[Federal Register Volume 82, Number 48 (Tuesday, March 14, 2017)]
[Notices]
[Page 13702]
[FR Doc No: 2017-05084]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a closed meeting on Thursday, March
16, 2017 at 2 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the closed meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or her designee, has
certified that, in her opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (a)(5), (a)(7), (a)(9)(ii) and (a)(10), permit
consideration of the scheduled matter at the closed meeting.
    Acting Chairman Piwowar, as duty officer, voted to consider the
items listed for the closed meeting in closed session.
    The subject matter of the closed meeting will be:
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings;
    Adjudicatory matters; and
    Other matters relating to enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed; please contact Brent J. Fields from
the Office of the Secretary at<PHONE_NUMBER>.

    Dated: March 9, 2017.
Brent J. Fields,
Secretary.
[FR Doc. 2017-05084 Filed 3-10-17; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register: July 15, 2010 (Volume 75, Number 135)]
[Notices]
[Page 41254-41258]
[DOCID:fr15jy10-107]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-62476; File No. SR-FINRA-2010-012]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Order Approving a Proposed Rule Change To Amend FINRA
Rule 8312 (FINRA BrokerCheck Disclosure)

July 8, 2010.

I. Introduction

    On March 30, 2010, the Financial Industry Regulatory Authority,
Inc. (``FINRA'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend FINRA Rule 8312 (FINRA BrokerCheck
Disclosure) to (i) expand the information released through BrokerCheck,
both in terms of scope and time; and (ii) establish a formal process to
dispute the accuracy of, or update, information disclosed through
BrokerCheck. The proposal was published for comment in the Federal
Register on April 22, 2010.\3\ The Commission received fourteen
comments on the proposal.\4\ FINRA responded to the comments on June
21, 2010.\5\ This order approves the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 61927 (April 16,
2010), 75 FR 21064 (April 22, 2010) (SR-FINRA-2010-012)
(``Notice'').
    \4\ See Exhibit A for a list of comment letters.
    \5\ See letter to Elizabeth M. Murphy, Secretary, Commission,
from Richard E. Pullano, Associate Vice President and Chief Counsel,
FINRA, dated June 21, 2010 (``Response Letter'').
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II. Description of the Proposal

A. Expansion of Information Released through BrokerCheck

    Pursuant to FINRA Rule 8312(b), BrokerCheck is an online
application through which the public may obtain information regarding
current and former members, associated persons and persons who were
associated with a member within the preceding two years. Historic
Complaints \6\ regarding such persons are disclosed pursuant to Rule
8312(b) only if: (i) A matter became a Historic Complaint on or after
March 19, 2007; (ii) the most recent Historic Complaint or currently
reported customer complaint, arbitration or litigation is less than ten
years old; and (iii) the person has a total of three or more currently
disclosable regulatory actions, currently reported customer complaints,
arbitrations or litigations, or Historic Complaints (subject to the
limitation that they became Historic Complaints on or after March 19,
2007), or any combination thereof (the ``three strikes provision'').\7\
In addition, pursuant to FINRA Rule 8312(c), BrokerCheck allows the
public to obtain certain limited information regarding formerly
associated persons, regardless of the time elapsed since they were
associated with a member, if they were the subject of any final
regulatory action.\8\
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    \6\ Historic Complaints are customer complaints that were
reported on a uniform registration form that are more than two years
old and that have not been settled or adjudicated and customer
complaints, arbitrations, or litigations that have been settled for
an amount less than the specified dollar amount (identified on the
customer complaint question) and are therefore no longer reportable
on a uniform registration form. See FINRA Rule 8312(b)(7).
    \7\ Id. In addition, if a person meets the three criteria
established for disclosing Historic Complaints, only those Historic
Complaints that became Historic Complaints after March 19, 2007 will
be displayed through BrokerCheck.
    \8\ A ``final regulatory action'' includes any final action of
the Commission, Commodity Futures Trading Commission, a Federal
banking agency, the National Credit Union Administration, another
Federal regulatory agency, a State regulatory agency, a foreign
financial regulatory authority, or a self-regulatory organization,
including actions that have been appealed. See Questions 14C, 14D,
and 14E on Form U4, as well as Question 7D of Form U5. See also
Section 3(a)(39) of the Act.
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    In connection with its most recent change to BrokerCheck,\9\ FINRA
stated that it would consider whether to provide greater disclosure of
information through BrokerCheck.\10\ Based on its continued evaluation
of the BrokerCheck program, FINRA proposes to (i) expand the
BrokerCheck disclosure period for formerly associated persons of a
member from two years to ten years and (ii) eliminate the conditions
that must be met before Historic Complaints will be displayed in
BrokerCheck (i.e. the three strikes provision) and, thereby, make
publicly available in BrokerCheck all Historic Complaints that were
archived after the implementation of Central Registration Depository
(``CRD[supreg]'' or ``Web CRD'') on August 16, 1999.\11\
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    \9\ See Securities Exchange Act Release No. 61002 (November 13,
2009), 74 FR 61193 (November 23, 2009) (SR-FINRA-2009-050).
    \10\ See letter to Elizabeth M. Murphy, Secretary, Commission,
from Richard E. Pullano, Associate Vice President and Chief Counsel,
Registration and Disclosure, FINRA, dated October 15, 2009, in
response to comments received regarding Securities Exchange Act
Release No. 60462 (August 7, 2009), 74 FR 41470 (August 17, 2009)
(SR-FINRA-2009-050); see also discussion of comments in Securities
Exchange Act Release No. 61002 (November 13, 2009), 74 FR 61193
(November 23, 2009) (SR-FINRA-2009-050).
    \11\ See proposed FINRA Rule 8312(b).
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    Additionally, FINRA proposes to make publicly available on a
permanent basis information regarding formerly associated persons,
regardless of the time elapsed since they were associated with a
member, if they were convicted of or pled guilty or nolo contendere to
a crime; \12\ were the subject of a civil injunction in connection with
investment-related activity or a civil court finding of involvement in
a violation of any investment-related statute or regulation; \13\ or
were named as a respondent or defendant in an investment-related,
consumer-initiated

arbitration or civil law suit which alleged that they were involved in
a sales practice violation and which resulted in an arbitration award
or civil judgment against the person,\14\ in each case as reported to
Web CRD on a uniform registration form.\15\ For such formerly
associated persons, FINRA proposes to disclose through BrokerCheck: (i)
Information concerning any such disclosure event(s); (ii) certain
administrative information, such as employment and registration history
as reported on a registration form; (iii) the most recently submitted
comment, if any, provided by the person, if the comment is relevant and
in accordance with the procedures established by FINRA; and (iv) dates
and names of qualification examinations passed by the formerly
associated person, if available.\16\ Disclosure pursuant to the
proposed rule change would not include other information in CRD, such
as customer complaints, historic complaints, terminations, bankruptcies
and liens. In addition, the expanded disclosure under the proposed rule
would not apply to formerly associated persons who exercised control
over an organization that was convicted of or pled guilty or nolo
contendere to a crime (Questions 14A(2) and 14B(2) on Form U4) or who
had an investment-related civil action brought against them by a State
or foreign financial regulatory authority, if the action was settled
(Question 14H(1)(c) on Form U4).
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    \12\ See Questions 14A(1)(a) and 14B(1)(a) on Form U4, as well
as Questions 7C(1) and 7C(3) on Form U5.
    \13\ See Questions 14H(1)(a) and 14H(1)(b) on Form U4.
    \14\ See Question 14I(1)(b) on Form U4 and Question 7E(1)(b) on
Form U5.
    \15\ See proposed FINRA Rule 8312(c). The proposal will apply
only to those individuals registered with FINRA on or after August
16, 1999, which is the date that Web CRD was implemented.
    \16\ Id. The information would mirror the information currently
disclosed permanently with respect to any formerly registered person
who is the subject of a final regulatory action.
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B. BrokerCheck Dispute Process

    FINRA also proposes to adopt paragraph (e) of Rule 8312 to codify a
process for persons to dispute the accuracy of, or update, the
information disclosed through BrokerCheck. FINRA presently has an
informal dispute process. Currently, upon the receipt of an inquiry
from a person who believes that information about him contained in
BrokerCheck is inaccurate, FINRA staff will review the alleged
inaccuracy; if appropriate, contact the entity that reported the
information; and make a determination as to whether the information is
accurate or should be modified or removed from BrokerCheck.
    Under proposed Rule 8312(e), in order to initiate a dispute
regarding the accuracy of information contained in BrokerCheck, an
``eligible party'' \17\ must submit a written notice to FINRA,
including all available supporting documentation.\18\ After receiving
the written notice, FINRA will determine whether the dispute is
eligible for investigation. Proposed Supplementary Material .02 to Rule
8312 provides examples of situations that are not eligible for
investigation, which include, but are not limited to, disputes that (i)
involve information previously disputed under the dispute resolution
process and that does not contain any new or additional evidence; (ii)
are brought by an individual or entity that is not an eligible party;
(iii) do not challenge the accuracy of information contained in a
BrokerCheck report but seek to explain information; and (iv) involve
information contained in the CRD that is not disclosed through
BrokerCheck. FINRA will presume that a dispute involving factual
information is eligible for investigation unless the facts and
circumstances suggest otherwise.\19\
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    \17\ Only an ``eligible party'' would be able to dispute the
accuracy of information disclosed in that party's BrokerCheck
report. An ``eligible party'' includes any current member; any
former member, provided that the dispute is submitted by a natural
person who served as the former member's Chief Executive Officer,
Chief Financial Officer, Chief Operating Officer, Chief Legal
Officer or Chief Compliance Officer, or an individual with similar
status or function, as identified on Schedule A of Form BD at the
time the former member ceased being registered with FINRA; or any
associated person of a member or person formerly associated with a
member for whom a BrokerCheck report is available. See proposed
FINRA Rule 8312(e)(1)(A).
    \18\ See proposed FINRA Rule 8312(e)(1)(B).
    \19\ See proposed FINRA Rule 8312(e)(2)(A).
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    Under the proposed rule, if FINRA determines that a dispute is
eligible for investigation, FINRA will add a general notation to the
eligible party's BrokerCheck report stating that the eligible party has
disputed certain information included in the report,\20\ which notation
will be removed when FINRA resolves the dispute. If FINRA determines
that a dispute is not eligible for investigation, it will notify the
eligible party in writing.\21\
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    \20\ In circumstances where a dispute involves a court order to
expunge information from BrokerCheck, FINRA will prevent the
disputed information from being displayed via BrokerCheck while
FINRA evaluates the matter.
    \21\ See proposed FINRA Rule 8312(e)(2)(C).
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    When a dispute is deemed eligible for investigation, FINRA will
evaluate the written notice and supporting documentation and, if FINRA
determines that it is sufficient to update, modify or remove the
information that is the subject of the request, FINRA will make the
appropriate change. When the written notice and supporting
documentation do not include sufficient information upon which FINRA
can make a determination, FINRA will, under most circumstances, contact
the entity that reported the information to the CRD and request that
this reporting entity confirm the accuracy of the information. If the
reporting entity acknowledges that the information is not accurate,
FINRA will update, modify or remove the information, as appropriate,
based on the information provided by the reporting entity. If the
reporting entity verifies the accuracy of the information, or the
reporting entity no longer exists or is unable to verify the accuracy
of the information, FINRA would not change the information.\22\
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    \22\ See proposed FINRA Rule 8312(e)(3)(A).
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    Upon making its determination, FINRA will notify the eligible party
in writing that the investigation resulted in a determination that (i)
the information is inaccurate or not accurately presented and has been
updated, modified or deleted; (ii) the information is accurate in
content and presentation and no changes have been made; or (iii) the
accuracy of the information or its presentation could not be verified
and no changes have been made. A determination by FINRA regarding a
dispute, including whether to leave unchanged or to update, modify or
delete disputed information, is not subject to appeal.\23\
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    \23\ See proposed FINRA Rule 8312(e)(3)(B) and (C).
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III. Summary of Comments and FINRA's Response

    The Commission received fourteen comment letters on the proposed
rule change.\24\ Most comments focus on three issues: (i) The proposed
expanded disclosure of Historic Complaints through BrokerCheck and the
format of such disclosure; (ii) limitations on information proposed to
be disclosed via BrokerCheck; and (iii) the formalized process to
dispute and/or update information in BrokerCheck.
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    \24\ See supra, note 4.
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A. Disclosure of Information in BrokerCheck

i. Expanded Disclosure of Historic Complaints
    Eight comment letters generally support expanded disclosure through
BrokerCheck, including the proposal to expand disclosure of Historic
Complaints.\25\ Three comment letters generally oppose any expanded
disclosure of Historic Complaints.\26\

Three additional commenters take issue with the scope, time period and/
or method of disclosure of Historic Complaints as set forth in the
proposed rule change.\27\ Four commenters believe that disclosure of
all Historic Complaints will only serve to confuse investors.\28\ One
commenter suggests that customer complaints that are found to be
without merit and closed without compensation to the investor should be
subject to the current two-year disclosure period.\29\ One comment
letter argues that previously archived Historic Complaints should not
be made available via BrokerCheck, and that Historic Complaints should
only be reported under the ten-year disclosure period on a going
forward basis.\30\ Two commenters recommend that BrokerCheck only
display Historic Complaints on or after March 18, 2002, the reporting
date that the Investment Adviser Public Disclosure-Individual (``IAPD-
I'') database will use, as opposed to August 16, 1999, the date that
Web CRD was implemented.\31\
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    \25\ See comment letters from Caruso, Cornell, NASAA, PIABA,
SIFMA, St. John's, Syracuse and Welker.
    \26\ See comment letters from Cutter, MWA and Oster.
    \27\ See comment letters from FSI, Janney and NAIBD.
    \28\ See comment letters from Cutter, MWA, NAIBD and Oster. The
comment letter from Oster argues that disclosing only those Historic
Complaints made on or after August 16, 1999 will result in investors
receiving biased data and drawing inappropriate conclusions
therefrom.
    \29\ See comment letter from Oster.
    \30\ See comment letter from FSI.
    \31\ See comment letters from FSI and NAIBD.
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    FINRA believes that implementing the proposed rule change to expand
disclosure to include Historic Complaints will allow investors and
other users of BrokerCheck to view information they may consider
important and relevant.\32\ In response to commenters who raise the
above objections, FINRA notes that under the proposed rule change,
Historic Complaints will be displayed for ten years following the
termination of an individual's registration, rather than on a permanent
basis,\33\ as other commenters suggest.\34\ FINRA also notes that
Historic Complaints displayed on BrokerCheck will include information
regarding the Historic Complaint's disposition and the individual's
comments on the matter, if any.\35\ Additionally, FINRA states that it
is in the process of modifying the CRD system to allow firms to more
easily update or otherwise provide context to Historic Complaints.\36\
FINRA disagrees, therefore, that the expanded disclosure will confuse
investors and believes investors and other users of BrokerCheck are,
and in the future will be even better able to, put such complaints in
the appropriate context.\37\
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    \32\ See Response Letter at 6.
    \33\ Id.
    \34\ See comment letters from Cutter and NAIBD.
    \35\ See Response Letter at 6.
    \36\ The Commission urges FINRA to ensure that firms do not,
under the guise of providing context to Historic Complaints, alter
the essence of the complaint.
    \37\ See Response Letter at 6.
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    FINRA disagrees with the suggestion that archived Historic
Complaints should not be made available via BrokerCheck, and that
Historic Complaints should only be reported under the ten-year
disclosure period on a going-forward basis. FINRA states that this
would result in far fewer Historic Complaints being disclosed than
would be under the proposal and would actually reduce the number of
Historic Complaints currently disclosed under FINRA Rule 8312.\38\
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    \38\ See Response Letter at 5.
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    With respect to timeframe, FINRA continues to believe that it
should disclose all Historic Complaints that became non-reportable
after implementation of Web CRD on August 16, 1999. FINRA believes it
is not necessary or desirable to harmonize the disclosure date for
Historic Complaints with the March 18, 2002 date used for complaint
disclosure in the IAPD-I database, as suggested by some commenters.\39\
FINRA notes that the two systems are separate, each system would note
its respective time frame, and using the 1999 date will provide more
information to investors than the 2002 date.\40\
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    \39\ See comment letters from FSI and NAIBD.
    \40\ See Response Letter at 4-5.
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    Commenters also propose changes to the way Historic Complaints are
displayed on BrokerCheck and argue that additional disclosure in
BrokerCheck is necessary to clarify that the complaints are based on
allegations and have not been finally resolved.\41\ FINRA notes that
similar disclosure already exists on each BrokerCheck report.\42\ FINRA
agrees, however, that customer complaint information should be clearly
identifiable and states that it is in the process of revising the
customer dispute disclosure section of BrokerCheck to provide further
clarity, including adding a new heading to the report to identify
customer disputes that a firm reports as closed with no action,
withdrawn, dismissed or denied.\43\
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    \41\ See comment letters from Cutter, FSI, Janney, MWA, NAIBD
and SIFMA.
    \42\ See Response Letter at 3.
    \43\ Id.
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ii. Expanded Disclosure, Generally
    Six commenters argue that all of the information contained in
BrokerCheck regarding currently and formerly registered individuals
should be made available permanently; \44\ one commenter argues against
any expansion whatsoever.\45\ Those commenters in favor of expanding
disclosure to include all information available in BrokerCheck believe
that information should not be removed from BrokerCheck for formerly
associated persons after the ten-year disclosure period.\46\ Four
commenters argue that there is no compelling reason (including the
justification espoused by FINRA \47\) to distinguish between currently
and formerly registered persons with respect to the disclosure time
period in BrokerCheck.\48\ Two commenters believe that if FINRA will
not eliminate the disclosure discrepancies between currently and
formerly associated persons, at a minimum the information disclosed
permanently should be expanded to include additional categories.\49\
Three commenters believe that the information on BrokerCheck should be
expanded to include all information made available through State
securities regulators as well as in CRD.\50\
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    \44\ See comment letters from Caruso, Cornell, NASAA, PIABA, St.
John's and Syracuse.
    \45\ See comment letter from MWA.
    \46\ Id.
    \47\ FINRA stated that each of the disclosure events proposed to
be permanently included in BrokerCheck constitutes a final
disposition. See Notice at 8.
    \48\ See comment letters from Caruso, PIABA, St. John's and
Syracuse.
    \49\ See comment letter from NASAA, arguing that BrokerCheck
should include on a permanent basis information on felony charges,
misdemeanor charges involving an investment-related business, fraud,
wrongful taking of property, bribery, perjury, forgery and other
crimes of property, employment terminations relating to allegations
of violations of investment-related statutes or fraud, bankruptcy
and unsatisfied judgments or liens. See also comment letter from
Syracuse, arguing that disclosure should be expanded to permanently
include bankruptcy filings and misdemeanor charges relating to fraud
and other crimes bearing on a broker's veracity in financial and
business matters.
    \50\ See comment letters from PIABA, St. John's and Syracuse.
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    In response, FINRA notes that the events proposed to be permanently
disclosed in BrokerCheck pursuant to the proposed rule change
constitute final dispositions which, in most circumstances, have been
determined by an impartial fact finder after the subject person has
been given the opportunity to refute the allegations.\51\ Finally,
FINRA points out that much of the information proposed to be disclosed
pursuant to the proposed rule change is already publicly available
through other sources.\52\
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    \51\ See Response Letter at 9. See also Notice at 8.
    \52\ Id.

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C. Formalized Process To Dispute and/or Update Information in
BrokerCheck

    All comment letters generally supported FINRA's proposed
codification of the process for disputing and updating information
displayed on BrokerCheck. Two comment letters request that a timeline
for submission and FINRA response be added to the rule, and these
commenters also request that FINRA allow firms or associated persons to
supplement descriptions of the incidents being reported.\53\ Another
commenter suggests that FINRA establish a standing national BrokerCheck
Record Review Committee (or delegate responsibility to FINRA's National
Adjudicatory Council) to investigate BrokerCheck inquiries and make
determinations with respect to eligibility and removal or modification
of information on BrokerCheck.\54\
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    \53\ See comment letters from FSI and NAIBD. The FSI letter
suggests requiring FINRA to make an eligibility determination within
30 days of receipt of notice, while the NAIBD letter suggests
requiring FINRA to make a determination regarding update or removal
of the disputed information within 30 days of the submission of
supporting evidence.
    \54\ See comment letter from SIFMA.
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    FINRA represents that it will work diligently to process disputes
as expeditiously as possible, and believes that it will be able to make
determinations regarding disputes within a reasonable time frame.\55\
FINRA does not believe that mandating time limitations for submitting
and responding to disputes or establishing a committee to make
determinations regarding disputes is necessary.\56\ FINRA states that
most disputes regarding the accuracy of information in BrokerCheck are
straightforward and unambiguous and requiring a committee to review
such disputes would increase the processing time.\57\ Finally, FINRA
believes it would be redundant to expand the dispute process to allow
individuals to supplement descriptions on BrokerCheck, as the
opportunity to provide context to a disclosed matter on BrokerCheck is
already available to individuals.\58\
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    \55\ See Response Letter at 7. FINRA notes, however, that in
certain circumstances the evaluation of a dispute will be outside of
its control.
    \56\ Id.
    \57\ Id.
    \58\ See Response Letter at 8. FINRA points out that individuals
can provide context to a matter disclosed on BrokerCheck through the
submission of Forms U4 and U5. In a separate section of the Response
Letter, FINRA also notes that firms and individuals may add or
revise comments to, or update information regarding, Historic
Complaints disclosed on BrokerCheck. See Response Letter at 4.
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    In response to a request for clarification regarding whether FINRA
rules prohibiting false filings would apply to the dispute process,\59\
FINRA notes that submissions by firms and individuals in connection
with the dispute process will be subject to FINRA rules.\60\
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    \59\ See comment letter from NASAA.
    \60\ See Response Letter at 7-8.
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IV. Discussion and Commission Findings

    After carefully reviewing the proposed rule change, the comment
letters, and the Response Letter, the Commission finds that the
proposed rule change is consistent with the requirements of the Act and
the rules and regulations thereunder applicable to a national
securities association.\61\ In particular, the Commission finds that
the proposed rule change is consistent with Section 15A(b)(6) of the
Act,\62\ 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.
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    \61\ In approving this proposed rule change, the Commission has
considered the proposed rule change's impact on efficiency,
competition, and capital formation. See 15 U.S.C. 78c(f).
    \62\ 15 U.S.C. 78o-3(b)(6).
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    Specifically, the Commission believes that expanding the
information available through BrokerCheck about (i) persons who were
previously associated with a member within the last two to ten years
and (ii) formerly associated persons who were convicted of or pled
guilty or nolo contendere to a crime, were the subject of a civil
injunction in connection with investment-related activity or a civil
court finding of involvement in a violation of any investment-related
statute or regulation, or were named as a respondent or defendant in an
investment-related, consumer-initiated arbitration or civil law suit
which alleged that they were involved in a sales practice violation and
which resulted in an arbitration award or civil judgment against the
person, will help members of the public to protect themselves from
unscrupulous people. The Commission believes that such information is
relevant to investors and members of the public who wish to educate
themselves with respect to the professional history of a formerly
associated person. Formerly associated persons, although no longer in
the securities industry in a registered capacity, may work in other
investment-related industries, such as financial planning, or may seek
to attain other positions of trust with potential investors. Disclosure
of such person's record while he was in the securities industry via
BrokerCheck should help members of the public decide whether to rely on
his advice or expertise or do business with him. Currently, Web CRD
would indicate that no information is available for a formerly
associated person, which could lead a person making an inquiry about a
formerly associated person to conclude that the formerly associated
person had a clean record. Expanding the disclosure period for formerly
registered individuals to ten years, as well as expanding certain
information made available through BrokerCheck on a permanent basis,
will provide investors and other users of BrokerCheck information that
should be useful and relevant regarding such formerly registered
individuals' history. In addition, if registered persons are aware that
their CRD information will be available for a longer period of time, it
should provide an additional incentive to act consistent with industry
best practices.
    The Commission also believes that the aspect of FINRA's proposal
that expands the information available through BrokerCheck regarding
Historic Complaints will further help members of the public to evaluate
an individual's record. The Commission believes that it is consistent
with the Act for FINRA to conclude that customer complaints should be
available to investors and members of the public who wish to educate
themselves with respect to the professional history of a current or
formerly associated person. Persons may take Historic Complaints filed
against an individual in the securities industry into account in
considering whether to do business with a current or former associated
person. The Commission agrees with FINRA and believes that potential
investors and members of the public who research a person with whom
they are considering doing business are capable of evaluating Historic
Complaints in the appropriate context.
    Finally, the Commission believes that creating a formalized process
for disputing and/or updating the information displayed through
BrokerCheck is appropriate. The written guidelines proposed provide
administrative transparency and should help persons better understand
the procedure for disputing or updating information in BrokerCheck,
ultimately allowing for greater efficiency keeping information in
BrokerCheck accurate.
    The Commission recognizes that the commenters make arguments with
respect to the usefulness of the

additional information they seek to have disclosed regarding registered
and formerly registered persons.\63\ The Commission recognizes that the
public's ability to access information, whether to inquire about a
registered person or a formerly associated person, may serve to protect
investors, the integrity of the marketplace, and the public interest.
The Commission urges FINRA to consider expanding the information as
suggested by the commenters. This information is available from the
individual States; however, it would be more accessible through
BrokerCheck. The Commission urges the public to utilize all sources of
information, particularly the databases of the State regulators, as
well as legal search engines and records searches, in conducting a
thorough search of any associated person's activities.
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    \63\ See page 4, which notes information in CRD that will not be
made available as a result of this rule change.
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    The Commission notes that FINRA stated it would continue to
evaluate all aspects of the BrokerCheck program to determine whether
future circumstances should lead to greater disclosure through
BrokerCheck.\64\ FINRA has a statutory obligation to make information
available to the public \65\ and, as stated in the past, the Commission
believes that FINRA should continuously strive to improve BrokerCheck
because it is a valuable tool for the public in deciding whether to
work with an industry member.\66\ The changes proposed in this filing
will enhance BrokerCheck by including more information that should
prove useful to the general public and by maintaining the accuracy of
such information. In addition, the disclosure of this additional
information may serve as a deterrent to questionable and fraudulent
activity.
---------------------------------------------------------------------------

    \64\ See Response Letter at 9.
    \65\ See Section 15A(i) of the Act.
    \66\ See, e.g., Securities Exchange Act Release No. 61002
(November 13, 2009), 74 FR 61193 (November 23, 2009) (SR-FINRA-2009-
050).
---------------------------------------------------------------------------

    For the reasons discussed above, the Commission finds that the rule
change is consistent with the Act.

V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\67\ that the proposed rule change (SR-FINRA-2010-012), be, and
hereby is, approved.
---------------------------------------------------------------------------

    \67\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\68\
---------------------------------------------------------------------------

    \68\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.

Exhibit A

List of Comment Letters Received for SR-FINRA-2010-012

1. Andrew Oster, President and CEO, Oster Financial Group, LLC, dated
May 4, 2010 (``Oster'').
2. Pamela Fritz, CSCP, AIRC, FFSI, FIC, Chief Compliance Officer, MWA
Financial Services, Inc., dated May 6, 2010 (``MWA'').
3. Lisa Roth, National Association of Independent Brokers-Dealers, Inc.
Member Advocacy Committee Chair, and CEO and COO, Keystone Capital
Corporation, dated May 6, 2010 (``NAIBD'').
4. Melanie Senter Lubin, Maryland Securities Commissioner and Chair,
North American Securities Administrators Association, Inc. CRD/IARD
Steering Committee, dated May 11, 2010 (``NASAA'').
5. Scott R. Shewan, President, Public Investors Arbitration Bar
Association, dated May 11, 2010 (``PIABA'').
6. Kelly R. Welker, Branch Manager, LPL Financial, dated May 12, 2010
(``LPL'').
7. Deborah Castiglioni, CEO and CCO, Cutter Company, Inc., dated May
12, 2010 (``Cutter'').
8. Lisa A. Catalano, Director, Associate Professor of Clinical Legal
Education and Christine Lazaro, Supervising Attorney, Securities
Arbitration Clinic, St. John's University School of Law, dated May 13,
2010 (``St. John's'').
9. William A. Jacobson, Esq., Associate Clinical Professor of Law,
Cornell Law School, and Director, Cornell Securities Law Clinic and
Adisada Dudic, Cornell Law School, 2011, dated May 13, 2010
(``Cornell'').
10. E. John Moloney, President and CEO, Moloney Securities Company,
Inc. and Chairman, Securities Industry and Financial Markets
Association Small Firms Committee, dated May 13, 2010 (``SIFMA'').
11. Joelle B. Franc, Student Attorney; Jonathan P. Terracciano, Student
Attorney; and Birgitta K. Siegel, Esq., Visiting Asst. Professor;
Securities Arbitration & Consumer Law Clinic, Syracuse University
College of Law, dated May 13, 2010 (``Syracuse'').
12. John M. Ivan, Senior Vice President, General Counsel, Janney
Montgomery Scott, LLC, dated May 14, 2010 (``Janney'').
13. Dale E. Brown, President and CEO, F.inancial Services Institute,
dated May 19, 2010 (``FSI'').
14. Steven B. Caruso, Maddox Hargett Caruso, P.C., dated May 25, 2010
(``Caruso'').

[FR Doc. 2010-17190 Filed 7-14-10; 8:45 am]
BILLING CODE 8010-01-P


[Federal Register: February 7, 2007 (Volume 72, Number 25)]
[Notices]
[Page 5701-5702]
[DOCID:fr07fe07-79]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Application Accepted for Filing, Soliciting Motions To
Intervene and Protests, Ready for Environmental Analysis, and
Soliciting Comments, Recommendations, Terms and Conditions, and Fishway
Prescriptions

January 31, 2007.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Amendment of License.
    b. Project No.: 2390-056.
    c. Date Filed: October 3, 2006.
    d. Applicant: Northern States Power Company of Wisconsin-d/b/a.
Excel Energy, Inc.
    e. Name of Project: Big Falls Hydroelectric Project.
    f. Location: The project is located on the Flambeau River, in Rusk
County, Wisconsin.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791 (a)-825(r).
    h. Applicant Contact: Mr. Robert W. Olson, Northern States Power
Company of Wisconsin, d.b.a. Excel Energy, Inc., 1414 West Hamilton
Avenue, P.O. Box 8, Eau Claire, WI 54702-008. Tel:<PHONE_NUMBER>.
    i. FERC Contact: Mr. Vedula Sarma, Telephone<PHONE_NUMBER>, and e-
mail<EMAIL_ADDRESS>    j. Deadline for filing motions to intervene and protests, comments,
recommendations, preliminary terms and conditions, and preliminary
fishway prescriptions is 60 days from the issuance of this notice;
reply comments are due 105 days from the issuance date of this notice.
All documents (original and eight copies) should be filed with: Magalie
R. Salas, Secretary, Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person 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.
    Motions to intervene, protests, comments, recommendations, terms
and conditions, and fishway prescriptions may be filed electronically
via the Internet in lieu of paper. The Commission strongly encourages
electronic filings. See 18 CFR 385.2001(a)(1)(iii) and the instructions
on the Commission's Web site (http://www.ferc.gov) under the ``e-

Filing'' link.
    k. This application has been accepted for filing and is now is
ready for environmental analysis.
    The applicant proposes to amend the license for the Big Falls
Project to include a jurisdictional Turtle-Flambeau Storage Reservoir
located on the North Fork of the Flambeau River near Mercer County,
Wisconsin, as a project feature of the Big Falls Project.
    l. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''

link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC Online Support at<EMAIL_ADDRESS>or toll-free at 1-
866-208-3676, or for TTY,<PHONE_NUMBER>. A copy is also available for
inspection and reproduction at the address in item h above.
    Register online at http://www.ferc.gov/esubscribenow.htm to be

notified via e-mail of new filings and issuances related to this or
other pending projects. For assistance, contact FERC Online Support.
    m. 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, 385.211, 385.214. 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.
    All filings must (1) bear in all capital letters the title
``PROTEST'', ``MOTION TO INTERVENE'', ``COMMENTS,'' ``REPLY COMMENTS,''
``RECOMMENDATIONS,'' ``TERMS AND CONDITIONS,'' or `` FISHWAY
PRESCRIPTIONS;'' (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
protesting or intervening; and (4) otherwise comply with the
requirements of 18 CFR 385.2001 through 385.2005. All comments,
recommendations, terms and

conditions or prescriptions must set forth their evidentiary basis and
otherwise comply with the requirements of 18 CFR 4.34(b). All comments,
recommendations, terms and conditions or prescriptions should relate to
project works which are the subject of the license amendment. Agencies
may obtain copies of the application directly from the applicant. A
copy of any protest or motion to intervene must be served upon each
representative of the applicant specified in the particular
application. A copy of all other filings in reference to this
application 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 4.34(b) and 385.2010.
    n. A license applicant must file no later than 60 days following
the date of issuance of this notice of acceptance and ready for
environmental analysis provided for in Sec.  4.34(b)(5)(i): (1) A copy
of the water quality certification; (2) a copy of the request for
certification, including proof of the date on which the certifying
agency received the request; or (3) evidence of waiver of water quality
certification.

Magalie R. Salas,
Secretary.
 [FR Doc. E7-1927 Filed 2-6-07; 8:45 am]

BILLING CODE 6717-01-P


individual adverse events in accordance with Sec.  803.12(b) and Sec.
803.20.
    (d) Form FDA 3500A is available on the Internet at http://www.fda.gov/medwatch/getforms.htm or from Division of Small
Manufacturers, International and Consumer Assistance, Office of
Communication and Education, Center for Devices and Radiological
Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 4621, Silver Spring, MD
20993-0002, by email<EMAIL_ADDRESS>FAX:<PHONE_NUMBER>, or
telephone:<PHONE_NUMBER>.

Sec.  803.12  How do I submit initial and supplemental or followup
reports?

    (a) Manufacturers and importers must submit initial and
supplemental or followup reports to FDA in an electronic format that
FDA can process, review, and archive.
    (b) User facilities that submit their reports and additional
information to FDA electronically must use an electronic format that
FDA can process, review, and archive. User facilities that submit their
reports to FDA on paper must submit any written report or additional
information required under this part to FDA, CDRH, Medical Device
Reporting, P.O. Box 3002, Rockville, MD 20847-3002, using Form FDA
3500A. Each report must be identified (e.g., ``User Facility Report''
or ``Annual Report'').
    (c) If you are confronted with a public health emergency, this can
be brought to FDA's attention by contacting FDA's Office of Crisis
Management, Emergency Operations Center by telephone, 24-hours a day,
at<PHONE_NUMBER> or toll free at<PHONE_NUMBER>, followed by the
submission of an email to<EMAIL_ADDRESS>
    Note: This action does not satisfy your obligation to report
under part 803.

    (d) You may submit a voluntary telephone report to the MedWatch
office at 800-FDA-1088. You may also obtain information regarding
voluntary reporting from the MedWatch office at 800-FDA-1088. You may
also find the voluntary Form FDA 3500 and instructions to complete it
at: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm.

Sec.  803.13  Do I need to submit reports in English?

    Yes. You must submit all reports required by this part in English.

Sec.  803.15  How will I know if you require more information about my
medical device report?

    (a) We will notify you in writing if we require additional
information and will tell you what information we need. We will require
additional information if we determine that protection of the public
health requires additional or clarifying information for medical device
reports submitted to us and in cases when the additional information is
beyond the scope of FDA reporting forms or is not readily accessible to
us.
    (b) In any request under this section, we will state the reason or
purpose for the information request, specify the due date for
submitting the information, and clearly identify the reported event(s)
related to our request. If we verbally request additional information,
we will confirm the request in writing.

Sec.  803.16  When I submit a report, does the information in my report
constitute an admission that the device caused or contributed to the
reportable event?

    No. A report or other information submitted by you, and our release
of that report or information, is not necessarily an admission that the
device, or you or your employees, caused or contributed to the
reportable event. You do not have to admit and may deny that the report
or information submitted under this part constitutes an admission that
the device, you, or your employees, caused or contributed to a
reportable event.

Sec.  803.17  What are the requirements for developing, maintaining,
and implementing written MDR procedures that apply to me?

    If you are a user facility, importer, or manufacturer, you must
develop, maintain, and implement written MDR procedures for the
following:
    (a) Internal systems that provide for:
    (1) Timely and effective identification, communication, and
evaluation of events that may be subject to MDR requirements;
    (2) A standardized review process or procedure for determining when
an event meets the criteria for reporting under this part; and
    (3) Timely transmission of complete medical device reports to
manufacturers or to us, or to both if required.
    (b) Documentation and recordkeeping requirements for:
    (1) Information that was evaluated to determine if an event was
reportable;

    (2) All medical device reports and information submitted to
manufacturers and/or us;
    (3) Any information that was evaluated for the purpose of preparing
the submission of annual reports; and
    (4) Systems that ensure access to information that facilitates
timely followup and inspection by us.

Sec.  803.18  What are the requirements for establishing and
maintaining MDR files or records that apply to me?

    (a) If you are a user facility, importer, or manufacturer, you must
establish and maintain MDR event files. You must clearly identify all
MDR event files and maintain them to facilitate timely access.
    (b)(1) For purposes of this part, ``MDR event files'' are written
or electronic files maintained by user facilities, importers, and
manufacturers. MDR event files may incorporate references to other
information (e.g., medical records, patient files, engineering
reports), in lieu of copying and maintaining duplicates in this file.
Your MDR event files must contain:
    (i) Information in your possession or references to information
related to the adverse event, including all documentation of your
deliberations and decision making processes used to determine if a
device-related death, serious injury, or malfunction was or was not
reportable under this part;
    (ii) Copies of all reports submitted under this part (whether paper
or electronic), and of all other information related to the event that
you submitted to us or other entities such as an importer, distributor,
or manufacturer; and
    (iii) Copies of all electronic acknowledgments FDA sends you in
response to electronic MDR submissions.
    (2) If you are a user facility, importer, or manufacturer, you must
permit any authorized FDA employee, at all reasonable times, to access,
to copy, and to verify the records required by this part.
    (c) If you are a user facility, you must retain an MDR event file
relating to an adverse event for a period of 2 years from the date of
the event. If you are a manufacturer or importer, you must retain an
MDR event file relating to an adverse event for a period of 2 years
from the date of the event or a period of time equivalent to the
expected life of the device, whichever is greater. If the device is no
longer distributed, you still must maintain MDR event files for the
time periods described in this paragraph (c).
    (d)(1) If you are a device distributor, you must establish and
maintain device complaint records (files). Your records must contain
any incident information, including any written, electronic, or oral
communication, either received or generated by you, that alleges
deficiencies related to the identity (e.g., labeling), quality,
durability, reliability, safety, effectiveness, or performance of a
device. You must also maintain information about your evaluation of the
allegations, if any, in the incident record. You must clearly identify
the records as device incident records and file these records by device
name. You may maintain these records in written or electronic format.
You must back up any file maintained in electronic format.
    (2) You must retain copies of the required device incident records
for a period of 2 years from the date of inclusion of the record in the
file or for a period of time equivalent to the expected life of the
device, whichever is greater. You must maintain copies of these records
for this period even if you no longer distribute the device.
    (3) You must maintain the device complaint files established under
this section at your principal business establishment. If you are also
a manufacturer, you may maintain the file at the same location as you
maintain your complaint file under part 820 of this chapter. You must
permit any authorized FDA employee, at all reasonable times, to access,
to copy, and to verify the records required by this part.
    (e) If you are a manufacturer, you may maintain MDR event files as
part of your complaint file, under part 820 of this chapter, if you
prominently identify these records as MDR reportable events. We will
not consider your submitted MDR report to comply with this part unless
you evaluate an event in accordance with the quality system
requirements described in part 820 of this chapter. You must document
and maintain in your MDR event files an explanation of why you did not
submit or could not obtain any information required by this part, as
well as the results of your evaluation of each event.

Sec.  803.19  Are there exemptions, variances, or alternative forms of
adverse event reporting requirements?

    (a) We exempt the following persons from the adverse event
reporting requirements in this part:
    (1) A licensed practitioner who prescribes or administers devices
intended for use in humans and manufactures or imports devices solely
for use in diagnosing and treating persons with whom the practitioner
has a ``physician-patient'' relationship;
    (2) An individual who manufactures devices intended for use in
humans solely for this person's use in research or teaching and not for
sale. This includes any person who is subject to alternative reporting
requirements under the investigational device exemption regulations
(described in part 812 of this chapter), which require reporting of all
adverse device effects; and
    (3) Dental laboratories or optical laboratories.
    (b) If you are a manufacturer, importer, or user facility, you may
request an exemption or variance from any or all of the reporting
requirements in this part, including the requirements of Sec.  803.12.
You must submit the request to us in writing at the following address:
MDR Exemption Requests, Office of Surveillance and Biometrics, 10903
New Hampshire Ave., Bldg. 66, Rm. 3217, Silver Spring, MD 20993-0002.
Your request must include information necessary to identify you and the
device; a complete statement of the request for exemption, variance, or
alternative reporting; and an explanation why your request is
justified. If you are requesting an exemption from the requirement to
submit reports to FDA in electronic format under Sec.  803.12(a), your
request should indicate for how long you will require this exemption.
    (c) If you are a manufacturer, importer, or user facility, we may
grant in writing an exemption or variance from, or alternative to, any
or all of the reporting requirements in this part, and may change the
frequency of reporting to quarterly, semiannually, annually or other
appropriate time period. We may grant these modifications in response
to your request, as described in paragraph (b) of this section, or at
our discretion. When we grant modifications to the reporting
requirements, we may impose other reporting requirements to ensure the
protection of public health.
    (d) We may revoke or modify in writing an exemption, variance, or
alternative reporting requirement if we determine that revocation or
modification is necessary to protect the public health.
    (e) If we grant your request for a reporting modification, you must
submit any reports or information required in our approval of the
modification. The conditions of the approval will replace and supersede
the regular reporting requirement specified in this part until such
time that we revoke or modify the alternative reporting requirements in
accordance with paragraph (d) of this

section or until the date specified in our response granting your
variance, at which time the provisions of this part will again apply.

Subpart B--Generally Applicable Requirements for Individual Adverse
Event Reports

Sec.  803.20  How do I complete and submit an individual adverse event
report?

    (a) What form must I complete and submit?
    (1) If you are a health professional or consumer or other entity,
you may submit voluntary reports to FDA regarding devices or other FDA-
regulated products using the Form FDA 3500.
    (2) To submit a mandatory report in written form, a user facility
must use Form FDA 3500A.
    (3) An electronic submission of a mandatory report from a user
facility, importer, or manufacturer must contain the information from
the applicable blocks of Form FDA 3500A. All electronic submissions
must include information about the patient, the event, the device, and
the ``initial reporter.'' An electronic submission from a user facility
or importer must include the information from block F. An electronic
submission from a manufacturer must include the information from blocks
G and H. If you are a manufacturer and you receive a report from a user
facility or importer, you must incorporate that information in your
electronic submission and include any corrected or missing information.
    (b) To whom must I submit reports and when?
    (1) If you are a user facility, you must submit MDR reports to:
    (i) The manufacturer and to us no later than 10 work days after the
day that you become aware of information that reasonably suggests that
a device has or may have caused or contributed to a death or
    (ii) The manufacturer no later than 10 work days after the day that
you become aware of information that reasonably suggests that a device
has or may have caused or contributed to a serious injury. If the
manufacturer is not known, you must submit this report to us.
    (2) If you are an importer, you must submit MDR reports to:
    (i) The manufacturer and to us, no later than 30 calendar days
after the day that you become aware of information that reasonably
suggests that a device has or may have caused or contributed to a death
or serious injury or
    (ii) The manufacturer, no later than 30 calendar days after
receiving information that a device you market has malfunctioned and
that this device or a similar device that you market would be likely to
cause or contribute to a death or serious injury if the malfunction
were to recur.
    (3) If you are a manufacturer, you must submit MDR reports to us:
    (i) No later than 30 calendar days after the day that you become
aware of information that reasonably suggests that a device may have
caused or contributed to a death or serious injury or
    (ii) No later than 30 calendar days after the day that you become
aware of information that reasonably suggests a device has
malfunctioned and that this device or a similar device that you market
would be likely to cause or contribute to a death or serious injury if
the malfunction were to recur; or
    (iii) Within 5 work days if required by Sec.  803.53.
    (c) What kind of information reasonably suggests that a reportable
event has occurred?
    (1) Any information, including professional, scientific, or medical
facts, observations, or opinions, may reasonably suggest that a device
has caused or may have caused or contributed to an MDR reportable
event. An MDR reportable event is a death, a serious injury, or, if you
are a manufacturer or importer, a malfunction that would be likely to
cause or contribute to a death or serious injury if the malfunction
were to recur.
    (2) If you are a user facility, importer, or manufacturer, you do
not have to report an adverse event if you have information that would
lead a person who is qualified to make a medical judgment reasonably to
conclude that a device did not cause or contribute to a death or
serious injury, or that a malfunction would not be likely to cause or
contribute to a death or serious injury if it were to recur. Persons
qualified to make a medical judgment include physicians, nurses, risk
managers, and biomedical engineers. You must keep in your MDR event
files (described in Sec.  803.18) the information that the qualified
person used to determine whether or not a device-related event was
reportable.

Sec.  803.21  Where can I find the reporting codes for adverse events
that I use with medical device reports?

    (a) The MedWatch Medical Device Reporting Code Instruction Manual
contains adverse event codes for use with Form FDA 3500A. You may
obtain the coding manual from FDA's Web site at: http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/FormsandInstructions/default.htm;
and from the Division of Small Manufacturers, International and
Consumer Assistance, Center for Devices and Radiological Health, 10903
New Hampshire Ave., Bldg. 66, Rm. 4621, Silver Spring, MD 20993-0002,
FAX:<PHONE_NUMBER>, or email to<EMAIL_ADDRESS>    (b) We may sometimes use additional coding of information on the
reporting forms or modify the existing codes. If we do make
modifications, we will ensure that we make the new coding information
available to all reporters.

Sec.  803.22  What are the circumstances in which I am not required to
file a report?

    (a) If you become aware of information from multiple sources
regarding the same patient and same reportable event, you may submit
one medical device report.
    (b) You are not required to submit a medical device report if:
    (1) You are a user facility, importer, or manufacturer, and you
determine that the information received is erroneous in that a device-
related adverse event did not occur. You must retain documentation of
these reports in your MDR files for the time periods specified in Sec.
803.18.
    (2) You are a manufacturer or importer and you did not manufacture
or import the device about which you have adverse event information.
When you receive reportable event information in error, you must
forward this information to us with a cover letter explaining that you
did not manufacture or import the device in question.

Sec.  803.23  Where can I find information on how to prepare and submit
an MDR in electronic format?

    (a) You may obtain information on how to prepare and submit reports
in an electronic format that FDA can process, review, and archive at:
http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm.
    (b) We may sometimes update information on how to prepare and
submit reports electronically. If we do make modifications, we will
ensure that we alert reporters by updating the eMDR Web page.

Subpart C--User Facility Reporting Requirements

Sec.  803.30  If I am a user facility, what reporting requirements
apply to me?

    (a) You must submit reports to the manufacturer or to us, or both,
as specified in paragraphs (a)(1) and (a)(2) of this section as
follows:
    (1) Reports of death. You must submit a report to us as soon as
practicable but

no more than 10 work days after the day that you become aware of
information, from any source, that reasonably suggests that a device
has or may have caused or contributed to the death of a patient of your
facility. You must also submit the report to the device manufacturer,
if known. You must submit the information required by Sec.  803.32.
Reports sent to the Agency must be submitted in accordance with the
requirements of Sec.  803.12(b).
    (2) Reports of serious injury. You must submit a report to the
manufacturer of the device no later than 10 work days after the day
that you become aware of information, from any source, that reasonably
suggests that a device has or may have caused or contributed to a
serious injury to a patient of your facility. If the manufacturer is
not known, you must submit the report to us. You must report
information required by Sec.  803.32. Reports sent to the Agency must
be submitted in accordance with the requirements of Sec.  803.12 (b).
    (b) What information does FDA consider ``reasonably known'' to me?
You must submit all information required in this subpart C that is
reasonably known to you. This information includes information found in
documents that you possess and any information that becomes available
as a result of reasonable followup within your facility. You are not
required to evaluate or investigate the event by obtaining or
evaluating information that you do not reasonably know.

Sec.  803.32  If I am a user facility, what information must I submit
in my individual adverse event reports?

    You must include the following information in your report, if
reasonably known to you, as described in Sec.  803.30(b). These types
of information correspond generally to the elements of Form FDA 3500A:
    (a) Patient information (Form FDA 3500A, Block A). You must submit
the following:
    (1) Patient name or other identifier;
    (2) Patient age at the time of event, or date of birth;
    (3) Patient gender; and
    (4) Patient weight.
    (b) Adverse event or product problem (Form FDA 3500A, Block B). You
must submit the following:
    (1) Identification of adverse event or product problem;
    (2) Outcomes attributed to the adverse event (e.g., death or
serious injury). An outcome is considered a serious injury if it is:
    (i) A life-threatening injury or illness;
    (ii) A disability resulting in permanent impairment of a body
function or permanent damage to a body structure; or
    (iii) An injury or illness that requires intervention to prevent
permanent impairment of a body structure or function;
    (3) Date of event;
    (4) Date of this report;
    (5) Description of event or problem, including a discussion of how
the device was involved, nature of the problem, patient followup or
required treatment, and any environmental conditions that may have
influenced the event;
    (6) Description of relevant tests, including dates and laboratory
data; and
    (7) Description of other relevant history, including preexisting
medical conditions.
    (c) Device information (Form FDA 3500A, Block D). You must submit
the following:
    (1) Brand name;
    (2) Product Code, if known, and Common Device Name;
    (3) Manufacturer name, city, and state;
    (4) Model number, catalog number, serial number, lot number, or
other identifying number, and expiration date;
    (5) Operator of the device (health professional, lay user/patient,
other);
    (6) Date of device implantation (month, day, year), if applicable;
    (7) Date of device explantation (month, day, year), if applicable;
    (8) Whether the device is a single-use device that was reprocessed
and reused on a patient (Yes, No)?
    (9) If the device is a single-use device that was reprocessed and
reused on a patient (yes to paragraph (c)(8) of this section), the name
and address of the reprocessor;
    (10) Whether the device was available for evaluation and whether
the device was returned to the manufacturer; if so, the date it was
returned to the manufacturer; and
    (11) Concomitant medical products and therapy dates. (Do not report
products that were used to treat the event.)
    (d) Initial reporter information (Form FDA 3500A, Block E). You
must submit the following:
    (1) Name, address, and telephone number of the reporter who
initially provided information to you, or to the manufacturer or
distributor;
    (2) Whether the initial reporter is a health professional;
    (3) Occupation; and
    (4) Whether the initial reporter also sent a copy of the report to
us, if known.
    (e) User facility information (Form FDA 3500A, Block F). You must
submit the following:
    (1) An indication that this is a user facility report (by marking
the user facility box on the form);
    (2) Your user facility number;
    (3) Your address;
    (4) Your contact person;
    (5) Your contact person's telephone number;
    (6) Date that you became aware of the event (month, day, year);
    (7) Type of report (initial or followup); if it is a followup, you
must include the report number of the initial report;
    (8) Date of your report (month, day, year);
    (9) Approximate age of device;
    (10) Event problem codes--patient code and device code (refer to
the ``MedWatch Medical Device Reporting Code Instructions'');
    (11) Whether a report was sent to us and the date it was sent
(month, day, year);
    (12) Location where the event occurred;
    (13) Whether the report was sent to the manufacturer and the date
it was sent (month, day, year); and
    (14) Manufacturer name and address, if available.

Sec.  803.33  If I am a user facility, what must I include when I
submit an annual report?

    (a) You must submit to us an annual report on Form FDA 3419. You
must submit an annual report by January 1, of each year. You may obtain
this form from the following sources:
    (1) On the Internet at: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM080796.pdf or
    (2) Division of Small Manufacturers, International and Consumer
Assistance, Office of Communication and Education, Center for Devices
and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 4621,
Silver Spring, MD 20993-0002, by email<EMAIL_ADDRESS>FAX: 301-
847-8149, or telephone:<PHONE_NUMBER>.
    (b) You must clearly identify your annual report as such. You must
submit your annual report to FDA, CDRH, Medical Device Reporting, P.O.
Box 3002, Rockville, MD 20847-3002. Your annual report must include:
    (1) Your CMS provider number used for medical device reports, or
the number assigned by us for reporting purposes in accordance with
Sec.  803.3;
    (2) Reporting year;
    (3) Your name and complete address;
    (4) Total number of reports attached or summarized;
    (5) Date of the annual report and report numbers identifying the
range of medical device reports that you

submitted during the report period (e.g.,<PHONE_NUMBER>-2011-0001 through
1000);
    (6) Name, position title, and complete address of the individual
designated as your contact person responsible for reporting to us and
whether that person is a new contact for you; and
    (7) Information for each reportable event that occurred during the
annual reporting period including:
    (i) Report number;
    (ii) Name and address of the device manufacturer;
    (iii) Device brand name and common name;
    (iv) Product model, catalog, serial and lot number;
    (v) A brief description of the event reported to the manufacturer
and/or us; and
    (vi) Where the report was submitted, i.e., to the manufacturer,
importer, or us.
    (c) In lieu of submitting the information in paragraph (b)(7) of
this section, you may submit a copy of each medical device report that
you submitted to the manufacturers and/or to us during the reporting
period.
    (d) If you did not submit any medical device reports to
manufacturers or us during the time period, you do not need to submit
an annual report.

Subpart D--Importer Reporting Requirements

Sec.  803.40  If I am an importer, what reporting requirements apply to
me?

    (a) Reports of deaths or serious injuries. You must submit a report
to us, and a copy of this report to the manufacturer, as soon as
practicable, but no later than 30 calendar days after the day that you
receive or otherwise become aware of information from any source,
including user facilities, individuals, or medical or scientific
literature, whether published or unpublished, that reasonably suggests
that one of your marketed devices may have caused or contributed to a
death or serious injury. You must submit the information required by
Sec.  803.42. Reports sent to the Agency must be submitted in
accordance with the requirements of Sec.  803.12(a).
    (b) Reports of malfunctions. You must submit a report to the
manufacturer as soon as practicable but no later than 30 calendar days
after the day that you receive or otherwise become aware of information
from any source, including user facilities, individuals, or through
your own research, testing, evaluation, servicing, or maintenance of
one of your devices, that reasonably suggests that one of your devices
has malfunctioned and that this device or a similar device that you
market would be likely to cause or contribute to a death or serious
injury if the malfunction were to recur. You must submit the
information required by Sec.  803.42. Reports to manufacturers may be
made in accordance with Sec.  803.11(b).

Sec.  803.42  If I am an importer, what information must I submit in my
individual adverse event reports?

    You must include the following information in your report, if the
information is known or should be known to you, as described in Sec.
803.40. These types of information correspond generally to the format
of Form FDA 3500A:
    (a) Patient information (Form FDA 3500A, Block A). You must submit
the following:
    (1) Patient name or other identifier;
    (2) Patient age at the time of event, or date of birth;
    (3) Patient gender; and
    (4) Patient weight.
    (b) Adverse event or product problem (Form FDA 3500A, Block B). You
must submit the following:
    (1) Identification of adverse event or product problem;
    (2) Outcomes attributed to the adverse event (e.g., death or
serious injury). An outcome is considered a serious injury if it is:
    (i) A life-threatening injury or illness;
    (ii) A disability resulting in permanent impairment of a body
function or permanent damage to a body structure; or
    (iii) An injury or illness that requires intervention to prevent
permanent impairment of a body structure or function;
    (3) Date of event;
    (4) Date of this report;
    (5) Description of the event or problem, including a discussion of
how the device was involved, nature of the problem, patient followup or
required treatment, and any environmental conditions that may have
influenced the event;
    (6) Description of relevant tests, including dates and laboratory
data; and
    (7) Description of other relevant patient history, including
preexisting medical conditions.
    (c) Device information (Form FDA 3500A, Block D). You must submit
the following:
    (1) Brand name;
    (2) Product Code, if known, and Common Device Name;
    (3) Manufacturer name, city, and state;
    (4) Model number, catalog number, serial number, lot number, or
other identifying number, and expiration date;
    (5) Operator of the device (health professional, lay user/patient,
other);
    (6) Date of device implantation (month, day, year), if applicable;
    (7) Date of device explanation (month, day, year), if applicable;
    (8) Whether the device is a single-use device that was reprocessed
and reused on a patient (Yes, No)?
    (9) If the device is a single-use device that was reprocessed and
reused on a patient (yes to paragraph (c)(8) of this section), the name
and address of the reprocessor;
    (10) Whether the device was available for evaluation, and whether
the device was returned to the manufacturer, and if so, the date it was
returned to the manufacturer; and
    (11) Concomitant medical products and therapy dates. (Do not report
products that were used to treat the event.)
    (d) Initial reporter information (Form FDA 3500A, Block E). You
must submit the following:
    (1) Name, address, and telephone number of the reporter who
initially provided information to the manufacturer, user facility, or
distributor;
    (2) Whether the initial reporter is a health professional;
    (3) Occupation; and
    (4) Whether the initial reporter also sent a copy of the report to
us, if known.
    (e) Importer information (Form FDA 3500A, Block F). You must submit
the following:
    (1) An indication that this is an importer report (by marking the
importer box on the form);
    (2) Your importer report number;
    (3) Your address;
    (4) Your contact person;
    (5) Your contact person's telephone number;
    (6) Date that you became aware of the event (month, day, year);
    (7) Type of report (initial or followup). If it is a followup
report, you must include the report number of your initial report;
    (8) Date of your report (month, day, year);
    (9) Approximate age of device;
    (10) Event problem codes--patient code and device code (refer to
FDA MedWatch Medical Device Reporting Code Instructions);
    (11) Whether a report was sent to us and the date it was sent
(month, day, year);
    (12) Location where event occurred;
    (13) Whether a report was sent to the manufacturer and the date it
was sent (month, day, year); and
    (14) Manufacturer name and address, if available.

Subpart E--Manufacturer Reporting Requirements

Sec.  803.50  If I am a manufacturer, what reporting requirements apply
to me?

    (a) If you are a manufacturer, you must report to us the
information required by Sec.  803.52 in accordance with the
requirements of Sec.  803.12(a), no later than 30 calendar days after
the day that you receive or otherwise become aware of information, from
any source, that reasonably suggests that a device that you market:
    (1) May have caused or contributed to a death or serious injury or
    (2) Has malfunctioned and this device or a similar device that you
market would be likely to cause or contribute to a death or serious
injury, if the malfunction were to recur.
    (b) What information does FDA consider ``reasonably known'' to me?
    (1) You must submit all information required in this subpart E that
is reasonably known to you. We consider the following information to be
reasonably known to you:
    (i) Any information that you can obtain by contacting a user
facility, importer, or other initial reporter;
    (ii) Any information in your possession; or
    (iii) Any information that you can obtain by analysis, testing, or
other evaluation of the device.
    (2) You are responsible for obtaining and submitting to us
information that is incomplete or missing from reports submitted by
user facilities, importers, and other initial reporters.
    (3) You are also responsible for conducting an investigation of
each event and evaluating the cause of the event. If you cannot submit
complete information on a report, you must provide a statement
explaining why this information was incomplete and the steps you took
to obtain the information. If you later obtain any required information
that was not available at the time you filed your initial report, you
must submit this information in a supplemental report under Sec.
803.56 in accordance with the requirements of Sec.  803.12(a).

Sec.  803.52  If I am a manufacturer, what information must I submit in
my individual adverse event reports?

    You must include the following information in your reports, if
known or reasonably known to you, as described in Sec.  803.50(b).
These types of information correspond generally to the format of Form
FDA 3500A:
    (a) Patient information (Form FDA 3500A, Block A). You must submit
the following:
    (1) Patient name or other identifier;
    (2) Patient age at the time of event, or date of birth;
    (3) Patient gender; and
    (4) Patient weight.
    (b) Adverse event or product problem (Form FDA 3500A, Block B). You
must submit the following:
    (1) Identification of adverse event or product problem;
    (2) Outcomes attributed to the adverse event (e.g., death or
serious injury). An outcome is considered a serious injury if it is:
    (i) A life-threatening injury or illness;
    (ii) A disability resulting in permanent impairment of a body
function or permanent damage to a body structure; or
    (iii) An injury or illness that requires intervention to prevent
permanent impairment of a body structure or function;
    (3) Date of event;
    (4) Date of this report;
    (5) Description of the event or problem, including a discussion of
how the device was involved, nature of the problem, patient followup or
required treatment, and any environmental conditions that may have
influenced the event;
    (6) Description of relevant tests, including dates and laboratory
data; and
    (7) Other relevant patient history including preexisting medical
conditions.
    (c) Device information (Form FDA 3500A, Block D). You must submit
the following:
    (1) Brand name;
    (2) Product Code, if known, and Common Device Name;
    (3) Manufacturer name, city, and state;
    (4) Model number, catalog number, serial number, lot number, or
other identifying number, and expiration date;
    (5) Operator of the device (health professional, lay user/patient,
other);
    (6) Date of device implantation (month, day, year), if applicable;
    (7) Date of device explantation (month, day, year), if applicable;
    (8) Whether the device is a single-use device that was reprocessed
and reused on a patient (Yes, No)?
    (9) If the device is a single-use device that was reprocessed and
reused on a patient (yes to paragraph (c)(8) of this section), the name
and address of the reprocessor;
    (10) Whether the device was available for evaluation, and whether
the device was returned to the manufacturer, and if so, the date it was
returned to the manufacturer; and
    (11) Concomitant medical products and therapy dates. (Do not report
products that were used to treat the event.)
    (d) Initial reporter information (Form FDA 3500A, Block E). You
must submit the following:
    (1) Name, address, and telephone number of the reporter who
initially provided information to you, or to the user facility or
importer;
    (2) Whether the initial reporter is a health professional;
    (3) Occupation; and
    (4) Whether the initial reporter also sent a copy of the report to
us, if known.
    (e) Reporting information for all manufacturers (Form FDA 3500A,
Block G). You must submit the following:
    (1) Your reporting office's contact name and address and device
manufacturing site;
    (2) Your contact person's telephone number;
    (3) Your report sources;
    (4) Date received by you (month, day, year);
    (5) PMA/510k Number and whether or not the product is a combination
product;
    (6) Type of report being submitted (e.g., 5-day, initial,
followup); and
    (7) Your report number.
    (f) Device manufacturer information (Form FDA 3500A, Block H). You
must submit the following:
    (1) Type of reportable event (death, serious injury, malfunction,
etc.);
    (2) Type of followup report, if applicable (e.g., correction,
response to FDA request, etc);
    (3) If the device was returned to you and evaluated by you, you
must include a summary of the evaluation. If you did not perform an
evaluation, you must explain why you did not perform an evaluation;
    (4) Device manufacture date (month, day, year);
    (5) Whether the device was labeled for single use;
    (6) Evaluation codes (including event codes, method of evaluation,
result, and conclusion codes) (refer to FDA MedWatch Medical Device
Reporting Code Instructions);
    (7) Whether remedial action was taken and the type of action;
    (8) Whether the use of the device was initial, reuse, or unknown;
    (9) Whether remedial action was reported as a removal or correction
under section 519(f) of the Federal Food, Drug, and Cosmetic Act, and
if it was, provide the correction/removal report number; and
    (10) Your additional narrative; and/or
    (11) Corrected data, including:
    (i) Any information missing on the user facility report or importer
report, including any event codes that were not

reported, or information corrected on these forms after your
verification;
    (ii) For each event code provided by the user facility under Sec.
803.32(e)(10) or the importer under Sec.  803.42(e)(10), you must
include a statement of whether the type of the event represented by the
code is addressed in the device labeling; and
    (iii) If your report omits any required information, you must
explain why this information was not provided and the steps taken to
obtain this information.

Sec.  803.53  If I am a manufacturer, in which circumstances must I
submit a 5-day report?

    You must submit a 5-day report to us with the information required
by Sec.  803.52 in accordance with the requirements of Sec.  803.12(a)
no later than 5 work days after the day that you become aware that:
    (a) An MDR reportable event necessitates remedial action to prevent
an unreasonable risk of substantial harm to the public health. You may
become aware of the need for remedial action from any information,
including any trend analysis or
    (b) We have made a written request for the submission of a 5-day
report. If you receive such a written request from us, you must submit,
without further requests, a 5-day report for all subsequent events of
the same nature that involve substantially similar devices for the time
period specified in the written request. We may extend the time period
stated in the original written request if we determine it is in the
interest of the public health.

Sec.  803.56  If I am a manufacturer, in what circumstances must I
submit a supplemental or followup report and what are the requirements
for such reports?

    If you are a manufacturer, when you obtain information required
under this part that you did not provide because it was not known or
was not available when you submitted the initial report, you must
submit the supplemental information to us within 30 calendar days of
the day that you receive this information. You must submit the
supplemental or followup report in accordance with the requirements of
Sec.  803.12(a). On a supplemental or followup report, you must:
    (a) Indicate that the report being submitted is a supplemental or
followup report;
    (b) Submit the appropriate identification numbers of the report
that you are updating with the supplemental information (e.g., your
original manufacturer report number and the user facility or importer
report number of any report on which your report was based), if
applicable; and
    (c) Include only the new, changed, or corrected information.

Sec.  803.58  Foreign manufacturers.

    (a) Every foreign manufacturer whose devices are distributed in the
United States shall designate a U.S. agent to be responsible for
reporting in accordance with Sec.  807.40 of this chapter. The U.S.
designated agent accepts responsibility for the duties that such
designation entails. Upon the effective date of this regulation,
foreign manufacturers shall inform FDA, by letter, of the name and
address of the U.S. agent designated under this section and Sec.
807.40 of this chapter, and shall update this information as necessary.
Such updated information shall be submitted to FDA, within 5 days of a
change in the designated agent information.
    (b) U.S.-designated agents of foreign manufacturers are required
to:
    (1) Report to FDA in accordance with Sec. Sec.  803.50, 803.52,
803.53, and 803.56;
    (2) Conduct, or obtain from the foreign manufacturer the necessary
information regarding, the investigation and evaluation of the event to
comport with the requirements of Sec.  803.50;
    (3) Forward MDR complaints to the foreign manufacturer and maintain
documentation of this requirement;
    (4) Maintain complaint files in accordance with Sec.  803.18; and
    (5) Register, list, and submit premarket notifications in
accordance with part 807 of this chapter.

Sec.  803.58  [Amended]

    3. Section 803.58 is stayed indefinitely.

    Dated: February 11, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03279 Filed 2-13-14; 8:45 am]
BILLING CODE 4160-01-P