blood establishments that collect blood and
blood components that we have determined babesiosis to be a relevant
transfusion-transmitted infection (RTTI) and provides recommendations
for donor screening, donation testing, donor deferral, and product
management to reduce the risk of transfusion-transmitted babesiosis
(TTB). The recommendations contained in the guidance apply to the
collection of blood and blood components, except Source Plasma. The
guidance announced in this notice finalizes the draft guidance of the
same title dated July 2018.

DATES: The announcement of the guidance is published in the Federal
Register on May 10, 2019.

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-2478 for ``Recommendations for Reducing the Risk of
Transfusion-Transmitted Babesiosis.'' 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.
     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.gpo.gov/fdsys/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.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), 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 the office in processing
your requests. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Jenifer Stach, 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 document entitled
``Recommendations for Reducing the Risk of Transfusion-Transmitted
Babesiosis.'' The guidance document notifies blood establishments that
collect blood and blood components that we have determined babesiosis
to be an RTTI under 21 CFR 630.3(h)(2) and provides recommendations for
donor screening, donation testing, donor deferral, and product
management to reduce the risk of TTB. The recommendations contained in
the guidance document applies to the collection of blood and blood
components, except Source Plasma.
    In the Federal Register of July 27, 2018 (83 FR 35657), FDA
announced the availability of the draft guidance of the same title. FDA
received several comments on the draft guidance, and those comments
were considered as the guidance was finalized. The guidance announced
in this notice finalizes the draft guidance dated July 2018.
    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 recommendations for reducing the risk of
transfusion-transmitted babesiosis. 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. This guidance is not subject to Executive
Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 601 have been approved under
OMB control number 0910-0338, and the collections of information in 21
CFR part 606, 21 CFR 610.40(h), and 21 CFR 630.40 have been approved
under OMB control number 0910-0116.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: May 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09676 Filed 5-9-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: November 6, 2008 (Volume 73, Number 216)]
[Notices]
[Page 66086-66090]
[DOCID:fr06no08-82]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-58886; File No. SR-FINRA-2008-010]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Order Approving a Proposed Rule Change Amending the
Codes of Arbitration Procedure To Establish Procedures for Arbitrators
To Follow When Considering Requests for Expungement Relief

October 30, 2008.

I. Introduction

    On March 13, 2008, the Financial Industry Regulatory Authority,
Inc. (``FINRA'') filed with the Securities and Exchange Commission
(``Commission'' or ``SEC''), pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to adopt Rule 12805 of the Code
of Arbitration Procedure for Customer Disputes (``Customer Code'') and
Rule 13805 of the Code of Arbitration Procedure for Industry Disputes
(``Industry Code'') to establish procedures that arbitrators must
follow when considering requests for expungement relief under Rule
2130.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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    The proposed rule change was published in the Federal Register on
April 3, 2008.\3\ The Commission received eleven comment letters on the
proposed rule change.\4\ FINRA responded to the comments on June 11,
2008.\5\ The Commission received an additional letter from one
commenter in furtherance of its original comments.\6\ On September 3,
2008, FINRA submitted a second response to comments.\7\ This order
approves the proposed rule change.
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    \3\ See Securities Exchange Act Release No. 57572 (March 27,
2008), 73 FR 18308 (April 3, 2008) (the ``Notice'').
    \4\ See letters to Nancy M. Morris, Secretary, Commission, from
Seth E. Lipner, Professor of Law, Bernard M. Baruch College, CUNY,
and Member Deutsch Lipner, dated April 8, 2008 (``Lipner letter'');
Steven B. Caruso, Maddox Hargett Caruso, P.C., dated April 8, 2008
(``Caruso letter''); Jill Gross, Director, Pace University, Investor
Rights Clinic, and Teresa Milano, dated April 15, 2008 (``Gross and
Milano letter''); Raghavan Sathianathan, dated April 17, 2008
(``Sathianathan letter''); William A. Jacobson, Associate Clinical
Professor, Director, Cornell Securities Law Clinic, Cornell Law
School and Arthur A. Andersen III, dated April 23, 2008 (``Cornell I
letter''); Barbara Black, Charles Hartsock Professor of Law,
director of Corporate Law Center, University of Cincinnati dated
April 24, 2008 (``Black letter''); Karen Tyler, President, North
American Securities Administrators Association, North Dakota
Securities Commissioner, dated April 24, 2008 (``NASAA letter'');
Scott R. Shewan, Born, Pape Shewan, LLP, dated April 24, 2008
(``Shewan letter''); Barry D. Estell, dated May 7, 2008 (``Estell
letter''), Brian N. Smiley, Smiley Bishop Porter LLP, dated May 8,
2008 (``Smiley letter''); and Laurence S. Schultz, President, Public
Investors Arbitration Bar Association, dated May 16, 2008 (``PIABA
letter'').
    \5\ See letter to Nancy M. Morris, Secretary, Commission, from
Margo A. Hassan, Counsel, FINRA, dated June 11, 2008 (``First
Response'').
    \6\ See letter to Nancy M. Morris, Secretary, Commission, from
William A. Jacobsen, Associate Clinical Professor, Director, Cornell
Securities Law Clinic, Cornell Law School, dated June 17, 2008
(``Cornell II letter'').
    \7\ See letter to Florence Harmon, Deputy Secretary [sic],
Commission, from Margo A. Hassan, dated September 3, 2008 (``Second
Response'').

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II. Description of the Proposed Rule Change

Background

    FINRA operates the Central Registration Depository (``CRD'') \8\
pursuant to policies developed jointly with the North American
Securities Administrators Association (``NASAA''). FINRA works with the
SEC, NASAA, other members of the regulatory community, and broker-
dealer firms to establish policies and procedures reasonably designed
to ensure that information submitted to and maintained in the CRD is
accurate and complete. These procedures, among other things, cover
expungement of information from the CRD.
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    \8\ The CRD is an online registration and licensing system used
by members of the securities industry, state and federal regulators,
and self-regulatory organizations. It contains administrative
information (e.g., personal, educational, and employment history)
and disclosure information (e.g., criminal matters, regulatory and
disciplinary actions, civil judicial actions, and information
relating to customer disputes) regarding broker-dealers and their
associated persons.
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    In December 2003, the SEC approved Rule 2130, which contains
procedures for expungement of customer dispute information regarding
member firms or associated persons from the CRD.\9\ Under Rule 2130,
FINRA members or associated persons seeking to expunge information from
the CRD arising from disputes with customers must obtain an order from
a court of competent jurisdiction directing expungement of information
or confirming an arbitration award that contains expungement
relief.\10\ It also requires that FINRA members or associated persons
name FINRA as an additional party in any court proceeding in which they
seek an order to expunge customer dispute information or request
confirmation of an award containing an order of expungement.\11\
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    \9\ See Securities Exchange Act Release No. 48933 (December 16,
2003), 68 FR 74667 (December 24, 2003)(SR-NASD-2002-168) (the
``Expungement Order''). See also NASD Notice to Members 04-16 (March
2004) (NASD Adopts Rule 2130 Regarding Expungement of Customer
Dispute Information From The Central Registration Depository).
    \10\ See NASD Conduct Rule 2130(a).
    \11\ See NASD Conduct Rule 2130(b).
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    FINRA may waive the requirement to be named as a party if it
determines that the expungement relief is based on an affirmative
judicial or arbitral finding that: (i) The claim, allegation, or
information is factually impossible or clearly erroneous; (ii) the
registered person was not involved in the alleged investment-related
sales practice violation, forgery, theft, misappropriation, or
conversion of funds; or (iii) the claim, allegation, or information is
false. If expungement relief is based on a judicial or arbitral finding
other than those above, FINRA may also waive the requirement to be
named as a party if it determines that the expungement relief and
accompanying findings on which it is based are meritorious and that
expungement would not have a material adverse effect on investor
protection, the integrity of the CRD, or regulatory requirements.\12\
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    \12\ Id.
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    According to FINRA, although arbitrators may order expungement at
the conclusion of an evidentiary hearing on the merits of a case, it is
more common for arbitrators to order expungement at the request of a
party to facilitate settlement of a dispute. For example, as part of a
settlement in which customers receive monetary compensation, the terms
of that settlement require the customer to consent to (or not oppose)
the entry of a stipulated award containing an order of expungement. In
such cases, FINRA expected that arbitrators would examine the amount
paid and any other terms and conditions of the settlement that might
raise concerns about the associated person's behavior before awarding
expungement.\13\ Contrary to this expectation, however, arbitrators
often do not inquire into the terms of settlement agreements. Recently,
for example, one New York state court expressed concern because
arbitrators did not describe ``a single fact or circumstance'' for
their conclusion that the grounds for expungement had been met.\14\
Another New York state court acknowledged that it has reservations
about the existing law on expungement, which resulted in the
confirmation of an award on which the arbitrator gave no explanation
for his factual finding.\15\
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    \13\ See NASD Notice to Members 04-43 (June 2004) (Members' Use
of Affidavits in Connection with Stipulated Awards and Settlements
to Obtain Expungement of Customer Dispute Information under Rule
2130).
    \14\ See Matter of Sage, Rutty & Co., Inc. v. Salzberg, Index
No. 2007-01942 (N.Y. Sup. Ct. May 30, 2007).
    \15\ See Matter of Kay v. Abrams, 853 N.Y.S.2d 862 (N.Y. Sup.
Ct. February 21, 2008).
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Proposed Rule Change

    Thus, FINRA developed proposed rules 12805 and 13805 which set
forth procedures that arbitrators must follow before granting
expungement of information from an associated person's CRD record.
Specifically, under the proposed rules, in order to grant expungement
of customer dispute information under Rule 2130, the panel must: (i)
Hold a recorded hearing session by telephone or in person regarding the
appropriateness of expungement, even if a claimant did not request a
hearing on the merits; (ii) for cases involving settlements, review the
settlement documents to examine the amount paid to any party and any
other terms and conditions of the settlement that might raise concerns
about the associated person's involvement in the alleged misconduct
before awarding expungement; (iii) indicate in the arbitration award
which of the grounds for expungement in Rule 2130(b)(1)(A)-(C) serves
as the basis for the expungement order and provide a brief written
explanation of the reason(s) for its finding that one or more grounds
for expungement exists; and (iv) assess forum fees for hearing sessions
in which the sole topic is the determination of the appropriateness of
expungement against the parties requesting expungement.
    The proposed rule change would not affect FINRA's current practice
of permitting expungement, without judicial intervention, of
information from the CRD as directed by arbitrators in intra-industry
arbitration awards that involve associated persons and firms based on
the defamatory nature of the information ordered expunged.\16\
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    \16\ In its original filing with the Commission proposing Rule
2130 (see SR-NASD-2002-168), NASD (now known as FINRA) explained in
Footnote 2 that ``NASD may execute, without a court order,
arbitration awards rendered in disputes between registered
representatives and firms that contain expungement directives in
which the arbitration panel states that expungement relief is being
granted because of the defamatory nature of the information. These
expungements are not covered by the moratorium and will not be
covered by the proposed rules and policies.'' In Amendment No. 1 to
that filing (at page five), NASD reiterated this point by stating
``NASD may execute, without a court order, an arbitration award
rendered in a dispute between a member and a current or former
associated person that contains an expungement directive in which
the arbitration panel states that expungement relief is being
granted based on the defamatory nature of the information.'' See
also NASD Notice to Members 04-16 (March 2004) (NASD Adopts Rule
2130 Regarding Expungement of Customer Dispute Information From The
Central Registration Depository).
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III. Summary of Comments

    As noted above, the Commission received twelve comment letters from
a variety of sources. Six comments supported the proposal,\17\ but a
majority of those six shared a variety of concerns and suggestions for
how to make the proposal more effective, as discussed in greater detail
below. Five commenters opposed the proposal, and one of those
commenters submitted two letters.\18\
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    \17\ See Caruso, Gross and Milano, NASAA, Shewan, Smiley, and
PIABA letters.
    \18\ See Lipner, Sathianathan, Cornell I (and in furtherance of
its original comments, Cornell II), Black, and Estell letters.
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    More specifically, the commenters raised the following issues:

    Argument 1: The proposed rule may enable the party requesting
expungement to use expungement findings against a customer in a
subsequent proceeding based on the doctrine of collateral estoppel.\19\
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    \19\ See Cornell I and Cornell II letters.
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    Response: FINRA was not persuaded by the argument and stated it
does not have the authority to dictate how parties may use an arbitral
finding after the arbitration is over; other forums are not bound to
accept FINRA's determination; and expungement findings, in FINRA's
view, should be treated in the same manner as other arbitral findings.
    An additional comment letter was submitted in rebuttal.\20\ The
commenter argued that nothing in FINRA's rules prohibits it from
exercising power to limit the use of expungement findings; FINRA may
promulgate rules regardless of whether a court will be ``bound'' by
those rules; and because the expungement process is unique and has a
public interest element with respect to regulatory record-keeping,
FINRA would be justified in treating expungement findings in a
different manner than other arbitral findings.
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    \20\ See Cornell II letter.
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    FINRA stated in its Second Response that modifying the proposal to
prohibit collateral use of expungement findings could result in
associated persons who are respondents asserting counterclaims against
customers in arbitration to preserve their ability to have the claims
resolved. In response to the argument that customers who settle and
agree to expungement may subsequently be subject to a lawsuit alleging
malicious prosecution based on the expungement findings, FINRA believes
that the high evidentiary standard applied in such cases, and the fact
that most customers are represented by counsel, provide sufficient
safeguards for the customer.\21\
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    \21\ See Second Response.
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    Argument 2: If customer claimants do not participate in the
expungement hearing, arbitrators will hear only the requesting party's
position.\22\
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    \22\ See Cornell I, NASAA, and Estell letters.
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    Response: FINRA noted that under the proposal, customers will
continue to have the opportunity to attend and participate in
expungement hearings in person or via telephone, and the customer may
submit a written statement if he chooses not to participate or attend
in person.\23\ In addition, FINRA vowed to take measures to ensure that
arbitrators are prepared to perform the critical fact-finding that is
required by the rule proposal, whether or not a customer is present at
the hearing.\24\
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    \23\ See First Response.
    \24\ FINRA will notify all arbitrators of the rule change. In
addition, FINRA will (i) update its online training program to
reflect the new expungement guidelines and encourage all of its
arbitrators to take the training; (ii) send arbitrators written
materials with questions and answers; (iii) publish an article in
The Neutral Corner explaining the new rules; (iv) conduct a call-in
workshop during which staff will discuss the rule change and answer
questions previously submitted by arbitrators and mediators; and (v)
have a broadcast e-mail which discusses the new rules. FINRA will
require arbitrators to certify in writing that they have
familiarized themselves with the new rule via at least one of the
training methods. Telephone call among Jean I. Feeney, Vice
President and Chief Counsel, FINRA Dispute Resolution, Katherine A.
England, Assistant Director, Commission, and Kristie Diemer, Special
Counsel, Commission on October 29, 2008.
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    Argument 3: The proposed rule inadequately attempts to fix the
expungement process.\25\
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    \25\ See Cornell I, NASAA, and Estell letters.
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    Argument 4: Expungement affects the integrity of the CRD by
permanently deleting information that is relevant to the regulatory
function of the SEC, FINRA, and the states, making the CRD an
unreliable and incomplete source of information.\26\ It may be possible
for the public to obtain more complete records through independent
investigation than regulators can obtain through the CRD.\27\
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    \26\ See Cornell I, Shewan, Estell, and Smiley letters.
    \27\ See Cornell I letter.
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    Response to Arguments 3 and 4: FINRA stated in its First Response
that arguments which express opinions on the expungement process set
forth in Rule 2130 are outside the scope of the present filing.
Nevertheless, FINRA also stated that it believes the current proposal
contains appropriate new procedures for arbitrators to follow when
considering expungement requests under Rule 2130 that should help
ensure that expungement is an extraordinary remedy and is granted only
under appropriate circumstances. FINRA stated it believes the proposal
would add transparency to the expungement process and would help
enhance the integrity of information in the CRD.\28\
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    \28\ See First Response.
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    Argument 5: Arbitrators may not be the proper parties to make
expungement decisions.\29\ Related comments (i) argue that expungement
decisions should be made by regulators and/or by a regulatory tribunal,
not by arbitrators,\30\ and (ii) question whether arbitrators may
exceed their authority when considering requests for expungement.\31\
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    \29\ See Caruso and Cornell I letters.
    \30\ See Lipner, Black, Shewan, and PIABA letters.
    \31\ See NASAA letter.
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    Response: FINRA believes that this argument also goes to Rule 2130
and is thus outside the scope of the proposal.\32\ FINRA noted,
however, that Rule 2130 requires a firm or associated person
petitioning a court for expungement relief or seeking judicial
confirmation of an arbitration award containing expungement relief to
name FINRA as a party in the court proceeding and serve FINRA with all
appropriate documents, unless FINRA waives this requirement. Therefore,
FINRA is able to conduct a regulatory review of all such waiver
requests and/or participate in the judicial expungement proceeding.
FINRA further noted it has a process whereby it notifies the states
where the individual is registered or seeking registration of the
expungement notice or waiver request,\33\ and if the state should wish
to intervene, it may petition the court.\34\ Finally, as discussed
above, FINRA would revise its arbitrator training to include guidance
on the proposed rule change.
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    \32\ See Second Response.
    \33\ See NASD Notice to Members 04-16 (March 2004) (NASD Adopts
Rule 2130 Regarding Expungement of Customer Dispute Information From
The Central Registration Depository).
    \34\ See the Expungement Order, supra note 9, 68 FR at 74671.
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    Argument 6: The proposal should address the situation in which an
arbitration brought against a firm that does not also name the
individual broker as a party is not considered a complaint against the
broker, even if the broker's name appears prominently in the text of
the arbitration complaint.\35\
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    \35\ See Lipner, Shewan, and PIABA letters.
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    Response: FINRA stated in its Second Response that this issue is
outside the scope of this proposal, but notes that in April 2008, it
sought comment on a proposed change which would revise the customer
complaint questions to elicit reporting of allegations of sales
practice violations made in arbitrations or civil suits against
registered persons not named as parties in those proceedings, and the
proposed revisions would require firms to treat these matters as
customer complaints.\36\
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    \36\ See FINRA Regulatory Notice 08-20 (April 2008) (Proposed
Changes to Forms U4 and U5). The comment period ended on May 27,
2008, and FINRA stated that it expects to file these changes with
the Commission shortly.
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    Argument 7: The proposal should include a provision to deter
overuse of expungement, particularly in settlements and/or as a
condition of monetary payment to the customer.\37\
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    \37\ See Cornell I, NASAA, and PIABA letters.
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    Response: FINRA has expressly stated that expungement should be an
extraordinary remedy \38\ and has

addressed the use of customer affidavits in settlements leading to
stipulated awards.\39\ The proposed rule would require arbitrators to
review settlement documents and consider the amount of payments made to
any party as well as any other terms and conditions of the settlement.
Arbitrators would be required to provide a written explanation of the
reasons for finding that one or more of the grounds for expungement
apply to the facts of the case. FINRA believes that the rule proposal
will help ensure that arbitrators fully evaluate each request for
expungement of information from the CRD.
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    \38\ See, e.g. , NASD Notice to Members 01-65 (October 2001)
(NASD Seeks Comment On Proposed Rules And Policies Relating To
Expungement Of Information From The Central Registration
Depository); Securities Exchange Act Release No. 47435 (March 4,
2003), 68 FR 11435 (March 10, 2003)(``Rule 2130 Notice''); Second
Response.
    \39\ See NASD Notice to Members 04-43 (June 2004) (Members' Use
of Affidavits in Connection with Stipulated Awards and Settlements
to Obtain Expungement of Customer Dispute Information under Rule
2130).
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    Argument 8: Payment for settlement in excess of the reporting
threshold on Forms U4 and U5 should raise a presumption that
expungement is not appropriate.\40\
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    \40\ See PIABA letter. The commenter states that this amount is
currently $10,000, but FINRA recently sought comment on a proposal
to increase this amount to $15,000. See FINRA Regulatory Notice 08-
20 (April 2008) (Proposed Changes to Forms U4 and U5). The comment
period ended on May 27, 2008.
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    Argument 9: There should be an express presumption that claims
should not be expunged from a representative's CRD record unless the
person seeking expungement is able to overcome the presumption by a
preponderance of the evidence.\41\
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    \41\ See NASAA and PIABA letters.
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    Response to Arguments 8 and 9: FINRA stated that because it is not
proposing to amend the evidentiary standards in the Codes, these
comments are outside the scope of the rule filing.\42\ Nonetheless,
FINRA states that the proposal requires arbitrators to evaluate fully
whether the party requesting expungement either in arbitration or in
connection with a settlement agreement has met the criteria promulgated
under Rule 2130(b)(1)(A)-(C), and FINRA notes that the proposal
requires the arbitrators, if expungement is ordered, to set forth a
written explanation regarding that decision.
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    \42\ See Second Response.
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    Argument 10: The effect of the proposal, combined with the current
rule, is that there will be greater potential for broker-dealer misuse
because (i) it will be more difficult to expunge defamatory information
filed on CRD and will increase the power that FINRA member firms have
over employees; and (ii) allegations by a whistleblower-employee of a
FINRA member firm of criminal activities by the FINRA member firm or
its senior executives can be expunged without judicial approval.\43\
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    \43\ See Sathianathan letter.
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    Response: FINRA stated in its First Response that Argument 10 is
outside the scope of the filing.

IV. Discussion and Commission Findings

    After careful review of the proposal and consideration of the
comment letters and FINRA's response to the comment letters, the
Commission finds that the proposed rule change is consistent with the
requirements of the Act and the rules and regulations thereunder
applicable to FINRA.\44\ In particular, the Commission finds that the
proposed rule change is consistent with Section 15A(b)(6) of the
Act,\45\ which requires, among other things, that FINRA's rules be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general, to protect investors and the public
interest.
---------------------------------------------------------------------------

    \44\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \45\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

    The Commission finds that the proposed rule change is reasonably
designed to accomplish these ends by establishing procedures that
arbitrators must follow when considering whether to grant requests for
expungement either in connection with arbitration or with a settlement
agreement, thus making the expungement process more transparent. The
additional procedures, such as the required review of settlement
documents, and the written explanation of the regulatory basis and
reason for granting expungement, in the proposed rule are designed to
help assure that the expungement process is not abused. This, in turn,
should help ensure that investors and regulators have access to all
relevant data in the CRD.
    The Commission believes that FINRA has adequately addressed the
issues raised by the commenters. The CRD is an important regulatory
tool as well as an important tool for investors who seek information
about associated persons and member firms.\46\ Once information is
removed from CRD via expungement it is lost to both the regulators and
the investing public. Therefore, the Commission takes seriously the
concerns raised by the commenters. The commenters raised concerns both
of a general nature and of a specific nature. The general concerns
related to the integrity of the CRD, who should make the decision to
grant expungement, and the frequency with which expungement is granted.
The specific concerns related to whether the new rules will result in
findings that can be used in a subsequent legal proceeding based on the
doctrine of collateral estoppel and the meaning of the standards in the
new rules and how the standards will be applied.
---------------------------------------------------------------------------

    \46\ See, e.g., http://www.finra.org/Investors/ToolsCalculators/
BrokerCheck/index.htm.
---------------------------------------------------------------------------

    The Commission agrees with FINRA that the comments about existing
Rule 2130 and the expungement process itself, as well as comments with
respect to whether arbitrators are the proper parties to decide if
information should be expunged from CRD, are technically outside the
scope of the proposed rule change.\47\ The Commission notes, however,
that FINRA has stated repeatedly that expungement is meant to be an
extraordinary remedy,\48\ and recognizes it ``should be used only when
the expunged information has no meaningful regulatory or investor
protection value.'' \49\ The Commission agrees with FINRA that
expungement should be an extraordinary remedy. Information that is
expunged from CRD is permanently deleted and thus no

longer available to regulators or the investing public.
---------------------------------------------------------------------------

    \47\ Another commenter's concern which FINRA stated was outside
the scope of the proposal was the belief that under the proposal,
allegations by a whistleblower-employee of a member firm of criminal
activities by either the FINRA member firm or senior executives of a
FINRA member firm could be expunged without judicial approval. The
Commission urges all persons to report allegations of criminal
activity to the relevant authority, regardless of the rules
governing expungement. Furthermore, the Commission notes that
criminal activity does not qualify for expungement under the current
rule, and thus would not be more easily expunged under FINRA's
proposed rules. As noted above, the arbitrator could not make an
affirmative finding that one of the conditions for waiver was met,
and FINRA would have to oppose the expungement. The Commission
expects FINRA to review any allegations of misuse of the CRD by
member firms. This is particularly important in light of the ruling
in New York that broker-dealer firms have absolute immunity for
statements made on U4 and U5. See Rosenberg v. MetLife, Inc., 493
F.3d 290 (2d Cir. N.Y., June 14, 2007). CRD should not be used by
broker-dealers against registered representatives. Such actions
would violate FINRA rules.
    \48\ See, e.g., NASD Notice to Members 01-65 (October 2001)
(NASD Seeks Comment On Proposed Rules And Policies Relating To
Expungement Of Information From The Central Registration
Depository); Securities Exchange Act Release No. 47435 (March 4,
2003), 68 FR 11435 (March 10, 2003); Second Response.
    \49\ See Rule 2130 Frequently Asked Questions, http://
www.finra.org/Industry/Compliance/Registration/CRD/FilingGuidance/
P005224.
---------------------------------------------------------------------------

    Under Rule 2130, FINRA must be named as a party when a respondent
is seeking confirmation from a court of an expungement award. FINRA can
waive its right to be named as a party in the court confirmation
process, if it makes an affirmative determination consistent with Rule
2130.\50\ The Commission believes that FINRA should use its authority
to review expungement requests to ensure that expungement is an
extraordinary remedy.\51\
---------------------------------------------------------------------------

    \50\ Rule 2130(b)(2), however, does allow for exceptions under
extraordinary circumstances.
    \51\ FINRA also provides the states with all requests for
expungement and petitions so that the states have an opportunity to
review them and/or participate in the hearing. The ability for FINRA
and the states to participate in the expungement process is critical
so that information that should remain in CRD is not expunged. The
Commission expects that all regulators will take these
responsibilities seriously and work cooperatively as the new rule is
implemented, and thereafter. See, e.g., UBS Financial Services, Inc.
v. Gibson, 851 N.Y.S.2d 75 (N.Y. Sup. Ct.)(consolidated with Johnson
v. Summit Equities, Inc., 238 N.Y.L.J. 109 (Nov. 15, 2007));
Zaferiou v. Holgado, Index No. 102996/07 (N.Y. Sup. Ct. April 14,
2008); Matter of Kay v. Abrams, 853 N.Y.S.2d 862 (N.Y. Sup. Ct. Feb.
21, 2008); and Karsner v. Lothian, 532 F.3d 876 (D.C. Cir. July 15,
2008).
---------------------------------------------------------------------------

    With respect to the issue of whether an associated person or member
will be able to use the arbitrators' written findings on expungement as
collateral estoppel in a subsequent legal proceeding against the
customer, FINRA believes that the high evidentiary standard that
applies in such cases, and the fact that most customers are represented
by legal counsel, should address this issue. The Commission believes
that this is a reasonable assessment and conclusion regarding this
potential situation.
    As discussed, the Commission believes that having accurate and
complete information in the CRD is vital; information that has
regulatory value or that could assist investors in protecting
themselves should not be removed from CRD.\52\ Because of the central
role that arbitrators have in the expungement process, the Commission
believes that it is critical for arbitrators to be well-informed
regarding FINRA's rules governing expungement. FINRA stated that this
proposal is part of its ``continuing effort to ensure that arbitrators
evaluate fully each request for expungement.'' \53\ The Commission
believes that the training and education FINRA provides in conjunction
with the proposed rule change will be critical to the implementation
and proper application of the rules. Proper training of arbitrators
should help make expungement the extraordinary remedy that it was meant
to be and should convey to the arbitrators the importance of their role
in maintaining the integrity of the CRD.
---------------------------------------------------------------------------

    \52\ FINRA routinely advises investors to check CRD before they
decide to do business with a firm or a broker. See e.g., http://
www.finra.org/Investors/SmartInvesting/GettingStarted/
SelectingInvestmentProfessional/index.htm; http://www.finra.org/
Investors/ProtectYourself/InvestorAlerts/FraudsAndScams/P01492; and
http://www.finra.org/Investors/ProtectYourself/BeforeYouInvest/
AvoidProblemswithYourBroker/index.htm.
    \53\ See Second Response.
---------------------------------------------------------------------------

    FINRA noted that it has requested comment on amendments to address
the issue of complaints that do not name a registered representative as
a party. FINRA stated that it expects to file these changes with the
Commission shortly.\54\ The Commission does not believe that it would
be in the interest of investors to delay approval of the instant
proposal while that rule change is being considered by FINRA; however
given the interrelationship of the issues, the Commission urges FINRA
to submit this filing as soon as possible so that this information will
be recorded in CRD.
---------------------------------------------------------------------------

    \54\ Id.
---------------------------------------------------------------------------

    In conclusion, the Commission believes that the proposed rule is
consistent with the Act and will help assure that accurate information
will remain in CRD and inaccurate information will be expunged. Given
the importance of CRD for regulators and to customers who want to get
information about registered persons or member firms before they do
business with them, the Commission urges FINRA in its regulatory role
to monitor how this rule is applied by arbitrators to assure that it is
achieving its goals, and to propose additional changes, if needed.

V. Conclusion

    For the foregoing reasons, the Commission finds that the proposed
rule change is consistent with the requirements of the Act and the
rules and regulations thereunder applicable to FINRA, and, in
particular, with Section 15A(b)(6) of the Act.\55\
---------------------------------------------------------------------------

    \55\ Id.
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\56\ that the proposed rule change (SR-FINRA-2008-010) is approved.
---------------------------------------------------------------------------

    \56\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\57\
---------------------------------------------------------------------------

    \57\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Acting Secretary.
 [FR Doc. E8-26442 Filed 11-5-08; 8:45 am]

BILLING CODE 8011-01-P


Carbon Monoxide Nonattainment Area Summary

As of July 31, 2009

   GRAND TOTAL: 	 	1 	 	1 	 	478,766

County subtotals and grand totals may not equal sum of parts. Part counties are only counted one time within groupings.


[Federal Register Volume 81, Number 241 (Thursday, December 15, 2016)]
[Notices]
[Pages 90833-90834]
[FR Doc No: 2016-30165]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

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

    Docket Numbers: ER16-1758-002.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Compliance filing: 2016-12-09_Addtl compliance re
revisions to SSR tariff provisions to be effective 8/22/2016.
    Filed Date: 12/9/16.
    Accession Number: 20161209-5084.
    Comments Due: 5 p.m. ET 12/30/16.

    Docket Numbers: ER17-382-000.
    Applicants: CED Ducor Solar 1, LLC.
    Description: Report Filing: Supplement to Market-Based Rate
Application to be effective N/A.
    Filed Date: 12/9/16.
    Accession Number: 20161209-5087.
    Comments Due: 5 p.m. ET 12/30/16.

    Docket Numbers: ER17-383-000.
    Applicants: CED Ducor Solar 2, LLC.
    Description: Report Filing: Supplement to Market-Based Rate
Application to be effective N/A.
    Filed Date: 12/9/16.
    Accession Number: 20161209-5088.
    Comments Due: 5 p.m. ET 12/30/16.

    Docket Numbers: ER17-384-000.
    Applicants: CED Ducor Solar 3, LLC.
    Description: Report Filing: Supplement to Market-Based Rate
Application to be effective N/A.
    Filed Date: 12/9/16.
    Accession Number: 20161209-5089.
    Comments Due: 5 p.m. ET 12/30/16.

    Docket Numbers: ER17-505-000.
    Applicants: Hydro-Quebec Energy Services (U.S.) Inc.
    Description: Request for Limited Waiver of H.Q. Energy Services
(U.S.) Inc.
    Filed Date: 12/7/16.
    Accession Number: 20161207-5207.
    Comments Due: 5 p.m. ET 12/21/16.

    Docket Numbers: ER17-510-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: 205(d) Rate Filing: Queue Position NQ127, Original
Service Agreement No. 4586 to be effective 2/8/2017.
    Filed Date: 12/8/16.
    Accession Number: 20161208-5138.
    Comments Due: 5 p.m. ET 12/29/16.

    Docket Numbers: ER17-511-000.
    Applicants: Weyerhaeuser NR Company.
    Description: Notice of Cancellation of market-based rate tariff, et
al. of Weyerhaeuser NR Company.
    Filed Date: 12/8/16.
    Accession Number: 20161208-5151.
    Comments Due: 5 p.m. ET 12/29/16.

    Docket Numbers: ER17-512-000.
    Applicants: Virginia Electric and Power Company.
    Description: Compliance filing: Baseline--Rate Schedule FERC No.
134 to be effective 9/1/2006.
    Filed Date: 12/9/16.
    Accession Number: 20161209-5001.
    Comments Due: 5 p.m. ET 12/30/16.

    Docket Numbers: ER17-513-000.
    Applicants: Alabama Power Company.
    Description: 205(d) Rate Filing: PowerSouth NITSA Amendment Filing
(Add Burkville Delivery Point) to be effective 11/9/2016.
    Filed Date: 12/9/16.
    Accession Number: 20161209-5086.
    Comments Due: 5 p.m. ET 12/30/16.

    Docket Numbers: ER17-514-000.
    Applicants: Alabama Power Company.
    Description: 205(d) Rate Filing: Amendment of Southern's Tariff
Volume No. 4 to be effective 2/8/2017.
    Filed Date: 12/9/16.
    Accession Number: 20161209-5103.
    Comments Due: 5 p.m. ET 12/30/16.

    Docket Numbers: ER17-515-000.
    Applicants: PacifiCorp.
    Description: 205(d) Rate Filing: BPA NITSA (SE Idaho Area) Rev 2 to
be effective 12/1/2016.
    Filed Date: 12/9/16.
    Accession Number: 20161209-5104.
    Comments Due: 5 p.m. ET 12/30/16.

    Docket Numbers: ER17-516-000.
    Applicants: Pacific Gas and Electric Company.
    Description: 205(d) Rate Filing: Transmission Access Charge
Balancing Account Adjustment (TACBAA) 2017 to be effective 3/1/2017.
    Filed Date: 12/9/16.
    Accession Number: 20161209-5121.
    Comments Due: 5 p.m. ET 12/30/16.

    Docket Numbers: ER17-517-000.
    Applicants: Midcontinent Independent System Operator, Inc., Great
River Energy, Northern States Power Company, a Minnesota corporation.
    Description: 205(d) Rate Filing: 2016-12-09_SA 2980 Northern States
Power-Great River Energy TIA (Quarry) to be effective 12/10/2016.
    Filed Date: 12/9/16.
    Accession Number: 20161209-5183.
    Comments Due: 5 p.m. ET 12/30/16.

    Docket Numbers: ER17-518-000.
    Applicants: Midcontinent Independent System Operator, Inc.,
Northern States Power Company, a Minnesota corporation, Great River
Energy.
    Description: 205(d) Rate Filing: 2016-12-09_SA 2981 Northern States
Power-Great River Energy TIA (St. Bonifacius) to be effective 12/10/
2016.
    Filed Date: 12/9/16.
    Accession Number: 20161209-5185.
    Comments Due: 5 p.m. ET 12/30/16.

    Take notice that the Commission received the following public
utility holding company filings:

    Docket Numbers: PH17-4-001.
    Applicants: Starwood Energy Group Global, L.L.C.
    Description: Starwood Energy Group Global, L.L.C. submits FERC 65-B
Material Change in Facts of Waiver Notification.
    Filed Date: 12/9/16.
    Accession Number: 20161209-5082.
    Comments Due: 5 p.m. ET 12/30/16.

    Take notice that the Commission received the following qualifying
facility filings:

    Docket Numbers: QF16-1069-000.
    Applicants: AEP OnSite Partners, LLC.
    Description: Refund Report of AEP OnSite Partners, LLC [Clyde].
    Filed Date: 12/8/16.
    Accession Number: 20161208-5178.
    Comments Due: 5 p.m. ET 12/29/16.

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

    Docket Numbers: RR17-2-000.

    Applicants: North American Electric Reliability Corporation.
    Description: Petition of the North American Electric Reliability
Corporation for Approval of Proposed Revisions to the Rules of
Procedure.
    Filed Date: 12/9/16.
    Accession Number: 20161209-5094.
    Comments Due: 5 p.m. ET 12/30/16.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: December 9, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-30165 Filed 12-14-16; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 153 (Wednesday, August 8, 2018)]
[Notices]
[Pages 39155-39156]
[FR Doc No: 2018-16950]

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

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

Reports, Forms, and Record Keeping Requirements Agency
Information Collection Activity Under OMB Review

AGENCY: National Highway Traffic Safety Administration (NHTSA), U.S.
Department of Transportation (DOT).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995, this
notice announces the Information Collection Request (ICR) abstracted
below will be submitted to the Office of Management and Budget (OMB)
for review and comment. The ICR describes the nature of the information
collection and its expected burden. A Federal Register Notice with a
60-day comment period soliciting public comments on the following
information collection

was published on May 17, 2018 (83 FR 23040). NHTSA did not receive any
public comments in response to the 60-day notice.

DATES: Comments must be received on or before September 7, 2018.

ADDRESSES: You may submit comments, within 30 days, to the Office of
Information and Regulatory Affairs, Office of Management and Budget,
725 17th Street NW, Washington, DC 20503, Attention NHTSA Desk Officer.

FOR FURTHER INFORMATION CONTACT: Dr. Kathy Sifrit, Office of Behavioral
Safety Research (NPD-320), National Highway Traffic Safety
Administration, 1200 New Jersey Avenue SE, W46-472, Washington, DC
20590. Dr. Sifrit's phone number is<PHONE_NUMBER> and her email
address is [email protected].

SUPPLEMENTARY INFORMATION:
    Title: In-Vehicle Drowsiness Detection and Alerting.
    Type of Request: New information collection requirement.
    Abstract: The National Highway Traffic Safety Administration
(NHTSA) is seeking approval to collect information from licensed young
drivers for a one-time voluntary driving simulator study of the
effectiveness of in-vehicle drowsiness detection and alerting systems
that aim to reduce drowsy driving. NHTSA proposes to collect
information from licensed young drivers to determine (1) their
eligibility to participate in a study evaluating systems designed to
detect and mitigate drowsy driving, (2) their driving performance
during a simulated driving task to measure drowsiness mitigation system
effectiveness, and (3) their opinions about the safety systems and
their perceptions of the benefits. NHTSA will collect information about
age, sex, driver license status, sleep and caffeine habits, and driving
habits from an estimated 120 young drivers through a one-time,
voluntary telephone interview to determine their eligibility for this
study. NHTSA will then invite 85 qualified young drivers to report to
the simulator to complete an informed consent form and other screening
activities including a ten-minute practice drive in the simulator and
an assessment of propensity for simulator sickness. NHTSA expects that
75 young drivers will pass the screening and will report for the
overnight study, which includes a four-hour drive in the simulator.
This collection is solely reporting, and there are no record-keeping
costs to the respondents. NHTSA will use the information to produce a
technical report that presents the results of the study. The technical
report will provide aggregate (summary) statistics and tables as well
as the results of statistical analysis of the information, but it will
not include any personal information. The technical report will be
shared with vehicle manufacturers and suppliers as well as other
stakeholders interested in improving traffic safety by decreasing
drowsy driving. The total estimated burden for qualifying 120
participants (30 hours), for screening 85 participants (85 hours) and
for 75 participants to complete the study (713 hours) is 828 total
hours.

Comments Are Invited on the Following

    (i) Whether the proposed collection of information is necessary for
the proper performance of the functions of the agency, including
whether the information will have practical utility;
    (ii) The accuracy of the Department's estimate of the burden of the
proposed information collection;
    (iii) Ways to enhance the quality, utility and clarity of the
information to be collected; and
    (iv) Ways to minimize the burden of the collection of information
on respondents, including the use of automated collection techniques or
other forms of information technology.
    A comment to OMB is most effective if OMB receives it within 30
days of publication of this notice.

    Authority:  44 U.S.C. Section 3506(c)(2)(A).

    Issued in Washington, DC, on August 3, 2018.
Jeff Michael,
Associate Administrator, Research and Program Development.
[FR Doc. 2018-16950 Filed 8-7-18; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register Volume 81, Number 174 (Thursday, September 8, 2016)]
[Notices]
[Pages 62160-62161]
[FR Doc No: 2016-21549]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2016-0261]

Collection of Information Under Review by Office of Management
and Budget; OMB Control Number: 1625-0063

AGENCY: Coast Guard, DHS.

ACTION: Thirty-day notice requesting comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995 the
U.S. Coast Guard is forwarding an Information Collection Request (ICR),
abstracted below, to the Office of Management and Budget (OMB), Office
of Information and Regulatory Affairs (OIRA), requesting an extension
of its approval for the following collection of information: 1625-0063,
Marine Occupational Health and Safety Standards for Benzene--46 CFR 197
Subpart C. Our ICR describes the information we seek to collect from
the public. Review and comments by OIRA ensure we only impose paperwork
burdens commensurate with our performance of duties.

DATES: Comments must reach the Coast Guard and OIRA on or before
October 11, 2016.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2016-0261] to the Coast Guard using the Federal
eRulemaking Portal at http://www.regulations.gov. Alternatively, you
may submit comments to OIRA using one of the following means:
    (1) Email<EMAIL_ADDRESS>    (2) Mail: OIRA, 725 17th Street NW., Washington, DC 20503,
attention Desk Officer for the Coast Guard.
    (3) Fax:<PHONE_NUMBER>. To ensure your comments are received in a
timely manner, mark the fax, attention Desk Officer for the Coast
Guard.
    A copy of the ICR is available through the docket on the Internet
at http://www.regulations.gov. Additionally, copies are available from:
COMMANDANT (CG-612), ATTN: PAPERWORK REDUCTION ACT MANAGER, U.S. COAST
GUARD, 2703 MARTIN LUTHER KING JR AVE SE., STOP 7710, WASHINGTON, DC
20593-7710.

FOR FURTHER INFORMATION CONTACT: Mr. Anthony Smith, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>,
for questions on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collection. There is one
ICR for each Collection. The Coast Guard invites comments on whether
this ICR should be granted based on the Collection being necessary for
the proper performance of Departmental functions. In particular, the
Coast Guard would appreciate comments addressing: (1) The practical
utility of the Collection; (2) the accuracy of the estimated burden of
the Collection; (3) ways to enhance the quality, utility, and clarity
of information subject to the Collection; and (4) ways to minimize the
burden of the Collection on respondents, including the use of automated
collection techniques or other forms of information technology. These
comments will help OIRA determine whether to approve the ICR referred
to in this Notice.
    We encourage you to respond to this request by submitting comments
and related materials. Comments to Coast Guard or OIRA must contain the
OMB Control Number of the ICR. They must also contain the docket number
of this request, [USCG-2016-0261], and must be received by October 11,
2016.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at http://www.regulations.gov and
can be viewed by following that Web site's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have

provided. For more about privacy and the docket, you may review a
Privacy Act notice regarding the Federal Docket Management System in
the March 24, 2005, issue of the Federal Register (70 FR 15086).
    OIRA posts its decisions on ICRs online at http://www.reginfo.gov/public/do/PRAMain after the comment period for each ICR. An OMB Notice
of Action on each ICR will become available via a hyperlink in the OMB
Control Number: 1625-0063.

Previous Request for Comments

    This request provides a 30-day comment period required by OIRA. The
Coast Guard published the 60-day notice (81 FR 28094, May 9, 2016)
required by 44 U.S.C. 3506(c)(2). That Notice elicited two comments
from one commenter. The comments are outside the scope of the Notice.
However, the Coast Guard will consider the comments in any future
rulemaking. Accordingly, no changes have been made to the Collections.

Information Collection Request

    Title: Marine Occupational Health and Safety Standards for
Benzene--46 CFR 197 Subpart C.
    OMB Control Number: 1625-0063.
    Summary: To protect marine workers from exposure to toxic Benzene
vapor, the Coast Guard implemented Title 46 CFR 197 Subpart C.
    Need: This information collection is vital to verifying compliance.
The Coast Guard authority is covered in Title 46 CFR 197 Subpart C.
    Forms: N/A.
    Respondents: Owners and operators of vessels.
    Frequency: On occasion.
    Hour Burden Estimate: The estimated burden remains 38,165 hours a
year.

    Authority:  The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended.

Marilyn Scott-Perez,
U.S. Coast Guard, Acting Deputy Chief Information Officer.
[FR Doc. 2016-21549 Filed 9-7-16; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 84, Number 187 (Thursday, September 26, 2019)]
[Notices]
[Page 50823]
[FR Doc No: 2019-20861]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2614-039]

City of Hamilton, Ohio and American Municipal Power, Inc.; Notice
of Application Accepted for Filing and Soliciting Comments, Motions To
Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Application Type: Amendment of License.
    b. Project No.: 2614-039.
    c. Date Filed: September 9, 2019.
    d. Applicant: City of Hamilton, Ohio and American Municipal Power.
    e. Name of Project: Greenup Project.
    f. Location: The Greenup Project is located at the U.S. Army Corps
of Engineers Greenup Locks and Dam in Scioto County, Ohio, in the
vicinity of the cities of Portsmouth, Ironton, and Wheelersburg, Ohio,
and Huntington, West Virginia, on the Ohio River between Ohio and
Kentucky.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791 (a)-825(r).
    h. Applicant Contact: Jim Logan, Executive Director of
infrastructure, City of Hamilton, 345 High Street 4th Floor, Hamilton,
Ohio 45011,<PHONE_NUMBER>; and Lisa McAlister, General Counsel for
Regulatory Affairs, American Municipal Power, Inc., 1111 Schrock Road,
Suite 100, Columbus, Ohio 43229;<PHONE_NUMBER>.
    i. FERC Contact: Zeena Aljibury,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and
protests: 30 days from the issuance date of this notice by the
Commission.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, and protests using the Commission's
eFiling system at http://www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at http://www.ferc.gov/doc-sfiling/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>(866) 208-3676 (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, please
send a paper copy to: Secretary, Federal Energy Regulatory Commission,
888 First Street NE, Washington, DC 20426. The first page of any filing
should include docket number P-2614-039. Comments emailed to Commission
staff are not considered part of the Commission record.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervenor files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency.
    k. Description of Request: The applicant proposes to amend the
Greenup Project license to remove 10.06 miles of the existing 14.51
mile transmission line from the project. The licensee states that the
10.06 mile long transmission segment is not used solely to transmit
power from the project to the interconnected grid and would remain part
of the interconnected transmission system even if the project did not
exist. Therefore, the licensee argues that this transmission segment
does not qualify as a primary transmission line and does not need to be
part of the licensed project.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street NE, Room 2A, Washington, DC
20426, or by calling<PHONE_NUMBER>. This filing may also be viewed on
the Commission's website at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. You may also register
online at http://www.ferc.gov/docs-filing/esubscription.asp to be
notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the address in item
(h) above. Agencies may obtain copies of the application directly from
the applicant.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Motions to Intervene, or Protests: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214, respectively. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Responsive Documents: Any filing must (1)
bear in all capital letters the title ``COMMENTS'', ``PROTEST'', or
``MOTION TO INTERVENE'' as applicable; (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person commenting, protesting or intervening; and (4)
otherwise comply with the requirements of 18 CFR 385.2001 through
385.2005. All comments, motions to intervene, or protests must set
forth their evidentiary basis. Any filing made by an intervenor must be
accompanied by proof of service on all persons listed in the service
list prepared by the Commission in this proceeding, in accordance with
18 CFR 385.2010.

    Dated: September 19, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-20861 Filed 9-25-19; 8:45 am]
 BILLING CODE 6717-01-P


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

General Comment:Dear Mr. Zeller:

I am writing you as a small business owner. I am concerned with your proposed rule regarding electronic cigarettes. I have thousands of Customers who would testify to the benefits of replacing their long term cigarette habit with e-cigs. Moreover, they would testify that their success has been largely due to the advanced custom products and tasty e-liquid flavors that specialty shops offer as opposed to what one might find in a convenience store. I am afraid that if you implement this proposed rule, that you will effectively wipe out all of the effective products currently on the market. (For example, just for my 1 line of juice I would have to submit 250 applications to you for approval. The cost of this could be millions of dollars with no guarantee that any of them would even be approved.) This will only leave room for the large companies who make the products that are far less effective and desirable. Big Tobacco and Big Pharma have already proven that they do not have the best interest of the people in mind, and I believe that this will only make that problem worse. It is my opinion that e-cigarettes should not only be embraced, but they should replace tobacco completely. If you really want to save lives, this is one idea that would accomplish that almost instantly.
I am requesting an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.
I appreciate your consideration of my request and am happy to discuss this issue with you further.
Respectfully,
Jason Bench