[Federal Register Volume 76, Number 171 (Friday, September 2, 2011)]
[Notices]
[Pages 54821-54822]
[FR Doc No: 2011-22571]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Rule 17a-7, SEC File No. 270-238, OMB Control No. 3235-0214.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collections
of information summarized below. The Commission plans to submit the
existing collection of information to the Office of Management and
Budget for extension and approval.
    Rule 17a-7 (17 CFR 270.17a-7) (the ``rule'') under the Investment
Company Act of 1940 (15 U.S.C. 80a-1 et seq.) (the ``Act'') is entitled
``Exemption of certain purchase or sale transactions between an
investment company and certain affiliated persons thereof.'' It
provides an exemption from section 17(a) of the Act for purchases and
sales of securities between registered investment companies
(``funds''), that are affiliated persons (``first-tier affiliates'') or
affiliated persons of affiliated persons (``second-tier affiliates''),
or between a fund and a first- or second-tier affiliate other than
another fund, when the affiliation arises solely because of a common
investment adviser, director, or officer. Rule 17a-7 requires funds to
keep various records in connection with purchase or sale transactions
effected in reliance on the rule. The rule requires the fund's board of
directors to establish procedures reasonably designed to ensure that
the rule's conditions have been satisfied. The board is also required
to determine, at least on a quarterly basis, that all affiliated
transactions effected during the preceding quarter in reliance on the
rule were made in compliance with these established procedures. If a
fund enters into a purchase or sale transaction with an affiliated
person, the rule requires the fund to compile and maintain written
records of the transaction.\1\ The Commission's examination staff uses
these records to evaluate for compliance with the rule.
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    \1\ The written records are required to set forth a description
of the security purchased or sold, the identity of the person on the
other side of the transaction, and the information or materials upon
which the board of directors' determination that the transaction was
in compliance with the procedures was made.
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    While most funds do not commonly engage in transactions covered by
rule 17a-7, the Commission staff estimates that nearly all funds have
adopted procedures for complying with the rule.\2\ Of the approximately
3318 currently active funds, the staff estimates that virtually all
have already adopted procedures for compliance with rule 17a-7. This is
a one-time burden, and the staff therefore does not estimate an ongoing
burden related to the policies and procedures requirement of the rule
for funds.\3\ The staff estimates that there are approximately 150 new
funds that register each year, and that each of these funds adopts the
relevant policies and procedures. The staff estimates that it takes
approximately 4 hours to develop and adopt these policies and
procedures. Therefore, the total annual burden related to developing
and adopting these policies and procedures would be approximately 600
hours.\4\
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    \2\ Unless stated otherwise, these estimates are based on
conversations with the examination and inspections staff of the
Commission and fund representatives.
    \3\ Based on our reviews and conversations with fund
representatives, we understand that funds rarely, if ever, need to
make changes to these policies and procedures once adopted, and
therefore we do not estimate a paperwork burden for such updates.
    \4\ This estimate is based on the following calculations: (4
hours x 150 new funds = 600 hours).
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    Of the 3318 existing funds, the staff assumes that approximately
25%, (or 830) enter into transactions affected by rule 17a-7 each year
(either by the fund directly or through one of the fund's series), and
that the same percentage (25%, or 38 funds) of the estimated 150 funds
that newly register each year will also enter into these transactions,
for a total of 868 \5\ companies that are affected by the recordkeeping
requirements of rule 17a-7. These funds must keep records of each of
these transactions, and the board of directors must quarterly determine
that all relevant transactions were made in compliance with the
company's policies and procedures. The rule generally imposes a minimal
burden of collecting and storing records already generated for other
purposes.\6\ The staff estimates that the burden related to making
these records and for the board to review all transactions would be 3
hours annually for each respondent, (2 hours spent by compliance
attorneys and 1 hour spent

by the board of directors) \7\ or 2604 total hours each year.\8\
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    \5\ This estimate is based on the following calculation: (830 +
38 = 868).
    \6\ Commission staff believes that rule 17a-7 does not impose
any costs associated with record preservation in addition to the
costs that funds already incur to comply with the record
preservation requirements of rule 31a-2 under the Act. Rule 31a-2
requires companies to preserve certain records for specified periods
of time.
    \7\ The staff estimates that funds that rely on rule 17a-7
annually enter into an average of 8 rule 17a-7 transactions each
year. The staff estimates that the compliance attorneys of the
companies spend approximately 15 minutes per transaction on this
recordkeeping, and the board of directors spends a total of 1 hour
annually in determining that all transactions made that year were
done in compliance with the company's policies and procedures.
    \8\ This estimate is based on the following calculation: (3
hours x 868 companies = 2604 hours).
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    Based on these estimates, the staff estimates the combined total
annual burden hours associated with rule 17a-7 is 3204 hours.\9\ The
staff also estimates that there are approximately 1018 respondents and
7094 total responses.\10\
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    \9\ This estimate is based on the following calculation: (600
hours + 2604 hours = 3204 total hours).
    \10\ This estimate is based on the following calculations: (150
newly registered funds + 868 funds that engage in rule 17a-7
transactions = 1018); (868 funds that engage in rule 17a-7
transactions x 8 times per year = 6944); (6944 + 150 = 7094
responses).
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    The estimates of burden hours are made solely for the purposes of
the Paperwork Reduction Act, and are not derived from a comprehensive
or even a representative survey or study of the costs of Commission
rules. The collection of information required by rule 17a-7 is
necessary to obtain the benefits of the rule. Responses will not be
kept confidential. An agency may not conduct or sponsor, and a person
is not required to respond to, a collection of information unless it
displays a currently valid control number.
    Written comments are invited on: (a) Whether the collections of
information are necessary for the proper performance of the functions
of the Commission, including whether the information has practical
utility; (b) the accuracy of the Commission's estimate of the burdens
of the collections of information; (c) ways to enhance the quality,
utility, and clarity of the information collected; and (d) ways to
minimize the burdens of the collections of information on respondents,
including through the use of automated collection techniques or other
forms of information technology. Consideration will be given to
comments and suggestions submitted in writing within 60 days of this
publication.
    Please direct your written comments to Thomas Bayer, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 6432 General Green Way, Alexandria, VA 22312; or send an
e-mail to<EMAIL_ADDRESS>
    Dated: August 29, 2011.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-22571 Filed 9-1-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 49 (Monday, March 14, 2016)]
[Notices]
[Pages 13372-13373]
[FR Doc No: 2016-05573]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0820]

Drug Safety and Risk Management Advisory Committee and the
Anesthetic and Analgesic Drug Products Advisory Committee; Notice of
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committees: Drug Safety and Risk Management Advisory
Committee and the Anesthetic and Analgesic Drug Products Advisory
Committee.
    General Function of the Committees: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on May 3, 2016, from 8 a.m.
to 5 p.m. and May 4, 2016, from 8 a.m. to 5 p.m.

ADDRESSES: FDA is opening a docket for public comment on this meeting.
The docket number is FDA-2016-N-0820. The docket will open for public
comment on March 14, 2016. The docket will close on June 4, 2016.
Interested persons may submit either electronic or written comments
regarding this meeting. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. All comments received will be posted
without change, including any personal information provided. It is only
necessary to send one set of comments. Identify comments with the
docket number found in brackets in the heading of this document.
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday. Comments received on
or before April 19, 2016, will be provided to the committees before the
meeting.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    Contact Person: Stephanie L. Begansky, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, Fax:
301-847-8533, email<EMAIL_ADDRESS>or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area). A notice in the Federal Register about last minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    Agenda: The Food and Drug Administration Amendments Act of 2007
(Pub. L. 110-85) requires FDA to bring, at least annually, one or more
drugs with Risk Evaluation and Mitigation Strategies (REMS) with
Elements to Assure Safe Use (ETASU) before its Drug Safety and Risk
Management Advisory Committee (DSaRM). On May 3 and 4, 2016, the
committees will discuss results from assessments of the extended-
release and long-acting (ER/LA) Opioid Analgesics REMS. The Agency will
seek the committees' comments as to whether this REMS with ETASU
assures safe use, is not unduly burdensome to patient access to the
drugs, and to the extent practicable, minimizes the burden to the
healthcare delivery system.
    The ER/LA Opioid Analgesics REMS requires that prescriber training
will be made available to healthcare providers who prescribe ER/LA
opioid analgesics. Training is considered ``REMS-compliant'' if: (1)
It, for training provided by continuing education providers, is offered
by an accredited provider to licensed prescribers, (2) it includes all
elements of the FDA Blueprint for Prescriber Education for ER/LA Opioid
Analgesics (Blueprint), (3) it includes a knowledge assessment of all
the sections of the Blueprint, and (4) it is subject to independent
audit to confirm that conditions of the REMS training have been met.
The Agency will seek the committees' input on possible modifications to
the ER/LA Opioid Analgesics REMS, including expansion of the scope and
content of prescriber training and expansion of the REMS program to
include immediate-release opioids.
    Comments from the public can be submitted to the docket (see the
ADDRESSES section) on a broad evaluation of the ER/LA Opioid Analgesics
REMS program and whether the ER/LA opioid analgesics REMS should be
modified as well as any proposed modifications. Comments may include
but are not limited to: (1) Alternative methodologies for evaluating
the overall impact of the program on knowledge and behavior by
prescribers and patients, (2) the overall impact of the REMS on the
adverse events it is intended to mitigate; (3) whether the FDA
Blueprint or other tools (e.g., Medication Guide or Patient Counseling
Document) should be revised and/or expanded; (4) the use of the
continuing education as a component of the REMS as a mechanism for
providing prescriber training; (5) whether to expand the REMS program
to include immediate-release opioids; and (6) how additional REMS tools
or ETASU (e.g., required prescriber or pharmacist training, required
patient agreements), if recommended, may impact the healthcare delivery
system and patient access to ER/LA opioid analgesics.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background

material on its Web site prior to the meeting, the background material
will be made publicly available at the location of the advisory
committee meeting, and the background material will be posted on FDA's
Web site after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the
appropriate advisory committee meeting link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committees.
All electronic and written submissions submitted to the Docket (see the
ADDRESSES section) on or before April 19, 2016, will be provided to the
committees. Oral presentations from the public will be scheduled
between approximately 10:30 a.m. and 12:30 p.m. on May 4, 2016. Those
individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
April 11, 2016. Time allotted for each presentation may be limited. If
the number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by April 12, 2016.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Stephanie L. Begansky at least 7 days in advance of the
meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: March 8, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-05573 Filed 3-11-16; 8:45 am]
 BILLING CODE 4164-01-P