expense ratio from either the prospectus or annual report, whichever is
more current. These commenters argued such a requirement would be too
burdensome and confusing to investors. American Funds argued that a
fund should be allowed to show current expenses based on a fund's
annualized monthly expense ratio, and not have to refer to the

prospectus. Vanguard supported the proposed change, but recommended
that the rule allow members to show the expense ratio from a fund's
prospectus if it reflects the fund's reasonable expectation of the
current year's expenses.
    FINRA had made this proposed change based on earlier industry input
that members should be allowed to show expenses from an annual report
if it is more current than the prospectus. However, in light of
comments received on the Notice proposal and the importance for expense
disclosure to be comparable among funds, FINRA is retaining the
standard reflected in NASD Rule 2210(d)(3), and requiring sales charges
and expense ratios to reflect a fund's current prospectus.
    The CAI requested confirmation that this disclosure requirement
does not apply to the presentation of performance of an underlying
investment option contained in a variable insurance product
communication. FINRA agrees the provision does not apply to such
communications.
    FINRA Rule 2210(d)(5)(B) in the Notice proposal required a print
advertisement to disclose standardized performance and expense-related
information in a prominent text box. Fidelity, the ICI and MBSC
requested confirmation that this requirement only applies to print
advertisements and not other forms of retail communications, such as
Web sites. The ICI and MBSC also recommended that FINRA eliminate the
text box requirement and replace it with a prominence requirement
applicable to all retail communications.
    Consistent with its application of NASD Rule 2210(d)(3), FINRA
confirms that the text box requirement only applies to print
advertisements. FINRA disagrees however, with the recommendation to
eliminate the text box requirement for print advertisements. FINRA
created this requirement due to past abuses in which non-standardized
performance was prominently displayed in print advertisements, while
disclosures regarding standardized performance and expenses were placed
in footnotes. FINRA believes that this requirement has helped to
prevent this kind of misleading presentation since the rule was
adopted.

Recommendations

    FINRA Rule 2210(d)(7)(A) in the Notice proposal required retail
communications, correspondence and public appearances to contain
certain disclosures if the communication included a recommendation of
securities. The communication would have to disclose if the member was
making a market in the security (or an underlying option or future), if
the member or its associated person will sell or buy the security from
customers on a principal basis, that the member or any associated
person with the ability to influence the substance of the communication
has a financial interest in the recommended security, and if the member
was manager or co-manager of a public offering of any securities of the
recommended issuer in the past 12 months.
    Cornell and PIABA both opposed limiting disclosures of financial
interests to the member and associated persons with the ability to
influence the substance of the communication. These commenters felt the
associated person standard was too narrow and vague. Fidelity
recommended that the disclosure standard for associated persons should
be limited to persons who are direct employees of the member or are
registered with the member, and who are directly and materially
involved in the preparation of the communication. Fidelity and Morgan
commented that disclosure should not be required unless an employee has
a direct and material financial interest in the recommended security.
This would exclude small investments and investments through mutual
funds.
    Morgan, SIFMA and WilmerHale commented that it would be impossible
for a member to track which associated persons have the ability to
influence the substance of a communication, and that FINRA must provide
more guidance as to which associated persons the disclosure
requirements would apply. The FSI inquired as to whether the disclosure
standard would apply to a supervisor of a registered representative who
emails a securities recommendation to a customer. SIFMA commented that
the disclosure requirement should be limited to the member and its
officers and partners, and that the rule permit generic, non-specific
disclosures regarding financial interests, market making and
underwriting activities.
    Morgan, SIFMA and WilmerHale commented that the provision not apply
to correspondence. WilmerHale also urged that the proposed rule exclude
retail communications and public appearances by research analysts,
since these situations are already covered by NASD Rule 2711.
    In response to these comments, FINRA has revised proposed paragraph
(d)(7)(A). First, paragraph (d)(7)(A) no longer applies to
correspondence. Given that correspondence may not be delivered to more
than 25 retail investors within a 30-calendar-day period, FINRA
believes that it is not necessary to include the extensive disclosure
required for retail communications in communications sent to a more
limited audience.
    Second, FINRA has added a requirement that a recommendation of
securities have a reasonable basis. This requirement is consistent with
NASD IM-2210-1(6)(A).
    Third, FINRA has modified the requirement to disclose the financial
interests of any associated person with the ability to influence the
substance of the communication. Instead, the disclosure requirement
will apply to any associated person with the ability to influence the
``content'' of the communication. While this modification is minor,
FINRA believes that it will help clarify which associated persons must
disclose their financial interests. FINRA continues to believe that
persons who influence the content of a communication that includes a
recommendation have a material conflict of interest that should be
disclosed if the person also has a financial interest in the
recommended security.
    Fourth, the disclosure requirement excludes financial interests
that are ``nominal.'' This revision makes the rule consistent with the
current disclosure requirements for advertisements and sales literature
that include securities recommendations under NASD IM 2210-1(6)(A)(ii).
    Fifth, FINRA has excluded from this disclosure requirement public
appearances by research analysts, since they are already covered under
NASD Rule 2711. The proposed language also excludes research reports
for the same reason.
    Proposed FINRA Rules 2210(d)(7)(C) revised the current disclosure
requirements for communications that contain past specific
recommendations.\86\ The revised provisions more closely reflect the
disclosure standards applicable to advertisements of investment
advisers that contain past specific recommendations. Wells Fargo
supported this change, but urged FINRA also to adopt the SEC's
interpretations of the Investment Advisers Act regarding
recommendations. While FINRA may look to past SEC interpretations of
its rules for guidance, FINRA declines to adopt any of the SEC
interpretations of the Investment Advisers Act regarding

recommendations for purposes of this filing.
---------------------------------------------------------------------------

    \86\ See NASD IM-2210-6(C) and (D).
---------------------------------------------------------------------------

Other Comments
    Fidelity, the ICI and Vanguard requested clarification as to
whether a member is responsible for content posted by third parties on
a member's Web site. These commenters also recommended that FINRA
develop interpretive guidance concerning the principles that members
should follow when developing communications intended for customers'
mobile electronic devices. For example, FINRA should address how
members may meet various disclosure requirements, such as the
requirement to disclose a member's name, fees, expenses and
standardized performance information.
    FINRA previously addressed the issue of third-party content in
Regulatory Notice 10-06. FINRA also agrees that issues related to
communications intended for mobile electronic devices is important and
will consider further guidance or rulemaking as issues arise, but does
not believe this proposed rulemaking is the appropriate vehicle to
address all issues raised by new technologies. In the past, when FINRA
has reviewed a member's advertisement or sales literature that includes
a bond fund's 30-day yield, and the fund's affiliates have subsidized
or reimbursed the fund's expenses, FINRA staff has required the member
also to disclose the fund's yield that would have occurred had expenses
not been subsidized (the ``unsubsidized yield''). FINRA has imposed
this requirement based on language contained in the SEC's 1988 adopting
release for Rule 482 under the Securities Act.\87\ The ICI and T. Rowe
both objected to this requirement and requested that FINRA clarify that
disclosure of the unsubsidized yield is unnecessary in such
circumstances. Because this issue involves an interpretation of Rule
482 under the Securities Act, FINRA declines to provide guidance
through the proposed rule change.
---------------------------------------------------------------------------

    \87\ See Securities Act Release No. 6753 (February 2, 1988), 53
FR 3868 (February 10, 1988) (Order Approving File No. S7-23-86), p.
37.
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Public Appearances
    Proposed FINRA Rule 2210(f) in the Notice proposal sets forth the
content and supervision requirements for members and associated persons
that participate in seminars, forums or radio or television interviews.
Paragraph (f)(1) specifies that the member or associated person must
follow the content standards of paragraph (d)(1), and if the member or
associated person recommends a security, paragraph (d)(7).
    Fidelity, Invesco, the ICI and Morgan opposed requiring associated
persons that make recommendations in public appearances to meet the
content standards of paragraph (d)(7). These commenters argued that it
would be impossible to monitor or supervise. Invesco also argued that
this requirement creates an uneven playing field between broker-dealers
and investment advisers, since investment advisers do not have a
similar disclosure requirement.
    FINRA disagrees with the comments that the disclosure requirements
regarding recommendations would be impossible to monitor or supervise.
Members that employ research analysts already must meet similar
requirements under NASD Rule 2711. Members could impose similar
policies and procedures for their associated persons who intend to
recommend securities in public appearances. The ICI requested
clarification that, if a member sponsors a seminar or forum, the member
is responsible only for its own presentation and not those of others.
This issue will be a matter of facts and circumstances, but generally a
member is only responsible for the communications of the member or its
associated persons, unless the member or its associated persons are
entangled with or adopt others' communications.
    NPHI requested clarification as to whether a discussion of a
general product category constitutes a recommendation for purposes of
the public appearance disclosure requirements. If a member or
associated person merely discusses a general product category without
recommending a particular security, the disclosure requirements would
not apply. Similarly, T. Rowe asked whether the mere reference to a
security is a recommendation. Generally the mere reference to a
security is not a recommendation, but this issue will be a matter of
facts and circumstances.
    Under NASD Rule 2210, ``public appearance'' is a separate category
of communications with the public.\88\ Proposed FINRA Rule 2210 does
not retain ``public appearance'' as a separate category of
``communications with the public.'' T. Rowe suggested that FINRA retain
its definition of ``public appearance,'' since otherwise an email to a
member of the media or private conversation might be viewed as a public
appearance. FINRA does not believe this is necessary. Proposed
paragraph (f)(1) makes clear that it applies only to ``a seminar,
forum, radio or television interview or * * * public appearances or
speaking activities * * *'' An email or private conversation would not
fall within this description.\89\ In addition, the language used to
describe a public appearance in proposed paragraph (f)(1) is similar to
the current definition of ``public appearance'' under NASD Rule
2210(a)(5).
---------------------------------------------------------------------------

    \88\ See NASD Rule 2210(a)(5).
    \89\ Moreover, proposed paragraph (f)(1) expressly excludes
correspondence from the description of a public appearance.
---------------------------------------------------------------------------

    Proposed paragraph (f)(2) would require members to adopt written
procedures that are appropriate to a member's business, size,
structure, and customers to supervise its associated persons' public
appearances. The procedures must include, among other things,
surveillance and follow-up to ensure that such procedures are
implemented and adhered to. T. Rowe requested clarification as to what
level of surveillance and follow-up is required, particularly for one-
time appearances. T. Rowe also commented that there should be an
exception if a member approves appearances in advance. FINRA does not
believe it would be appropriate to pre-determine how a member must
supervise its associated persons' public appearances, since this will
vary depending on a member's business model, size, and the type of
public appearance involved. FINRA also does not agree that a member
should have no obligation to review public appearances after the fact
for compliance with applicable rules as long as it approves the
appearance in advance.
    FINRA is making one additional change to the proposed paragraph (f)
in light of other changes to the proposed rule. Paragraph (f)(1) of the
Notice proposal also covered ``interactive electronic forums'' within
its description of a public appearance. To the extent participation in
an interactive electronic forum takes the form of a written
communication disseminated through an interactive Web site, FINRA
considers such a communication to be a retail communication rather than
a public appearance. However, as discussed above, proposed FINRA Rule
2210(b)(1)(D)(ii) allows a member to supervise and review retail
communications that are posted on online interactive electronic forums
in the same manner as required for supervising and reviewing
correspondence. Accordingly, FINRA has deleted ``(including an
interactive electronic forum)'' from proposed paragraph (f)(1).

Investment Analysis Tools
    Proposed FINRA Rule 2214 of the Notice proposal codifies largely
without change current NASD IM-2210-6 (Requirements for the Use of
Investment Analysis Tools).\90\ Fidelity, the ICI, MBSC and T. Rowe
commented that Rule 2214 should be revised to allow members to present
projections of performance in retail communications even in cases where
the tool is not interactive with customers. These commenters argue that
a firm should be permitted to show projected performance of an
investment in a communication that is not based on information provided
by a customer independently or with the assistance of the member firm.
T. Rowe also commented that members should be allowed to use the data
generated by an investment analysis tool in sales material for target
date funds provided that these illustrations are limited to a
discussion of a fund's investment strategy and not used to project
performance.
---------------------------------------------------------------------------

    \90\ Certain of NASD IM-2210-6's text that appears either in the
Interpretive Material itself or in footnotes to the Interpretive
Material have been moved to Supplementary Material.
---------------------------------------------------------------------------

    FINRA disagrees with the comment that proposed Rule 2214 should be
revised to eliminate the requirement that an investment analysis tool
be interactive. The purpose of NASD IM-2210-6 and proposed FINRA Rule
2214 is to allow members to use interactive tools with customers to
show the likelihood of various investment outcomes under different
scenarios, thereby serving as an additional resource to investors to
evaluate their specific investment choices. It is not to allow the use
of performance projections in retail communications in all
circumstances as long as an investment analysis tool is used to create
the projections. In the case of retail communications concerning target
date funds that do not include projections, reliance on the proposed
rule is unnecessary, since it only applies to retail communications
that contain projections.
    Supplementary Material 2214.06 provides that a retail communication
that contains only an incidental reference to an investment analysis
tool need not include the disclosures required by the proposed rule and
would not need to be filed with the Department. Vanguard commented that
proposed Rule 2214 should be revised to allow members not to include
all of the proposed rule's required disclosures as long as the
communication does not include the tool itself or any data or results
produced by the tool.
    FINRA agrees that, under these circumstances, some of the proposed
rule's required disclosures, such as those required by paragraph (c)(1)
(a description of the tool's methodology) or paragraph (c)(3) (certain
disclosures in situations in which the tool analyzes only a limited
range of investments), are unnecessary. FINRA believes however, that a
retail communication that refers to an investment analysis tool in more
detail than an incidental reference but does not provide access to the
tool or the results generated by the tool must disclose that results
may vary with each use (as required by paragraph (c)(2)) and the
warning required by paragraph (c)(4) that the projections generated by
the tool are hypothetical and are not guarantees of future results.
FINRA has revised proposed Rule 2214.06 accordingly.
Security Futures
    Proposed FINRA Rule 2215 (Guidelines for Communications with the
Public Regarding Security Futures) is the successor to current NASD IM-
2210-7. TD Ameritrade commented that paragraph (b)(1)(A)(iii), which
prohibits projections of performance in communications used prior to
the delivery of a security futures risk disclosure statement, should be
modified to permit examples of hypothetical transactions. This comment
is similar to another TD Ameritrade comment on proposed FINRA Rule
2210(d)(1)(F) (which also prohibits performance projections), and
FINRA's response is the same as discussed above.
    Proposed paragraph (b)(2)(A)(iv) requires any communication
concerning a security future to include a statement that supporting
documentation for any claims, comparisons, recommendations, statistics
or other technical data will be supplied upon request. TD Ameritrade
commented that FINRA should clarify that this disclosure requirement
only applies if a communication actually includes a claim, comparison,
recommendation, statistics or other technical data. While this issue
will be a matter of facts and circumstances, FINRA agrees that no such
disclosure would be required if a communication does not contain any
statement or data that requires supporting documentation.
Transition Period
    Fidelity, Invesco and NPHI requested that FINRA allow members at
least six months before having to comply with the new rules. The ICI
suggested a compliance date of 10 business days after the second
quarter ending following adoption of the final rule changes. PSD
requested nine months' lead time, and suggested that members should be
permitted to ``grandfather'' and continue to use communications that
were filed under the current rules. Alternatively, members should have
a minimum of two years from the date the new rules become effective to
continue to use communications filed under the existing rules.
    FINRA plans on publishing a Regulatory Notice no later than 90 days
following SEC approval of the rule changes. The implementation date
will be no later than 365 days following SEC approval. In establishing
the implementation schedule, FINRA will consider members' need to adopt
and implement new policies and procedures necessary to comply with the
new rules.
    In most cases, FINRA expects that communications that are in
compliance with the current communication rules will continue to be in
compliance with the new rules, and thus ``grandfathering'' of past
filed material will be unnecessary. To the extent a member has
questions about whether a previously filed communication continues to
be compliant under the new rules, the member should discuss this issue
with its assigned Department advertising analyst.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) by order approve or disapprove such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

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

Number SR-FINRA-2011-035 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-FINRA-2011-035. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for Web site
viewing and printing in the Commission's Public Reference Room, 100 F
Street, NE., Washington, DC 20549, on official business days between
the hours of 10 a.m. and 3 p.m. Copies of such filing also will be
available for inspection and copying at the principal office of FINRA.
All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-FINRA-2011-035
and should be submitted on or before August 24, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\91\
---------------------------------------------------------------------------

    \91\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-19645 Filed 8-2-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 178 (Thursday, September 13, 2012)]
[Notices]
[Pages 56647-56649]
[FR Doc No: 2012-22604]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0356]

Lisa Jean Sharp: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
permanently debarring Lisa Jean Sharp from providing services in any
capacity to a person that has an approved or pending drug product
application. We base this order on a finding that Lisa Jean Sharp was
convicted of a felony under Federal law for conduct relating to the
development or approval, including the process for development or
approval, of a drug product under the

FD&C Act. Ms. Sharp was given notice of the proposed permanent
debarment and an opportunity to request a hearing within the timeframe
prescribed by regulation, but failed to respond. Ms. Sharp's failure to
respond constitutes a waiver of her right to a hearing concerning this
action.

DATES: This order is effective September 13, 2012.

ADDRESSES: Submit applications for special termination of debarment to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kenny Shade, Division of Compliance
Policy (HFC-230), Office of Enforcement, Office of Regulatory Affairs,
Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857,
301-796-4640.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(a)(2)(A) of the FD&C Act (21 U.S.C. 335a(a)(2)(A))
requires debarment of an individual if FDA finds that the individual
has been convicted of a felony under Federal law for conduct relating
to the development or approval, including the process for development
or approval, of a drug product under the FD&C Act.
    On March 26, 2012, the U.S. District Court for the District of
Kansas entered judgment against Ms. Sharp after she entered a guilty
plea to, among others, a felony count of failing to prepare and
maintain records required under section 505(i) of the FD&C Act, with
the intent to defraud and mislead, in violation of sections 301(e) and
303(a)(2) of the FD&C Act (21 U.S.C. 331(e), 333(a)(2), and 18 U.S.C.
2).
    FDA's finding that debarment is appropriate is based on the felony
conviction referenced herein for conduct relating to the development or
approval, including the process for development or approval, of a drug
product under the FD&C Act.
    The factual basis for this conviction is as follows: Ms. Sharp was
the Director of Clinical Trials for Lee Research Institute. Schering/
Plough was a pharmaceutical company engaged in developing and marketing
pharmaceutical products. In or about July 2009, Schering/Plough chose
Lee Research Institute, Ms. Sharp's employer, to perform a clinical
study known as ``A 28-Day Study Evaluating the Safety of Ragweed
Sublingual Tablet in Adult Subjects 50 Years of Age and Older with
Ragweed-Induced Rhino conjunctivitis.'' Ms. Sharp was the Lead Clinical
Research Coordinator for the clinical study.
    Before beginning the clinical study, FDA required Schering/Plough
to provide the Agency with a study protocol. The study protocol
contained information about how the clinical study would be conducted,
where studies would be done and by whom, how the drug's safety would be
evaluated, and what findings would require the study to be changed or
halted. According to the study protocol, each subject had to be 50
years of age or older. Additionally, the study protocol excluded
subjects who were a member or a family member of the personnel of the
investigational or sponsor staff directly involved with the clinical
trial. Under section 505(i) of the FD&C Act (21 U.S.C. 355(i)) and 21
CFR 312.62(b), Ms. Sharp was required to maintain adequate and accurate
case histories on each individual who was administered Schering/
Plough's investigational drug.
    Beginning in or about January 2010, and continuing through in or
about May 2010, Ms. Sharp, with the intent to defraud and mislead,
failed to prepare and maintain the required records described above.
Specifically, Ms. Sharp falsified the birth dates of two participants
such that they appeared to be older than 50 years of age; falsely
indicated that physical examinations had been performed when they had
not been performed; and indicated on required forms that two
participants met the inclusion criteria and had no reasons for
exclusion, when she knew that the participants did not meet the
inclusion criteria of age and should have been excluded as employees of
Lee Research Institute.
    As a result of her conviction, on June 20, 2012, FDA sent Ms. Sharp
a notice by certified mail proposing to permanently debar her from
providing services in any capacity to a person that has an approved or
pending drug product application. The proposal was based on a finding,
under section 306(a)(2)(A) of the FD&C Act (21 U.S.C. 335a(a)(2)(A)),
that Ms. Sharp was convicted of a felony under Federal law for conduct
relating to the development or approval, including the process for
development or approval, of a drug product under the FD&C Act.
    The proposal also offered Ms. Sharp an opportunity to request a
hearing, providing her 30 days from the date of receipt of the letter
in which to file the request, and advised her that failure to request a
hearing constituted a waiver of the opportunity for a hearing and of
any contentions concerning this action. Ms. Sharp received the proposal
on June 25, 2012. She failed to respond and has, therefore, waived her
opportunity for a hearing and has waived any contentions concerning her
debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Director, Office of Enforcement, Office of
Regulatory Affairs, under section 306(a)(2)(A) of the FD&C Act (21
U.S.C. 335a(a)(2)(A)), under authority delegated to the Director (Staff
Manual Guide 1410.35), finds that Lisa Jean Sharp has been convicted of
a felony under federal law for conduct relating to the development or
approval, including the process for development or approval, of a drug
product under the FD&C Act.
    As a result of the foregoing finding, Lisa Jean Sharp is
permanently debarred from providing services in any capacity to a
person with an approved or pending drug product application under
sections 505, 512, or 802 of the FD&C Act (21 U.S.C. 355, 360b, or
382), or under section 351 of the Public Health Service Act (42 U.S.C.
262), effective (see DATES), (see section 306(c)(1)(B), (c)(2)(A)(ii),
and 201(dd) of the FD&C Act (21 U.S.C. 335a(c)(1)(B), (c)(2)(A)(ii),
and 321(dd))). Any person with an approved or pending drug product
application who knowingly employs or retains as a consultant or
contractor, or otherwise uses the services of Ms. Sharp, in any
capacity during Ms. Sharp's debarment, will be subject to civil money
penalties (section 307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))).
If Ms. Sharp provides services in any capacity to a person with an
approved or pending drug product application during her period of
debarment she will be subject to civil money penalties (section
307(a)(7) of the FD&C Act (21 U.S.C. 335b(a)(7)). In addition, FDA will
not accept or review any abbreviated new drug applications submitted by
or with the assistance of Ms. Sharp during her period of debarment
(section 306(c)(1)(A) of the FD&C Act (21 U.S.C. 335a(c)(1)(A)).
    Any application by Ms. Sharp for special termination of debarment
under section 306(d)(4) of the FD&C Act (21 U.S.C. 335a(d)(4)) should
be identified with Docket No. FDA-2012-N-0356 and sent to the Division
of Dockets Management (see ADDRESSES). All such submissions are to be
filed in four copies. The public availability of information in these
submissions is governed by 21 CFR 10.20(j).
    Publicly available submissions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: September 4, 2012.
Armando Zamora,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2012-22604 Filed 9-12-12; 8:45 am]
BILLING CODE 4160-01-P